prismaflex user manual

Prismaflex

Operator's ManualFor use with software versions 6.xx

An integrated system for:• CRRT (Continuous Renal Replacement

Therapies)• HP (Hemoperfusion)• TPE (Therapeutic Plasma Exchange)

Manufacturer:Gambro Lundia ABBox 10101, Magistratsvägen 16, SE-220 10 Lund, SwedenTel: +46-46-16 90 00, Fax: +46-46-16 96 96www.gambro.com

Questions or comments about this publication can be directed to your local representative or to the manufacturer.

Order number:G5036003

Copyright:© 2005–2011 Gambro Lundia ABGambro, Prismaflex, Adsorba, Prismaflo, Prismacomfort, Prismatherm, MARSFLUX, diaFLUX,diaMARS, X-MARS, septeX, oXiris, Hospal and MARS are trademarks belonging to the GambroGroup.

G5036003 Revision 05.2011Program version 6.xx

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Prismaflex

1. Before you get started

2. Description of the Prismaflex® System

3. General Prismaflex Functions

4. Operating the Prismaflex® System

5. Continuous Renal Replacement Therapies (CRRT)

6. Therapeutic Plasma Exchange (TPE)

7. Hemoperfusion (HP)

8. Anticoagulation Methods

9. Blood Warmers

10. Alarm System

11. Troubleshooting

12. Maintenance

13. Specifications

14. Guidance and Manufacturer's Declaration —Electromagnetic Emissions and Immunity

15. Prismaflex Disposable Sets

16. Index


Chapter 1

Before you get startedContents

General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:2Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:2Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:2Keywords Used in this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:2

Where to Find Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:3Operator’s Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:3On-line Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:3Instructions for Use of Prismaflex Disposable Sets . . . . . . . . . . . . . . . . . . . . . . 1:3

Therapies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:3Prismaflex Anticoagulation Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:5

Responsibility and Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:5Safety Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:6General Warnings and Cautions before Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:7Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:7Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:10

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:12Certification Marks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:14Installation, Service and Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:15Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:15Disposal of Packaging Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:15Disposal of Discarded Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:15Hazardous Substances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:16Removal of waste batteries and accumulators . . . . . . . . . . . . . . . . . . . . . . . . . . 1:16


Before you get started 1:1

General Information

Intended UseThe Prismaflex control unit is intended for:

• Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failureand/or fluid overload.

• Therapeutic Plasma Exchange Therapy (TPE) for patients with diseases whereremoval of plasma components is indicated.

• Hemoperfusion (HP) for patients with conditions where removal of toxic substancesis indicated.

All treatments administered via the Prismaflex control unit must be prescribed by aphysician.

ContraindicationsThere are no known contraindications to Continuous Renal Replacement Therapies.

There are no known contraindications to Therapeutic Plasma Exchange.

There are no known contraindications to Hemoperfusion.

For contraindications that may apply for the disposable set selected for the therapy, referto the Instructions For Use of the disposable set.

Note: The Prismaflex system is intended for continuous operation.

Keywords Used in this ManualAuthorized service techniciansRefers to Gambro trained and certified service technicians.

FilterFilter stands for:

• hemofilter/dialyzer

• plasmafilter

• adsorption cartridge

depending on the therapy in use.

ManualWhenever the word Manual is used within this manual, it always refers to this Operator'sManual for the Prismaflex unless another is specified.

OperatorIn this manual, an Operator designates an appropriately trained and qualified clinical staffwho is in charge of the machine. The operator makes the machine settings in accordancewith prescribed treatment, responds to alarms, troubleshoots the machine, handles thebags and so on.

1:2 Before you get started G5036003 Revision 05.2011Program version 6.xx

ScreensThe Prismaflex displays different screens during operation. Whenever a screen isreferred to in this manual, it is identified by its title, e.g. Enter Flow Settings screen orStatus screen.

SoftkeysWhenever a Softkey on the Prismaflex screen is referred to in this manual, it is written incapital italic letters, e.g. NEW PATIENT or CHANGE BAG.

Where to Find Information

Operator’s ManualThis manual provides operating, maintenance, and troubleshooting instructions, as wellas general information. “Chapter 2: Description of the Prismaflex® System” providesinformation about the Prismaflex control unit and system components. “Chapter 3:General Prismaflex Functions” describes the principles of operation of the system, notablyabout fluid and pressure management. “Chapter 4: Operating the Prismaflex® System”explains the system interface, gives an overview of a treatment sequence and describes theroutine handling steps. Specific therapy information is provided in dedicated chapters for:

• CRRT in “Chapter 5: Continuous Renal Replacement Therapies (CRRT)”

• TPE in “Chapter 6: Therapeutic Plasma Exchange (TPE)”

• HP in “Chapter 7: Hemoperfusion (HP)”

• Anticoagulation in “Chapter 8: Anticoagulation Methods”

On-line InstructionsDetailed operating instructions are incorporated in the software of the Prismaflex. Theinstructions are available on-line, through the interactive display. Instructions include thefollowing screens:

• Operating screens (step-by-step instructions that the operator follows each time insetting up, administering, verifying settings and ending patient treatments).

• Alarm screens (instructions when an alarm situation occurs).

• Help screens (additional information about an Operating or Alarm screen).

Instructions for Use of Prismaflex Disposable SetsInstructions for use are provided with Prismaflex disposable sets, and provide operatingflow rates, filter pressures, priming requirements, performance data and other informationfor use of the set with the Prismaflex system.

TherapiesThe Prismaflex control unit pumps blood from the patient, through the filter in aPrismaflex disposable set, and back to the patient’s venous circulation. As the bloodpasses through the filter, the desired treatment processes take place. Depending on the



therapy in use, these processes can include fluid removal and/or solute clearance. Forinstructions about the different therapies, see each respective therapy chapter.

During the setup procedure, the operator selects the therapy desired. ThePrismaflex system provides:

CRRT – Continuous Renal Replacement Therapies;

• SCUF – Slow Continuous Ultrafiltration

• CVVH – Continuous Veno-venous Hemofiltration

• CVVHD – Continuous Veno-venous Hemodialysis

• CVVHDF – Continuous Veno-venous Hemodiafiltration

CRRT septeX – Continuous Renal Replacement Therapies with High Cut-Offmembrane;


• CVVHD+post – Continuous Veno-venous Hemodialysis + post infusion

CRRT MARS®– Contiunous Renal Replacement Theapies supporting MolecularAdsobents Recirculation System;


• CVVHDF – Continuous Veno-venous Hemodiafiltration

TPE – Therapeutic Plasma Exchange

HP – Hemoperfusion

Note: All therapies beside CRRT require a service configuration. Contact your localrepresentative for additional information.

Note: Check your local regulations for any restrictions on therapies, disposables,solutions etc.


Prismaflex Anticoagulation MethodsFor detailed instructions about the different anticoagulation methods, see “Chapter 8:Anticoagulation Methods”.

During the setup procedure, the operator selects the desired anticoagulation method.The Prismaflex system provides:

• Standard – Syringe

• No Syringe

• Citrate – Calcium via External Infusion Pump

• Citrate – Calcium via Prismaflex Syringe Pump

Note: All anticoagulation methods beside No Syringe require a service configuration.Contact your local representative for additional information.

Responsibility and DisclaimerGambro accepts responsibility for the safety, reliability, and performance of thisequipment only:

• If any modifications to the equipment are authorized in writing by Gambro and carriedout by an authorized service technician.

• If the electrical installation for powering the equipment complies with all applicablelocal electrical codes and requirements including, if applicable, IEC requirements.

• If the equipment is used in accordance with this manual.

Gambro will provide on request, a service manual which contains all necessary circuitdiagrams, calibration instructions, and service information to enable authorized servicetechnicians to repair those parts of this equipment which Gambro considers to berepairable.

This manual contains references to accessories and disposables for use with thePrismaflex system, see “Chapter 2: Description of the Prismaflex® System” on page 2:1.The Prismaflex system has been tested and validated for use with these accessories anddisposables. Gambro does not accept any responsibility or liability for use of accessoriesor disposables other than those specified in this manual or if any specified accessoryor disposable is not used in accordance with this manual, on-line instructions and theInstructions for Use accompanying those accessories and disposables.

Since Gambro has no control over service work which is not performed by authorizedservice technicians, Gambro will in no way be responsible or liable for any damagesresulting from the operation or performance of any device, or any injury caused thereby,after repair has been performed by any person other than a factory representative ofGambro.

Under no circumstances will Gambro be liable for any indirect, incidental, special orconsequential damages of any kind, its liability being hereby limited solely to repairor replacement.

Note: Check your local regulations for any restrictions on therapies, disposables,solutions etc.



Safety DefinitionsThis manual uses the following safety definitions:

WARNINGA warning alerts the reader about a situation which, if not avoided, could resultin an adverse reaction, injury or death.

WARNING

CAUTIONThe term caution is used for the statement of a hazard alert that warns thereader of a potentially hazardous situation which, if not avoided, may result inminor or moderate injury to the user or patient or damage to the equipmentor other property.

CAUTION

Note: Notes are added to give more information.


General Warnings and Cautions before Use

WarningsWARNING

GeneralCarefully read this Prismaflex Operator’s Manual and the Prismaflex disposableset and solution bag Instructions for Use before operating this device. Note:Deviation in the classification of a Warning and a Caution between the manualand disposable IFU may occur. If found, refer to the manual. Before first use,ensure that the installation test has been successfully performed.

Operate the Prismaflex control unit in accordance with this manual, theInstructions for Use of the Prismaflex disposable set and solutions, and theon-line instructions. The use of operating or maintenance procedures otherthan those published by the manufacturer, or the use of accessory devices notrecommended by the manufacturer, can result in patient injury or death.

The manufacturer will not be responsible for patient safety if the procedures tooperate, maintain, and calibrate the Prismaflex system are other than thosespecified in this manual, the Service Manual, the Instructions for Use of thePrismaflex disposable set and solutions, and the on-line instructions. Theseprocedures are only allowed to be performed by authorized service technicians.

Procedures using the Prismaflex system must be performed under theresponsibility of a physician.

TPE in conjunction with citrate containing replacement solutions may requirecalcium substitution in order to avoid hypocalcaemia.

Service and RepairsThe accuracy of the Prismaflex control unit depends on accurate scale andpressure calibration. Ensure that scales and pressure sensors are accuratelycalibrated. Calibrations must be performed by an authorized service technician.Calibration instructions are provided in the PrismaflexService Manual.

Electrical safetyUse only the Prismaflex hospital grade power cord to plug the Prismaflex controlunit to the facility electrical outlet.

Although all Prismaflex machines comply to IEC 60601-1 requirements forhemodialysis machines (Type BF Applied Part), it is recommended to use aPrismaflex machine Type CF Applied Part when the blood access is from aCentral Dialysis Catheters (CDC). The type label at the back of the controlunit indicates the classification.Note: When combining the Prismaflex system and MARS system it complieswith the Type B applied part classification per IEC 60601–1 standard.

Install the discharger ring in its guide before connecting a patient tothe Prismaflex set in order to minimize cardiac monitor disturbance.Misinterpretation of ECG artefacts may lead to patient serious injury or death(See also Troubleshooting, chapter 11).

Do not use cellular phone or other radio frequency equipment within ashort distance from Prismaflex since disturbance may occur. For additionalinformation about special precaution regarding EMC, refer to Guidance andManufacturer´s Declaration — Electromagnetic Emissions and Immunity inthis manual.

WARNING → → →



→ → → WARNINGThe correct installation of a Medical Electrical System requires that eachsystem component be individually connected to the main power. It is stronglyrecommended: Not to use multiple portable socket-outlets. However, if usingmultiple portable socket-outlets, they must comply with IEC 60601-1-1 Standardand must not be placed on the floor.

All electrical installations must comply with all applicable local electrical codesand the manufacturer’s specifications.

EnvironmentDo not use the Prismaflex control unit near flammable gas, or a flammableanaesthetic mixture with air, oxygen or nitrous oxide.

Handling the machineLock brakes on the wheels to limit movement of the control unit that might pullon tubing connected to the patient or significantly alter fluid balance, resulting inpatient injury or death.

After turning ON the control unit, verify the audible alarm and that the green,yellow and red status lights are lit alternately during Prismaflex start upsequence. In case of malfunction, switch OFF the control unit and call forService.

Accessories and remote alarmsUse only the blood warmers listed in this manual. Install and operate themfollowing the Operator’s Manual provided with the selected blood warmer.

The Prismaflex makes available the treatment related data through connectionto external devices (personal computer or communication network) for storageand display. The intended use of this information is to support the physicians,but it cannot be considered as the sole data to prescribe any therapeutic orpharmacological action for the patient. It is the responsibility of the physicianto verify all data.

The clinic/user is solely responsible for connecting a remote alarm to thePrismaflex and for verifying its function. If a remote alarm is used, the operatoris responsible for periodically checking on the patient in person.

Setup and primingDuring priming and operation, observe closely for leakage at joints andconnections within the set. Leakage can cause blood loss or air embolism. Ifleakage cannot be stopped by tightening the connections, replace the set.

Before connecting the blood return line to the patient, make sure there is no airbetween the segment of line inserted in the air bubble detector and the patientend of the return line. If air is present in this part of the return line, connect theaccess line to the patient and start the blood pump while leaving the returnline connected to the collection bag. Purge the air present in the end-part ofthe return line, then stop the blood pump. Disconnect the return line from thecollection bag, and connect it to the patient. If there is too much air in the bloodcircuit, reprime the circuit completely before patient connection.

Clamp unused lines after priming is complete and before starting a patienttreatment according to therapy configuration.

Check for the correct increment and sequential order of parametersettings when the arrow keys are pressed in Enter Flow Settings,Enter Anticogulation Settings or Enter TPE Prescription screens. If theincrement or sequence is incorrect, terminate the treatment and call for service.See “Chapter 13: Specifications” on page 13:1 for a list of the correct increments.

Treatment monitoringMonitor patient temperature to avoid hypothermia. Pay special attention whenusing high fluid exchange rates, or when treating low body weight patients.

WARNING → → →


→ → → WARNINGAlways inspect the blood flowpath for signs of clotting before returning the bloodin the set to the patient. If clotting is suspected, do not return the blood to thepatient.

Blood or fluid leakage from a pod diaphragm, or wetting of the fluid barrier atthe distal end of the monitor line, will impair the pressure monitoring systemof the Prismaflex system and require immediate troubleshooting. Follow theinstructions in "Leakage in pressure pods or blood reaching fluid barrier" inchapter 11.

Collecting blood samples from improper sample sites in the set can lead toincorrect blood chemistry results. Dilution effect of infusions must be consideredaccording to the flow settings and sample sites (for example PBP infusion rateon an Access site blood sample). Wait for some minutes before taking a bloodsample after pumps have been stopped, so as to get samples representativeof the stabilised conditions.

Always connect the return line directly to the blood access device. Do notconnect additional devices between the return line and the blood accessdevice. The use of additional devices, such as three-way valves, stopcocks, orextension lines, may impair return pressure monitoring. Their use can impedethe detection of return disconnections, potentially resulting in severe blood loss.

The control unit may not be able to detect disconnections of the set from theblood access device, which can result in severe blood loss. Ensure that thepatient's blood access and return connections are firmly secured; pay specialattention in case a warmer sleeve is in use. Carefully observe the set and alloperation while using the Prismaflex system for a patient treatment.

Fluid managementDo not hang anything except fluid bags on the scales on the bottom of thePrismaflex control unit. Foreign objects on the scales can significantly alter fluidbalance, resulting in patient injury or death.

The Prismaflex control unit is intended to be used on patients weighing 8 kg ormore. A higher minimum patient weight limit may apply for the disposable setselected for the therapy. Refer to the Instructions For Use of the disposable setand Table “Sets and patient weight limits” on page 2:17.

Fluid balance deviations, even if within the specified Prismaflex accuracy, canexceed a level that can be tolerated by low-weight patients.

The Prismaflex system is unable to detect all of the situations where a bag hasbeen attached to the wrong line or has been hung on the incorrect scale. Theuse of color coded lines, color coded clamps or specific label on the PBP lineare intended to prevent such errors.

When hanging a fluid bag, always centre it on the 3- hook assembly, so thatits weight is evenly distributed. Do not support the fluid bags by any meansother than the provided scale carrying bars. Fluid balance can be significantlyaltered, resulting in patient injury or death.

Leakages from the fluid bags can significantly alter fluid balance, resulting inpatient injury or death. Carefully observe the fluid bags and all operation whileusing the Prismaflex system for a patient treatment.

“Operator-set” Patient fluid removed must be calculated multiplying Run Time inHistory screen by Patient fluid removal rate.

WARNING → → →



→ → → WARNINGIf you receive additional weight alarms and the cause cannot be identified, thenconsider discontinuing and restarting the treatment, if possible.

Ignoring and/or indiscriminately pressing the CONTINUE softkey as a responseto weight alarms may lead to incorrect patient weight loss or gain, and mayresult in serious patient injury or death. Always identify and solve the originatingcause of a Weight alarm before pressing the CONTINUE softkey.

Solutions and bagsEnsure that dialysate solution and infusion solutions (PBP and replacement)are of appropriate composition and at appropriate temperature, as prescribedby a physician. Before using a solution/fluid, make sure it is free of precipitatesand other particulate matter. The use of incorrect solution/fluid can result inpatient injury or death.

When connecting solution bags, follow the instructions in the solution bagleaflet for correct use of the access ports. Incorrect use of the access ports canrestrict fluid flow and might lead to incorrect patient fluid removal, resulting inpatient injury or death.

Hygienic considerationsUse aseptic technique when handling the blood and fluid lines in the disposableset.

Do not use the Prismaflex disposable set if the package is damaged, if thesterilization caps are missing or loose, or if the blood lines are kinked.

When handling Prismaflex disposable sets, hospital personnel should takeadequate precautions at all times to prevent exposure to or transmission of HIV,hepatitis virus, or other infectious agents.

After blood leakage from the pressure pod diaphragm (Access or Filter),the machine must be put into a quarantine and tagged as “DO NOT USE”.Additional verification is required either by the facility’s biomedical and/orauthorized service technician.

WARNING

CautionsCAUTION

Service and RepairsThere are no operator-serviceable parts inside this device. Repairs must beperformed by an authorized service technician.

Only authorized service technicians can access Service mode. If Service modeis inadvertently entered, turn the unit off, then on to return to Operating mode.

Do not use any type of lubricant on the internal or external components of thePrismaflex control unit or Prismaflex disposable set. Only authorized servicetechnicians can apply lubricants to machine components. Improper use oflubricant can adversely affect performance of the control unit.

Electrical safetyDevices connected to the RS232 serial communication port or the Ethernet portmust comply with IEC 60950. Connected cables must have a Kitagawa RFC-10ferrite or equivalent to fulfill EMC requirements.

EnvironmentRelating to the Prismaflex set/solution storage conditions and temperature; referto the Prismaflex set/solution Instruction for Use (IFU).

CAUTION → → →


→ → → CAUTIONVariations in room temperature of ±3 °C (5.4 °F) or more can cause the scalesto become inaccurate.

Handling the machine and its accessoriesAvoid moving the Prismaflex control unit when a blood warmer is installed.Adjust the warmer to resting position before moving the control unit.

Never insert fingers in the return line clamp or in the pinch valves.

Use a 21-gauge (or smaller diameter) needle to obtain blood or fluid samplesor to reposition pod diaphragms. Use of larger needles can cause holes in thesample sites, resulting in blood loss or air embolism. Use aseptic techniquewhenever inserting needles into sample sites.

After switching the machine off, wait at least 5 seconds before turning it on again.

If the display goes blank while power is on, immediately terminate the treatmentand call for service.

Before moving the machine, check that the brake is released and ensure that allthe scales are firmly closed.

Setup and primingIf a patient is not connected to the Prismaflex disposable set shortly afterpriming is complete, flush the set with at least 500 ml priming solution (salinewith heparin added) before connecting a patient. This may require use of anew bag of priming solution and a new (empty) collection bag. Consult theInstructions For Use packaged with the set for details about priming volumes.

Pay particular attention to the extracorporeal blood volume. For patients witha high “extracorporeal volume/patient blood volume” ratio, the physician maydecide to prime the extracorporeal circuit with adequate volume substitutionbefore patient connection.

Blood return from a blood primed extracorporeal circuit can result inhypervolemia. Consult physician's prescription.

Treatment monitoringDo not allow air to enter the blood compartment of the filter after priming hasstarted. If a large amount of air enters, the set must be replaced.

Due to the nature of use of the Prismaflex disposable set (low blood flow rate,extended treatment time, and other special factors), the risk of coagulationwithin the blood flow path is substantially enhanced. Give careful attention tothe possible medical hazards associated with coagulation of the blood flow path.

Fluid managementIn all CRRT therapies, the Prismaflex system accounts for syringe infusionvolumes in the Patient Fluid Removal, whatever the selected anticoagulationmethod.

Hygienic considerationsTo prevent contamination, the Prismaflex disposable set must be used as soonas its package and sterilization caps are removed.

Destroy the Prismaflex disposable set after a single use, using appropriateprocedures for potentially contaminated material. Do not resterilize.

Chemicals other than those recommended in this manual for cleaning anddisinfection could damage the Prismaflex control unit and Prismaflex disposablesets. Obtain permission from the manufacturer before using a non-recommendedchemical on the Prismaflex system. The following are especially forbidden: (a)halogenated aromatic and aliphatic solvents; (b) ketonic solvents.

CAUTION



SymbolsIf applicable, the following symbols appear on or near the serial number label or otherpermanently affixed labels of this device. For more information, see “Chapter 13:Specifications” on page 13:1.

This symbol indicates that the equipment applied part is Type BF, defibrillation -proof per IEC 60601-1.Note: To be sure of the machine's classification see type label found at the back ofthe machine.

This symbol indicates that the equipment applied part is Type CF,defibrillation-proof per IEC 60601-1.Note: To be sure of the machine's classification see type label found at the back ofthe machine.

This symbol indicates that consultation of the accompanying documents prior toequipment operation is critical to the safe operation of the device. The backgroundcolour is white.

This symbol indicates that consultation of the accompanying documents prior toequipment operation is critical to the safe operation of the device. The coloursare blue and white.Note: This symbol is a complement to the warning triangle symbol.

This symbol indicates that the device meets the “drip proof” classificationrequirements.

This symbol indicates that the device requires an alternating supply current.

This symbol indicates that conductors carrying high voltage are nearby and thatthese could be hazardous if contacted.

This symbol is located near functional ground locations on this device.

This symbol is located near protective ground locations on this device.

This symbol identifies the point of connection of a potential equalization conductor.

This symbol indicates a fuse.

This symbol indicates that certain components within this equipment are sensitiveto electrostatic discharge.


This symbol indicates the date of manufacture. It is accompanied by the yearexpressed as four digits.

This symbol indicates the manufacturer. The year of manufacture may be includedin the symbol expressed as four digits.

This symbol indicates the presence of an Ethernet port.

This symbol indicates the presence of an RS232 Serial Communication port.

This symbol indicates the presence of a remote alarm connection.

This symbol indicates that:– since the equipment contains dangerous substances, it must not be disposedtogether with other municipal waste. It must be recycled;– the equipment was placed on the market after 13 August 2005.

This symbol is a warning label not to lean the machine more than 5° from the floor.Note: This warning label must be applied on the warmer holder before use. Itshould be mounted on deliverance. The background colour is yellow.

The Prismaflex control unit contains hazardous substances. See Table HazardousSubstances on page 1:16. The environmental protection use period is 25 years.

Recycle the cardboard.

Fragile – handle with care.

Keep dry.

The maximum stacking load permitted on the transport package is 100 kg.



This way up

Pull out scale completely before hanging bag.

Pull out scale completely before hanging bag.

Certification MarksThe CE-conformity mark indicates that the Prismaflex control unit conforms to therequirements in the EC Council Directive 93/42/EEC of 14 June, 1993 concerningmedical devices. It also indicates that the notified body British StandardsInstitution (BSI, No. 0086) has approved the Quality Management System. TheCE conformity mark is only valid for the Prismaflex control unit. Disposablesand any accessories specified for use with the Prismaflex control unit are markedwith CE conformity marks in their own right. (See “Prismaflex Disposable Sets”on page 2:16.)

The CSA (C-US) mark indicates that the Prismaflex control unit conforms to therequirements related to safety of medical devices for the US and Canada. The“C” and the “US” adjacent to the CSA mark indicate that the Prismaflex controlunit has been evaluated to the applicable ANSI/UL and CSA standards for usein the US and Canada.

The CCC mark indicates that the Prismaflex control unit conforms to the safetyrequirements for China Compulsory Certification (CCC) as described by thecompetent authority Certification and Accreditation Administration of People'sRepublic of China (CNCA). The “S” adjacent to the CCC mark indicates thatsafety requirements are met.


Installation, Service and TransportPlease note that Prismaflex has to be installed by an authorized service technician. Forinstallation information, see Prismaflex Service Manual.

For technical assistance, contact your local representative.

CAUTIONDo not connect a patient to the Prismaflex system during the installation test. Besure that the test is conducted using a container of water to substitute for thepatient.

The Prismaflex control unit weighs approximately 60 kg (132 lb). Use at leasttwo people to lift it out of the shipping carton. Handle the control unit carefully.

Remove the calibration weights, if equipped in the machine foot, before tiltingthe machine into horizontal position.

Prior to using the Prismaflex control unit, let the unit rest at ambient operatingtemperature for 1 hour.

CAUTION

Disposal

Disposal of Packaging MaterialThe Prismaflex control unit shipping carton, foam packing, and other packaging materialshould be disposed of according to local regulations.

Disposal of Discarded EquipmentDiscarded electromedical equipment must not be disposed of together with municipalwaste but must be collected separately in order to guarantee ecologically correct disposalto prevent dispersion of potential pollutants into the environment.

Pay attention to the fact that some components of the machine (display, batteries, circuitboards, etc.) may contain toxic substances which, if released into the environment, pose arisk to the health of living organisms and the environment itself.



Hazardous Substances

Hazardous Substances

Hazardous substancesPart

Lead(Pb)

Mer-cury(Hg)

Cad-mium(Cd)

Hexava-lent chr-omium(Cr6+)

Polybromi-natedbiphenyls(PBB)

Polybrominateddiphenyl ethers(PBDE)

Printedcircuit boardassemblies

X O O O O O

Electro-mechanicalcomponents in-cluding wiring

X O O O O O

Power supply X O O O O O

Batteries X O O O O O

Metals O O O O O O

Plastics O O O O O O

Enclosures O O O O O O

O: Indicates that the concentration of the hazardous substance in all homogeneous materials ofthe part is below the SJ/T 11363-2006 limit (Chinese regulation).X: Indicates that the concentration of the hazardous substance in at least one homogeneousmaterial of the part is above the SJ/T 11363-2006 limit (Chinese regulation).

Removal of waste batteries and accumulatorsAccording to Directive 2006/66/EC and RAEE Directive concerning batteries themanufacturer shall provide instructions how to replace/remove batteries in a safely andenvironmentally friendly manner. By following this directive we are helping man andnature from being exposed to harmful substances. Examples of harmful substances aremercury, cadmium and lead.

The labelling with a crossed-over waste bin indicates that the batteries shall not bediscarded in normal waste.

Labelling with a chemical symbol indicates potential presence of this chemical.

Figure 1:2 Hg = Mercury, Pb = Lead, Cd = Cadmium.

Batteries shall not be discarded in normal waste, instead separate and proper collectionsystems shall be used. Please use available collection systems for used batteries, andalways check local regulations for correct and environmental disposal.


The tables below describe where the batteries are located, the type of battery and chemicalcomposition for correct disposal.

Batteries found in Prismaflex

Item Description Type Location

7319090001VL2330

Memory backup Vanadiumrechargeable lithiumbattery 3V

Carrier Board

210224003CR2032

Battery to real timeclock and BIOS

Lithium battery 3V PC-104 Board

BR1632 Battery to real timeclock and BIOS

Lithium battery 3V PC-104 Board

7319260003 Battery back-upduring power failure.12V

One 12 voltrechargeable leadbattery

Bottom inside of themachine

100224039 Battery back-upduring power failure.(2x12V)

Two 12 voltrechargeable leadbattery

Bottom inside of themachine

Chemical Composition

Item Active ingredients Approx. percentage(%) of total weight

Main passivematerials

Weight

7319090001VL2330

-Vanadiumpentoxide-Lithium alloy-Organic electrolyte

5-210.2-25-15

Steel 3.5 g

210224003CR2032

-Lithium (Li)-Manganese dioxide(MnO2)-Organic electrolyte,consisting of lithiumperchlorate, organiccarbonates andethers(Cadmium < 1mg/kgLead <10 mg/kgMercury <0.1mg/kg)

1–313–403–9---

Steel and nickel 3 g

BR1632 -Polycarbon-monofluoride-Lithium metal-Organic electrolyte

5–150.9–46–16

Steel 1.5 g

7319260003 -Metallic lead andlead compounds-Sulphuric Acidsolution

60–7020–30

-ABS resin-Glass separator

580 g

100224039 -Lead (Pb, PbO2,PbSO4)-Sulphuric acid

7020

-ABS plastic-Fiberglass

1180 g (for onebattery)



Chapter 2

Description of the Prismaflex® SystemContents

System components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:2Prismaflex control unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:2Control Unit Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:2Control Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:2Front Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:3Rear Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:14Interior Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:15

Prismaflex Disposable Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:16Low and High Flow Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:16Minimum Patient Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:16

Disposable Set Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:18Prismaflex® Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:20Hardware Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:20Blood Warmers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:20HP Cartridge Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:20UPS Requirements for Installation with Prismaflex® . . . . . . . . . . . . . . . . . . . 2:20

Disposable Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:20Effluent Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:20Calcium Infusion Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:22SP-394 Accessory for TPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:22Stand alone fluid barrier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:22Prismatherm II extension line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:22


Description of the Prismaflex System 2:1

System componentsThe Prismaflex system consists of the Prismaflex control unit, a Prismaflex disposableset, disposable solutions and optional accessories. Prismaflex disposable sets, disposablesolutions and accessories are purchased separately.

Prismaflex control unit

Control Unit FunctionsThe Prismaflex control unit is a software controlled device that performs the followingfunctions:

• Loads and primes the Prismaflex disposable set automatically.

• Pumps blood through the blood flowpath of the Prismaflex disposable set.

• Delivers anticoagulant solution into the blood flowpath.

• Pumps sterile infusion solutions into the blood flow path of the Prismaflex disposableset according to therapy in use.

• Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies.

• Controls the patient fluid removal or plasma loss according to the therapy in use.

• Monitors the system and alerts the operator to abnormal situations through alarms.

Control UnitEach Prismaflex control unit is pre-attached to a column and a base with casters. ThePrismaflex control unit comes packaged with the following items:

• Installation kit:

- United States-style power cord, with retaining bracket

- Continental European-style power cord, with retaining bracket

- 4 screws

- 4 scale carrying bars

• 20 ml syringe clip

• Pump crank

• Caution stickers

• Potential equalization connector

• Prismaflex Operator’s manual on CD

• Software CD

2:2 Description of the Prismaflex System G5036003 Revision 05.2011Program version 6.xx

Front Panel ComponentsThe front panel components of the Prismaflex control unit are illustrated and describedin the following figures.

• Figure 2:1 on page 2:4 shows the pumps.

• Figure 2:2 on page 2:6 shows the pressure components.

• Figure 2:3 on page 2:8 shows sensors and clamps.

• Figure 2:4 on page 2:10 shows the scale components.

• Figure 2:5 on page 2:12 shows miscellaneous components.



Figure 2:1 Pumps


1. Dialysate/Replacement 2 pumpCVVHD, CVVHDF: Pumps dialysate solution into the fluid compartment of the filter.

CVVH: If post-filter replacement delivery has been chosen and replacement solutionhas been placed on the green scale, this pump delivers replacement solution intothe post-filter blood flowpath.

2. Replacement pumpPumps replacement solution/fluid into the blood flowpath.

CRRT: Replacement solution can be delivered either pre or post-filter.

TPE: Replacement fluid is always delivered 100% post filter.

3. Blood pumpPumps blood through the blood flowpath of the Prismaflex disposable set.

4. Pre-blood pump (PBP)If required, pumps a solution into the blood access line at a location immediately afterpatient blood enters the line and before the blood pump.

In regional citrate anticoagulation the PBP is the pump infusing the citrate solutioninto the blood access line.

5. Syringe pump assemblyThe pump assembly holds the solution filled syringe and controls the rate of delivery.Delivery can be continuous or in boluses.

In “Standard − Syringe” anticoagulation method, syringe pump delivers anticoagulantinto the blood flow path.

In “Citrate – Calcium via Prismaflex Syringe Pump” anticoagulation method, syringepump delivers calcium solution into patient via a separate central venous access.

6. Effluent pumpCRRT: Pumps ultrafiltrate/dialysate; automatically controls the ultrafiltration rate,based on the operator-set patient fluid removal rate, PBP, dialysate, replacement andsyringe flow rates (if applicable).

TPE: Pumps removed plasma; automatically controls the plasmafiltration rate basedonly on the operator-set patient plasma loss and replacement fluid rates. PBP andsyringe flow rates are not considered in the effluent pump rate.

7. Pump racewayTubing pathway within each peristaltic pump. The raceways accept the pumpsegments of the Prismaflex disposable set.

8. RotorCenter component of each peristaltic pump that rotates during pump operation. Holdstwo rollers that occlude the pump segment in the raceway. Occlusion moves the fluidin the pump segment forward in discrete amounts and prevents backflow.



Figure 2:2 Pressure components


1. Return pressure portConnects to the monitor line of the deaeration chamber on the Prismaflex disposableset. A pressure sensor (transducer) located behind the pressure port enablesnoninvasive pressure monitoring of the return line and deaeration chamber. A fluidbarrier at the distal end of the monitor line protects the return pressure sensor fromaccidental blood entry.

2. Effluent pressure pod

3. Deaeration chamber holderHolds the deaeration chamber of the Prismaflex disposable set.

4. Filter pressure pod

5. Access pressure pod

6. Pressure sensor housingsHousings that hold the pressure pods of the Prismaflex disposable set. A pressuresensor (transducer) is located behind each housing. The sensors and pressure podsenable noninvasive pressure monitoring of the access line, filter, and effluent line.There are no air-blood interfaces.

7. Pressure pod (not used, for future therapy)



Figure 2:3 Sensors and clamps


1. Discharger ring guideHolds the electrostatic discharger ring of the Prismaflex disposable set. The mainfunction of the discharger ring is to lower the voltage potential in the blood/fluid path.As a result artefacts on cardiac monitors will be minimized.Always install the discharger ring in its guide before connecting a patient to thePrismaflex disposable set.

2. Air bubble detector (housing also has a tubing detection switch and apatient blood sensor)Ultrasonic transmission/detection device that continuously monitors the return line forair bubbles. A Warning alarm occurs if a bubble is detected.Tubing detection switch (physically moves down when tubing is installed).Patient blood sensor (infrared sensor that detects if blood is in the tubing).

3. Return line clamp (assembly also has a tubing detection switch)Occlusive clamp that closes during all Warning and Malfunction alarms, when poweris off, and during some self-tests. Prevents blood and/or air from passing to the patient.For patient safety, a tubing detection switch is also located in the return clampassembly. The switch physically moves down when tubing is correctly installed underthe clamp.

4. Pinch valves (upper and lower)CVVH, CVVHDF: Upper pinch valve accepts tubing coming from thedialysate/replacement 2 pump; lower pinch valve accepts tubing coming from thereplacement pump. The valves open/close automatically to allow pre- and post-filteroptions for delivery of replacement solution. For more information, see “Chapter 4:Therapy Operation” on page 4:8.

5. Bar code readerLaser scanner that reads the bar code on the Prismaflex disposable set during the setloading procedure. With this information, Prismaflex software accesses the defaultalarm limits, flow rate ranges and priming sequence for the set that is loaded.

6. Syringe control panelConsists of UP and DOWN buttons that allow installation and removal of the syringe.The buttons are activated/inactivated by Prismaflex software, depending on operatingconditions.

7. Blood leak detectorContinuously monitors the effluent line for the presence of red blood cells, indicatinga leak in the filter membrane. A Warning alarm occurs if red blood cells are detected.Note: The blood leak detector does not detect the presence of hemolyzed blood. Formore information, see Additional Troubleshooting on page 11:73.



Figure 2:4 Scale components


1. Dialysate scale (green square)

2. Replacement scale (purple octagon)

3. Scale carrying bar assemblyThe bar tray on each scale holds a removable carrying bar with three hooks. Using atable or other support, bags may be attached to/removed from the hooks. After thecarrying bar is replaced in the bar tray, it must be rotated so the handle is toward thefloor, so the scale can be properly closed.Various sizes of bags can be used, depending on the scale. For more information, see“Scales Characteristics” in “Chapter 13: Specifications” on page 13:1.

4. Effluent scale (yellow circle)

5. PBP scale (white triangle)

6. General scale InformationIndependently monitor fluid bag/container weights. Weight is used byPrismaflex software to precisely control solution flow rates and patient fluid removal/plasma loss. An alarm sounds when the PBP, dialysate and replacement solutionbags/containers are nearly empty, or when the effluent bag is nearly full.The operator pulls the bar tray of a scale out (away from) the control unit to attach orremove bags/containers. When the tray is pulled out, the scale is in “open” position;when the tray is completely pushed in, the scale is in “closed” position. An alarmsounds if the scale is open when operating conditions require it to be closed.



Figure 2:5 Miscellaneous components


1. Status lightLights up to give a general indication of operating conditions.

Green: Indicates that all monitored parameters are normal during administrationof the treatment (Run mode).

Yellow: Indicates that a Caution or Advisory alarm has occurred, or an alarm hasbeen overridden. Immediate patient safety is not compromised, but the operatorshould investigate.Note: In Setup, Standby, End, and Custom modes, yellow indicates that all monitoredparameters are normal, but a patient treatment is not in progress.

Red: Indicates that a Warning or Malfunction alarm has occurred because of acondition of possible patient hazard. Immediate operator intervention is required.

2. Clips (left and right side)Secure the blood access and return lines going to the patient; also support the PBPline. (The clip on the side closest to the patient is used.)

3. Tubing guidesHold the lines of the Prismaflex disposable set in correct position on the control unit.The color of each tubing guide matches the color of the line it holds.

4. LoaderLoads the Prismaflex disposable set.

5. Side hook (left and right side)Bags can be put on this hook.

6. Recessed handle (left and right side)

7. DisplayShows text and softkeys. Provides operating, alarm, and help instructions. Pressingthe softkeys allows the operator to change settings, start and stop functions andnavigate between screens.

8. Upper clipSupports the calcium infusion line when performing Citrate – Calcium via PrismaflexSyringe Pump anticoagulation method.Temporarily holds the return line during setup of hemoperfusion sets.



Rear Panel ComponentsThe rear panel components of the Prismaflex control unit are illustrated and describedin the figure below.

Figure 2:6 Prismaflex control unit: Rear Panel

1. SpeakerTransmits a continuous or intermittent beep if an alarm condition occurs. For moreinformation, see “Chapter 10: Alarm System” on page 10:1.

2. FanProvides continuous ventilation for the interior components of the control unit.

3. Hour meterDisplays operating hours (cumulative time that power to the machine has been on).


4. Remote alarm connectionConnection for an optional remote alarm (for example installed in a nursing station).

5. Buzzer (inside)Transmits a continuous buzz if a power loss occurs.

6. Rear handle (bottom)

7. Power cord holder

8. Power cord socket

9. Connection for potential equalization conductor

10. Power switch

11. Pump crank

12. Technical data card holderYou can copy history data to a technical data card. See “Saving the History Data”on page 4:5.

13. Ethernet portAn IP addressable port for data exchange with a personal computer or communicationnetwork.

14. RS232 serial communication portFor data exchange with a personal computer, communication network or modem.

15. Rear handle (top)

Interior ComponentsAccess to the interior of the Prismaflex control unit is gained through the rear panel.Only authorized service technicians should repair the interior components. Completedescriptions of these components are provided in the Prismaflex Service Manual.



Prismaflex Disposable Sets

The Prismaflex disposable sets are single use disposable devices intended for use with thePrismaflex control unit. Each set consists of:

- a cartridge holding the lines, the pump segment tubes and the filter making theinterface with the machine loader

- a preconnected blood flow path

- preconnected flow paths for PBP, dialysate, replacement and effluent as applicable.

Each set is identified by a bar code label allowing the machine to automatically identifythe set that is loaded.

Note: The MARS Treatment Kit type 1116/1 - X-MARS is an exception from this generaldescription, see specific section about CRRT MARS modality on page 5:21.

Note: The Prismaflex Adsorba kits are exceptions to this general description, see chapter7.

WARNINGUse only the Prismaflex disposable sets listed in this manual with thePrismaflex control unit. The use of Prismaflex disposable sets other than thoselisted in this manual may result in patient injury or death.

Ensure the proper Prismaflex disposable set has been loaded for the selectedtherapy. Using the wrong set for the therapy can cause patient injury or death.

WARNING

Low and High Flow SetsTwo families of disposable sets are defined according to the size of blood pump andblood transport tubes:

- Low Flow sets (LF sets) offer the benefits of low extra corporeal blood volume; bloodflow ranges and ultrafiltration capacities are limited.

- High Flow sets (HF sets) provide wide capabilities for blood flow and ultrafiltrationrates.

Prismaflex disposable sets available for use with the Prismaflex control unit are listedin chapter 15.

Minimum Patient WeightAlarm limits defined on page 3:10 set the minimum patient body weight allowing for asafe treatment with respect to fluid imbalance issues, namely:• 8 kg for Low Flow sets,

• 20 kg for High Flow sets.

These restrictions should be combined with the weight limitations of disposable sets inrelation to extracorporeal blood volume. Combination of these independent limitationsresult in the minimum patient weight specifications, described in Table “Sets and patientweight limits” on page 2:17.


Sets and patient weight limits

Control unit limitations Disposable limitation Applicable minimum patientweight

Low Flow set 8 kg HF20M60ST60TPE1000

8 kg11 kg11 kg9 kg

8 kg11 kg11 kg9 kg

High Flowsets

20 kg HF1000HF1400M100M150ST100ST150TPE2000septeXoXiris

30 kg30 kg30 kg30 kg30 kg30 kgAdults30 kg30 kg

30 kg30 kg30 kg30 kg30 kg30 kgAdults30 kg30 kg

Some sets are not available in some countries due to local regulations. Check with thelocal representative for availability.



Disposable Set ComponentsThe disposable set components are illustrated and described in the figure below.

Figure 2:7 Disposable Set components

1. Sample sitesColor-coded ports with a plug that allow needle entry to the set. Used to obtain fluid orblood samples. Access is gained via a 21-gauge (or smaller diameter) needle attachedto a syringe. The sample site marked orange in figure 2:7 is optional.

2. Pressure podsThere are three circular “pods” in the set. Each contains a diaphragm and fits into apressure sensor housing on the control unit. The pods and pressure sensors (inside thecontrol unit) enable noninvasive pressure monitoring.

3. Deaeration chamberA component on the return line that allows the Prismaflex control unit to manage air,monitor return line pressure, and add post-filter replacement solution to the return line.


4. PBP (Pre-blood pump) line (white-striped)If required, conveys a prescribed infusion solution from the bag on the PBP scale(white) to the blood access line. The PBP solution enters the access line at a locationimmediately after patient blood enters and before the blood pump.

In “Citrate – Calcium via External Infusion Pump” anticoagulation method the PBPline conveys the citrate solution.

In “Citrate – Calcium via Prismaflex Syringe Pump” anticoagulation method the PBPline conveys the citrate solution.

5. Replacement line (purple-striped)Conveys replacement solution from the bag on the replacement scale (purple) to theblood flowpath, not available in all therapies.

6. Dialysate/replacement 2 line (green-striped)Conveys solution from the green coded scale to the fluid compartment of the filter(dialysate) or to blood flow path (replacement 2). Availble in CRRT sets only. Seechapter 5, “Continuous Renal Replacement Therapies (CRRT)”.

7. Effluent line (yellow-striped)Conveys ultrafiltrate and/or spent dialysate from the fluid compartment of the filterto the effluent bag.

8. Access line (red-striped)Conveys blood from the patient’s blood access site to the filter.

9. Warmer connectionMale-female Luer connectors allow connection of blood warmer circuits, see chapter“9” on page 9:1 for more information.

10. Syringe lineIn “Standard − Syringe” anticoagulation method, the syringe line on the disposable setconveys anticoagulant from the syringe to the blood flowpath. A non-return valve ispresent on the syringe line. The syringe line is pre-clipped to the cartridge and shouldremain so if not using the standard anticoagulation method.

11. Chamber monitor lineConnects the deaeration chamber with the return pressure port, enabling pressuremonitoring and removal of air, if needed. The Prismaflex system can remove airsemiautomatically by drawing it out through the return pressure port. A fluid barrier atthe distal end of the line protects the return pressure port from accidental blood/fluidentry. See “Air Removal Procedures” on page 11:84.

12. CartridgePlastic component in the center of the set that holds the filter, pump segments, andpinch valve segments. Has slots for the loader on the control unit. Allows automaticloading/unloading of the set.

13. FilterFilter characteristics are dependant on the chosen Prismaflex disposable set. Refer totherapy sections for more information.



14. Pump segmentsTubing that threads into the raceway of each peristaltic pump. Loaded automaticallywhen the loader pulls the Prismaflex disposable set flush with the control unit.

15. Electrostatic discharger ringIn the HP sets, the discharger ring is located on the PBP line.

16. Return line (blue-striped)Conveys blood from the filter to the patient’s blood return site.

Prismaflex® AccessoriesFor information about accessories and spare parts, see the Prismaflex Spare PartCatalogue provided by the local representative.

Hardware Accessories

Blood WarmersSee “Chapter 9: Blood Warmers” on page 9:1.

HP Cartridge HolderSee the Prismaflex Spare Part Catalogue.

UPS Requirements for Installation with Prismaflex®

An external UPS (uninterruptible power supply) can be used together with thePrismaflex control unit. A Spare part instruction with installation details and requirementsfor the external UPS is available from technical support.

Disposable AccessoriesFor information and supply of all listed disposable accessories, contact the localrepresentative.

Effluent BagCRRT sets come with a 5000 ml effluent bag. TPE sets come with a 5000 ml effluent bag.5000 ml (SP414) and 9000 ml (SP418) bags can be purchased separately.


Figure 2:8 The SP-418, 9l Effluent bag

1. Bag for collection ultrafiltrate or waste dialysate depending on therapy in use2. Eyelets for hanging effluent bag on scale hook3. Outlet port for easy draining of the bag before disposal4. Female Luer lock for connection to the end of Prismaflex disposable set effluent line



Calcium Infusion LineFor the “Citrate – Calcium via Prismaflex Syringe Pump” anticoagulation method, thededicated calcium infusion line (CA 250) must be used.

Figure 2:9 The Prismaflex CA 250 Calcium Line assembly

1. Low volume infusion tube2. Luer lock connectors to patient vascular access and syringe3. “Ca++” (Calcium) tags for easy identification4. Non-return check valve for prevention of line draining and backflow

SP-394 Accessory for TPEThe SP-394 accessory is designed for connecting several replacement containers at a timeduring TPE therapy. The SP-394 accessory for TPE is illustrated in the TPE chapteron page 6:14.

Stand alone fluid barrierFor replacing the fluid barrier during therapy, the VP-2 pressure transducer protectoraccessory must be used. See “chapter 11: Troubleshooting” on page 11:83.

Prismatherm II extension lineFor using the Prismatherm II blood warmer, the SP420 warmer extension line must beused and connected during setup. See “chapter 9: Blood Warmers” on page 9:1.


Chapter 3

General Prismaflex FunctionsContents

About the Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:2Blood Flow Path Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:2Blood Access Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:2Blood Pump and Pre Blood Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:3Pressure Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:3Components for Access, Filter, and Effluent Monitoring . . . . . . . . . . . . . . . . 3:3Components for Return Pressure Monitoring . . . . . . . . . . . . . . . . . . . . . . . . 3:4Pressures During Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:4Extreme Pressure Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:5Pressure Operating Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:5“Cannot Detect Disconnection” Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:7Software-calculated Pressures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:7Filter Pressure Drop (Pressure Drop) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:7

Fluid Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:8Pumps and Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:8Solution Bags and Containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:8Empty Bag Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:9

Effluent Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:9Protecting from Flow Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:9How Prismaflex system Monitors the Flow Rates and Fluids . . . . . . . . . . . . 3:10“Weight” Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:10“Incorrect Flow” Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:11Remedying the “Weight” and “Incorrect Flow” Alarms . . . . . . . . . . . . . . . . 3:11

Air Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:11Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:11Deaeration Chamber Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:12Changing the Fluid Barrier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:12

Anticoagulation Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:12Treatment Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:12Set loading and Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:12Set Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:13

Alarm Safety and Monitoring Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:13Alarm Safety System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:13Monitoring Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:13

Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:13Blood Leak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:13Air Bubble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:13Patient Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:14Flow rates and volumes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:14

Self-tests of the Prismaflex® System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:14Initialization Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:14Prime Self-test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:15Periodic Self-test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:15Alarm Monitoring During the Periodic Self-test . . . . . . . . . . . . . . . . . . . . . . 3:15


General Prismaflex Functions 3:1

About the ChapterThis chapter describes the Prismaflex control unit functions.

