user´s manual servo-i ventilator system...

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User´s Manual

SERVO-i VENTILATOR SYSTEM V5.0

4 SERVO-i VENTILATOR SYSTEM V5.0, User´s ManualInfologic 1.34

| TABLE OF CONTENTS |

1.1 DEVICE DESCRIPTIONS

This section provides general informationabout the SERVO-i Ventilator System alongwith guidelines for appropriate use.

1.1.1 DEVICE DIAGRAM

SVX-128a

2

1

3

1.1.2 DEVICE COMPONENTS

The SERVO-i Ventilator System consists ofthe following components:1. User Interface—for setting ventilation

modes, displaying patient data, andindicating alarms

2. Patient Unit—for mixing gases

3. Patient Breathing System—for deliveringand exchanging gases

1.1.3 INTENDED USE

The SERVO-i Ventilator System is intendedfor treating and monitoring patients rangingfrom neonates to adults with respiratory failureor respiratory insufficiency.

1.1.4 INTENDED USER

The SERVO-i Ventilator System should beused only by those who:

are a professional health care provider, and

have received training in the use of thissystem, and

have experience with ventilation treatment.

6 SERVO-i VENTILATOR SYSTEM V5.0, User´s Manual

| 1 | Introduction |

1.1.5 INTENDED USE ENVIRONMENT

The SERVO-i Ventilator System should beused only:

in hospitals

in facilities whose primary purpose is toprovide health care

during transport of a patient within hospitalsor health care facilities

for interhospital transport if the conditionsstated in the SERVO-i InterhospitalTransport declaration (order no. 66 64 721)are fulfilled and an agreement with MAQUETis signed

during MR examinations of patients if theconditions in the SERVO-i MR Environmentdeclaration (order no. 66 71 670) are metand an agreement with MAQUET is signed.

1.1.6 CLEANING AND MAINTENANCE

Please refer to the SERVO-i/s Cleaning andMaintenance User's Manual.

1.1.7 SERVICING GUIDELINES

CAUTIONS:Regular Service: The SERVO-i VentilatorSystem must be serviced at regularintervals by MAQUET authorizedpersonnel who have received specializedtraining.

Complete Service Records: All serviceperformed on the SERVO-i VentilatorSystem must be recorded in a servicelog in accordance with hospitalprocedures and local and nationalregulations.

Service Contract: We stronglyrecommend that all service on theSERVO-i Ventilator System should beperformed as part of a service contractwith MAQUET.

1.1.8 DISCLAIMERS

Improper Use EnvironmentMAQUET has no responsibility for the safeoperation of SERVO-i Ventilator System ifthe Intended Use Environment requirementsspecified in this document are not followed.

Nonprofessional ServicingMAQUET has no responsibility for the safeoperation of the SERVO-i Ventilator Systemif installation, service or repairs areperformed by persons other than MAQUETauthorized personnel.



1.2 WARNING, CAUTION,IMPORTANT AND NOTE

Follow these safety guidelines. Additionalwarnings appear in context throughout thisdocument.

Information is highlighted with Warning,Caution, Important or Note, where:

WARNING! Indicates critical informationabout a potential serious outcome to thepatient or the user.

CAUTION: Indicates instructions that mustbe followed in order to ensure the properoperation of the equipment.

Important: Indicates information intendedto help you operate the equipment or itsconnected devices easily and conveniently.

Note: Indicates information requiring specialattention.

1.2.1 GENERAL

This manual summarizes the functions andsafety features of the SERVO-i VentilatorSystem. It is not all-inclusive and should notbe construed as a substitute for training.

WARNINGS!Always perform a Pre-use check beforeconnecting the ventilator to a patient.

If any of the following occurs, discontinueuse of the ventilator and contact aservice technician:- Unfamiliar pop-up windows on the

screen

- Unresolvable alarms

- Unfamiliar sounds

- Any unfamiliar or unexplained event

Keep the ventilator upright during use.

When the ventilator is connected to apatient:- Do not lift or disconnect the expiratory

cassette.

- Continuously monitor the settings andmeasurements displayed on thescreen.



WARNINGS!The SERVO-i Ventilator System must beoperated only by authorized personnelwho are well trained in its use. It must beoperated according to the instructions inthis User´s Manual.

Do not cover the ventilator in any way,since the functioning of the equipmentmay be adversely affected.

When the ventilator is used for MCareRemote Service, use only networkequipment that is safe and in compliancewith the relevant electrical and EMCstandards such as IEC-60950.

Note: The network cable is excludedfrom this requirement.

Always disconnect the network cablebefore starting ventilation when theventilator is used for MCare RemoteService.

Positive pressure ventilation can beassociated with the following adverseevents: barotrauma, hypoventilation,hyperventilation or circulatoryimpairment.

The SERVO-i Ventilator System shouldnot be used in MR environments unlessthe requirements described in theSERVO-i MR Environment Declaration(order no. 66 71 670) are met and anagreement with MAQUET is signed.

CAUTIONS:In USA, Federal law restricts this deviceto sale by or on the order of a physician.

The expiratory channel and expired gasfrom the exhaust port may becontaminated.

Refer to the Installation instructions toassemble the system or options to obtaina proper mechanical assembly.

When lifting or moving the ventilatorsystem or parts of the system, followestablished ergonomic guidelines, askfor assistance, and take appropriatesafety precautions.

Before use, make sure the systemversion displayed under Statuscorresponds to the system versiondescribed in the User´s Manual.

Extra care should be taken whenhandling tubes, connectors and otherparts of the patient circuit. The use of asupport arm to relieve the patient fromthe weight of the tubing system isrecommended.

When using the MCare Remote Servicefunction, install the network cable so thatthere is no risk of anyone tripping overit.



CAUTIONS:When the ventilator is connected to apatient:- Do not leave the patient unattended.

- Make sure a resuscitator is readilyavailable.

Do not modify or remove any originalparts.

MAQUET has no responsibility for thesafe operation of SERVO-i VentilatorSystem if the Intended Use requirementsspecified in this document are notfollowed.

Contact a MAQUET representativeregarding decommissioning of theequipment.

Only accessories, supplies, and auxiliaryequipment recommended by MAQUETshould be used with the ventilatorsystem. Use of any other accessories,spare parts or auxiliary equipment maycause degraded system performanceand safety.

Important:Always use heat and moisture exchanger(HME) or equipment to preventdehydration of lung tissue.

While in use the wheels of the carriershall be locked and the carrier shall bein a horizontal position.

Securely attach all cables, etc, tominimize the risk of unintentionaldisconnection.

1.2.2 POWER SUPPLY

WARNINGS!The power cord must be connected onlyto a properly grounded AC electricaloutlet.

To guarantee reliable battery backup,two fully charged battery modules shouldbe installed at all times.

Make sure there are at least two fullycharged batteries installed at all times.

CAUTIONS:Do NOT use antistatic or electricallyconductive tubing with this system.

Avoid contact with external electricalconnector pins.

Unused module compartments shouldalways contain an empty module toprotect the electrical connector pins fromspillage and dust.



1.2.3 FIRE HAZARD

WARNINGS!Keep the system and its gas hoses clearof all ignition sources.

Do not use the system with worn orfrayed hoses or hoses that have beencontaminated by combustible materialssuch as grease or oil.

Oxygen-enriched gas is extremelyflammable: if you detect a burning odor,disconnect the oxygen supply, mainspower and remove the batteries.

Make sure that both the mains poweroutlet and the power supply connectorare accessible.

1.2.4 GASES

CAUTION: The system is not intended tobe used with any anesthetic agent.

Important:Supplied gases shall meet therequirements for medical grade gasesaccording to applicable standards.Maximum levels:

AirH2O < 7 g/m3

Oil < 0.5 mg/m3

Chlorine: must not be detectable 1

OxygenH2O < 20 mg/m3

Oil < 0.3 mg/m3

1.2.5 AUXILIARY EQUIPMENT

CAUTIONS:Accessories, supplies, and auxiliaryequipment used with the ventilatorshould:- be recommended by MAQUET

- meet IEC 60601-1-1 standards

- meet IEC standards as a whole system

If a scavenging system (i.e. gasevacuation) is connected to the ventilator,it must conform to ISO8835-3 guidelinesfor subatmospheric pressure andinduced flow.

Measurements of parameter values thathave been processed by auxiliaryequipment:- may be inaccurate if equipment not

authorized by MAQUET is used- should be discounted if they conflict

with information on the ventilatorscreen

- must not substitute for therapeutic ordiagnostic decisions

1. If the compressed air is generated by a liquid ring compressor there is a potential risk of chlorine in the supplied

air.



1.3 VERSION ANDCONFIGURATIONS

This manual applies to version 5.0 of theSERVO-i Ventilator System, which can bedelivered in three configurations: SERVO-iInfant; SERVO-i Adult and SERVO-i Universal(Basic or Extended edition). Details about eachconfiguration follow on page 13.

1.3.1 CONFIGURATIONS

The Main Rotary Dial and Direct Access Knobsbecome inoperative for 2 seconds when theuser reaches a defined safety limit for theparameter being adjusted.



1.3.2 WEIGHT RANGES SERVED BY EACH CONFIGURATION OF THE SERVO-iVENTILATOR SYSTEM

Weight rangeConfiguration

Non invasive ventilationInvasiveventilation

NIV NasalCPAP

NIV NAVA InfantNIV PC + PSInfant

Adult range

0.5 kg – 10 kg0.5 kg – 30 kg3 kg – 30 kgNot Applicable0.5 kg – 30 kgSERVO-i Infant

Not ApplicableNot ApplicableNot Applicable10 kg – 250 kg10 kg – 250 kgSERVO-i Adult

0.5 kg – 10 kg0.5 kg – 30 kg3 kg – 30 kg10 kg – 250 kg0.5 kg – 250 kgSERVO-iUniversal

NIV = Non-Invasive Ventilation

1.3.3 SERVO-i VENTILATOR SYSTEM CONFIGURATIONS - LISTS THE AVAILABLEFUNCTIONS AND INDICATES IF INCLUDED OR OPTIONAL WITH EACH CONFIGURATION

StandardConfiguration

Infant

OptionsAdult

Not applicableUniversal BasicEdition

UBE

Universal ExtendedEdition

UEE



UEEUBE

Heliox

Nasal CPAP

Non InvasiveVentilation(NIV)

Y SensorMeasuring

CO2 Analyzer

Nebulizer

Bi-Vent

Open LungTool® (OLT)

Automode®

UEEUBE

SIMV (PRVC)+ PS

PRVC

VS (VolumeSupport)

SIMV (VC) +PS

VC (VolumeControl)

SIMV (PC) +PS

PC (PressureControl)

PS/CPAP

NAVA

NIV NAVA



2.1 VENTILATOR

The User Interface is used to control ventilatorsettings. Settings may be adjusted usingtouchpads on the screen or a rotary dial.

Breathing parameters are continuouslymeasured and controlled. A differencebetween the actual measured value of aparameter and the preset or calculated valueresults in the adjustment of gas delivery toachieve the target value.

The system has two gas modules, one for airand one for O2. Gases may be supplied by a

medical pipeline system, a compressor, or bygas tanks.

CAUTION: Lock the wheels if the ventilatoris not to be used for transportation.

Ensure that the ventilator is positioned into itslocked position on the cart or holder used, toprevent unintentional movements.


| 2 | System Overview |

6

7

8

9

1010

1. Air and O2 supply

2. Power cable

3. User Interface

4. Patient Unit

5. Expiratory inlet

6. Servo Duo Guard, viral/bacterial filter

7. Inspiratory outlet

8. Patient system

9. Module compartment

10. Emergency air intake

2.2 USER INTERFACE -CONNECTIONS, LABELS ANDSYMBOLS

The User Interface includes:a screen with active touchpads

fixed keys

rotary dials



2.2.1 USER INTERFACE DIAGRAM



2.2.2 USER INTERFACE COMPONENTS

Refer to the User Interface Diagram forlocations of the following numberedcomponents:1. Patient category

2. Active mode of ventilation

3. Automode On/Off (option)

4. Admit patient/Entered patient data andadmission date

5. Nebulizer On/Off (option)

6. System status parameters

7. Fixed keys

8. Main Rotary Dial—used to select a menutouchpad or parameter box, to adjustvalues, and to confirm settings

9. Special Function Keys—used to startspecial ventilatory functions

10. Direct Access Knobs—used for immediateadjustment of breathing parameters

11. AC Power indicator (green)

12. Standby indicator (yellow)

13. Start/Stop (Standby) ventilation key

14. On/Off switch (rear side)

15. Slot for Ventilation Record Card (frontview)

16. Luminescence detector—for automaticallyadjusting screen brightness

17. Informative text messages, which includea purple symbol when triggered by thepatient

18. Alarm messages

19. Waveform area—for monitoring two tofour individually scaled parameters,including a volume/pressure loop and aflow/volume loop

20. Measured values and alarm limits display(customizable)

21. Additional settings

22. Additional measured values

23. Loudspeaker

24. Cable reel for the control cable

25. Slot for Ventilation Record Card (side/rearview)

26. Screen rotation locking lever

27. Locking screw for alternative cartmounting

28. Panel holder for positioning on the MobileCart

29. Control cable (2.9 m long)

30. Service connector

31. On/Off switch (Set to On; when off, batterycontinues to charge)

32. Locking arm for tilting the screen

33. Model number

34. Serial number

35. Manufacturing information



2.2.3 USER INTERFACE SYMBOLS

DescriptionSymbolAudio Pause - silence or confirm analarm. Note: This symbol may bedifferent depending on panel version.

Audio off

Audio pause - all alarms, active andinactive, are pre-silenced.

Alarm on

Alarm off

Fixed key reserved for future use

Attention—consult documentationNote: This symbol may be differentdepending on panel version

Standby/Start ventilation—yellowindicates Standby

Power indicator—green indicates ACpower connected

Battery—indicates ventilator is usingbattery power, with estimatedminutes remaining

ON/OFF switch

Trigger indication—appears in themessage/alarm field when the patienttriggers a breath

Indicates that the system iscompensated for Heliox.

Infant patient category

Adult patient category

Note: The patient unit symbols aredescribed later in this chapter.



2.3 NAVIGATING THE USERINTERFACE

The following subsections provide generalprocedures for working with the user interface.More detailed procedures for specific tasksare found in later chapters and in theAppendix.

2.3.1 TOUCH SCREEN

To adjust ventilator settings:1. Open the desired window by pressing one

of the touchpads on the screen or one ofthe fixed keys.

2. Activate the desired touchpad by pressingit.The touchpad is now highlighted in whitewith a blue frame and it is possible to seta new value.

1. Turn the Main Rotary Dial to the desiredvalue.

2. Confirm the settings by pressing theparameter touchpad or by pressing theMain Rotary Dial.

3. The touchpad turns blue again indicatingthat the new setting has been entered.

4. Press Accept to activate the new settings,or Cancel to start over.

Important: Do not use sharp tools on thescreen.



2.3.2 MAIN ROTARY DIAL

SVX-6021_XX

To use an alternative method for adjustingventilator settings once the desired menu isactivated:1. Turn the Main Rotary Dial until the desired

menu touchpad is marked with a blueframe.

2. Press the Main Rotary Dial to confirm.The menu touchpad is highlighted in whitewith a blue frame, indicating you can entera new value.

3. Turn the Main Rotary Dial to the desiredvalue or line.

4. Confirm the setting by pressing the MainRotary Dial.The parameter touchpad turns blue againindicating a new setting has been entered.

5. Touch Accept to activate your settings,or Cancel to start over.

Note: When the defined safety limits for agiven parameter have been reached, theMain Rotary Dial becomes inoperative for2 seconds to indicate that a limit has beenreached.

2.3.3 FIXED KEYS

There are two groups of fixed keys on the userinterface screen:

The keys in group 1 activate user interfacefunctions such as Save and access variousscreens such as Menu.

The keys in group 2 start special ventilatoryfunctions

Important: The special ventilatoryfunctions require continuous supervision.



2.3.4 DIRECT ACCESS KNOBS

The four dials along the bottom of the UserInterface screen are the Direct Access Knobs.They permit direct control of four breathingparameters, which are automatically selecteddepending on ventilation mode.

Using Direct Access Knobs

To adjust a breathing parameter directly:1. Turn the Direct Access Knob

corresponding to the parameter you wishto change until the desired value isdisplayed on the screen.

WARNING! When you adjust a breathingparameter using a Direct Access Knob, theparameter will change immediately startingwith the next breath; no additionalconfirmation is required.



Direct Access Knobs - Safety

The four Direct Access Knob parameters aredisplayed at the bottom of the screen withcolor-coded bars that indicate whether theparameter values are withingenerally-recognized safety limits.

The figure above shows the followingcomponents.1. A Direct Access Knob

2. A yellow bar indicating the correspondingparameter value is outside safety limits;advisory information is displayed.

3. A red bar indicating the correspondingparameter value is significantly outsidesafety limits; an advisory warning isdisplayed accompanied by an audiblesignal.

Note: When the defined safety limits for agiven parameter have been reached, theDirect Access Knob becomes inoperativefor 2 seconds to indicate that a safety limithas been reached.



2.3.5 MENU KEY

To access the user interface windows:1. Press the fixed key Menu.

Touchpads leading to the user interfacewindows appear.

2. If the touchpad shows a sheet icon, pressthe touchpad to open a user interfacewindow, OR

3. If the touchpad shows an arrow icon,press the touchpad to display thesubmenu.

Press any of the following touchpads.4. Alarm5. Review6. Options

7. Compensate

8. Copy (to Ventilation Record Card)

9. Biomed

10. Panel lock

11. Change patient category (option)

For more information see Appendix • Userinterface on page 251.



2.3.6 STATUS TOUCHPAD

The Status touchpad indicates the powersupply currently being used by the ventilator(AC power, battery power, or external 12V DCpower). If the ventilator is running on batterypower, the estimated remaining battery timein minutes is shown.

CAUTION: When using an external 12V DCsupply, battery modules must be installedto ensure proper operation.

To access the status window:1. Press the Status touchpad.

Touchpads leading to status windows appear.

Press any of the following touchpads.2. General system information

3. Status of O2 cell / O2 Sensor

4. Status of expiratory cassette

5. Status of batteries

6. Status of CO2 module (if fitted)

7. Status of Y Sensor measuring (if fitted)

8. Installed options

9. Status of Pre-use check



2.4 PATIENT UNIT - CONNECTIONS, LABELS AND SYMBOLS

The patient unit consists of the following components:gas supplies and their connectors

power supplies and their connectors

connectors for accessories

2.4.1 PATIENT UNIT COMPONENTS

Refer to the Patient Unit Diagram for locationsof the following numbered components:

A

1. Handle

2. Gas inlet for air

3. Gas inlet for O2

4. Air / Luft

5. O2

6. Model number

7. Serial number

8. Manufacturing information

9. Equipotentiality terminal, label

10. Fuse label T 2.5AL

11. AC power supply voltage

12. AC power supply connector with fuse

13. Cooling fan with filter

14. Alarm output connection option

15. External +12V DC inlet

16. Fuse for external DC power supply

17. Optional connector

18. User interface connector

19. RS232 connector

20. Expiratory outlet

B

21. Cover, inspiratory channel

22. Expiratory inlet

23. Battery lock

24. Module compartment

25. Nebulizer connector (only for Servo UltraNebulizer)

26. Inspiratory outlet



2.4.2 PATIENT UNIT DIAGRAM

0413 LR56549 E 01

12V+-



2.4.3 PATIENT UNIT SYMBOLS

ExplanationSymbolCE label—indicates compliance withthe requirements of the MedicalDevice Directive 93/42/EEC

CSA label—Indicates compliancewith Canadian and US standards

C US

PCT label - indicates compliance withRussian standards

E 01Class I equipment, Type B—indicatesclassification according to IEC60601-1/EN 60601-1

Type BF applied part — indicatesclassification according to IEC60601-1/EN 60601-1Note: This classification is applicablefor the CO2 Analyzer (option).

Equipotentiality terminalNote: The equipotentiality terminalis designed for the connection of apotential equalization conductoraccording to DIN 42 801 andEN/IEC 60601-1. The function of theequipotentiality terminal is to equalizepotentials between the system andother medical electrical devices thatcan be touched simultaneously. Theequipotentiality terminal must not beused for a protective earthconnection.

Nebulizer Connector

RS 232 / Serial port—connector fordata communication.Note: This symbol may be differentdepending on panel version

User Interface connector / PanelNote: This symbol may be differentdepending on panel version

ExplanationSymbolOptional connector / ExpansionNote: This symbol may be differentdepending on panel version

10A Fuse for external DC powersupply.

12V DC / Ext. bat 12V—External 12VDC inputNote: This symbol may be differentdepending on panel version

Expiratory label—gas flow frompatient.