Blood Flow Path ManagementBlood flow path consists of:

• access line connecting the patient to the blood pump

• peristaltic blood pump

• filter line connecting blood pump outlet to filter inlet

• blood compartment of the filter

• return line connecting filter outlet to the patient

Each segment of the blood flow path is equipped for pressure monitoring, see “PressureManagement” on page 3:3. Return line is also equipped for the collection of air and theprevention of air infusion to the patient, see Figure 2:7 on page 2:18.

WARNINGAlways connect the return line directly to the blood access device. Do notconnect additional devices between the return line and the blood accessdevice. The use of additional devices, such as three-way valves, stopcocks, orextension lines, may impair return pressure monitoring. Their use can impedethe detection of return disconnections, potentially resulting in severe blood loss.

The control unit may not be able to detect disconnections of the set from theblood access and return connections, which can result in blood loss. Ensurethat the patient's blood access and return connections are firmly secured; payspecial attention in case a warmer sleeve is in use. Carefully observe the setand all operation while using the Prismaflex system for a patient treatment.

WARNING

Blood Access MonitoringThe most commonly used blood access method for Prismaflex therapies is central venousaccess and return. A dual-lumen venous catheter is the recommended blood accessdevice; however, two single-lumen venous catheters can also be used.

In certain circumstances, arterial blood access via arterio-venous (A-V) fistula may bedesirable. Blood access may also be via an external blood access device connected to thePrismaflex disposable set. In some situations blood return is via a single lumen venouscatheter or a large peripheral vein.

The size of the catheter should be adapted to patient and blood flow rate prescription forthe extracorporeal therapy. Inadequate catheter – blood flow rate combination may leadto very negative access pressure and/or very positive return pressure with a possiblehigh occurrence rate of the Warning: Access Pressure Extremely Negative alarm or theWarning: Return Extremely Positive alarm. Reduction of blood flow rate or change ofvascular access to a larger catheter shall then be considered. At the opposite, inadequatecatheter – blood flow combination can result in access or return pressure close to zero andprevent the system from detecting disconnection at the vascular access. Increase of bloodflow rate or change of vascular access to a smaller catheter shall then be considered.

3:2 General Prismaflex Functions G5036003 Revision 05.2011Program version 6.xx

Blood Pump and Pre Blood PumpThe PBP solution is added to the access line immediately after the patient’s blood entersfrom the access site, and before the access line reaches the blood pump. Because of this,the amount of blood actually pumped with each revolution of the blood pump is reduced.To maintain the set blood flow, the Prismaflex software increases the blood pump flow:

QBP = Qb + Qpbp

Where QBP is Blood pump flow (ml/min), Qb is Set blood flow (ml/min) and Qpbp isSet PBP flow (ml/min)

During priming of the set (Setup mode), the blood pump turns clockwise (except for a fewseconds in counterclockwise) and performs forward priming of the blood lines and filter.

Pressure ManagementThe Prismaflex control unit has an integral pressure monitoring system providingnoninvasive assessment of the access, filter, return and effluent lines.

Monitoring provides notification to the operator of abnormal pressure conditions, suchas extreme positive pressure in the return line. Monitoring also provides data needed byPrismaflex software to calculate other vital pressure conditions such as filter pressuredrop (Pressure Drop). These calculations are used to provide notification that clotting hasbegun in the filter or that the filter has clotted and the set must be changed.

Components for Access, Filter, and Effluent MonitoringComponents for monitoring the pressures in the access line, filter and effluent line includethe following:

• Pressure pods. Prismaflex disposable sets have a pressure pod in these locations:access line (access pod), filter inlet (filter pod) and effluent line (effluent pod). SeeFigure 2:2 on page 2:6.

• Pressure sensor housings. The front panel of the control unit has three sensor housingsthat accept the pressure pods described above. The housings provide connectionbetween the pods and the pressure sensors inside the control unit. The locations of thesensor housings are shown in Figure 2:3 on page 2:8.

Note: A fourth pressure sensor housing (upper left of control unit), is for use with futuretherapies and not applicable to current therapies.

• Pressure sensors. A pressure sensor (transducer) is located inside the control unit,behind each pressure sensor housing.

Each pressure pod has a fluid compartment (top side) and an air compartment (bottomside). The compartments are separated by a flexible diaphragm, which normally rests inthe middle of the pod, at the pressure neutral position. During a patient treatment, thefluid compartment of the pod is filled with the fluid flowing through the line to whichthe pod is attached.

Fluctuations in fluid pressure cause the diaphragm of the pod to move, compressingor expanding the air column on the other side of the diaphragm. The pressure sensorreceives these fluctuations and converts them to electrical signals that are sent toPrismaflex software and interpreted as a pressure value.



During operation, the pressure diaphragms can move slightly out of neutral position. ThePrismaflex control unit has an automatic reposition system (ARPS), located internally. Toensure proper pressure monitoring, every two hours the ARPS moves all diaphragms backto neutral position and tests the pressure sensors for correct functioning.

Components for Return Pressure MonitoringComponents for monitoring the pressure in the return line include the following:

• Deaeration chamber, located on the return line of the set.

• Chamber monitor line. An integral part of the deaeration chamber, this line provides aconnection between the top portion of the deaeration chamber and the return pressureport on the control unit.

• Return pressure port. The front panel of the control unit has a luer-lock port locatedon the upper right (see Figure 2:2 on page 2:6). The port connects with the chambermonitor line.

• Pressure sensor. The return pressure sensor is located inside the control unit, behindthe return pressure port.

During a patient treatment, blood flows out of the outlet port of the filter, into a shortportion of the return line, then into the deaeration chamber on the return line. Thechamber also receives any post-filter replacement solution that is in use. The fluid in thechamber then flows into the final portion of return line leading to the patient.

The topmost portion of the deaeration chamber and the chamber monitor line are filledwith a few milliliters of air (between 1 and 2 ml). Fluctuations in the pressure exerted bythis column of air are received by the pressure sensor located behind the return pressureport. To ensure proper pressure monitoring, every two hours the automatic repositionsystem (ARPS) tests the return pressure sensor for correct functioning.

Pressures During OperationPressures vary within the set depending on individual patient characteristics (bloodpressure and blood viscosity), as well as size of the patient catheter, flow rates, andtherapy being delivered. The actual pressures at all monitoring sites can be viewed on theStatus screen during a patient treatment.

The following information is general and intended only to acquaint the operator withbroad pressure ranges that can be expected with use of the Prismaflex system.

Access pod pressure Can be negative or positive, depending on the bloodsource to which the access line is connected.

Return pressure Always positiveFilter pod pressure Always positive and higher than Return pressure. The

filter pod is located immediately before the filter andmeasures the area of most positive (highest) pressure inthe set.

Effluent pod pressure Can be positive or negative, depending on theultrafiltration rate and therapy chosen.


Extreme Pressure LimitsPressure limits are enforced by Prismaflex software to ensure patient safety. If amonitored pressure goes outside the manufacturer-established extreme limits, a Warningalarm occurs. Warning alarms stop all pumps and close the return line clamp. Extremepressure default limits for CRRT on page 3:5 shows the manufacturer-established extremepressure limits.

Access and Return “Extreme” Warning alarms feature a self-clearing functionality.If the monitored pressure returns to normal values within a 15 second period and noother self-clear attempt was performed with the previous 2 minutes, the alarm will clearautomatically. During the self-clear time the monitor will not give an audible alarm.

Detailed information on the individual alarms is also available in the "Troubleshooting"chapter starting on page 11:1

Three of the extreme pressure alarm limits, Warning: Access Extremely Negative alarm,Warning: Access Extremely Positive alarm, and Warning: Return Extremely Positivealarm are operator-settable in Custom mode. If desired, the operator can modify theselimits, so that an alarm will occur prior to reaching the manufacturer-established extremelimit. For more information, see “Custom Mode” on page 4:21 and “User-controllableSettings” on page 4:22.

Extreme pressure default limits for CRRT

mmHg Alarm

+450 Warning: Filter Extremely Positive

+350 Warning: Return Extremely Positive

+300 Warning: Access Extremely Positive

+10 Warning: Set Disconnection; Warning: Return Disconnection

0

–250 Warning: Access Extremely Negative

Pressure Operating PointsWhenever the Prismaflex control unit is operating, a reference pressure value is stored insoftware memory for each pressure pod and the return line sensor. This value is calledthe pressure operating point. Software continually compares the current pressure ateach monitoring site with the pressure operating point. In this way, the control unit candetect changing pressure conditions in the set and notify the operator with an Advisoryor Warning alarm.



Initial Values

Operating points are initially established a short time after the control unit enters Runmode, when pumps have attained the proper speed and blood flow through the setis stabilized. The amount of time that elapses before all initial operating points areestablished depends on the operator-set blood flow rate and the filter blood volume.

The initial operating points are established by recording the current pressure at eachpressure pod at the end of the time periods shown above.

Note: Some pressure alarms cannot be issued until the operating points are established.

Subsequent Values

During operation, certain events cause the control unit to reset (re-establish) all pressureoperating points by again recording the current pressure at each monitoring site andstoring the value in memory. This ensures that pressure monitoring remains accurateduring the patient treatment.

Operating points are re-established whenever one or more of the following occurs:

• After the blood pump changes speed during Run mode (due to operator changingthe flow rate).

• After the blood pump restarts (following an alarm or after pressing RESUME from theStop screen).

• After the operator presses the CONTINUE softkey from a Caution alarm screen.

• The pressure operating points are also updated after periodic self-test.

Pressure Trending Limits

If the access or return pressure changes 50 mmHg (or 70 mmHg if blood flow >200ml/min) negative or positive from its established pressure operating point, the control unitnotifies the operator by issuing an Advisory alarm or a Warning alarm. See Pressuretrending limits for an overveiw of the different trending and related alarms. Detailedinformation on the individual alarms is also available in the Troubleshooting chapterstarting on page 11:1.

larms can be cleared by pressing the CONTINUE key on the alarm screen. This resets thepressure operating points to the current pressures at each monitoring site.

Pressure trending limits

mmHg Alarm

+50/+70Advisory: Check AccessAdvisory: Check Return↑

Pressure Operating Point

↓ –50/–70Warning: Return Pressure DroppingAdvisory: Check Access

–150 Warning: Access Extremely Negative


“Cannot Detect Disconnection” LimitsThe detection of return disconnections requires a suitably large pressure drop on thereturn line. If pressure and/or flow conditions on the blood return result in an operatingpoint that is below +10 mmHg, the Prismaflex control unit cannot enable disconnectionmonitoring. The control unit then issues an Advisory: Cannot Detect Return alarm inorder to notify the operator and to give instructions how to remedy the situation.

Detailed information on the individual alarms is also available in the Troubleshootingchapter starting on page 11:1.

Software-calculated PressuresPrismaflex software uses monitored pressure values to calculate other vital pressureconditions, including filter pressure drop and other parameters depending on the therapyin use. These pressures indicate conditions within the filter. They are used to providenotification that clotting or membrane pore plugging (clogging) is beginning in thefilter—or that the filter has clotted or membrane pores have plugged (clogged) and theset must be changed.

These additional pressure data are displayed and updated on the Status screen during apatient treatment. In addition, a Status Graph (line graph) showing the trends of thesepressures over an operator-settable period of 1 to 3 hours can be displayed, see “CustomMode” on page 4:21.

Filter Pressure Drop (Pressure Drop)Filter pressure drop is a calculated value used to determine pressure conditions in theblood compartment of the filter. Filter pressure drop is calculated by Prismaflex softwareas follows:

ΔPfil = Pfil – Pret

Where ΔPfil is Filter pressure drop (mmHg), Pfil is Filter pod pressure (mmHg) andPret is Return sensor pressure (mmHg)

Filter pressure and Return pressure readings are automatically corrected by softwarefor hydrostatic pressure biases to compute and display Pressure Drop data (–25 mmHgcorrection).

During a patient treatment, microclotting can occur in the blood compartment of the filter,eventually leading to gross clotting and the need to change to a new set. Clotting createsresistance as blood flows through the filter and causes the filter pressure drop to increase.

The following example shows how filter pressure drop increases with filter use:

Increase of Filter Pressure Drop with Filter Use

Begin Time After Filter Has Been in Use

Filter pod pressure 150 mmHg 300 mmHg

– Return sensor pressure 90 mmHg 180 mmHg

= Filter pressure drop 60 mmHg 120 mmHg

= Displayed Filter pressure drop 35 mmHg 95 mmHg

In the above example, filter pressure drop increased by 60 mmHg.

During operation, software sets the initial value for filter pressure drop at the same timethe initial operating points are established (shortly after entering Run mode), see “Pressure



Operating Points” on page 3:5. This initial value is reset each time the blood flow rateis changed. The amount of increase above the initial filter pressure drop contributesto the Advisory: Filter Is Clotting alarm. The operator can set the amount of increasethat will trigger the alarm. For more information, see “Custom Mode” on page 4:21,“User-controllable Settings” on page 4:22. For “Filter Pressure—Plasmafilter Is ClottingAdvisory Limits” in “Chapter 13: Specifications” on page 13:1.

Fluid Management

Fluid management in Prismaflex system is based on three fundaments:

- pumps and scales

- bags and containers

- protection from fluid imbalance

Pumps and ScalesThe Prismaflex system controls flow rate of solutions by combining a pump and a scale.The machine has four occlusive, peristaltic pumps and four scales. Color coding of thescales matches the color coding of disposable lines and clamps. Shape and color codingof the scales match shape and color coding of the instructions and alarm screens. Thenumber of pumps used and their function depends on the selected therapy.

The Prismaflex software controls the speed of the peristaltic pumps to constantly maintainthe set flow rates, based on the changing weight of the fluid bags/containers in use.

Set flow rates are:

- either directly set by the operator, like dialysate or replacement

or

- computed by the software as a function of the operator-set flow and anticoagulationsettings and the therapy in use, like PBP and effluent. See chapter 5: “ContinuousRenal Replacement Therapies (CRRT)”, chapter 6: “Therapeutic Plasma Exchange(TPE)” and chapter 8: “Anticoagulation Methods”.

During a patient treatment (Run mode), all the peristaltic pumps turn clockwise and ifthe blood pump stops for any reason, all other pumps also stop. When the blood pumpresumes, the other pumps also resume after a short delay.

Solution Bags and ContainersThe Prismaflex system is validated to operate with GAMBRO® bags. Standard dialysate,PBP and replacement solution bags are 5000 ml. Standard effluent bags are 5000 ml or9000 ml, see “Effluent Bag” on page 2:20. Prismaflex scales can accept bags/containerswith a total weight of up to 11kg (see also chapter 13, Specifications).

Before using any bag that is not a GAMBRO® bag on the Prismaflex system, the operatormust verify that:

- the bag or container does not interact with the machine cabinet or basement


- the bag or container does not interact with bags hung on the next scales

- Prismaflex disposable set lines are not kinked or interacting with the basement whenconnected to the bag/container.

- bag perforations match the removable carrying bar with three hooks − to get a steadyassembly for the scales

- the bag is compatible with the selected Empty Bag method, see next section

See “Changing a Bag During Treatment” on page 4:30 for changing bags instructions.

Empty Bag MethodsThe Prismaflex system offers two methods for automatic detection of empty state ofbag or container:

- Fixed Empty Bag method: machine stops when weight hung on scale reaches 230 g

- Variable Empty Bag method: machine stops after the specified solution volume hasbeen pumped from the bag or container

When an empty bag is detected, machine stops and informs operator via the screen.

Variable Empty Bag method is especially designed for the use of containers like bottles.

This method is the only method available for:

• TPE therapies. See operating instructions in chapter 6.

• HP therapies. See operating instructions in chapter 7.

Fixed Empty Bag method is the default method in CRRT therapy and is validated forGAMBRO® bags. If using any bag that is not a GAMBRO® bag, the operator must verifyif they are compatible with the Fixed Empty Bag method.

Empty Bag method is user-selectable in custom mode; see ”User-controllable Settings:CRRT specific settings” on page 4:24. Incorrect selection of the Empty Bag method orof the bag/container volume may result in failure of the Empty Bag alarm, leading toair intake in the blood flow path.

Effluent BagPrismaflex system manages the effluent bag in a way similar to the Variable Empty Bagmethod by controlling the amount of fluid pumped into the effluent bag. This volumecan be adjusted according to the size of effluent bag in use; see accessories description“Effluent Bag” on page 2:20.

Protecting from Flow ProblemsThe Prismaflex system is designed to provide for safe fluid balance management.Flow problems in the fluid lines, bags, or pump segments can change the flow ratewithin the fluid lines and the filter and cause errors in the patient fluid balance. ThePrismaflex protective software protects from these situations via alarms that suspend thetreatment and alert the operator. This section describes the alarms which apply to alltherapies.



How Prismaflex system Monitors the Flow Rates and FluidsThe scales continuously monitor the weight of the PBP, dialysate, replacement, andeffluent bags and provide information to Prismaflex software about how much fluid thecontrol unit has pumped. The information is subject to the accuracy specifications of thescales. See Accuracy Specification in “Chapter 13: Specifications” on page 13:6.

During operation, software compares the actual bag weights to the expected weights. Theexpected weights are continually computed, based on the flow rates that the operator hasset. The control unit stops all fluid pumps and issues a Caution: Weight alarm if the actualweight of a bag varies too much from the expected value. The alarm usually indicatesa flow obstruction.

In addition to bag weights, Prismaflex software monitors the speed of PBP, dialysate,replacement and effluent pumps. The machine stops all fluid pumps and issues a Caution:Incorrect Flow alarm if the speed of a pump has stayed constantly at its minimal ormaximal allowed speed for too long. The alarm usually indicates a problem with solutionsnot infusing at their expected rates, often due to partial flow obstructions.

“Weight” AlarmThe Prismaflex system continuously monitors the weight of the PBP, dialysate,replacement, and effluent bags. The different scales provide information to the Prismaflexsoftware about how much fluid the control unit has pumped. During operation, thesoftware compares the actual bag weights to the expected weights. The control unit stopsall fluid pumps and issues a “Weight” caution alarm if the actual weight of an individualbag varies too much from the expected value.

The Prismaflex system has two different thresholds for issuing “Weight” alarms: one for"Immediate" deviations, and one for “Cumulative" deviations within a one hour period.The threshold for the “Immediate” alarm is fixed to a deviation of 20 ml, whereas the“Cumulative” alarm is set to either 40 ml or 120 ml, depending on the set type.

Thresholds for “Weight” Alarms

The control unit stops all fluid pumps if an alarm is issued. The blood pump continues to runand circulates the patient's blood through the blood flow path.

Seta Immediate alarm Cumulative alarm

Low flow sets 20 ml 40 ml over 1 hour

High flow sets 20 ml 120 ml over 1 hour

a. See “Table Sets and patient weight limits” on page 2:17 for a list of High Flow/Low Flow sets.

Common causes of an Immediate “Weight” alarm:

• Flow obstruction (e.g. unintentionally clamped fluid line, or incorrect break of thefrangible pin or peeling of the seal of a fluid bag)

• Major fluid leakage

• Swinging or partially supported bag

• Environment with vibrations

Common causes of a Cumulative "Weight” alarm:

• Partial flow obstruction (e.g. incorrect break of the frangible pin, kink)

• Fluid leakage


• Degassing (highly negative effluent pressure, or incorrect break of the frangible pinor peeling of the seal of a solution bag)

• Pump occlusivity problems

“Incorrect Flow” AlarmMinimum and maximum speeds of PBP, dialysate, replacement and effluent are computedas a function of set flow rate. In most circumstances, the “Incorrect Flow” alarm istriggered when a pump operates for five minutes at its extreme allowed speed; this timemay be longer for low flow rate settings.

Common causes of an "Incorrect Flow” alarm:

• Partial flow obstruction (e.g.incorrect break of the frangible pin, kink)

• Fluid leakage

• Degassing (highly negative effluent pressure, or incorrect break of the frangible pinor peeling of the seal of a solution bag)

• Pump occlusivity problems

Remedying the “Weight” and “Incorrect Flow” AlarmsInstructions are provided on the alarm screens and in the “Chapter 11: Troubleshooting”.The operator should thoroughly investigate and remedy all possible problems beforepressing the CONTINUE softkey on the alarm screen, which restarts the fluid pumps.Once the underlying problems are resolved, the Prismaflex control unit will temporarilyadjust the fluid flow on the affected bag in order to compensate for the occurred flowdeviation.

If the underlying problem persists, subsequent alarms will occur. Episodes of unresolvedIncorrect “Weight”, or “Incorrect Flow” alarms can result in substantial fluid losses orgains in the patient. These are additionally monitored by the Prismaflex system and ifindicated, additional alarms are issued. See “Chapter 5: Continuous Renal ReplacementTherapies (CRRT)”,“chapter 6: Therapeutic Plasma Exchange (TPE)”and “chapter 7:Hemoperfusion (HP)” for treatment specific details on these alarms.

Air Management

DescriptionPrismaflex blood flow path is designed to minimize trapping of air bubbles and to collectall air in the deaeration chamber. To this end upward blood flow is managed in the filterand in the pods. The specific design of the deaeration chamber provides for:

- a stable layer of infusion fluid at the top of the chamber when using post-replacementinfusion, thus preventing air-blood interface and minimizing clotting

- a circular blood flow pattern in the chamber allowing for efficient removal of airbubbles within a limited blood volume



Deaeration Chamber MonitoringThe fluid level in the deaeration chamber may vary due to procedures during treatment. Asmall amount of air may be introduced each time, e.g. when changing bags. Frequentmonitoring of the level is necessary. If the fluid level in the deaeration chamber is notaccurate (refer to the drawing displayed on the screen), the level can be adjusted while allpumps remain running. See “Deaeration Chamber” on page 4:32.

Changing the Fluid BarrierIn case the fluid barrier has been wet, it is recommended to interrupt the therapy andchange the set. Trained and experienced operators may however change the fluid barriercomponent; instructions are provided in chapter 11: “Troubleshooting” on page 11:84.

Anticoagulation MethodsThe Prismaflex control unit has a syringe pump that delivers anticoagulant to the bloodflow, if desired. Various syringe sizes and brands can be used.

The syringe pump can also be used for calcium infusion during citrate treatment, ifconfigured in service mode by an authorized service technician. Contact the localrepresentative for further information.

The following anticoagulation methods are selectable on theChoose Anticoagulation Method screen:

• Standard – Syringe. For treatments with anticoagulation regimen, using thePrismaflex syringe pump.

• Standard – No Syringe. For treatments performed without anticoagulation regimen.The Prismaflex syringe pump is disabled during the entire treatment.

• Citrate – Calcium via External Infusion Pump. For treatments using Citrateanticoagulation. Requires Citrate solution on the PBP scale. The Prismaflex syringepump is disabled during the entire treatment. Calcium must be infused via an externalinfusion pump.

• Citrate – Calcium via the Prismaflex Syringe Pump. For treatments using Citrateanticoagulation. Requires Citrate solution on the PBP scale. The Prismaflex syringepump is used for calcium infusion. Requires dedicated Prismaflex calcium infusionline connected to syringe.

Regional citrate anticoagulation methods are not available in all therapies. For detailedinstructions about anticoagulation management, see “Anticoagulation Methods” onpage 8:1.

Treatment Preparation

Set loading and IdentificationLoading sequence automatically installs all the pump segments of thePrismaflex disposable set in the pump raceways. It identifies the set by reading its barcode. This identification allows the system for selecting the relevant operating flow andpressure ranges, as well as the specific priming sequence.


Set PrimingSet priming is structured in one or more priming cycles. The operator initiates eachpriming cycle which usually requires 1000 ml of priming fluid. During priming, thePrismaflex system checks for common handling errors, e.g. clamped lines and tangledlines, and gives troubleshooting instructions when necessary. The operator must connectone or more solution bags to blood flow path to prime according to instructions givenon the screen. Solution bags/containers will be required on the scales according to theselected therapy.

PBP solution bag is not requested if not part of the prescription and if default PBP flowrate is zero.

PBP solution bag will be systematically requested in the following situations:

• When having selected “Citrate – Calcium via External Infusion Pump” anticoagulationmethod.

• When having selected “Citrate – Calcium via the Prismaflex Syringe Pump”anticoagulation method.

• After a CHANGE SET sequence where PBP was prescribed.

Alarm Safety and Monitoring Systems

Alarm Safety SystemThe Prismaflex control unit continually monitors itself and the Prismaflex disposableset for abnormal conditions. Depending on the circumstance, the operator is alerted bythe following:

• Red or yellow status light

• Audible alarm

• Alarm screen on the display, giving instructions for responding to the abnormalcondition

Alarms are prioritized into Warning, Malfunction, Caution, and Advisory alarms. See“Chapter 10: Alarm System” on page 10:1, for more information.

Monitoring SystemsPressureThe Prismaflex control unit has an integral pressure monitoring system. The system alertsthe operator (via alarms) to abnormal pressure conditions, such as clotting or extremepositive pressure in the return line For more information, see “Components for ReturnPressure Monitoring” on page 3:4.

Blood LeakThe Prismaflex control unit has an infrared blood leak detector that monitors the effluentline for blood. If blood is detected, the operator is notified via a Warning alarm whichstops the blood pump and closes the return line clamp.

Air BubbleThe Prismaflex control unit has an ultrasonic air bubble detector that continually monitorsthe return line for the presence of air. The detector consists of two ultrasonic transducers



(transmitter and receiver). If air is detected, the operator is notified via a Warning alarmthat stops the blood pump and closes the return line clamp.

Patient ConnectionThe Prismaflex control unit has additional sensors within the housing of the airbubble detector, including a tubing detection switch and a patient blood sensor. Thesesensors can detect the presence/absence of the return line and whether blood is inthe line. The presence of blood in the return line at this location on the machine isinterpreted by Prismaflex software as an indication that a patient is connected to a loadedPrismaflex disposable set.

A Warning alarm occurs if the operating mode of the machine indicates that a returnline should NOT be installed and/or that blood should NOT be in the return line. Theoperator is required to verify whether a patient is connected and take appropriate action.Depending on operator response, patient safety alarms may be enabled immediately ormay be disabled until start of treatment. See Warning: Blood Detected in Sets alarm inchapter 11: “Troubleshooting”.

Flow rates and volumesThe Prismaflex control unit has scales that continually monitor pumped volumes andflow rates of the PBP, dialysate, replacement and effluent pumps. For more informationrefer to page 3:8 of this chapter.

Self-tests of the Prismaflex® SystemThe Prismaflex software continually monitors the operation of the control unit and thePrismaflex disposable set. As part of this regular monitoring, three different types ofself-tests are performed. Each self-test consists of a series of subtests done in a sequentialorder.

The first self-test is the initialization test. This test series is done after the operator turnsthe power switch to “On.” The initialization test ensures that the Control and Protectivesubsystems are operating properly. When the initialization test is successfully completed,the control unit enters Setup mode.

The second self-test is the prime self-test. This occurs when the device is in Setup mode,while the operator is selecting the physician-ordered therapy, and is loading, priming, andinspecting the Prismaflex disposable set.

The third test series is the periodic self-test, which is conducted every two hours duringRun mode while the patient treatment is underway. Following is a summary of the threeself-tests.

Note: Complete descriptions of these self-tests and all other monitoring routines of thePrismaflex control unit are provided in the Prismaflex Service Manual. For Prime Self-testand Periodic Self-test, see also “Chapter 11: Troubleshooting”.

Initialization TestThe initialization test begins after the operator turns the power switch to the “On” position.The Logo screen appears on the machine display, the non-mutable buzzer sounds, andsome status lights are lit during the test. After the initialization test completes, the controlunit enters Setup mode.


Prime Self-testThe prime self-test consists of two phases of subtests: pre-prime and post-prime.The pre-prime phase starts together with the LOAD phase. The operator manuallystarts the post-prime phase of testing by pressing the PRIME TEST softkey on thePriming X of Y Cycles Complete screen. It includes all the subtests done during theperiodic self-test of Run mode, as well as additional subtests.

During the testing process, if any subtest fails, an alarm occurs informing the operatorabout the specific failure and providing instructions.

Periodic Self-testA periodic self-test is conducted by the control unit at the following times:

• During a patient treatment (Run mode): A periodic self-test is conducted every twohours. The first periodic self-test starts 10 minutes1 after Run mode is entered.Periodic self-test may be delayed 10 min by selecting the DELAY softkey. Timeschedule of the periodic self-test may also be automatically modified by the systemaccording to next intervention schedule (bag change or syringe empty).

• Following an operator’s request (Run mode): A periodic self-test is conducted bypressing the SELF-TEST softkey from the System Tools screen.

CAUTIONThe DELAY function must not be used more than twice in a row. Failure ofpressure monitoring systems may occur if there are too many consecutive usesof the DELAY function.

CAUTION

Periodic self-test appears as an Advisory alarm with no CONTINUE softkey. Flow Ratesand History information can be read from the self-test alarm screen. A complete periodicself-test takes approximately 1 to 6 minutes.

Note: This alarm signal is silent. Only yellow light on top during self test.

During the testing process, if any subtest fails, the entire periodic self-test fails and theMalfunction: Self-test Failure alarm occurs. The alarm screen identifies the subtest thatfailed and provides instructions for the operator.

Alarm Monitoring During the Periodic Self-testPressure management is affected by an ongoing periodic self-test. Dependent on thevarious sub-tests in progress, pressure limits are either replaced by temporary limits, orare temporarily disabled. Occurrences of related alarms may be postponed until aftercompletion of the test.

Note: Return pressure monitoring and related alarms remain active during periodicself-tests.

1 If another alarm occurs at the scheduled start of a periodic self-test, the self-test may be delayedup to 15 seconds.



Chapter 4

Operating the Prismaflex® SystemContents

About the Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:2System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:2Communicating with the Prismaflex® Control Unit . . . . . . . . . . . . . . . . . . . . . . 4:2Interactive Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:2User-controllable Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:2Default Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:2Current Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:3Safety Relevant Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:3

Prescription Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:3Adjusting the Prescription Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:4Viewing the Prescription Settings during Treatment . . . . . . . . . . . . . . . . . . . 4:4

History Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:4History Data After a Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:5History Data During a Power Loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:5Saving the History Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:5I/O Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:5View Periods for I/O Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:5

Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:6Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:7Fluid Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:7Pressure Graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:7

Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:7Therapy Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:8Moving the Prismaflex® control unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:8Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:8Shutting Prismaflex® off: Query screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:8Control and Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:9Screen Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:9Operating modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:10Setup Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:10Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:14Run Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:15End Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:16Change Set and End Treatment Procedures . . . . . . . . . . . . . . . . . . . . . . . 4:17

Recirculation in End Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:18Saline Recirculation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:18Blood Recirculation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:20

Custom Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:21User-controllable Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:22Change Bags Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:29Prismaflex® Control Unit Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:29Modifying the Allowed Bag Volume During Treatment in Variable Empty Bagmode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:29Changing a Bag During Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:30

Initiation of PBP Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:30Change Syringe Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:31Syringe Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:31Syringe Change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:32

Deaeration Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:32Fluid level management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:32Foam management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:33


Operating the Prismaflex System 4:1

About the ChapterThis chapter contains information about the user interface, definitions, access to treatmenthistory and general handling of the machine during start up, treatment and termination oftreatment.

System Overview

Communicating with the Prismaflex® Control UnitThe Prismaflex control unit has a color touch screen display. The touch screen allows theoperator to interact with the control unit by pressing various softkeys.

Interactive DisplayDuring operation, different screens appear on the display, showing information aboutthe treatment, giving steps the operator should take, and alerting the operator to anyabnormal conditions. Specific display contents depend on the software mode andoperating conditions at the moment. Some types of operating data, such as historydata, are only displayed when requested by the operator. The display is also a vehiclefor servicing the system.

Softkeys are located along the bottom of each screen and may also appear on the sides.Softkeys allow the operator to give commands to the control unit and navigate betweenscreens. The operator presses the desired softkey to initiate the function described by itsname. The name and function of many of the softkeys change, depending on operatingconditions. In this way, the operator is led through operating and alarm responsesituations.

In most cases, when the operator presses a softkey, a new screen appears immediately. Inother cases, the same screen remains on the display and the color of the pressed softkeychanges to indicate that it is selected. The selected softkey may need to be pressed againto deselect it before the action requested can occur. Instructions on the screen guidethe operator if this is required.

Softkeys appearing on certain screens may be inactive until the operator makes a certainchoice or performs a required action. When a softkey is not available for use, its nameor symbol is gray. When the softkey becomes available, its name or symbol assumes itsnormal color.

User-controllable SettingsIn order to administer the specific patient treatment prescribed by the physician, theoperator controls many of the control unit’s settings. Other settings are controlled onlyby the manufacturer or by authorized service technicians.

The tables in “User-controllable Settings” starting on page 4:22 lists all user-controllablesettings, their default values, setting options, and the operating mode in which they can bechanged.

Default ValuesThere are default values for each setting. Default values are initially set by themanufacturer. The following information pertains to default values:

• Each possible therapy/set combination has its own default values, including values forflow rates, bag volumes, and alarm limits.

4:2 Operating the Prismaflex System G5036003 Revision 05.2011Program version 6.xx

• There are additional default values for settings that apply to all therapy/setcombinations, for example, the decibel level of the audible alarm beep, and the sizeand brand of the syringe allowed for use.

• The default value of a setting controls operation, unless the operator selects a newvalue for that setting during setup or administration of a treatment.

• All settings revert to their default values whenever a New Patient procedure is chosen.

• The operator can change the default values of the user-controllable settings. Thiscan only be done in Custom mode. For more information, see “Custom Mode” onpage 4:21.

Current ValuesCurrent values are those that control operation during a patient treatment.

When the operator chooses a particular therapy/set combination during the Setupprocedure, the control unit uses the default values assigned to that combination. Theoperator can modify some of these values during the Setup procedure (Setup mode) orwhile the patient treatment is underway (Run mode). Any changes made in Setup or Runmodes apply only to that treatment and do not affect the default values.

Safety Relevant SettingsSome user-controllable settings are critical to patient safety. These include alltreatment- flow rate- and anticoagulation settings. These settings are modifiable via theEnter Treatment Settings- Enter Flow Settings- and Enter Anticoagulation Settings screens.

Whenever the operator modifies a safety relevant setting, the new value is shown twicefor operator confirmation. The modified value is shown on the Enter Flow Settings orEnter Anticoagulation Settings screens, then again on a separate screen. In Setup mode,the separate screen is the Review Prescriptions screen; in Run mode, it is the Status screen.

The operator must assure that the values of safety relevant settings are the same in theEnter Flow Settings and Enter Anticoagulation Settings screens as on the confirmationscreen. If the screens display different values for the same setting, a data corruption hasoccurred. In this event, use of the Prismaflex control unit must be discontinued untilservice has made repairs.

Prescription SettingsPrescription settings include both Flow Rates and Anticoagulation Settings.

Flow rates are the settings that control the rate of blood flow, PBP and replacementinfusion, dialysate and/or other flows depending on the therapy in use. Flow rates aredirectly user-controllable except:

- the effluent flow rate in CRRT

- the effluent flow rate in TPE

- the PBP flow rate when using regional citrate anticoagulation methods.

- the syringe flow rate when using “Citrate - Calcium via the Prismaflex Syringe Pump”as a regional citrate anticoagulation method.

These flows are automatically set by software, based on all other flow rates andanticoagulation settings. See chapter 5, 6and 7 for the description of available flow ratesettings in each therapy.



Anticoagulation settings are the settings that control the intensity of the anticoagulation;setting parameters are dependent on the anticoagulation method in use. All anticoagulationsettings are directly user-controllable. See chapter 8 for the description of availablesettings in each anticoagulation method.

Adjusting the Prescription SettingsDuring the Setup procedure (Setup mode), the Enter Flow Settings andEnter Anticoagulation Settings screens are displayed. The operator is prompted to assessthe default flow rates for the therapy/set chosen, make any changes desired for the currenttreatment, and confirm all values shown on the Review Prescription Settings screen priorto starting the patient treatment.

The VIEW CHANGES softkey (only available in Run mode) is lit when a change inthe settings has been made. By pressing this button you can see the previously enteredvalues and the new values.

In Custom mode, if desired, the operator can change the default flow rates. See “CustomMode” on page 4:21.

In Run mode, the operator can access the Enter Flow Settings andEnter Anticoagulation Settings screens for adjusting the prescription parameters asneeded. See “Operating modes” on page 4:10 and “User-controllable Settings” on page4:22.

Viewing the Prescription Settings during TreatmentDuring a patient treatment (Run mode), the current prescription settings are displayed onthe Status screen. For more information, see “Operating modes” on page 4:10.

History DataVital machine conditions and operating data is stored and updated minute-by-minute insoftware memory. The memory stores up to 90 hours of treatment data; thereafter, the olddata is deleted and the new data are added minute-by-minute.

History data includes

• I/O Data

• Events

• Graphs

Each category of data may be viewed on a History screen specific to it. I/O Data aredisplayed on the main History screen. Treatment data are also displayed on this screen.The Events and Graph screens are available from the main History screen.

The History screen can be accessed from the Status screen during a treatment (Run mode)and from the Treatment Complete screen when ending a treatment (End mode). Historydata for the last treatment performed can be accessed from the Choose Patient screen(Setup mode). History data can also be saved onto a technical data card, if desired. See“Saving the History Data” on page 4:5.


History Data After a TreatmentAfter a treatment is concluded, the history data is stored in the Prismaflex softwarememory. It can be viewed from the Choose Patient screen (Setup mode) by pressing theLAST HISTORY softkey. The last history data is deleted when the NEW PATIENT softkeyis pressed, or whenever the date or time is changed in Custom mode.

History Data During a Power LossIf a power loss occurs during a treatment, the history data is retained in thePrismaflex software memory.

Saving the History DataIf desired, the history data can be copied electronically to a removable technical data card.The card is placed in the technical data card holder on the rear of the Prismaflex controlunit and the data is copied using the DOWNLOAD DATA softkey on the History screen.The data is saved in a text format as an .txt file, which can be imported into softwareprograms. Each time the DOWNLOAD DATA softkey is pressed, all of the information inall of the History screens is copied.

The card has to be placed in the technical data card holder to copy data and has to beremoved from the technical data card holder after data is saved. It is recommended to usea separate technical data card for each patient whose record is being saved.

In End mode (at the end of a treatment), the History data for the current treatment isdownloaded automatically.

In Setup mode while the Choose Patient screen is displayed, the History data for the lasttreatment can be downloaded. This is the process to follow in case automatic downloadhas previously failed.

Note: The content of History data is reset when choosing New Patient.

I/O DataTo facilitate periodic totalling of patient I/O (input and output) volumes during atreatment, the cumulative totals of all Prismaflex system controlled fluids are computedand updated minute-by-minute. This process begins when treatment (Run mode) starts.These cumulative totals, called I/O Data, are reported on the main History screen. ForCRRT it is also shown on the Status screen (Run mode).

View Periods for I/O DataDepending on the default View Period stipulated in Custom mode, the initial view on theHistory screen is either the default I/O Period or the default History Time Period. I/OPeriod is an operator-controllable setting of either 60, 30, or 15 minutes, whereas theHistory Time Period is an operator-defined period of time which can span the entiretreatment (up to 90 hours).

Before beginning the Setup procedure, the operator can use Custom mode to change thedefault values for View Period, I/O Period, and the number of hours for the History TimePeriod1. These settings can also be changed during treatment, using the softkeys on themain History screen. I/O Period is also modifiable from the Modify Settings screen,accessible via the Status/System tool screen.

1 In Custom mode, the default History Time Period is indirectly set by selecting the defaultCumulative Hours value.



Note: During treatment, the History Time Period displayed can be changed by pressingthe START TIME and END TIME keys. The period of time selectable is: from the lastminute of treatment to the last 90 hours of treatment with increments of 1 minute.

Information included in I/O data is dependent on therapy in use, see chapter 5, 6 and 7.

EventsCertain events that may occur during setup and delivery of a treatment are stored anddisplayed on the three Events screens. The control unit stores the date, hour and minutethat events occur, as well as description of the event. Up to five thousand events canbe stored.

Events are displayed in chronological order, starting with the most recent. Arrow keyson the Events screens allow the operator to scroll up or down the chronological list.When the operator presses the EVENTS softkey from the History screen, all events aredisplayed. If desired, the operator can then view only the alarm-related events or only theevents related to flow rates and anticoagulation settings.

An event is recorded when any of the following occurs:

• Patient ID is entered/not entered.

• Patient weight and Hct are entered.

• Therapy and Anticoagulation method are initially selected (Setup mode).

• A Prismaflex disposable set is loaded and automatically identified by the bar codereader or manually identified by the operator.

• A Bar Code reading failure occurs.

• Flow rates and anticoagulation settings are initially set (Setup mode).

• TPE Prescription setting are initially set (Setup mode).

• A syringe is installed/removed from the syringe pump.

• When an anticoagulation bolus dose is infused from the Prismaflex syringe pump.

• TMPa self-calibration values are determined.

• Prime test is passed.

• Treatment is started (Run mode).

• Initial TMPa and Filter Pressure Drop are established.

• A flow rate or anticoagulation setting is changed during treatment.

• The level of the deaeration chamber has been adjusted

• TPE Prescription setting is changed during treatment.

• The Allowed Volume of a bag or container is changed.

• The System Tools functions “Blood Leak Detector normalization” or “Manual podrepositioning” are used.


• An alarm occurs.

• An alarm screen is cleared from the display.

• Any of these softkeys are pressed: LOAD, PRIME, PRIME TEST, STATUS (whenpressed on the Change Bags screen), CHANGE BAGS, RESUME, STOP,START RECIRC, STOP RECIRC, RESUME RECIRC, START RETURN,END TREATMENT, CHANGE SET, UNLOAD.

• TPE is continued after the physician prescription is delivered.

GraphsHistory information related to fluid flows and operating pressures is available onGraph screens, allowing easy visualization of trends over time. Graphs are accessed fromthe main History screen.

The operator selects the desired amount of time to view, using the START/END TIME andarrow softkeys, and the graphs automatically adjust to the selected time period2. For timeperiods of 12 or fewer hours, the time increment on the graphs is one hour. For timeperiods greater than 12 hours, the time increment is divided evenly over the requestedtime span. The graph displays information from less recent data (left) to more recent data(right). In addition to a graph, the Graph screens also display the Cumulative Hours andRun Time pertinent to the selected time period.

Fluid GraphsThe Fluid Graphs include the Cumulative Volumes Graph (line graph) and other graphsdepending on the therapy in use.

For each fluid in use, the Cumulative Volumes Graph reports the total volume pumpedduring each time increment of the graph. There is a separate line for each fluid in use. Onthe right side of the screen, the total volume pumped over the requested time period isreported for each fluid. See chapter 5, 6 and 7 for more information.

Pressure GraphThe Pressure Graph displays history information for the measured and computedpressures depending on the therapy in use. By using the softkeys provided, the operatorcan view all the pressures, a combination of pressures, or just one pressure at a time.

Status ScreenThe Status screen is the main operating screen while a treatment is underway. On theStatus screen the pressure conditions in the set, the flow rate and anticoagulation settingsare displayed. The operator is also notified of when next intervention is required, e.g.changing a bag or syringe empty. If abnormal situations occur, an alarm screen willappear that provides information about action that needs to be taken.

2 The START/END TIME and arrow softkeys must be deselected before the graph updates tothe requested time period.



Therapy Operation

Moving the Prismaflex® control unitThe wheel size of the Prismaflex control unit allows it to pass over an 8 mm step. To passover a 2 cm step, do not push, but pull the control unit.

CAUTIONWhen moving the Prismaflex control unit, grab the recessed handles at left andright hand side. Do not apply pull/push force to e.g. syringe pump or scales.

CAUTION

StartupStartup of the Prismaflex control unit consists of the following steps:

1. Connect the power cord to the wall socket.

2. Operator turns the power switch to the “On” position.

WARNINGAfter turning ON the control unit, verify the audible alarm and that the green,yellow and red status lights are lit alternately during the start up sequence. Incase of malfunction, switch OFF the control unit and call for Service.

WARNING

3. The control unit performs an initialization test to check the system electronics. TheLogo screen is displayed, the non-mutable buzzer sounds, and status lights arelit during the test.

4. When the initialization test is successfully completed, the Prismaflex control unit isin the Setup mode and is ready for operation. If desired, the operator can look attherapy information screens for an overview of the Prismaflex system therapies andthe Prismaflex disposable sets, or can proceed to the Choose Patient screen.

Note: The above actions occur when a new Prismaflex control unit is initially turned on.These actions also occur whenever the unit is turned on after being turned off in theTreatment Complete screen. If the control unit was last turned off in a screen other thanTreatment Complete, a Query screen appears after the initialization test is completed.

From the Query screen, the operator can choose one of two actions:

• Begin on the same operating screen as when the unit was turned off by pressing theCONTINUE key.

• Stop treatment and start over in Setup mode by pressing the NEW PRIME key.

Starting over in Setup mode requires priming a new set. The operator is prompted toconfirm this choice by pressing the CONTINUE softkey.

Shutting Prismaflex® off: Query screenTroubleshooting may require the operator to switch off the machine via the main powerswitch, located at the bottom of the right side of the machine see figure 2:6 on page 2:14.


In both of the following situations, as the machine is turned on again, the Query screenwill be displayed:

1. Patient is connected:

- if Manual Termination procedure has not been performed while the machinewas shut down, press CONTINUE and follow the on-line instructions to resumeoperation at the point where the system was shut off. Define appropriate operatorresponse to the specific alarm or condition that lead to switching off the machine.Operator response may require to disconnect, return blood (when applicable) andor end treatment. See “Manual Termination of Treatment“ on page 11:76.

CAUTIONIn case the machine has been switched off while the patient was connected, it isimportant to assess blood clotting in the circuit before resuming the treatment.

CAUTION

- if Manual Termination procedure has been performed while the machine wasshut down and no set loaded on the machine, press NEW PRIME to initiate a newtreatment.

2. Patient is not connected:

From the Query screen, the operator can choose one of two actions:

• Begin on the same operating screen as when the unit was turned off by pressing theCONTINUE key.

• Stop treatment and start over in Setup mode by pressing the NEW PRIME key.

Starting over in Setup mode requires priming a new set. The operator is prompted toconfirm this choice by pressing the CONTINUE softkey.

Control and NavigationThe Prismaflex control unit is operated by means of the interactive display on the upperfront panel. The screens displayed lead the operator through the operating procedures.Help screens provide additional information, if needed. The softkeys that appear on eachscreen enable the operator to give commands to the control unit and navigate betweenscreens.

Screen LayoutScreens (text and softkeys) displayed by the Prismaflex control unit have the followinglandmarks:

• The top of the screen shows the screen title.

• The upper right corner shows the date, time, current operatingmode and the therapy selected by the operator.

• The bottom right softkey of most operating and alarm screens hasa HELP key. Pressing this key provides more detail about thedisplayed screen and softkey functions.



• The bottom right softkey of Help screens is labeled EXIT HELP.Pressing this key allows the operator to return to the screen thatwas displayed when HELP was pressed.

• An EXAMINE ALARMS key appears above the HELP keywhenever an alarm occurs, whenever the operator overrides analarm, or whenever one or more lower-priority alarms are pendingduring an alarm.3 For more information, see “Chapter 10: AlarmSystem” on page 10:1.

• A drawing may appear on certain screens, such as theLoad Set screen. The drawing provides an easy visual reference forthe operator in performing the actions described on the screen.

• The CONFIRM ALL softkey appears on Flow Rates andAlarm Limits (Custom mode), Enter Flow Settings andEnter Anticoagulation Settings screens. CONFIRM ALL placesall operator choices into software memory and exits the currentlydisplayed screen.

• Arrows appear on certain screens. These enable the operator toadjust settings. For example, arrows are used to set the flow rates orview a certain time period within the history data. By pressing andholding the arrows, the operator can scroll through the availableoptions. By pressing and releasing the arrows, the operator canmake fine adjustments. The arrows also allow the operator toincrease/decrease fluid level in the deaeration chamber of the set.

Operating modesIn the course of performing a treatment, the control unit passes through four normalOperating modes: Setup, Standby, Run, and End. Following is a description of each ofthese Operating modes.

Additional and specific instructions and descriptions are available in the separate therapyand anticoagulation methods chapters.

Setup ModeThe control unit automatically goes into Setup mode after successful completion of theinitialization test. Setup mode enables the operator to load the Prismaflex disposable setonto the control unit, prepare and connect needed solutions, and prime the set.

The operator follows the instructions on the display to perform the following sequentialactions:

1. Perform preliminary procedures, if desired.

• Enter Custom mode to alter default settings of one or more Prismaflex systemtherapies. For more information, see “Custom Mode” on page 4:21.

• Enter Therapy Information screen to read an overview of the Prismaflex systemtherapies and Prismaflex system sets.

3 The EXAMINE ALARMS key does not appear on the Enter Flow Settings screen, theEnter Anticoagulation Settings screen or any other screen accessed via these screens. (See“Chapter 10: Alarm System” on page 10:1.)


• View/download history data of the last treatment.

2. Choose NEW PATIENT or SAME PATIENT.

If NEW PATIENT is chosen, the control unit deletes the history data of the lasttreatment and advances to the Choose Therapy screen.

If SAME PATIENT is chosen, the control unit retains the history data of the lasttreatment, retains the last therapy and anticoagulation choices and advances to theLoad Set screen (move to Step 7 below).

• If SAME PATIENT is chosen, PBP, dialysate and/or replacement solution bagsin use can remain in use until empty.

3. Enter an identification for the patient (optional).

4. Enter the patient’s current weight, then enter the patient's current hematocrit.

5. Press CONFIRM softkey to continue, or press the appropriate softkey to correctpatient information.

6. Choose therapy.

7. Choose anticoagulation method.

8. Positioning of the desired set onto the control unit may vary depending on the therapyand set chosen. See information on control unit’s display. Make sure the lines movesfreely in their guides and are not pinched.

WARNINGEnsure that the proper Prismaflex disposable set has been chosen for theselected therapy. Using the wrong set for the therapy can cause patient injuryor death.

WARNING

9. Automatically load the set by pressing the LOAD softkey. When LOAD ispressed, the following occurs: (a) the peristaltic pumps begin turning; (b) thePrismaflex disposable set is pushed outwards and then drawn inward; (c) the pumpsegments are threaded into the pump raceways; (d) the pinch valve segments arethreaded into the pinch valves; (e) the bar code reader scans the bar code label onthe Prismaflex disposable set.

Note: When the LOAD softkey is pressed, the control unit automatically performs a test.If the test fails, the Warning: Set-up Error alarm or the Warning: Wrong Set Loadedalarm is generated.

10. Confirm the identity of the set that has been loaded.

Note: If the bar code reader cannot read the bar code, the operator must manually enterthe set’s identity and confirm it. Once the set’s identity is confirmed, the control unitaccesses the default settings and screens for the therapy/set selected.

11. Press the radio buttons on the display in turn. Follow the text and illustrations of thestep-by-step instructions for each button.

12. Route lines through tubing guides and prepare and connect fluid bags and primingsolution bag according to on-line instructions.

13. Install a syringe, if applicable. Confirm the syringe installation, if applicable



14. Verify the setup. Make sure that all used lines are unclamped. Verify that allconnections are correct and secure.

15. Automatically prime the set by pressing the PRIME softkey. Priming period andsequence depends on therapy/set selected.

CAUTIONAfter priming is complete, do not remove the pressure pods from their pressuresensor housings and do not disconnect the deaeration chamber monitor linefrom the return pressure port. If one or more pods are removed, the DiaphragmReposition Procedure must be performed on the affected pod(s) and the setmust be reprimed. If the Diaphragm Reposition Procedure fails, the set mustbe changed. If the monitor line is disconnected, the set must be reprimed andthe fluid level in the deaeration chamber adjusted.

CAUTION

Note: When PRIME is pressed, a priming sequence specific to the chosen therapy isconducted. During this sequence, the pumps run at internally set speeds. The blood pumpturns clockwise (except for a few seconds in counterclockwise) and forward primesthe blood lines and filter.

Note: Do not remove the pressure pods from the pressure sensor housings after priming iscomplete. If pods are removed, the set must be changed or the Diaphragm Repositionprocedure performed.

16. Perform the prime test by pressing the PRIME TEST softkey. The control unitperforms multiple self-tests lasting between 5 and 10 minutes depending on thetherapy selected. Refer to the Prismaflex Service Manual for a list of the primeself-tests.

Note: After pressing the CONTINUE softkey on the Prime test passed screen there is nopossibility of returning to previous screens.

17. Adjust the deaeration chamber fluid level if needed.

18. Enter Pre-treatment settings:

18.a. Set Patient Fluid Loss/Gain LIMIT in Enter Treatment Settings (only CRRT)

18.b. Enter TPE prescription settings (only TPE)

19. Adjust flow rates and anticoagulation settings if anticoagulation is used.

20. Review the prescription settings and confirm by pressing CONTINUE. The systemwill now proceed to Standby mode.

The operating screens that appear in Setup mode are listed by title in Table “OperatingScreens in Setup Mode” on page 4:13. Screens are listed in the order in which theyappear during the Setup procedeure.

Note: The written information on the screens varies, depending on the therapy chosen. Inthis way, the instructions pertinent to each therapy are displayed for the operator.


Operating Screens in Setup Mode

Logo ScreenChoose PatientEnter Patient ID (optional)Enter Patient WeightEnter Patient HematocritConfirm Patient InformationChoose TherapyChoose Anticoagulation Method

Confirm Anticoagulation MethodTherapy and Anticogulation ChoiceLoad SetLoading Pumps, please waitConfirm Set LoadedPrepare and Connect SolutionsInstall Syringe (depending on anticoagulation method in use)Confirm Syringe Installation (depending on anticoagulation method in use)Verify SetupPriming, please waitPriming, Access Line CompletePriming X of X Cycles CompletePrime Test, please waitPrime Test PassedEnter Treatment SettingsEnter TPE PrescriptionEnter Flow SettingsEnter Anticoagulation Settings (not available for “Standard — No Syringe” anticoagulationmethod)

Review Prescription



Standby ModeThe control unit automatically goes into Standby mode after the operator completes allSetup procedures and presses the CONTINUE softkey on the Review Prescription screen.The Connect Patient screen appears. The operator can connect the patient to the primedset at this time.

If necessary, the Enter Flow Settings and Enter Anticoagulation Settings screens can bere-accessed for further adjustments before starting the treatment.

WARNINGConnect patient

Before connecting the blood return line to the patient, check for absence of airbetween the segment of line inserted in the air bubble detector and the patientend of the return line. If air is present in this part of the return line, connect theaccess line to the patient and start the blood pump while leaving the returnline connected to the collection bag. Purge the air present in the end-part ofthe return line, then stop the blood pump. Disconnect the return line from thecollection bag, and connect it to the patient. If the amount of air in the bloodcircuit is too large, reprime the circuit completely before patient connection.

Clamp unused lines after priming is complete and before starting a patienttreatment according to therapy configuration.

WARNING

CAUTIONIf a patient is not connected to the Prismaflex disposable set shortly afterpriming is complete, flush the set with at least 500 ml priming solution (salinewith heparin added) before connecting a patient. This may require use of anew bag of priming solution and a new (empty) collection bag. Consult theInstructions For Use packaged with the set for details about priming volumes.

CAUTION

The control unit also enters Standby mode each time the STOP softkey is pressedduring Run mode. The Stop screen appears and provides options to re-enter Runmode by pressing RESUME, or proceed to End mode by pressing CHANGE SET,END TREATMENT, or RECIRC.

During Standby mode all pumps are stopped, appropriate alarms are enabled, and theyellow status light is lit. The screens that appear in Standby mode are listed in table“Operating Screens in Standby Mode” on page 4:14.

Operating Screens in Standby Mode

Connect Patient (Standby mode entered from Setup mode)Blood Prime (available when HF20 disposable set is selected)

Verify Patient Connection

Reconnect Patient (after Recirculation procedure) (Standby mode entered from End mode)

Change BagsStop (Standby mode entered from Run mode)


Run ModeThe control unit enters Run mode after the operator connects the patient to the primed setand presses the START softkey from the Verify Patient Connection screen.

During Run mode, all appropriate alarms are enabled and the green status light is lit,unless an alarm occurs or the CHANGE BAG softkey is selected.

The Status screen is the main Run mode screen and is normally displayed during the entirepatient treatment. From the Status screen, the operator can access all the other Run modescreens. Run mode allows the operator to perform the following actions:

1. Administer the treatment to the patient. The fluid pumps operate according tosettings validated by the operator. Bag weights are monitored and history data isaccumulated and stored.

2. Adjust flow rates and anticoagulation settings as needed. This includes changing thesyringe if needed.

3. Change fluid bags at any time through the Change Bags/Containers function. Modifythe Allowed Volume for any bag if Variable Empty Bag Method is active and ifnecessary.

4. Adjust the Deaeration Chamber.

5. View history data.

6. Temporarily stop the patient’s treatment by pressing the STOP softkey.

7. From the System Tools screen, do any of the following:

• View instruction screens for performing the Pressure Pod Adjustment Procedure.Instructions specific to each pod are available.

• Adjust the following settings: Status Graph Period, I/O Period, audible alarm volume,value for Patient Weight and the value for Patient Hematocrit.

• Clean the touch screen (an empty screen is displayed to avoid an unwanted selectionof softkeys).

• Perform an immediate self test sequence.

• Change the occurrence period of the Advisory: Anticoagulation Checkpoints alarm(valid only when performing regional citrate anticoagulation).

• Retest (re-normalize) the sensitivity of the blood leak detector.

Here are the operating screens in Run Mode listed. If a screen is accessed from aprior-appearing screen, it is indented in the table.



Operating Screens in Run Mode

StatusEnter Flow Settings

View Prescription ChangesEnter TPE Prescription (TPE)

Enter Anticoagulation Settings (not available for “Standard — No Syringe”anticoagulation method)

Change Syringe (depending on anticoagulation method in use)Confirm Change Syringe (depending on anticoagulation method in use)View Prescription ChangesView Anticoagulation Solution (“Citrate – Calcium via External Infusion Pump”anticoagulation method)

HistoryEvents screens

Graph screens (Fluid and Pressure)

Change Period

Change Bags/ContainersAdjust Deaeration ChamberSystem Tools

Pod Adjustment ProcedureModify SettingsClean ScreenInitiate Self TestNormalize Blood Leak Detector (Not valid for HP)Anticoagulation Check Points (“Citrate – Calcium via External Infusion Pump”and “Citrate – Calcium via Prismaflex Syringe Pump” anticoagulation method)

End ModeThe control unit enters End mode when the operator presses STOP, then presses theCHANGE SET, END TREATMNT, or RECIRC softkey. Appropriate alarms are enabledand the yellow status light is lit.

End mode allows the operator to perform the following procedures:

1. Change Set – Remove the present set, with or without returning blood to the patientand load a new set.

2. End Treatment – Terminate the present treatment, with or without returning bloodto the patient; view/download history data if desired.

3. Recirculate – Temporarily disconnect patient and recirculate saline or blood throughthe blood lines. Reconnect patient and resume treatment when ready.


WARNINGAlways inspect the blood flowpath for signs of clotting before returning the bloodin the set to the patient. If clotting is suspected, do not return the blood to thepatient.

WARNING

Following is a description of the operator and machine actions that occur in each Endmode procedure.

Change Set and End Treatment ProceduresAfter pressing CHANGE SET or END TREATMNT, the operator follows the instructionsdisplayed to perform the following actions:

1. Return blood to the patient if desired. This is done by pressing theRETURN BLOOD softkey, selecting the desired blood return rate and following theinstructions on the Return Blood screen or by returning blood manually.

CAUTIONBlood return from a blood primed extracorporeal circuit can result in Hypervolemia.Consult physician´s prescription.

CAUTION

Note: The blood pump runs at the operator-selected Blood Return Rate when theMANUAL RETURN softkey is pressed and held.

Note: Returning blood manually involves turning the machine off and cranking the bloodpump clockwise. Step-by-step instructions are provided in “Manual Termination ofTreatment” in “Chapter 11: Troubleshooting” on page 11:76.

2. Disconnect the patient from the set, clamp all lines and unload the set bypressing the UNLOAD softkey. The machine automatically advances to theTreatment Complete screen.

Note: History data is automatically downloaded to the Technical Data Card when set isunloaded.

3. Remove the set, syringe (if empty or unwanted), and fluid bags (if empty orunwanted).

Note: To remove syringe, open plunger clamp latch. Press and hold “Down button” onSyringe control panel until arm reaches lowest position.

WARNINGFollow facility procedures for the proper disposal of the usedPrismaflex disposable set and fluid bags, in accordance with local regulations.

WARNING

If CHANGE SET has been selected:

4. Return to the Load Set screen in Setup mode.

5. Place a new set on the control unit and load it by pressing the LOAD softkey.Treatment continues once the control unit reaches Run mode.

If END TREATMNT has been selected:

4. View history data, if desired.



5. Turn off the control unit if no more patient treatments are desired or press theNEW TREAT softkey to start a new patient treatment and load a new set.

The Change Set and End Treatment screens available in End mode are listed in Table“Change Set and End Treatment Screens in End Mode” on page 4:18. If a screen isaccessed from a prior-appearing screen, it is indented in the table.

Change Set and End Treatment Screens in End Mode

End TreatmentPrepare to Return Blood (optional)Enter Blood Return Rate (optional)Return Blood (optional)Disconnect PatientConfirm UnloadUnloading pumps, please wait

Remove set (for Change Set procedure)

Treatment Complete (for End Treatment procedure)History (for End Treatment procedure)

Recirculation in End ModeRecirculation may be necessary if the patient needs to be temporarily disconnected from theset. Two recirculation procedures are available from Choose Recirculation Mode screen:

• saline recirculation which recirculates saline solution in the blood lines after bloodreturn. This procedure will require a priming before patient reconnection

• blood recirculation which recirculates the blood in the blood lines after the patienthas been disconnected

Saline recirculation can be performed for maximum 120 minutes. Blood recirculationcan be performed for maximum 60 minutes. See Warning: Recirculation Time Exceededalarm in chapter 11, “Troubleshooting”.

Saline Recirculation ProcedureTo perform a Saline recirculation procedure following is needed:- Saline bag to return blood to patient and to perform the recirculation

- Priming solution to prime the set after the recirculation and before reconnectingto patient

- A Y−line connector to joint the access and return lines during the recirculation

Press SALINE RECIRC softkey on the Choose Recirculation mode screen and follow theoperating steps according to instructions on the screen:

1. Hang a bag of sterile saline on priming hook and connect a Y-line to the saline bag.Prime the Y-line with priming solution.

2. Enter the desired Blood Return rate, then disconnect the access line from the patientand connect it to the bag of sterile saline using the Y-line.


3. Return blood to the patient by pressing and holding the MANUAL RETURN softkeyto pump saline through the access line.

Note: If the set has significant clotting, the operator can choose to automaticallyunload it and cycle into the Change Set procedure. This can be done by pressingDISCONNECT without returning the patient’s blood.

4. Enter the desired Recirculation Rate.

Note: The Recirculation Rate can be changed at any time while Recirculation is inprogress.

5. Set the syringe pump to deliver an Immediate Bolus to the access line if “Standard −Syringe” anticoagulation method is active and as needed.

Note: The only syringe pump delivery available in the Recirculation procedure isImmediate Bolus. Whenever the operator sets the Immediate Bolus Volume to a valuegreater than zero, a bolus is administered on exiting the Enter Recirc Flow Rates screen.If needed, a new (full) syringe can be installed during Recirculation.

6. Disconnect the patient from the return line, connect the return line to the saline bagusing the second Y-line extension and begin Recirculation.

Note: The Recirculation in Progress screen reports the following information:Recirculation Time, Recirculation Rate, Status of the Set (liters of patient blood and/orsaline that have been processed through the filter). Most alarms are disabled duringRecirculation.

Note: If necessary, Recirculation can be stopped and the treatment ended. This requiresunloading the set, automatically advancing to the Treatment Complete screen, andfollowing the instructions to remove the set, syringe, and bags. If desired, the patient’streatment can be restarted by selecting Same Patient when the machine is again in Setupmode.

Note: The set must be replaced if the maximum saline recirculation time is exceededor in case of poor blood return.

7. When ready, stop recirculating and prepare to reprime the set. The set is preparedby: (a) disconnecting the access and the return line from each other, (b) connectingthe access line to a bag of priming solution, (c) connecting the return line to a new(empty) prime collection bag.

8. Prime the set. When the prime test is successfully completed, reconnect the patient;resume treatment by pressing the START softkey on the Reconnect Patient screen.

Note: If needed, prescription parameters can be reached and modified by pressingREVIEW PRESCR in Reconnect Patient screen.

Note: Abbreviated priming and prime test sequences are conducted when aPrismaflex disposable set is primed following the saline Recirculation procedure.

The recirculation screens available before patient connection are listed in “SalineRecirculation Screens from Stop to Patient Connection” on page 4:20. If a screen isaccessed from a prior-appearing screen, it is indented in the table.



Saline Recirculation Screens from Stop to Patient Connection

Stop

Stop Calcium Infusion (applicable to “Citrate – Calcium via External Infusion Pump”anticoagulation method)

Choose Recirculation mode

Prepare to Return Blood

Return Blood

Enter Blood Return Rate

Initiate Saline Recirculation

Recirculation in Progress

Adjust Chamber

Enter Recirculation Flow Rate

Change Syringe (applicable to “Standard − Syringe” anticoagulation method)

Confirm Change Syringe

Saline Recirculation Stopped

Change Syringe and Calcium Line (applicable to “Citrate – Calcium via Prismaflex syringepump” anticoagulation method)

Prime Calcium Line (applicable to “Citrate – Calcium via Prismaflex syringe pump”anticoagulation method)

Confirm Change Syringe & Ca Line (applicable to “Citrate – Calcium via Prismaflex syringepump” anticoagulation method)

Prepare to Prime

Priming

Priming Complete

Prime Test

Prime Test Passed

Blood Recirculation ProcedureTo perform a Blood Recirculation procedure following is needed:

• A Y−line connector to joint the access and return lines during the recirculation

• A small volume saline bag to perform the recirculation

After pressing BLOOD RECIRC, the operator follows the instructions displayed toperform the following actions:

1. Hang a bag of sterile saline, 100 ml or less, on priming hook and connect a Y-line tothe saline bag. Prime the Y-line with priming solution.

2. Disconnect the access line from the patient and connect it to the bag of sterile salineusing the Y-line.

3. Disconnect the patient from the return line, connect the return line to the saline bagusing the second Y-line extension.

4. Unclamp any clamp line: saline bag, Y line and set lines

5. Press START RECIRC to begin Recirculation. The blood recirculates within a closeloop.


Note: If the set has significant clotting, the operator can choose to automaticallyunload it and cycle into the Change Set procedure. This can be done by pressingDISCONNECT without returning the patient's blood. The control unit automaticallyadvances to the Disconnect Patient screen where instructions are provided.

Note: The Recirculation in Progress screen offers the same information as in SalineRecirculation. The same functions are also available to change Recirculation Rate, deliveran Immediate syringe bolus or stop the Recirculation.

Note: The set must be replaced if the maximum recirculation time is exceeded.

6. When ready, stop recirculation and follows the steps to reconnect the patient.

Note: The operator will be required to change both the syringe and the calcium line afterrecirculation for the Citrate – Calcium via the Prismaflex syringe pump anticoagulationmethod.

7. Resume treatment by pressing the START softkey on theVerify Patient Connection screen.

The recirculation screens available in End mode are listed in Table “Blood RecirculationScreens in End Mode” on page 4:21. If a screen is accessed from a prior-appearingscreen, it is indented in the table.

Blood Recirculation Screens in End Mode

Recirculate

Prepare Blood Recirculation

Initiate Blood Recirculation

Recirculation in Progress

Adjust Chamber

Enter Recirculation Flow Rate

Change Syringe (STANDARD Anticoagulation method only)

Confirm Change Syringe

Blood Recirculation Stopped

Change Syringe and Calcium Line (applicable to “Citrate – Calcium via Prismaflex syringepump” anticoagulation method)

Prime Calcium Line (applicable to “Citrate – Calcium via Prismaflex syringe pump”anticoagulation method)

Confirm Change Syringe & Ca Line (applicable to “Citrate – Calcium via Prismaflex syringepump” anticoagulation method)

Custom ModeCustom mode allows authorized service technicians to change the default values ofuser-controllable settings4. The tables in “User-controllable Settings” starting on page4:22 provides a list of the user-controllable settings and the mode(s) in which they canbe altered.

4 Only the default values of enabled Prismaflex therapies and filters can becustomized. Prismaflex therapies can be enabled/ disabled only in Service mode, byauthorized service technicians. The enabled Prismaflex therapies are identified on theWelcome to Custom Mode screen.



To change a default value, the operator follows the instructions on the display to performthe following steps:

1. Enter Custom mode by pressing CUSTOM MODE on the Choose Patient screen.

2. When the Modify Defaults screen in Custom mode appears, select the defaultsetting(s) to customize. Specify the new default value(s) on the appropriate Custommode sub-screen.

Note: To modify default flow rates and alarm limits, the operator first chooses the desiredtherapy/set combination, then chooses Flow Rates or Alarm Limits and sets the desireddefault value(s).

Note: CRRT: To modify the Empty Bag Method and the Allowed Bag Volume forDialysate, PBP and Replacement bags, the operator first selects the type of therapy(CRRT), then selects the Empty Bag Method. If the Empty Bag Method selected is“Variable”, the operator selects the bag (Dialysate, PBP or Replacement) and sets thedesired default value.

Note: To modify Allowed Bag Volume, the operator first selects the type of therapy, thenselects the bag and sets the desired default value.

Note: The new default values are saved in memory each time the operator presses theMODIFY DEFAULTS softkey and whenever the EXIT CUSTOM softkey is pressed fromany screen.

The screens available in Custom mode are listed in Table “Screens in Custom Mode”on page 4:22.

Screens in Custom Mode

Welcome to Custom Mode

Modify Defaults

Alarms & Flows – Menu

Alarms & Flows – therapy selected

Alarms & Flows – therapy/set selected

Flow Rates – therapy/set selected

Alarm Limits – therapy/set selected

Syringe Brand

Citrate (available for “Citrate – Calcium via External Infusion Pump” anticoagulation method)

Bag Volume – Menu

Bag Volume – therapy selected

Other Settings

Time/Date

Citrate & Calcium (available for “Citrate – Calcium via Prismaflex syringe pump”anticoagulation method)

User-controllable SettingsUser-controllable settings and the mode in which they can be altered are listed in thetables below. Each setting has a default value and a range of setting options.


Most of the user-controllable settings can be adjusted in more than one mode. Somesettings, such as alarm limits, can only be adjusted in Custom mode, and some settings,such as I/O Period can only be adjusted in Run mode

User-controllable Settings: General settings

ChangeDefault

Change PresentTreatmentSetting Default Options

Custom Setup Run

Time A timeset by themanufacturer

Should always be setto current hour andminute (24-hour clock)Increments: 1 hour; 1minute

X

Date A dateset by themanufacturer

Should always be set tocurrent year, month, andday Increments: 1 year; 1month; 1 day

X

Date Display Day/Month/Y-ear

Day/Month/Year, orMonth/ Day/Year

X

Patient Body Weight Mandatoryinput duringsetup

1–999 kg X X

Patient Hematocrit 30% 10 to 60%Increment: 1%

X X

Return Blood FlowRate Note: End Modeonly

Specific totherapy / set

10 to 100 ml/minIncrement: 10 ml/min5

Recirculation RateNote: End mode,Recirculation only

Specific to set 10 to 150 ml/minIncrement: 10 ml/min

Initial View Period,History screen

I/O Period I/O Period or HistoryTime Period

X

I/O Period, Historyscreen

60 minutes 15, 30, or 60 minutes X X

Cumulative Hours,History screen

Last 12 hoursNote: Thisvalue is also thedefault HistoryTime Period

Last 1 to 90 hoursIncrement: 1 hour

X

Status Graph Display(line graph of TMPand Pressure Droptrends)

On On, Off X

Status Graph Period Last 3 hours Last 1, 2, or 3 hours X X

I/O Reminder Beep On On, Off X

Audible alarm volume Moderate Low, Moderate, High X



User-controllable Settings: CRRT specific settings

ChangeDefault


Custom Setup Run

“Time to Change Set”Advisory Limit

After 72 hoursof use

After 24 to 72 hours ofuse. Increment: 24 hours

X

“TMP Too High”Advisory Limit

+300 mmHg +70 to +300 mmHgIncrement: 10 mmHg

X

“Filter is Clotting”Advisory Limit

Filter pressuredrop is +100mmHg greaterthan initialfilter pressuredrop

+10 to +100 mmHggreater than initial filterpressure dropIncrement: 10 mmHg

X

“Loss Or Gain LimitReached” CautionLimit

(Body Weight* 18 - 70) ml.The value isrounded toclosest 10ml. If thevalue exceedsthe limit forthe set, themaximumvalue for theset will beused.

HF20: 60 - 150 mlM60, ST60: 60 - 200 mlOther sets: 100 - 400 mlIncrement: 10 ml

X

Blood Flow Rate Specific totherapy / set

Specific to therapy/setMaximum Range: 10 to450 ml/min Increment:Specific to set / therapy 5

X X X

PBP Flow RatePBP = pre-blood pump

0 ml/h Specific to therapy/setMaximum Range: 0, 10to 4000 ml/h Increment:flow rate dependent (min30ml/h) 5(see Warningbelow tables)

X X X

Replacement FlowRate

0 ml/h Specific to therapy/setMaximum Range: 0, 50to 8000 ml/h Increment:50 ml/h 5Increment: 20 ml/h forHF20.

X X X

Replacement SolutionDelivery Method

CVVH: 100%Pre-filterCVVHDF:Pre-filter

CVVH: 0 to 100%Pre-filter UsingReplacement PRE%:increment 5% CVVHDF:Pre-filter or Postfilter (seeWarning below tables)

X X X

Dialysate Flow Rate 0 ml/h Specific to therapy/setMaximum Range: 0, 50to 8000 ml/h Increment:50 ml/h 5

X X X


ChangeDefault


Custom Setup Run

Patient Fluid RemovalRate

0 ml/h Specific to therapy/setMaximum Range: 0, 10to 2000 ml/h Increment:10 ml/h 5

X X X

Empty Bag Method Fixed Fixed or Variable X

Allowed Bag Volume— PBP Bag

5000 ml 250 to 5000 mlIncrement: 50 ml

X X

Allowed Bag Volume— Replacement Bag


X X

Allowed Bag Volume— Dialysate Bag


X X

Allowed Bag Volume— Effluent Bag

5000 ml 5000 or 9000 ml 5 X X

“Access ExtremelyNegative” WarningLimit

–250 mmHg –10 to –250 mmHgIncrement: 5 mmHg

X

“Access ExtremelyPositive” WarningLimit


X

“Return ExtremelyPositive” WarningLimit


X

User-controllable Settings: TPE specific settings

ChangeDefault


Custom Setup Run

“TMPa Too High”Advisory Limit

+100 mmHg 0 to +100 mmHgIncrement: 10 mmHg

X

“Plasmafilter isClotting” AdvisoryLimit

Filter pressuredrop (PressureDrop) is +60mmHg greaterthan initialfilter pressuredrop.

+10 to +60 mmHg greaterthan initial filter pressuredrop.Increment: 10 mmHg

X



X X X


0 ml/h Specific to therapy/setMaximum Range: 0, 10to 1000 ml/h Increment:flow rate dependent (min30ml/h) 5 (see Warningbelow tables)

X X X

Replacement FluidFlow Rate

0 ml/h 0, 50 to 5000 ml/hIncrement: 10 ml/h

X X X



ChangeDefault


Custom Setup Run

Patient Plasma LossRate

0 ml/h 0, 10 to 1000 ml/hIncrement: 10 ml/h

X X X

Empty Bag Method Variable Variable X

Total ReplacementVolume

3000 ml 0 to 10,000 mlIncrement: 100 ml

X X

ReplacementContainer Volume

N/A 0 to 5000 mlIncrement: 10 ml

X X



X X

Allowed Bag Volume— Effluent Bag

5000 ml 5000 or 9000 ml 5 X X



X



X



X

User-controllable Settings: HP specific settings

ChangeDefault


Custom Setup Run

“HP Cartridge isClotting” AdvisoryLimit

Filter pressuredrop is +30mmHg greaterthan initialfilter pressuredrop

+10 to +30 mmHg greaterthan initial filter pressuredropIncrement: 10 mmHg

X



X X X


0 ml/h Specific to therapy/setMaximum Range: 0, 10to 1000 ml/h Increment:flow rate dependent (min30ml/h) 5(see Warningbelow tables)

X X X

Time to Change Set 6 hours 1 to 6 hoursIncrement 1 hour

X X X

Empty Bag Method Variable Variable X

5 See “Chapter 13: Specifications” on page 13:1.


ChangeDefault


Custom Setup Run



X X



X



X



X

User-controllable Settings: Anticoagulation related settings

ChangeDefault


Custom Setup Run

Standard anticoagulation method

Syringe Brand6 TERUMO 50 10 ml (Holder 10):BD PLASTIPAKTERUMOB. Braun (Omnifix)Others20 ml (Holder 20):BD PLASTIPAKTERUMOKendall MonojectB. Braun (Omnifix)Others30 ml (Holder 30):BD PLASTIPAKTERUMOICO GAMMA PlusPIC 30 LLB. Braun (Omnifix)Others50 ml (Holder 50):BD PLASTIPAKTERUMOCodan Luer lockFresenius InjectomatEcojectKendall MonojectB. Braun (Omnifix)B. Braun (Perfusor)Others50 ml (Holder 50B):B. Braun (Perfusor)Others

X

Syringe DeliveryMethod

Continuous Continuous or Bolus X X



ChangeDefault


Custom Setup Run

Syringe ContinuousDelivery Rate

0 ml/h 0, 1.0 to 5.0 ml/h for 10ml syringe; 0, 0.5 to 5.0ml/h for 20 ml syringe;0, 0.5 to 10.0 ml/h for 30ml syringe. 0, 2.0 to 20.0ml/h for 50 ml syringeIncrement: 0.1 ml/h

X X

Syringe BolusDelivery Volume

0 ml 0, 0.5 to 5.0 ml for 10ml and 20 ml syringe; 0,1.0 to 5.0 ml for 30 mlsyringe; 0, 2.0 to 9.9 mlfor 50 ml syringeIncrement: 0.1 ml

X X

Syringe BolusDelivery Interval

Once every 6hours.

Once every 1 to 24 hoursIncrement: 1 hour Note:Immediate option alsoavailable in Run mode

X X

Syringe “Immediate”Bolus VolumeNote: End mode,Recirculation only

0 ml (nodelivery)

0 ml, or 0.5 to 5.0 mlIncrement: 0.1 ml

Regional citrate anticoagulation method

Syringe Brand6 TERUMO 50 50 ml (Holder 50):BD PLASTIPAKTERUMOCodan Luer lockFresenius InjectomatEcojectKendall MonojectB. Braun (Omnifix)B. Braun (Perfusor).50 ml (Holder 50B): B.Braun (Perfusor)

X

Calcium solution Defined inService mode,then solutionselectable inCustom mode

Calcium concentration:80 to 1000 mmol/lIncrement: 1 mmol/l

X

Citrate solution Defined inService mode,then solutionselectable inCustom mode

Citrate concentration7:10 to 600 mmol/l (CRRT)75 to 600 mmol/l (CRRTand septeX)50 to 300 mmol/l (TPE)Citric acid concentration7:0 to 100 mmol/l (CRRT,CRRT and septeX)0 to 50 mmol/l (TPE)Increment: 1 mmol/l

X

Calcium compensation 100% 5 to 200% X X X

6 Syringe holder size is configurable in Service Mode.7 The sum of the citrate and citric acid concentrations is not allowed to exceed the maximumcitrate concentration applicable to the selected therapy.


ChangeDefault


Custom Setup Run

Citrate Dose 3.0 mmol/l ofblood

0, 1.5 to 6.0 mmol/l ofbloodIncrement: 0.1 mmol/l ofblood

X X X

Replacement CalciumConcentration

0.00 mmol/l Calcium concentration:0.00 to 1.75 mmol/lIncrement: 0.05 mmol/l

X

WARNINGChanging of the therapy settings that implies the use of lines containingnon-circulating fluid (for example, changing the pre- and post-filter options fordelivery of the replacement solution or starting using the PBP Pump) during thetreatment may increase the risk of clot release to the patient. It is the operator’sresponsibility to verify that no clots are present in the line before using it.

WARNING

Change Bags FunctionAny of the bags in use can be changed at any time during a patient treatment (Run mode)or when in Connect Patient in Standby Mode, not just when a Bag Empty/Bag Full alarmoccurs. This is done by using the Change Bags function available on the Status screen andon the Connect Patient screen.

Prismaflex® Control Unit ActionsWhen CHANGE BAGS on the Status screen is pressed, the following control unit actionsoccur:

• Blood pump continues to operate; all other pumps stop8.

• Yellow status light lights up as a reminder that therapy is not being delivered.

• Audible alarm sounds as a reminder that therapy is not being delivered.

• Change Bags/Containers screen appears and provides on-line instructions.

Modifying the Allowed Bag Volume During Treatment in Variable EmptyBag modeWhile changing any bag, the operator can also change to using a different size of bag ifVariable Empty Bag method is used. For example, the operator can change from using aneffluent bag of 5000 ml total capacity to using an effluent bag of 9000 ml total capacity.This is done by using the Modify Bag function on the Change Bags/Containers screen.

When the MODIFY BAG softkey is pressed, a list of bags in use appears, alongwith softkeys for selecting the bags. The operator presses the softkey for the bagvolume to be modified, then uses the Arrow keys to choose a new Allowed Volume.An alarm occurs when resuming the treatment if there is a discrepancy between theAllowed Volume of a bag and the actual volume sensed by the scale on which the

8 Anticoagulant syringe does not stop and continues to operate when Standard-Syringeanticoagulation method is selected.



bag is hanging. MODIFY BAG softkey is available only when Variable Empty Bagmethod has been selected from CUSTOM mode. Effluent bag always provides forMODIFY EFFLUENT softkey.

Changing a Bag During TreatmentChange fluid bags when the appropriate Caution alarm occurs (PBP Bag Empty,Replacement Bag Empty, Dialysate Bag Empty or Effluent Bag Full). Changing a bagbefore the alarm occurs may only be done by using the Change Bags function andfollowing the instructions on the Change Bags/Containers screen.

To change a bag during treatment, perform the following steps.

1. Press CHANGE BAGS on the Status screen to access theChange Bags/Containers screen.

2. Press the MUTE key to silence the audible alarm.

3. Open the scale of the bag to be changed. The Changing Bag screen is displayed.

4. Move the scale carrying bar to the side hook.

5. Clamp the bag and the line of the set connected to it. Disconnect the bag from the line.

6. Hang a new bag on the scale carrying bar and connect it to the line.

7. Unclamp the new bag and line.

8. Hang the scale carrying bar with bag on the scale; close the scale.

9. If changing to a larger/smaller bag when using the Variable Empty Bag method,press MODIFY BAG or MODIFY EFFLUENT and use the arrows to select the totalvolume capacity of the new bag9.

10. Verify that lines to bags in use are unclamped and unused lines are clamped.

11. Press CONTINUE to return to the Status screen and resume the patient treatment.

Initiation of PBP FlowIn case no PBP bag was present during priming, it remains possible to initiate PBPsolution flow when the treatment is running.

The operator must perform the following sequential actions:- press CHANGE BAG and hang a PBP bag on the scale

- set the desired PBP flow rate in the Enter Flow Settings screen

- monitor fluid level in the deaeration chamber for the next five minutes as some airmight flow through the blood flow path.

9 With Fixed Empty Bag method, no action is required when changing to a larger/smallerbag. For Effluent bag it is possible to change only the total volume capacity by pressingMODIFY EFFLUENT in the Change Bags screen.


Change Syringe ProceduresIt is necessary to install and use a syringe if Standard − Syringe anticoagulation methodis selected during setup.

It is necessary to install and use a syringe if Citrate – Calcium via Prismaflex syringepump anticoagulation method is selected during setup.

Installing a syringe in the Prismaflex syringe holder requires that the appropriate syringesize and brand are used. Syringe size is predefined in Service mode by an authorizedservice technician and syringe brand is selected by the operator in Custom mode. Selectedsyringe size shall correspond to the numerical label on the mounted Syringe holder.For the B.Braun (Perfusor) a separate holder (50B) can be ordered. Contact your localrepresentative for additional information.

Syringe InstallationA luer lock syringe of the allowed brand and size should be filled and installed in thesyringe pump during Setup mode. This is done while the Install Syringe screen isdisplayed. Detailed instructions with drawings are available on the Prismaflex controlunit screens. Main installation steps are:

- open the syringe plunger clamp latch and press the AUTO DOWN softkey so that thesyringe arm reaches its lowest position

- connect the filled syringe to the syringe line, applicable to Standard − Syringeanticoagulation method

- connect the filled syringe to the dedicated calcium infusion line, applicable to “Citrate– Calcium via Prismaflex Syringe Pump” anticoagulation method

- set the syringe in its holderwhen installing the B. Braun (Perfusor) − push the plunger clamp latch correctly on tothe syringe plunger, as illustrated in figure 4:2

Figure 4:2 B. Braun (Perfusor) installation

- press the AUTO UP softkey until the CONFIRM softkey gets visible



- lock the syringe plunger

The line connected to the syringe is primed during the automatic priming cycle.

Note: As an alternative to the AUTO DOWN and AUTO UP softkeys, syringe controlpanel buttons can be used to move the syringe arm. In this case, keep the button presseduntil the syringe arm is moved to its lowest position or until the CONFIRM key appears.These buttons are disabled outside the syringe installation or change procedures.

Syringe ChangeThe syringe must be changed after the Advisory: Syringe Empty alarm, and can also bechanged at any time during treatment from the Anticoagulation Settings screen. Changesyringe steps are similar to the ones for installation, after the syringe infusion line hasbeen clamped and the empty syringe unlocked.

Deaeration Chamber

Fluid level managementThe fluid level in the deaeration chamber may vary due to procedures during treatment.A small amount of air may be introduced each time e.g. when changing bags. Frequentmonitoring of the level is necessary.

Figure 4:3 Suggested fluid level in the deaeration chamber.

If the fluid level in the deaeration chamber is not accurate (refer to the drawing displayedon the screen), the level can be adjusted while all pumps remain running. From theStatus screen, press ADJUST LEVEL softkey and use the Up or Down arrows to bring thefluid level to the correct height.

Note: When the Up arrow is pressed, the excess air is drawn into the monitor line andpassed out through the return line pressure port. Maintain the fluid level of the deaerationchamber periodically:

• A too high level increases the risk of wetting the fluid barrier of the monitor line. Awet fluid barrier will lead to obstruction of the monitor line and consequently lossof return pressure monitoring.


• A too low level may trigger a premature AIR IN BLOOD alarm due to the proximityof air bubbles coming from the infusion fluids and accumulating into the deaerationchamber.

Note: To reduce the risk of early clotting at the top of the chamber when operatingwithout post-replacement infusion, it is recommended to adjust the chamber level to about1 centimeter below the usual level; refer to the drawing displayed on the screen.

Foam managementIn some circumstances, a significant amount of foam may develop at the top of thedeaeration chamber. In this situation some foam may reach the fluid barrier in case ofsudden return access obstruction and pressure increase. Experience shows that increase ofthe post-replacement infusion rate reduces the amount of foam.



Chapter 5

Continuous Renal ReplacementTherapies (CRRT)Contents

General Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:2Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:2Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:3

About the Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:3Therapy Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:3Mechanisms of CRRT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:3Available CRRT Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:4

SCUF (Slow Continuous Ultrafiltration) . . . . . . . . . . . . . . . . . . . . . . . . . 5:6CVVH pre+post filter (Continuous Veno-venous Hemofiltration) . . . . . . . 5:7CVVHD (Continuous Veno-venous Hemodialysis) . . . . . . . . . . . . . . . . . 5:8CVVHDF (Continuous Veno-venous Hemodiafiltration) . . . . . . . . . . . . . 5:9

Available anticoagulation methods in CRRT . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:10CRRT Disposable Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:10

Specific Functions in CRRT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:12Machine Control of Patient Fluid Removal Rate . . . . . . . . . . . . . . . . . . . . . . . . 5:12Protecting From Fluid Imbalance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:12Setting the Patient Fluid Loss/Gain Limit . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:12Patient Fluid Loss or Gain Limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:12Loss or Gain Limit Reached Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:13

Pressure Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:13Therapy Operation in CRRT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:14CRRT Treatment Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:14Prescription Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:14Replacement Solution Delivery Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:14Total predilution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:15Filtration Fraction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:16

Patient Fluid Removal Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:16Calculating the Desired Patient Fluid Removal Rate . . . . . . . . . . . . . . . . . . . 5:16Adjusting the Patient Fluid Removal Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:16

Monitoring Patient Fluid Removed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:17Measuring Patient Fluid Removed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:17Viewing Patient Fluid Removed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:17

Fluid Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:17Information Included in I/O Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:18CRRT Prescription indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:18

Equations for CRRT Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:19Time to Change Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:19

CRRT with HF20 Disposable Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:20CRRT septeX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:20Therapy Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:20Therapy Operation in CRRT septeX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:21Flow rate Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:21Anticoagulation Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:21

CRRT MARS® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:21Description of CRRT MARS® Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:21CRRT MARS® Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:23CRRT MARS® Disposable Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:24Operating during CRRT MARS® Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:25Setup and Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:25Run Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:27Pressure management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:27Blood leak monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:27

End Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:27


CRRT 5:1

General Warnings and Cautions

WarningsWARNING

Weigh the patient daily, or as appropriate, to ensure proper fluid balance.Monitor the patient’s blood chemistry and patient vital data as often asnecessary.

The Prismaflex disposable set must be changed after 72 hours of use or 780liters of blood have been processed through the filter. Continued use beyondthese limits could result in rupture of the pump segments, with patient injuryor death.Note: To ensure adequate filter performance, it is recommended that thedisposable set of the Prismaflex system is changed after 24 hours of use.

Renal replacement therapy with high-permeability hemofilters may reduce theconcentration of therapeutic drugs in the patient. The prescribing physicianshould consult the literature of the drug manufacturer for further information andconsider the need to monitor the concentration of the drug in order to ensurean appropriate therapeutic dosage.

Changing of the therapy settings that implies the use of lines containingnon-circulating fluid (for example, changing the pre- and post-filter options fordelivery of the replacement solution or starting using the PBP Pump) during thetreatment may increase the risk of clot release to the patient. It is the operator’sresponsibility to verify that no clots are present in the line before using it.

Use only prescribed dialysate solution and replacement solution/fluid with thePrismaflex system. The solution must have a density similar to that of salinesolutions (close to 1) in order to avoid errors in the volumes used for fluidexchange. Use only dialysate solution and replacement solution/fluid thatconform to applicable national registration, standards, or laws. If a commerciallyavailable replacement solution is used, it must be labeled as intended forHemofiltration and Hemodialysis. For CVVH and CVVHDF it should also belabeled as intended for intravenous injection.The use of non sterile dialysate could induce risks of bacterial and pyrogeniccontamination for the patient.

As treatment proceeds, carefully monitor patient fluid balance levels and all theI/O Data on the Status and History screens. Fluid balance monitoring shouldinclude frequent totaling of patient fluid input/output and periodic verification ofthe patient's weight using an independent device.

The blood leak detector must be re-normalized if the effluent line is removedand then reinserted into the blood leak detector after treatment (Run mode) hasstarted. See Troubleshooting chapter on page 11:85.

WARNING

5:2 CRRT G5036003 Revision 05.2011Program version 6.xx

CautionsCAUTION

The Prismaflex system is not designed for a heater to be connected to theinfusion solution lines. A heater generates air bubbles which collect in thedeaeration chamber. Therefore, it is recommended not to use a heater on thereplacement or on the PBP infusion lines.

The Prismaflex system is not designed for a heater to be connected to thedialysate line. A heater generates air bubbles which are accumulated in thefilter/dialyzer dialysate compartment, impairing solutes transfer. Therefore, it isrecommended not to use a heater on the dialysate line.

Monitor hypothermia and pay special attention when increasing exchangevolumes above 2 L/h. See “Chapter 9:Blood Warmers” on page 9:1.

Observe the effluent bag for pink or red tinge as an indicator of undetectedmicro blood leaks. Discoloration of effluent due to the patient’s disease process(rhabdomyolysis for example) should also be considered as a root cause.

Filter performance specifications require a minimum blood flow rate, specificto each filter, to avoid risk of hemoconcentration.

Use saline or alkaline solution (pH ≥ 7.3) with heparin added to prime the set.

CAUTION

About the ChapterThis chapter completes and deepens the information given in chapter 2, 3 and 4 whenoperating in CRRT. This chapter provides information about specific functions in CRRTand general operating instructions in CRRT as a complement to chapter 4.

At the end of this chapter there are detailed information given for following CRRTmodalities:

• CRRT with HF20 Disposable set

• CRRT septeX Disposable set

• CRRT MARS

Therapy Description

Mechanisms of CRRTThe mechanisms of ultrafiltration, hemofiltration and hemodialysis are used in providingthe Prismaflex system CRRT options.

Ultrafiltration In ultrafiltration, plasma water with solutes is drawn fromthe patient’s blood across the semipermeable membranein the filter. The effluent pump automatically controlsthe ultrafiltration rate.

Hemofiltration In hemofiltration, plasma water with solutes is drawnfrom the patient’s blood across the semipermeablemembrane by means of ultrafiltration. A replacementsolution is simultaneously infused into the bloodflowpath, either pre and/or post-filter.


CRRT 5:3

The replacement solution adds back some or all of thewater removed, as well as the required solutes. Unwantedsolutes are not replaced, so their concentration decreasesin the patient’s blood. Solute removal is achieved byconvection (solvent drag across the membrane).

Hemodialysis In hemodialysis, unwanted solutes pass from the patient’sblood across the semipermeable membrane and intodialysate flowing at counter flow through the fluidcompartment of the filter.The concentration of unwanted solutes is lower in thedialysate than in the blood, causing the solutes to diffusefrom an area of greater concentration (the patient’s blood)to an area of lesser concentration (the dialysate solution).Solute clearance is achieved by diffusion.

Hemodiafiltration In hemodiafiltration, both hemodialysis andhemofiltration are used. Solute removal occurs byconvection and diffusion.Dialysate solution is pumped through the fluidcompartment of the filter. At the same time, the effluentpump controls ultrafiltration and a replacement solutionis infused into the blood flowpath.

Available CRRT ModesThe following section describes the way the various available therapies are implementedin the Prismaflex system. Operating flow ranges for blood flow and the various solutionsflows are dependent on the selected therapy and disposable set, see Table “High Flowsets” on page 15:2 and Table “Low Flow sets” on page 15:3.

Available modes in CRRT:

- SCUF

- CVVH

- CVVHD

- CVVHDF

Available modes in CRRT septeX :

- CVVHD

- CVVHD+

Available modes in CRRT MARS:

- CVVHD

- CVVHDF


Available flow rate parameters depending on selected CRRT Mode

CRRT mode SCUF CVVH CVVHD CVVHDF

Blood flow X X X X

PBP flow X X X X

Dialysate flow — — X X

Replacementflow

— X — X

PRE-POSTinfusion

— PRE% — PRE/POST

Patient FluidRemoval rate

X X X X

Available flow rate parameters depending on selected CRRT septeX Mode

CRRT mode CVVHD CVVHD+

Blood flow X X

PBP flow X X

Dialysate flow X X

Replacement flow — POST

Patient Fluid Removal rate X X

Available flow rate parameters depending on selected CRRT MARS Mode

CRRT mode CVVHD CVVHDF

Blood flow X X

PBP flow X X

Dialysate flow X X

Replacement flow — X

PRE-POST infusion — PRE/POST

Patient Fluid Removal rate X X


CRRT 5:5

SCUF (Slow Continuous Ultrafiltration)The Prismaflex system SCUF provides patient fluid removal and allows for PBP infusion.

Figure 5:1 SCUF flow

1. Filter2. Conductive clip3. Blood leak detector4. Syringe pump5. Blood pump6. Return clamp7. Air bubble detector, patient sensor and line sensor8. Deaeration chamber9. Return pressure10. PBP bag11. Effluent bag12. Pressure sensor13. Pump14. Sample site


CVVH pre+post filter (Continuous Veno-venous Hemofiltration)The Prismaflex system CVVH provides hemofiltration with both pre and post-filterreplacement infusion and allows for PBP infusion

Figure 5:2 CVVH pre+post filter flow

1. Filter2. Conductive clip3. Blood leak detector4. Syringe pump5. Blood pump6. Return clamp7. Air bubble detector, patient sensor and line sensor8. Deaeration chamber9. Return pressure10. Scale, PBP bag11. Scale, Replacement bag12. Scale, Effluent bag13. Scale, Replacement bag 214. Pinch valve15. Pump16. Pressure sensor17. Sample site


CRRT 5:7

CVVHD (Continuous Veno-venous Hemodialysis)The Prismaflex system CVVHD provides hemodialysis and allows for PBP infusion.