Inspiratory label—gas flow to patient.

Gas exhaust port label—exhaust gasflow from ventilatorNote: This port should not beconnected to a spirometer becausethe volume through the exhaust portis not equal to the expired volumefrom the patient.

Alarm output connectionoption—external alarm outputcommunication



ExplanationSymbolSingle use

2Special waste. This productcontains electronic and electricalcomponents. Discard disposable,replaced and left-over parts inaccordance with appropriateindustrial and environmentalstandards.

Recycling. Worn-out batteries mustbe recycled or disposed of properlyin accordance with appropriateindustrial and environmentalstandards.

Hazardous waste (infectious) Thedevice contains parts which must notbe disposed of with ordinary waste.

Caution

Consult Instructions for use

2.5 INTRA-HOSPITAL TRANSPORTAND STORAGE

2.5.1 BEFORE TRANSPORT

Before transporting the ventilator with orwithout a patient connected, follow facilityguidelines and:

Be sure the patient unit and the userinterface panel are securely attached andlocked.

Be sure all accessories such as modules,gas cylinders, and humidifier are securelyattached and locked.

Be sure the gas cylinders are connectedand have sufficient gas.

Be sure the batteries are fully charged.

Important: At least two batteries shouldbe connected during transport.

Inspect the resuscitator.

Inspect the Mobile Cart for damage.

Be sure the straps are firmly wrappedacross the center of the gas cylinders sothat the cylinders do not move duringtransport.



2.5.2 DURING TRANSPORT

While transporting the ventilator with orwithout a patient connected, follow facilityguidelines and:

Use the handles on the Mobile Cart.

Transport the bed and the ventilator slowly,and watch the patient connection carefullyto see that no pulling or other movementoccurs.

When moving the Support Arm or changingposition, watch the patient connectioncarefully to see that no pulling or othermovement occurs.

Be careful not to tip the Mobile Cart whencrossing an obstacle like a doorstep.

2.5.3 INTERHOSPITAL TRANSPORT

The SERVO-i ventilator system may be usedfor interhospital transport if the conditionsstated in the SERVO-i Interhospital Transportdeclaration (Order no. 66 64 721) are fulfilledand an agreement with MAQUET is signed.

2.5.4 STORAGE

When the SERVO-i Ventilator System is instorage, keep the ventilator connected tomains power to maintain full charge in thebatteries.

Do not dispose of battery modules and O2

cells with ordinary waste.

Be sure the system is not exposed totemperatures below -25oC (-13oF) or above

+60oC (140oF).

Be sure the system is not exposed to arelative humidity above 95%.



3.1 INTRODUCTION

The SERVO-i Ventilator System is equippedwith an AC power supply with automatic rangeselection. The ventilator will automaticallyoperate correctly using 100-120V AC or220 - 240V AC outlets.

The ventilator is equipped with at least twobattery modules which automatically supply12V DC power in case of an AC power failure,ensuring that ventilator settings and storeddata remain intact in the event of an AC powerfailure.

Note: Batteries can be added to availableslots during operation.

The ventilator also comes equipped with aninput jack for an external 12V DC powersupply. This power supply activatesautomatically in case of an AC power failure,and ventilator settings and stored data remainintact.

3.1.1 POWER SUPPLY SPECIFICATIONS

Power supply, automatic range selection100-120V ± 10%, 220-240V ± 10%,AC 50-60 Hz.

Battery backupTwo to six battery modules, each 12V, 3.5Ah,3-hour recharge time, providing up to threehours of backup operation.

External 12V DC12.0V - 15.0V DC, 10A

Type of connector is stated in theService Manual.

CAUTION: When using external 12V DC,at least two installed Battery modules arerequired to ensure proper operation.

Maximum power consumptionAt 110-120V: 2A, 190VA, 140W.

At 220- 240V: 1A, 190VA, 140W.

Alarms and MessagesSee Alarms and Safety later in this chapter.


| 3 | Power supply |

3.1.2 BATTERY DATA SUMMARY

Battery Data Summary

2.5 years frommanufacture date

Lifetime

2Minimum modulesinstalled

6Maximum modulesinstalled

30 minutesRunning time per fullycharged module

n x 30 minutesRunning time with n fullycharged modulesinstalled

3 hours (up to 12 hoursif battery is completelydischarged)

Module recharge time

15 - 20°C (59 - 68°F)Recommended storagetemperature(disconnected battery)

3.2 VIEWING BATTERY STATUS

When operating from batteries, the estimatedremaining battery time in minutes is displayedin the upper right corner of the screen on theStatus touch pad.

WARNING! If the remaining battery time onthe Status touchpad is displayed in red, thebattery modules have very little operationaltime left and battery modules must bereplaced. If possible, connect the ventilatorto AC power.

Note: The total usable backup time is thesum of the estimated operation timedisplayed for each battery module minus10 minutes.



Detailed battery status information is availablevia the Battery Status Window:1. Press the Status touchpad at the top-right

of the user interface to display the StatusWindow.

SVX-9033

2. Press the Batteries touchpad to displaythe Battery Status Window.

SVX-9032

The following information is displayed for eachmounted battery module:

Slot number

Serial number

Charge indicator, where0 boxes filled = < 10% relative charge

1 box filled = 10-25% relative charge

2 boxes filled = 26-50% relative charge

3 boxes filled = 51-75% relative charge

4 boxes filled = 76-100% relative charge,

Remaining operating time in minutes

Activity Instruction—an instruction may bedisplayed next to the remaining operatingtime in minutes:

ResponseActivity Instruction

Order a new batterymodule.

Expires soon

The battery no longerreliable; replace itimmediately.

Replace battery

Note: If the Replace battery or the Expiressoon Activity Instruction is displayed, thebattery has become unreliable or will soonbecome unreliable, regardless of theoperating time displayed in the BatteryStatus Window. In this situation, replacethe battery even when the status windowindicates significant operating time remains.



3.3 ALARMS AND SAFETY

The status of the battery modules iscontinuously monitored by the ventilator. If thestatus is unsatisfactory, four types ofmessages may be displayed at the top of theuser interface:

Technical Error Message

High Priority Alarm Message

Medium Priority Alarm Message

Low Priority Alarm Message

Informative Text Message

This section describes the sequence of alarmsthat are triggered in the event of an AC powerfailure or disconnection from AC power;warnings that should be heeded to ensure areliable backup power supply; and statusmessages relevant to battery operation.

WARNING! If a battery status message isdisplayed on the user interface, check thebattery status as soon as possible. If noaction is taken, the ventilator may eventuallyshut down.

3.3.1 WARNINGS

WARNINGS!To guarantee reliable battery backup,two fully charged battery modules mustbe installed at all times.

Always replace batteries when theventilator software notifies you ofimminent expiration or of diminishedoperating capacity.

Do not disconnect and store batterymodules over long periods of timebecause this will degrade their capacity.If used battery modules need to be

stored for short periods of time (up toone week), then store them fully chargedin a cool (15-20°C or 59-68°F), dryenvironment.

Batteries that have been stored ordisconnected should be rechargedbefore use.

Dispose of batteries according to localregulations and not with ordinary waste.

After a new battery module is installed,display the Battery Status Window toensure safe battery operation.

When delivered, the battery modules maynot be fully charged. Check the status ofthe batteries via the user interface and,if necessary, charge the battery beforeuse by connecting the ventilator to thepower supply.

Always recharge discharged batteries.

When not in use, the ventilator shouldalways be connected to the power supplyto ensure fully charged batteries.

When the ventilator is running onbatteries, the Servo Ultra Nebulizer isdisabled to reduce power consumption.



3.3.2 STATUS MESSAGES

ExplanationMessage (message type)

Power failure.Technical error no. 1 - 6, 29, 10001 (technical error)

There is a problem with the battery modules. Oneor more battery modules must be replaced.

Check battery status (Informative Text Message)

Ventilator is running on batteries and the Servo UltraNebulizer has been disabled to reduce the powerconsumption.

Battery mode! Nebulizer switched off (MediumPriority Alarm)

AC power is off line due to a power failure ordisconnection.

Battery operation (Medium Priority Alarm)

Less than 10 minutes left of battery operation.Limited battery capacity (High Priority Alarm)

Less than 3 minutes left of battery operation.No battery capacity (High Priority Alarm)

Battery voltage too low. Cannot guaranteecontinued ventilator operation.

Low battery voltage (High Priority Alarm)

3.3.3 AC POWER FAILURE

In the event of an AC power failure ordisconnection, the ventilator switches tobattery operation and activates mediumpriority alarms, see Table above in StatusMessages for details.



4.1 WORKFLOW SUMMARY

The following summary procedure providesan overview of the operation of the SERVO-iVentilator System.1. Turn on the ventilator and perform a

Pre-use check.

2. Select patient category (option).

3. Enter data for the new patient, includingheight and weight.

4. Select type of ventilation (option).

5. Set the ventilation mode.

6. Check, and if necessary, adjust the alarmprofile.

7. Connect ventilator to patient and startventilation.

8. During ventilation you can:use the Additional Settings and Alarmprofile touchpads to review and adjustsettings

adjust the O2 cell (not when O2 sensor

is used)

use suction support

The following sections describe each of theabove steps in more detail.

4.2 PRE-USE CHECK

The Pre-use check includes tests andmeasurements of:

internal technical functionality

gas supply

internal leakage

pressure transducers

safety valve

O2 cell / O2 sensor

flow transducers

battery modules

patient breathing system leakage

circuit compliance

WARNINGS!Always perform a Pre-use check beforeconnecting the ventilator to a patient.

The volume of the patient circuit usedduring Pre-use check should be the sameas, and must never be higher than, duringventilation e.g. the active humidifier mustbe filled before Pre-use check.

The separate Patient Circuit Test that canbe performed in Standby mode does notreplace the Pre-use check.

If any malfunctions are detected duringthe start-up procedure, refer to theSystem Messages chapter for moreinformation.


| 4 | Operation overview |

WARNINGS!Do not connect the ventilator to a patientwhile a malfunction persists.

Do not lift or disconnect the expiratorycassette while the ventilator is inoperation; if necessary, lift the cassettewhile in Standby mode.

Important: If you change the breathingcircuit after completion of the Pre-usecheck, perform a new Pre-use check or apatient circuit test.

4.2.1 PRE-USE CHECK WITH HeO2

The Pre-use check can be performed withHeO2 instead of air if desired (only if Heliox

option is installed).

Always perform the Pre-use check on a warmexpiratory cassette when HeO2 is used. In

order for the expiratory cassette to get warmenough, the system must be in the power-onstate for 15-30 minutes.

Note: For optimum Oxygen calibration theHeO2 gas used should contain 21%

Oxygen.

1. Follow the normal Pre-use checkprocedure.

2. The HeO2 icon (1) indicates that the

ventilator is adjusted for Heliox use.

SVX-9042

Note: If the identified gas mixture is notapproved for use with the SERVO-iVentilator System (e.g. pure helium or Heliox70:30), then the Gas supply test and O2

cell/sensor test are not passed and thePre-use check will fail. The messageUnapproved gas mixture identified. Checkgas supply is displayed.



4.2.2 START-UP

1. Connect power and gas supplies:Power: AC outlet

Gas: Air and O2

2. Turn the ventilator on.

3. Start the Pre-use check by pressing Yes.

4. Follow the on-screen instructions.

5. After pressing the touchpad Pre-usecheck the message Do you really want tostart a pre-use check? is displayed -confirm by pressing Yes.

CAUTION: Ensure that the cable to the UserInterface is never disconnected while theSERVO-i Ventilator System is powered on.

4.2.3 INTERNAL TESTS

Connect the blue test tube between theinspiratory outlet and the expiratory inlet.

Important: Use only the MAQUET blue testtube.

4.2.4 CHECK SWITCH BETWEEN AC ANDBATTERY

The Pre-use check tests the ventilator’s abilityto switch between AC and battery power whenAC power is lost and restored:

When the on-screen instruction appears,disconnect the ventilator from AC power.

When the on-screen instruction appears,reconnect the ventilator to AC power.

Note: This test will not be performed if thereis less than 10 minutes of battery operationavailable.



4.2.5 CHECK PATIENT BREATHINGSYSTEM/Y SENSOR

1. Connect a complete breathing systemincluding (if available) a humidifier and aServo Ultra Nebulizer. If an activehumidifier is used, it must be filled withwater.

SVX-155a_XX

Important: When blocking the Y pieceor Y Sensor, make sure there is noleakage. Leakage will affect the circuitcompliance compensation calculation.

2. If no Y Sensor is connected then:Block the Y piece and follow the onlineinstructions. The circuit compliance isautomatically measured. Go toCompensate for Circuit compliance (seepage 44).

SVX-155b_XX

3. If a Y Sensor is connected then:Block the Y Sensor and follow theon-screen instructions. The circuitcompliance is automatically measured.Go to Compensate for Circuit compliance(see page 44).

SVX-155c_XX

4. If a Y Sensor is connected then:Unblock the Y Sensor and follow theon-screen instructions.

SVX-155d_XX



4.2.6 COMPENSATE FOR CIRCUITCOMPLIANCE

�

When the Compensate for circuitcompliance? dialog appears on the screen,do one of the following:

To add the compensation, press Yes,-

- To refuse the compensation, press No.

Important: If the patient circuit is changed,a Patient Circuit Test must be performed.

Note: Circuit compliance compensation isnot available in NIV modes (option).

4.2.7 TEST ALARM OUTPUT CONNECTION(OPTION)

If the Alarm Output Connection option isinstalled, a dialog for the external alarm systemtest appears on the screen.

�

Do one of the following:To perform the test, press Yes and followthe on-screen instructions.

-

- To cancel the test, press No.



4.2.8 COMPLETE THE PRE-USE CHECK

A message appears on screen for eachPre-use check test, as appropriate: Cancelled,Failed, Not Completed, Passed or Running.

1

Press OK to confirm and to have thePre-use check tests logged. The ventilatornow switches to Standby mode.

Notes:After the Pre-use check is completed (orskipped), you will be prompted to keepor discard old patient-related data.

By accessing the Status menu, theresults of the two latest Pre-use checksare displayed under General.



4.2.9 PRE-USE CHECK TESTS

Remedy if test failsDescriptionTest

Make sure the patient unit front coverand the user interface rear cover arecorrectly mounted.

Audio test and other internal tests(memory and safety-related hardware).

Internal test

Check the barometric pressure value inthe Status Window.

Checks the barometric pressuremeasured by the internal barometer.

Barometer test

Check that the gas supply pressure(air/HeO2 and O2) is within the specifiedrange, and that the gas used is approvedfor the SERVO-i Ventilator System. Seepage 224 for specification.

Checks that the gas supply pressures(air/HeO2 and O2) measured by theinternal gas supply pressure transducersare within the specified range. The testchecks the presence of different gastypes.

Gas supply test

If message Leakage or Excessive leakageappears:

check that the test tube is correctlyconnected,check all connections for theexpiratory cassette and inspiratorychannel,make sure the expiratory cassette andthe inspiratory channel are clean anddry, ORcontact a service technician.

Checks for internal leakage, with testtube connected, using the inspiratory andexpiratory pressure transducers.Allowed leakage: 10 ml/min at 80 cmH2O.

Internal leakage test

If the Internal leakage test passed (seeabove):

check/replace inspiratory or expiratorypressure transducercheck that there is no excess water inthe expiratory cassette

Calibrates and checks the inspiratory andexpiratory pressure transducers.

Pressure transducertest

Check the inspiratory section:check that the safety valve membraneis correctly seated in the inspiratorypipecheck that the inspiratory pipe iscorrectly mounted in inspiratorysectioncheck that the safety valve closesproperly when the Pre-use check isstarted (distinct clicking sound fromthe valve)

Checks and if necessary adjusts theopening pressure for the safety valve to117 ± 3 cmH2O.

Safety valve test



Remedy if test failsDescriptionTest

Check that the connected gas supplypressure (air and O2) is within thespecified range.Replace the O2 cell.

Replace gas modules (air and/or O2).

Calibrates and checks the O2 cell /sensor at 21% O2 and 100% O2.

Checks if the O2 cell is worn out.

Because different gas mixtures arerequired for this test, it will not beperformed if one gas is missing.

O2 cell / sensor test

Check that the connected gas supplypressure (air and O2) is within thespecified range.Check that the cassette is correctlyseated in the cassette compartment.

Checks the inspiratory flow transducers.Calibrates and checks the expiratory flowtransducer.

Flow transducertest

Check that the total remaining time forthe connected battery modules are atleast 10 minutes. If not, replace thedischarged battery with a fully chargedbattery and repeat the test.

If battery modules are installed, testsswitching to battery power when ACpower is lost and back to AC powerwhen it is restored.

Battery switch test

If the internal leakage test has passed,the leakage is located in the patientcircuit. Check for leakage or replace thepatient circuit.

Checks the patient circuit leakage, withpatient tubing connected, using theinspiratory and expiratory pressuretransducers.Allowed leakage: 80 ml/min at 50 cmH2O.

Will allow the system to calculate acompensation for circuit compliance (ifthe leakage requirements are met).

Patient circuitleakage test

Check Y Module and Y Sensor. If theproblem persists, change the YModule/Sensor.

Checks the pressure and flowmeasurement of the Y Sensor.

Y Sensor test

Refer to service technician.Checks that no Technical error alarmsare active during the Pre-use check

Alarm state test



4.3 PATIENT CIRCUIT TEST

In Standby mode, the Patient Circuit Test maybe performed separately from the Pre-usecheck. This is useful, for example, whenchanges are made to the circuit or additionalaccessories are connected. The test evaluatescircuit leakage and measures the circuitcompliance.

SVX-9042

Press the Patient circuit test touchpad andfollow the on-screen instructions.

WARNINGS!A Pre-use check must always be donebefore connecting the ventilator to apatient.

The Patient Circuit Test does not replacethe Pre-use check.

Note: Considerable leakage may occuraround the endotracheal tube if it isuncuffed. The combination of small tidalvolumes, leakage around the tube, andactivated compliance compensation maytrigger the Low Expiratory Minute Volumealarm due to a very low expiratory flowpassing from the patient through theexpiratory channel. By observing thedifference between the Vti and Vte valuespresented on the user interface, a leakagecan be detected and its extent easilycontrolled. The first time an unacceptablylarge leakage occurs around the tube,correct this problem to avoid triggering theLow Expiratory Minute Volume alarm. If theleakage persists, either adjust the alarmlimit down to its lowest level (10 ml) orpermanently silence the alarm (seepage 184)—if this step is clinicallyappropriate. Finally, if the leakage still hasnot been remedied, deactivate thecompliance compensation to avoidtriggering the alarm. If the compliancecompensation is deactivated while inPressure Control, Pressure Support, orSIMV (Pressure Control) ventilation modes,then no further settings need to be adjusted.However, in volume-related modes, the setvolumes must be adjusted.



4.4 ENTER THE PATIENT DATA

1. Press the Admit patient touchpad.

2. Activate touchpads by turning andpressing the Main Rotary Dial or bypressing the appropriate touchpads.

Enter/edit the following characteristics:3. Patient name

4. Identity number

5. Date of birth

6. Date of admission

7. Body height

8. Body weight

9. Press, for example, Name to enter thepatient’s name.

10. Press Close keyboard when entry iscomplete.

11. When the ID touchpad is pressed, akeypad appears in the window.

12. Press Accept to confirm new data orCancel to cancel new data.

Important:Adult weights are in kilograms.

Infant weights are in grams.

Copy patient data before you enter a newname or ID, otherwise all datacorresponding to the previous patient willbe lost.

The calculation of tidal and minutevolume is based on entered body weight.If you omit this data, default values willbe used for ventilation. An automaticcalculation of Tidal Volume (based onbody weight and immediately executed)will be performed only if the system isconfigured for Tidal Volume based onbody weight.



PROCEDURE DIAGRAM: ENTER PATIENTDATA

1

21213

9

10

11

a_XX



4.5 SELECT THE TYPE OFVENTILATION (OPTIONS)

Press Invasive ventilation or NIV (Non invasiveventilation).

Note: The factory default values may havebeen changed by a previous user.

4.6 SET VENTILATION MODE

To set ventilation mode and parameters:1. Press the Mode touchpad.

2. Press the arrow at the active Mode pad.Available ventilation modes appear.

3. Press the touchpad for desired mode ofventilation.

Note: If the type of ventilation is set toNIV, the only available modes are NIVPressure Support, NIV Pressure Control(option), Nasal CPAP (option) and NIVNAVA (option).

4. If Automode is selected and the patient istriggering the ventilator, a green indicatormark will appear.

Note: Automode is not available in NIV.

5. When a ventilation mode has beenselected, all related parameters can beset in the same window. Calculations arealso displayed in this window.