Figure 5:3 CVVHD flow

1. Filter2. Conductive clip3. Blood leak detector4. Syringe pump5. Blood pump6. Return clamp7. Air bubble detector, patient sensor and line sensor8. Deaeration chamber9. Return pressure10. PBP bag11. Effluent bag12. Dialysate bag13. Pinch valve14. Pump15. Pressure sensor16. Sample site


CVVHDF (Continuous Veno-venous Hemodiafiltration)The Prismaflex system CVVHDF provides hemodiafiltration with either pre or post-filterreplacement infusion and allows for PBP infusion.

Figure 5:4 CVVHDF flow

1. Filter2. Conductive clip3. Blood leak detector4. Syringe pump5. Blood pump6. Return clamp7. Air bubble detector, patient sensor and line sensor8. Deaeration chamber9. Return pressure10. Scale, PBP bag11. Scale, Replacement bag12. Scale, Effluent bag13. Scale, Dialysate bag14. Pinch valve15. Pump16. Pressure sensor17. Sample site


CRRT 5:9

Available anticoagulation methods in CRRTAnticoagulation methods available in each CRRT therapy are identified in “Therapies andAnticoagulation Methods” on page 8:3.

CRRT Disposable SetThe full range of Prismaflex disposable sets available for CRRT is described below.Further information about characteristics and operating ranges can be found in theInstructions for Use that comes enclosed with the disposable set and in “CRRT DisposableSets” on page 15:2.

Low Flow sets: HF201M60ST60

High Flow Sets: M100ST100M150ST150HF1000HF1400septeX2oXirisMARS3

1 Refer to CRRT with Prismaflex HF20 disposable set on page 5:20.2 Refer to CRRT septeX on page 5:20.3 Refer to CRRT MARS® on page 5:21.


Figure 5:5 CRRT Disposable Set components

1. Sample sitesIn the CRRT disposable sets, sample sites are located as follows: access line beforethe junction with PBP infusion line (red), access line before the blood pump (red),filter line (red), return line between filter outlet and deaeration chamber (blue), effluentline (yellow). The sample site marked orange in figure 5:5 is optional.

2. Pressure podsIn the CRRT sets, pods are located as follows: access line before blood pump (accesspod), access line after blood pump (filter pod) and effluent line before effluent pump(effluent pod).

3. FilterFilter containing hollow fibers made of a semipermeable membrane. Blood flowsthrough the hollow fibers; filtrate and/or dialysate flow counter currently in the fluidcompartment.


CRRT 5:11

4. Upper pinch valve segment (green-striped)Tubing that threads automatically through the upper and lower pinch valves when theset is loaded. Can be occluded or opened by the pinch valves, depending on operatorselections for therapy and replacement solutions delivery.CVVHD, CVVHDF: Allows dialysate hanging on the dialysate (green) scale to beconveyed to the fluid side of the filter.CVVH: Allows solution from a second bag of replacement solution (replacement 2hanging on the green scale) to be delivered post-filter to the deaeration chamber onthe return line.

5. Lower pinch valve segment (purple-striped)Tubing that threads automatically through the upper and lower pinch valves when theset is loaded. Can be occluded or opened by the pinch valves, depending on operatorselections for therapy and replacement solution delivery.CVVH, CVVHDF: Allows replacement solution hanging on the replacement scale(purple) to be delivered either: (a) pre-filter (to the access line just before the filter) or(b) post-filter (to the deaeration chamber on the return line).

Specific Functions in CRRT

Machine Control of Patient Fluid Removal RateThe Prismaflex software automatically calculates the effluent flow rate needed to achievethe patient fluid removal rate. Any PBP, dialysate, replacement and syringe solutioninfused by the Prismaflex control unit is automatically accounted for, as shown below.

During operation, software controls the effluent pump speed to maintain the requiredeffluent rate.

The formula which governs the effluent pump rate for CRRT:

Qeff = Qpfr + Qpbp + Qrep + Qdial + Qsyr

WhereQeff is Effluent rate (ml/h), Qpfr is Patient fluid removal rate (ml/h), Qpbp is PBPflow rate (ml/h), Qrep is Replacement solution rate (ml/h), Qdial is Dialysate solutionrate (ml/h) and Qsyr is Syringe flow rate (ml/h)

Protecting From Fluid Imbalance

Setting the Patient Fluid Loss/Gain LimitIn addition to the alarm system described in chapter 3 to prevent flow errors, thePrismaflex system monitors automatically the Patient Fluid Removed as to detectanomalies and protect from fluid imbalance.

In CRRT, additional information is reported on the History screen to help the operatorunderstand the larger picture related to the patient's fluid balance. This informationincludes the Unintended Patient Fluid Loss or Gain, that is the amount of fluid removalvariance that exists within the last three hours.

Patient Fluid Loss or Gain LimitA safety limit ensures that excessive fluid cannot be unintentionally removed from orinfused to the patient across the semipermeable membrane of the filter. This limit protectsthe patient during abnormal conditions.


To correlate the safety limit to the individual patient, during the Setup procedure, theoperator is prompted to enter the physician-prescribed Patient Fluid Loss/Gain Limit. ThePatient Fluid Loss/Gain Limit must be prescribed by the physician. The value prescribedshould be based on the patient's ability to tolerate potential fluid imbalance. The limitcontrols the amount of unintended patient fluid loss or gain that is allowed within the lastthree hours. The allowed range is dependent on the type of disposable set used for thetreatment. If the limit is reached, an alarm occurs that disables all fluid pumps from furtheruse and requires the operator to end the treatment. During treatment the set prescribedPatient Fluid Loss/Gain Limit can be checked in I/O data section of History screen.

Note: If the SAME PATIENT is chosen during the setup mode, the cumulative count forUnintended Patient Fluid Loss/Gain over the last 3 hours begins again at 0 ml whenthe treatment starts.

Loss or Gain Limit Reached AlarmThe Caution: Loss/Gain Limit Reached alarm occurs whenever the operator-set limit forUnintended Patient Fluid Loss or Gain is reached. Occurrence of this alarm indicates thatthere are ongoing problems with unresolved “Weight” or “Incorrect Flow” alarms.

To prevent serious, unintended patient fluid loss or gain, the Caution: Loss/Gain LimitReached alarm permanently suspends treatment (fluid pumps will not re-start). This alarmrequires the operator to end the treatment.

The alarm screen reports the amount of unintended patient fluid loss or gain that hasaccumulated and shows the operator that this amount now matches the allowed limit.For patient charting, the operator should make a written note of the ml of UnintendedPatient Fluid Loss or Gain reported.

The STOP softkey is provided on the alarm screen and accesses the Stop treatment screen.When ready to end the treatment, the operator should press this key and follow the on-lineinstructions. The Return Blood option will be available.

WARNINGThe Prismaflex control unit is intended to be used on patients weighing 8 kg ormore. A higher minimum patient weight limit may apply for the disposable setselected for the therapy. Refer to the Instructions For Use of the disposable setand Table “Sets and patient weight limits” on page 2:17.

WARNING

Pressure Management

Software-calculated PressuresDuring CRRT, Prismaflex software uses monitored pressure values to calculatetransmembrane pressure (TMP) in addition to the filter pressure drop (Pressure Drop).Both computed pressures are used to provide notification that clotting or membrane poreplugging (clogging) is beginning in the filter, or that the filter has clotted or membranepores have plugged (clogged) and the set must be changed.

The TMP and Pressure Drop are displayed and updated on the Status screen during apatient treatment. In addition, a Status graph (line graph) showing the trends of thesetwo pressures over an operator-settable period of one to three hours, can be displayed.See Custom Mode on page 4:21.

Transmembrane Pressure (TMP)Transmembrane pressure is the pressure exerted on the filter membrane during operationof the Prismaflex system. It reflects the pressure difference between the blood and fluidcompartments of the filter.


CRRT 5:13

The TMP is calculated by Prismaflex software as follows:

TMP = [(Pfil + Pret) / 2] – Peff

Where TMP is Transmembrane pressure (mmHg), Pfil is Filter pressure (mmHg), Pret isReturn pressure (mmHg) and Peff is Effluent pressure (mmHg)

Filter pressure and Effluent pressure readings are automatically corrected by software forhydrostatic pressure biases to compute and display TMP data (–18 mmHg correction).

During a patient treatment, permeability of the membrane decreases due to protein coatingon the blood side of the membrane. This causes the TMP to increase.

During operation, software sets the initial TMP value at the same time as the initialpressure operating points are established (shortly after entering Run mode), see “PressureOperating Points” on page 3:5. Thereafter, the initial TMP value is reset each time theblood flow, patient fluid removal or replacement solution rates are changed and alsoafter self-test.

The amount of increase above the initial TMP value contributes to the Advisory: Filter IsClotting alarm. This TMP parameter can be set only in Service mode by an authorizedservice technician. For more information, see “Filter Pressure—Filter Is ClottingAdvisory Limits” in “Chapter 13: Specifications” on page 13:1.

If the TMP rises above +300 mmHg, the Advisory: TMP Too High alarm occurs. Ifdesired, the operator can lower this Advisory alarm limit, so that the advisory occurs priorto reaching +300 mmHg. For more information, see “Custom Mode” on page 4:21 and“User-controllable Settings” on page 4:22. If the TMP increases beyond the membranecapacity that is product dependent, the Caution: TMP Excessive alarm occurs.

Therapy Operation in CRRT

CRRT Treatment SettingsThe operator is required to confirm the Patient Fluid Loss/gain Limit prescription for theindividual patient. See Protecting from Fluid Imbalance section in this chapter.

Prescription SettingsThe table Available flow rate parameters depending on selected CRRT Mode on page 5:5shows the flow rate settings possibilities for each mode when running CRRT. The operatorcan set the flow rates on the Enter Flow Settings screen, during Setup or Run modes.

PBP flow rate is not available when running regional citrate anticoagulation method,see chapter 8.

For information about PRE/POST infusion, refer to Replacement Solution DeliveryOptions section on page 5:14.

For information about Patient Fluid Removal Rate section, refer to page 5:16.

Replacement Solution Delivery OptionsThe desired replacement solution delivery is selected on the Enter Flow Settings screenafter the set has been primed. There are various delivery options, depending on the CRRTtherapy and anticoagulation method selected.


CVVH: Replacement solution can be delivered 100% pre-filter, 100% post-filter or ina combination of pre- and post-filter (pre/post), for example: 50% pre-filter and 50%postfilter.

CVVH requires that two bags of replacement solution always be hung, so that the setcan be primed appropriately. One bag is placed on the replacement scale (purple) andthe second bag is placed on the replacement 2 scale (green). The way these 2 bags areused is described in Table “Components used with Replacement Solution DeliveryOptions” on page 5:15.

CVVHDF: Replacement solution can be delivered either 100% pre-filter or 100%postfilter. The replacement solution is always delivered through the replacement scale andpump (purple). One bag of replacement solution is hung on the replacement scale.

Table “Components used with Replacement Solution Delivery Options” on page 5:15shows the components used with each possible replacement solution delivery optionin CVVH and CVVHDF.

Note: Not all configurations are supported in regional anticoagulation, using the “Citrate– Calcium via Prismaflex Syringe Pump” Method in combination with calcium containingReplacement solutions. Refer to chapter 8 for further information.

Components used with Replacement Solution Delivery Options

Therapy Delivery Scale/Pump Pinch Valve/ Segment

100% Prefilter ReplacementGreen: no delivery

Lower (purple-striped)

Pre/Post Replacement (deliversprefilter portion)


Green (deliverspost-filter portion)

Upper (green-striped)

100% Post-filter Replacement (delivers1/2 of the selectedflow rate)


CVVH

Green (delivers 1/2 ofthe selected flow rate)

Upper (green-striped)

100% Pre-filter Replacement Lower (purple-striped)

CVVHDF

100% Post-filter Replacement Lower (purple-striped)

CVVHD+post 100% Post-filter Replacement Lower (purple-striped)

Total predilutionThe Prismaflex software calculates the total predilution value, which is the ratio ofprefilter blood dilution to the total blood dilution. Total predilution is calculated accordingto the formula below:

PRE%tot = (Qpbp + Qreppre) / (Qpbp + Qrep)

Where PRE%tot is Total predilution (%), Qpbp is PBP flow rate (ml/h), Qreppre isPre-filter replacement flow rate (ml/h), Qrep is Replacement flow rate (ml/h)

The total predilution value is displayed in the Enter Flow Settings screen.


CRRT 5:15

Filtration FractionThe Prismaflex software calculates the filtration fraction value, which reflects the level ofblood hemoconcentration present at filter outlet. Filtration fraction (FF%) is calculatedaccording to the formula below:

FF% = 100 × (Qreppost + Qpfr) / (Qplasma + Qpbp + Qreppre)

Where FF% is Filtration fraction (%),Qreppost is Post-filter replacement flow rate (ml/h),Qpfr is Patient fluid removal rate (ml/h), Qplasma is Plasma flow rate (ml/h), Qpbp isPBP flow rate (ml/h) and Qreppre is Pre-filter replacement flow rate (ml/h)

Plasma flow rate is computed as a function of blood flow rate and patient’s hematocrit:

Qplasma = [1 – (Hct / 100)] × Qb

Where Qplasma is Plasma flow rate (ml/h), Hct is Hematocrit (%), Qb is Blood flowrate (ml/h)

The filtration fraction value is displayed in the View Changes screen. Prescription settingswith filtration fraction above 25% may lead to fast increase of the filter transmembranepressure and require early replacement of the disposable set.

Patient Fluid Removal RateThe patient fluid removal rate is the net amount of fluid the Prismaflex control unitremoves from the patient each hour (after accounting for any PBP and replacementsolutions as well as syringe infusion volumes being used). Net fluid removal occurswhenever the operator sets the patient fluid removal rate to a value above zero.

Calculating the Desired Patient Fluid Removal RateThe Prismaflex software does not measure or account for sources not supported by thePrismaflex system of patient fluid intake (such as hyperalimentation, blood, or druginfusion) or fluid output (such as urine and wound drainage). The operator must accountfor these other sources when calculating the patient fluid removal rate, as well as whencalculating the patient’s input/ output totals.

The following formula may be useful:

Qpfr = QPpfl + Qextin – Qextout

Where Qpfr is Patient fluid removal rate (ml/h) to be set on the Prismaflex control unit,QPpfl is Prescribed patient fluid loss (ml/h), Qextin is fluid inputs (ml/h), not supportedby the Prismaflex system, and Qextout is fluid outputs (ml/h), not supported by thePrismaflex system.

The patient fluid removal rate must be adjusted if the weight loss prescribed by thephysician is changed or if the patient’s fluid inputs or outputs, not supported by thePrismaflex system, change.

Adjusting the Patient Fluid Removal RateDuring the setup procedure (Setup mode), the Enter Flow Settings screen is displayed.The operator is prompted to assess the default patient fluid removal rate, make anychange desired for the current treatment, and confirm the patient fluid removal rate on theReview Prescription screen prior to starting the patient treatment.


During the patient’s treatment (Run mode), the operator can access theEnter Flow Settings screen and adjust the patient fluid removal rate as needed. See“Operating modes” on page 4:10 and “User-controllable Settings” on page 4:22 formore information.

If desired, the operator can change the default patient fluid removal rate in Custom mode.See “Custom Mode” on page 4:21.

Monitoring Patient Fluid RemovedPatient Fluid Removed is the net amount of fluid removed from the patient by thePrismaflex system during a specified time period. It is the patient’s “Prismaflex systemoutput” for use in periodic totalling of patient I/O (input and output) volumes.

Measuring Patient Fluid RemovedThe four precision scales mounted on the bottom of the Prismaflex control unit supportthe PBP, replacement solution, dialysate, and effluent bags and constantly measure theweight of the bags. The change in combined weight of the fluid bags in use indicates howmuch fluid has been removed from the patient by the control unit. When fluid bags arereplaced, the software automatically accounts for the new bag weights. The followingformula applies:

Vpfr = Veff – Vpbp – Vdial – Vrep – Vsyr

Where Vpfr is Patient fluid removed (ml), Veff is Effluent bag volume (ml), Vpbp is PBPpumped (ml), Vdial is Dialysate pumped (ml), Vrep is Replacement solution pumped(ml) and Vsyr is Syringe solution pumped (ml)

The total Patient Fluid Removed should equate with the operator-set patient fluid removalrate4. For example, if the patient fluid removal rate is 100 ml/h and 95 minutes oftreatment has elapsed, with only 90 minutes of Effective Run Time, the expected PatientFluid Removed will be (100/60)*90 = 150 ml.

Viewing Patient Fluid RemovedDuring a patient treatment (Run mode), the Patient Fluid Removed is displayed on theHistory screen. The operator can view the amount of Patient Fluid Removed for the lastfull I/O Period or for a time period stipulated by the operator. See “History Data” onpage 4:4 for more information.

Fluid GraphsThe Fluid Graphs include the Pt Fluid Balance Graph (bar graph), the Dose Graph (linegraph), and the Cumulative Volumes Graph (line graph).

The Pt Fluid Balance Graph displays the Patient Fluid Removed during each timeincrement of the graph. On the right side of the screen, the total Patient Fluid Removedover the requested time period is reported.

The Dose Graph displays the ml/h/kg flow that was occurring at each time point on thegraph. There is a separate line for each fluid in use. The following are reported: PBP

4 Patient Fluid Removed will differ from the operator-set Patient Fluid Removal rate if: (a)treatment is stopped, then later resumed; (b) an alarm occurs that stops the PBP, replacement,dialysate, and effluent pumps.


CRRT 5:17

solution, Replacement solution, Dialysate, and Effluent. On the right side of the screen,the total volume pumped over the requested time period is reported for each fluid.

For each fluid in use, the Cumulative Volumes Graph reports the total volume pumpedduring each time increment of the graph. There is a separate line for each fluid in use.The following are reported: PBP solution, Replacement solution, Dialysate, Effluent. Onthe right side of the screen, the total volume pumped over the requested time period isreported for each fluid.

Information Included in I/O DataI/O Data include the information below. Only the data appropriate to the selected therapyare displayed.

Note: All I/O Data, except Blood Volume Processed, are totals covering only the operatorselected View Period.

• Blood/Fluid Volume Processed (total liters pumped through the current filter sincestart of treatment, including any fluid pumped during Recirculation procedure).

• Run Time (time the infusion pumps were running during the selected View Period)

• Cumulative Hours reported (does not display when I/O Period is the selected view)

• PBP Solution Input

• Replacement Solution Input

- Pre-filter Input

- Post-filter Input

• Dialysate Used

• Effluent Volume (ultrafiltrate; spent dialysate)

• Patient Fluid Removed

• Current Unintended Patient Fluid Loss/Gain

• Patient Fluid Loss/Gain Limit set during set-up

• Syringe volume

CRRT Prescription indicators2 indicators of the CRRT treatment dose (in ml/h/kg) are computed as a function of FlowRates settings and patient body weight:

- Effluent Dose represents the Effluent flow rate normalized to patient body weight,

- UFR Dose represents the fluid amounts contributed by PBP, replacement and patientfluid removal rates, if they were delivered in a post dilution mode and normalizedto patient body weight.


Equations for CRRT Dose

DCRRT-eff = Qeff / BW

DCRRT-UFR = [Qplasma / (Qplasma + Qpre)] × (Quf / BW)

With

Qeff = Qpbp + Qdial + Qrep + Qpfr

Qplasma = Qb × (1 – Hct/100)

Qpre = Qpbp + (PRE% / 100) × Qrep

Quf = Qpbp + Qrep + Qpfr

Abbreviation Explanation Unit

DCRRT-eff Effluent dose ml/kg/h

Qeff Effluent flow rate ml/h

BW Patient body weight kg

DCRRT-UFR UFR dose ml/kg/h

Qplasma Plasma flow rate ml/h

Qpre Pre-infusion flow rate ml/h

Quf Ultrafiltration rate ml/h

Qpbp PBP flow rate ml/h

Qdial Dialysate flow rate ml/h

Qrep Replacement flow rate ml/h

Qpfr Patient fluid removal flow rate ml/h

QPpfl Prescribed patient fluid loss ml/h

Qb Blood flow rate ml/h

PRE% Predilution %

Hct Hematocrit (default value 30%) %

Time to Change SetGambro recommends changing of CRRT sets after a treatment time of 24 hours. Thisrecommendation is based on experience with treatment performance, for instanceclearance, and pressure stability. Set performance is maximal within this period, butcan be expected to deteriorate in the course of prolonged treatments exceeding this 24hour interval.

In CRRT, the Advisory: Time to Change Set alarm may appear and recommend to changeset. The alarm is dependent on two parameters:

- Time spent in treatment, including recirculation, with the disposable set. Soluteremoval performance of the device can not be guaranteed over excessive usage time.This time is settable to 24, 48 or 72 hours in CUSTOM mode

- Blood processed volume as performance and integrity of the blood pump segmentcannot be guaranteed over excessive processed volumes. The 780 liters limit matcheswith a constant blood flow rate of 180 ml/min over 72 hours and may restrict usagetime of High Flow sets only.


CRRT 5:19

See “Troubleshooting” for more information.

The Advisory: Time to Change Set alarm is overrideable, and adherence to appropriatelimits is up to the discretion of the operator.

CRRT with HF20 Disposable SetThe HF20 disposable set is especially designed for the treatment of low body weightpatients down to 8 kg. Blood flow path consists of dedicated small transport tubes tominimize blood volume and risk of blood sedimentation at low blood flow rate.

Running of CRRT therapy and anticoagulation methods with HF20 disposable set areidentical to treatment with all other CRRT disposable sets.

The Priming Complete screen however offers the specific BLOOD PRIME softkey. In caseblood prime is part of physician prescription, this function offers instructions and relevantfunctions for the filling of the extracorporeal circuit with blood prior to patient connection.

Note: The Warning: Blood Detected in Set alarm is inhibited when initiating blood primefrom the Blood Prime screen.

The use of calcium solutions with a concentration lower than 300 mmol/l is recommendedwhen running the “Citrate – Calcium via Prismaflex Syringe Pump” anticoagulationmethod with HF20 set. See “Anticoagulation Methods” on page 8:1 for more information.

CRRT septeX

Therapy InformationCRRT septeX identifies CRRT therapies performed with High cut-off membranes. Thesemembranes allow transfer of high molecular weight solutes across the membrane.Hemodialysis is the only allowed mode as to prevent excessive protein losses in effluent.

Prismaflex CRRT septeX provides two operating modes:

• CVVHD (Continuous Veno-venous Hemodialysis) having the same implementationas CVVHD in CRRT (see Figure 5:3 on page 5:8)

• CVVHD+ post: having an implementation similar to CVVHDF in CRRT withpost-filter replacement infusion only (see Figure 5:4 on page 5:9)

CVVHD+post provides post-replacement infusion into the deaeration chamber; thisinfusion is intended to reduce the risk of clotting in the chamber that may occur inCVVHD.

Excessive protein losses during Prismaflex system CRRT septeX therapies are preventedthrough the restrictions that apply to the convective flow rates (PBP, replacement andPatient Fluid Removal).

Anticoagulation methods available in CRRT septeX therapy are identified in “Therapiesand Anticoagulation Methods” on page 8:3.

The septeX sets are identical to the standard CRRT disposable sets, described on page2:18.


Therapy Operation in CRRT septeXUnless specified below, operation of the Prismaflex system in CRRT septeX therapy isstrictly identical to its operation in standard CRRT. Pressure and fluid balance monitoringremain unchanged with respect to CRRT.

Flow rate SettingsFlow rate prescription parameters available in CRRT septeX therapy modes aresummarized in table “Available flow rate parameters depending on selected CRRT septeXMode” on page 5:5.

Anticoagulation SettingsBecause of the restricted flow rate during CRRT septeX, regional citrate anticoagulationcan be performed only with relatively high concentration citrate solutions. See chapter8 for more information.

CRRT MARS®

Description of CRRT MARS® TherapyCRRT MARS therapy is specifically designed for the combination of the MARS systemand Prismaflex system.

The MARS liver support system is designed to remove protein-bound and water-solubletoxins from the blood in cases of acute or chronic liver failure. The MARS systemneeds to be combined with a dialysis system. For instructions and information about theMARS machine and treatment, see the separate manual “MARS Liver Support Therapy,Operating Instructions” and “Instructions for Use MARS Treatment kit”. Contact thelocal representative for more information and supply.

The CRRT MARS therapy is optimized for the delivery of continuous renal replacementtherapy in combination with MARS system by:

- using a specially designated disposable set, see CRRT MARS® Disposable Set onpage 5:24

- providing setup instructions on the Prismaflex control unit screen for both thePrismaflex system and MARS systems

- adapting pressure monitoring to the specific combination of the two machines


CRRT 5:21

To perform a CRRT MARS treatment, first press the CRRT MARS softkey on the bottomof the Choose Therapy screen. The following modes are available in CRRT MARS:

• CVVHD

• CVVHDF

Anticoagulation methods available in the CRRT MARS therapy are identified in“Therapies and Anticoagulation Methods” on page 8:3.


CRRT MARS® FlowchartThe CRRT MARS flowchart shows the overall organisation of the Prismaflex systemand MARS systems during treatment mode. The interfaces between the two systemsare described.

Figure 5:6 CRRT MARS Flowchart

1. MARSFLUXMARSFLUX filter is a component of the “MARS® Treatment Kit Type 1116/1– X-MARS.” It is to be connected to the filter and return line extensions of thePrismaflex MARS set to close the blood flow path. The fluid compartment of theMARSFLUX filter is connected to the albumin circuit of the MARS system.

2. diaFLUX extension lines and albumin circuitThe diaFLUX extension lines are to be connected to the albumin circuit of the MARSsystem.

3. Return extension line and MARS clampReturn extension line of the Prismaflex system and the Prismaflex MARS set is tobe set in the MARS machine's clamp. In this way, the MARS system can stop theblood flow if a blood leak is detected.


CRRT 5:23

CRRT MARS® Disposable SetThe specially designated Prismaflex MARS disposable set must be used onPrismaflex control unit to perform the CRRT MARS therapy.

The Prismaflex MARS disposable set is supplied within the MARS Treatment Kit Type1116/1 – X-MARS. Beside the Prismaflex MARS disposable set, the kit also containsall other setup components necessary for the CRRT MARS treatment, notably theMARSFLUX filter. For information about the specific kit, refer to the Brief instruction forthe MARS® Treatment Kit Type 1116/1 – X-MARS that comes enclosed in the kit carton.

CAUTIONPay particular attention to the extracorporeal blood volume. For patients with highextracorporeal volume/patient blood volume ratio, the physician may decide toprime the extracorporeal circuit with adequate volume substitution before patientconnection.

CAUTION

Figure 5:7 The Prismaflex MARS disposable set


1. diaFLUX filterDuring treatment mode, albumin solution flows inside the hollow fibres of thediaFLUX, while dialysate flows counter-currently in the fluid compartment. ThediaFLUX is preconnected to dialysate and effluent lines.

2. diaFLUX extension linesThese lines allow for connecting the albumin circuit of the MARS system to thediaFLUX filter.

3. Filter line extensionThis line connects the blood flow path to the top inlet of the MARSFLUX filter.

4. Return line extensionThis line connects the blood flow path to the bottom outlet of the MARSFLUX filter.This line is also to be set in the return clamp of the MARS machine.

Operating during CRRT MARS® TherapyThis section contains specific information about CRRT MARS therapy.

The MARS machine must be placed on the left side of the Prismaflex control unit fromuser point of view. Pay attention to prevent interaction of extension lines with Prismaflexscales.

Note: The specification parameters about ambient temperature, humidity and airpressure differ between the Prismaflex system and the MARS system, see chapter 13:“Specifications” on page 13:1 for the Prismaflex control unit specifications and fortechnical data about the MARS system refer to the MARS Liver Support Therapy,Operating Instructions.

Note: Heparinised priming solution is recommended for the blood circuit. Do not useheparinised priming solution for the albumin circuit since the heparin will be trapped inthe adsorption cartridges, and thus may reduce effectiveness of the MARS treatment.

Setup and PrimingThe setup and priming procedures of CRRT MARS takes between one to two and ahalf hours to perform. For the setup a MARS Treatment Kit Type 1116/1 – X-MARS isneeded, which contains all necessary components for the setup. Follow instructions onthe Prismaflex screen to do the setup and priming. These instructions specify whether theinstructions on the MARS system are to be followed or disregarded.

Due to the standby time during the filling and recirculation of the MARS albumin circuit,it is strongly recommended to flush the blood flow path with at least 500 ml primingsolution before connecting the patient. This is done by using theMANUAL PRIME softkeyon the Connect Patient screen.

CAUTIONUse saline or alkaline solution (pH ≥ 7.3) with heparin added to prime the set.

CAUTION


CRRT 5:25

Operating Screens in CRRT MARS Setup Mode

Logo Screen

Choose PatientEnter Patient IDEnter Patient WeightConfirm Patient InformationChoose Therapy (press CRRT MARS)Choose Therapy (CVVHD and CVVHDF are selectable)Choose Anticoagulation Method (“Standard — Syringe” or “Standard — No Syringe”

Confirm Anticoagulation MethodTherapy and Anticogulation ChoiceMARS — PreparationMARS — Install Unit 1MARS — Install Unit 2MARS — Install Unit 3MARS — Install Unit 4Install Prismaflex set

Connect Prismaflex & MARSLoading Pumps, please waitConfirm Set LoadedPrepare and Connect SolutionsInstall Syringe (standard anticoagulation method)Confirm Syringe Installation (standard anticoagulation method)Verify SetupPriming, please waitPrismaflex Priming CompleteMARS — Prepare to PrimeMARS — Priming, 1st CycleMARS — Priming, 2nd CycleMARS — Priming, 3rd CyclePriming completePrime Test, please waitPrime Test PassedMARS — Albumin FillingMARS — Albumin CirculationEnter Treatment SettingsEnter Flow SettingsEnter Anticoagulation Settings (standard anticoagulation method)Review PrescriptionConnect PatientVerify Patient Connection


Start Treatment

Run ModeDuring run mode the Status screen will display the same parameters as during ordinaryCRRT. The operating screens in CRRT MARS do not differ from the operating screens inordinary CRRT treatment. See “Operating Screens in Run Mode” on page 4:16.

Pressure managementDuring CRRTMARS, the Prismaflex software uses monitored pressure values to calculatetransmembrane pressure (TMP) in the same way as in ‘standard’ CRRT. However,because of the specific therapy configuration, the measured value matches with the sumof MARSFLUX and diaFLUX transmembrane pressures. Due to this, the filter pressuredrop is the only value used to provide notification about clotting in the MARSFLUX filter.During CRRT MARS, displayed TMP values and TMP related alarms are no suitableindicators for clotting in the MARSFLUX filter.

Blood leak monitoringDuring CRRT MARS therapy, the MARS machine monitors the albumin circuit for blood.If blood is detected because of a leakage at the MARSFLUX filter, the MARS machinenotifies the operator via an alarm and closes its return clamp as to stop the blood flow.

Closure of the MARS return clamp triggers one or several pressure alarms in thePrismaflex system that will stop the blood pump and close the return clamp, e;g. Warning:Filter Clotted alarm, Warning: Filter Pressure Extremely Positive alarm, Warning: ReturnPressure is Dropping alarm.

End ModeThe disposable kit in CRRT MARS must be changed after 24 hours treatment at the latest.

When ending treatment, press STOP on the Prismaflex control unit and follow instructionson the screen.


CRRT 5:27

Chapter 6

Therapeutic Plasma Exchange (TPE)Contents


About the Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:3Therapy Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:4Mechanism of TPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:4

TPE Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:4TPE and Anticoagulation Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:5TPE Disposable Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:6

Specific Functions in TPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:7Bag Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:7Machine control of Patient Plasma Loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:7Protecting from Fluid Imbalance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:7Protecting the Patient from Plasma Imbalance . . . . . . . . . . . . . . . . . . . . . . . 6:7“Weight” and “Incorrect Flow” Alarms in TPE . . . . . . . . . . . . . . . . . . . . 6:8“Incorrect Weight Change Alarm Not Cleared” Alarm . . . . . . . . . . . . . . . 6:8

Protecting from Excessive Fluid Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:8Pressure Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:8Start-up Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:9TPE prescription delivered . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:9End Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:9

Therapy Operation in TPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:10TPE Prescription and Flow Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:10Adjusting the TPE Prescription and Flow Rates . . . . . . . . . . . . . . . . . . . . . . 6:10Considerations When Using PBP Solution . . . . . . . . . . . . . . . . . . . . . . . . . . 6:10Patient Plasma Loss Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:10Software Calculations of Target Patient Plasma Loss . . . . . . . . . . . . . . . . . . 6:11Setting the Pt Plasma Loss Rate to Achieve Prescribed Target Loss . . . . . . . 6:11Formulas Used in TPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:11

Plasma Balance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:12Patient Plasma Loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:12Measuring Patient Plasma Loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:12Viewing Patient Plasma Loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:12

History Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:13Information Included in Treatment Data . . . . . . . . . . . . . . . . . . . . . . . . . 6:13Fluid Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:13

Replacement Bag Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:13Using multiple bags or containers in parallel . . . . . . . . . . . . . . . . . . . . . . . . . 6:14Handling Empty Bag/Container alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:15


Therapeutic Plasma Exchange (TPE) 6:1


6:2 Therapeutic Plasma Exchange (TPE) G5036003 Revision 05.2011Program version 6.xx


WarningsWARNING

In TPE, the blood flow rate should not be set below 100 ml/min for TPE 2000and below 50 ml/min for TPE 1000 sets due to risk of hemolysis. Effluentmonitoring for hemolysis is recommended.

It is recommended to obtain a detailed drug history before each TPE procedure.For drugs potentially affected by TPE, the physician should either adjust thedoses or give the medications immediately after the procedure, since drugs willpass through the membrane of the filter.

As treatment proceeds, carefully monitor patient plasma balance levels and allthe I/O Data on the Status and History screens. Plasma balance monitoringshould include frequent totaling of patient fluid input/output.

The blood leak detector must be re-normalized if the effluent line is removedand then reinserted into the blood leak detector after treatment (Run mode) hasstarted. See Troubleshooting chapter on page 11:85.

TPE in conjunction with citrate containing replacement solutions may requirecalcium substitution in order to avoid hypocalcaemia.

WARNING

CautionsCAUTION

The Prismaflex system is not designed for a heater to be connected to theinfusion solution lines. A heater generates air bubbles which collect in thedeaeration chamber. Therefore, it is recommended not to use a heater on thereplacement or on the PBP infusion lines.

Monitor hypothermia and pay special attention when increasing exchangevolumes above 2 L/h. See “Chapter 9:Blood Warmers” on page 9:1.

PBP solution delivery is not removed in TPE. Therefore this fluid volume isconsidered as a fluid input in the patient fluid balance.

Observe the effluent bag for pink or red tinge as an indicator of undetectedmicro blood leaks. Discoloration of effluent due to the patient’s disease process(hemolysis for example) should also be considered as a root cause.

When changing bags/ containers during TPE, it is important to enter the newreplacement container volume on the Change Bags/Containers screen. If thevolume for the replacement container is wrong, air could be introduced intothe set.

CAUTION

About the ChapterThis chapter completes and deepens the information given in chapter 2, 3 and 4 whenoperating in TPE. This chapter provides information about specific functions in TPEand general operating instructions in TPE as a complement to chapter 4.



Therapy Description

Mechanism of TPEIn Therapeutic Plasma Exchange (TPE), blood plasma and therein contained diseasemediators are removed from the patient's blood through filtration over a filter membrane.A replacement fluid is administered in order to compensate for the plasma volume that isremoved through this plasmafiltration process.

The Prismaflex system TPE provides plasmafiltration with post-filter replacement andallows for PBP infusion.

TPE Flowchart

Figure 6:1 TPE flow

1. Conductive clip2. Filter3. Blood leak detector4. Syringe pump5. Blood pump6. Return clamp7. Air bubble detector, patient sensor and line sensor8. Deaeration chamber9. Return pressure10. Scale, PBP bag11. Scale, Effluent bag12. Scale, Replacement solution


13. Pinch valve14. Pump15. Pressure sensor16. Sample site

TPE and Anticoagulation MethodsAnticoagulation methods available in TPE therapy are identified in “Therapies andAnticoagulation Methods” on page 8:3.



TPE Disposable SetThe available disposable sets for TPE are:

- TPE 1000

- TPE 2000

Refer to the Instructions for Use enclosed with the set.

Figure 6:2 TPE disposable Set components

1. Sample sitesIn the TPE disposable sets there are five sample sites, located as follows: patient endof access line (red), access line before the blood pump (red), filter line (red), returnline, between filter outlet and deaeration chamber (blue); effluent line (yellow). Thesample site marked orange in figure 6:2 is optional.


2. Pressure podsIn TPE disposable sets, there are three pods, located as follows: access line before theblood pump (access pod), access line after the blood pump (filter pod) and effluentline before the effluent pump (effluent pod).

3. Replacement line (purple-striped)Conveys replacement fluid from the bag/container on the replacement scale (purple)to the blood flowpath in the return line. The fluid is delivered postdilution (to thedeaeration chamber, just beyond the filter blood outlet).

4. Effluent line (yellow-striped)Conveys removed plasma from the plasma/fluid compartment of the filter to theeffluent bag.

5. FilterFilter containing hollow fibers made of a specialized membrane. Blood flows throughthe hollow fibers and plasma is pulled into the plasma/fluid compartment of the filter.

Specific Functions in TPE

Bag ManagementTPE replacement solutions are being administered from containers having variousweights and sizes. Accordingly, the Replacement and PBP scales in TPE are per defaultmanaged with the Variable Empty Bag method. To facilitate the use of small size TPEreplacement containers, volumes can be adjusted down to a minimum of 10 ml, in steps of10 ml. See chapter 4 for more information.

Machine control of Patient Plasma LossThe Prismaflex software automatically calculates the effluent flow rate needed to achievethe patient plasma loss rate. Any replacement solution infused by the Prismaflex controlunit is automatically accounted for, as shown below:

Qeff = Qppl + Qrep

Where Qeff is Effluent rate (ml/h), Qppl is Patient plasma loss rate (ml/h) and Qrepis Replacement fluid rate (ml/h)

During operation, software controls the effluent pump speed to maintain the requiredeffluent rate. PBP solution and syringe infused volumes are not accounted for whendefining the TPE effluent flow rate; these infused volumes are net fluid inputs for thepatient.

Protecting from Fluid Imbalance

Protecting the Patient from Plasma ImbalanceThe Prismaflex system is designed to provide solute removal from the patient's blood,net fluid removal from the patient's blood, or both. If net plasma loss is not desired, the



Prismaflex system is designed to operate to maintain a zero plasma balance in the patient'sblood (no net plasma loss or gain).

Flow problems in the fluid lines, bags, or pump segments can change the flow rate withinthe fluid lines and the filter and cause errors in the amount of patient plasma loss. ThePrismaflex Safety System protects from these situations via alarms that suspend thetreatment and alert the operator. In addition to the alarm system described in chapter 3, athird alarm “Incorrect Weight Change Alarm Not Cleared” is active during TPE therapy.All these alarms are described in detail below.

“Weight” and “Incorrect Flow” Alarms in TPEEach of the PBP, Replacement and Effluent flow rates are monitored according to theprocess described in chapter 3 on page 3:10. When a “Weight” or “Incorrect Flow” alarmis triggered on Replacement or Effluent scales, the Actual Patient Plasma Loss is higheror lower than the target value set by the Patient Plasma Loss. When the alarm is triggeredon PBP scale, the PBP input is higher or lower than the target value set by the PBP inputflow rate and Patient Plasma loss remains unaffected.

“Incorrect Weight Change Alarm Not Cleared” AlarmThe Caution: Incorrect Weight Change Alarm Not Cleared alarm occurs when the limit ofthe “Weight” and/or “Incorrect Flow” alarms have occurred within the last three hoursof treatment. Occurrence of this alarm indicates that there are ongoing problems withunresolved alarms.

To prevent serious, unintended patient fluid removal loss or gain, the Caution: IncorrectWeight Change Alarm Not Cleared alarm permanently suspends treatment (fluid pumpswill not re-start). This alarm requires the operator to end the treatment.

The STOP softkey is provided on the alarm screen and accesses the Stop screen. Whenready to end the treatment, the operator should press this key and follow the on-lineinstructions. The Return Blood option will be available.


WARNING

Note: STOP softkey should be pressed only when ready to proceed with the end treatmentsequence. (Pressing STOP softkey, stops the blood pump).

Protecting from Excessive Fluid InputAs the effluent pump does not account for PBP solution, any PBP solution constitutes anadditional fluid input to the patient. To prevent unintended fluid input, the “Patient FluidGain Excessive” caution alarm occurs once the volume of infused PBP solution reachesthe predefined threshold and suspends the treatment. The operator can then decide to eitherstop or to continue the treatment. See chapter 11 for detailed troubleshooting information.

Pressure ManagementSoftware-calculated PressuresDuring TPE therapy, Prismaflex software uses monitored pressure values to calculateAccess Transmembrane pressure (TMPa) in addition to the filter pressure drop (PressureDrop). Both computed pressures are used to provide notification that clotting or


membrane pore plugging (clogging) is beginning in the filter, or that the filter has clottedor membrane pores have plugged (clogged) and the set must be changed. The TMPa andPressure Drop are displayed and updated on the Status screen during a patient treatment.In addition, a Status Graph (line graph) showing the trends of these two pressures overan operator-settable period of one to three hours can be displayed. See Custom Modeon page 4:21.

Access Transmembrane Pressure (TMPa)Access transmembrane pressure is the pressure difference between the blood and fluidcompartments at the inlet side of the filter.

The TMPa is calculated by Prismaflex software as follows:

TMPa = Pfil – Peff

Where TMPa is Access transmembrane pressure (mmHg), Pfil is Filter pressure (mmHg)and Peff is Effluent pressure (mmHg)

Filter pressure and Effluent pressure readings are automatically corrected by software forhydrostatic pressure biases to compute and display TMPa data (–30 mmHg correction).

During a patient treatment, permeability of the membrane decreases due to protein coatingon the blood side of the membrane. This causes the TMPa to increase. In order to helpprevent hemolysis, the pressure gradient between blood inlet and the effluent outlet of thefilter should be strictly controlled and the blood flow rate should not fall below minimumrecommended flow rate of the selected Prismaflex system TPE disposable set.

There are two alarms specific to TMPa: the Caution: TMPa Excessive alarm and theAdvisory: TMPa Too High alarm. If desired, the operator can lower the alarm limit of theAdvisory alarm so that it occurs prior to reaching the manufacturer-established limit of+100 mmHg. For more information, see “Custom Mode” on page 4:21 in “Chapter 4:Therapy Operation” on page 4:8 and “User-controllable Settings: TPE specific settings”on page 4:25.

Start-up PhaseTo promote blood safety, the start-up of replacement and effluent pumps is delayed (fromentering Run mode) by a few minutes. This allows blood to initially contact the filterwithout the influence of ultrafiltration pressures. This TPE start-up phase also allows theoperator to change bags/containers as wished, before the actual treatment commences.

TPE prescription deliveredUnlike CRRT, a TPE therapy is not a continuous treatment. For the Prismaflex systemthe duration of a TPE treatment is defined in respect to a target replacement volume thatis to be exchanged (Total Replacement Volume). Once this prescribed volume has beendelivered the Prismaflex control unit notifies the operator through a “TPE PrescriptionDelivered” caution alarm. The operator can then choose either to stop the treatment, tocontinue the treatment until the replacement bag is empty, or to set a new replacementvolume target.

End TreatmentPer design, TPE treatments will commonly be ended on occurrence of Caution: TPEPrescription Delivered alarm. See chapter 11 on page 11:1 for more information. If



needed, treatment can be ended any time by pressing the STOP softkey present on theStatus screen.

Therapy Operation in TPE

TPE Prescription and Flow RatesThe TPE Prescription consists of three settings: Patient Hematocrit; Total ReplacementVolume (total amount of replacement fluid to infuse over the entire treatment); andReplacement Container Volume (volume of replacement fluid in the bag/ containerhanging on the scale).

Flow rates are the settings that control the rate of blood flow, patient plasma loss, PBPand replacement fluid infusion, and effluent flow during a patient treatment. All flowrates except effluent are user-controllable.

Adjusting the TPE Prescription and Flow RatesDuring the Setup procedure (Setup mode), the Enter TPE Prescription screen is displayedfirst and the Enter Flow Settings screen is displayed next. The operator is prompted toassess the default TPE Prescription settings and flow rates, make any changes desired forthe current treatment, and confirm all values prior to starting the patient treatment. Duringtreatment (Run mode), press the TPE PRESCR softkey on the Enter Flow Settings screento reach the Enter TPE Prescription screen

Note: There is no default value for the Replacement Container Volume. The volume offluid in the replacement container must be entered for each treatment.

In Custom mode, if desired, the operator can change the default flow rates. See “CustomMode” on page 4:21.

Considerations When Using PBP SolutionWhen using PBP solution during TPE, be aware of the considerations below:

• The effluent pump rate does not account for PBP solution. Any PBP solution infusedmust be counted as a separate fluid input when calculating patient Input/Output totals.

• The software-calculated Target Patient Plasma Loss does not account for PBPsolution. (See “Patient Plasma Loss Rate” on page 6:10.)

Patient Plasma Loss RateThe patient plasma loss rate is the net amount of plasma the Prismaflex system removesfrom the patient each hour after accounting for any replacement fluid being used.

If the patient plasma loss rate is set above zero, a net plasma loss occurs, resulting ina negative plasma balance in the patient.

In TPE, the physician usually prescribes a zero net plasma loss; therefore, in most casesthe patient plasma loss rate is set to 0 ml/h.


Software Calculations of Target Patient Plasma LossPrismaflex software calculates a Target Patient Plasma Loss based on settings enteredby the operator. This calculated value is displayed on the Enter TPE Prescription andEnter Flow Settings screens.

Software calculates the Target Patient Plasma Loss by first determining the treatment timeaccording to the formula below.

T = Vreptot / Qrep

Where T is Treatment time (h), Vreptot is Volume to replace (Total replacement Volume(ml)) and Qrep is Replacement fluid rate (ml/h)

Target Patient Plasma Loss is then calculated as follows:

Vppltgt = Qppl × T

Where Vppltgt is Target patient plasma loss (ml), Qppl is Patient plasma loss rate (ml/h)and T is Treatment time (h)

If the total replacement volume, replacement fluid rate, or patient plasma loss rate ischanged during a treatment, the Target Patient Plasma Loss also changes.

Note: The Target Patient Plasma Loss for the treatment must be the same number as thenet plasma loss prescribed by the physician, whether this is zero or a number above zero.

Setting the Pt Plasma Loss Rate to Achieve Prescribed Target LossIf the prescribed net plasma loss is above zero, the operator must indirectly enter thisvolume as the Target Patient Plasma Loss value. This is done during the Setup procedureby performing the steps below (in the order listed).

1. On the Enter TPE Prescription screen, enter the prescribed Total ReplacementVolume. Press CONFIRM to proceed to the Enter Flow Settings screen.

2. On the Enter Flow Settings screen, enter the prescribed replacement fluid rate. Whenthe calculated Target Patient Plasma Loss appears, adjust the patient plasma loss rate(up or down) until the calculated loss equals the physician-prescribed net plasma loss.

Note: The software-calculated Target Patient Plasma Loss does not account for PBPsolution. To remove the PBP volume infused as treatment is progressing, the patientplasma loss rate can be set to equal the PBP solution rate. If this is done, be aware thatplasma is being removed while non-plasma (PBP solution) is being added.

Formulas Used in TPEBelow is a summary of the formulas used by Prismaflex software in managing TPE.Software calculations are based on the operator-set TPE Prescription and flow rate values.The results of software calculations are displayed on the Enter TPE Prescription and/orFlow Rates screens.