6. Values are adjusted by turning the MainRotary Dial.

7. Confirm each setting by pressing theparameter touch pad or pressing the MainRotary Dial.

8. To activate all settings in the windowpress Accept, or to cancel the settingspress Cancel.



PROCEDURE DIAGRAM: SET VENTILATIONMODE

SVX-6032a_XX



4.7 SET ALARM LIMITS

To set alarm limits:1. Press the fixed key Alarm Profile.

2. Press the touchpad corresponding to thealarm limit you want to adjust or press theAlarm sound level touchpad.

3. Turn the Main Rotary Dial to adjust values.

4. Confirm each setting by pressing theparameter touchpad or Main Rotary Dial.

5. Press Autoset, if desired, to get a proposalfor alarm limits in VC, PC, and PRVCmodes.

Important: Before accepting Autosetvalues, make sure they are appropriatefor the patient. If not, enter settingsmanually.

6. Press Accept to activate the new alarmlimits.

Notes:Autoset is not possible in Standby modebecause the ventilator requires patientvalues in order to propose alarm limits.

Autoset is not available in supported orNIV (optional) modes.

Current alarm limits are displayed duringventilation in smaller figures to the rightof the parameter display.

The Main Rotary Dial becomesinoperative for 2 seconds when a definedsafety limit for the alarm limit beingadjusted is reached. Then, it will beoperable again.



4.8 START VENTILATION

The fixed key Standby is used to start andstop both invasive and noninvasive ventilation.

4.8.1 START INVASIVE VENTILATION

1. When the system is configured forinvasive ventilation press the fixed keyStandby (1) to start ventilation.

4.8.2 START NON INVASIVE VENTILATION(NIV) (OPTION)

00:14

SVX-9028_EN

1. When the Standby key is pressed and theSERVO-i Ventilator System is configuredfor NIV, a waiting position dialog is shown.

Note: All patient-related alarms areturned off for 120 seconds.

2. Press the Start ventilation touchpad.

Note: Ventilation starts automaticallyupon patient effort.



4.9 CHANGE THE PATIENTCATEGORY (OPTION)

To change the patient category in Runningmode.

To change patient category while editing theStart-up Configuration:

After pressing Menu>Biomed>Editconfiguration>Start-up configuration, pressthe Patient category touchpad and followthe on-screen instructions.

To change the patient category in Runningmode (during ventilation):1. Press the fixed key Menu.

2. Press the Change patient categorytouchpad.

3. Press Yes to confirm OR,

4. Press No to cancel.

Note:Changing the patient category affects thefollowing settings:

default values for alarm limits

allowed ranges for alarm limits

default values for breathing parameters

allowed ranges for breathing parameters

pressure and flow regulation

scaling

Note: The factory default values for theAdult and Infant patient categories mayhave been changed by a previous user.

Important: Always check the alarmsettings after changing the patient category.

4.9.1 PROCEDURE DIAGRAM: CHANGETHE PATIENT CATEGORY IN RUNNINGMODE

SVX 5083a XX



4.10 ADDITIONAL SETTINGSWINDOW

To adjust breathing parameters duringventilation, press the Additional settingstouchpad to open the Additional SettingsWindow.1. The Additional settings touchpad is in the

lower left corner of the screen.

2. Values derived from settings such asinspiration time in seconds and calculatedinspiratory flow are displayed.

3. A white bar indicates that the selectedsetting is within generally recognizedsafety limits.

4. A yellow (advisory) bar indicates that theselected setting is beyond generallyrecognized safety limits.

5. A red (warning) bar indicates that theselected setting is significantly beyondgenerally recognized safety limits (thiswarning is accompanied by an audiosignal and text message).

6. Turning and pressing the Main Rotary Dialallows you to select settings and adjustvalues.

Note: New settings are effective fromthe first breath after adjustment (whenthe touchpad is deactivated).

7. The waveforms and measured values aredisplayed. Thus, the effects of theadjustments made can be checkedimmediately.

8. The Close touchpad closes the AdditionalSettings Window.

Note: The trigger sensitivity bar hasdifferent colors based on the setting. Agreen bar indicates a normal setting forflow triggering. The risk ofself-triggering increases when the baris red. A white bar indicates thatpressure triggering is required.

THE ADDITIONAL SETTINGS WINDOW

SVX-9001



4.11 USE SUCTION SUPPORT

The Suction Support function makes itpossible to automatically inhibit the ventilatorfrom cycling during a tracheal suctionprocedure without activating alarms.

Suction Support includes:preparation phase

disconnect phase

post-oxygen phase

WARNINGS!Suction Support is not intended to beused together with closed-suctionsystems.

The minimum PEEP level during suctionsupport is 3 cmH2O. The ventilator will

adjust to minimum level if the PEEP levelis below 3 cmH2O in order to detect

disconnection of the patient.

Important: Alarms are turned off duringthe disconnect phase for a maximum of 60seconds. If the patient has not beenreconnected within 60 seconds, alarms areactivated.

Notes:Suction Support is not available in NIVmode or when the O2 Breaths function is

activated.

During the disconnect phase in SuctionSupport, the Servo Ultra Nebulizer istemporarily paused.

When only one gas is connected, anelevated oxygen level cannot be setduring the preparation phase. In thiscase, the post-oxygen phase will beskipped.



4.11.1 PREPARATION PHASE

SVX-9000 XX

To enter the preparation phase:1. Press the fixed key Quick access.

2. Press the Suction Support touchpad.

3. Set the desired pre-oxygen value byturning and pressing the Main Rotary Dial.

The Check tubing alarm is turned off: themaximum duration of the preparation phaseis 120 seconds. After 120 seconds, the systemautomatically returns to ventilation using theprevious oxygen setting.

Note: The Cancel pad will close the SuctionSupport program.

4.11.2 DISCONNECT PHASE

The system automatically enters thedisconnect phase when the patient isdisconnected during the preparation phase.

During the disconnect phase the followingalarms are turned off for up to 60 seconds:

Apnea

Minute volume

Respiratory rate

EtCO2

PEEP

When the patient is reconnected, the systemautomatically enters the post-oxygen phaseand restarts ventilation.

It is also possible to restart the ventilationmanually by pressing the Start ventilationtouchpad.

4.11.3 POST-OXYGEN PHASE

After reconnection, the ventilator will deliverthe same oxygen concentration as in thepreparation phase for 60 seconds.

After 60 seconds the system automaticallyreturns to ventilation using the previousoxygen setting.



4.12 RE-ADJUST THE OXYGENCELL

If the ventilator has been in continuous use foran extended period, the measured O2

concentration may drop due to normaldegradation of the oxygen cell. In order toavoid nuisance alarms in this situation, it ispossible to temporarily adjust the O2 cell

during ventilation.

When the O2 cell adaptation function is

activated, the oxygen cell is re-adjusted sothat the current measured O2 concentration

is equal to the O2 concentration set by the

user. This temporary adjustment will be validuntil the ventilator is switched off.

Note: This does not apply if the SERVO-iVentilator System has an O2 sensor fitted.

Important: Before using the SERVO-iVentilator System, always perform a Pre-usecheck to make sure the O2 cell is properly

calibrated.

SVX-6089a_XX

To re-adjust the O2 cell:

1. Press the fixed key Menu.

2. Press the Biomed touchpad.

3. Press the O2 cell adaptation touchpad.

4. Press the Yes touchpad to perform the O2

cell adaptation.



4.13 DISCONNECT THE PATIENT

To disconnect and stop ventilation:1. Physically disconnect the patient from the

ventilator.

2. Press the fixed key Standby.

3. Press Yes to stop ventilation.

4. Turn the ventilator off using the On/Offswitch behind the User Interface.



5.1 MEASURED VALUES DISPLAY

During ventilation, measured or calculatedvalues of breathing parameters are displayed.This section describes the display, gives theprocedure for displaying additional pages ofmeasured and calculated values, and lists allviewable values.

5.1.1 DESCRIPTION

6.28.5

6.5

15 20

10

8.5 8.5

6.5

30 40

116

Breathing parameter values are displayed onthe right side of the screen.

1. Alarm limits are displayed.

2. An up or down arrow indicates whetherthe upper or lower alarm limit has beenexceeded.

If a high priority alarm limit is exceeded,the box turns red.

If a medium priority alarm limit isexceeded, the box turns yellow.

3. Off-scale values are indicated by ***.

4. It is possible to change which values aredisplayed in the measured value boxes.(See Configuration chapter)

5.1.2 DISPLAY ADDITIONAL PAGES

SVX.5092_EN

To view more values:1. Press the Additional values touchpad in

the lower right corner of the screen.

2. View desired values.

3. Press the Additional values touchpadagain to view the next page of values.

Notes:In NIV mode there is only one page ofadditional values.

In Nasal CPAP mode no additional valuesare displayed.


| 5 | Monitor and record |

5.1.3 VALUES LIST

Values in boldface are shown on the first pageby default.

Maximum inspiratory pressurePpeak

Pressure during end-inspiratory pausePplat

Mean airway pressurePmean

Positive end expiratory pressurePEEP

Set PEEP + Intrinsic PEEPPEEP tot

Continuous Positive Airway Pressure (NIV Nasal CPAP only)CPAP

Respiratory RateRR

Measured oxygen concentration in vol.%O2

Inspiration timeTi

Time constantTc

Inspiration to expiration ratio (during controlled ventilation)I:E

Duty cycle or ratio of inspiration time to total breathing cycle time (duringspontaneous breathing and Bi-Vent).

Ti/Ttot

Spontaneous expiratory minute volume (Bi-Vent)MVe sp

The relation between spontaneous expired minute volume and total expiredminute volume (Bi-Vent).

MVe sp / MVe

Inspiratory Minute VolumeMVi

Expiratory Minute VolumeMVe

Leakage % (NIV)Leakage

Inspiratory Tidal VolumeVTi

Expiratory Tidal VolumeVTe

End expiratory flowee

End tidal carbon dioxide concentration (CO2 Analyzer - option)etCO2

Volume of expired CO2 per minute (CO2 Analyzer - option)CO2

CO2 tidal elimination (CO2 Analyzer - option)VTCO2

Dynamic characteristicsCdyn

Static compliance, respiratory systemCstatic

ElastanceE

Inspiratory resistanceRi

Expiratory resistanceRe

Work of breathing, ventilatorWOB v

Work of breathing, patientWOB p



Indicator for respiratory driveP0.1

Shallow Breathing IndexSBI

5.2 WAVEFORM DISPLAY

If the optional CO2 Analyzer is connected, the

following color-coded waveforms are shownon the user interface screen by default:

pressure vs. time

flow vs. time

volume vs. time

CO2 concentration vs. time.

This section describes the waveform display,and the procedures for hiding/displaying thevolume and CO2 waveforms and for adjusting

the sweep speed and scale of the waveforms.

5.2.1 DESCRIPTION

The default waveform display has the followingcharacteristics:

The value of a measured parameter vs. timeis displayed.

The displayed parameter and the scale areindicated on the y-axis.

The pressure vs. time display is dark yellow.

The flow vs. time display is green.

The volume vs. time display is light blue.

The CO2 concentration vs. time display is

light yellow.

5.2.2 SHOW AND HIDE

SVX-6029a_XX

To show or hide the volume waveform or theCO2 waveform display:

1. Press the fixed key Quick access.

2. Press the Waveform configurationtouchpad.

3. Press the touchpad corresponding to thewaveform you wish to show or hide.



Notes:The pressure waveform and the flowwaveform are always displayed. Thevolume and CO2 waveforms may be

hidden. Thus, 2, 3, or 4 waveforms maybe displayed.

When you hide a waveform, theremaining waveforms are expanded touse all available screen space.

5.2.3 ADJUST SCALE/SWEEP SPEED

SVX-6008a_XX

To set the sweep speed and amplitude fordisplayed waveforms:1. Press the fixed key Quick access.

2. Press the Waveform Scales touchpad.

3. Press the touchpad corresponding to thewaveform whose scale you wish tochange or select a sweep speed (5, 10 or20 mm/s).

4. To adjust the scale of a waveform, turnthe Main Rotary Dial to the desired valueor use auto scale (press Auto).

Important: MAQUET does not recommendusing auto scale in Bi-Vent mode, whenpatient breathing is spontaneous on bothlevels.



5.3 SHOW EVENT LOG

To view the Event Log:1. Press the fixed key Menu.

2. Press the Review touchpad.

3. Press the Event log touchpad to view alllogged events.

4. Use the arrows to scroll.



5.4 SHOW LOOPS

The Loops function provides a graphicalrepresentation of the relationship betweenflow-volume and pressure-volume.

SVX-6004a_XX

To activate the Loops function:1. Press the fixed key Quick access.

2. Press the Loops touchpad

3.Press [reference loop] to store areference loop.

4. Press [overlay loops] to see the twoprevious loops simultaneously.

5. To close the window, press Close.



5.5 SHOW TRENDS

Trend values are stored every 60 seconds andretained as far back as 24 hours. Storedevents and system changes are shown asevent stamps.

To show trends:1. Press the fixed key Trends.

2. Use the up and down arrows to scrollbetween the different trend channels.

3. To quit the Trends Window press Close.

4. To adjust the time resolution press theHours touchpad and turn the Main RotaryDial.

5. Activate the Cursor. Move it back andforth on the time axis using the MainRotary Dial or touch screen.

6. Time valid for the cursor position. Forevent stamps, an explanation appears.

7. Logged event stamps.

8. If a recording is saved at a timecorresponding to the cursor position, arecording button is shown. To view therecording, press the button.



5.6 SAVE DATA

Waveforms and settings may be saved in thefollowing ways:

A 20-second recording may be taken forimmediate on-screen analysis.

Screen data or patient data may be writtento an optional Ventilation Record Card forlater analysis (patient data file is readableby Microsoft Excel).

5.6.1 RECORD WAVEFORMS

Press the fixed key Save.

To save one recording of the current waveformalong with breathing parameter values:

A total of 20 seconds of data will be recorded:10 seconds before the Save key was pressedand 10 seconds after the Save key waspressed.

Note: If Save is pressed again, the previousrecording will be erased. Using Admitpatient also erases the previous recording.



5.6.2 USE RECORDED WAVEFORMS.

SVX-5093a_XX

To view the data in a recorded waveform:1. Press the fixed key Menu.

2. Press the Review touchpad.

3. Press the Recorded waveform touchpad.Vertical gray lines indicate the time whenthe Save key was pressed.

4. View measured/calculated values next tothe vertical gray lines.

5. Press the Settings touchpad to open thelist of parameter settings in use at the timethe Save key was activated.

6. Press the Cursor touchpad to activate thecursor. Move the cursor using the MainRotary Dial.

7. Press Close to quit the RecordedWaveform Window.



5.6.3 VENTILATION RECORD CARD(OPTION)

The Ventilation Record Card (VRC) can beused in Standby mode or during ventilation.The following data can be saved for analysis:

screen data

patient data

Important: Always handle the VRC and itscontents in accordance with regulationsand hospital routines.

Copy Screen Data to a Ventilation RecordCard

To make a copy of the screen, a VRC must beinserted and the Save key must be configured.It is possible to copy multiple data sets to thesame Ventilation Record Card.

SVX-9007_XX

After inserting the VRC:1. Press the fixed key Menu.

2. Press the Copy touchpad.

3. Press the Copy screen touchpad.

4. Press OK to continue.

5. Press the fixed key Save.

A copy of the screen is stored on the VRC.

Notes:To make another screen copy, press theSave key again.

When the VRC is removed or theventilator is restarted, the Save key isautomatically reconfigured to save arecording.



Copy Patient Data to a Ventilation RecordCard

The following patient data may be copied toa VRC: Event Log, Trends, Recordings, OpenLung Tool data. Included in all data files are:patient name and ID, ventilator serial numbersand Pre-use check status.

To copy patient data to a VRC:1. Press the fixed key Menu.

2. Press the Copy touchpad.

3. Press the Copy data touchpad.

Insert the VRC.

4. Press the Copy data touchpad.

Remove the VRC when copying is complete.



6.1 INTRODUCTION

The SERVO-i Ventilator System can operatein several different modes. This chapterdescribes the modes, their settings, andassociated safety information.

It also summarizes special ventilatoryfunctions, backup ventilation, and breathingparameters.

See the Technical data chapter for defaultvalues and allowed ranges for the breathingparameters.

Note:The SERVO-i Ventilator System is deliveredpreset with the following configurationoptions:

Breathing parameters are based on eitherMinute Volume or Tidal Volume.

Breathing parameters are based on eitherI:E Ratio or Inspiration Time.

6.1.1 WARNINGS

Note: Not all warnings apply to all modes.

WARNINGS!Be sure to set alarm limits as appropriatefor each mode. It is especially- Minute Volume Alarm

- Apnea Alarm

Self-triggering should be avoided. Do notset the trigger sensitivity too high.

To protect the patient’s lungs fromexcessive pressure it is important to setthe upper pressure limit to a suitablevalue.

The following warnings apply toNon-Invasive Ventilation (NIV) only:- Avoid high inspiratory pressure as it

may lead to gastric overdistention andrisk of aspiration. It may also causeexcessive leakage.

- Use of the Nebulizer is notrecommended.

- We recommendventilator-independent monitoring forNasal CPAP.

Ensure that PRVC, SIMV (PRVC) and VSfunction properly (especially for smallpatients):- Avoid leakage (e.g. due to an uncuffed

endotracheal tube).

- If compliance compensation is used,make sure that the compressiblevolume of the patient circuit is notchanged after the Pre-use check /Patient Circuit Test has beenperformed (e.g. filling an activehumidifier with water after the test hasbeen made).


| 6 | Ventilation, modes and functions |

6.1.2 APPLICATION

The SERVO-i ventilator system also containstools to assist the user in application of lungrecruitment methodologies.

6.1.3 SCOPE - VENTILATORY NEEDS

The ventilator can be used for:1. controlled ventilation

2. supported ventilation, or

3. spontaneous breathing/CPAP

It also allows for combined ventilatory controlor support. Spontaneous breathing efforts aresensed during controlled ventilation, e.g.Volume Control. Mandatory ventilation can beused during supported/spontaneousbreathing, e.g. the enhanced SIMVfunctionality.

The Automode functionality continuouslyadapts to the patient´s breathing capability.

When required, all ventilation is provided formandatorily. When the patient is able to initiatea breath, the ventilator supports and monitorsthe patient´s breathing capability and controlsventilation only if required.



6.1.4 IMPLEMENTATION

SVX-132_XX

Ventilation can be used and administered witha focus on:A. pressure and volume

B. pressure

C. flow/volume.

PRESSURE AND VOLUME IN FOCUS

In the pressure- and flow- oriented modes, aconstant inspiratory Tidal Volume ismaintained. The inspiratory pressure level isconstant during each breath. (PRVC, VolumeSupport.)

PRESSURE IN FOCUS

In the pressure-oriented modes, a constantpreset pressure level is maintained duringinspiration. (Pressure Control, PressureSupport)

FLOW/VOLUME IN FOCUS

In the flow/volume oriented modes a constantinspiratory volume is maintained. Theinspiratory flow is constant during each breath(Volume Control).

EXTRA FLOW AND EXTRA BREATHS

In flow/volume- oriented modes of ventilation,additional on-demand flow can be triggeredduring inspiration. Additional breaths canalways be triggered between the ordinarybreaths if the set trigger criteria are met.

TIMING

In controlled ventilation modes, timing isrelated to preset values. In supportedventilation modes, timing is related to patienttriggering and Inspiratory cycle-off setting.



6.1.5 BASIC FUNCTIONALITY - AN OVERVIEW

SVX-133_EN

1. (PRVC) PRESSURE REGULATEDVOLUME CONTROL

Breaths are delivered mandatorily to assurepreset volumes, with a constant inspiratorypressure continuously adapting to the patient´scondition. The flow pattern is decelerating.

2. VOLUME CONTROL

Breaths are delivered mandatorily with aconstant flow to assure preset volumes.



3. VOLUME SUPPORT

A patient-adapted constant inspiratory supportis supplied when activated by patient effort.The resulting volume is continuouslymonitored and the constant inspiratorypressure automatically adjusts to the requiredlevel. The patient determines frequency andduration of the breaths which show adecelerating flow pattern.

4. SPONTANEOUS BREATHING (CPAP)

When sufficient inspiratory volumes areachieved, spontaneous breathing withoutventilator support is allowed for in VolumeSupport.

5. PRESSURE CONTROL

Breaths are delivered mandatorily at a presetpressure level, causing a decelerating flowpattern.

6. PRESSURE SUPPORT

Inspiration is supported by a constant presetpressure when activated by patient effort. Thepatient determines frequency and duration ofthe breaths, which show a decelerating flowpattern. Inspiratory breath duration can beinfluenced by adjusting the Inspiratorycycle-off criteria.

7. SPONTANEOUS BREATHING/CPAP

True spontaneous breathing (CPAP) occurswhen the inspiratory pressure level is set tozero in Pressure Support.

8. NASAL CPAP

Spontaneous breathing on a set pressure level.



6.1.6 COMBINED MODES - AN OVERVIEW

AUTOMODE

The ventilator continuously adapts to thepatient's breathing capability and allows thepatient to better interact with the ventilator.The ventilator automatically shifts betweencontrolled ventilation, supported ventilationand spontaneous ventilation. Each controlledventilation mode has a corresponding supportmode.

Volume Control <----> Volume Support

PRVC <----> Volume Support

Pressure Control <----> Pressure Support

When the patient is making a breathing effort,the ventilator immediately switches to asupport mode of ventilation. If the patient isnot making any breathing effort, the ventilatorwill return to the controlled mode and delivercontrolled breaths.

SYNCHRONIZED INTERMITTENTMANDATORY VENTILATION (SIMV)

The ventilator provides mandatory breathswhich are synchronized with the patient´sspontaneous efforts at a preset rate. Themandatory breaths can be Volume Control,Pressure Control or PRVC breaths.

BI-VENT

Bi-Vent is pressure controlled breathing, givingthe patient the opportunity of unrestrictedspontaneous breathing. Two pressure levelsare set together with the individually setduration of each level. Spontaneous effortscan be assisted by pressure support.



6.2 IMPORTANT DEFINITIONS

The graphic display of pressure, flow andvolume is visualized in wave forms. Modes ofventilation directly affect flow, pressure andvolume patterns.

6.2.1 VOLUME CONTROL

P

1

2

34

56

t

t

8

10

11

12

13

14

1516

t

V

V

x y z

I:E

9

7

PRESSURE-TIME WAVEFORM. POINTSAND REGIONS OF INTEREST

X. Inspiration time

Y. Pause time

Z. Expiration time

1. Start of Inspiration

2. Peak inspiratory pressure

3. Early inspiratory pause pressure

4. End inspiratory pause pressure

5. Early expiratory pressure

6. End expiratory pressure

FLOW-TIME WAVEFORM. POINTS ANDREGIONS OF INTEREST

X. Inspiration time

Y. Pause time

Z. Expiration time

7. Peak inspiratory flow

8. Zero flow phase

9. Peak expiratory flow

10. Slope decelerating expiratory limb

11. End expiratory flow

VOLUME-TIME WAVEFORM. POINTS ANDREGIONS OF INTEREST

X. Inspiration time

Y. Pause time

Z. Expiration time

12. Start of inspiration

13. The slope represents current delivery ofinspiratory tidal volume

14. End inspiration

15. The slope represents current patientdelivery of expiratory tidal volume

16. End expiration



6.2.2 PRESSURE CONTROL

V

V

P

1

2

3

4

5

6

7

8

10

9

I:E

X Z

t

t

t

PRESSURE-TIME WAVEFORM. POINTSAND REGIONS OF INTEREST

X. Inspiration time

Z. Expiration time

1. Start of Inspiration

2. Peak inspiratory pressure

3. End expiratory pressure

FLOW-TIME WAVEFORM. POINTS ANDREGIONS OF INTEREST

X. Inspiration time

Z. Expiration time

4. Peak inspiratory flow

5. End inspiratory flow

6. Peak expiratory flow

7. End expiratory flow

VOLUME-TIME WAVEFORM. POINTS ANDREGIONS OF INTEREST

X. Inspiration time

Z. Expiration time

8. Start of inspiration

9. End inspiration

10. End expiration



6.3 SETTINGS

6.3.1 TRIGGER FUNCTIONALITY

5Trigg. Flow

-2Trigg. Pressure

SVX-638_EN

This determines the level of patient effort totrigger the ventilator to inspiration.

Trigger sensitivity can be set in flow triggering(Trigg. Flow) or pressure triggering (Trigg.Pressure). Normally flow triggering ispreferable as this enables the patient tobreathe with less effort.

The sensitivity is set as high as possiblewithout self-triggering. This ensures thattriggering is patient initiated and avoidsauto-cycling by the ventilator.

Pressure triggering can be set in the range -20to 0 cmH2O (in reference to set PEEP level,

white area on the bar).

When the trigger sensitivity is set above 0(green and red area on the bar), flow triggeringis set, i.e. the amount of the bias flow that thepatient has to inhale to trigg a new breath. Thesensitivity can be set from 100% of the biasflow (left), to 0% of the bias flow (right).



WARNING! The trigger sensitivity bar hasdifferent colors based on the setting. Agreen bar indicates a normal setting for flowtriggering. The risk of self-triggeringincreases when the bar is red. A white barindicates that pressure triggering isrequired.

Important: In NIV it is not possible to settrigger sensitivity.

The ventilator continuously delivers a gas flowduring expiration, which is measured in theexpiratory channel.

1. Inspiration.

2. Bias flow during expiration:Infant 0.5 l/min.

Adult 2 l/min.



WEAK PATIENT EFFORT

SVX-141_EN

5Trigg. Flow

1. At a Trigger sensitivity level above zero(0), the ventilator senses deviations in thebias flow caused by inspiratory efforts ofthe patient. The more to the right on thescale, the more sensitive is the triggerfunction.

2. Weak inspiratory effort.

3. Very weak inspiratory effort.

WARNING! If the trigger sensitivity is settoo high, a self triggering (auto-triggering)condition may be reached. This conditioncan also be reached if there is leakage inthe breathing system, e.g. if an uncuffedendotracheal tube is used. Triggering willthen be initiated by the system and not bythe patient.This should always be avoidedby decreasing the trigger sensitivity.

STRONGER PATIENT EFFORT

SVX-142_EN

-2Trigg. Pressure

1. At a Trigger sensitivity level below zero(0), the ventilator senses negativepressures created by the patient. Requiredpreset negative pressure to initiate abreath is shown numerically. The more tothe left on the scale, the more effort isrequired to trigger.

2. Stronger patient effort.

WARNING! The trigger sensitivity bar hasdifferent colors based on the setting. Agreen bar indicates a normal setting for theflow triggering. The risk of self-triggeringincreases when the bar is red. A white barindicates that pressure triggering isrequired.

For more information see Additional settingswindow on page 56.



6.3.2 INSPIRATORY RISE TIME

0

0

PInsp rise time

t

t

100 %

SVX-644_EN

Time to peak inspiratory flow or pressure atthe start of each breath as a percentage of therespiratory cycle time or in seconds. Increasedrise time will affect the rate of flow/pressureincrease and can be evaluated by the shapeof the flow and pressure waveforms.

Inspiratory rise time (%) is applicable inPressure Control, Volume Control, PRVC,SIMV-Volume Control, SIMV-Pressure Control,SIMV-PRVC. Setting can be in the range0-20% of the respiratory cycle time.

Inspiratory rise time set in seconds isapplicable in Pressure Support, VolumeSupport and Bi-Vent. For adults the range is0-0.4 seconds and for infants the range is0-0.2 seconds.

Note: When the ventilator is configured forsetting of Inspiration time, the unit forInspiratory rise time then automaticallyswitches to seconds for all ventilationmodes.

Normally in supported modes the Inspiratoryrise time should be increased from the defaultsetting and to give more comfort to thepatient.



6.3.3 INSPIRATORY CYCLE-OFF

SVX-205_XX

Inspiratory Cycle-off is the point at whichinspiration changes to expiration inspontaneous and supported modes ofventilation. A decrease of the inspiratory flowto a preset level causes the ventilator to switchto expiration. This preset level is measured asa percentage of the maximum flow duringinspiration. The range of Inspiratory cycle-offis 1 - 70%.

Note: In NIV the range is 10-70%.

6.3.4 BREATH CYCLE TIME

This is the length of the breath i.e. the totalcycle time of the mandatory breath in SIMV(inspiration, pause plus expiration). This is setin seconds within the range:Infants: 0.5 -15 seconds in half second steps.

Adults: 1-15 seconds in one second steps.

Note: The soft key Breath cycle time is notshown when an SIMV mode is selected andinspiration time is configured. Refer toheading I:E ratio / Inspiration times.



6.3.5 TRIGGER TIMEOUT

Trigger Timeout is the maximum allowedapnea time in Automode before controlledventilation is activated. It is applicable in:

Automode:Volume Control <--->Volume Support

PRVC <--->Volume Support

Pressure Control <--->Pressure Support

The settings are within the ranges:Infant: 3-15 seconds

Adult: 7-12 seconds

Initially the ventilator adapts with a dynamicTrigger Timeout limit. This means that for thespontaneously triggering patient the timeoutincreases successively during the first tenbreaths.

6.3.6 PEEP

PEEP

SVX-646_EN

Positive End Expiratory Pressure (PEEP) canbe set in the range of 0 - 50 cmH2O. A Positive

End Expiratory Pressure is maintained in thealveoli and may prevent the collapse of theairways.

Note: In NIV the range is 2-20 cmH2O.



6.3.7 I:E RATIO / INSPIRATION TIME

The setting of breathing parameters inSERVO-i Ventilator System can be configuredin two different ways, based on:

I:E ratio (independent of changes of e.g. thebreathing frequency) or,

Inspiration time in seconds (independent ofchanges of e.g. the breathing frequency),to better meet the requirements for infantcare.

When the ventilator is configured for settingof Inspiration time, the unit for Pause time andInsp. rise time then automatically switches toseconds. The resulting I:E ratio for each settingis shown in the upper right information areaof the ventilation mode window.

As the inspiration time is explicitly set, achange of for example the Respiratory Ratewill affect the I:E ratio. As a safety precaution,it will therefore be indicated when the resultingI:E ratio passes 1:1 in either direction.

Note: The soft key Breath cycle time is notshown when an SIMV mode is selected,since there is no need to set Breath cycletime when Inspiration time is directly set.

Note: The configuration is done by a servicetechnician with a service card.

6.3.8 VOLUME SETTING

Depending on the ventilator configuration theinspiratory volume can be set as:

Minute Volume or,

Tidal Volume

Note: The configuration is done by a servicetechnician with a service card.

6.3.9 CONTROLLED / SUPPORTEDPRESSURE LEVEL

PC (Pressure Control level) above PEEP is theset inspiratory pressure level for eachmandatory breath in Pressure Control andSIMV (PC) + PS, and also for Apnea backupin Pressure Support.

PS (Pressure Support level) above PEEP is theset inspiratory pressure support level fortriggered breaths in Pressure Support, SIMVmodes and Bi-Vent.



6.3.10 O2 CONCENTRATION

The setting range for the gas mixer is 21% O2

to 100% O2. The alarm limits are automatically

set at approximately 5% O2 above or below

the set concentration value. The alarm isdelayed 40 seconds after changing the O2

concentration setting. There is also anabsolute minimum alarm limit of 18% O2 which

is independent of operating settings.

6.3.11 RESPIRATORY RATE / SIMVFREQUENCY

Respiratory rate is the number of controlledmandatory breaths per minute in controlledmodes excluding SIMV. The respiratory rateis also used for calculation of tidal volume ifthe ventilator is configured for Minute volumesetting. SIMV rate is the number of controlledmandatory breaths in SIMV modes.

6.3.12 PREVIOUS MODE

23

1. Time when previous mode wasinactivated.

2. Name of the previous mode.

3. Press the pad Show previous mode torecall the previous accepted ventilationmode.

4

4. Activate the previous used ventilationmode settings by pressing the Acceptpad.



Notes:The previous mode function is notavailable after a Pre-use check, changingof patient category, admitting a newpatient, use of the same ventilation modefor more than 24 hours or after start-up(cold start) of the system.

When Previous Mode is activated duringBackup ventilation, the ventilator returnsto the mode that was active beforeSupport mode was initiated.

A recall of previous settings is onlypossible after a change of ventilationmode.



6.4 CONTROLLED VENTILATION - PRVC

6.4.1 FUNCTIONAL DESCRIPTION PRVC

The Pressure Regulated Volume Control(PRVC) mode is a controlled breathing mode.

SERVO-i Ventilator System can be configuredto set Tidal Volume or Minute Volume. Thefollowing parameters are set:1. Tidal Volume (ml) or Minute Volume (l/min)

2. Respiratory Rate (b/min)

3. PEEP (cmH2O)

4. Oxygen concentration (%)

5. I:E ratio / Insp. time

6. Inspiratory rise time (%/s)

7. Trigg. Flow / Trigg. Pressure

The ventilator delivers a pre-set Tidal Volume.The pressure is automatically regulated todeliver the pre-set volume but limited to5 cmH2O below the set upper pressure limit.

The flow during inspiration is decelerating. Thepatient can trigger extra breaths.



6.4.2 PRVC IN DETAIL

1 2 3

SVX-9006_XX

1. PRVC assures a set target minuteventilation to the patient. The targetvolume is based upon settings for TidalVolume, frequency and inspiration time.

2. The inspiratory pressure level is constantduring each breath, but automaticallyadapts in small incrementsbreath-by-breath to match the patient´slung mechanical properties for targetvolume delivery.

3. Inspiration starts according to a presetfrequency or when the patient triggers.

Expiration starts:a. After the termination of preset inspiration

time

b. If the upper pressure limit is exceeded.



SVX-697_EN

The first breath of a start sequence is avolume-controlled test breath with Pause timeset to 10%. The measured pause pressure ofthis breath is then used as the pressure levelfor the following breath. An alarm is activatedif the pressure level required to achieve theset target volume cannot be delivered due toa lower setting of the Upper pressure limit(- 5 cmH2O).



6.5 CONTROLLED VENTILATION - VOLUME CONTROL

6.5.1 FUNCTIONAL DESCRIPTION VOLUMECONTROL

Volume Controlled ventilation ensures that thepatient receives a certain pre-set Minute/TidalVolume.

SERVO-i Ventilator System can be configuredto set Tidal Volume or Minute Volume. Thefollowing parameters are set:1. Tidal Volume (ml) or the Minute Volume

(l/min)


3. PEEP (cmH2O)



6. Pause time (%/s)



The airway pressure is dependent on the tidalvolume, inspiration time and the resistanceand compliance of the respiratory system. Theset tidal volume will always be delivered. Anincrease in the resistance and decrease incompliance will lead to an increased airwaypressure. To protect the patient's lungs fromexcessive pressure, it is very important to setthe upper pressure limit to a suitable value.

It is possible for the patient to trigger extrabreaths if they can overcome the pre-settrigger sensitivity. It is also possible for thepatient, by their own inspiratory efforts, toreceive a higher inspiratory flow and TidalVolume during an inspiration than pre-set. Theflow during inspiration is constant. The patientcan trigger extra breaths.



Volume Controlled ventilation has, by tradition,delivered each breath with a constant flow andconstant inspiratory and expiratory times,according to the settings. The SERVO-iVentilator System gives the possibility to thepatient to modify both flow rate and timing.So, if a pressure drop of 3 cmH2O is detected

during inspiration, the ventilator cycles toPressure Support with a resulting increase ininspiratory flow. When the flow decreases tothe calculated target level this flow will bemaintained until the set Tidal Volume isdelivered.

SVX-652_EN

The illustrated waveform show some practicalconsequences of this enhanced functionality.

the top waveform shows the trace for anormal Volume Controlled breath

the second waveform shows a situationwhen inspiration is prematurely interruptedas the set tidal volume has been delivered

the third waveform shows a situation wherethe patient maintains a flow rate higher thanthe calculated target value. The set TidalVolume has been delivered when calculatedtarget flow is reached and the inspiration isprematurely interrupted

the bottom waveform, shows a situationwhere the increased flow rate is maintainedinto the expiratory period. The patient willreceive a higher tidal volume than set dueto a higher flow/volume demand thancalculated.



6.5.2 VOLUME CONTROL IN DETAIL

1 2 3

SVX-9002_XX

4

1. Volume Control assures a preset tidalvolume with constant flow during a presetinspiratory time at a preset frequency.

2. The inspiratory flow is constant anddepends on User Interface setting.

3. Inspiration starts according to the presetfrequency or when the patient triggers.

4. If the patient makes an inspiratory effortduring the inspiratory period, the ventilatorwill switch to Pressure Support to satisfythe patient´s flow demand.

Expiration starts:a. When the preset tidal volume is delivered

and after the preset pause time.

b. When the flow returns to the set value afterthe preset tidal volume is delivered andafter the preset pause time (on-demandsupport). The patient is however alwaysguaranteed an expiration timecorresponding to at least 20% of the totalbreath.

c. If the upper pressure limit is exceeded.



6.6 CONTROLLED VENTILATION - PRESSURE CONTROL

6.6.1 FUNCTIONAL DESCRIPTIONPRESSURE CONTROL

The Pressure Controlled mode is a controlledbreathing mode.

The following parameters are set:1. PC (Pressure Control level) above PEEP

(cmH2O)


3. PEEP (cmH2O)





The delivered volume is dependent upon thepressure above PEEP, lung compliance andresistance in the patient tube system andairways. This means that the Tidal Volume canvary. Pressure Controlled mode is preferredwhen there is leakage in the breathing systeme.g. due to uncuffed endotracheal tube or insituations when the maximum airway pressuremust be controlled. The flow during inspirationis decelerating. The patient can trigger extrabreaths. If the patient tries to exhale duringthe inspiration, the expiratory valve will allowexhalation as long as the pressure is morethan 3 cmH2O above the set pressure level.

As the delivered tidal volume can vary it is veryimportant to set alarm limits for Minute Volumeto adequate levels.



6.6.2 PRESSURE CONTROL IN DETAIL

1 2 3

SVX-9003_XX

1. Pressure Control assures that the presetinspiratory pressure level is maintainedconstantly during the entire inspiration.Breaths are delivered according to thepreset frequency, inspiration time andinspiratory pressure level resulting in adecelerating flow.

2. The preset pressure level is controlled bythe ventilator. The resulting volumedepends on the set pressure level,inspiration time and the patient´s lungmechanical properties during each breathwith a decelerating flow.

3. Inspiration starts according to the presetfrequency or when the patient triggers.

Expiration starts:a. After the termination of preset inspiration

time.




ACTIVE EXPIRATORY VALVE

SVX-9008_XX

t

If a patient tries to exhale during theinspiration, pressure increases. When itincreases 3 cmH2O above the set inspiratory

pressure level, the expiratory valve opens andregulates the pressure down to the setinspiratory pressure level.

SVX-9009_EN

Upper pressureLimit

t

If the pressure increases to the set upperpressure limit e.g. the patient is coughing, theexpiratory valve opens and the ventilatorswitches to expiration.



6.7 SUPPORTED VENTILATION - VOLUME SUPPORT

6.7.1 FUNCTIONAL DESCRIPTION VOLUMESUPPORT

The Volume Support mode is a patient initiatedbreathing mode, where the patient will begiven support in proportion to their inspiratoryeffort and the target Tidal Volume.

7

8

9

5

6

41

2

3

The following parameters are set:1. Tidal Volume (ml)

2. PEEP (cmH2O)


4. Inspiratory rise time (s)


6. Inspiratory Cycle off (%)

7. PC above PEEP (cmH2O) in backup

ventilation

8. Resp.Rate (b/min) in backup ventilation

9. I:E / Ti (s) in backup ventilation (dependingon configuration)

If the patient’s activity increases the inspiratorypressure support will decrease provided theset Tidal Volume is maintained. If the patientbreathes below the set Tidal Volume theinspiratory pressure support will increase.



SVX-657_EN

The start breath is given with 10 cmH2O

support. From that breath the ventilatorcalculates and continuously regulates thepressure needed to deliver the pre-set TidalVolume.

During the remaining 3 breaths of the start upsequence the maximum pressure increase is20 cmH2O for each breath. After the start up

sequence the pressure increases or decreasesin steps of maximum 3 cmH2O.

If the delivered Tidal Volume decreases belowthe set Tidal Volume the pressure support levelis increased in steps of maximum 3 cmH2O

until preset Tidal Volume is delivered. If thepressure support level causes a larger TidalVolume than preset, the support pressure islowered in steps of maximum 3 cmH2O until

the preset Tidal Volume is delivered.

The maximum time for inspiration is:Infant 1.5 seconds

Adult 2.5 seconds

An alarm is activated if the pressure levelrequired to achieve the set target volumecannot be delivered due to a lower setting ofthe upper pressure limit - 5 cmH2O.

In this mode it is also important to set theapnea time appropriate to the individualpatient situation. If this time is reached thenthe ventilator will automatically switch tobackup ventilation. In all spontaneous modesit is important to set the Minute Volume alarm.



6.7.2 VOLUME SUPPORT IN DETAIL

1 2 3

SVX-9005_XX

1. Volume Support assures a set target TidalVolume upon patient effort by an adaptedinspiratory pressure support.

2. The inspiratory pressure level is constantduring each breath, but alters in smallincrements, breath-by-breath, to matchthe patient´s breathing ability and lungmechanical properties.