Vplasma = (100 – Hct) × 0.7 × BW

where Vplasma is Patient plasma volume (ml), Hct is Hematocrit (%), BW is Patientbody weight (kg)

Rexch = Vreptot / Vplasma



where Rexch is Plasma volume exchange (dimensionless), Vreptot is Total ReplacementVolume (ml) and Vplasma is Patient plasma volume (ml)

Hctpost = [(Qb / (Qb – Qeff)] × Hct

where Hctpost is Post-filter Hematocrit (%), Qb is Operator set blood flow rate (ml/h),Hct is Hematocrit (%) and Qeff is Effluent flow rate (ml/h)

FF% = (Qeff / Qplasma) × 100

Qplasma = (1 – Hct / 100) × Qb

where FF% is Filter fraction (%), Qeff is Effluent rate (ml/h), Qb is Operator set bloodflow rate (ml/h), Hct is Hematocrit (%) and Qplasma is plasma flow rate (ml/h)

Vefftgt = Qeff × T

where Vefftgt is Target effluent (ml), Qeff is Effluent rate (ml/h) and T is Treatmenttime (h)

Vppltgt = Qppl × T

where Vppltgt is Target patient plasma loss (ml), Qppl is Patient plasma loss rate (ml/h)and T is Treatment time (h)

Plasma BalancePatient Plasma LossPatient Plasma Loss is the net amount of plasma removed from the patient by thePrismaflex system during a specified time period. In TPE, the physician usually prescribesa zero net plasma loss for the patient.

Measuring Patient Plasma LossThe replacement scale and effluent scale mounted on the bottom of the Prismaflex controlunit support the replacement fluid bag/container and effluent bag and constantly measuretheir weights. The change in combined weight of the fluid bags/containers in use indicateshow much plasma has been removed from the patient by the control unit.

When fluid bags/containers are replaced, the software automatically accounts for theirnew weights. The following formula applies:

Vppl = Veff – Vrep

Where Vppl is Patient plasma loss (ml), Veff is Effluent bag volume (ml) and Vrep isReplacement solution volume (ml)

The Displayed Actual Patient Plasma Lost will be less than the one calculated from the“operator-set” Patient Plasma Loss rate and the Elapsed time shown in the Status screen(this applies also in the History screen) if:a. treatment is voluntarily stopped and then later resumed; or

b. an alarm occurs that stops the fluid pumps.

“Operator-set” Patient Plasma Loss shall be calculated multiplying Run Time inHistory screen by Patient Plasma Loss rate.

Viewing Patient Plasma LossDuring a patient treatment (Run mode), the Patient Plasma Loss is displayed on theHistory screen. The operator can view the amount of Patient Plasma Loss for the last full


I/O Period or for a time period stipulated by the operator. See “History Data” on page 4:4in “Chapter 4: Therapy Operation” on page 4:8, for more information.

History Data

Information Included in Treatment DataNote: All Treatment Data, except Blood Volume Processed, are totals covering only theoperator-selected View Period.

Treatment Data include the information below.

• Blood Volume Processed (total liters pumped through the current filter since start oftreatment, including any fluid pumped during Recirculation procedure.)

• Treatment Time (time the blood pump was running)

• Cumulative Hours reported (does not display when I/O Period is the selected view)

• PBP Input

• Patient Plasma Loss (net plasma volume removed)

• Replacement Fluid

- Total Replacement Volume (a TPE Prescription value)

- Actual Volume Delivered (replacement fluid pumped)

• Effluent (total plasma volume removed)

Fluid GraphsThe Fluid Graphs include the Pt Plasma Loss Graph (bar graph) and the CumulativeVolumes Graph (line graph).

The Pt Plasma Loss Graph displays the plasma loss during each time increment of thegraph. On the right side of the screen, the total Patient Plasma Loss over the requestedtime period is reported.

For each fluid in use, the Cumulative Volumes Graph reports the total volume pumpedduring each time increment of the graph. There is a separate line for each fluid. Thefollowing are reported: PBP solution, Replacement fluid, Effluent. On the right side of thescreen, the total volume pumped over the requested time period is reported for each fluid.

Replacement Bag HandlingReplacement fluid for TPE may be stored in small volumes bags or containers that requiremultiple changes during the treatment.



Using multiple bags or containers in parallel

WARNINGWhen hanging a fluid bag, always centre it on the 3- hook assembly, so thatits weight is evenly distributed. Do not support the fluid bags by any meansother than the provided scale carrying bars. Fluid balance can be significantlyaltered, resulting in patient injury or death.

WARNING

Using the accessory SP394 with the Prismaflex system in TPE requires a specialprocedure. The device can be used to connect together several containers (bags or bottles)of replacement fluid. See Figure 6:3 on page 6:14.

a. The end of the line equipped with the vented spike (accessory with blue cap) mustbe connected to the first container. The other end of this line is then connectedto the second container.

b. The second line (with the non-vented spike) is used to connect the second containerto the third one.

c. The third container is then connected to the replacement line of the Prismaflex systemTPE disposable set.

When bottles are used, the vented cap (blue) of the spike attached to the first bottle mustbe open.

When bags are used, the vented cap (blue) of the spike can remain closed.

Note: After one of the lines is connected to a container, it is recommended to prime theline by gravity and clamp it before attaching the other end of the line to another container.

Figure 6:3 Accessory SP394 with the Prismaflex system in TPE

1. Replacement fluid line of TPE set

2. Second line equipped with the non-vented spike

3. First line equipped with the vented spike (blue cap)


Handling Empty Bag/Container alarmThe Advisory: Replacement Container Empty alarm appears when the machine hasconsumed the set volume for the replacement container. The operator then has twooptions:

a. Change the container;

b. Decide to use a residual volume in the container already hanging on the scale. In thiscase an opening/closing sequence (without changing container) must be performedon the scale, and the residual volume to consume must be set.



Chapter 7

Hemoperfusion (HP)Contents


About the Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:2Therapy Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:2Mechanism of HP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:2HP and Anticoagulation Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:2

HP Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:3HP Disposable Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:4

Specific Functions in HP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:5User-controllable Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:5Bag Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:5Fluid Infusion Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:5

“Incorrect Weight Change Alarm Not Cleared” Alarm . . . . . . . . . . . . . . . 7:5Protecting from Excessive Fluid Input . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:6

Pressure Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:6Operating in HP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:6Flow Rates Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:6Considerations When Using PBP Solution . . . . . . . . . . . . . . . . . . . . . . . . . . 7:6

History Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:6Fluid Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:6

Setup Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:6Run Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:7End Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:7


Hemoperfusion (HP) 7:1


WarningsWARNING

During HP, carefully monitor patients with severe thrombocytopenia,leukocytopenia or other coagulation disorders.

WARNING

CautionsCAUTION

PBP solution delivery is not removed in HP. Therefore this fluid volume isconsidered as a fluid input in the patient fluid balance.

CAUTION

About the ChapterThis chapter completes and deepens the information given in chapter 2, 3 and 4 whenoperating in HP. This chapter provides information about specific functions in HPand general operating instructions in HP as a complement to chapter 4.

Therapy Description

Mechanism of HPIn HP, toxic substances and/or drugs are adsorbed from the plasma as the patient’s bloodis perfused through a charcoal cartridge. No fluid removal occurs.

HP therapy provides hemoperfusion and allows for PBP infusion.

HP and Anticoagulation MethodsAnticoagulation methods available in HP therapy are identified in “Therapies andAnticoagulation Methods” on page 8:3.

7:2 Hemoperfusion (HP) G5036003 Revision 05.2011Program version 6.xx

HP Flowchart

Figure 7:1 HP flow

1. Filter2. Syringe pump3. Blood pump4. Return clamp5. Air bubble detector, patient sensor and line sensor6. Deaeration chamber7. Return pressure8. Scale, PBP bag9. Conductive clip10. Pump11. Pressure sensor12. Sample site



HP Disposable KitThe HP Disposable Kit is designed to perform Hemoperfusion therapies. The kit consistsof an extracorporeal circuit (Hemoperfusion set) and an Adsorba cartridge.

CAUTIONPay particular attention to the extracorporeal blood volume. For patients with highextracorporeal volume/patient blood volume ratio, the physician may decide toprime the extracorporeal circuit with adequate volume substitution before patientconnection.

CAUTION

Prismaflex® disposable kits intended for HP therapy

Low Flow sets High Flow sets

None Adsorba 150

Adsorba 300

Refer to the Instructions for Use enclosed with the kit, for more information. Some kitsare not available in some countries due to local regulations.

Figure 7:2 HP Kit components

1. Sample sitesIn the HP sets sample sites are located as follows: access line before the junction withPBP infusion line (red), access line before the blood pump (red), filter line (red),return line between filter outlet and deaeration chamber (blue). The sample sitemarked orange in figure 7:2 is optional.

2. Pressure podsIn the HP sets pods are located as follows: access line before blood pump (access pod)and access line after blood pump (filter pod).


3. HP CartridgeCartridge containing activated charcoal granules that are encapsulated with abiocompatible cellulose membrane. As the patient’s blood perfuses through thecartridge, toxic substances in the blood are adsorbed by the charcoal.Note: Refer to the Instructions for Use packaged with the HP kit for the specifications,physical characteristics, materials, performances, and limits of use of thehemoperfusion cartridge.

4. Electrostatic discharger ringIn the HP sets, the discharger ring is located on the PBP line.

Note: On HP sets there is no dialysate line, replacement line or effluent line.

Specific Functions in HP

User-controllable SettingsThe tables in “User-controllable Settings” starting on page 4:22 lists all user-controllablesettings, their default values, setting options, and the mode in which they can be changed.

Bag ManagementPBP scale is managed with Variable Empty Bag method in HP.

Fluid Infusion ManagementIn HP therapy, there is no fluid balance system and, at most, infusion of PBP solutionas net fluid input to the patient. The same protecting system as for TPE therapy applies,although HP configuration is much simpler.

“Incorrect Weight Change Alarm Not Cleared” AlarmThe Caution: Incorrect Weight Change Alarm Not Cleared alarm occurs when the limit ofthe “Weight” and/or “Incorrect Flow” alarms have occurred within the last three hoursof treatment. Occurrence of this alarm indicates that there are ongoing problems withunresolved alarms.

To prevent serious, unintended patient fluid removal loss or gain, the Caution: IncorrectWeight Change Alarm Not Cleared alarm permanently suspends treatment (fluid pumpswill not re-start). This alarm requires the operator to end the treatment.

The STOP softkey is provided on the alarm screen and accesses the Stop screen. Whenready to end the treatment, the operator should press this key and follow the on-lineinstructions. The Return Blood option will be available.


WARNING

Note: STOP softkey should be pressed only when ready to proceed with the end treatmentsequence. (Pressing STOP softkey, stops the blood pump).



Protecting from Excessive Fluid InputIn HP therpay, any PBP solution infused should be counted as a separate fluid inputto patient as fluid removal is not possible. The Caution: Patient Fluid Gain Excessivealarm occurs when the PBP solution infused volume reaches a predefined threshold. Toprevent unintended excessive PBP fluid input, the Caution: Patient Fluid Gain Excessivealarm temporarily suspends treatment. The operator may decide to stop or continue thetreatment. See chapter 11, “Troubleshooting” for more information.

Pressure ManagementPrismaflex software does not calculate other pressure values than the Cartridgepressure drop (Pressure Drop) during HP therapy. This single calculation is used toprovide notification that clotting has begun in the hemoperfusion cartridge or that thehemoperfusion cartridge has clotted and the set must be changed. See “Filter PressureDrop (Pressure Drop)” on page 3:7 for more information.

Operating in HP

Flow Rates SettingsFlow rates are the settings that control the rate of blood flow and PBP solution flowduring a patient treatment.

Considerations When Using PBP SolutionDuring HP, count any PBP solution infused as a fluid input when calculating patientInput/Output totals.

CAUTIONPBP solution delivery is not removed in HP. Therefore this fluid volume isconsidered as a fluid input in the patient fluid balance.

CAUTION

History Data

Fluid GraphsIf PBP solution is in use, the Cumulative Volume Graph reports the volume pumpedduring each time increment of the graph. On the right side of the screen, the total PBPvolume pumped over the requested time period is reported.

Setup ModeIn HP, the setup sequence remains identical to the general pathway described in chapter 4.Specific instructions steps are presented in priming screens for:

- the composition of priming fluids: glucose followed by heparinised saline

- filling the access line of the blood circuit prior to its connection to the HP cartridge

- connecting the water-filled HP cartridge to the blood flow path


CAUTIONIn HP, use 5% glucose solution for the first priming cycle. Then use salineor alkaline solution (pH ≥ 7.3) to rinse in a second priming cycle, to preventfrom hemolysis.

CAUTION

Run ModeIn HP, the structure of the Run mode is identical to the generic description of chapter 4.

End TreatmentIn HP, structure of the end mode is identical to the generic description of chapter 4.Blood Return screen provides specific instructions for rotating the cartridge as to optimisereturn of blood.



Chapter 8

Anticoagulation MethodsContents


About the Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:2Prismaflex Anticoagulation Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:2

Configuration of Anticoagulation Methods . . . . . . . . . . . . . . . . . . . . . . . . . . 8:3Therapies and Anticoagulation Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:3

“Standard – Syringe” Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:4Adjusting the Anticoagulation Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:5Viewing the Anticoagulation Settings during Treatment . . . . . . . . . . . . . . . . 8:5Changing the Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:5Recirculation Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:5

“Standard – No Syringe” Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:5Regional Citrate Anticoagulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:6Regional Citrate Anticoagulation using the Prismaflex system . . . . . . . . . . . . . . 8:6Citrate Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:7Citrate Prescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:7Viewing the Anticoagulation Settings during Treatment . . . . . . . . . . . . . . 8:7Adjusting the Citrate Anticoagulation Settings . . . . . . . . . . . . . . . . . . . . . 8:7Citrate Anticoagulation Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:7Recirculation Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:8

Operating Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:8Citrate Dose Ranges: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:8Blood Flow Range: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:8

Calcium Management in “Citrate – Calcium via External Infusion Pump”Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:9

Calcium Loss Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:9Calcium Management in “Citrate – Calcium via Prismaflex Syringe Pump”Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:9Calcium Prescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:10Using calcium containing replacement solutions . . . . . . . . . . . . . . . . . . . 8:10Replacement solution delivery options . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11Viewing the Calcium Compensation Settings during Treatment . . . . . . . . 8:11Adjusting the Calcium Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11

Operating Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11Calcium Compensation Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11Flow Settings and Citrate Dose Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:12Calcium Solution Concentration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:12

Safety System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:13Factors to Consider . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:14Empty Bag method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:14Calcium containing solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:14


Anticoagulation Methods 8:1


WarningsWARNING

To assure proper flow control of syringe solution, use only the syringes approvedfor use with the Prismaflex system. The internal diameter of approved syringeshas been verified at the time of printing this manual. The manufacturer of thePrismaflex system cannot be held liable for subsequent changes that may occurto syringe dimensions.

Closely monitor the patient’s clotting parameters, especially when increasingand/or decreasing the amount of anticoagulant delivered or after changing theprescribed therapy setting or after changing the syringe.

WARNING

CautionsCAUTION

When setting up a patient treatment, install only the allowed syringe. Theallowed syringe is the syringe size/brand that has been selected in Custommode from among the approved syringes. See the Specifications chapter fora list of approved syringes.

Use only luer lock syringes with the Prismaflex control unit and monitor syringeline connection.

Keep the syringe line clamped and stowed along the left side of the set duringthe entire treatment when not running the Standard Syringe method.

CAUTION

About the ChapterThis chapter contains information about available anticoagulation methods for eachtherapy and how these are handled by the machine.

Prismaflex Anticoagulation Methods

Exposing a patient's blood to an extracorporeal circuit as done during thePrismaflex control unit treatments initiates coagulation. Effective anticoagulation isessential to optimize fluid and/or solute removal and filter longevity. Little or noanticoagulation may be needed for patients with coagulopathies, trombocytopenia orliver failure. Anticoagulation is administered during the treatments in accordance withphysician prescription.

The following anticoagulation methods are selectable on theChoose Anticoagulation Method screen:

• Standard – Syringe. For treatments with anticoagulation regimen, using thePrismaflex syringe pump.

• Standard – No Syringe. For treatments performed without anticoagulation regimen.The Prismaflex syringe pump is disabled during the entire treatment.

8:2 Anticoagulation Methods G5036003 Revision 05.2011Program version 6.xx

• Citrate – Calcium via External Infusion Pump. For treatments using Citrateanticoagulation. Requires Citrate solution on the PBP scale. The Prismaflex syringepump is disabled during the entire treatment. Calcium must be infused via an externalinfusion pump.

• Citrate – Calcium via Prismaflex Syringe Pump. For treatments using Citrateanticoagulation. Requires Citrate solution on the PBP scale. The Prismaflex syringepump is used for calcium infusion. Requires dedicated Prismaflex calcium infusionline connected to syringe.

WARNINGThe “Citrate – Calcium via External Infusion Pump” anticoagulation methoddisables the Prismaflex syringe pump for the entire treatment. An externalsyringe/infusion pump must be used to ensure the Calcium supplementationto the patient.

A dedicated Prismaflex calcium infusion line must be used when choosing“Citrate – Calcium via Prismaflex Syringe Pump” method.

WARNING

Configuration of Anticoagulation MethodsUsing the Prismaflex syringe pump requires relevant configuration of holder size inService mode and syringe brand in Custom mode.

For the regional citrate anticoagulation methods, service and custom configurations arealso required. Through the service mode, an authorized service technician can configurethe citrate and/or calcium solution parameters to be used during treatment, accordingto the facility's demands. Contact the local representative for additional information.Through the custom mode, the operator selects which citrate or calcium solution(s) to usefor the treatment. See the section, “Regional Citrate Anticoagulation” on page 8:6.

Therapies and Anticoagulation MethodsThe anticoagulation methods available for each Prismaflex system therapy are listedbelow:

CRRT:


• Standard – No Syringe



CRRT septeX:







CRRT MARS:



TPE:




HP:



“Standard – Syringe” Method

WARNINGConsider syringe accuracy specifications when using highly concentratedanticoagulants. See Table “Specifications” on page 13:1.

WARNING

The anticoagulation settings control delivery of anticoagulant solution from thePrismaflex system syringe to the blood flow. The settings are user-controllable andinclude the following delivery methods:

Continuous:

• The rate can be set within different ranges depending on syringe size. Seespecifications data for syringe settings in Specifications chapter on page 13:1.

Bolus:

• Bolus volume can be set within ranges depending on syringe size, defined in Syringesettings section in chapter Specifications on page 13:1.

• Delivery interval can be set as “immediate” in Run and Recirculation modes

• Delivery interval can be set to once every hour to 24 hours

See the bolus volume range in Specifications chapter on page 13:1.

Note: In CRRT therapies additional fluid volumes infused by the Prismaflex syringe pumpare removed through the effluent, except for Immediate Boluses.


Adjusting the Anticoagulation SettingsEnter Anticoagulation Settings screen is displayed during the Setup procedure. Theoperator is prompted to assess the default flow rates and syringe settings for the therapy/setchosen, make any changes desired for the current treatment, and confirm all values shownon the Enter Anticoagulation Settings screen prior to starting the patient treatment.

In Custom mode, the operator can change the syringe brand allowed for use. See “CustomMode” on page 4:21.

In Run mode, the operator can access the Enter Anticoagulation Settings screen and adjustthe settings as needed. See “Operating modes” on page 4:10 and “User-controllableSettings” on page 4:22.

Viewing the Anticoagulation Settings during TreatmentDuring a patient treatment (Run mode), the current anticoagulation settings are displayedon the Status screen.

Changing the SyringeIn Standard − Syringe anticoagulation method, the syringe must be connected to thesyringe line on the disposable set to infuse anticoagulant between blood pump and filter.The syring line on the disposable set is initially stowed along the left side of the setcartridge. Follow instructions and drawings on the screen for the correct connection ofthe syringe. Instructions on how to install and change syringes are also described inchapter 4 on page 4:31.

Recirculation ProceduresIn Standard − Syringe anticoagulation method, anticoagulant boluses can be deliveredduring the Saline or Blood Recirculation procedures. Press RECIRC RATES softkey onthe Recirculation in progress screen if this is desired.

“Standard – No Syringe” MethodThe selection of Standard − No Syringe disables the Prismaflex syringe pump until anew set is loaded.

Note: Even if no anticoagulation is required at start of the treatment, it is recommendedto choose “Standard – Syringe” anticoagulation method and to connect a syringe filledwith sterile saline solution. This ensures that the syringe line will be primed duringthe automatic priming cycle and is ready for anticoagulation any time during treatmentthrough CHANGE SYRINGE softkey.

Note: If starting up the anticoaglulation therapy via the Prismaflex syringe pump andsetting the infusion flow rate to a minimum, it will take time before the anticoagulationsolution reaches the set and is effective. Therefore, consider filling a syringe withanticoagulation solution from the start. This ensures that the syringe line will be primedduring the automatic priming cycle and is ready for effective anticoagulation any timeduring treatment.



Regional Citrate Anticoagulation

Citrate binds and forms a complex with ionized calcium from the patient’s blood. Thisprocess inhibits coagulation within the set. Systemic anticoagulation does not occur. Thecalcium-citrate-complex is metabolized by the patient’s liver. This process convertscitrate to bicarbonate and releases the ionized calcium, thus restoring patient homeostasis.

When using citrate as anticoagulation method, a certain amount of ionized (and bound)calcium will be cleared through the filter and lost in the effluent. This amount must becompensated to avoid hypocalcemia in the patient. Calcium can either be infused via anexternal syringe/infusion pump or preferably by the Prismaflex syringe pump.

Magnesium also binds to citrate and may have to be compensated. The use of Citraterequires additional monitoring of the patient’s parameters Ca2+, Mg2+, Na+, HCO3-, pH.

WARNINGUsing concentrated citrate solutions may cause hypernatremia. Consultphysician when using concentrated citrate solutions.

Consult physician for use of citrate anticoagulation on patients with liverinsufficiency, as this may cause metabolic acidosis and calcium imbalance.

During citrate anticoagulation, infuse calcium into a separate central venousline. Do not infuse calcium into a peripheral blood vessel as this may causedamage to the blood vessel and the peripheral tissue. Avoid infusing calciuminto the extracorporeal circuit as this may cause clotting in the deareationchamber or the return vascular access.

Wait a few minutes before taking a blood sample after the PBP citrate pump hasbeen stopped. This makes sure that the samples at the filter outlet are correct.

Always connect the return line directly to the blood access device. Do notconnect additional devices between the return line and the blood accessdevice. The use of additional devices, such as three-way valves, stopcocks, orextension lines, may impair return pressure monitoring. Their use can impedethe detection of return disconnections, potentially resulting in severe blood loss.

WARNING

CAUTIONDuring regional citrate anticoagulation, use calcium-free dialysate andreplacement solutions to avoid clotting.

With respect to the patient’s citrate load, restrict the buffer concentration(bicarbonate or lactate) of solutions to avoid metabolic alkalosis.

Consult physician for use of citrate anticoagulation in SCUF therapy mode asthe patient citrate load might be excessive and lead to metabolic alkalosis.

CAUTION

Regional Citrate Anticoagulation using the Prismaflex systemThe Prismaflex system is designed to adapt to the clinic's requirements for RegionalCitrate Anticoagulation. A broad range of citrate and calcium solutions can be usedwithin the system. Allowed concentration ranges are dependent on therapy. The clinic'schoice of solutions are preset in Service mode by an authorized service technician. Theoperator selects which solution to use for the treatment according to the prescription andchanges default values for Anticoagulation Settings parameters in Custom mode.


Citrate ManagementNote: this section is applicable to both “Citrate – Calcium via External Infusion Pump”and “Citrate – Calcium via Prismaflex Syringe Pump” anticoagulation methods.

Use of Regional Citrate Anticoagulation in the Prismaflex system requires a citratesolution bag on the PBP scale. This solution is infused into the access line of the set atwhich the anticoagulation starts.

Citrate PrescriptionIn citrate anticoagulation, PBP flow rate is kept proportional to blood flow rate andcomputed by the software through the equation:

Qpbp = (Qb × Dcit) / [Cit]

Where Qpbp is PBP flow rate (ml/h), Qb is Blood flow rate (ml/h), Dcit is Citrate doseexpressed in millimole per liter of blood (mmol/l blood) and [Cit] is citrate concentrationof the PBP solution (mmol/l).

Citrate dose is defined as the amount of citrate infused per liter of patient's blood treated,expressed in mmol/l blood.

Citrate dose is the user-controllable setting. Citrate concentration is the sum of citrate andcitric acid concentration as defined in Service mode for the selected citrate solution.

Blood flow rate affects the PBP citrate flow rate. A change of the blood flow rate willautomatically result in:

• Change of the PBP citrate flow rate.

• Change of the treatment dose (ml/kg/hr)

• Change of the estimated patient citrate load

Viewing the Anticoagulation Settings during TreatmentDuring a patient treatment (Run mode), the current anticoagulation settings are displayedon the Status screen: citrate solution name and citrate dose. In addition, the operator canaccess information about the anticoagulation solution by pressing VIEW SOLUTION fromthe Enter Anticoagulation Settings screen.

Adjusting the Citrate Anticoagulation SettingsEnter Anticoagulation Settings screen is displayed during the Setup procedure (Setupmode). The operator is prompted to assess the default blood flow rate and citrate dose forthe therapy/set chosen and confirm both values prior to starting the patient treatment.

During a patient treatment (Run mode), the operator can access theEnter Anticoagulation Settings screen and adjust the settings as needed. See “Operatingmodes” on page 4:10 and “User-controllable Settings” on page 4:22.

Citrate Anticoagulation IndicatorEstimated Citrate Load represents the amount of citrate effectively delivered to thepatient. It provides an indication of potential alkalosis in the patient.

The calculation of the citrate load is based on the following two factors:

• Rate of citrate infusion, based on blood flow rate and citrate dose.



• Estimation of citrate clearance as a function of blood, PBP, replacement, dialysate andpatient fluid removal rates, as well as on disposable set in use and patient hematocrit.

Recirculation ProceduresIn regional citrate anticoagulation, it is not possible to infuse citrate with the preblood–pump during a Saline or Blood Recirculation procedure. Avoid initiating a BloodRecirculation procedure from a Caution alarm, as well as from a change bag procedure,since the amount of citrate in blood can be very low in these circumstances.

Operating LimitsCitrate Dose Ranges:The Prismaflex software restricts citrate dose to a specific range with predefined minimumand maximum values of 1.5 and 6.0 mmol/l blood respectively.

Existing limits on PBP flow rate can however further restrict this range:

• to higher minimum dose when using highly concentrated PBP citrate solution andlow blood flow rate leading to very low PBP flow rate,

• to lower maximum dose when using diluted PBP citrate solution and high blood flowrate leading to very high PBP flow rate.

In these situations a change of the blood flow rate will lead to an update of the availablecitrate dose range.

Blood Flow Range:Available blood flow rate range may be reduced with respect to usual operating rangeof the disposable set in use. Minimum available blood flow rate can be increased inrelation to the minimum allowed PBP flow rate (30 ml/h) when using concentrated citratesolutions.

Maximum blood flow rate can be decreased in relation to the maximum available PBPflow rate (set dependent) when using diluted citrate solutions.

Note: maximum available PBP flow rate is also dependent on Dialysate and/orReplacement flow rates when the sum of the 3 flow rates reaches up to a maximum of8000 ml/h or less, depending on the filter in use.

Risk of patient citrate accumulation must be considered when increasing the blood flowrate.

Changing Factors in Citrate Anticoagulation

Blood flowincrease

Blood flowdecrease

Citrate doseincrease

Citrate dosedecrease

Blood flow increase decrease unchanged unchanged

Citrate dose unchanged unchanged increase decrease

PBP citrate increase decrease increase decrease

Citrate load increase decrease increase decrease


Calcium Management in “Citrate – Calcium via External InfusionPump” MethodThe syringe pump of the Prismaflex will be disabled for the entire treatment. An externalinfusion pump must be used to re-infuse the lost calcium.

When using an external infusion pump for the calcium infusion, adjust or stop calciuminfusion according to physician's prescription when citrate anticoagulation is stopped.Follow your facility protocol for adjustment of calcium infusion.

The Prismaflex control unit provides for reminders to start the external calcium infusionat the beginning of the treatment and to stop it when entering End mode.

WARNINGIf “Citrate – Calcium via External Infusion Pump” anticoagulation method hasbeen selected for the treatment, the external syringe/infusion pump is stillrunning while treatment and anticoagulation have been stopped. The externalcalcium infusion must be stopped manually.

WARNING

Calcium Loss IndicatorEstimated Change of Calcium Loss Rate in Effluent represents the relative variation ofcalcium losses in effluent due to change(s) in prescription settings.

This calculation is based on the estimation of calcium clearance as a function of blood,PBP, replacement, dialysate and patient fluid removal rates, as well as on disposableset in use.

Relative change in calcium clearance provides an estimation of the relative changein calcium loss rate in effluent. The calcium loss change is expressed as a negativepercentage (less loss) or as positive percentage (more loss). This percentage can help theoperator to adjust the calcium infusion to the patient, but does not release the operatorfrom monitoring the patient's parameters Ca2+, Mg2+, Na+, HCO3-, pH. The computationof calcium loss change is based on the assumption that dialysate and replacementsolutions contain no calcium.

Calcium Management in “Citrate – Calcium via PrismaflexSyringe Pump” MethodWhen choosing “Citrate – Calcium via Prismaflex Syringe Pump” anticoagulationmethod, the Prismaflex syringe pump will be used for calcium infusion.

Note: only 50 ml syringes of the allowed brand can be used for the calcium solution when“Citrate – Calcium via Prismaflex Syringe Pump” is used as anticoagulation method.

Using the Prismaflex syringe pump for the calcium infusion will facilitate maintenanceof normocalcemia in the patient. During treatment, the Prismaflex syringe pump, usedfor calcium infusion, is synchronized with the PBP Citrate pump. Whenever the citrateinfusion stops, the calcium infusion stops as well.

The Prismaflex syringe pump for calcium infusion is synchronized with the calcium lossin the effluent, and the calcium content of Replacement solutions used in post-dilution(settable using the REPLACEMENT CA CONC setting in Custom Mode).

The corresponding calcium solution volume infused by the Prismaflex syringe pump,will be removed in the effluent.



“Citrate – Calcium via Prismaflex Syringe Pump” anticoagulation method requiresusing the dedicated calcium line “Prismaflex - CA 250”, connected to the syringe. See“Calcium Infusion Line” on page 2:22.

WARNINGIf “Citrate – Calcium via Prismaflex Syringe Pump” anticoagulation has beenselected, use calcium-free Dialysate solutions to avoid hypercalcemia.

If “Citrate – Calcium via Prismaflex Syringe Pump” anticoagulation has beenselected, make sure to match the setting REPLACEMENT CA CONC in CustomMode with the calcium concentration of the prescribed Replacement solutions toavoid hyper- or hypocalcemia.

WARNING

CAUTIONDo not operate the control unit without the non-return valve present at the endof the calcium infusion line.

CAUTION

Calcium PrescriptionIn “Citrate – Calcium via Prismaflex Syringe Pump” anticoagulation method, the syringeflow rate is kept proportional to the estimated calcium loss rate in effluent. It is computedby the software of the Prismaflex system through the equation:

Qsyr = CaComp × JCa / [Ca] - Qrep × [Carep] / [Ca]

Where CaComp is the Calcium Compensation, Qsyr is Syringe flow rate (ml/h), JCa isestmated calcium loss rate in effluent (mmol/h), [Ca] is calcium concentration of thesyringe solution (mmol/l), Qrep is the Replacement flow rate (ml/h), and [Carep] is calciumconcentration of the Replacement solution in post-dilution (mmol/l).

Calcium compensation is defined as the relative dosage of calcium infusion to compensatefor the estimated calcium loss in effluent, expressed in percentage. Calcium compensationis the user-controllable setting. Calcium concentration is the concentration of the calciumsolution as defined in Service mode for the selected calcium solution.

Estimated calcium loss represents the amount of calcium removed in the effluent. Itscalculation is based on several factors:

- the estimation of calcium clearance as a function of blood, PBP, replacement,dialysate and patient fluid removal rates, as well as on disposable set in use andpatient's hematocrit

- the assumption that the patient Total Calcium is 2.2 mmol/l

- the assumption that pre-dilution replacement solutions and/or dialysate solutionsare calcium-free.

Any change of one or more flow rates or of anticoagulation settings affects the calciumsyringe flow rate, reflecting the estimated calcium clearance change and the inflow ofcalcium from Replacement solutions used in post-dilution.Note: in a similar way, any update of the patient’s hematocrit in theModify Settings screenduring the treatment affects the calcium syringe flow rate.

Using calcium containing replacement solutionsThe Prismaflex system supports the use of calcium containing replacement solutionsin CVVH and CVVHDF modes.


If informed about the calcium concentration of the prescribed Replacement solution,the Prismaflex system will deliver the desired Calcium Compensation, adjusted for theReplacement flow.

The default calcium concentration of the Replacement solution is to be set according tothe prescribed solution. See “Custom Mode” on page 4:21.

Replacement solution delivery optionsThe adjustment of calcium infusion incorporating calcium containing Replacementsolutions is limited to post dilution only. Pre-dilution with calcium containing solutions isnot supported.

For CVVH, 100% Post-filter delivery is set as a non-changeable default in case a non-zerocalcium concentration of Replacement has been selected in Custom Mode.

For CVVHDF, Post-filter delivery is set as a non-changeable default in case a non-zerocalcium concentration of Replacement has been selected in Custom Mode.

Refer to section ”Replacement Solution Delivery Options” on page 5:14 for details onthese settings.

Viewing the Calcium Compensation Settings during TreatmentDuring a patient treatment (Run mode), the current anticoagulation settings aredisplayed on the Status screen: calcium solution name and calcium compensation. Inaddition, the operator can access information about the calcium solution by pressingVIEW SOLUTION from the Enter Anticoagulation Settings screen.

Adjusting the Calcium CompensationThe operator is prompted to assess the default flow rates and syringe settings, makeany changes desired for the current treatment and confirm all values shown on theEnter Anticoagulation Settings screen prior to starting the patient treatment. To adjustcalcium infusion settings, press CALCIUM COMP softkey and use the softkey arrows tomodify the percentage value and then press CONFIRM ALL. The calcium compensationvalue is set and displayed in percentage while the corresponding infusion rate is expressedin ml/h and mmol/h.

In Custom mode the operator can change the syringe brand allowed for use. See “CustomMode” on page 4:21. The default calcium compensation percentage value is alsoadjustable in Custom mode, together with the calcium concentration of Replacementsolutions used in post-dilution.

In Run mode, the operator can access the Enter Anticoagulation Settings screen andadjust the settings as needed.

Operating Limits

Calcium Compensation RangeThe Prismaflex system software restricts calcium compensation to a specific range withpredefined minimum and maximum values of 5% and 200% respectively. Existing limitsof syringe flow rate can, however, further restrict this range:

- The minimum available compensation will raise when using highly concentratedcalcium solutions, high flows of calcium-containing replacement solutions, or loweffluent flow rates.



- The maximum available compensation will decrease when using highly dilutedcalcium solutions, or high effluent flow rates.

In these situations a change of the Citrate Dose, Dialysate or Replacement flow rate willlead to the most significant changes of the calcium compensation range.

Flow Settings and Citrate Dose RangesAvailable range of the flow or anticoagulation settings may be reduced with respectto usual operating range of the disposable set in use. These restrictions occur inrelation to the minimum and maximum allowed flow rates for the calcium syringepump, 2 – 100 ml/h. The Prismaflex system computes and displays the availablerange for each prescription parameter when making settings on the Enter Flow orEnter Anticoagulation Settings screens. Selection of a parameter outside the availablerange is prevented by the system.

Calcium Solution ConcentrationAs shown in the calcium prescription section on page 8:9, the concentration of thecalcium solution is one of the three main factors defining the calcium syringe flow rates:

• Concentrated calcium solutions can lead to syringe flow rates in the lower range.This may significantly increase the minimum allowed settings for Dialysate and/orReplacement flow rates, as well as for Citrate Dose.

• Diluted calcium solutions can lead to syringe flow rates in the higher range and maydecrease the maximum allowed settings of most prescription parameters.

• The software of the Prismaflex system restricts calcium concentration to a specificrange as defined in Service mode, with predefined minimum and maximum values of80 mmol/l and 1000 mmol/l, respectively.

Assuming calcium free Replacement and Dialysate solutions and a calcium loss rate ineffluent as proportional (coefficient “k”) to the removal of small molecules and CRRTdose, a relation between patient body weight and calcium concentration can be established:

Qsyr = [(CaComp / 100) × k × DCRRT × BW] / [Ca]

Where Qsyr is Syringe flow rate (ml/h), CaComp is Calcium compensation (%), DCRRTis CRRT dose (ml/kg/h), BW is Patient body weight (kg), [Ca] is Calcium concentrationof the syringe solution (mmol/l) and k is a proportionality coefficient (mmol/l).

Above relation is used to set recommendations for the patient body weight range suitablefor each calcium solution. A reminder of these recommendations is given on theTherapy and Anticoagulation Choice screen.


Figure 8:1 A) Represents the upper weight limit, B) represents the recommendedpatient weight range, C) represents the lower weight limit.

Safety SystemThe Prismaflex system provides additional alarms when citrate anticoagulation isperformed:

Alarm specific to all regional citrate anticoagulation methods

• ADVISORY: Anticoagulation Checkpoints alarm reminds the additional monitoringof patient’s parameter. The occurrence of the alarm can be selected in ‘System Tools’as well as in Custom mode.

Alarm specific to “Citrate – Calcium via External Infusion Pump” anticoagulationmethod

• ADVISORY: Fluid Pump Stopped alarm occurs only when fluid pumps have stoppeddue to an alarm for more than ten minutes during treatment. Under this conditiontreatment and anticoagulation are interrupted while calcium delivery by the externalinfusion pump continues. The alarm reminds for additional monitoring of patient’sparameter.

Alarms specific to “Citrate – Calcium via Prismaflex Syringe Pump” anticoagulationmethod

• WARNING: Unsuitable Calcium Solution alarm occurs afterConfirm Loaded Set screen if the Calcium solution selected in custommode is not suitable for use with the selected therapy or set type. (see previous section“Calcium Solution Concentration” on page 8:12)

• WARNING: Ca Line Not Connected alarm is the equivalent of Advisory: CalciumLine Not Connected alarm for Setup mode; see below.

• CAUTION: Calcium Infusion Stopped alarm occurs when calcium syringe pump hasbeen stopped for more than six minutes over the last two hours of treatment. Underthis condition treatment and anticoagulation infusion are interrupted until calciumsyringe infusion is resumed.



• ADVISORY: Ca Line Not Connected alarm occurs when calcium infusion is notreconnected after syringe change or installation. It may also occur if connectingan infusion line other than the calcium line “Prismaflex - CA 250. See “CalciumInfusion Line” on page 2:22.

Refer to chapter 11 for troubleshooting instructions.

Factors to ConsiderEmpty Bag methodUse Variable Empty Bag method when using citrate solution bags and dialysate bags ofdifferent volumes, to prevent situations of wrong bag on wrong scale.

Calcium containing solutionsIn case non calcium-free Dialysate or Replacement solutions are prescribed together withthe “Citrate – Calcium via Prismaflex Syringe Pump” method in non-post delivery modeshypercalcemia may develop if operating with the default calcium compensation setting of100%. In these conditions, the initial calcium compensation should be set below 100% asto take into account the amount of calcium infused through the Dialysate or Replacementflow. Standard patient monitoring and calcium infusion adjustment protocols shall applyafter this initiation phase.


Chapter 9

Blood WarmersContents

Warming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:2About the Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:2Prismatherm II blood warmer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:2Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:2Prismatherm ll operating temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:2Prismatherm ll pressure drop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:3

Sleeve Blood Warmers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:3Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:3


Blood Warmers 9:1

WarmingWARNING

Monitor patient temperature to avoid hypothermia. Pay special attention whenusing high fluid exchange rates, or when treating low body weight patients.

WARNING

CAUTIONAvoid moving the Prismaflex control unit when a blood warmer is installed.Adjust the warmer to resting position before moving the control unit.

CAUTION

CRRT may induce significant hypothermia. TPE may also induce significant hypothermia.The cooling power depends primarily on the fluid exchange rate and the temperature ofthe fluid bags. The Prismaflex control unit allows for several blood warmer accessories tocompensate for heat losses.

About the ChapterThis chapter provides information when handling Blood warmers. Each warmer, that canbe used with the Prismaflex system, is described in a dedicated section with details abouthow to operate the warmer unit during setup, treatment and end of treatment.

Prismatherm II blood warmer

DescriptionPrismatherm II consists of a heated aluminium cylinder and an extension linecoiled into the cylinder groove. The Prismatherm II extension line connects at thePrismaflex disposable set warmer connection, between the filter outlet and the deaerationchamber. The extension line of a blood heater must be placed upstream of the air bubbledetector. The Prismaflex system cannot detect air introduced in the line, for instance dueto a blood warmer, downstream of the air bubble detector.

Prismatherm ll operating temperatureOperating temperature of the heating cylinder is user selectable and matched with themaximum temperature of the cylinder, not the blood outlet temperature.

Connection of Prismatherm II extension line SP420 to the Prismaflex system circuitsignificantly increases the volume to the extra corporeal blood circuit. This added volumerequires attention during prescription, especially with low body weight patients (seealso Prismaflex sets IFU).

Post-replacement infusion solution flows into the deaeration chamber downstream of thewarmer connection. Efficiency of the Prismatherm II blood warmer is thus reduced whenhigh rates of post-dilution replacement are prescribed.

Prismatherm II blood warmer is only compatible with the sets specified in Table“Maximum blood flow rate (Qbmax) compatible with the use of Prismatherm II BloodWarmer” on page 9:3.

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Prismatherm ll pressure dropThe use of Prismatherm II extension line causes pressure drop between filter outlet anddeaeration chamber. This pressure drop is basically proportional to blood flow rate butalso dependent on blood hemoconcentration at filter outlet.

Therefore the utilization of Prismatherm II blood warmer biases to some extent FilterPressure Drop and TMP measurements (see Prismatherm II Operator Manual “PressureEffects” section).

The Warning: Filter Extremely Positive alarm and the Warning: Filter Clotted alarm maybe triggered when using Prismatherm II at high blood flow rate. The table below givesindications about the maximum blood flow rates that are compatible with the variousPrismaflex system sets when using Prismatherm II. The table shows maximum blood flowrate (Qbmax) compatible with the use of Prismatherm II Blood Warmer, as determinedfrom in vitro experiments using bovine blood (hematocrit 32%, protein content 60g/L)and a 13F catheter.Maximum blood flow rate (Qbmax) compatible with the use ofPrismatherm II Blood Warmer

Prismaflex disposable set Qbmax ml/min Preturn mmHg

M60, ST60 180 80

M100, ST100 300/320 130

M150, ST150, oXiris 350/370 160

HF 1000, septeX 330/350 150

HF 1400 350/360 150

TPE 1000 180 80

Note: The above values are determined to provide an operating Filter pressure below+400 mmHg. For TPE1000, the “Plasmafilter is Clotted” alarm defines the threshold.

In the clinical setting, the above flow rate values may need to be significantly decreased incase of high blood viscosity (high hematocrit or other causes).

Refer to Prismatherm II Operator Manual for more information.

Sleeve Blood Warmers

DescriptionSleeve blood warmers consist of a control unit and a silicone sleeve to be set around thereturn line of the Prismaflex disposable set, downstream of the return clamp. This sleeveis warmed with electrical wire resistors.

The Prismaflex system offers the following two sleeve warmer accessories having similarcharacteristics and performance:

- PrismaComfort

- Prismaflo II

Efficiency of the sleeve blood warmers is independent of the therapy configuration and onthe infusion of replacement solution in pre or post dilution.

Two sizes of sleeves are available to fit the full range of the Prismaflex disposable setsand the tubing diameter of return line. Sleeve size must match tubing size for efficientwarming.


Blood Warmers 9:3

WARNINGHighest set point (43°C) of PrismaComfort and Prismaflo II must be used withcare when operating the Prismaflex system at low Effluent flow rates (below 500ml/h) with patients below 30 kg. Global positive heat balance and net patientwarming may be present in such circumstances.


WARNING

Refer to Prismacomfort Operator Manual or the Prismaflo II Operator Manual for moreinformation.

For information about availability of sleeve warmers and sleeve size, refer to the localGambro representative.

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Chapter 10

Alarm SystemContents

About the Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:2Warning Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:2Prismaflex® Control Unit Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:2Operator Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:3Overridden Warning Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:3

Malfunction Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:4Prismaflex® Control Unit Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:4Operator Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:4Overridden Malfunction Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:4

Caution Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:5Prismaflex® Control Unit Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:5Operator Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:5

Advisory Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:6Prismaflex® Control Unit Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:6Operator Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:6Overridden Advisory Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:6

Alarm Priorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:7


Alarm System 10:1

The Prismaflex control unit continually monitors itself and the Prismaflex disposable setfor proper functioning during operation. If an abnormal situation occurs, the control unitsignals a Warning, Malfunction, Caution, or Advisory alarm.

The operator is notified of an alarm condition via a red or yellow status light, an audiblealarm, and an alarm screen on the display. Each alarm screen provides instructions onhow to respond to the alarm and provides a MUTE key, which allows the operator totemporarily silence the audible alarm (for 2 minutes). When applicable, a Help screen isavailable to provide additional information.

WARNINGWhen responding to any alarm, carefully follow the instructions on the displayedalarm screen and its associated Help screen.

To clear some alarms, the Prismaflex control unit must override the alarm for abrief time (60 seconds). The alarm screen notifies the operator that the alarm willbe overridden if the OVERRIDE softkey is pressed. A new alarm for the samecondition cannot occur during the override period. Therefore, carefully observethe set and all operation during the override period. If the alarm condition is stillpresent after the override period, the control unit issues a new alarm.

Do not override the same alarm repeatedly. End treatment and call for service.

When the blood is returned manually, there is no air detection. Visually checkfor air in the return line until patient is disconnected.


WARNING

About the ChapterThis chapter gives an overview of the alarm system and describes the different levels ofsignals given by the Prismaflex control unit. In chapter 11, all alarms are described withinformation about how to troubleshoot each alarm.

Warning AlarmsWarning alarms occur if conditions of possible patient hazard exist that require promptoperator intervention; for example, air bubbles in the return line or extreme positivepressure in the return line.

Prismaflex® Control Unit ActionsThe following actions occur during a Warning alarm:

• The Prismaflex control unit enters a “safe state” by stopping all pumps and closingthe return line clamp. Treatment is suspended. The patient’s blood does not circulatethrough the blood flowpath.

• Red light is lit.

• Audible alarm sounds with a fast beeping tone.

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• Warning screen appears on the display.

• EXAMINE ALARMS softkey appears except for when Self-Test in progress is active.

Operator ResponseThe Warning screen gives the operator instructions for responding to the Warning alarm.Appropriate responses are different for each warning.

When the alarm has been cleared, the following occurs:

• Warning screen leaves the display.

• Green light is lit.

• EXAMINE ALARMS softkey disappears, unless there are other active alarms.

• Blood pump restarts and return line clamp opens. Seven seconds later, other pumpsrestart.

Overridden Warning AlarmsTo clear some Warning alarms, the Prismaflex control unit must override the alarm for ashort period of time. After completing the response instructions given on the Warningscreen, the operator presses the OVERRIDE softkey. During the override period, thefollowing occurs:

• Warning screen leaves the display.

• Yellow light is lit.

• EXAMINE ALARMS softkey remains displayed.


When the override period is complete, the alarm either clears or recurs.


Alarm System 10:3

Malfunction AlarmsMalfunction alarms occur if patient safety cannot be monitored due to a failure of thesystem; for example, failure during self-tests, errors in the software, or hardware failure.

Prismaflex® Control Unit ActionsThe following actions occur during a Malfunction alarm:

• The Prismaflex control unit enters a “safe state” by stopping all pumps and closingthe return line clamp. Treatment is suspended. The patient’s blood does not circulatethrough the blood flowpath.

• Red light is lit.

• Audible alarm sounds with a fast beeping tone.

• Malfunction screen appears on the display.


Operator ResponseSome malfunctions can be cleared by the operator; others require service by an authorizedservice technician. The Malfunction screen gives instructions for responding to theMalfunction alarm. Appropriate responses are different for each malfunction.


• Malfunction screen leaves the display.




If the operator cannot clear a particular Malfunction alarm, it must be cleared in Servicemode by an authorized service technician. The Malfunction screen gives appropriateinstructions, which include the following:

• End the patient’s treatment (with or without returning blood).

Note: If the DISCONNECT key is not available, the treatment should be terminatedmanually. See “Manual Termination of Treatment” on page 11:76.

• Turn off the power.

• Call for service to repair the control unit and clear the alarm.

Overridden Malfunction AlarmsTo clear some Malfunction alarms, the Prismaflex control unit must override the alarmfor a brief time. After completing the response instructions given on the Malfunction


screen, the operator presses the OVERRIDE softkey. During the override period, thefollowing occurs:

• Malfunction screen leaves the display.