3. Inspiration with Volume Support starts:When the patient triggers.

Expiration starts:a. When the inspiratory flow decreases below

a preset fraction of the inspiratory peakflow (Inspiratory cycle-off)


c. Maximum time for inspiration is exceeded.



6.8 SUPPORTED VENTILATION - PRESSURE SUPPORT

6.8.1 FUNCTIONAL DESCRIPTIONPRESSURE SUPPORT

Pressure Support is a patient initiatedbreathing mode in which the ventilatorsupports the patient with a set constantpressure.

7

8

9

5

6

41

2

3

The following parameters are set:1. PS (Pressure Support level) above PEEP

(cmH2O)

2. PEEP (cmH2O)




6. Inspiratory Cycle-off (%)


ventilation



During Pressure Supported ventilation thepatient regulates the respiratory rate and theTidal Volume with support from the ventilator.The higher the pre-set inspiratory pressurelevel from the ventilator the more gas flowsinto the patient. As the patient becomes moreactive the pressure support level may begradually reduced. It is important to set theInspiratory rise time to a comfortable value forthe patient. In Pressure Support the Inspiratoryrise time should normally be increased.



Always set the Apnea time appropriate to theindividual patient situation. If the apnea alarmlimit is reached the ventilator will automaticallyswitch to backup ventilation.

It is also very important to set lower and upperalarm limit for expired Minute Volume.

70%

Inspiratory Cycle-off is important for thepatient’s comfort and ventilatorsynchronization with the patient. InspiratoryCycle-off is the point when inspirationswitches to expiration. E.g. for a patient withexpiratory resistance the inspiratory Cycle-offshould be set to a high value to guaranteeenough time for expiration.

Note: It is important to monitor thecorresponding Tidal Volume levels.

Inspiration: when the patient triggers a breath,gas flows into the lungs at a constantpressure. Since the pressure provided by theventilator is constant, the flow will decreaseuntil the Inspiratory Cycle-off is reached.

Expiration starts when:The inspiratory flow decreases to thepre-set Inspiratory Cycle-off level.

If the upper pressure limit is exceeded.

If the flow drops to a flow range between25% of the peak flow and lower limit forInspiratory Cycle-off fraction level and thespent time within this range exceeds 50%of the time spent in between the start of theinspiration and entering this range.


Adult 2.5 seconds



6.8.2 PRESSURE SUPPORT IN DETAIL

1 2 3

SVX-9004_XX

1. Pressure Support assures that a presetinspiratory pressure level is constantlymaintained upon patient effort.

2. The preset pressure level is controlled bythe ventilator, while the patient determinesfrequency and inspiration time.

3. Inspiration starts when the patient triggers.







6.9 SPONTANEOUS/CPAP

6.9.1 FUNCTIONAL DESCRIPTIONSPONTANEOUS BREATHING/CPAP

The mode Continuous Positive AirwayPressure is used when the patient is breathingspontaneously.


(cmH2O)

2. PEEP (cmH2O)





7. PC (pressure control level) above PEEP(cmH2O).

A continuous positive pressure is maintainedin the airways. Properly set this may preventcollapse of airways. Inspiration starts uponpatient effort. Expiration starts as for PressureSupport above. Always set the Apnea timeappropriate to the individual patient situation.If the apnea alarm limit is reached theventilator will automatically switch to backupventilation.



The alarm should alert staff to take action,either to go back to supported mode orchange to a controlled mode of ventilation.

It is also very important to set lower and upperalarm limit for expired Minute Volume


Adult 2.5 seconds.

6.9.2 SPONTANEOUS BREATHING/CPAPIN DETAIL

True spontaneous breathing will occur:In Volume Support when the targetvolume is maintained without support(automatically regulated by the ventilator)

-

- In Pressure Support when the inspiratorypressure level is set to zero

- In Automode when either of the abovedefined conditions is met.

Inspiration starts upon patient effort.





6.10 AUTOMODE

6.10.1 AUTOMODE FUNCTIONALDESCRIPTION

SVX-602_EN

Automode is a ventilator functionality wherethe ventilator adapts to the patient's varyingbreathing capacity and automatically shiftsbetween a control mode and a support modeusing a fixed combination of ventilationmodes. There are three different combinations,depending on the modes installed:Volume Control <----> Volume Support

PRVC <----> Volume Support

Pressure Control <----> Pressure Support.

Note: Automode is not possible in NIV.



6.10.2 VOLUME CONTROL<->VOLUMESUPPORT

The ventilator uses the plateau pressure in theVolume Controlled breath as a referencepressure for the first Volume Supportedbreath.

6.10.3 PRVC <-> VOLUME SUPPORT

The first supported breath delivered to thepatient has the same pressure level as thepreceding PRVC breath.

6.10.4 PRESSURE CONTROL<->PRESSURESUPPORT

In this combination of Automode – PressureControl and Pressure Support – the DirectAccess Knob will always regulate the PressureControl level (PC above PEEP). The PressureSupport level (PS above PEEP) can beadjusted through Additional Settings or in theVentilation Mode window.



6.10.5 AUTOMODE IN DETAIL

1. The ventilator starts in control mode andoperates according to the Volume Control,PRVC or Pressure Control mode. If thepatient triggers a breath, the ventilator willturn to support mode, to encourage thepatient's respiratory drive.

2. If the patient is breathing adequately:In Volume Support the ventilatoradjusts the inspiratory pressure levelbreath-by-breath to assure the presettarget volume.

a.

b. In Pressure Support the ventilatorassures that the preset inspiratorypressure level is maintained constantlyduring the entire inspiration.

3. Exceeding the default or manually settrigger timeout limit without a sufficientpatient effort will cause:

In Volume Support; a PRVC or Volumecontrolled breath will be deliveredaccording to the selected automodefunctionality.

a.

b. In Pressure Support; a Pressurecontrolled breath will be delivered.

4. The ventilator initially adapts with adynamic trigger timeout limit. This meansthat for the spontaneously triggeringpatient, the trigger timeout limit increasessuccessively until the set trigger timeoutlimit is reached.



PRVC - VOLUME SUPPORT

SVX-165_EN

VOLUME CONTROL - VOLUME SUPPORT

SVX-222_EN

PRESSURE CONTROL - PRESSURESUPPORT

SVX-167_EN



6.11 SIMV

6.11.1 FUNCTIONAL DESCRIPTION SIMV

SIMV is a combination mode where the patientreceives mandatory breaths synchronized withhis breathing efforts and according to theselected SIMV mode. The patient can breathspontaneously with Pressure Support inbetween the mandatory breaths.

There are three different SIMV modes,depending on the modes installed:

SIMV (PRVC) + Pressure Support

SIMV (Volume Control) + Pressure Support

SIMV (Pressure Control) + Pressure Support

6.11.2 THE MANDATORY BREATH

SIMV (PC) + PSSIMV (PRVC)+PSSIMV (VC)+ PS

XPC above PEEP

XXTidal volume /Minutevolume

XXXSIMV rate

X1X1X1Breath cycle time

XXXI:E ratio / Inspiration time

XXXInsp. rise time

XPause time

1 Only when the ventilator is configured for I:E ratio setting.



The Mandatory breath is defined by the basicsettings (as shown in the table above): MinuteVolume/Tidal Volume (depending onconfiguration), PC above PEEP, I:Eratio/Inspiration time (depending onconfiguration), Pause time, Inspiratory rise timeand Breath cycle time.

Note: In the Minute Volume configurationthe Tidal Volume is determined by MinuteVolume divided by SIMV rate.

The Breath cycle time is the length of themandatory breath in seconds.

For example: A SIMV rate of 6, a breath cycletime of 3 seconds with an I:E ratio of 1:2means that the inspiration will take 1 secondand the expiration 2 seconds.

SIMV Period

10 sec

SIMV Cycle

SIMV Period Spon. Period3 7 3

SVX-9010_EN

During the SIMV period, the first triggeredbreath will be a mandatory breath. If thepatient has not triggered a breath within thefirst 90% of the Breath Cycle time a mandatorybreath will be delivered.

Note: If the ventilator is configured forsetting of Inspiration time, an I:E ratio of 1:2will be used to estimate the Breath cycletime.

The spontaneous/pressure supported breathsare defined by setting the Pressure supportlevel above PEEP.



6.11.3 SIMV (PRVC) + PRESSURE SUPPORT

The following parameters are set:1. Tidal Volume (ml)/Minute Volume (l/min)

2. SIMV rate (b/min)

3. PEEP (cmH2O)




7. Breath cycle time (s)

Note: The soft key Breath cycle time isnot shown when an SIMV mode isselected and inspiration time isconfigured.



10. PS (Pressure Support level) above PEEP(cmH2O)



6.11.4 SIMV (PRVC) + PRESSURESUPPORT

34

1

2

SVX-9027_EN

SIMVBreath cycletime

V

P

Spont. periodSIMV

Breath cycletime

90%time

time

6.11.5 SIMV - IN DETAIL

1. This combined control and pressuresupport/spontaneous function allows forpreset mandatory breaths synchronizedwith the patient's breathing.

2. If there is no trigger attempt within a timewindow equal to 90% of the set Breathcycle time, a mandatory breath isdelivered. (The Breath cycle time is thetotal time for one mandatory breath.)

3. The mandatory breath is defined by thebasic settings (mode of ventilation, breathcycle time, respiratory pattern andvolumes/pressures).

4. The spontaneous/pressure supportedbreaths are defined by the setting forPressure Support.



6.11.6 SIMV (VOLUME CONTROL) + PRESSURE SUPPORT

The following parameters are set:1. Tidal Volume (ml)/Minute Volume (l/min)


3. PEEP (cmH2O)



6. Pause time (%/s)






11. PS (Pressure support) above PEEP(cmH2O)



6.11.7 SIMV (VOLUME CONTROL) + PRESSURE SUPPORT

4

1

3

2

SVX-9011_EN

V

P

SIMVBreath cycle time Spont. period

SIMVBreath cycle time

90%time

time








6.11.9 SIMV (PRESSURE CONTROL) + PRESSURE SUPPORT


(cmH2O)


3. PEEP (cmH2O)











6.11.10 SIMV (PRESSURE CONTROL) + PRESSURE SUPPORT

34

1

2

SVX-9027_EN

SIMVBreath cycletime

V

P

Spont. periodSIMV

Breath cycletime

90%time

time








6.12 BI-VENT

6.12.1 FUNCTIONAL DESCRIPTION

Bi-Vent is pressure controlled breathing thatallows the patient the opportunity ofunrestricted spontaneous breathing. Twopressure levels are set together with theindividually set duration of each level.Spontaneous breathing efforts can be.assisted by pressure support

The following parameters are set:1. Pressure high (PHigh) for the higher

pressure level (cmH2O)

2. PEEP for the lower pressure level (cmH2O)


4. Time at the higher pressure (THigh) level(s)

5. Time at the lower pressure (TPEEP) level(s)




9. Pressure Support level above PHigh(cmH2O)

10. Pressure Support level above PEEP(cmH2O)



In the Bi-Vent mode the ventilator uses twoshifting pressure levels, with the patient beingable to breath spontaneously on both theselevels.

Since Bi-Vent is basically a controlled modeof ventilation, apnea alarm and backupventilation are not available. It is also veryimportant to set lower and upper alarm limitfor expired Minute Volume.

Every Bi-Vent cycle is regarded asautonomous and therefore most of themeasured values are updated every Bi-Ventcycle, i.e. minute volumes, respiratory rate,mean pressure and end expiratory pressure.In accordance to this, associated alarms arealso handled for every Bi-Vent cycle.

At extreme settings the update of measuredvalues and alarms will show a mandatoryfrequency dependence even in the face ofpreserved spontaneous breathing.

As a result of switching between two differentpressure levels, the tidal volumes may varysignificantly between different breaths. Thismay also be the case for etCO2 concentration.

It is not recommended to use Auto scale inBi-Vent mode, when patient is breathingspontaneous on both levels.



6.12.2 BI-VENT IN DETAIL

3

1

2 4

5

SVX-184_XX

This function allows for spontaneous breathing/ pressure supported ventilation at twodifferent pressure levels. These basic levelsare individually set, as well as the time inseconds at each level.The ventilator alwaystries to synchronize with the patient´sbreathing.

1. Bi-Vent cycle; THigh + TPEEP

2. PEEP

3. PHigh

4. PS above PEEP

5. PS above PHigh



6.13 NON INVASIVE VENTILATION

6.13.1 NON INVASIVE VENTILATION

This chapter refers to when the SERVO-iVentilator System is used during Non InvasiveVentilation (NIV). NIV refers to ventilation,where the patient is not intubated ortracheotomized. It is achieved using a nasalmask / prongs, face mask / prongs or full-facemask / prongs. See chapter Introduction,section The NIV Helmet with SERVO-iVentilator System Universal on page 203 forfurther information about using a helmet.

Note: In NIV, flow and pressure curves andthe measured values: VTi, VTe, MVe, MViare compensated for leakage.

The NIV disconnect function is available in allNIV modes including Nasal CPAP and can beset via the Biomed>Edit startup configurationwindow.

The setting can be used to ensure a constantdisconnect flow while ventilation is paused(High flow and Low flow) or as a way to avoidpausing ventilation in case of high leakage(Disabled).

AdultHigh flow: 40 l/min

Low flow: 7.5 l/min

Disabled: The ventilator will continue todeliver assist even when leakage isexcessive.

InfantHigh flow: 15 l/min

Low flow: 7.5 l/min

Disabled: The ventilator will continue todeliver assist even when leakage isexcessive.



WARNINGS!Avoid high inspiratory pressure as it maylead to gastric overdistension and risk ofaspiration. It may also cause excessiveleakage.

The dead space will increase when useof a mask / prongs.

NIV is not intended to be used onintubated patients.

CO2 measurement will be affected by

mask / prongs leakage.

CAUTIONS:Mask / prongs leakage might affect thenebulizer efficiency.

It is not recommended to use thenebulizer during NIV as the nebulizeddrug might come in contact with thepatient eyes in case of leakage.

Important:The mask / prongs must be applied inorder to avoid leakage.

Selection of the mask / prongs must takeinto consideration proper size and anaccurate adaptation to the patient.

CO2 rebreathing will increase during NIV

and use of a face mask / prongs.

Read about alarm settings on page 186.

See also Set Ventilation Mode on page 51.



6.13.2 FUNCTIONAL DESCRIPTIONPRESSURE CONTROL

The Pressure Controlled (NIV) mode is acontrolled breathing mode.

SVX-9013_XX


(cmH2O)


3. PEEP (cmH2O)




Differences from invasive Pressure controlmode:

When the Standby key is pressed a waitingposition dialog is shown. All patient relatedalarms are turned off during 120 seconds.Press the Start ventilation pad to start theventilation.

During NIV the ventilator automaticallyadapts to variations in leakage in order tomaintain the required pressure and PEEPlevel. If leakage is excessive, the ventilatorwill issue a high priority alarm and deliver aflow according to settings. Ventilation willresume automatically if the leakagedecreases. Ventilation can also be startedmanually by pressing the Resume ventilationpad in the dialog.

Trigger sensitivity cannot be set in NIV.

Detection of pressure below PEEP orexpiratory volume decrease will start a newbreath.





6.13.3 FUNCTIONAL DESCRIPTIONPRESSURE SUPPORT

Pressure Support (NIV) is a patient initiatedbreathing mode in which the ventilatorsupports the patient with a set constantpressure.

6

7

8

541

2

3

SVX-9014_XX


(cmH2O)

2. PEEP (cmH2O)





ventilation



Differences from invasive Pressure supportmode:

When the Standby key is pressed a waitingposition dialog is shown. All patient relatedalarms are turned off during 120 seconds.Press the Start ventilation pad to start theventilation.

During NIV the ventilator automaticallyadapts to variations in leakage in order tomaintain the required pressure and PEEPlevel. If leakage is excessive, the ventilatorwill issue a high priority alarm and deliver aflow according to settings. Ventilation willresume automatically if the leakagedecreases. Ventilation can also be startedmanually by pressing the Resume ventilationpad in the dialog.

The ventilator will not lock in backupventilation. There is no limit on the numberof times the ventilator can switch betweensupported mode and backup.

Trigger sensitivity cannot be set in NIV.





6.14 NASAL CPAP

6.14.1 FUNCTIONAL DESCRIPTION NASALCPAP

The mode Nasal Continuous Positive AirwayPressure is used when the patient is breathingspontaneously.

SVX-9057

The following parameters are set:1. CPAP (cmH2O)


SVX-9061

During NIV the ventilator automatically adaptsto the variation of leakage in order to maintainthe required pressure. If the leakage isexcessive, the ventilator will issue a highpriority alarm, deliver a continuous flow andpause breath cycling. Ventilation will resumeautomatically if the leakage decreases.Ventilation can also be started manually bypressing the Start ventilation pad in theexcessive leakage dialog.

Differences from invasive CPAPWhen the Standby key is pressed a waitingposition dialog is shown. All patient relatedalarms are turned off during 120 seconds.Press the Start ventilation pad to start theventilation.

Trigger and cycle-off is automaticallyadapted to the leakage and cannot be setin Nasal CPAP.



There is no backup ventilation available inNasal CPAP.

The apnea alarm can be turned off in NasalCPAP.

The following functions are not availableduring Nasal CPAP ventilation:

- Volume curve

- Loops

- Open Lung Tool

- Additional values

- Additional settings

- Inspiratory hold

- Expiratory hold

- CO2 Analyzer.

WARNINGS!When using Nasal CPAP, make sure thatthe airways are kept clear of mucus anddebris.

If Nasal prongs are used make sure thatthey are applied so that air can flow freelythrough both prongs.

Patient effort and artifacts affectingpatient flow or pressure such as heartbeats, movement of patient tubing,intermittent leakage may not always becorrectly detected or discriminated. Thismay affect the accuracy of alarms andmeasured parameters, so therefore weadvise that additional patient monitoringshould be in place.



Important:The patient interface (e.g. nasal mask,nasal prongs, endotracheal tube abovethe vocal cords) must be applied in orderto avoid leakage.

Make sure that the patient interface isthe correct size and is accuratelyadapted to the patient.

CO2 re-breathing will increase during

Nasal CPAP if a nasal or facial mask isused.



6.15 BACKUP VENTILATION

Volume support

Pressure support/CPAP, NIV PS, NAVA, NIV NAVA

Apnea

Pressure control

Volume control

Backup ventilation is available in all supportmodes (not applicable in Automode and NasalCPAP).

The apnea alarm can be set in infant mode(5-45 seconds) and in adult mode(15-45 seconds). The minimum backuppressure level is 5 cmH2O.

See the tabulated breathing parameter settingson page 241.



6.15.1 INVASIVE VENTILATION

FUNCTIONAL DESCRIPTION

Backup ventilation switches Volume Supportto Volume Control and PressureSupport/CPAP and NAVA PS to PressureControl.

1

2

3

The following parameters are set:1. PC above PEEP (cmH2O) in backup

ventilation, Pressure Support and NAVA

Tidal Volume (ml) in backup ventilation,Volume Support



NO PATIENT EFFORT

In case of apnea, the ventilator will switch tobackup ventilation according to the backupsettings at the end of the set apnea time minusone second.

The Apnea time can be set in the Alarm Profilewindow.

Backup is indicated in the active Ventilationmode touchpad and the alarm No patient effortis displayed on the screen.

The No patient effort alarm can be audiodelayed in Infant category only, see page 130.

If the patient triggers, the ventilatorautomatically switches back to the supportedmode.



APNEA AUDIO DELAY (INFANT ONLY)

The Apnea audio delay (silencing the Nopatient effort alarm) can be set via theBiomed>Edit configuration>Infant alarm limitswindow.

The delay can be set between 0 and 30 s.

During backup ventilation the message Alarmaudio pause is displayed on the screen.

Apnea audio delay is not shown in the Alarmprofile window.

NO CONSISTENT PATIENT EFFORT

If the patient fulfils the criteria for the Noconsistent patient effort alarm, the ventilatorwill lock in backup ventilation.

A dialog You are in Backup ventilation. Reviewventilation settings or continue in supportmode is displayed on the screen. As long asthis dialog is open no other menu window ordialog can be accessed. Only the Standbytouchpad is active.

The user will be given the following choices:

1 2

1. Review vent. settings

2. Continue in support mode

The ventilator will remain in backup ventilationuntil a choice is made.



REVIEW VENTILATION SETTINGS

Press Review vent. settings in the Backupventilation window to return to the SetVentilation Mode window.

321

The following functions are available:1. Previous Mode - recalls the previous

accepted ventilation mode.

2. Cancel - closes the Set Ventilation Modewindow without changes being applied,i.e. ventilation will continue as before.