When the override period is complete, the alarm either clears or recurs.

Caution AlarmsCaution alarms occur if a condition exists for which the proper action is to suspendtreatment, but it is safe to continue blood and syringe pump flow; for example, the PBP,dialysate or replacement solution bag is empty or the effluent bag is full.

Prismaflex® Control Unit ActionsThe following actions occur during a Caution alarm:

• PBP, replacement, dialysate, and effluent pumps stop.

• Blood and syringe pumps continue to operate and the return line clamp remains open.The patient’s blood continues to circulate through the blood flowpath, but treatmentis suspended.


• Audible alarm sounds with a moderate beeping tone.

• Caution screen appears on the display.


Operator ResponseThe Caution screen gives the operator instructions for responding to the Caution alarm.Appropriate responses are different for each caution.


• Caution screen leaves the display.



• PBP, replacement, dialysate, and effluent pumps restart within a few seconds.


Alarm System 10:5

Advisory AlarmsAdvisory alarms occur if a condition exists of which the operator should be aware, but thepatient is not at immediate risk; for example, when preventive maintenance is due. Thepatient’s treatment continues during an Advisory alarm.

Prismaflex® Control Unit ActionsThe following actions occur during an Advisory alarm:

• No pumps stop; treatment continues.


• Audible alarm sounds with a slow beeping tone except for when alarm Self-Test inprogress is active.

• Advisory screen appears on the display.


Operator ResponseThe “Preventive Maintenance Due” Advisory alarm can only be cleared by an authorizedservice technician; the other advisories can either be cleared or overridden by theoperator; some advisories are also self-clearing.

The Advisory screen gives the operator instructions for responding to the Advisory alarm;appropriate responses are different for each advisory.

When an advisory has been cleared (self-cleared or cleared by the operator), the followingoccurs:

• Advisory screen leaves the display.



Overridden Advisory AlarmsMany Advisory alarms can be overridden by the operator. If an Advisory alarm isoverridden, it remains overridden indefinitely. If the overridden alarm is a self-clearingalarm, it clears when the condition no longer exists. If the overridden alarm is notselfclearing, it remains in a list of pending alarms. Pending alarms can be viewed bypressing the EXAMINE ALARMS softkey. See “Alarm Priorities” on page 10:7 formore information.

If the Advisory Check Return alarm is overridden by the operator it will be reactivated.

If the operator overrides an Advisory alarm, the following control unit actions occur:• Advisory screen leaves the display.

• Yellow light remains illuminated.



Alarm PrioritiesAll alarms are prioritized. This means that if multiple problems exist, only thehighest-priority alarm screen is displayed. Clearing the highest-priority alarm causes thesecond highest-priority alarm screen to be displayed, and so on. As each alarm appearson the display, the operator follows the instructions on the screen in order to respond tothe alarm.

The Service Manual shows the priority for each alarm.

Whenever an alarm occurs, the EXAMINE ALARMS softkey appears and the name ofthe alarm is stored in a pending (active) alarms list. Until the alarm is cleared, theEXAMINE ALARMS softkey remains displayed and the alarm name remains in thepending alarms list. Overridden alarms are considered active alarms.

The operator can press EXAMINE ALARMS to view the list of pending alarms.


Alarm System 10:7

Chapter 11

TroubleshootingContents


About the Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:2Warning Alarms Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:3Caution Alarms Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:21Advisory Alarms Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:35Malfunction Alarms Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:53Additional Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:73Power Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:76Manual Termination of Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:76Manual Termination With Blood Return . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:76Manual Termination Without Blood Return . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:78

Pressure Pod Adjustment Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:78Pressure Pod Adjustment (CRRT, HP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:79Supplies Needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:79Access Pod and Effluent Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:79Filter Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:80

Pressure Pod Adjustment (TPE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:81Supplies Needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:81Access Pod (TPE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:81Filter and Effluent Pods (TPE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:82

Leakage in pressure pods or blood reaching fluid barrier . . . . . . . . . . . . . . . . . . . . .11:82Fluid Barrier Related Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:83Fluid Barrier Recovery in Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:83Fluid Barrier Change in Run Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:84

Air Removal Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:84Deaeration Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:84Air in Blood Alarm – Manual Air Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:84

Blood Leak Detector Normalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:85Cardiac Monitor Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:86


Troubleshooting 11:1


WarningsWARNING

When the blood is returned manually, there is no air detection. Visually checkfor air in the return line until patient is disconnected.

After clearing the “Weight” or “Incorrect Flow” caution alarms, verify accuracyof Patient Fluid Removal (in CRRT) or Patient Plasma Loss (in TPE) in theHistory screen.

WARNING

CautionsCAUTION

Carefully observe the patient and the Prismaflex control unit during an alarmoverride period. A new alarm for the same condition cannot occur during theoverride period. The Prismaflex control unit status light will display a yellowindication during an Override period.

CAUTION

About the ChapterThe alarm screens give on-line instructions for responding to most alarm situations.Under certain circumstances, however, the alarm screens cannot give the necessarydetailed instructions. This chapter of the manual provides the additional informationthat may be needed.

The Prismaflex system alarms are listed in the following categories:Table 7.1 Warning Alarms Troubleshooting on page 11:3Table 7.2 Malfunction Alarms Troubleshooting on page 11:53Table 7.3 Caution Alarms Troubleshootingon page11:21Table 7.4 Advisory Alarms Troubleshootingon page 11:35Possible causes for each alarm and appropriate operator actions are given.Table 7.5 Additional Troubleshooting on page 11:73, provides instructions for handlingother abnormal situations that can occur.

Note: The alarms are listed in alphabetical order within each category.

This chapter also contains instructions for Manual Termination of Treatment procedures(with and without returning blood to the patient), Pressure Pod Adjustment procedures,Air Removal procedures and Fluid Barrier related procedures.

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Warning Alarms Troubleshooting

Access Extremely Negative

Observation:Alarm occurs if the access pressure is more negative than the user-settable “Access ExtremelyNegative” Warning Limit. or if access pressure is 150 mmHg or more below its operating point.

Note: An operating point is the pressure value when the pressure is considered stable after an eventsuch as an alarm, change of blood flow etc.

This alarm self-clears if pressure goes back to normal limits within 15 secondsc. During theself-clear time the monitor will not give an audible alarm.

Possible cause(s): Operator action(s):

Patient is moving, coughing, orbeing suctioned.

Wait 15 seconds for self-clearingc attempt.

Note: If a self-clear attempt fails wait until the pressure is back to normal in the non self-clearingscreen, then press CONTINUEa.

Access line clamped, kinked orpartially blocked.

Note: If a self-clear attempt fails, wait until the pressureis back to normal in the non self-clearing screen, thenpress CONTINUEa.

Access catheter clotted or out ofposition in vein, or blood flow ratetoo high for the access device.

Flush/reposition access catheter per hospital protocol.Use access sample site to infuse saline to releasenegative pressure and/or lower blood flow rate. PressCONTINUEa.

Access pressure sensor failed. End treatment, call service.Note: If the above operator responses do not clear the alarm, the set can be changed and the alarmcleared via STOPb. If alarm recurs with a new set, end treatment via STOPb. Call service.

Access Extremely Positive

Observation:Alarm occurs if the access pressure is more positive than the user-settable “Access ExtremelyPositive” Warning Limit.


External device (if in use) isdelivering blood at a too highpressure.

Reduce the delivery pressure of the external device.



Warning

AlarmsTroubleshooting

Warning Alarms in Alphabetical Order

Blood flow rate has been set toolow according to the blood pressuredelivered by the external device.

Increase blood flow rate. Return to alarm screen andpress CONTINUE.

Access pressure sensor failed. End treatment. Call service.Note: If the above operator responses do not clear the alarm, the set can be changed and the alarmcleared via STOPb. If alarm recurs with a new set, end treatment via STOPb. Call service.

Access pressure measurementfailure.

Perform a self-test for repositioning the pressure podmembranes. Clear the alarm to reach Status screen.Press SYSTEM TOOLS and perform SELF-TEST. If thepod problem is not solved, perform Pod Adjustmentprocedure on access pod. See instructions at the end ofthis chapter. Or, change set via STOPb. If alarm recurswith new set, end treatment via STOP. Call service.

Air in Blood


Disconnected line, leakingconnection, set not fully primed.

a. Remedy possible causes.

b. Press Up arrow until return pressure isNEGATIVE. If unsuccessful, proceed withmanual procedure (see “Air in Blood Alarm –Manual Air Removal” on page 11:84).

c. Press RELEASE CLAMP to remove air and drawblood from patient into the return line / deaerationchamber.

d. If needed, use arrows to adjust the level of fluidin the chamber.

e. When ready, press CONTINUE.

Note: If air is present in entire set, pressDISCONNECT to load and prime a new set.

Air/foam in the tubing. In case of recurring alarm, open door of air bubbledetector and look for air/ foam in the tubing; inspectlevel of fluid in deaeration chamber. Close air bubbledetector door. Press CONTINUE.


Warning



Bag/Container Empty

Observation:Bag/container is empty.

Depending on therapy, the following bag/container may be identified:Replacement bagDialysate bagPBP bagReplacement bag 2 (green scale)

The alarm appears during priming only.


Identified bag is emptyd. Connect a new bag. Press CONTINUE.

Identified bag is partially supported(not hanging freely).

Remove partial support. Press CONTINUE.

Bag Volume Incorrect

Observation:Bag volume incorrect. Amount of fluid in bag does not match Allowed Volume.

The following may be identified:Replacement bag

Dialysate bag

PBP bag

Replacement bag 2 (green scale)

Valid only if Variable Tare is selected as Empty bag method.



Amount of fluid in the identifiedbag does not match the currentAllowed Volume.

Choose one of the three options on the alarm screen.Caution:Choose Keep Bag only to use a partially full bag thatis of the same total volume capacity as the currentAllowed Volume.

No bag on scale. Place the appropriate bag on the scale. PressCONTINUE.

Note: If hanging multiple bags on the scale, the total fluid capacity of all bags on the scale mustnot exceed the allowed volume for that scale.



Warning



Foreign object on scale. Remove foreign object. Press CONTINUE.



Battery Low

Observation:Main power is still out and batteries are out of energy.Applicable when machine configuration includes the back-up battery (check with the localrepresentative for more information). See Power Failure on page 11:76


Main power has been lost andbattery is out of energy.

If patient is in treatment, press STOP softkey to endtreatment.If a patient is connected in SETUP mode, pressDISCONNECT softkey to disconnect the patient. Switchoff the machine.If a patient is connected in END mode, pressOVERRIDE softkey to end the treatment. Switch offthe machine.

Machine is unplugged and batteryis out of energy.

Connect power cord. Press STOP and select RESUME torestart the treatment.

Blood Detected in Set

Observation:Patient blood sensor identifies blood in tubing.


In Priming mode:Blood is actually present in theset, foam in return line, return lineinstalled in air bubble detectorbefore expected, or is out ofposition in the air bubble detector.

Verify if blood is present in the set. If blood IS presentin the set (although blood priming is not performed),press DISCONNECT to change the set. If blood ISNOT present in the set, check return line installation,press OVERRIDE to continue with priming and patientconnection. If alarm recurs with a new set. Call service.Note: The alarm does not occur during blood priming.

During resuming after previousswitching OFF:During a patient treatment, the setactually contains blood.

To go on with treatment, press OVERRIDE. Otherwisepress END TREATMENT to terminate use of loaded set.


Warning



During saline recirculation:Poor blood rinseback done beforeRecirculation.Note: The alarm does not occurduring blood recirculation.

Verify that patient is disconnected. Verify the properset-up of recirculation circuit and that access and returnlines are connected to recirculation bag. If correct andpatient is disconnected, press CONTINUE to go onwith recirculation. If patient is connected then pressDISCONNECT and change set.

Patient sensor has failed. Press DISCONNECT. Call service.

Blood Leak Detected


Air bubble in effluent line at levelof blood leak detector.

Press OVERRIDEa to dislodge bubble. In case ofrecurring air bubbles (effluent fluid degassing), checkfor kink in effluent line and/or reduce ultrafiltration rate.

Effluent line not properly installedin blood leak detector.

Press line into detector from the bottom up and routesecurely through tubing guides. Press OVERRIDEa.

Liquid or other debris in tubingpath through the detector.

Remove line from detector. Using a “flossing” action,clean inside the detector with a lint-free cloth andisopropyl alcohol. Dry thoroughly. Clean effluentline with water and dry thoroughly. Reinsert line intodetector and tubing guides. Press OVERRIDEa.Warning:The blood leak detector must be re-normalized if theeffluent line is removed and then reinserted into theblood leak detector after treatment (Run mode) hasstarted. See Troubleshooting chapter on page 11:85.

Leak in filter membrane. Change the set via STOPb.

TPE: formed elements or lipids inplasma, discolored plasma.

Press OVERRIDEa. Lower replacement rate and/orpatient plasma loss rate.Note: If this does not clear the alarm, the set can bechanged via STOPb. If alarm recurs with a new set andlowered flow rates, discontinue treatment.

Calcium Line Clamped


The calcium infusion line isclamped.

Unclamp the calcium infusion line. Press CONTINUE.



Warning



Incorrect installation of calciuminfusion line.

Inspect calcium infusion line, remove any clamps, kinksor other obstructions. Use the clip above the syringepump for the calcium infusion line to avoid kinks. PressCONTINUE.Note: In case of recurring alarm, pressCHANGE SYR/LINE softkey to change both thesyringe and the calcium infusion line.

Calcium Syringe Empty

Observation:Occurs during priming only.


Calcium syringe is empty. Press CHANGE SYR/LINE softkey and follow theinstructions on the screen to install a full syringe andreturn to alarm screen. Press CONTINUE.

Ca Line Not Connected


The calcium infusion line is notconnected to the syringe.

Connect a dedicated calcium infusion line to the syringe.Press CONTINUE.

Wrong line connected. Use only a dedicated infusion line for the calciuminfusion when the “Citrate – Calcium via PrismaflexSyringe Pump” method is chosen.

The unused and stowed syringe lineon the disposable set is connectedto the calcium syringe.

Clamp the unused line on the disposable set and leave itunused during entire treatment when “Citrate – Calciumvia Prismaflex Syringe Pump” method is chosen. PressCHANGE SYR/LINE softkey and follow the instructionson the screen to connect a dedicated calcium infusionline to the syringe.

A syringe of the wrong size isinstalled.

Use only a 50 ml syringe of the allowed brand whenthe “Citrate – Calcium via Prismaflex Syringe Pump”method is chosen.

Air in syringe. Press CHANGE SYR/LINE. Follow instructions toinstall a full syringe and return to alarm screen. PressCONTINUE.


Warning



Clamped Lines


One of the lines is clamped. Unclamp the line. Press REPRIME.

Occluded disposable set. Press DISCONNECT. Change set.

One or more pressures sensorsfailed.

Press DISCONNECT. Call service.

Crossed Lines


The lines are crossed or tangled. Check and correct lines and bags setup. PressREPRIME.

Foreign object on scale. Remove the object. Press REPRIME.

One or more scales failed. Press DISCONNECT, turn off the machine. Call service.

Effluent Bag Full

Observation:Effluent bag is full.



Effluent bag is full. Connect a new effluent bag via instructions on the alarmscreen. Press CONTINUE.

Foreign object on effluent scale. Remove foreign object. Press CONTINUE.



Warning



Effluent Bag Incorrect

Observation:Effluent Bag volume does not match Allowed Volume.Cause: a 5000 ml empty bag is hung on scale while Effluent Allowed Volume is 9000 ml.



A 5000 ml empty bag is hung onthe scale while Effluent AllowedVolume is 9000 ml.

Replace the 5000 ml bag hung on the scale by a 9000 mlbag or change the Effluent Allowed Volume by pressingMODIFY BAG. Press CONTINUE.


Effluent bag is partially supported(not hanging freely).


Filter Clotted

Observation:Filter pressure drop is ≥ limit value fixed for the filter in use, or both the “Filter is Clotting”Advisory and the “TMP Excessive” Caution limits are reached.Note: TMP value in the MARSFLUX filter is not considered for this alarm during CRRT-MARStherapy; see section “Pressure management” on page 5:27.


Clots have formed in the filter.Note: Clotting is usually due toinadequate anticoagulation of theblood flowpath.

Change the set via STOPb. Test patient’s clottingparameters and adjust anticoagulant delivery if needed.

Clamped line(s) in blood flowpath. Unclamp lines. Press CONTINUE.

Ultrafiltration rate is too high forfilter in use.

Press CONTINUE and then reduce replacement solutionflow rate and/or PBP solution flow rate and/or patientfluid removal rate.

Pressure measurement failure. Perform a self-test for repositioning the pressure podmembranes.

During Standard-Syringeanticoagulation:Anticoagulation delivery has failed.

Press STOPb and change the set. Ensure that syringeis properly installed in syringe pump and plungeris moving upward during treatment. If plunger isnot moving, syringe pump has failed. If desired,connect syringe line to a medically acceptable alternate


Warning



anticoagulant delivery system. Call service to repairpump.

During regional citrateanticoagulation:Citrate delivery has failed.

Press STOPb and change the set. Ensure that PBP pumpworks properly. If PBP pump has failed, call service.

During CRRT MARS treatment:The MARS monitor has detecteda blood leak.

If blood leak confirmed, press STOP and change theset. If not, troubleshoot the MARS monitor and pressCONTINUE.

Filter Extremely Positive

Observation:Alarm occurs if filter pod pressure is ≥450 mmHg


Line between filter pressure podand filter or line between filter anddeaeration chamber is clamped orkinked.

Remedy and press CONTINUE.

Machine is operating at high returnpressure and clotting has begun infilter.

Press FLOW SETTINGS and lower blood flow rate.Check catheter.

Excessive pressure. Relieve excess pressure in return line by pressingRELEASE CLAMP. If desired, lower the blood flowrate, press CONTINUE.

Note 1: The RELEASE CLAMP key is available only if no other alarm requiring the clamp closedis presente.

The filter pressure will drop as operation commences. (The appropriate Advisory or Warning alarmoccurs when filter clotting becomes problematic.)

Note 2: If the above operator responses do not clear this alarm, the set can be changed via STOPb.If alarm recurs with new set, end treatment via STOPb. Call service.

Filter pressure sensor failed. End treatment via STOPb. Call service.


If blood leak confirmed, press STOP and change theset. If not, troubleshoot the MARS monitor and pressCONTINUE.



Warning



HP Cartridge Clotted

Observation:Filter pressure drop is ≥ limit value fixed for the HP cartridge in use.


Clots have formed in the cartridge.Note: Clotting is usually due toinadequate anticoagulation of theblood flowpath.




Press STOPb and change the set. Ensure that syringeis properly installed in syringe pump and plungeris moving upward during treatment. If plunger isnot moving, syringe pump has failed. If desired,connect syringe line to a medically acceptable alternateanticoagulant delivery system. Call service to repairpump.


Loading Error

Observation:Not possible to load/unload the set.


Pinch valves position not correct. Press RETEST to reposition the pinch valves and clearthe alarm.


Warning



Plasmafilter Clotted

Observation:Filter pressure drop is ≥ limit value fixed for the plasmafilter in use, or both the “Plasmafilter isClotting” Advisory and the “TMPa Excessive” Caution limits are reached.


Clots have formed in theplasmafilter.Note: Clotting is usually due toinadequate anticoagulation of theblood flowpath.



Ultrafiltration rate is too high forfilter in use.

Press CONTINUE and then reduce replacement solutionflow rate and/or patient plasma loss rate.



Press STOPb and change the set. Ensure that syringeis properly installed in syringe pump and plungeris moving upward during treatment. If plunger isnot moving, syringe pump has failed. If desired,connect syringe line to a medically acceptable alternateanticoagulant delivery system. Call service to repairpump.

During regional citrateanticoagulation:Citrate delivery has failed.

Press STOPb and change the set. Ensure that PBP pumpworks properly. If PBP pump has failed, call service.

Power Failure

Observation:Power lost for more than 15 seconds after machine entered Run mode.


Main power failure; machinesuddenly unplugged.

Inspect blood flowpath. If clotted, change the set viaSTOPb.

If flowpath is not clotted, press CONTINUE. (Clears alarm and restarts treatment at same placeas when power was lost.)

Note: If set was manually unloaded during power loss, either:(a) continue treatment with a new set by pressing STOPb, then CHANGE SET, or(b) end the treatment by pressing STOPb, then END TREATMENT.



Warning



Recirculation Time Exceeded


Recirculation Time has exceededthe manufacturer-set limit.

Press STOP RECIRC. and resume the treatment.

Return Disconnection

Observation:Alarm occurs if return pressure is lower than +10 mmHg and the return pressure operating pointis higher than +10 mmHg. The alarm reoccurs if the following return pressure operating pointis lower than +10 mmHg.

Alarm also occurs once if the operating point is lower than +10 mmHg after an operator induced(re)start of the blood pump. Should this pressure condition persist, it will be indicated bysubsequent Advisory Cannot Detect Return alarms.

Note: An operating point is the pressure value when the pressure is considered stable after an eventsuch as an alarm, change of blood flow etc.


Return line or catheter isdisconnected.

Make sure return catheter is securely connected to boththe return line and the patient.To resume treatment, press CONTINUEa.

Chamber monitor line not properlyconnected to return pressure port orfluid barrier wet.

Press STOPb and use CHANGE SET to load/prime anew set. If fluid barrier wetting recurs call service.

Blood flow path obstructed beforedeaeration chamber.

Remedy, if possible. Press CONTINUE. If not possible,press STOPb and use CHANGE SET to load/prime anew set.

Return pressure sensor failed. End treatment via STOPb. Call service.

Return Extremely Positive

Observation:Alarm occurs if return pressure is more positive than the user-settable “Return Extremely Positive”Warning Limit.

This alarm self-clears if pressure goes back to normal limits within the self-clear time and themonitor will not give an audible alarm.


Warning




Patient is moving, coughing, orbeing suctioned.

Wait 15 seconds for self-clearingc attempt.

Return line clamped or kinked. Remedy, and wait for self-clearing attemptNote: If a self-clear attempt fails, wait until the pressure is back to normal in the non self-clearingscreen, then press RELEASE CLAMP and then CONTINUEa.

Return catheter clotted or out ofposition in vein, or blood flow ratetoo high.

Flush/reposition retun catheter per hospital protocoland/or lower the blood flow rate. Relieve excesspressure in return line by pressing RELEASE CLAMP.Press CONTINUE.

Note: The RELEASE CLAMP is only available if there is no other alarm requiring clamp closed.

Return pressure sensor failed. End treatment, call service.If the above operations do not clear the alarm, the set can be changed and the alarm cleared viaSTOPb. If alarms recur with a new set, end treatment via STOPb. Call service.

Return Pressure Dropping

Observation:This alarm occurs if return pressure is 50 mmHg or 70 mmHg (with blood flow>200ml/min)below its operating point.


Possible leakage or disconnectionof return line or catheter.

Make sure return catheter is securely connected to boththe return line and the patient.To resume treatment, press CONTINUEg

Patient is moving or being moved. Press CONTINUEg.

Blood flow path obstructed orleaking before deaeration chamber.

Remedy, if possible. Press CONTINUE.If not possible, press STOPb and use CHANGE SET toload/prime a new set.

The hydrophobic membrane is wet,and/or service line is disconnected.

Press STOPb and use CHANGE SET to load/prime anew set. If fluid barrier gets wet again with a new set,call service.



If blood leak confirmed, press STOP and change the set.If blood leak not confirmed, troubleshoot the MARSmonitor and press CONTINUE.



Warning



Scale Open

Observation:Scale(s) is not properly closed.

Scales identified: Effluent, PBP, Replacement, Dialysate, Replacement 2.



Impeding object blocking scalefrom fully closing, bag improperlypositioned on hooks, carrying barnot centred on bar tray or handlenot rotated down (toward floor).

Inspect and remedy possible causes. Press scale towardmachine until it locks into closed position. PressCONTINUE.

Scale sensor failed. Press DISCONNECT. Call service.

Set Disconnection

Observation:Alarm occurs if filter pressure is lower than +10 mmHg and the filter pressure operating pointis higher than +10 mmHg.


Filter pressure pod not installed ordebris in sensor housing.

Clean pod from debris and reinstall pod as applicable.Press OVERRIDE to clear alarm and perform self-testthrough SYSTEM TOOLS as to reposition podmembrane. If the pod problem recurs, press STOP tochange the set. If alarm recurs with new set, endtreatment and call service.

Line between blood pump and filteris disconnected.

Make sure the line is securely connected. To resumetreatment, press OVERRIDEa.

Blood flow path is obstructedbefore filter pressure pod.

Remedy, if possible. Press OVERRIDEa If not possible,press STOP b and pressCHANGE SET to load/prime anew set.

Blood flow rate too low for theaccess device.

Increase the blood flow rate and press OVERRIDEa.

Filter pressure sensor failed. End treatment via STOPb. Call service.

Return line disconnection andfailure of return pressure alarm.

Check return line and catheter; remedy as applicable. Iffluid barrier wet, press STOP and press CHANGE SET toload/prime a new set.


Warning



If fluid barrier is not wet, press OVERRIDEa to clear alarm and perform self-test through SYSTEMTOOLS as to check if return pressure sensor has failed or not.

Pressure measurement failure. Perform a self-test for repositioning the pressure podmembranes. Clear the alarm to reach Status screen.Press SYSTEM TOOLS and perform SELF-TEST. If thepod problem is not solved, perform Pod Adjustmentprocedure on access pod. See instructions at the end ofthis chapter. Or, change set via STOPb. If alarm recurswith new set, end treatment via STOP. Call service.

Set-up Error

Observation:Alarm occurs if pre-prime self-test fails.


Set-up is incorrect. Check Return line in clamp. Press RELEASE CLAMP toreposition. Reinstall the return line in clamp.Check chamber monitor line installation, Filter andEffluent pods installation, clamp on Dialysate line.Check that the pressure sensors has not failed.Check that the Dialysate pump segment is loaded.Check that the syringe line and/or one-way valve areconnected.Check that the syringe line is clamped.Check that the right set is loaded. (see HELP)Remedy and press RETEST.If alarm still recurs, press UNLOAD and load a new set.If alarm recurs with a new set, call service.

Syringe Empty


Syringe is empty. Press CHANGE SYRINGE, follow instructions toinstall a full syringe and return to alarm screen. PressCONTINUE.

Note: A full syringe is required during priming. If anticoagulation of blood flowpath is not desired,syringe should be filled with sterile saline solution.



Warning



Syringe Line Clamped


Syringe line clamped, kinked orobstructed.

Inspect syringe line; remove any clamps, kinks or otherobstruction. Press CONTINUEa.

Incorrect installation of syringe line Reinstall syringe line. Press CONTINUEa.

Alam is recurring. Press CHANGE SYRINGE; follow instructions tochange the syringe and return to alarm screen. Thenpress CONTINUE.

Unsuitable Ca solution

Observation:Alarm occurs after Confirm Loaded Set screen if no valid set of initial flow settings withreasonable operating ranges is available when using the selected calcium solution. SeeAnticoagulation chapter page 8:13. Alarm screen indicates if selected calcium solution is toodiluted or too concentrated.


The calcium solution selected incustom mode is not suitable foruse with the selected therapy or settype.

Press MODIFY SOLUTION. Use arrows to selectanother calcium solution. Press CONTINUE. TheCONTINUE button will only be available if suitablecalcium solution is selected.

Alarm is recurring; no suitablecalcium solution is available.

Press UNLOAD to load a different set type. Consultphysician.


Warning



Wrong Set Loaded

Observation:This set cannot be used with the therapy selected.


Failure of recognition test. Check that the set matches the selected therapy.Verify physician prescription for the therapy and set.Press UNLOAD to access the Load Set Screen.If needed, press CANCEL on the Load Set Screen,select the prescribed therapy, then load the prescribedset.If needed, remove the set attached to the control unit(wrong set), then load the prescribed set.Note: If alarm occurs repeatedly, do not use the machineuntil repairs are made.

Wrong Set Selected


Mix up of high flow and low flowset after Bar Code Reading Failure.At the end of the first primingcycle in case of “Bar code readingfailure”, the operator has toverify that the loaded set and theprescribed set are the same, bypressing CONFIRM.

If loaded set does match set identified on screen, pressCONFIRM. Otherwise, press DISCONNECT and reloadset.

Foreign object on scale. Remove foreign object.If loaded set does match set identified on screen, press CONFIRM. Otherwise, pressDISCONNECT and reload set.

Return line not connected toeffluent bag or effluent bag cockopened.

If loaded set does match set identified on screen, pressCONFIRM. Otherwise, press DISCONNECT and reloadset.

Scale failed Press DISCONNECT, remove set. Call service.



Warning



a. OVERRIDE briefly overrides the alarm. Monitor closely.b. STOP stops all pumps, clears the alarm and displays the Stop screen. The following options areavailable: resume treatment, change set, end treatment and recirculate.c. A self-clearing attempt is started if the pressure has returned to normal limits within 15 secondsand there are no other active Warning or Malfunction alarms. If self-clear is unsuccessful, returnline clamp closes and blood pump stops. In that case the alarm must be manually cleared by theoperator. During the self-clearing period there will be no audible signal. Both for Access and forReturn pressure alarms, self-clearing can start only if another self-clearing procedure has notbeen performed in the last 2 minutes.d. This alarm occurs when the registered weight is less than the tare of the bag. The tare of eachbag is automatically calculated by the control unit depending on the Empty Bag Method setting inCustom mode. If Empty Bag Method is set to “Fixed”, the tare of the Dialysate/Replacement2,PBP and Replacement bag is set to 230 g. If Empty Bag Method is set to “Variable”, the tare ofthe Dialysate/Replacement2, PBP and Replacement bag is automatically calculated each timea new bag is loaded.e. If the RELEASE CLAMP softkey is not available and opening of the return clamp is notconsidered a risk, open the return line clamp using the STOP and RESUME softkeys. If openingof the return clamp is considered a risk, insert a 21-gauge needle with syringe into the upper redsample site closest to the filter pod to aspirate air/blood until the filter pressure reaches a valuelower than 450 mmHg.f. If the RELEASE CLAMP softkey is not available and opening of the return clamp is notconsidered a risk, open the return line clamp using the STOP and RESUME softkeys. If openingof the return clamp is considered a risk, insert a 21-gauge needle with syringe into the bluesample site (return line) to aspirate air/blood until the return pressure reaches a value lower thanthe alarm limit setting.g. CONTINUE resets all operating points and clears the alarm.


Warning



Caution Alarms Troubleshooting

Bag Volume Incorrect

Observation:Bag Volume incorrect. Amount of fluid in bag does not match Allowed Volume.

Depending on therapy, the following may be identified:Replacement bagDialysate bagPBP bagReplacement bag 2

Only valid with variable Empty Bag method.


Amount of fluid in the identifiedbag does not match the currentAllowed Volume.

Choose one of the options on the alarm screen.

Caution:Choose Keep Bag only to use a partially full bag that is of the same total volume capacity as thecurrent Allowed Volume.


Foreign object on scale. Remove foreign object. Press CONTINUE.



Note: Use the STOPb softkey to suspend the treatment, if desired.



CautionAlarmsTroubleshooting

Caution Alarms in Alphabetical Order

Calcium Infusion Stopped

Observation:Syringe pump has been stopped for more than 6 minutes during the last 2 hours.


Clamped line, empty syringe,change syr/line in progress.

Unclamp the calcium infusion line, if applicable, andpress CONTINUE.

To install a new syringe and a new calcium line press CHANGE SYR/LINE softkey and follow theinstructions on the screen. Then return to the alarm screen and press CONTINUE.

Note: Calcium infusion requires additional monitoringof patient's parameters.

Dialysate Bag Empty

Observation:Dialysate bag empty a.


Dialysate bag is empty. Connect a new dialysate bag (see instructions on alarmscreen). Press CONTINUE when ready.

Dialysate bag partially supported(not hanging freely).


Dialysate bag has fallen down. Connect a new dialysate bag (see instructions on alarmscreen). Press CONTINUE when ready.

Dialysate Weight

Observation:Incorrect weight change detected.


Closed clamp or major leak ondialysate line or bag, bag isswinging, kinked line.

Remedy and press CONTINUEc.

Foreign object on dialysate scale,dialysate bag is partially supported(not hanging freely).

Remove object or partial support. Press CONTINUEc.


Caution



If bag connected through spike,incorrect puncture of the bag.

Using aseptic technique to make sure that the solutionbag is correctly punctured.

If bag connected through Luer lock,incorrect break of the frangible pin(if relevant).

Break the frangible pin correctly. Press CONTINUE. Ifthe problem persists, replace the solution bag using theCHANGE BAGS procedure.

If double compartment bag in use,incorrect opening of the secondcompartment.

Check bag connections. Remedy and pressCONTINUEc.

Air bubbles in the solution bag orline.


Non occlusive Dialysate pump orDialysate scale failed.

Press STOP and end the treatment. Call service.

Non breathing spike used with arigid container.

Replace the non breathing spike with a breathing spike.Press CONTINUE.

Dialysate line connected to wrongbag or dialysate bag on wrongscale.

Make sure that the green line is connected to thedialysate bag on green scalec.

Environment with vibrations. If the source of vibrations cannot be stopped, pressSTOP and end the treatment. Call service.

Effluent Bag Full


Effluent bag is full. Connect a new effluent bag (see instructions on alarmscreen). If changing to a larger/smaller bag, pressMODIFY BAG and use arrows to set a new AllowedVolume. Press CONTINUE.

Foreign object on effluent scale. Remove foreign object. Press CONTINUE.





Effluent Bag Incorrect

Observation:Effluent Bag volume does not match Allowed Volume. Cause: a 5000 ml empty bag is hung onscale while Effluent Allowed Volume is 9000 ml.


A 5000 ml empty bag is hung onthe scale while Effluent AllowedVolume is 9000 ml.

Replace the 5000 ml bag hung on the scale by a 9000 mlbag or change the Effluent Allowed Volume by pressingMODIFY BAG. Press CONTINUE.


Note: If hanging multiple bags on the scale, the total fluid capacity of all bags on the scale mustnot exceed the allowed volume for that scale.

Effluent bag is partially supported(not hanging freely).


Effluent Weight

Observation:Incorrect weight change detected for effluent bag.


Effluent bag drain port opened,leaking or clamped effluent lineor bag; bag is swinging on scalecarrying bar; kinking BLD tubesegment.


Foreign object on effluent scale;effluent bag is partially supported(not hanging freely).

Remove foreign object or partial support. PressCONTINUEc.

Non occlusive Effluent pump orEffluent scale failed.


Gain Limit Reached

Observation:The Unintended Patient Fluid Gain exceeded the selected limit and the treatment was thereforepermanently suspended for safety reasons. Fluid pumps are stopped and will not re-start; theblood pump continues to run.


Caution




A flow problem has caused thePrismaflex control unit to infuseexcess fluid to the patient:Repeated flow obstructions due toclosed clamps or kinked lines;Flow errors due to incorrect use ofthe acccess port on the Effluent bag.

Press STOP and end the treatment. If indicated, restarttreatment with a new set.

Incorrect Dialysate Flow


Leak on Dialysate line or bag,kinked line.










Non occlusive Dialysate pump orDialysate scale failed.


Incorrect Effluent Flow


Effluent bag drain port not fullyclosed, leak on effluent line or bag,kink on effluent line between podand pump.


Air bubbles in the effluent fluid. Check effluent line for kink between pod and pump.Remedy and press CONTINUEc. If effluent pressureis below -200 mmHg, consider reducing ultrafiltrationflow rate or changing the set.





Non occlusive Effluent pump orEffluent scale failed.


Incorrect PBP Flow


Leak on PBP line or bag, kinkedline










Non occlusive PBP pump or PBPscale failed.


Incorrect Replacement 2 Flow


Leak on Replacement 2 line or bag,kinked line.

Remedy and press CONTINUE.






Check bag connections. Remedy and press CONTINUE.




Caution



Non occlusive Replacement 2pump or Replacement 2 scalefailed.


Incorrect Replacement Flow


Leak on Replacement line or bag,kinked line.










Non occlusive Replacement pumpor Replacement scale failed.


Incorrect Weight Change Alarm Not Cleared

Observation:Too many attempts to remedy “Weight” and/or “Incorrect Flow” alarms. Accuracy of patientfluid removal may be compromised.


Clearing attempts have exceededthe manufacturer-set limit of 10tries in 3 hours.


Use History to verify exact fluid exchange status at STOP time.





Loss Limit Reached

Observation:The Unintended Patient Fluid Loss exceeded the selected limit and the treatment was thereforepermanently suspended for safety reasons. Fluid pumps are stopped and will not re-start; theblood pump continues to run.


A flow problem has caused thePrismaflex control unit to pullexcess fluid from the patient:Repeated flow obstructions due toclosed clamps or kinked lines;Flow errors due to incorrect use ofthe access port on a solution bag(PBP, dialysate, replacement);Flow errors due to effluent fluiddegassing.


Patient Fluid Gain Excessive


PBP fluid input has reached themaximum allowed Patient FluidGain for the therapy/set.

Stop PBP infusion and continue therapy without furtherpatient fluid gain: Press FLOW SETTINGS, set PBPrate to zero.

Continue therapy with further fluid gain for the patient: Press CONTINUE. Alarm will recur whenPatient Fluid Gain increases 10% beyond the maximum allowed value.

Stop therapy immediately: Press STOPb.

PBP Bag Empty

Observation:


PBP bag is empty. Connect a new PBP bag (see instructions on alarmscreen). If the Empty Bag Method set in Custom modeis “Variable”, it is possible to change to a larger/smallerbag, by pressing MODIFY BAG and using arrows to seta new Allowed Volume. Press CONTINUE when ready.

PBP bag partially supported (nothanging freely).

Remove partial support, press CONTINUE.


Caution



PBP bag has fallen down. Connect a new PBP bag (see instructions on alarmscreen). Press CONTINUE when ready.

PBP Weight

Observation:Incorrect weight change detected for PBP bag.PBP = pre-blood pump


Closed clamp (2 clamps) or majorleak on PBP lines or bag, bag isswinging, kinked line.


Foreign object on PBP scale, PBPbag is partially supported (nothanging freely).

Remove foreign object or partial support. PressCONTINUEc.




Break the frangible pin correctly. Press CONTINUE.If the problem persists, replace the solution bag usingthe CHANGE BAGS procedure.


Press CONTINUE and immediately replace the solutionbag using the CHANGE BAGS procedure.Caution:Monitor closely level of deaeration chamber as asignificant amount of air will reach the blood flowpath.



Non occlusive PBP pump or PBPscale failed.




PBP line connected to wrong bagor PBP bag on wrong scale.

Make sure to have connected the white line to the PBPbag on white scalec.






Replacement 2 Weight

Observation:Incorrect weight change detected for replacement bag 2 (green scale).


Closed clamp or major leak onreplacement line or bag, bag isswinging, kinked line.


Foreign object on replacementscale, replacement bag partiallysupported (not hanging freely).





Break the frangible pin correctly. Press CONTINUE.If the problem persists, replace the solution bag usingthe CHANGE BAGS procedure.





Non occlusive Replacement 2pump or Replacement 2 scalefailed.




Replacement 2 line connected towrong bag or replacement 2 bag onwrong scale.

Make sure to have connected the green line to thereplacement 2 bag on green scalec.



Caution



Replacement Bag 2 Empty

Observation:Bag on green scale.


Replacement bag 2 (green scale) isempty.

Connect a new replacement bag 2. If the EmptyBag Method set in Custom mode is “Variable”, it ispossible to change to a larger/smaller bag, by pressingMODIFY BAG and using arrows to set a new AllowedVolume. Press CONTINUE when ready.

Replacement bag 2 is partiallysupported (not hanging freely).


Replacement bag 2 has fallen down. Connect a new replacement bag 2 (see instructions onalarm screen). Press CONTINUE when ready.

Replacement Bag Empty


Replacement bag is empty. Connect a new replacement bag (see instructionson alarm screen). If the Empty Bag Method set inCustom mode is “Variable”, it is possible to change toa larger/smaller bag, by pressing MODIFY BAG andusing arrows to set a new Allowed Volume. PressCONTINUE when ready.

Replacement bag partiallysupported (not hanging freely).


Replacement bag has fallen down. Connect a new replacement bag (see instructions onalarm screen). Press CONTINUE when ready.

Replacement Container Empty


Replacement container is empty. Connect a new replacement container. PressREPLACEMENT softkey, use arrows to enter a newcontainer volume. Press CONTINUE.

Replacement container partiallysupported (not hanging freely).






Replacement container has fallendown.

Connect a new replacement container (see instructionson alarm screen). Press CONTINUE when ready.

Replacement Weight

Observation:Incorrect weight change detected for replacement bag.


Closed clamp or major leak onreplacement line or bag, bag isswinging, kinked line.


Foreign object on replacementscale, replacement bag partiallysupported (not hanging freely).



Use aseptic technique to make sure that the solution bagis correctly punctured.







Non occlusive Replacement pumpor Replacement scale failed.




Replacement line connected towrong bag or replacement bag onwrong scale.

Make sure to have connected the purple line to thereplacement bag on purple scalec.



Caution



Scale Open

Observation:Scale not properly closed.

Scales identified: Effluent, PBP, Replacement, Dialysate, Replacement 2.


Impeding object blocking scalefrom fully closing, bag improperlypositioned on hooks, carrying barnot centred on bar tray or handlenot rotated down (toward floor).

Inspect and remedy possible causes. Press scale towardmachine until it locks into closed position. PressCONTINUE.

Scale sensor failed. Press STOPand end treatment. Call serviceb.

TMPa Excessive

Observation:Access transmembrane pressure exceeds the safe limit.


Effluent rate is too high. Too muchplasma is being removed.(Effluent rate = patient plasma lossrate + replacement fluid rate)

Decrease the replacement fluid or increase blood flowrate. Return to alarm screen, press CONTINUE.

Plasmafilter pressure drop isincreasing, possibly due toinsufficient anticoagulation.

Decrease blood flow rate and/or adjust anticoagulationprescription.

TMP Excessive

Observation:Transmembrane pressure exceeds membrane pressure limit.


Ultrafiltration rate (UFR) is toohigh. Too much fluid is beingremoved. (UFR = patient fluidremoval rate + replacement solutionrate + PBP rate)

- Decrease the PBP, replacement and/or patient fluidremoval rates or, alternatively, increase blood flowrate.

- Return to alarm screen, press CONTINUE.





Wrong measurement of Filter andEffluent pressure.

Clear the alarm by temporarily decreasing UFR. PressSYSTEM TOOLS from Status screen and perform aself-test. Set previous flow rates back. If alarm recursdecrease UFR or change the set.

Inadequate anticoagulation of theextra corporeal circuit.

Press STOP and change the set or test patient’s clottingparameters and adjust anticoagulant delivery if needed.Note: “Filter Clotted” warning occurs when the bloodin the filter is clotted.

During CRRT MARS treatment:MARSFLUX and diaFLUXcombined transmembrane pressureexceeds membrane pressure limit.

Decrease replacement and/or patient fluid removaland/or PBP rates. Press CONTINUE.

TPE Prescription Delivered

Observation:Prescribed Total Replacement Volume has been delivered.


Total Replacement Input has beenachieved.

To continue treatment until remaining replacementfluid is used, press CONTINIUE. When ReplacementContainer Empty caution occurs, press STOP andEnd treatment. To set new TPE PrescriptionDelivered alarm point, press CONTINUE, thenincrease the Total Replacement Input on theSET TPE Prescription screen.

a. This alarm occurs when the registered weight is less than the tare of the bag. The tare ofeach bag is automatically calculated by the control unit depending on the Empty Bag Methodsetting in Custom mode. If Empty Bag Method is set to “Fixed”, the tare of the Dialysate, PBP,Replacement, Replacement2 bag is set to 230 g. If Empty Bag Method is set to “Variable”, thetare of the Dialysate, PBP, Replacement, Replacement2 bag is automatically calculated eachtime a new bag is loaded.b. Pressing STOP stops all pumps, clears the alarm, and displays the Stop screen. The followingoptions are available: resume treatment, change set, end treatment, or temporarily disconnectpatient from set.c. Too many unsuccessful attempts to clear this alarm could lead to error in patient fluidbalance/fluid removal that could result in patient injury or death. Verify fluid removal accuracy.In case of discrepancy between the prescribed value and fluid removed, consult physician anddiscontinue the treatment if required. CRRT: When the error in patient fluid balance/fluid removalexceeds the Patient Fluid Loss/Gain Limit a Caution: Loss Limit Reached alarm or Caution: GainLimit Reached alarm will occur requiring therapy to be discontinued or the set to be changed.TPE: After 10 unsuccessful attempts to clear this alarm in less than 3 hours, a Caution: WeightAlarm Not Cleared alarm will occur requiring therapy to be discontinued or the set to be changed.


Caution



Advisory Alarms Troubleshooting

Anticoagulation Check Points


Citrate anticoagulation requiresadditional monitoring of patient’sparameters. This advisory occurs ata specific time interval when citrateis used.

Ensure proper delivery of calcium using an externalsyringe / infusion pump.Note: To change this interval, use SYSTEM TOOLS inStatus screen. Check with your physician for theoccurrence of this advisory.

Battery Exhausted

Observation:Applicable when machine configuration includes the back-up battery (check with the localrepresentative for more information).Appears when the power level of the back-up battery is too low.


Back-up battery is depleted. Press OVERRIDE and continue with setup. Machineneeds to remain on for charging the battery at least 4hours.Note: In case of main power lost before the batteryback-up is fully charged again, the machine will operateas if no battery back-up was installed. See “PowerFailure” on page 11:76 for more information.

Alarm recurs due to old battery orbroken internal wiring.

Leave the machine on or operate for more than 24 hours.If the alarm does not self-clear within 24 hours, callservice.

Blood Flow Stopped

Observation:Machine has been left in the Stop screen for 60 seconds.


Machine left in the Stop screen formore than 60 seconds (all pumpsstopped).

Inspect blood flowpath for signs of clotting. If clotted,change the set. Press CONTINUE to clear alarm andreturn to the Stop screen, then choose CHANGE SET.If flowpath not clotted, press CONTINUE to clear alarmand return to the Stop screen.



AdvisoryAlarmsTroubleshooting

Advisory Alarms in Alphabetical Order

Calcium Line Clamped

Observation:Occurs during run mode only.


Calcium line is clamped. Unclamp the calcium infusion line. Press CONTINUE.

The central venous access on thepatient is clamped.

Unclamp the central venous access on the patient.

The central venous access on thepatient is obstructed by clots orsticks fast to the intima of the vein.

Check patient access patency for potential obstructions.Consult a physician for assessment of the central venouscatheter.

Incorrect installation of syringeline.

Inspect calcium infusion line, remove any clamps, kinksor other obstructions. Use the clip above the syringepump for the calcium infusion line to avoid kinks. PressCONTINUE.

Note: In case of recurring alarm, pressCHANGE SYR/LINE softkey to change both thesyringe and the calcium line.

Calcium Syringe Empty

Observation:Occurs during treatment mode only.


Calcium syringe is empty. Press CHANGE SYR/LINE softkey and follow theinstructions on the screen to install a full syringe. Thenreturn to alarm screen and press CONTINUE.

Note: Use only a 50 ml syringe of the allowed brandwhen the “Citrate – Calcium via Prismaflex SyringePump” method is chosen.


AdvisoryAlarm

sTroubleshooting


Ca Line Not Connected

Observation:Occurs during treatment mode.


Calcium line is not connected tothe syringe.

Connect a dedicated calcium infusion line to the syringe.Press CONTINUE.

Wrong line connected. Use only a dedicated infusion line for the calciuminfusion when the “Citrate – Calcium via PrismaflexSyringe Pump” method is chosen.

The unused syringe line on thedisposable set is connected to thecalcium syringe.

Clamp the unused syringe line on the disposable setand left unused during entire treatment when “Citrate– Calcium via Prismaflex Syringe Pump” method ischosen. Press CHANGE SYR/LINE softkey and followthe instructions on the screen to connect a dedicatedcalcium infusion line to the syringe.

A syringe of the wrong size isinstalled.

Use only a 50 ml syringe of the allowed brand whenthe “Citrate – Calcium via Prismaflex Syringe Pump”method is chosen.

Air in syringe. Press CHANGE SYR/LINE. Follow instructions toinstall a full syringe and return to alarm screen. PressCONTINUE.

Missing non-return valve oncalcium infusion line.

Press CHANGE SYR/LINE. Follow instructions toinstall a new calcium infusion line with a non-returnvalve and return to alarm screen. Press CONTINUE.

Cannot Detect Return

Observation:This alarm occurs when the return pressure operating point is more negative than +10 mmHg.Machine is unable to detect return line and catheter disconnections.