3. Accept - accepts the settings andcontinues in the supported mode withreset apnea time.

CONTINUE IN SUPPORT MODE

Press Continue in support mode in the Backupventilation window to continue in supportmode. The apnea time will be reset.



6.15.2 NON INVASIVE VENTILATION

FUNCTIONAL DESCRIPTION

Backup ventilation switches both NIV PressureSupport and NIV NAVA to NIV PressureControl.

1

2

3


ventilation



NO PATIENT EFFORT

In case of apnea, the ventilator will switch tobackup ventilation according to the backupsettings at the end of set apnea time minusone second.

Backup is indicated in the active Ventilationmode touchpad and the alarm No patient effortis displayed on the screen.

The No patient effort alarm can be audiodelayed for the Infant patient category only,see page 133.

If the patient triggers, the ventilatorautomatically switches back to the supportedmode.



APNEA AUDIO DELAY (INFANT ONLY)

The Apnea audio delay (silencing the Nopatient effort alarm) can be set via theBiomed>Edit configuration>NIV Infant alarmswindow.

The delay can be set between 0 and 30 s.

During backup ventilation the message Alarmaudio pause is displayed on the screen.

Apnea audio delay is not shown in the Alarmprofile window.

6.15.3 DISABLING BACKUP VENTILATION

It is possible either to enable or disablebackup ventilation via the Biomed menu (thisis possible in Pressure Support and VolumeSupport). If this choice is made, then an extratouchpad (Backup ventilation) (1), is displayedin the Set Ventilation Mode window duringventilation.

Note: It is only possible to deactivatebackup ventilation in running mode, not inStandby mode.

1



To disable backup ventilation:1. Press the Backup ventilation touchpad.

2. A confirmation dialog Do you really wantto deactivate backup ventilation? isdisplayed. Confirm by pressing Yes.

3. Backup ventilation off is displayed on theVentilation mode touchpad.

4. Press Accept in the Set Ventilation Modewindow.

The backup function is automaticallyre-activated if the user:

Changes to a controlled mode of ventilation.

Sets the ventilator to Standby mode.

Turns off the system.

Note: The backup ventilation remainsinactive if the user changes mode betweenPressure Support and Volume Support.



6.16 VENTILATORY PARAMETERS - OVERVIEW

SVX-202_EN

When a ventilation mode is selected, the onlyparameters shown are those affecting theactual mode. Below are all the mode-relatedparameters presented.

1. Respiratory rate (RR) Rate of controlledmandatory breaths or used for calculationof target volume (b/min).

2. Tidal volume (VT) Volume per breath ortarget volume (ml).Minute volume (Vmin) Volume per minuteor target Minute volume (ml/min or l/min).Presentation can be configured to eithertidal or minute volume.

3. PC above PEEP Inspiratory pressure levelfor each breath (cmH2O) in Pressure

Control.

4. PS above PEEP Inspiratory pressuresupport level for triggered breaths(cmH2O) in Pressure Support.

5. Inspiratory rise time (T inspiratory rise)Time to full inspiratory flow or pressure atthe start of each breath, as a percentageof the breath cycle time (%), or in seconds(s).

6. I:E ratio (I:E) (Inspiration time + Pausetime): Expiration time.



7. Inspiration time (Ti) Time for active flow orpressure delivery to the patient (s).

8. Pause time (Tpause) Time for no flow orpressure delivery (% or s).

9. Trigger sensitivitya. Below zero: Trigger sensitivity is

pressure dependant. The pressurebelow PEEP which the patient mustcreate to initiate an inspiration (cmH2O)

is indicated.

b. Above zero: Trigger sensitivity is flowdependent. As the dial is advanced tothe right (step wise from the green intothe red area) the trigger sensitivityincreases i.e the inhaled fraction of thebias flow leading to triggering isreduced.

10. PEEP Positive End Expiratory Pressure(cmH2O).

11. Inspiratory cycle-off Fraction of maximumflow at which inspiration should switch toexpiration (%).



SVX-218_EN

SVX-203_EN

12. Breath cycle time (Breath cycle T) Totalcycle time per mandatory breath in SIMV(inspiratory + pause + expiratory). Set inseconds.

13. SIMV rate Rate of controlled mandatorybreaths (b/min).

14. Trigger timeout The maximum allowedapnea time in Automode, after which thesystem switches to controlled ventilation(s).

O2 concentration (O2 Conc.) O2 concentration

in inspiratory gas (not shown in the figure).



SVX-204_XX

15. Time high (THigh) Time at PHigh level inBi-Vent (s).

16. Time PEEP (TPEEP) Time at PEEP levelin Bi-Vent (s).

17. Pressure Support above Pressure high(PS above PHigh) Inspiratory pressuresupport level for breaths triggered duringthe THigh period in Bi-Vent (cmH2O).

18. Pressure Support above PEEP (PS abovePEEP) Inspiratory pressure support levelfor breaths triggered during the TPEEPperiod in Bi-Vent (cmH2O).

19. Pressure high (PHigh) Positive EndExpiratory Pressure at the upper level inBi-Vent (cmH2O).

20. PEEP Positive End Expiratory Pressure atthe lower level in Bi-Vent (cmH2O).



6.17 SPECIAL FUNCTIONS

6.17.1 FIXED KEYS

1. Start breath

2. O2 breaths

3. Expiratory hold

4. Inspiratory hold

Can all be chosen by manually pressing therespective fixed key.

START BREATH

The ventilator will initiate a new breath cycleaccording to the current ventilator settings.



O2 BREATHS

This function allows 100% oxygen to be givenfor 1 minute. After this time the oxygenconcentration will return to the pre-set value.The oxygen breaths can be interrupted byrepressing the O2 breaths fixed key during the

1 minute interval.

EXPIRATORY HOLD

Expiratory and inspiratory valves are closedafter the expiration phase is completed, for aslong as the fixed key is depressed, up to amaximum of 30 seconds. Expiratory holdprovides an exact measurement of the endexpiratory pause pressure. It can be used forstatic compliance measuring and to determinethe total PEEP. The dynamic pressure isshown on the PEEP numerical value.



INSPIRATORY HOLD

Inspiratory hold is activated by manuallypressing the fixed key. The maximum time is30 seconds. The inspiratory and expiratoryvalves close after inspiration. This function canprovide an exact measurement of the endinspiratory lung pressure. It can be usedduring x-ray or to determine Plateau pressure,or static compliance calculation.



6.18 OPEN LUNG TOOL

The Open Lung Tool providesbreath-by-breath graphical presentation of thefollowing parameters:

End inspiratory pressure

PEEP

VT

Dynamic compliance

Tidal CO2 elimination (with CO2 Analyzer -

option)

Note:The Open Lung Tool is not available inBi-Vent and NIV modes.

When the Y Sensor Measuring (option)function is active, the values recorded inthe Open Lung Tool are based on valuesmeasured at the Y Piece. When this functionis disabled or enabled, the compliance inthe patient circuit may cause the values inthe Open Lung Tool to change.

6.18.1 USE THE OPEN LUNG TOOL

SVX-6069a_XX

To use the Open Lung Tool:1. Press the fixed key Quick access.

2. Press the Open Lung Tool touchpad.

3. Activate Cursor Mode by pressing theCursor touchpad. Move the cursor usingthe Main Rotary Dial or touch screen.



Note: The cursor allows you to analyze thestored breath-by- breath data. When theCursor touchpad is activated the cursorvalues will be shown in the value field.

4. To clear all waveforms press the Cleartouchpad.

Note: The Clear touchpad is not active inCursor Mode.

5. To close the Open Lung Tool Window,press the Close touchpad.

6. Alter the resolution on the time axis.

7. Real-time value field.

Note: If additional windows such as loopsare activated, the Open Lung Tool Windowwill be minimized and some functionbuttons will not be visible.

6.18.2 ADJUST SCALES IN OPEN LUNGTOOL DISPLAY

To set the amplitude for displayed waveforms:1. Press the fixed key Quick access.

2. Press the Open Lung Tool scalestouchpad.

3. Press the touchpad corresponding to thewaveform whose scale you want to adjust.

4. Turn the Main Rotary Dial to the desiredvalue.



Notes:When you reach a maximum allowedvalue, its display will flash.

The time parameter displayed in thelower right corner of the user interfacescreen indicates how long it will take atthe current settings for the waveform tocomplete one left-to-right sweep acrossthe screen. Change the scaling with thezoom in/out function to speed up or slowdown the screen-filling process.

The breaths parameter displayed in thelower right corner of the user interfacescreen indicates the number of breathsat the current respiratory rate requiredfor the waveform to fill the screen.



6.19 HELIOX

6.19.1 GENERAL DESCRIPTION

A Heliox enabled SERVO-i Ventilator Systemcompensates monitoring and flow deliverywhen HeO2 is used. HeO2 gas is connected

to the SERVO-i Ventilator System via a Helioxadapter, which is connected to the Air/HeO2

inlet. A pressure regulator is integrated in theHeliox adapter.

Four different Heliox adapters can be usedwith the SERVO-i Ventilator System:

DISS (both Air and Heliox adapters)

NIST/NIST

AGA/NIST

French/NIST

A. B.

A. Air adapter DISS B. Heliox adapter DISS

Heliox adapter (NIST/NIST)

The HeO2 mixtures approved for the SERVO-i

Ventilator System with the Heliox option are:Helium/Oxygen mixture 80:20

Helium/Oxygen mixture 79:21

Helium/Oxygen mixture 78:22

Mixing tolerance must not exceed + 5%.(i.e. ±1 vol% O2 in concentration)

AIR/HeO2 O2

AIR, O2: 2.0 - 6.5 kPa x 100 (29 - 94 psi)HeO2 : Heliox adapter

Vmax 60 l/min

The approved gas supply pressure applied tothe Heliox adapter inlet is 3.4 - 6.5 kPa x 100(49 - 94 psi).



6.19.2 WARNINGS, CAUTIONS ANDIMPORTANT INFORMATION

WARNINGS!Always follow the policy and procedureof the hospital before starting Helioxtreatment.

Never use an HeO2 gas which has an O2

concentration of less than 20%.

The Y-sensor is incompatible with HeO2

and will be disabled when HeO2 is used.

The O2-sensor is incompatible with

Heliox option and will generate atechnical alarm.

Use only the MAQUET approved activehumidifier F&P MR850 with HeO2. Use

of non-approved active humidifiers mayresult in higher gas temperatures.

During nebulization, there may be ahigher deposition of drug used whenHeO2 is used instead of Air.

The Heliox supply hose shall bedisconnected from the Heliox adapter orcylinder regulator before the cylinder ismoved away from the ventilator.

Additional patient monitoring (e.g. SPO2,

CO2) is needed when ventilating patients

in Infant mode with a tidal volume below100 ml due to reduced expiratorymeasurement accuracy.

CAUTIONS:Ensure that O2 gas is always connected

when HeO2 is used with the SERVO-i

Ventilator System.

Do not remove the adapter(s) safetywire(s)

Important:When flow triggering is used andcompensation for HeO2 is made, then

the sensitivity is automatically adjustedto a flow trigger level of 1 (if previouslyset to a higher level). This is done toavoid a self-triggering (auto-triggering)condition due to the different propertiesof HeO2.

The O2 alarm limits are adjusted to + 7%

O2 when the system has been

compensated for HeO2.

Notes:When ventilating with HeO2, the

stabilization of expiratory measurementsis delayed after the concentration ofdelivered O2 is changed.

Due to the lower density of HeO2

compared to Air/O2, the inspiratory flow

in pressure controlled modes increases.In NIV this may shorten the inspiratorytime.



6.19.3 CONNECTING HeO2 TO THESERVO-i VENTILATOR SYSTEM

The system is set up for Heliox usage asillustrated below.

Note: Ensure that the HeO2 gas supply

pressure is within specified range(3.4 - 6.5 kPa x 100 / 49 - 94 psi) beforeconnecting the HeO2 high pressure hose

and Heliox adapter to the SERVO-iVentilator System.

NIST, FRENCH AND AGA ADAPTERS

1. Remove the Heliox adapter from theholder and connect it to the HeO2 high

pressure hose.

2. Connect the Heliox adapter to the Air inlet.

Connecting HeO2 to the SERVO-i Ventilator System



DISS ADAPTERS

1. Connect the high pressure HeO2 hose to

the Heliox adapter.

2. Remove the air adapter from the Air/HeO2

inlet of the ventilator.

3. Press the Heliox adapter onto theAir/HeO2 inlet and place the air adapter

onto the adapter holder.

Connecting HeO2 to the SERVO-i Ventilator System with air

adapter DISS and Heliox adapter DISS

6.19.4 CHANGING GAS TYPE

You can change the gas type from air to HeO2

and vice-versa both in the Standby mode andduring ventilation.

The instructions below show how to changefrom air to HeO2, but the same procedure

applies when changing from HeO2 to air.

CHANGING FROM AIR TO HeO2

1. Change the gas type by pressing:Menu > Compensate > Gas type

1



2. The message Make sure HeO2 is

connected before compensating. Do youreally want to compensate for HeO2?

Yes/No is displayed.

1

2

3. Remove the air supply and connect theHeliox adapter to the Air/HeO2 inlet.

Confirm the change by pressing Yes.

4. The HeO2 icon appears in the top

left-hand corner of the screen, indicatingthat the system has been adjusted forHeO2.

5. Another message informs that the systemhas been compensated for HeO2, that

applicable adjustments have been madeand that ventilator settings should bechecked.

6. To confirm press OK.

Note: Both the O2 concentration: High and

Gas supply pressures: Low alarms can beactivated while changing gas duringventilation.

When changing gas type during ventilation,an automatic gas identification function isactive.

If the ventilator identifies a mismatch betweenthe gas selected manually and the gasconnected to the system, then the messageHeO2 not connected. System resets to Air

compensation. Check gas supply. is displayed(1).

1



If more than one minute passes without thedialog being confirmed, then the alarmRequested gas type not connected is activated(2).

2

ALTERNATIVE PROCEDURE FORCHANGING GAS DURING VENTILATION

The automatic gas identification functionmakes it possible to change gas duringventilation by simply changing the gassupplied to the ventilator.

CHANGING FROM AIR TO HeO2

1. Remove the air supply and connect theHeliox adapter to the Air/HeO2 inlet.

2. When the ventilator identifies HeO2, then

the HeO2 icon is displayed next to the

patient category icon and a messageinforms that the system has beencompensated for HeO2, that applicable

adjustments have been made and thatventilator settings should be checked.

3. To confirm press OK (2).

1

2



Notes:The time of automatic gas identificationmay be prolonged when there are lowtidal/minute volumes and high O2

concentrations.

Automatic gas identification is disabledfor set O2 concentrations higher than

75%.

When changing gas type from Air toHeO2 or vice versa, the measured values

on the screen relating to the expiratoryflow may be affected for a short periodof time.



7.1 BEFORE USE

7.1.1 GENERAL DESCRIPTION

NAVA and NIV NAVA ventilation deliversventilatory assist in proportion andsynchronized to the patient’s Edi (the electricalactivity of the diaphragm). The Edi waveformis also available in other ventilation modes formonitoring the patient’s own breathing effortsas well as in Standby.

7.1.2 PATIENT CATEGORIES

NAVA and NIV NAVA can be used on allpatients who require ventilatory assistance(neonatal, pediatric and adult patients). Theadded indications for use of the NAVA orNIV NAVA software are that the electricalsignal from the brain to the diaphragm isintact, and that there is no contraindication forinsertion/exchange of nasogastric tube.

7.1.3 TERMS AND ABBREVIATIONS

Electrical activity of thediaphragm.

Edi:

A single-use feeding tubewith measuring electrodes.

Edi Catheter:

The predefined level that theEdi signal has to reach tostart a new inspiration.

Edi Trigger:

The distance between the EdiCatheter electrodes.

IED:

Neurally Adjusted VentilatoryAssist. Used to refer toinvasive NAVA.

NAVA:

The relation betweenmeasured Edi signal andpressure assist provided.

NAVA level:

Ventilation with NAVA or NIVNAVA.

NAVAventilation:

Non Invasive VentilationNeurally Adjusted VentilatoryAssist. Used to refer to noninvasive NAVA.

NIV NAVA:

Neuro Ventilatory Tool.NVT:


| 7 | NAVA |

7.1.4 WARNINGS, CAUTIONS ANDIMPORTANT INFORMATION

Important:Ensure that the electrical connector onthe Edi Catheter does not get wet. Thismay result in degradation of the function.

The feeding lumen of the Edi Catheter isslightly smaller compared to the feedinglumen of a standard feeding tube of thesame size; this must be taken intoconsideration especially for Edi catheters6 and 8 Fr.

When ventilating patients weighing lessthan 3 kg in NIV NAVA, externalmonitoring (e.g. SpO2 or CO2) is required.

In NIV NAVA, small tidal volumes incombination with high leakage reducethe accuracy of expiratorymeasurements.

Notes:External equipment (e.g. heatingblankets) may cause disturbances in theEdi signal.

Continuous movement of the EdiCatheter (e.g. against another person'sbody when holding the baby in kangarooposition) may cause disturbances in theEdi signal.

Be observant when using NAVAventilation on patients with implanteddefibrillators since this device mayinterfere with Edi signals when activated.

7.2 PATIENT SAFETY

Patients with indwelling electrical devicesshould be carefully monitored to ensurecorrect ventilation.

7.2.1 Edi CATHETER

WARNINGS!The Edi Catheter and guide wire are forsingle use only. Reprocessing willdegrade biocompatibility and/orcleanliness. Each Edi Catheter may beused for up to 5 days.

The Edi Catheter must be removed fromthe patient before an MR examination.Due to the metallic electrodes:- The strong magnetic and RF fields

could generate heat in the electrodes.

- Artifacts (distortions) may appear inthe MR images.

Note: All disposable parts must bediscarded according to hospital routinesand in an environmentally safe way.


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7.2.2 SYMBOLS ON THE Edi CATHETERPACKAGING

ExplanationSymbol

Order number for Edi Catheter

Outer diameter in millimeters

Inner diameter in millimeters

Circumference/lengthFr/cm

Use by date

Number to identify the productionbatch

Do not re-use. Single use only.

Do not use if packaging is damaged

Attention—consult documentation

Note: This symbol may bedifferent depending on panelversion

Keep away from sunlight

Method of sterilization usingirradiation

Manufacturer

The CE mark indicates that thedevice fulfils the provisions of theCOUNCIL DIRECTIVE 93/42/EEC of14 June 1993 concerning medicaldevices applied by the manufacturer.

Manufacturing date

Phthalates

7.3 DESCRIPTION

7.3.1 SYSTEM OVERVIEW

Electrical activity in the diaphragm precedesmechanical contraction of the diaphragmmuscle.

By inserting an Edi Catheter into theesophagus to the gastric ventricle theelectrical activity can be monitored.

Edi Catheter

The Edi Catheter is a single-use feeding tubewith measuring electrodes.

It is positioned in the esophagus so that theset of measuring electrodes spans the path ofmovement of the diaphragm.

The SERVO-i Ventilator System receivesseveral signals from the Edi Catheter and, byfiltering, uses the Edi signal for ventilatorymonitoring and regulation. It also displays theEdi signal as a waveform on the User interface.


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SYSTEM COMPONENTS

The Edi interchangeable plug-in Module slotsinto the module compartment in the SERVO-iVentilator System:

Edi Module (1).

Edi Cable (2).

Edi Test Plug (3).

Edi Catheter (4).


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7.3.2 FUNCTIONAL DESCRIPTION

GENERAL

NAVA and NIV NAVA are patient initiatedbreathing modes in which the breathingsupport is triggered by the electrical activityof the diaphragm (Edi).

During NAVA ventilation the patient controlsthe respiratory rate and the tidal volume withthe assist from the ventilator.

The operator sets the NAVA level. The higherthe NAVA level is set, the more assist is givento the patient.

This NAVA level value is multiplied by themeasured Edi signal to provide a set pressurefor the delivered gas.

NAVA:Edi x NAVA level = gas pressure delivered,above PEEP. For example:5 µV x 3 cmH2O/µV = 15 cmH2O (above PEEP)

NIV NAVA:Edi x NAVA level + 2 cmH2O = gas pressure

above PEEP. For example:5 µV x 3 cmH2O/µV + 2 cmH2O = 17 cmH2O

(above PEEP)

The set pressure varies during the entireinspiration due to the Edi variation, but islimited to 5 cmH2O below the set upper

pressure limit.

If three consecutive breaths are limited, amessage will be presented on the screen.

During the expiratory phase, the Edi does notinfluence the ventilation, therefore the operatorshould set an appropriate PEEP value.

Important:Set upper pressure alarm limit.

Set lower and upper alarm limits forexpired Minute Volume and RespiratoryRate.

Should the ventilator fail to trigger on Edi, buttrigger on pneumatic criteria e.g., if the EdiCatheter moves out of position, there is aguaranteed level of 2 cmH2O for all triggered

breaths (cannot be changed).

The inspiratory cycle off for these breaths willbe either based on pressure (3 cmH2O above

given pressure level) or on time (1.5 s forInfant; 2.5 s for Adult).

See Backup Ventilation on page 128.


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NAVA PARAMETERS

654 7 821 3 109

The following parameters are set:1. NAVA level: The relation between

measured Edi signal and pressure assistprovided. (cmH2O/µV)

2. PEEP (cmH2O)


4. Trigg. Edi: The predefined level that theEdi signal has to reach to start a newinspiration. Too low a value may give extraundesired breaths. Too high a value mayresult in missed inspirations. (µV)

5. Pneumatic trigger (flow or pressure)

6. Pneumatic inspiratory Cycle-off (%)


8. PC (Pressure Control level) above PEEP(cmH2O) in backup ventilation

9. Resp. Rate in backup ventilation

10. I:E / Ti in backup ventilation (dependingon configuration)

NIV NAVA PARAMETERS

1 2 3 4 5 6 7

The following parameters are set:1. NAVA level: The relation between

measured Edi signal and pressure assistprovided. (cmH2O/µV)

2. PEEP (cmH2O)


4. Trigg. Edi: The predefined level that theEdi signal has to reach to start a newinspiration. Too low a value may give extraundesired breaths. Too high a value mayresult in missed inspirations. (µV)

5. PC (Pressure Control level) above PEEP(cmH2O) in backup ventilation

6. Resp. Rate in backup ventilation

7. I:E / Ti in backup ventilation (dependingon configuration)


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7.3.3 RESPIRATION CYCLE

Inspiration starts:When the patient triggers a breath gas flowsinto the lungs at a varying pressureproportional to the patient's Edi.

Expiratory phase starts:When the Edi decreases below 70% of thepeak value (during the ongoing inspiration).

If the pressure increases 3 cmH2O above

the inspiratory target pressure.

If the upper pressure limit is exceeded.


Adult 2.5 seconds

7.4 VENTILATION

Important:As soon as the Edi Catheter position ischecked and verified, it is important toattach the Edi Catheter securely to thepatient.

The patient must have an intactrespiratory drive. Muscle relaxants caninhibit diaphragm activity and preventNAVA ventilation: the Edi Catheter canstay in place until the Edi isre-established (when the relaxant effectshave worn off), and it is possible toventilate with NAVA.


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7.4.1 WORKFLOW

Notes:Always perform a visual inspection of theequipment before use.

The patient will already be ventilated bySERVO-i Ventilator System in aconventional mode.

1. Insert Edi Module and Edi Cable intoSERVO-i Ventilator System, as shown onpage 162.

2. Test the Edi Module and the Edi Cablewith the test plug, as shown on page 162.

3. Select the correct Edi Catheter size forthe patient according to the packagelabelling.

4. Estimate the length of Edi Catheter to beinserted into the patient, as shown onpage 163.

5. Dip the Edi Catheter in water momentarily,as shown on page 164.

6. Insert Edi Catheter into the patient toestimated length, as shown on page 164.

7. Plug the Edi Catheter Cable connectorinto the Edi Cable.

8. Position the Edi Catheter according to theprocedure described on page 165.

9. Check the position of the Edi Catheter asa feeding tube according to hospitalguidelines. Secure as described onpage 168.

10. Set the initial NAVA level with the help ofthe NAVA preview tool, as shown onpage 169. NAVA preview can only be usedin NIV NAVA if NIV PS and/or Nasal CPAPis installed.

11. Select NAVA or NIV NAVA, set theventilation and backup parameters andstart ventilating.

12. Check that the cables are safelypositioned.

13. The Edi signal can also be displayed whenventilatory modes other than NAVA modeare used as well as in Standby. The Edisignal will then be used to monitorsynchrony and patient efforts enabling theuser to manually fine-tune the ventilatorsettings or to monitor when the Edi returnsafter pharmaceutical blocking.


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7.4.2 INSERT Edi MODULE INTO PATIENTUNIT

Important: If the Edi Module is dropped onthe floor a leakage current check must beperformed.

Note: Do not insert two Edi modules at thesame time. The SERVO-i Ventilator Systemcan only handle one Edi module at a time.

To insert the Edi Module:1. Insert the Edi Module into a free slot in the

module compartment on the Patient Unit.2. Make sure it clicks into place.

When required, the Edi Module can beremoved by pushing the lock handle aside andsliding out the module.

7.4.3 Edi MODULE FUNCTION CHECK

1. Connect the Edi Cable to the Edi Module:hold the ribbed part of the connector(white marks to the right) and insert intothe socket.

2. Remove the cap from the test plug andconnect the test plug to the other end ofthe Edi Cable. The Edi Module test willthen start automatically.

3. Wait until the dialog 'Edi Module testpassed' shows on the display.

- If the test fails, replace the Edi Cableand/or Edi Module and re-run the test.To remove the Edi Cable hold theribbed part of the connector and pullgently to release.

4. Press OK, remove the test plug andreplace the cap.


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7.4.4 BEFORE INSERTING THE EdiCATHETER

Important:Always use the correct Edi Catheter sizefor the patient.

The feeding lumen of the Edi Catheter isslightly smaller compared to the feedinglumen of a standard feeding tube of thesame size; this must be taken intoconsideration especially for Edi catheters6 and 8 Fr.

Note: Follow hospital hygiene routines forhandling nasogastric tubes when handlingthe Edi Catheter. The Edi Catheter ispacked sterile.

1. Select the correct Edi Catheter size forthe patient according to the packagelabelling.Verify, by visual inspection, that thepackage and the Edi Catheter areundamaged.

2. Measure the distance from the bridge ofthe Nose (N) via the Earlobe (E) to theXiphoid process (X). This is referred to asthe NEX measurement.

N

E

X

3. Note down the NEX measurement incentimetres, then calculate Y:

For nasal insertion multiply the NEX valueby 0.9 and add the extra centimetres asshown here:

Insertion length YEdiCathetersize

(NEX x 0.9) + 18 = Y cm16 Fr

(NEX x 0.9) + 15 = Y cm12 Fr

(NEX x 0.9) + 18 = Y cm8 Fr 125 cm

(NEX x 0.9) + 8 = Y cm8 Fr 100 cm

(NEX x 0.9) + 3.5 = Y cm6 Fr 50 cm

(NEX x 0.9) + 2.5 = Y cm6 Fr 49 cm

For oral insertion multiply the NEX valueby 0.8 and add the extra centimetres asshown here:

Insertion length YEdiCathetersize

(NEX x 0.8) + 18 = Y cm16 Fr

(NEX x 0.8) + 15 = Y cm12 Fr

(NEX x 0.8) + 18 = Y cm8 Fr 125 cm

(NEX x 0.8) + 8 = Y cm8 Fr 100 cm

(NEX x 0.8) + 3.5 = Y cm6 Fr 50 cm

(NEX x 0.8) + 2.5 = Y cm6 Fr 49 cm

4. Note down the calculated value for theEdi Catheter insertion length Y incentimeters.


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7.4.5 INSERT THE Edi CATHETER

WARNING! Never re-insert the guide wireinto the Edi Catheter when the it ispositioned in the mouth /esophagus,otherwise the guide wire may penetrate afeeding hole.

Important:Do not apply any other substance thanwater to the Edi Catheter. Lubricants,gels or solvents may destroy the coatingand the contact with the electrodes.

When the Edi Catheter is inserted intothe esophagus, do not insert any otherprobe or feeding tube.

If a guide wire is used, only use a wirefrom Maquet.

Note: Make sure that the connector cannothurt the patient; be aware of the distancefrom patient to connector and possiblefixation of connector.

1. Dip the Edi Catheter in water for a fewseconds to activate its lubrication prior toinsertion, avoiding wetting the connectors.

H2O

2. Insert the Edi Catheter and advance itdown the esophagus to the calculated Ylength.

Nasal insertion:

Y cm

Oral insertion:

Y cm


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7.4.6 POSITION THE Edi CATHETER

1. Connect the Edi Catheter to the Edi Cable.Remove the cap from the Edi Catheter,hold the connector and plug it into the EdiCable connector.

Note: To prevent contamination of the EdiCatheter connector, always keep theprotective cap on the connector when it isnot connected to the ventilator.

If already four waveforms are shown on thescreen, the Volume curve will automaticallybe replaced by the Edi curve.

2. Open the Neural access menu using themembrane button Neural access (1)

3. Select Edi Catheter positioning (2).


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The Edi Catheter positioning window opens:

2

3 4 5 6 7

8

1

1. Electrode signalsBlue segments indicate the electrodes with the strongest signals.

2. Edi curve

3. Freeze; freezes the screen image

4. Leads scale (auto, 10 - 200)

5. Edi scale (auto, 5 - 200)

6. Sweep speed (5 – 40 mm/s)

7. Close window

8. Numeric values of the Edi peak and Edi minimum levels


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4. Check the position of the Edi Catheter bymeans of the ECG waveforms:

Verify that the P and QRS waves arevisible on the top leads, and that the Pwaves disappear and the QRS waveamplitude decreases on the lowerleads.

Verify that the Edi scale is fixed and setto 5 µV. Set a sufficiently high upperlimit on the scale that the Edi signaldoes not clip.

If the Edi deflections are present,observe which leads are highlighted inblue.

If the leads highlighted in blue are in thecenter, i.e. second and third leads, thenthe Edi Catheter is aligned correctly andready for fixing.

5. If not already aligned then adjust the EdiCatheter position:

If the top leads are highlighted in blue,pull out the Edi Catheter in stepscorresponding to the IED, until the bluehighlight appears in the centre. Do notexceed 4 IED steps.

If bottom leads are highlighted in blue,insert the Edi Catheter further in stepscorresponding to the IED, until the bluehighlight appears in the center. Do notexceed 4 IED steps.

Inter ElectrodeDistance, IED

Edi Catheter size

16 mm16 Fr

12 mm12 Fr

16 mm8 Fr 125 cm

8 mm8 Fr 100 cm

6 mm6 Fr 50 cm

6 mm6 Fr 49 cm


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6. Before fixation, take up the slack verygently in the Edi Catheter.

7. Note the actual length inserted, in thepatient's journal and mark on the EdiCatheter.

8. Secure the Edi Catheter well, being carefulnot to manipulate or move it in order toavoid interference (of Edi monitoring).

9. Check the Edi curve at the bottom of thepositioning window.

If low or no Edi activity is observed:Verify that the effects of musclerelaxants have worn off.

Verify the patient's sedation level. Theapneic threshold might be higher dueto CNS depressant drugs.

Verify, by blood gas or end tidal CO2,

that the patient is not hyperventilated,as this may affect the Edi.

Too high PEEP level and/or too highsupport pressures may flatten thediaphragm due to hyperinflation, whichwill diminish the diaphragm electricalactivity to a level where it is difficult todetect. In this case gradual reductionof these levels may restore Edi anddiaphragm activity.

10. Check the position of the Edi Catheter asa feeding tube according to hospitalguidelines.

Note: If the Edi is not synchronized withpressure and flow, this may mean that theEdi Catheter is displaced and registeringthe electrical activity of another muscle. Thiswill be indicated by the Pneumatic-Edi outof synch alarm for NAVA and Unreliable Edisignal alarm for NIV NAVA.

Important:Never switch to NAVA ventilation if theEdi deflection is out of sync with thepressure and flow.

When not in use, it is recommended thatthe feeding lumen is covered in order toavoid incorrect use.

If the Edi Catheter is not connected tothe ventilator system, do not touch theEdi Catheter connector duringdefibrillation.


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7.4.7 SET NAVA LEVEL

Set the alarm limits to relevant values toprovide adequate patient safety.

Never switch to NAVA ventilation if no Ediactivity is observed.

1. Press the neural access button.

2. Select NAVA preview.

3. On the uppermost waveform, there aretwo curves presented simultaneously. Thegray curve shows the estimated pressurePest based on Edi and the set NAVA level.

The yellow curve is the current patientpressure.

4. Press the NAVA level button and use theMain rotary dial to set the NAVA level.Press the NAVA level button a secondtime to save the NAVA level. The NAVAlevel will be transferred to the NAVAventilation mode window.

5. To close the window, press Close.


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7.5 NAVA

7.5.1 VENTILATE WITH NAVA

SET UP AND START VENTILATION

Important: Before switching to NAVA /NIV NAVA ventilation, all settings includingbackup settings must be set to achieveadequate ventilation.

1. Open the Select Ventilation Mode window.

2. Choose NAVA.

1 2

3. The Set Ventilation Mode parameterswindow opens.

3

4 5 6

7

8

4. There are three basic settings: NAVA level,PEEP, and O2 conc. The initial NAVA level

has been set. Use adequate values forPEEP and O2 conc.

5. The Edi trigg. can be set between 0.1 and2.0 µV. If no breaths are given while thereis an adequate Edi signal, set a lowertrigger level. If too many breaths are givendue to noise in the Edi signal, raise theEdi trigger level. The trigger is shown witha symbol and a color mark on thewaveform.

6. Pressure support: select values forPneumatic trigger, Insp. cycle off, andPressure Support level.

7. Backup ventilation: select the Pressure,Resp. Rate and I:E / Ti backup levels toachieve adequate ventilation in case ofapnea.

See Backup Ventilation on page 129.

8. Select Accept to accept the settings andproceed with NAVA ventilation.


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If you select Cancel the Set NAVAVentilation Mode window will closewithout changes being implemented. i.e.ventilation will continue as before.

7.5.2 PNEUMATIC-Edi OUT OF SYNCHALARM (NAVA ONLY)

Check for possible causes of asynchronywhen the system activates a Pneumatic-Ediout of synch alarm.

Check:Edi signal

Catheter position

Pneumatic trigger setting

Edi trigger setting

The window will disappear when adequatecorrections are made. If the alarm remainsselect Back to NAVA (1) or Change mode (2).

1 2

A


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BACK TO NAVA

Important: Make sure that there is noasynchrony before using Back to NAVA.

A. Press Back to NAVA (1) to switch fromNAVA (PS) to NAVA.

B. Select Yes (3) to change to NAVA. SelectNo (4) to return to ventilation in NAVA (PS).

3 4

B

CHANGE MODE

1 2

A

A. Select Change mode (2) to open the Setventilation mode window.

B. Select a new ventilation mode and pressAccept (5). Press Previous Mode (6) toreturn to the mode set before NAVA.

6 7 5

B


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Note: If the Accept button is pressedwithout a new ventilation mode being set,the system returns to the Pneumatic-Ediout of synch window and to NAVA (PS).

The system returns to the Pneumatic-Edi outof synch window if Cancel (7) is pressed.

7.6 NIV NAVA

7.6.1 VENTILATE WITH NIV NAVA

NIV NAVA refers to ventilation using:nasal mask

nasal prongs

face mask

total face mask

single tube above the vocal cords

NIV helmet

SET UP AND START VENTILATION

Important: Before switching to NAVA /NIV NAVA ventilation, all settings includingbackup settings must be set to achieveadequate ventilation.

1. Open the Select Ventilation Mode window.

2. Choose NIV NAVA (1).

1


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3. The Set Ventilation Mode parameterswindow opens.

2 43

Basic settings (2):NAVA level, PEEP and O2 conc. The initial

NAVA level has been set. Use adequatevalues for PEEP and O2 conc.

Trigg. Edi (3):The Trigg. Edi can be set between 0.1 and2.0 µV. If no breaths are given while thereis an adequate Edi signal, set a lower triggerlevel. If too many breaths are given due tonoise in the Edi signal, raise the Edi triggerlevel. The trigger is shown with a symboland a color mark on the waveform.

Backup ventilation (4):Select the Pressure, Resp. Rate and I:E / Tibackup levels to achieve adequateventilation in case of apnea.

See Backup Ventilation on page 132 .


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7.7 NEURO VENTILATORY TOOL

The Neuro Ventilatory Tool (NVT) can be usedto study the change in breathing pattern andbreathing related parameters during a changein the assist (NAVA level) in NAVA andNIV NAVA.

The Neuroventilatory Tool window is reachedfrom the Neuroventilatory Tool button of theNeural Access menu.

Curves in the NTV window will be presentedas follows:

First graph: Peak pressure and NAVA levelas curves with relating values, PEEP asnumerical value.

Second graph: Edi peak and min. as curveswith relating values. RR as numerical valueonly.

Third graph: VTe and etCO2 as curves with

relating values, P0.1 and SBI as numericalvalues only.

The scales can be set by accessing NVTscales from the Neural Access menu.

To select which NAVA level to use, increasethe NAVA level from a low to a high assist andlook for an inflection point (plateau) in thewindow. An assumption is that the NAVA levelat the inflection point gives the optimal assistlevel in NAVA.

To select which NAVA level to use in NAVA ,increase the NAVA level from a low to a highassist and look for an inflection point (plateau)in the window. An assumption is that the NAVAlevel at the inflection point gives the optimalassist level in NAVA.

The functionality and interface of the NeuroVentilatory Tool window is similar to the OpenLung Tool window; i.e. data is presented andstored breath by breath, and can be exportedto a PC card.


| NAVA | 7 |


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8.1 INTRODUCTION

The SERVO-i Ventilator System is equippedwith an alarm system to help ensure patientsafety. Visual and audible alarms warn about:

patient breathing problems e.g., apnea

power problems e.g., loss of AC power

problems with gases e.g., low supplypressure

hardware problems e.g., overheating

software problems e.g., memory failure

This chapter describes general responses toalarms, provides the procedure for settingalarm limits (see also the Operation Overviewchapter), and lists breathing-related alarmsettings along with their allowed ranges.

The Power Supply chapter describes powersupply-related alarms.

The System Messages chapter lists all alarmsalong with possible causes and remedies.

WARNINGS!The default setting of the high airwaypressure alarm is 40 cmH2O. It is

important to adjust this setting asappropriate to avoid excessive airwaypressures.

A potential hazard can arise if differentdefault alarm settings are used onventilators or similar equipment whichare located within the same intensivecare unit or cardiac operating theatres.

Important: Those responding to alarmsmust be health care professionals who haveexperience in ventilation treatment and whohave been trained in the use of the SERVO-iVentilator System.


| 8 | Alarms |

8.1.1 ALARM OUTPUT CONNECTIONOPTION

If your system is equipped with the alarmoutput connection option, high and mediumpriority alarms can be transferred to anexternal signal system. The alarm output signalis active as long as the audio alarm is activeon the ventilator.

WARNING!Never leave the patient unattended; theexternal alarm is designed to alert thosealready in attendance.

CAUTION:The alarm output is a nonguaranteed alarmaccording to IEC 60601-1-8 and it isrecommended that users establish aPre-use check routine for this application.

8.1.2 VISUAL ALARM DISPLAY

When an alarm is activated, the followinginformation is supplied on the screen.1. A text message explaining the cause of

the alarm flashes in the alarm messagearea. The alarm with highest priority isdisplayed first.

2. The corresponding measured value or setvalue box flashes and an arrow points atthe exceeded limit.

Note: Two bells in the alarm message areaindicate that more than one alarm isactivated.


| Alarms | 8 |

8.2 HANDLING ALARMS

The system can signal four types of alarm:High Priority—red background

Medium Priority—yellow background

Low Priority—yellow background

Technical—a numeric code

The following sections provide generalinformation about viewing, responding to,silencing, and turning off alarms.

8.2.1 VIEWING THE CURRENT ALARMSWINDOW

If more than one alarm is active, view theCurrent Alarms Window by:1. Press the bell(s) in the alarm message

touchpad.All alarms (up to 10 listed by priority) areshown in a dynamic window that will beupdated if more alarms occur while thewindow is open.

2. View the current alarms.

3. Press the History touchpad.The previous 16 alarm-dependent eventsare listed chronologically, with the mostrecent event at the bottom.

Note: For viewing more than the latest 10alarms, use the Event log to view all loggedalarms.


| 8 | Alarms |

8.2.2 RESETTING LATCHED ALARMS

High Priority alarms are “latched”—the alarmmessage remains on the screen even if thealarm condition ceases. Medium and LowPriority alarms are not latched. The fixed keyAudio Pause resets latched alarms and clearsthe alarm message from the screen.

The Audio Pause key is identified by the symbol.

Note: The NIV alarm Leakage out of rangeis not latched.

8.2.3 RESPONDING TO ALARMS

The procedure for responding to High Priorityalarms differs slightly from that for Mediumand Low Priority alarms. For both, refer to theUsing the Audio Pause Key figure.

To respond to a High or Medium priority alarm:1. If desired, press the Audio Pause fixed

key for less than two seconds to silencethe alarm for two minutes.