Return line or catheter isdisconnected.

Make sure return catheter is securely connected to boththe return line and the patient.To override this alarm, press OVERRIDE.Use the STOP softkey to suspend the treatment, ifdesiredb.

Catheter size too large or bloodflow too low.

If catheter size is too large for the prescribed blood flowrate, consider to change to a smaller catheter.





If compatible with prescription, pressFLOW SETTINGS and increase the blood flowrate. When back in the alarm screen, press OVERRIDE.

Chamber monitor line not securelyconnected to return pressure port.

If the fluid barrier is not damaged, secure monitor lineto the luer lock of the return pressure port and pressOVERRIDE. If the fluid barrier is damaged, change theset (press STOP, then CHANGE SET.)


Ca Syringe Almost Empty

Observation:


Calcium syringe will be empty in5 minutes.

To install a full syringe when this advisory appears,press CHANGE SYR/LINE and follow instructionson the screen. Then return to alarm screen and pressCONTINUE.

Ca Syringe Not Loaded

Observation:Applicable to “Citrate – Calcium via the Prismaflex Syringe Pump” anticoagulation method.


The calcium syringe is not loaded. Press the CHANGE SYR/LINE softkey to load a calciumsyringe. Then press RETEST to restart Syringe Test. Iffailure recurs, end treatment via DISCONNECT. Callservice.

Check Access

Observation:When running with an operating point below -10mmHg, this alarm occurs if access pressure is50 mmHg or 70 mmHg (if blood flow>200 ml/min) above or below its operating point, or ifthe pressure rises above 0 mmHg.

When running with an operating point in the range between -10mmHg and +20mmHg, this alarmoccurs if the access pressure is 50mmHg or 70 mmHg (if blood flow>200 ml/min) below itsoperating point, or if the access pressure is 10mmHg or more above its operating point.


AdvisoryAlarm

sTroubleshooting


When running with an operating point above +20mmHg, this alarm occurs if the access pressuredrops below +10mmHg.

NOTE: An operating point is the pressure value when the pressure is considered stable afteran event (alarm, change of blood flow etc).


Possible leakage or disconnectionof access line or catheter.

Make sure access line is securely connected tocatheter/blood source. Remedy, press CONTINUEa.Use the STOP softkey to suspend the treatment, ifdesired.

Possible kink or obstruction inaccess line or catheter.

Remedy, press CONTINUEa.Use the STOP softkey to suspend the treatment, ifdesired.

Patient is coughing or being moved. Press CONTINUEa.

Catheter is clotted or out ofposition.

Check the position of the catheter in the vein.

Blood flow rate is too high. Decrease blood flow rate, return to alarm screen andpress CONTINUEa.

Blood flow path is obstructed afteraccess pressure pod.

Remedy, if possible. Press CONTINUEa. If not possible,press STOPb and use CHANGE SET to load/prime anew set.

Check Return

Observation:This alarm occurs if return pressure is 50 mmHg or 70 mmHg (if blood flow>200ml/min) above itsoperating point.

NOTE: An operating point is the pressure value when the pressure is considered stable afteran event (alarm, change of blood flow etc).


Possible kink or obstruction inreturn line or catheter.

Remedy, press CONTINUEa.

Patient is moving. Press CONTINUEa.

Catheter is clotted or out of positionin vein.

Remedy, press CONTINUEa.

Blood flow rate is too high. Decrease blood flow rate, return to alarm screen andpress CONTINUE.





NOTE: Use the STOPa softkey to suspend the treatment, if desired. Alarm self-clears if conditionno longer exists.

Check Syringe Line

Observation:Alarm occurs when pressure exerted by syringe pump indicates syringe line may be clamped. Allpumps are stopped while confirmation of clamping is in progress.This alarm self-clears if condition no longer exists.

Note: If this alarm is not cleared within 8 seconds the Advisory: Syringe Line Clamped alarmoccurs.

Clamped Bag-Dialysate

Observation:No flow from bag detected since last CONTINUE action. Appears after a fluid pump start.


Clamped line(s) or bag(s). Remedy and press CONTINUEd.

Seal on a bag is not completelybroken.

Press STOP. Manipulate bag seal to provideunobstructed fluid pathway. Press RESUMEd.

Pump segments improperly loaded;obstructions in pump raceways.

Press STOP, then CHANGE SETd.

Scale failed; internal malfunction. Press STOP and end the treatmentd. Call service.




Clamped Bag-Effluent





AdvisoryAlarm

sTroubleshooting






Clamped Bag-PBP












Clamped Bag-Replacement
















Clamped Bag-Replacement 2












Download Interrupted

Observation:Download of history data to the technical data card has failed.


The technical data card is full. Insert an empty technical data card into the technicaldata card holder. Press DOWNLD DATA to retrydownloading the history data.


AdvisoryAlarm

sTroubleshooting


There is no technical data card inthe technical data card holder or thetechnical data card in the holder isdamaged.

Insert a new technical data card into the technicaldata card holder. Press DOWNLD DATA to retrydownloading the history data.

Internal malfunction related to thetechnical data card holder/reader.

Press CONTINUE to clear the alarm and proceedwithout downloading history data.Note: If alarm continues to occur with subsequenttreatments, call service.

Filter is Clotting

Observation:Increasing TMP and/or Pressure Drop.

Note: TMP value in the MARSFLUX filter is not considered for this alarm during CRRT-MARStherapy; see section “Pressure management” on page 5:27



Press STOP, change the set or test patient’s clottingparameters and adjust anticoagulant delivery if needed.“Filter Clotted” warning occurs when the blood in thefilter is clotted.

Ultrafiltration is too high. Lower TMP by: (a) decreasing the PBP, replacementand/or patient fluid removal rates; (b) increasing theblood flow rate. Press OVERRIDEc; continue to monitorthe set.

Kinked lines in blood flowpath. Remedy and press OVERRIDEc.

If syringe pump is being used foranticoagulation, syringe may beincorrectly installed or syringepump may have failed.

Ensure syringe is properly installed in syringe pumpholder and plunger is moving upward during treatment.If plunger is not moving, syringe pump has failed. Ifdesired, connect syringe line to a medically acceptablealternate anticoagulant delivery system. Call serviceto repair pump.

Air leak between deaerationchamber monitor line and returnpressure sensor.

If the fluid barrier is not wet with blood, secure monitorline to the luer lock of the return pressure port and pressOVERRIDE. If the fluid barrier is wet with blood, pressSTOP and change the set.

Wrong measurement of Filter orEffluent pressure.

Press OVERRIDE to reach Status screen. PressSYSTEM TOOLS and perform a self-test.

Filter, Effluent or return pressuresensor failed.

Press OVERRIDE to reach Status screen. PressSYSTEM TOOLS and perform a self-test. If pressuresensor failure is confirmed, end the treatment and callservice.





Fluid Pumps Stopped


Citrate anticoagulation is used andfluid pumps have stopped for morethan 10 minutes.Not applicable to “Citrate –Calcium via Prismaflex SyringePump” anticoagulation method.

Remedy the cause of interruption. Additionalmonitoring of patient’s laboratory chemistry must beperformed on patient: ionized calcium (Ca2+)

HP Cartridge is Clotting

Observation:Increasing Pressure Drop.



Press STOP, change the set or test patient’s clottingparameters and adjust if needed.

Note: The Warning: HP Cartridge Clotted alarm occurs when the blood in the HP cartridgeis clotted.






Filter or return pressure sensorfailed.

Clear the alarm to reach Status screen. PressSYSTEM TOOLS and perform SELF-TEST. If thepod problem is not solved, press STOP and end thetreatment. Turn off machine. Call for service.Or operator's action directs wrong measurement.


AdvisoryAlarm

sTroubleshooting


Wrong measurement of Filterpressure.

End treatment by pressing STOP. Call service.

Main Power Lost

Observation:Main power is lost and system operates on battery backup


Power Cord is not connected. Reconnect the power cord.Press OVERRIDE to continue treatment until the Warning: Battery Low alarm occurs.Note: The alarm self-clears if condition no longer exists.

MARS Treatment


CRRT MARS treatment ongoingfor more than 1 minute.

Set the MARS pump to the prescribed flow rate andpress the START softkey on the MARS monitor. PressCONTINUE on the Prismaflex screen to return to Statusscreen. Make sure that all blue clamps are open.





Memory Back-Up

Observation:Applicable when machine configuration does not include the back-up battery (check with the localrepresentative for more information).


Memory back-up battery isdepleted.

Press OVERRIDEc and continue with setup. Machineneeds to remain on for charging the battery at least 4hours.Note: In case of main power lost before the battery ischarged again, the machine will stop. When resumingpower, machine will start up with Query screen. SelectNEW PRIME or CONTINUE and follow the instructionson the screen.

Alarm recurs due to old battery orbroken internal wiring.

Leave the machine on or operate for more than 24 hours.If the alarm does not self-clear within 24 hours, callservice.

Plasmafilter is Clotting

Observation:Increasing Pressure Drop.




Note: The Warning: Plasmafilter clotted alarm occurs when the blood in the Plasmafilter is clotted.

Blood flow rate is too high orplasmafiltration rate is too high.

Decrease blood flow rate or decrease PBP and/orreplacement flow ratesc.







AdvisoryAlarm

sTroubleshooting


Filter or return pressure sensorfailed.

Clear the alarm to reach Status screen. PressSYSTEM TOOLS and perform SELF-TEST. If thepod problem is not solved, press STOP and end thetreatment. Turn off machine. Call for service.



Preventive Maintenance Due


Time for Preventive Maintenance. Press OVERRIDE; schedule preventive maintenance atearliest convenience.Note: This alarm must be cleared in Service mode by anauthorized service technician.

Self-Test in Progress

Observation:Test complete in: min. 1 minute, max. 6 minutes.

Note: Audible alarm is silent.


Self-test is underway. Test occursevery 2 hours to ensure properfunctioning of safety systems; ifthe self-test is interrupted due to aWarning or a Caution alarm, it willrestart in the next 10 minutes. Thereturn line clamp is closed and thenopened during the test. Pressuresdisplay is not available duringrepositioning of Pod diaphragms.

None required. Self-clears when complete. WhileSelf-test is underway, monitor periodically the patient.DELAY TEST softkey is available for use if it is necessaryto stop and postpone self-test; REVIEW PRESCR andHISTORY softkey are available for use if it is necessaryto view flow settings and history data before the self-testprocess completion.

Note: In case of abnormal pressure during self-test execution, it is recommended to re-launch aself-test by pressing the SELF-TEST softkey from the System Tools screen.

Note: Dependent on the various sub-tests in progress, pressure limits are either replaced bytemporary limits, or are temporarily disabled. Occurrences of related alarms may be postponeduntil after completion of the test. Return pressure monitoring and related alarms remain activeduring periodic self-tests.





Syringe Almost Empty


Syringe will be empty in 5 min. To install a full syringe when this advisory appears, pressCHANGE SYRINGE and follow instructions on screen.Then return to alarm screen and press CONTINUE.

Syringe Empty


Syringe pump is in end-of-travelposition, indicating all solution insyringe has been delivered.

Note: Action is only possible in standard anticagulation.Press CHANGE SYRINGE,follow instructions to installa full syringe, press CONTINUE.Note: Install only the allowed syringe (size/brandspecified in Custom mode). If desired, continue withoutsyringe delivery. To do this:a. Press ANTICOAG SETTINGS, change to

“Continuous, 0 ml/h”; return to alarm screen.

b. Push plunger clamp release button to releasesyringe pump from end-of-travel position.

c. Press CONTINUE and alarm clears.

Syringe Line Clamped

Observation:Syringe line is clamped.

Occurs during treatment mode only.


Syringe line on the disposable setis clamped, kinked or obstructed inanother way.

Inspect syringe line; remove any clamps; kinks, or otherobstructions. Press CONTINUE.

Incorrect installation of syringeline.

Reinstall syringe line. Press CONTINUE.

Alarm is recurring. Press CHANGE SYRINGE; follow instruction to changethe syringe and return to alarm screen. Then PressCONTINUE.


AdvisoryAlarm

sTroubleshooting


Syringe Not Loaded

Observation:The syringe is not loaded


The syringe is not loaded afterSyringe Test has been performed.

a. Press CHANGE SYRINGE, follow instructions toload the syringe and return to alarm screen.

b. Press RETEST to restart Syringe Test.

c. If alarm recurs, continue without usingthe syringe pump, if desired. To dothis, press SYRINGE DISABLE and thenCONFIRM DISABLE or End treatment

d. DISCONNECT. Call service to repair the syringepump.

Time to Change Set (CRRT only)

Observation:Hours of use have reached the operator-set “Time to Change Set” limit for this therapy/setcombination or 780 liters have been processed.


A “Time to Change” set advisorylimit has been reached.Note: Litres counted for the “Timeto change set” advisory occurrencesare: blood, PBP solution andsaline solution pumped during theRecirculation procedure.

Press STOPe and change the set or pressOVERRIDE andcontinue to monitor the setf.

Warning:The Prismaflex disposable set must be changed after 72 hours of use or 780 liters of blood havebeen processed through the filter. Continued use beyond these limits could result in rupture of thepump segments, with patient injury or death.Note: To ensure adequate filter performance, it is recommended that the disposable set of thePrismaflex system is changed after 24 hours of use.

During CRRT MARS treatment:A “Time to Change” set advisorylimit has been reached.

Press STOPe and change the disposable sets onboth the Prismaflex and the MARS monitor or pressOVERRIDE and continue to monitor the setf.

Warning:Do not use the X-MARS kit beyond 24 hours. The adsorption columns (diaMARS IE 250 anddiaMARS AC 250) can be saturated after this operating time.





Time to Change Set (HP only)

Observation:Hours of use have reached the user-set “Time to Change Set” advisory limit for this therapy/setcombination.


A “Time to Change” set advisorylimit has been reached.


Warning:To ensure adequate adsorption performance, it is recommended that the Adsorba kit is changedafter 4 hours of use.

Time to Change Set (TPE only)

Observation:Hours of use have reached the advisory limit for this therapy/ set combination.


A “Time to Change” set advisorylimit has been reached.


TMPa Too High

Observation:Access transmembrane pressure has reached user-set pressure limit.




Note: The Warning: Plasmafilter clotted alarm occurs when the blood in the Plasmafilter is clotted.

Blood flow rate is too high orplasmafiltration rate is too high.

Decrease blood flow rate or decrease PBP and/orreplacement flow ratesc.



AdvisoryAlarm

sTroubleshooting




Filter or Effluent pressure sensorfailed.

Clear the alarm to reach Status screen. PressSYSTEM TOOLS and perform SELF-TEST. If thepod problem is not solved, press STOP and end thetreatment. Turn off machine. Call for service.Or operator's action directs wrong measurement.

TMP Too High

Observation:Transmembrane pressure has reached user-set pressure limit.


Ultrafiltration rate (UFR) is toohigh for the present blood flow rate.(UFR = patient fluid removal rate+ replacement solution rate + PBPrate)

Decrease the replacement and/or patient fluid removalflow rates and/or PBP or increase the blood flow rate.Return to alarm screen and press OVERRIDEc.


Press STOP, change the set or test patient’s clottingparameters and adjust anticoagulant delivery if needed.Note: The Warning: Filter Clotted alarm occurs whenthe blood in the filter is clotted.






Filter or effluent pod failure. Clear the alarm to reach Status screen. PressSYSTEM TOOLS and perform SELF-TEST. If the podproblem is not solved, press STOP and change the set.





Filter or Effluent pressure sensorfailed.

Clear the alarm to reach Status screen. PressSYSTEM TOOLS and perform SELF-TEST. If thepressure problem is not solved, press STOP and end thetreatment. Turn off machine. Call for service.



During CRRT MARS treatment:MARSFLUX and diaFLUXtransmembrane pressure hasreached user-set pressure limit.

Decrease the replacement and/or patient fluid removaland/or PBP rates.

a. CONTINUE resets all operating points and clears the alarm.b. Pressing STOP stops all pumps, clears the alarm, and displays the Stop screen. The followingoptions are available: resume treatment, change set, end treatment, or temporarily disconnectpatient and recirculate sterile saline though set.c. Alarm can also be overridden if operator decides action is not necessary at this time. Alarmself-clears if condition no longer exists.d. Too many unsuccessful attempts to clear this alarm could lead to error in patient fluidbalance/fluid removal that could result in patient injury or death. If alarm reoccurs, pressHISTORY and verify fluid removal accuracy. In case of discrepancy between the prescribed valueand fluid removed, consult physician and discontinue the treatment if required.e. Pressing STOP stops all pumps and displays the Stop screen. The set can be changed bypressing CHANGE SET on the Stop screen. Alarm clears when set is unloaded.f. Alarm can also be overridden if operator decides action is not necessary at this time. Alarmclears when set is unloaded.


AdvisoryAlarm

sTroubleshooting


Malfunction Alarms Troubleshooting

Air Detector


Air bubble detector failed self-tests. Press RETEST. If alarm does not clear, end treatment viaDISCONNECT or manually a. Call service to remedybefore using machine again.

Return line not installed orimproperly installed in air bubbledetector.

Install return line in air bubble detector. When ready,press CONTINUE.

Blood Leak Detector

Observation:Effluent line not properly installed in blood leak detector. Blood leak detector failed self-tests.


Effluent line is not installed, isimproperly installed, or is removedfrom detector.

Press line into detector from bottom up; route throughtubing guides. Press RETEST.

Room or sun light. Protect BLD from light source.


Remove line from detector. Using a “flossing” action,clean inside the detector with a lint-free cloth andisopropyl alcohol. Dry thoroughly. Clean effluentline with water and dry thoroughly. Reinsert line intodetector and tubing guides. Press RETEST.Warning:The blood leak detector must be re-normalized if theeffluent line is removed and then reinserted into theblood leak detector after treatment (Run mode) hasstarted. See Troubleshooting chapter on page 11:85.

Blood leak detector failed. If alarm does not clear, change set via CHANGE SET orend treatment via DISCONNECTa. Call service.



MalfunctionAlarmsTroubleshooting

Malfunction Alarms in Alphabetical Order

Blood Pump

Observation:Rate is incorrect.


Momentary problem with pumproller or pump segment in raceway.

Press CONTINUE.

Impeding object, clamped lineor kinked line in pump raceway;thumb screw in center of rotor hasloosened.

If alarm recurs, end treatment:a. Press CONTINUE. When Status screen appears,

immediately press STOP.

b. On Stop screen, choose END TREATMENT andfollow the instructions to disconnect patient andunload set.

c. Call service to remedy/clear alarm b.

Pump failed. Call for service.

Cannot Save Custom Data


Error in saving newly customizedvalues.

Press EXIT CUSTOM. If desired, return to Custommode, and try again to customize. If alarm recurs, callservice to remedy/clear alarm b.

Note: Patient treatments can be conducted before problem is remedied. The last saved Custommode values guide these treatments.

Ca Syringe Not Loaded

Observation:Occurs during priming only.


The calcium syringe is not loaded. Press the CHANGE SYR/LINE to load a calcium syringe.Then press RETEST to restart the Syringe Test. If failurerecurs, end treatment via DISCONNECT. Call service.


Malfunction



Checksum Interrupted

Observation:Cannot verify data in block.

Data block in question is identified on the alarm screen.


Power loss occurred while internal“checksum” information updatewas in progress. Some settingsmight have been lost.

End treatment via DISCONNECT or manually a, thenstart a new treatment.

Clamp Stuck Closed


External force on return line clamp. Remove external force. Press RETEST.

Return line clamp failed. If alarm does not clear, change set via CHANGE SET orend treatment via DISCONNECTa. Call service.

Communication Error

Observation:Error Code: 2 to 7Due to:Code=2 No communication with the protective taskCode=3 Communication link error on the protective slaveCode=4 Communication link error on the control systemCode=5 Missing status command from protective slaveCode=6 Missing alarm command from protective slaveCode=7 The protective task isn’t able to send message to the slave


See “Due to” message on alarmscreen.

a. Turn machine off, remove return line from returnline clamp, and return blood (when applicable).See “Manual Termination of Treatment” on page11:76.Note: Treatment can not resume using the loadedset once blood has been returned.

b. Restart machine. Once Query screen appears,make choice and carefully follow instructions.See “Shutting Prismaflex® off: Query screen” onpage 4:8.





c. If alarm recurs, end treatment manually (seeabove). Call service and report failure code beforeusing machine again.

Custom Data


Not able to access Custom modevalues for selected therapy/set.

Discontinue use. If applicable, use DISCONNECT tounload/remove set. Turn machine off and call service toremedy and clear the alarm.b

Dialysate Pump


Dialysate pump = green pump



Press CONTINUE.






Clamped line. Check for clamped line. Press CONTINUE



Malfunction



Dialysate Scale Sensor

Observation:The alarm appears during priming only.


The bar tray of the dialysate scalehas not been pulled out and thenpushed into the control unit toattach the dialysate bag.

Place the scale in open position and then in closedposition. Press RETEST. If this does not clear the alarm,end treatment via DISCONNECT. Call Service.

The scale position sensor failed. End treatment via DISCONNECT. Call Service.

Effluent Pump

Observation:Rate is incorrect.Effluent pump = yellow pump.



Press CONTINUE.











Effluent Scale Sensor



The bar tray of the effluent scalehas not been pulled out and thenpushed into the control unit toattach the effluent bag.

Place the scale in open position and then in closedposition. Press RETEST. If this does not clear the alarm,End treatment via DISCONNECT. Call Service.


General System Failure

Observation:Error Code: 1 to 6


Turning Fluid pumps or Bloodpump when machine in Safe state;Clamp forced to wrong positionwhen machine in Safe state; Nocommunication.




Library Data


Cannot access manufacturer-setdefault values.

Discontinue use. If applicable, use DISCONNECT tounload/remove set. Turn machine off and call service toremedy and clear the alarm.b


Malfunction



Line in Air Detector


Return line installed in air bubbledetector before loading a set.

If return line is installed in the air bubble detector, opendoor of air bubble detector and remove line from airbubble detector, then close door of air bubble detector.Press RETEST. If alarm doesn’t clear and the line is notinserted in the air bubble detector, see next OperatorResponse.

Tubing detection switch failed. Turn off machine or continue the treatment bypressing OVERRIDE. In this case it is the operator’sresponsibility to visually monitor the set and checkthe correct placement of return line in the air bubbledetector for the remainder of the treatment. Call Service.

Line in Clamp


Return line installed in Return LineClamp before loading a set.

If return line is installed in the Return Line Clamp,remove line from Return Line Clamp. Press RETEST.If alarm doesn’t clear and the line is not inserted in theReturn Line Clamp, see next Operator Response.

Tubing detection switch failed. Turn off machine or continue the treatment bypressing OVERRIDE. In this case it is the operator’sresponsibility to visually monitor the set and check thecorrect placement of return line in the clamp for theremain.der of the treatment. Call Service

Lower Pinch Valve


The lower pinch valve is in thewrong position for the therapyselected and the current infusionmethod selected (Pre/Post) due toobstructions.

Remove any obstructions and press RETEST. If this doesnot clear the alarm, end treatment via DISCONNECT.Call Service.





The lower pinch valve failed. End treatment via DISCONNECT. Call Service.

Memory Error

Observation:Error Code: number 1, 3 – 7Due to:Code=1 Memory error on Protective task.Code=3 Wrong CRC of a set value.Code=4 Set value incongruence between Protective slave and task.Code=5 Incongruence on the alarm structure of the control system.Code=6 Set value incongruence between protective and control.cCode=7 Backup memory


See “Due to” message on alarmscreen.




No Line in Air Detector


Return line not installed or notproperly installed in air bubbledetector.

If return line is NOT installed in the air bubble detector,open door of air bubble detector and insert line intoair bubble detector. If return line is installed in the airbubble detector, press line into detector from bottomup and route securely through tubing guides. PressRETEST. If alarm doesn’t clear and the line is correctlyinserted in the air bubble detector, see next OperatorResponse.

Tubing detection switch failed. End treatment via DISCONNECT or continue thetreatment by pressing OVERRIDE. In this case it is theoperator’s responsibility to visually monitor the setand check the correct placement of return line in the


Malfunction



air bubble detector for the remainder of the treatment.Call Service.

No Line in Clamp


Return line not installed or notproperly installed in Return LineClamp.

If return line is NOT installed in the clamp, insert lineinto the clamp. If return line is installed in the clamp,press line into the clamp. Press RETEST. If alarmdoesn’t clear and the line is correctly inserted in theclamp, see next Operator Response.

Tubing detection switch failed. End treatment via DISCONNECT or continue thetreatment by pressing OVERRIDE. In this case it is theoperator’s responsibility to visually monitor the set andcheck the correct placement of return line in the clampfor the remainder of the treatment. Call Service.

Normalization Failed

Observation:Attempt to normalize blood leak detector has failed.


Filter blood leak; defective effluentline; air bubble in effluent lineat level of BLD; effluent line notcorrectly installed; blood leakdetector failed.Note: The “Malfunction:Normalization failed” alarm isdisplayed when the blood leakdetector normalization has failed 3times in a row.

Press CHANGE SET and follow the instructions to loada new set. If alarm recurs with new set, detector hasfailed. Press DISCONNECT to end treatment. Callservice.

PBP Pump

Observation:Rate is incorrect.PBP pump = Pre-blood pump (white).







Press CONTINUE.







PBP Scale Sensor

Observation:The alarm appears during priming or when flow rate is set to > 0.


The bar tray of the PBP scale hasnot been pulled out and then pushedin the control unit to attach the PBPbag.



Pressures Circuit Board


Hardware failure on pressurescircuit board.

Turn machine off, remove return line from return lineclamp, and return blood (when applicable). See ManualTermination of Treatment on page11:76. Call service.

Pressure Zero Test

Observation:Zero test of one or more pressure sensors failed.


Malfunction




One or more pressure podsare installed in pressure sensorhousings, but should not beinstalled yet.

If pressure pods are installed in housings, remove them.Press RETEST.

One or more pressure sensors failedor are incorrectly calibrated.

If alarm does not clear, turn off machine. Call service.

Prime Self-Test

Observation:Code: number 1 to 28.

General information on Prime selftest, for more information on different alarms, see below.


One or more of the tests conductedduring prime self-test failed.

Softkeys on alarm screen vary, depending upon failurereason. All softkeys clear the alarm.• DISCONNECT provides instructions to

unload/remove set.

• NEW SET gives instructions to unload set, load anew set, and start a new priming cycle.

• REPRIME provides instructions to reprime the set.

• RETEST restarts the prime test.

Prime Self-Test

Observation:Code: 1–7.Due to: Pressure pod/sensorAll affected pods are reported.

Code=1 Access

Code=2 Filter

Code=3 Access and Filter

Code=4 Effluent (CRRT, TPE)

Code=5 Access and Effluent (CRRT, TPE)

Code=6 Filter and Effluent (CRRT, TPE)

Code=7 Access, Effluent and Filter (CRRT, TPE)






Pressure pod(s) not installed; debrisin sensor housing(s); leaking pod.

Do Pressure Pod Adjustment procedure on all podsreported on alarm screen. Press RETEST.

Clamped lines in set. Unclamp any clamped lines. Press RETEST.

Pressure sensor(s) failed. Unload set via DISCONNECT. Call service and reportfailure code.

Prime Self-Test

Observation:Code=16Due to: Return pressure sensor


Clamped lines in set. Unclamp any clamped lines. Press RETEST.

Chamber monitor line not securelyconnected to return pressure port.

Verify the fluid barrier is not wet/ damaged. If notwet/damaged, secure monitor line to the luer lock of thereturn pressure port and press REPRIME to prime thesame set again. If the fluid barrier is wet/damaged, pressDISCONNECT and use CHANGE SET to load/prime anew set.

Pressure sensor(s) failed. If failure occurs again with a new set, unload set viaDISCONNECT. Call service and report failure code.

Air in set and bad priming quality. Press REPRIME to prime the set again.

Prime Self-Test

Observation:Code=17 and 18Due to: Blood leak detector normalization timeout or Blood leak detector threshold error.


Effluent line not correctly installedin blood leak detector.

Reinstall effluent line (from bottom up); route throughtubing guides. Press RETEST.

Air bubble in effluent line at levelof blood leak detector.

Dislodge bubble by removing line from detector /tapping on tube. Press RETEST.


Malfunction



Set not fully primed. Check for clamped lines and for connections; remedy.Press REPRIME and follow instructions. If failurerecurs after the above Operator Responses, retry with anew set (Press NEW SET and follow instructions.)

Blood leak detector failed. If failure occurs with the new set, unload set viaDISCONNECT. Call service and report failure code.


Remove line from detector. Using a “flossing” action,clean inside the detector with a lint-free cloth andisopropyl alcohol. Dry thoroughly. Clean effluentline with water and dry thoroughly. Reinsert line intodetector and tubing guides. Press OVERRIDEa.

Prime Self-Test

Observation:Code=19Due to: Air/pumps security test.


Internal malfunction. Press RETEST. If failure recurs, unload set viaDISCONNECT. Call service and report failure code.

Presence of air at ABD level. Disconnect monitor line and refill the chamber.

Prime Self-Test

Observation:Code=20Due to: Pump occlusivity test.


Return line not properly installedin return line clamp; obstruction inreturn line clamp.

Press and hold return clamp button; remove return line;remove any obstructions; reinstall line, making sure it iscompletely under clamp and not kinked. Press RETEST.RETEST: Becomes active when retest is possible.Clears alarm and restarts prime self-tests. If tests fail,alarm recurs.Note: Pressing RETEST more than twice requires theconnection of a new priming bag.

Deaeration chamber monitor linenot connected to return pressureport; errors occurred duringpriming cycle.

Verify the fluid barrier is not damaged and tightenfluid barrier connection to chamber monitor line. Ifnot damaged, secure monitor line to the luer lock ofthe return pressure port and press REPRIME to primeagain the same set. If the fluid barrier is damaged, press





DISCONNECT and use CHANGE SET to load/prime anew set.

Pump segments improperly loaded;obstructions in pump raceways;external leakage in set.

Check for leakages and tighten connections. If failurerecurs for three times, retry with a new set (PressNEW SET and follow instructions.)

Pump(s) failed. If failure occurs with a new set, unload set viaDISCONNECT. Call service and report failure code.

Prime Self-Test

Observation:Code=21 – 23Due to: Pinch valve(s).


Pinch valve(s) segment(s) notproperly positioned in pinchvalve(s).

Press RETEST. If failure recurs, retry with a new set(Press NEW SET and follow instructions.)

Pinch valve(s) failed. If failure occurs with a new set, unload set viaDISCONNECT. Call service and report failure code.

Prime Self-Test

Observation:Code=24Due to: 24 volt / 12 volt.


24 volt / 12 volt test failed. Press RETEST. If failure recurs, unload set viaDISCONNECT. Call service and report failure code.

Prime Self-Test

Observation:Code=25Due to: Return clamp sensor.


Malfunction




Obstruction in return line clamp. Press and hold return clamp button. With the otherhand, remove obstruction. Press RETEST.

Return clamp sensor failed. If alarm failure recurs, unload set via DISCONNECT.Call service and report failure code.

Prime Self-Test

Observation:Code=26Due to: 24 volt Return clamp sensor.


24 volt and return clamp sensortests failed.

Press RETEST. If failure recurs, unload set viaDISCONNECT. Call service and report failure code.

Prime Self-Test

Observation:Code=27Due to: TMPa.


Return line not in clamp. Ensure chamber monitor line is securely connected toluer lock of the return pressure port. Press RETEST.

Filter or effluent pressure pod notinstalled; debris in filter and/ oreffluent sensor housings.

Do Pressure Pod Adjustment procedure on anyuninstalled pod (see instructions at the end ofTroubleshooting chapter).Note: Pressure Pod Adjustment requires removal,adjustment, and reinstallation of the affected pods.Install and press RETEST. If all pods are installed, doAdjustment procedure on filter and effluent pods toremove possible debris. Install and press RETEST.

Set not fully primed. Press REPRIME, follow instructions. If failure recurs,retry with new set. (Press NEW SET and followinstructions.)

Filter, effluent, or return pressuresensor failed; ARPS failed.

If alarm occurs with a new set, press unload set viaDISCONNECT. Call service and report failure code.





Prime Self-Test

Observation:Code=28Due to: Syringe Circuit Board.


Internal malfunction: syringe testnot completed within 600 s.

Press RETEST to restart Syringe Test. If failure recurs, itwill not be possible to use the syringe for the treatment.

Choose one of the actions:

a. Unload set via DISCONNECT

b. Proceed with the treatment without using thesyringe by pressing SYRINGE DISABLE and thenCONFIRM DISABLE.

Replacement Pump


Replacement pump = purple pump.



Press CONTINUE.







Replacement Pump 2



Malfunction



Replacement pump 2 = green pump.



Press CONTINUE.







Replacement Scale Sensor



The bar tray of the replacementscale has not been pulled out andthen pushed into the control unit toattach the replacement bag.



Scales

Observation:Scale out of calibration.

Scale in question is specified on the alarm screen.


Specified scale is out of calibration. Press RETEST. If alarm does not clear, end treatmentvia DISCONNECTd. Turn machine off, remove returnline from return line clamp, and return blood (whenapplicable). See Manual Termination of Treatment onpage11:76. Call service.





Scales Circuit Board


Hardware failure on scales circuitboard.

End treatment via DISCONNECT. Call Service.

Scale Zero Test

Observation:Zero test of one or more scales failed.


Unexpected presence of bag. Remove bag from scale. Close scale and press RETEST.

Carrying bar missing from one ormore scales.

Place carrying bar back on scale. Close scale and pressRETEST.

Foreign objects are touching scalesor hanging from scale carryingbars.

Make sure nothing is touching scales and no foreignobjects are on scale carrying bars. Press RETEST.

One or more scales failed. If alarm does not clear, turn off machine. Call service.

Self-Test Failure

Observation:For Possible cause(s) and Operators action(s),see correspondent code for Prime Self-Test Alarm.Code=1–7, Pressure pod/sensorCode=16, Return pressure sensorCode=18, Blood leak detector threshold errorCode=24, 24 volt / 12 voltCode=25, Return clamp sensorCode=26, 24 volt Return clamp sensor

WARNINGThe blood leak detector must be re-normalized if the effluent line is removedand then reinserted into the blood leak detector after treatment (Run mode) hasstarted. See Blood Leak Detector Normalization on page 11:85.

WARNING


Malfunction



Syringe Not Loaded


The syringe is not loaded afterSyringe Test has been performed.

- Press CHANGE SYRINGE, follow instructions toload the syringe and return to alarm screen.

- Press RETEST to restart Syringe Test.

- If alarm recurs, continue without usingthe syringe pump, if desired. To dothis, press SYRINGE DISABLE and thenCONFIRM DISABLE or end treatment viaDISCONNECT. Call service to repair the syringepump.

Syringe Pump

Observation:Code: 1–9.Code = 1 Working mode incongruence between Syringe pump and set mode.Code = 2 Rate is incorrect.Code = 3 Syringe pump is moving in the wrong direction.Code = 4 Configuration incongruence between Syringe pump and the system / wrong version offirmware.Code = 5 Lower sensor out of order.Code = 6 Maximum of load sensor / unable to read force (short circuit).Code = 7 Minimum of load sensor / unable to read force (grounded).Code = 8 Working mode incongruence between Syringe pump and Control unit.Code = 9 Encoder signal error / engine mechanically blocked.


Syringe pump failed. Press OVERRIDEe. The syringe pump test will restartafter 60 seconds.For “Standard — Syringe” method: if alarm recurs, it ispossible to continue without using the syringe pump, ifdesired. To do this, press ANTICOAG SETTINGS andset the syringe pump delivery to “Continuous, 0 ml/h.”Return to alarm screen and press OVERRIDEe orturn machine off, remove return line from return lineclamp, and return blood (when applicable). See ManualTermination of Treatment on page 11:76. Call service.

For “Citrate – Calcium via Prismaflex Syringe Pump” method: if alarm recurs, it is not possible toproceed. Press END TREATMENT and follow the instructions on the screen.

Note: Always call service to repair the syringe pump and clear the alarm.





Upper Pinch Valve


The upper pinch valve is in thewrong position for the therapyselected due to obstructions.

Remove any obstructions and press RETEST. If this doesnot clear the alarm, end treatment via DISCONNECT.Call Service.

Pinch valve(s) failed. End treatment via DISCONNECT. Call Service.

Voltage Out of Range


Internal malfunction related tothe machine Power Supply or thePower supply cabling.


a. Manual termination instructions are provided at the end of the Troubleshooting chapter.b. This alarm must be cleared in Service mode by an authorized service technician.c. Memory Error code 6 is triggered when Flow Rate Discrepancy occurs. A Flow RateDiscrepancy is when any flow rate displayed on the Status screen differs from that displayed onthe Enter Flow Settings Screen.d. DISCONNECT key is available only if set is loaded onto control unit.e. OVERRIDE briefly overrides the alarm. Monitor closely.


Malfunction



Additional Troubleshooting

Display Error

Observation:Display goes blank, status lights go off, non-mutable buzzer sounds.


Power loss, internal power supplyfailure.

Turn off machine to stop buzzer, end treatmentmanually, if desireda.

Display Error

Observation:Display goes blank momentarily, then screen reappears.


Power was lost and restored within15 seconds.

None required.

Display Error

Observation:Display goes blank or logo screen fails to leave display, status lights may still be on, no buzzer.


Internal power supply failure;internal malfunction.


Display Error

Observation:Display “floats around”



AdditionalA

larm

sTroubleshooting

Additional Alarms in Alphabetical Order


Display failure. Turn machine off, remove return line from return lineclamp, and return blood (when applicable). See ManualTermination of Treatment on page11:76. Call service.

Loader

Observation:Loader is already in loaded position, so that a set cannot be loaded.


Last set was manuallydisconnected.

Begin normal Setup procedure. WhenLoad Set screen appears, press LOAD. PressSTOP in Loading pumps, please wait screen, thenpress UNLOAD. When Load set screen reappears afterUnloading pumps, please wait screen, follow on-lineinstructions to load the set.

Miss-coloured Effluent bag

Observation:Effluent bag is tinged pink or red.

(CRRT, TPE)


Patient’s disease state may causediscoloration of the effluent.

Inspect for kinks (hemolysis). If no kinks, change setand send effluent sample to laboratory for analysis. Iffree of red blood cells, continue treatment. If red bloodcells are present, change the set. If conditions recurswith new set, patient’s disease state might be the rootcause (to confirm with lab results).

Effluent contains red blood cells,but level is below blood leakdetection limit.

Send effluent sample to laboratory for analysis. If redblood cells are present, change the set.

Hemolysis is occurring due toocclusion.

Verify that the correct clamps are open for the therapyin use, especially for the access line (red) and return line(blue). Verify no kinks in the access and return lines. Ifhemolysis continues, change the set via the STOP keyb.


AdditionalAlarmsTroubleshooting


Hemolysis is occurring during TPEtherapy.

Press STOP and change set.

Set Connections

Observation:Leakage from set connections.


Connections are loose. Tighten the connections. If leakage continues, changethe set via STOP keyb.

Softkeys

Observation:Softkeys won’t work.


Touchscreen failed. Turn machine off, remove return line from return lineclamp, and return blood (when applicable). See ManualTermination of Treatment on page11:76. Call service.

a. Manual termination instructions are provided at the end of the Troubleshooting chapter.b. See “Change Set and End Treatment Procedures” in “Chapter 4: End Mode” on page 4:16.



AdditionalA

larm

sTroubleshooting


Power FailureA main power failure may occur prior switching on the machine or while in treatmentfor two reasons:

1. Loss of main power supply in the facility

2. The machine power cord is not connected.

Machine needs to be switched on with main power. If no main power, the machine willnot start.

When a main power failure occurs there are two possible scenarios. These are dependingon availability of a battery back-up installed or not in the machine (check with the localrepresentative for more information).

1. Battery back-up is installed: the Advisory: Main Power Lost alarm will appear onthe screen. The treatment can proceed until the power supply is back or until theWarning: Battery Low alarm occurs. A battery icon will be visible at the top of thescreen just below the date to indicate that the machine is running on battery. Whenthe Warning occurs the treatment must be ended as soon as possible, unless the mainpower supply of the facility is restored or the power cord reconnected. Follow theinstructions on the screen.

2. Battery back-up is not installed: the machine will shut down. If the power supplyis back in less than 15 seconds the treatment can proceed as before. If the power isout for more than 15 seconds, the Warning: Power Failure alarm will appear on thescreen. Follow the instructions on the screen.

See also Advisory: Battery Exhausted and Advisory: Memory Back-up for moreinformation.

Manual Termination of TreatmentThe patient’s treatment can be terminated manually at any time. Manual termination maybe required due to an alarm, power failure or other emergency.

Manual Termination With Blood Return(See Figure 11:1 on page 11:77.)

Note: A sterile spike connector may be required.

1. Turn off the power. Clamp the access line (red-striped) and disconnect from thepatient. Attach the access line to a 1 liter bag of sterile saline. (Use spike connector,if needed.) Unclamp the access line.

2. Press the return clamp button1 and hold in the “In” position. With the other hand,remove the return line (blue-striped) from the return line clamp.

3. Visually check the fluid level in the deaeration chamber. If the level is too low,remove excess air as follows (depending on the Prismaflex disposable set version):

1 Return clamp button is located on the left side of the return line clamp assembly.


• Air removal through the chamber monitor line: Place a clamp on the chambermonitor line; disconnect the chamber monitor line from the return pressure port;by opening/closing the clamp, let blood fill the deaeration chamber until fluidlevel is at the correct height.

Note: In case no blood pressure is available, attach a 30 ml luer-lock sterile syringe(without the needle) to the distal end of the chamber monitor line; aspirate air/blood untilfluid level is at the correct height on the deaeration chamber.

WARNINGWhen the blood is returned manually, there is no air detection. Visually checkfor air in the return line until patient is disconnected.

WARNING

4. Remove the pump crank from its holder on the rear panel. Insert crank into the rotorof the blood pump and turn clockwise until sufficient blood is returned to the patient.

5. Clamp the return line (blue-striped) and disconnect from the patient. Clamp lines toall bags.

6. Press the two clips of the loader to release the Prismaflex disposable set. Pull out theregressed “screw driver” from the pump crank. Starting with any peristaltic pump,insert the screw driver into the rotor and turn each pump counterclockwise. (Thepump segment will work itself out of the pump raceway in a few turns of the rotor.)To assist, gently tug on the Prismaflex disposable set while turning a pump.

7. When the pump segments are free, use the crank to set the pinch valves in neutralposition.

8. Grasp the Prismaflex disposable set and pull out to disengage the lines from the pinchvalves. Take the set off the control unit and discard as usual.

Note: Remaining solutions may be used with a new set, if desired.

Figure 11:1 Manually Terminating Treatment (CRRT set shown)

A. To manually return the patient’s blood, connect saline to access line, check the fluidlevel in the deaeration chamber, use pump crank to turn the blood pump clockwise.



WARNINGWhen the blood is returned manually, there is no air detection. Visually checkfor air in the return line until patient is disconnected.

WARNING

B. To manually remove the set from the control unit, press clips of loader to releasethe Prismaflex disposable set. Pull the Prismaflex disposable set outward to disengagefrom pinch valves.

WARNINGEnsure patient is disconnected from set before removing set from control unit.

WARNING

Manual Termination Without Blood ReturnNote: The patient will lose the blood contained in the blood flowpath during a manualtermination without blood return. For the exact blood volume, see the Instructions forUse packaged with the Prismaflex disposable set.

1. Turn off the power. Clamp the access line (red-striped) and return line (blue-striped)and disconnect from the patient.

2. Clamp lines to all bags.

3. Press the two clips of the loader to release the Prismaflex disposable set. Pull out theregressed “screw driver” from the pump crank. Starting with any peristaltic pump,insert the screw driver into the rotor and turn each pump counterclockwise. (Thepump segment will work itself out of the pump raceway in a few turns of the rotor.)To assist, gently tug on the Prismaflex disposable set while turning a pump.

4. When the pump segments are free, use the crank to set the pinch valves in neutralposition.

5. Grasp the Prismaflex disposable set and pull out to disengage the lines from the pinchvalves. Take the set off the control unit and discard as usual.

Pressure Pod Adjustment ProcedureIf a pressure pod is accidentally removed after priming is complete, or if an alarm screenidentifies one or more pods as a possible cause of the alarm, press the SELF-TEST softkeyfrom the System Tools screen to recover from the failure.

If SELF-TEST fails, the Pressure Pod Adjustment procedure can be performed. Thisprocedure is done separately for each affected pod.

The adjustment procedure moves the pod diaphragm back to the center of the pod, sothat pressure monitoring can again occur. The procedure also clears the pressure sensorhousing of any debris that may be preventing a tight seal between the pod and the sensorhousing.

The steps of the Pressure Pod Adjustment procedure vary, depending on the followingfactors:• Type of Prismaflex disposable set in use

• Exact pressure pod(s) affected


Instructions for performing the proper Reposition procedure for the situation at handare provided below.

CAUTIONUse aseptic technique with syringe, needle and sample site.

When adjusting pod diaphragms, injecting or removing more than 1 ml of fluidmay move the diaphragm beyond the centre point of the pod.

CAUTION

Pressure Pod Adjustment (CRRT, HP)

Supplies Needed• Isopropyl alcohol and lint-free cloth;

• 21-gauge (or smaller diameter) needle attached to a ≤ 5 ml syringe;

• Sterile saline (needed only for access and effluent pods);

• 2 tubing clamps.

Access Pod and Effluent PodNote: The effluent pod is not used in HP.

Note: Manual repositioning of the access pod is possible only on Prismaflex disposablesets featuring an access pod sample site.

Follow the steps below to reposition the diaphragm of the access line pod (near lowest redsample site) or the effluent line pod (near the yellow sample site).

1. Stop all pumps.

Note: Pumps might already be stopped.

2. By using two clamps, isolate the pressure pod and its color-coded sample site.

3. Twist the affected pod slightly to release/remove it from its pressure sensor housing.

Note: Pod might already be removed.Use a lint-free cloth and alcohol to clean the sealing cone inside the sensor housing.

4. Draw 3 ml saline into the ≤ 5 ml syringe.

5. Inject a maximum of 1 ml of saline into the sample site between the clamps. (Ifresistance is felt, remove 1/2 ml volume.)

6. Remove needle from sample site. Reinstall the pressure pod in the correct pressuresensor housing and remove the clamps from the line.

7. Resume treatment, or press the appropriate softkey on the alarm screen.



8. For access pod: Perform the following test to ensure proper functioning of the accesspod. When the control unit is in Run mode, place a clamp on the access line belowthe access pressure pod. The Warning: Access Pressure Extremely Negative alarmshould occur. Unclamp the access line and press the CONTINUE softkey on theWarning screen. Verify that the alarm is cleared (Display of Warning screen ends,green light is lit).

WARNINGIf the Warning: Access Pressure Extremely Negative alarm fails to occur, theaccess pod diaphragm has been adjusted incorrectly. Perform the adjustmentprocedure again.

WARNING

9. For effluent pod: Perform the following test to ensure proper functioning of theeffluent pod. When the control unit is in Run mode, place a clamp on the effluent linebelow the effluent pressure pod. Verify that effluent pressure decreases. Unclamp theeffluent line and verify that effluent pressure increases.

WARNINGIf the effluent pressure fails to respond properly, diaphragm has been adjustedincorrectly. Do adjustment procedure again.

WARNING

Filter PodFollow the steps below to adjust the diaphragm of the filter pod (near upper red samplesite).

1. Stop all pumps.





4. Insert the needle with empty syringe into the sample site between the clamps.Remove a maximum 1 ml fluid (if resistance is felt, reinject 1/2 ml.)

5. Remove the needle from the sample site. Reinstall the pressure pod in its pressuresensor housing and remove the clamps from the line.

6. When the procedure has been completed, resume treatment, or press the appropriatesoftkey on the alarm screen.

7. Perform the following test to ensure proper functioning of the filter pressure pod.When the control unit is in Run mode, place a clamp on the line above the filterpressure pod. The Warning: Filter Clotted alarm or the Warning: Filter is extremelypositive alarm should occur. Unclamp the line and press the CONTINUE softkey onthe Warning screen. Verify that the alarm is cleared (Warning screen leaves thedisplay, green light is lit).


WARNINGIf the Warning: Filter Clotted alarm fails to occur, the pressure pod diaphragmhas been adjusted incorrectly. Perform the adjustment procedure again.

WARNING

Pressure Pod Adjustment (TPE)

Supplies Needed• Isopropyl alcohol and lint-free cloth;

• 21-gauge (or smaller diameter) needle attached to a ≤ 5 ml syringe;

• Sterile saline (needed only for access and effluent pods);

• 2 tubing clamps.

Access Pod (TPE)Note: Manual repositioning of the access pod is possible only on Prismaflex disposablesets featuring an access pod sample site

Follow the steps below to adjust the diaphragm of the access line pod (near lowest redsample site).

1. Stop all pumps.





4. Draw 3 ml sterile saline into the ≤ 5 ml syringe.

5. Inject a maximum of 1 ml saline into the sample site between the clamps. (Ifresistance is felt, remove 1/2 ml.)

6. Remove the needle from the sample site. Reinstall the pressure pod in its pressuresensor housing and remove clamps from the line.


8. For access pod adjustment (TPE): Perform the following test to ensure properfunctioning of the access pod. When the control unit is in Run mode, place aclamp on the access line below (upstream from the way blood/fluid is flowing) theaccess pod. The Warning: Access Pressure Extremely Negative alarm should occur.Unclamp the access line and press the CONTINUE softkey on the Warning screen.Verify that the alarm is cleared (Warning screen leaves the display, green light is lit).



WARNINGIf the Warning: Access Extremely Negative alarm fails to occur, the access poddiaphragm has been adjusted incorrectly. Perform the adjustment procedureagain.

WARNING

Filter and Effluent Pods (TPE)Follow the steps below to adjust the diaphragm of the filter pod (near upper red samplesite) or the effluent line pod (near the yellow sample site).

1. Stop all pumps.





4. Insert the needle with empty syringe into the sample site between the clamps.Remove a maximum 1 ml fluid (if resistance is felt, reinject 1/2 ml.)

5. Remove the needle from the sample site. Reinstall the pressure pod in the correctpressure sensor housing and remove the clamps from the line.


7. For filter pod adjustment (TPE): Perform the following test to ensure properfunctioning of the plasmafilter pressure pod. When the control unit is in Runmode, place a clamp on the line above the plasmafilter pressure pod. The Warning:Filter Extremely Positive alarm should occur. Unclamp the line and press theCONTINUE softkey on the Warning screen. Verify that the alarm is cleared (Warningscreen leaves the display, green light is lit).

WARNINGIf the Warning: Filter Extremely Positive alarm fails to occur, the pressure poddiaphragm has been adjusted incorrectly. Perform the adjustment procedureagain.

WARNING

8. For effluent pod: Perform the following test to ensure proper functioning of theeffluent pod. When the control unit is in Run mode, place a clamp on the effluent linebelow the effluent pressure pod. Verify that effluent pressure decreases. Unclamp theeffluent line and verify that effluent pressure increases.

Leakage in pressure pods or blood reaching fluidbarrierUnder normal conditions, the Prismaflex pressure transducers have proven to be safeand effective in measuring during treatment. However, in the unlikely event of ablood/infusion solution leakage from a pod diaphragm or if blood has reached the fluidbarrier of the monitor line, carry out the procedures below on the appropriate sensor:


Blood leakage from the pressure pod diaphragm (Access and Filter)At the end of the treatment the machine must be put into a quarantine and tagged as“DO NOT USE”. Additional verification is required either by the facility’s biomedicaland/or authorized service technician.

Blood/infusion fluid reached the fluid barrier (Return)a. Blood/infusion solution has been blocked at the fluid barrier, set needs to be

changed. Alternatively fluid barrier component might be replaced according toinstructions given in next section on page 11:84.

b. Blood/infusion solution has passed through the fluid barrier and reached the returnpressure port. Treatment shall be stopped immediately and the machine must be putinto quarantine and tagged as “DO NOT USE“. Additional verification is requiredeither by the facility’s biomedical and/or authorized service technician.

Fluid Barrier Related ProceduresIn case fluid barrier is wet during setup or treatment, it is recommended to change theset. However, trained and experienced users may recover or change the fluid barrier byfollowing procedures below. Both procedures require use of aseptic technique and toSTOP the blood pump when applicable in Priming or Run Mode.

Fluid Barrier Recovery in PrimingIn case fluid barrier is wet during priming or prime-test steps, the fluid barrier can berecovered and therefore used for the treatment.

Materials needed:

- 5 ml syringe

- clamp

Follow these steps to clear the monitor line of fluid:

1. Clamp the monitor line between the deaeration chamber and fluid barrier. Disconnectmonitor line from return pressure port.

2. Check and secure connection of the fluid barrier to monitor line.

3. Attach a sterile 5 ml syringe filled with air to monitor line end (fluid barrier).Unclamp the monitor line and inject about 3 ml air into the line. This pushes the fluidin the monitor line back into the deaeration chamber.

4. Keeping syringe attached, adjust the deaeration chamber fluid level to proper height(pull on plunger to move level up, push on plunger to move level down).

5. Clamp the monitor line and remove syringe. Reattach monitor line to the returnpressure port and secure it with the luer lock.

6. Unclamp the monitor line. Press START/REPRIME.



Fluid Barrier Change in Run ModeIn case fluid barrier is wet during treatment, the fluid barrier must be changed.

Materials needed:- Disposable fluid barrier

- 5 ml syringe filled with saline

- 5ml syringe

- clamp

Note: This procedure needs to be followed and performed within a short period of time.Stagnation of blood in the circuit may induce early clotting.

Follow these steps to change the fluid barrier component:

1. Clamp the monitor line between the deaeration chamber and fluid barrier. Disconnectmonitor line from return pressure port.

2. Disconnect and discard the wet fluid barrier.

3. Attach a sterile 5 ml syringe filled with saline to monitor line. Unclamp the monitorline and inject about 3 ml of saline to rinse the monitor line. Clamp the monitorline and disconnect the syringe.

4. Connect a sterile 5 ml syringe filled with air to monitor line. Unclamp the monitorline and inject about 3 ml air into the line. This pushes the fluid in the monitor lineback into the deaeration chamber.

5. Keeping syringe attached, adjust the deaeration chamber fluid level to proper height(pull on plunger to move level up; push on plunger to move level down).

6. Clamp the monitor line and remove syringe. Connect a disposable fluid barrieraccessory.

7. Reattach monitor line to the return pressure port and secure it with the luer lock.

8. Unclamp the monitor line. Press RESUME.

CAUTIONDo not operate the machine without a fluid barrier present at the end of monitorline.

CAUTION

Air Removal Procedures

Deaeration ChamberFrequent monitoring of the level is necessary. See “Air Management” section on page3:11.

Air in Blood Alarm – Manual Air RemovalIf pressing the Up arrow until return pressure is NEGATIVE is unsuccessful, proceedwith manual procedure:


1. Insert the 20-gauge needle with syringe into the blue sample site (return line).

2. Aspirate air/blood until the return pressure reaches a negative value (0 mmHg to –100 mmHg).

3. Remove the needle.

4. Press RELEASE CLAMP to remove air and draw blood from patient into the returnline / deaeration chamber.

Note: When the return line clamp releases, air in the blood is drawn into the chambermonitor line and automatically eliminated from the set through the return pressure port.Blood is also drawn from the patient into the return line and deaeration chamber.

5. If needed, use arrows to adjust the level of fluid in the chamber.

Blood Leak Detector NormalizationThe Blood Leak Detector is an infrared transmission/detection device that continuouslymonitors the effluent line for blood that may have passed through the filter.

The Blood Leak Detector is automatically normalized after the end of the primingsequence, when the effluent line is full of priming solution. The infrared transmitter/detector is adjusted to receive a signal range between 40000 and 46000. If the receivedsignal goes above or below the alarm limits, the Blood Leak Detected warning alarm istriggered.

If the effluent line has been removed/reinserted in the detector, the Blood Leak Detectorhas to be normalized also in Run mode, from the System Tool screen.

To normalize the Blood Leak Detector during treatment, perform the following steps:1. Press NORM BLD from the System Tool screen.

2. Draw a sample from effluent line and test for blood. If blood present, discontinue thetreatment and change the set. If no blood is present, proceed with the following step.

WARNINGBefore normalizing the Blood Leak Detector, fluid in effluent line must be testedand verified to be free of blood.

WARNING

3. Verify the signal value displayed in the screen is 38000 or greater. If necessary, moveeffluent line slightly up or down in the blood leak detector to raise the signal value.

Note: If the received signal value goes below 38000 as displayed on theNormalize BLD screen, the blood leak detector cannot be re-normalized and the set has tobe changed. This prevents normalization when a blood leak is occurring.

4. Press START NORM. The infrared LED drive signal is still adjusted so the receivedA/D signal range is 40000 to 46000.

5. When normalization finishes, control unit automatically returns to the Status screen.



Cardiac Monitor ProceduresElectrically isolated peristaltic pumps such as those on the Prismaflex® control unit canproduce electrostatic charges in the disposable set. While these electrostatic charges arenot hazardous to the patient, they may appear as an artefact on cardiac monitors.

To minimize this electrical interference:

• always install the discharger ring in its guide before connecting a patient to thePrismaflex disposable set

• follow the ECG supplier’s instructions for chronic patient monitoring carefullyregarding:

- use of specific electrodes with low contact impedance,

- correct application of the electrodes, including appropriate placement of the Nelectrode

CAUTIONWhen starting a treatment with the Prismaflex system, observe the cardiacmonitor before and after starting the blood pump to verify that the artefact is notpresent. If a cardiac dysrhythmia is exhibited, stop the blood pump and reassessthe cardiac rhythm before resuming treatment and/or treating the patient.

CAUTION


Chapter 12

MaintenanceContents

Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:2Hygiene and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:2Routine Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:2Cleaning the Blood Leak Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:2Cleaning the Touch screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:2

Technical Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:3Periodic Safety Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:4


Maintenance 12:1

ServiceThere are no user-serviceable parts inside the Prismaflex control unit. Do not attempt anyinternal or external maintenance or repair, other than the routine cleaning described below.All other maintenance and repairs must be done by an authorized service technician.

For service or to order parts, contact your representative.

Hygiene and maintenance

Routine CleaningCAUTION

Using a stronger Bleach solution than recommended can cause damage ordiscoloration.

Do not clean the pump crank with sodium hypochlorite (Bleach). Sodiumhypochlorite (Bleach) may damage the pump crank.

Do not use other cleaning solutions than those recommended as the touchscreen may be damaged.

CAUTION

The following cleaning procedures should be done after completion of each patienttreatment with the Prismaflex control unit, or as required during treatment:

1. Clean spills from the surface of the machine using a mild detergent.

2. Disinfect the surfaces of the machine using a solution of 90% ethyl alcohol; 70%isopropyl alcohol, or 0.1% sodium hypochlorite (Bleach).

Cleaning the Blood Leak DetectorThe tubing path through the blood leak detector should be cleaned as required to removeliquid or other debris. Using a “flossing action,” clean inside the detector with a lint-freecloth and isopropyl alcohol. Dry thoroughly when finished.

Cleaning the Touch screenThe Touch screen may be cleaned also when the Prismaflex control unit is performinga treatment. To clean the Touch screen press the CLEAN SCREEN softkey from theSystem Tools screen: for 10 seconds an empty screen is displayed to allow cleaningwithout unwanted pressing of softkeys.

You can clean the Touch screen with:

• Isopropyl alcohol (70%);

• Sodium hypochlorite solution (active chlorine from 50,000 to 60,000 ppm) / Bleachdiluted with water at a ratio of 1:50.

12:2 Maintenance G5036003 Revision 05.2011Program version 6.xx

Technical Preventive MaintenanceTechnical preventive maintenance is by default required every 6000 hours of operationor once per year. These intervals can be changed in Service mode by authorized servicetechnicians. Only authorized service technicians are approved to perform preventivemaintenance procedures.

When the Advisory: Preventive Maintenance Due alarm signal occurs, pressure podsealing cones replacement is required.

The operator can override this alarm until it is convenient to perform the maintenance.This advisory can only be cleared in Service mode.

During preventive maintenance the following components should be replaced:

• Pressure pod sealing cones; (6000 h or 12 months)

• Automatic Reposition System (ARPS) filter and pump segment; (6000 h or 12 months)

• Blood Pump Rotor (only after 20000 hours of operation have elapsed).

During preventive maintenance the authorized service technician should verify the properoperation and/or calibration of the following items in Service mode:

• Pumps;

• Scales;

• Reposition pressure;

• Return pressure sensor;

• Light and alarm tones;

• Air Bubble Detector;

• Syringe pump;

• Return line clamp;

• Blood Leak Detector;

• Pod reposition;

• Internal system;

• Load/unload functions;

• Communication system.

During preventive maintenance the authorized service technician should also perform thefollowing tests, verifications, operations:

• Clean any dust, debris and/or dried fluids from the external and internal machinesurfaces, including pump rotors;

• Perform the rotor occlusion test for all the pumps;

• Verify the proper functioning and integrity of the Blood Pump rotor;


Maintenance 12:3

• Verify the presence and the integrity of the conductivity gaskets of the scales;

• Apply the proper quantity of grease on the scale bearings.

Periodic Safety InspectionA safety inspection of the Prismaflex control unit is required every 12 months, or asstipulated by local requirements. Only authorized service technicians are approved toperform the safety inspection procedures.

12:4 Maintenance G5036003 Revision 05.2011Program version 6.xx

Chapter 13

SpecificationsEnvironmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:2Physical Characteristics of the Prismaflex control unit . . . . . . . . . . . . . . . . . . . . 13:2Medical Device Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:3Scales Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:3AC Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:3Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:4

AC Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:4Defibrillation-proof Applied Part . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:4Radio Frequency Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:4Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:4Potential Equalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:4

Conformity to International Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:4Syringe Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:5Standard – Syringe anticoagulation method . . . . . . . . . . . . . . . . . . . . . . . . . 13:5Citrate – Calcium via Prismaflex Syringe Pump anticoagulation method . . . . 13:6

Flow Rates and Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:6TPE Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:7Audible Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:8Access Line Pressure Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:8Return Line Pressure Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:9Filter Pressure Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:9Effluent Line Pressure Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13:10Air Bubble Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13:10Blood Leak Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13:11


Specifications 13:1

Environmental RequirementsAmbient OperatingTemperature:

16 °C to 38 °C(60 °F to 100 °F)

Ambient Operating Humidity(for control units with serialnumber up to PA5409):

15% to 65% (Non-condensing)

Ambient Operating Humidity(for control units with serialnumber from PA5410 and on):

Lower ambient operating humidity limit:15% (Non-condensing) in the temperature interval 16°C to 38 °C.Upper ambient operating humidity limit:85% (Non-condensing) in the temperature interval 16 °Cto 28 °C. In the temperature interval 28 ºC to 38 ºC theupper limit is reduced by 2% per degree and at maximumambient temperature (38 ºC) the maximum operatingrelative humidity is consequently 65% (Non-condensing).

Ambient Operating AirPressure:

70 to 106 kPa(525 to 795 mmHg)

Transport and StorageTemperature1:

–18 °C to +54 °C(0 °F to 130 °F)Prior to use, let unit rest at ambient operating temperaturefor 1 hour.

Transport and StorageHumidity1:

10% to 95% (Non-condensing)

Transport and Storage AirPressure:

50 to 106 kPa(375 to 795 mmHg)

Noise level < 65 dB(A) over a 24 h period, measured at a distance of0.5 m from the Prismaflex control unit, during normaloperation and without any alarm condition.

Vibrations during operation Acceleration Spectral Density (ASD), isotropic, 2-200 HzASD ≤ 5×10-8 g2/Hz

Fluid Spillage: IPX1 (Protection against vertically falling water drops)As specified in IEC 60529

Cleanability: Not damaged by mild detergent; liquid soap; ethyl alcohol(90%); isopropyl alcohol (70%); sodium hypochlorite(0.1%). Pump rotors are removable.

Physical Characteristics of the Prismaflex control unitWeight: Approximately 60 kg (132 lb)

Without fluid bags and Prismaflex disposable setHeight: Approximately 162 cm (64 in)Width: Approximately 49 cm (19 in)Base: Approximately 60 cm × 63 cm (24 in × 25 in)

1 For transport and storage longer than 15 weeks, use ambient operating conditions.

13:2 Specifications G5036003 Revision 05.2011Program version 6.xx

Medical Device ClassificationClassification, EU Class II b per COUNCIL DIRECTIVE 93/ 42/EECClassification, USA Class II per FDA 21 CFR 860Classification, Canada Class III per SOR/98-282Classification, Australia Class II b per Therapeutic Goods Act 1989, Bill 2002

Scales CharacteristicsScale Weight Range

Weight range for each scale includes the scale components (bar tray, carrying bars).

Dialysate: 0 to 11 KgReplacement: 0 to 11 KgPBP: 0 to 11 Kg (PBP = pre-blood pump)Effluent: 0 to 11 KgScale accuracy: ≤7 g error for a mass from 0 to 5200 g and,

≤14 g error for a mass from 5201 g to 11000 g

Maximum Bag Configuration Allowed on Scales

Three scales (Dialysate, Replacement, PBP), each holding a 5000 ml solution bag; plusone scale (Effluent) holding a 9000 ml effluent bag.

AC PowerLine Voltage: 100 – 240 VacFrequency: 50/60 HzPower: 500 – 600 WAverage EnergyConsumption:

<150 W (CVVHDF treatment)


Specifications 13:3

Electrical SafetyCAUTION

Devices connected to the RS232 serial communication port or the Ethernet portmust comply with IEC 60950. Connected cables must have a Kitagawa RFC-10ferrite or equivalent to fulfill EMC requirements.

CAUTION

Note! To be sure of the machine's classification see type label found at the back of themachine

Classification: Mobile, Class I, applied part is Type CF, defibrillationproof per IEC 60601-1Mobile, Class I, applied part is Type BF, defibrillationproof per IEC 60601-1Mobile, Class I, applied part is Type B, per IEC 60601-1when using the Prismaflex system in combination withthe MARS system.

AC Leakage Current

Protective ground open300 μA maximum rms 100/115 Vac, 50/60 Hz500 μA maximum rms 220/240 Vac, 50/60 Hz

Defibrillation-proof Applied PartApplied part is Type CF, defibrillationproof per IEC 60601-1

Applied part is Type BF, defibrillationproof per IEC 60601-1

Defibrillator equipment meets requirements of IEC 60601-2-4

Radio Frequency InterferenceMeets European Standard EN 55011, limit BMeets IEC 60601-1-2

Electromagnetic CompatibilityMeets IEC 60601-1-2

Potential EqualizationMeets IEC 60601-1

The Prismaflex control unit has a connection for a Potential Equalization Conductor.

Conformity to International RulesIEC 60601-1 :1988 Medical Electrical Equipment-Part 1 ; General

Requirements for Safety Plus am 1 :1991, am2: 1995.European Norm EN60601-1: 1990 Plus A1: 1992 PlusA2:1995

IEC 60601-1-1: 2000 Medical Electrical Equipment -Part 1 ;GeneralRequirements for safety, 1. Collateral Standard: SafetyRequirements for Electrical Systems. European NormEN60601-1-1: 2001


IEC 60601-1-2 Ed.2: 2001 Medical electrical equipment - Part 1-2: Generalrequirements for safety - Collateral standard:Electromagnetic compatibility - Requirements and tests.European Norm EN 60601-1-2:2001

IEC 60601-1-4:1996 Medical electrical equipment - Part 1-4: Generalrequirements for safety - Collateral Standard:Programmable electrical medical systems, includingA1:1999. European Norm EN60601-1-4: 1996 includingA1/1999

IEC 60601-2-16: 1998 Medical Electrical Equipment - Part 2-16: Particularrequirements for the safety of haemodialysis,haemodiafiltration and haemofiltration equipment.European Standard : EN 60601-2-16: 1998

IEC 60601-2-24:1998 Medical Electrical Equipment - Part 2-24: Particularrequirements for the safety of infusion pumps andcontrollers. European Standard: EN 60601-2-24:1998

CAN/CSA No.601.1-M90incl. S1-94 (R1999)CAN/CSA No. 601.1B-90(R2002)

Medical Electrical Equipment, Part 1: GeneralRequirements for safety

UL 60601-1 Medical electrical equipment - Part 1: Generalrequirements for safety

Syringe Settings

Standard – Syringe anticoagulation method

Syringe Continuous Delivery Rate

Range User settable;0, or 1.0 to 5.0 ml/h (10 ml syringe)0, or 0.5 to 5.0 ml/h (20 ml syringe)0, or 0.5 to 10.0 ml/h (30 ml syringe)0, or 2.0 to 20.0 ml/h (50 ml syringe)

Increment 0.1 ml/hAccuracy ±5 % ≥ 1 ml/h (10 ml syringe)

±15 % < 2 ml/h, ±5 % ≥ 2 ml/h (20 ml syringe)±10 % < 2 ml/h, ±5 % ≥ 2 ml/h (30 ml syringe)±10 % < 3 ml/h, ±5 % ≥ 3 ml/h (50 ml syringe)Pressure between 0 and +600 mmHg. Use of approvedsyringes

Syringe Bolus Delivery Volume

Range User settable;0, or 0.5 to 5.0 ml (10 ml and 20 ml syringe)0, or 1.0 to 5.0 ml (30 ml syringe)0, or 2.0 to 9.9 ml (50 ml syringe)

Increment 0.1 mlAccuracy ±10 % < 1 ml, ±5 % ≥ 1 ml (10 ml syringe)

±15 % < 2 ml, ±5 % ≥ 2 ml (20 ml syringe)±10 % < 2 ml, ±5 % ≥ 2 ml (30 ml syringe)±10 % < 3 ml, ±5 % ≥ 3 ml (50 ml syringe)


Specifications 13:5

Syringe Bolus Delivery Interval

Range User settable; Once every 1 to 24 hours Note: Immediateoption also available in Run mode and Recirculationmode.

Increment 1 hour

Syringe Bolus Delivery Rate 1 ml/≤20 secUse of approved syringes

Citrate – Calcium via Prismaflex Syringe Pump anticoagulation method

Syringe continuous delivery rate

Range 0, or 2.0 to 100 ml/hIncrement Not applicableAccuracy 7%

Flow Rates and AccuracyBlood Flow Rate2

Range 10 to 450 ml/minIncrement 10 ml/min, 2 ml/min for low flow setsAccuracy ±10% of user-set rate

The accuracy of blood flow is maintained if:– the inlet pressure is higher (less negative) than –250mmHg;– the outlet pressure is lower than +350 mmHg.

Return Blood Flow Rate 10 to 100 ml/minWhen START RETURN softkey is pressed

Recirculation Flow Rate 10 to 150 ml/min

Replacement Solution/Fluid Flow Rate2

CVVH; CVVHDFRange 0 to 8000 ml/hIncrement 50 ml/h, 20 ml/h for low flow setsCVVHPredilution percentage 0 to 100%Increment 5%CVVHDFPredilution percentage 0 (postdilution) or 100% (predilution)TPERange 0 to 5000 ml/hIncrement 10 ml/hAccuracy ± 30 ml/h

Dialysate Flow Rate2

CVVHD; CVVHDFRange 0 to 8000 ml/hIncrement 50 ml/hAccuracy ± 30 ml/h

2 User settable; Flow rate range depends on the Prismaflex therapy/set combination selectedby the operator


PBP Solution Rate2

CVVH; CVVHD; CVVHDFRange 0 to 4000 ml/hSCUF; TPE; HPRange 0 to 1000 ml/h

Note: Total PBP Volume is 2000 ml/treatment for TPEand HP.

Increment 30 ml/h < Qpbp < 100 ml/h: 2 ml/h100 ml/h < Qpbp < 200 ml/h: 5 ml/h200 ml/h < Qpbp < 1500 ml/h: 10 ml/hQpbp > 1500 ml/h: 50 ml/hQpbp = PBP Solution Flow Rate

Accuracy ± 30 ml/h

Patient Fluid Removal Performance / Patient Plasma Loss Performance2

Range 0 to 2000 ml/h maximum in CRRT0 to 1000 ml/h for TPE

Increment 10 ml/h5 ml/h for the Prismaflex HF20 CRRT set

Accuracy ±30 ml/h±70 ml/3 hr±300 ml/24 hrScales calibrated at ambient temperature at which theywill be used. Ambient temperature change less than±3 °C (5.4 °F) during treatment.

Effluent Flow Rate2

Range 0 to 10,000 ml/hDepending on the therapy selected.

TPE SettingsPatient Hematocrit

Range 10 to 60%Increment 1%Default 30%

Total Replacement Volume

Range 0 to 10,000 mlIncrement 100 mlDefault 3000 ml

Replacement Container Volume

Range 0 to 5000 mlIncrement 10 ml


Specifications 13:7

Audible AlarmAudible Alarm Volume (decibel level)

LowModerateHigh

Meets IEC 60601-2-16

Can be muted for 2 minutes, after which audible resumes if alarm conditionhas not been remedied.

Fast beep Warning and Malfunction alarmsModerate beep Caution alarmsSlow beep Advisory alarms

Non-mutable

Continuous for at least 2minutes

Power loss

Access Line Pressure SensorOperating Range –250 to +450 mmHgAccuracy ±10% of reading or ±8 mmHg, whichever is greater

“Access Extremely Negative”Warning Limit

Warning alarm occursPressure in access pod equals warning limit.User settable:–10 to –250 mmHg

Default: –250 mmHg150 mmHg below operating point

Increment: 5 mmHg

“Access Extremely Positive”Warning Limit

Warning alarm occursPressure in access pod equals warning limit.User settable:+10 to +450 mmHg

Default: +300 mmHgIncrement: 5 mmHg

“Check Access” AdvisoryLimit

Advisory alarm occursWhen running with an operating point below -10mmHg,this alarm occurs if access pressure is 50 mmHg or 70mmHg (if blood flow>200 ml/min) above or below itsoperating point, or if the pressure rises above 0 mmHg.When running with an operating point in the rangebetween -10mmHg and +20mmHg, this alarm occurs ifthe access pressure is 50mmHg or 70 mmHg (if bloodflow>200 ml/min) below its operating point, or if theaccess pressure is 10mmHg above its operating point.When running with an operating point above +20mmHg,this alarm occurs if the access pressure drops below+10mmHg.


Return Line Pressure SensorOperating Range –50 to +350 mmHgAccuracy ±10% of reading or ±8 mmHg, whichever is greater

“Return Extremely Positive”Warning Limit

Warning alarm occursUser settable;+15 to +350 mmHgDefault: +350 mmHgIncrement: 5 mmHgPressure in return deaeration chamber equals warninglimit.

“Check Return” AdvisoryLimit

Advisory alarm occursThis alarm occurs if return pressure is 50 mmHg or 70mmHg (if blood flow >200 ml/min) above its operatingpoint.

“Return Pressure Dropping”Warning Limit

Warning alarm occursPressure in the return deaeration chamber is 50 mmHg(or 70 mmHg if blood flow>200 ml/min) more negativethan the established operating point.

“Return Disconnection”Warning Limit

Warning alarm occursPressure in the return deaeration chamber is lower than+10 mmHg and the established operating point is higherthan +10 mmHg.

Filter Pressure SensorOperating Range –50 to +450 mmHgAccuracy ±10% of reading or ±8 mmHg, whichever is greater

“Set Disconnection” WarningLimit

Warning alarm occursPressure in filter pod (immediately before the filter) islower than +10 mmHg.

“Filter Extremely Positive”Warning Limit

Warning alarm occursPressure in filter pod (immediately before the filter) is≥450 mmHg.

“Filter Is Clotting” AdvisoryLimits

Advisory alarm occursOne or both limits are reached. (CRRT)

a) Filter pressure drop a) User settable;+10 to +100 mmHg greater than initial filter pressuredrop Default: +100 mmHg Increment: 10 mmHg

b) TMP increase b) Service settable;+50 to +100 mmHg greater than initial TMP Default:+100 mmHg Increment: 5 mmHg

“Plasmafilter is Clotting”Advisory Limit

Advisory alarm occursUser settable; Filter pressure drop is +10 to +60 mmHggreater than initial filter pressure drop Default: +60mmHg Increment: 10 mmHgLimit is reached (TPE)


Specifications 13:9

“HP Cartridge is Clotting”Advisory Limit

Advisory alarm occursUser settable;Filter pressure drop is +10 to +30 mmHg greater thaninitial filter pressure drop Default: +30 mmHg Increment:10 mmHgLimit is reached (HP)

“Filter Clotted” WarningLimit

Warning alarm occursFilter pressure drop is ≥ limit value fixed for the filterin use, or both the “Filter is Clotting” Advisory and the“TMP Excessive” Caution limits are reached. (CRRT)

“Plasmafilter Clotted”Warning Limit

Warning alarm occursFilter pressure drop is ≥ limit value fixed for theplasmafilter in use, or both the “Plasmafilter is Clotting”Advisory and the “TMPa Excessive” Caution limits arereached. (TPE)

“HP Cartridge Clotted”Warning Limit

Warning alarm occursFilter pressure drop is ≥ limit value fixed for the HPcartridge in use.

“TMP Too High” AdvisoryLimit

Advisory alarm occurs User settable;+70 to +350 mmHg Default: +350 mmHg Increment:10 mmHgTMP equals user-set limit. (CRRT)

“TMPa Too High” AdvisoryLimit

Advisory alarm occursUser settable; 0 to +100 mmHg Default: +100 mmHgIncrement: 10 mmHgTMPa equals user-set limit. (TPE)

“TMP Excessive” CautionLimit

Caution alarm occursTMP > limit value fixed for the filter in use (CRRT)

“TMPa Excessive” CautionLimit

Caution alarm occursTMPa greater than a value automatically calculated bythe machine depending on the blood flow rate and theplasmafilter in use. (TPE)

Effluent Line Pressure SensorOperating Range –350 to +400 mmHg (CRRT) and (TPE)Accuracy ±10% of reading or ±8 mmHg, whichever is greater.

Air Bubble DetectorMacro air/foam detection Warning alarm occurs

The transducer receives one voltage decrease of nominalsignal level, which corresponds to detecting a singlebubble/foam of approximately 20 μl.Foam sensitivity was tested using bovine blood. Air wasinjected into the pre-filter blood line at a rate of 1 ml/ mincreating foam in the post-filter blood circuit.


Blood Leak DetectorMinimum blood leak detection Warning alarm occurs within 7 seconds of detection.

Leak ≥0.35 ml/min at 0.25 Hct, for effluent flow ratebelow 5500 ml/h Leak ≥0.50 ml/min at 0.32 Hct, athighest effluent flow rate.


Specifications 13:11

Chapter 14

Guidance and Manufacturer's Declara-tion — Electromagnetic Emissions andImmunity


Guidelines and Manufacturer's DeclarationElectromagnetic Emissions and Immunity

14:1

Guidance and manufacturer's declaration – Electromagnetic Emissions

The Prismaflex system is intended for use in the electromagnetic environment specified below.The customer or the user of the Prismaflex system should ensure that it is used in such anenvironment.

Emission Test Compliance ElectromagneticEnvironment – Guidance

RF emission CISPR 11 / EN55011

Group 1 The Prismaflex system usesRF energy only for its internalfunction. Therefore, itsRF emissions are very lowand are not likely to causeany interference in nearbyelectronic equipment.

RF emission CISPR 11 / EN55011

Class B

Harmonic emissions IEC / EN61000-3-2

Class A

Voltage fluctuations/ flickeremissions IEC / EN 61000-3-3

Complies

The Prismaflex systemis suitable for use in allestablishments, includingdomestic establishments andthose directly connected tothe public low-voltage powersupply network that suppliesbuildings used for domesticpurposes.

14:2 Guidelines and Manufacturer's DeclarationElectromagnetic Emissions and Immunity


Guidance and manufacturer's declaration – Electromagnetic Immunity


Immunity Test IEC 60601 Test Level Compliance Level ElectromagneticEnvironment –Guidance

Electrostaticdischarge (ESD)IEC/EN 61000-4-2

±6 KV contact±8 KV air

±6 KV contact±8 KV air

Floors should bewood, concrete orceramic tile. If floorsare covered withsynthetic material,the relative humidityshould be at least30%.

Electrical fasttransient / burstIEC/EN 61000-4-4

±2 KV for powersupply lines±1 KV forinput/output lines

±2 KV for powersupply lines±1 KV forinput/output lines

Mains power qualityshould be that of atypical commercial orhospital environment.

Surge IEC/EN61000-4-5

±1 KV differentialmode±2 KV common mode

±1 KV differentialmode±2 KV common mode

Mains power qualityshould be that of atypical commercial orhospital environment.

<5% UT(>95% dip in UT) for0.5 cycles

<5% UT(>95% dip in UT) for0.5 cycles

40% UT (60% dip inUT) for 5 cycles

40% UT(60% dip inUT) for 5 cycles

70% UT (30% dip inUT for 25 cycles

70% UT (30% dip inUT) for 25 cycles

Voltage dips, shortinterruptions andvoltage variations onpower supply inputlines IEC/EN 61000-4-11

<5% UT (>95% dip inUT) for 5 sec.

<5% UT (>95% dip inUT) for 5 sec.

Mains power qualityshould be that of atypical commercial orhospital environment.If the user of thePrismaflex systemrequires continuedoperation duringpower mainsinterruptions, it isrecommended thatthe Prismaflex systembe powered from anuninterruptable powersupply or a battery.

Power frequency (50/60 Hz) magnetic fieldIEC / EN 61000-4-8

3 A/m 3 A/m Power frequencymagnetic fieldsshould be at levelscharacteristic of atypical commercial orhospital environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.



14:3

Guidance and manufacturer's declaration – Electromagnetic Immunity


ImmunityTest

IEC 60601Test Level

Com-plianceLevel

Electromagnetic Environment – Guidance

Portable and mobile RF communicationsequipment should be used no closer to any partof the Prismaflex system including cables, thanthe recommended separation distance calculatedfrom the equation applicable to frequency of thetransmitter.Recommended separation distance

Conducted RFIEC/EN61000-4-6

3 Vrms150 KHz to 80MHz

3 Vrms d = 1.2 √P 80 MHz to 800 MHz

Radiated RFIEC/EN61000-4-3

3 V/m80 MHz to 2.5GHz

3 V/m d = 1.2 √P 80 MHz to 800 MHzd = 2.3 √P 800 MHz to 2.5 GHzwhere “P” is the maximum output power ratingof the transmitter in watts (W) according tothe transmitter manufacturer and “d” is therecommended separation distance in meters (m).Field strengths from fixed RF transmitters, asdetermined by an electromagnetic site survey1,should be less than the compliance level in eachfrequency range2.Interference may occur in the vicinity ofequipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation isaffected by absorption and reflection from structures, objects and people.

1 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcastcannot be predicted theoretically with accuracy. To asses the electromagnetic environment dueto fixed transmitters, an electromagnetic site survey should be considered. If the measuredfield strength in the location in which the Prismaflex system is used exceeds the applicable RFcompliance level above, the Prismaflex system should be observed to verify normal operation. Ifabnormal performance is observed, additional measures may be necessary, such as reorientingor relocating the Prismaflex system.2 Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.



Recommended separation distances between portable and mobile RFcommunications equipment and the Prismaflex system

The Prismaflex system is intended for use in the electromagnetic environment in which radiatedRF disturbances are controlled. The customer or the user of the Prismaflex system can helpprevent electromagnetic interference by maintaining a minimum distance between portable andmobile RF communications equipment (transmitters) and the Prismaflex system as recommendedbelow, according to the maximum output power of the communications equipment.

Separation distances according to frequency of transmitter (m)Ratedmaximumoutput powerof transmitter(W)

150 KHz to80 MHzd = 1.2 √P

80 KHzto 800MHzd = 1.2√P

800 KHz to 2.5 GHzd = 2.3 √P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at maximum output power not listed above, the recommended separationdistance d in meter (m) can be estimated using the equation applicable to the frequency ofthe transmitter, where P is the maximum output power rating of the transmitter in watts (W)according to the transmitter manufacturer.NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency rangeapplies.NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation isaffected by absorption and reflection from structures, objects and people.



14:5

Chapter 15

Prismaflex Disposable SetsCRRT Disposable Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15:2TPE Disposable Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15:3HP Kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15:4


Prismaflex Disposable Sets 15:1

Minimum blood flow range allowed by the monitor is 10 ml/min during Run mode for allsets and therapies. Reported low blood flow range limit refers to the minimum blood flowrate recommended for each set.

Maximum allowed flow rate values reported in this chapter are absolute maximumpossible settings for each individual flow. Available maximum flow rate will be loweredin some therapy modes (i.e. pre- or post-replacement infusion, SCUF) and with respect tothe current value of the other flow or anticoagulation settings.

CRRT Disposable Sets

High Flow sets

Set Numberof primingcycles

Totalprimingvolume (ml)

Bloodflow range(ml/min)

Bloodvolume (ml)

UnintendedFluid Lossor Gain limit(ml/3 h)

M100 1 1000 80 to 400 152 100 to 400

ST100 1 1000 80 to 400 152 100 to 400

M150 2 2000 100 to 450 189 100 to 400

ST150 2 2000 100 to 450 189 100 to 400

HF1000 1 1000 80 to 400 165 100 to 400

HF1400 2 2000 100 to 450 186 100 to 400

oXiris 2 2000 100 to 450 189 100 to 400

septeX 1 1000 80 to 450 164 100 to 400

MARS* 1 2000 130 to 450 279 100 to 400

*The CRRT MARS set on the Prismaflex control unit requires one single priming cycle.Full priming of the X-MARS kit requires further priming cycles from the MARS monitor.Refer to MARS® Liver Support Therapy Operating Instructions and follow instructionson the Prismaflex screen.

Maximum allowed flow rates (ml/h)

Set PBP Dialysate Replacement Patient FluidRemoval

Effluent

M100 4000 8000 8000 2000 10000

ST100 4000 8000 8000 2000 10000

M150 4000 8000 8000 2000 10000

ST150 4000 8000 8000 2000 10000

HF1000 4000 8000 8000 2000 10000

HF1400 4000 8000 8000 2000 10000

oXiris 4000 8000 8000 2000 10000

septeX 500 8000 500 1000 9000

MARS 4000 8000 4000 1000 9000

15:2 Prismaflex Disposable Sets G5036003 Revision 05.2011Program version 6.xx

Low Flow sets

Set Numberof primingcycles

Totalprimingvolume (ml)

Bloodflow range(ml/min)

Bloodvolume (ml)

UnintendedFluid Lossor Gain limit(ml/3 h)

M60 1 1000 50 to 180 93 60 to 200

ST60 1 1000 50 to 180 93 60 to 200

HF20 1 500 20 to 100 58 60 to 150


Set PBP Dialysate Replacement Patient FluidRemoval

Effluent

M60 2000 4000 4000 2000 10000

ST60 2000 4000 4000 2000 10000

HF20 1000 2500 2500 500 3000

CRRT Priming parameters

CRRT set No. of priming cycles Priming volumes (ml)

M60/ST60 1 1000

M100/ST100 1 1000

M150/ST150 2 2000

HF20 1 500

HF1000 1 1000

HF1400 2 2000

oXiris 2 2000

septeX 1 1000

TPE Disposable Sets

High Flow sets

Set Number ofpriming cycles

Total primingvolume (ml)

Blood flowrange (ml/min)

Blood volume(ml)

TPE2000 3 3000 100 to 250/4001 125


Set PBP Replacement Patient PlasmaLoss

Effluent

TPE2000 1000 5000 1000 6000

1 Depending on machine default set up


Prismaflex Disposable Sets 15:3

Low Flow sets

Set Number ofpriming cycles

Total primingvolume (ml)


Blood volume(ml)

TPE1000 2 2000 50 to 180 71


Set PBP Replacement Patient PlasmaLoss

Effluent

TPE1000 1000 5000 1000 6000

HP KitsSet Number of

priming cyclesTotal primingvolume (ml)


Blood volume(ml)

Adsorba 150 3 2500 50 to 250 247

Adsorba 300 3 2500 100 to 350 367


Set PBP

Adsorba 150 1000

Adsorba 300 1000

15:4 Prismaflex Disposable Sets G5036003 Revision 05.2011Program version 6.xx

Chapter 16

Index


Index 16:1

AAccessblood . . . . . . . . . . . . . . . . . . . . . . . . . 3:2pressure pod . . . . . . . . . . . . . . . 2:7, 2:18transmembrane pressure . . . . . . . . . . . 6:9

Airbubble detector . . . . . . . . . . . . . 2:9, 3:13removal procedure . . . . . . . . . . . . . .11:84

Alarmadvisory . . . . . . . . . . . . . . . . . . . . . 10:6caution . . . . . . . . . . . . . . . . . . . . . . 10:5malfunction . . . . . . . . . . . . . . . . . . . 10:4priorities . . . . . . . . . . . . . . . . . . . . . 10:7warning . . . . . . . . . . . . . . . . . . . . . . 10:2

Anticoagulation . . . . . . . . . . . . . . . . 1:5, 8:2citrateexternal calcium . . . . . . . . . . . . . . . 8:9integrated calcium . . . . . . . . . . . . . 8:9

safety system . . . . . . . . . . . . . . . . . . 8:13syringe . . . . . . . . . . . . . . . . . . . . . . . 8:4bolus . . . . . . . . . . . . . . . . . . . . . . . 8:4continuous . . . . . . . . . . . . . . . . . . . 8:4

Automatic reposition system . . . . . . 3:4, 12:3

BBar code reader . . . . . . . . . . . . . . . . . . . 2:9Battery back-up . . . . . . . . . . . . . . . . . .11:76Blood leak detector . . . . . . . . . . . . . . . . 2:9normalization . . . . . . . . . . . . . . . . . .11:85

Blood pump . . . . . . . . . . . . . . . . . . . . . 2:5Blood warmer . . . . . . . . . . . . . . . . . . . . 9:1

CCalciumcompensation . . . . . . . . . . . . . . . . . . 8:10integrated . . . . . . . . . . . . . . . . . . . . . 8:9

Changebags . . . . . . . . . . . . . . . . . . . . . . . . 4:29set . . . . . . . . . . . . . . . . . . . . . . 4:17, 5:19syringe . . . . . . . . . . . . . . . . . . . . . . 4:31

Citrateanticoagulation method . . . . . . . . . 8:3, 8:6

Cleaning . . . . . . . . . . . . . . . . . . . . . . . 12:2CRRT . . . . . . . . . . . . . . . . . . . . . . . 1:2, 5:3Custom mode . . . . . . . . . . . . . . . . . . . 4:21CVVH . . . . . . . . . . . . . . . . . . 1:4, 5:7, 5:15CVVHD . . . . . . . . . . . . . . . . . . . . . 1:4, 5:8CVVHDF . . . . . . . . . . . . . . . . 1:4, 5:9, 5:15

DDeaeration chamber . . . . . . . . 2:18, 3:4, 3:12Default values . . . . . . . . . . . . . . . . . . . . 4:2Dialysatepump . . . . . . . . . . . . . . . . . . . . . . . . . 2:5scale . . . . . . . . . . . . . . . . . . . . . . . . .2:11

Discharger ring guide . . . . . . . . . . . . . . . 2:9Display . . . . . . . . . . . . . . . . . . . . . 2:13, 4:2Disposable sets . . . . . . . . . . 2:16, 5:10, 15:1high flow . . . . . . . . . . . . . . . . . . . . . 2:16

low flow . . . . . . . . . . . . . . . . . . . . . 2:16Doseeffluent . . . . . . . . . . . . . . . . . . . . . . 5:18ultrafiltration . . . . . . . . . . . . . . . . . . 5:18

EEffluentdose . . . . . . . . . . . . . . . . . . . . . . . . 5:18pressure pod . . . . . . . . . . . . . . . 2:7, 2:18pump . . . . . . . . . . . . . . . . . . . . . . . . . 2:5scale . . . . . . . . . . . . . . . . . . . . . . . . .2:11

Empty bagfixed . . . . . . . . . . . . . . . . . . . . . . . . . 3:9variable . . . . . . . . . . . . . . . . . . . 3:9, 4:29

End mode . . . . . . . . . . . . . . . . . . . . . . 4:16Events . . . . . . . . . . . . . . . . . . . . . . . . . . 4:6

FFilter . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:2pressure pod . . . . . . . . . . . . . . . 2:7, 2:18

Filtration fraction . . . . . . . . . . . . . . . . . 5:16Fluidbags . . . . . . . . . . . . . . . . . . . . . . . . . 3:8barrier . . . . . . . . . . . . . . . . . . . . . . . 4:32barrier change . . . . . . . . . . . . . . . . .11:84barrier recovery . . . . . . . . . . . . . . . .11:83management . . . . . . . . . . . . . . . . . . . 3:8

HHematocrit . . . . . . . . . . . . . . . . . 6:11, 13:7Hemodiafiltration . . . . . . . . . . . . . . . . . . 5:4Hemodialysis . . . . . . . . . . . . . . . . . . . . 5:4Hemofiltration . . . . . . . . . . . . . . . . . . . . 5:3History data . . . . . . . . . . . . . . . 4:4, 6:13, 7:6download . . . . . . . . . . . . . . . . . . . . . 4:5

HP . . . . . . . . . . . . . . . . . . . . . . . . . 1:2, 7:2Cartridge . . . . . . . . . . . . . . . . . . . . . . 7:5

II/O Data . . . . . . . . . . . . . . . . . . . . 4:5, 5:18

MManualair removal . . . . . . . . . . . . . . . . . . .11:84pressure pod adjustment . . . . . . . . . .11:78termination of treatment . . . . . . . . . .11:76

MARS . . . . . . . . . . . . . . . . . . . . . . . . 5:21

PPatient blood sensor . . . . . . . . . . . . 2:9, 3:14Patient fluidloss or gain limit . . . . . . . . . . . . . . . 5:12removal . . . . . . . . . . . . . . . . . . . . . . 5:16

PBPpump . . . . . . . . . . . . . . . . . . . . . . . . . 2:5scale . . . . . . . . . . . . . . . . . . . . . . . . .2:11

Pinch valve . . . . . . . . . . . . . . . . . . . . . . 2:9Plasma balance . . . . . . . . . . . . . . . . . . 6:12Power failure . . . . . . . . . . . . . . . . . . . .11:76

Index G5036003 Revision 05.2011Program version 6.xx

Pressuremanagement . . . . . . . . . . . . . . . . . . . 3:3operating point . . . . . . . . . . . . . . . . . . 3:5pod adjustment . . . . . . . . . . . . . . . .11:79

Priming . . . . . . . . . . . . . . . . . . . . . . . . 3:13

QQuery screen . . . . . . . . . . . . . . . . . . . . . 4:9

RRecirculation . . . . . . . . . . . . . . . . . . . . 4:18blood . . . . . . . . . . . . . . . . . . . . . . . . 4:20saline . . . . . . . . . . . . . . . . . . . . . . . 4:18

Remote alarm . . . . . . . . . . . . . . . . . . . 2:15Replacementbag handling . . . . . . . . . . . . . . . . . . 6:13pump . . . . . . . . . . . . . . . . . . . . . . . . . 2:5scale . . . . . . . . . . . . . . . . . . . . . . . . .2:11

Return line clamp . . . . . . . . . . . . . . . . . 2:9Return pressure port . . . . . . . . . . . . . . . . 2:7Rotor . . . . . . . . . . . . . . . . . . . . . . . . . . 2:5Run mode . . . . . . . . . . . . . . . . . . . . . . 4:15

SSample sites . . . . . . . . . . . . . . . . . . . . 2:18SCUF . . . . . . . . . . . . . . . . . . . . . . . 1:4, 5:6Self-testinitialization . . . . . . . . . . . . . . . . . . 3:14

periodic . . . . . . . . . . . . . . . . . . . . . . 3:15prime . . . . . . . . . . . . . . . . . . . . . . . 3:15

septeX . . . . . . . . . . . . . . . . . . . . . . . . 5:20Settings . . . . . . . . . . . . . . . . . . . . . . . . 4:22Setup mode . . . . . . . . . . . . . . . . . . . . . 4:10Softkey . . . . . . . . . . . . . . . . . . . . . . . . . 4:2Standby mode . . . . . . . . . . . . . . . . . . . 4:14Statuslight . . . . . . . . . . . . . . . . . . . . . . . . 2:13screen . . . . . . . . . . . . . . . . . . . . . . . . 4:7

Syringeinstallation . . . . . . . . . . . . . . . . . . . . 4:31pump . . . . . . . . . . . . . . . . . . . . . . . . . 2:5

System tools . . . . . . . . . . . . . . . . . . . . 4:15

TTechnical data card . . . . . . . . . . . . . . . . 4:4holder . . . . . . . . . . . . . . . . . . . . . . . 2:15

TMP . . . . . . . . . . . . . . . . . . . . . . . . . . 5:13TPE . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:2

UUltrafiltration . . . . . . . . . . . . . . . . . . . . 5:3dose . . . . . . . . . . . . . . . . . . . . . . . . 5:18

WWeight alarm . . . . . . . . . . . . . . . . . . . . 3:10


Index

prismaflex user manual

Documents