2. Take action to resolve the alarm condition.

3. Press the Audio Pause key to reset thelatched high priority alarm and clear themessage from the screen.

To respond to a Low priority alarm:1. If desired, press the Audio Pause key for

less than two seconds to reset the alarmeven if the alarm condition remains.

2. Take action to resolve the alarm condition.

The alarm is automatically reset once thealarm condition ceases.


| Alarms | 8 |

Note:The following Medium Priority alarmsdisplay an Audio off? message whenactivated:

Air/HeO2 Supply Pressure: Low

O2 Supply Pressure: Low

Battery Operation

For these alarms, you can silence the audiosignal even if the alarm condition is notresolved. However, the system willeventually reactivate the alarm.

Using the Audio Pause Key

SVX-5098_EN

Pressing the Audio Pause fixed key for lessthan two seconds has the following results:

Active alarms are silenced for two minutes.

A crossed bell symbol along with the timeremaining in the silent period are displayedin the message area.

Each press of the Audio Pause key restartsthe two minute silent period from when theuser last pressed the key.

Latched alarms are reset if the alarmcondition has ceased.

Note: The No battery capacity alarm andtechnical alarms cannot be silenced.


| 8 | Alarms |

8.2.4 PRE-SILENCING ALARMS

To silence most alarms (active and inactive)for two minutes, press and hold the AudioPause fixed key for more than two seconds.This action has the following results:

All alarms, active and inactive, are silencedfor two minutes from the time the key waspressed.

A double crossed bell symbol along withthe time remaining in the silent period aredisplayed in the message area.

Pressing the Audio Pause key again for lessthan two seconds will now restart the silentperiod for two additional minutes from whenthe user last pressed the key.

Latched alarms are reset if the alarmcondition has ceased.

SVX-5099_EN

When the alarms are pre-silenced, pressingand holding the Audio Pause key again formore than 2 seconds will reactivate all audiblealarms.

8.2.5 PERMANENTLY SILENCING ALARMS

ALARMS - NON INVASIVE VENTILATION

To permanently silence certain alarms in NIVmode:1. Press the Alarm Profile fixed key.

2. Press the touchpad corresponding to oneof the following alarms:

Minute Volume

Respiratory Rate

End Exp. pressure

End tidal CO2 (CO2 Analyzer - option)

CPAP ( Nasal CPAP - option)

3. Press the bell-symbol touchpad.The symbol changes to a crossed bellindicating audio is off.

Note: If the system is set in standby modeand used in an invasive mode, the NIValarms will return to their default states.


| Alarms | 8 |

LOW MINUTE VOLUME ALARM - AUDIOOFF

For Infant invasive ventilation only, the LowMinute Volume alarm may be permanentlysilenced (Audio off) when the Upper minutevolume alarm is set to 1 l/min or less.

The function of muting the Low Minute Volumealarm is enabled or disabled viaMenu>Biomed>Edit configuration>Infant alarmlimits window. The setting is called Low MVaudio off and is disabled as the default. Whenenabled the audio off (bell symbol) is displayednext to the Minute Volume Alarm in the Alarmprofile window.

WARNING! Always use additional patientmonitoring (e.g. SpO2, CO2) when the low

expiratory minute volume alarm is set toaudio off.

3 2

SVX.5092_EN

A symbol in the list of measured values (2) anda text message Alarm(s) audio off (3) indicatethat the Low Minute Volume audio alarm isturned off.

8.2.6 TURNING OFF THE APNEA ALARM

To turn off the apnea alarm in Nasal CPAPmode:1. Press the fixed key Alarm Profile.

2. Press the touchpad corresponding to theapnea alarm.

3. Turn the Main Rotary Dial until the timelimit has reached its maximum.

4. Continue turning the control wheel.

A message is displayed indicating the apneaalarm is turned off.


| 8 | Alarms |

8.2.7 TURNING OFF THE LEAKAGEFRACTION TOO HIGH ALARM

The Leakage fraction too high alarm is analarm in Infant configuration for NIV NAVA.

The alarm can be configured via theMenu>Biomed>Edit configuration>NIV infantalarms window.

To turn off the Leakage fraction too high alarmin NIV NAVA mode:

Press the fixed key Alarm Profile.

Press the symbol touchpad indicating theLeakage fraction too high alarm. When thesymbol is crossed out, the alarm is turnedoff.

If the leakage fraction is disabled in the AlarmProfile window the message Alarm (s) off isdisplayed.

8.2.8 RESPONDING TO TECHNICALALARMS

In some cases, restarting the system mayresolve a technical alarm. However, technicalalarms often necessitate taking the ventilatorout of operation and having it serviced. Seethe chapter System Messages, sectionTechnical error messages on page 216 forfurther details.


| Alarms | 8 |

8.3 ALARM SETTINGS FORBREATHING PARAMETERS

This section discusses viewing and settingalarm limits, lists alarm settings, explains theconditions under which alarm limits are set totheir default values, and provides a table ofallowed values of alarm settings.

8.3.1 VIEWING ALARM LIMITS

Alarm limits may be viewed in the MeasuredValues Display on the right side of the screen.See the Monitoring and Recording chapter fordetails on the Measured Value Display.

8.3.2 SETTING ALARM LIMITS

To set alarm limits, touch the fixed key AlarmProfile in the upper right corner of the screen(see the Operation Overview chapter for detailsabout setting limits).

8.3.3 LIST OF ALARM SETTINGS

Automatically Set—These settings aredetermined automatically by the ventilatorbased on the related parameter settings:

O2 concentration high (based on O2

concentration setting)

O2 concentration low (based on O2

concentration setting)

High continuous pressure (based on PEEPsetting)

Upper Limit - These settings define an upperlimit based on a condition that is monitoredby the ventilator.

Paw high (airway pressure too high)

Apnea (maximum time exceeded)

Breathing Parameter Alarms—These settingsdefine an allowed range for a breathingparameter:

Expired minute volume (high and low)

Respiratory rate (high and low)

End Exp. Pressure (high and low)

End Tidal CO2 (high and low)

CPAP (high and low)


| 8 | Alarms |

8.3.4 CONDITIONS LEADING TO DEFAULTALARM SETTINGS

Alarm limits become set to their default valueswhen:

restarting the ventilator

admitting a new patient

changing type of ventilation (option)

changing patient category (option)

the ventilator has been totally without powerfor more than 2 minutes.


| Alarms | 8 |

8.3.5 ALARM RANGES AND DEFAULTS

Audio Off (onlyfor NIV)

Allowed Range; (Factory Default Value)Alarm (priority)a

NoNA; (Set Value + 5 vol%)O2 concentration high (HP)

NoNA; (Set Value - 5 vol% or 18 vol%)O2 concentration low (HP)

NoNA; (Set PEEP level + 15 cmH2O for > 15 sec)High continuous pressure (HP)

NoAdult: 16 - 120 cmH2O

Infant: 16 - 90 cmH2O

Paw high (HP)b

NoAdult: 16 - 40 cmH2O


Paw high in NIV (HP)b

NoAdult: 15 - 45 sec; (20)Infant: 5 - 45 sec; (10)

Apnea (HP)c

YesAdult: 0.5 - 60 l/min; (40)Infant: 0.01 - 30 l/min; (5)

Expired minute volume high (HP)

YesAdult: 0.5 - 40 l/min; (5)Infant: 0.01 - 20 l/min; (2)

Expired minute volume low (HP)

YesAdult: 1 - 160 b/min; (30)Infant: 1 - 160 b/min; (50)

Respiratory rate high (MP)

YesAdult: 1 - 160 b/min; (5)Infant: 1 - 160 b/min; (20)

Respiratory rate low (MP)

Yes0 - 55 cmH2O; (10)End Exp. Pressure high (MP)

Yes0 - 47 cmH2O; (2)End Exp. Pressure low (MP)d

Yes0.5 - 20%; (6.5)4 - 100 mmHg; (49)0.5 - 14 kPa; (6.5)

End Tidal CO2 high (MP)e

Yes0.5 - 20%; (4)4 - 100 mmHg; (30)0.5 - 14 kPa (4)

End Tidal CO2 low (MP)

YesInfant: 0 - 25 cmH2O; (7)CPAP high (MP)

YesInfant: 0 - 25 cmH2O; (3)CPAP low (MP)


| 8 | Alarms |

a. HP = High priority alarm, MP = Medium priority alarm.

b. If Paw rises 6 cmH2O above the set limit or if system pressure exceeds 117 ± 7 cmH2O, the

safety valve opens.

c. Apnea alarm can be turned off in Nasal CPAP .

d. Setting the alarm limit to 0 (zero) is equivalent to turning the alarm off.

e. If the alarm limit is set outside the measuring range, no alarm will be activated even if thelimit is exceeded.


| Alarms | 8 |


| 8 | Alarms |

9.1 ACTIVE HUMIDIFIERS

The use of an active humidifier is oftenbeneficial for patients undergoing ventilatorytreatment.

The following humidifiers can be used with theSERVO-i Ventilator System:

Fisher & Paykel Humidifier MR850

Teleflex Medical Conchaterm NeptuneHeated humidifier

Please refer to the manufacturer's operatingmanual for instructions on use.

WARNINGS!The active humidifier must be switchedoff when using the Servo Ultra Nebulizer,otherwise the particle size may beaffected.

Use only the MAQUET approved activehumidifier F&P MR850 with HeO2. Use

of non-approved active humidifiers mayresult in higher gas temperatures.

CAUTIONS:If the Aeroneb nebulizer is used withactive humidification, then the particlesize of the medication may be affected.

Important:If a single heated breathing circuit is usedin the system a water trap must be usedon the expiratory tube to avoidcondensation in the system. Duringoperation the water traps must bechecked regularly and if necessaryemptied.

Use only tubes recommended byMAQUET. Soft tubing may negativelyaffect the performance of the ventilator.

Accessories connected to the tubingsystem may cause changes in patientpressure.

An extended leakage test duringPre-use-check must be performed whenusing the Teleflex Medical ConchatermNeptune Heated humidifier. This can beenabled in the Edit star-up configurationwindow.


| 9 | Optional Accessories |

9.2 AERONEB PROFESSIONALNEBULIZER SYSTEM

See Aeroneb Professional Nebulizer System'sown User Manual for instructions.

WARNING! During nebulization, there maybe a higher deposition of drug used whenHeO2 is used instead of Air.

Important:When using the Aeroneb ProfessionalNebulizer System, the accuracy of the YSensor (option) measurement may becompromised. Therefore, you shouldremove the Y Sensor from the patientcircuit when the Aeroneb ProfessionalNebulizer System is in use.

CAUTION: If a nebulizer and the CO2

Analyzer are in use simultaneously, the CO2

reading may be affected.



9.3 SERVO ULTRA NEBULIZER(OPTION)

The Servo Ultra Nebulizer is intended foradministering nebulizing drugs to patientsrequiring mechanical ventilation or positivepressure breathing assistance via anendotracheal tube or face mask/prongs.

The nebulizer operates continuouslyregardless of ventilation mode setting. Noextra gas volume is added to the inspiratoryminute volume and thus neither the ventilatorsettings nor the readings are affected.

WARNINGS!Before administering any medication viathe nebulizer, consult the manufacturerregarding the appropriateness ofultrasonic nebulization for thatmedication.

During nebulization, there may be ahigher deposition of drug used whenHeO2 is used instead of Air.

CAUTION: If a nebulizer and the CO2

Analyzer are in use simultaneously, the CO2

reading may be affected.

Notes:The Servo Ultra Nebulizer may beinterrupted briefly due to overheating. Itwill automatically start again when thebuffer water has cooled. During this shortperiod of time no alarm is activated andthe timer is not interrupted.

The nebulizer module becomes disabledwhenever the ventilator is running onbattery power.



9.3.1 NEBULIZER USE GUIDELINES

These guidelines are reminders for health careprofessionals who have already been trainedto use the Servo Ultra Nebulizer:

WARNINGS!Disconnect the Servo Humidifier/HMEduring nebulization; otherwise thehumidifier may become blocked or thedrug may be trapped in the humidifier

Do not use the nebulizer without a filtere.g. Servo Duo Guard, connected to theexpiratory inlet of the ventilator.

For adult/pediatric patients, never fill themedication cup with more than 10 ml.

For neonatal patients, never fill themedication cup with more than 4 ml.

If the patient unit of the nebulizer is tiltednebulizer function may be affected, thedrug can flow into the patient´s lungs orthe ventilator.

The nebulizer must not be left unattendedwhen connected to a patient.

To avoid explosion hazards, flammableagents such as ether and cyclopropanemust not be used with this device.

Turn off the heated humidifier duringnebulization; otherwise the particle sizemay be affected.

Do not use the nebulizer without bufferliquid (sterile water); otherwise theultrasonic generator crystal may break.

Before starting the nebulizer check thatthe medication cup is undamaged andfirmly in place.

During nebulization, check the bufferliquid level. The level must be betweenMIN and MAX when the nebulizer isoperating.

During nebulization, carefully monitor theairway pressure. Increased airwaypressure could result from a cloggedfilter. Replace the filter if the expiratoryresistance increases or after 24 hours ofnebulizer use, whichever comes first.

During nebulization, frequently check thatmoisture is being generated from themedication cup.



9.3.2 NEBULIZER COMPONENTS

3

4

5

6

7

SVX-136_XX

1

2

1. Gas from ventilator

2. Cable from ventilator

3. Ultrasonic generator

4. Sterile buffer water

5. Medication mist produced in themedication cupThe 10 ml cup is disposable. It can befilled during nebulization through aninjection membrane in the T-piece, orbefore mounting the T-piece. Themedication mist is carried to the patientby the inspiratory flow.

6. T-piece with mechanical particleseparation system (baffles).The system ensures a mass mediandiameter (MMD) of approximately 4.0 µmfor droplets in the mist delivered to thepatient. Larger droplets are renebulized.

7. Injection membrane



9.3.3 OPERATION

To operate the nebulizer:1. Press the Nebulizer touchpad.

2. Press the Time touchpad.

3. Set the time using the Main Rotary Dial.

4. Touch Accept to accept the time.

5. Check that medication mist is produced.

6. View the remaining nebulization time.

7. Press the Nebulizer touchpad to changethe time or cancel nebulization.

9.4 CO2 ANALYZER (OPTION)

When the CO2 Analyzer is in use, the following

data is displayed on the screen:CO2 concentration vs. time (waveform)

End Tidal CO2 concentration (etCO2)

CO2 minute elimination

CO2 tidal elimination

Note: Alarm limits for high and low etCO2

can be individually set.

Important: If the upper alarm limit is setabove the maximum measuring range, noalarm will be activated even if the upperlimit is exceeded.

CAUTION: If a nebulizer and CO2 Analyzer

are in use simultaneously, the CO2 reading

may be affected.



9.4.1 CO2 ANALYZER USE GUIDELINES

These guidelines are reminders for health careprofessionals who have already been trainedto use the CO2 Analyzer:

The capnostat sensor and airway adapterwindows should be placed vertically toreduce the possibility of optical interferencedue to window contamination. Connect theairway adapter between the Y-piece/ServoHumidifier and the endotracheal tube/facemask/prongs.

Do not insert two CO2 modules at the same

time. The SERVO-i Ventilator System canonly handle one CO2 module at a time.

Use only a MAQUET airway adapter withthe capnostat sensor.

If the message Check CO2 airway adapter

appears, then make sure that the adapteris completely inserted.Clean the airway adapter if necessary.

9.4.2 CO2 ANALYZER COMPONENTS

1. Gas flow through the airway adapter inthe capnostat sensor.

2. The sensor uses a solid state and IRbased optical system with no moveableparts. It measures the difference betweena reference light beam and one filtered forCO2 wave lengths.



9.4.3 CO2 ANALYZER CALIBRATION

Before beginning the calibration proceduremake sure the capnostat sensor is warm.Values displayed during warm-up havereduced accuracy. If calibration is needed, amessage will appear.

There are two calibration options: cell zeroand verification (see later in this section).

To calibrate the CO2 Analyzer:


2. Press the Options touchpad.

3. Press the CO2 calibration touchpad.

4. Press the Cell zero touchpad if thecapnostat sensor has been shifted.

5. Press the Verification touchpad to performa calibration including cell zeroing,verification against reference cell, andadapter zeroing.

Important: Verification calibration isrecommended. Always perform averification when the airway adapter isaltered, a faulty capnostat sensor issuspected, or the system requestscalibration.

Procedure Diagram: CO2 AnalyzerCalibration

SVX-6025a_XX

The etCO2 concentration low alarm can be

permanently silenced (Audio off) when themessage Silence alarm permanently? isshown.

During calibration no CO2 waveforms or

measured CO2 values will be displayed.

During zero calibration the adapter mustcontain room air only.



Cell Zero Calibration

SVX-5078_XX

1. Press the Cell zero touchpad; wait foron-screen instructions.

2. Place the capnostat sensor on the zerocell.

Verification Calibration

1. Press the Verification touchpad; wait foron-screen instructions.

2. Place the capnostat sensor on the zerocell; wait for on-screen instructions.

3. Place the capnostat sensor on thereference cell; wait for on-screeninstructions.

4. Place the capnostat sensor on anunconnected airway adapter, containingroom air.



9.5 Y SENSOR (OPTION)

The Y Sensor is a fixed-orifice, differentialpressure sensor. It allows the pressure andflow to be measured close to the patient’sairway. The Y Sensor can be used in allventilation modes.

WARNING! The Y-sensor is incompatiblewith HeO2 and will be disabled when HeO2

is used.

Important: When using the AeronebProfessional Nebulizer System, theaccuracy of the Y Sensor measurement maybe compromised. Therefore, you shouldremove the Y Sensor from the patient circuitwhen the Aeroneb Professional NebulizerSystem is in use.

Notes:To guarantee that waveforms andmeasured values are always displayedon the screen, the internal pressure andflow sensors are at all times active asbackup. Their readings are comparedwith the Y Sensor measurement. The YSensor is disabled if there is a significantdeviation or malfunction.

A Pre-use check or a Patient Circuit Testis required to prior to using the Y Sensor.



9.5.1 Y SENSOR USE GUIDELINES

These guidelines are reminders for health careprofessionals who have already been trainedto use the Y Sensor.

CAUTIONS:The Y Sensor is intended for singlepatient use only, do not re-use, clean orsterilize.

Frequently check for condensed wateror other fluids in the Y Sensor. Fluids inthe Y Sensor can cause immediate lossof accuracy or long-term drift.

Do not insert two Y Sensor modules at thesame time. The SERVO-i Ventilator Systemcan handle only one Y Sensor module at atime.

Do not apply tension to the Y Sensor tubing.

Make sure that the connectors to theSERVO-i Ventilator System are pointingupwards.

Make sure there are no kinks in the YSensor tubing.

If the Y Sensor is not connected to themodule, do not connect to the patientcircuit as this may cause leakage.

9.5.2 Y SENSOR COMPONENTS

SVX-9049



9.6 THE NIV HELMET WITH SERVO-iVENTILATOR SYSTEM, UNIVERSAL

This section is intended to clarify the use ofthe non invasive helmet application with theSERVO-i Ventilator System. For userinstructions for the helmet application refer tothe helmet manufacturers instructions.

9.6.1 BEFORE USE

The use of SERVO-i Ventilator SystemUniversal is recommended with the helmetapplication to ensure adequate flow can bedelivered to all patients regardless of patientlung capacity in all relevant settings.

9.6.2 PATIENT RANGES

The helmet application can be used withSERVO-i Ventilator System for patientsbetween 10 and 250 kg. Use only the Adultpatient range on the SERVO-i Universal.

9.6.3 VENTILATION MODES

The helmet application must only be used withpressure supported ventilation (invasive,non-invasive or NIV NAVA).

CAUTION: When using the NIV PressureSupport or NIV NAVA mode the user mustinitiate the filling of the helmet by pressingthe Resume ventilation pad on the screen.This must also be done after disconnection.

Important: To secure a proper patienttriggering function the PEEP level shouldnever be set below 3 cmH2O. When helmets

with a safety valve are used, it isrecommended to set a PEEP level ofminimum 5 cmH2O.

9.6.4 ALARMS

Important: Alarms related to volume arenot reliable.To avoid nuisance alarms thecorresponding alarm limits must be properlyset.



9.6.5 SAFE USE OF HELMETAPPLICATIONS WITH SERVO-iVENTILATOR SYSTEM

Do not rely on flow and volume parameters.

The volume in the helmet serves as acapacitance and may cause delays inpatient triggering.

Make sure that the helmet used eliminatesCO2 re-breathing .

High pressure levels may effect the patient’sears and the flow may effect the patient’seyes.

Patients can perceive the helmet applicationas noisy. A Servo Duo Guard filter used onthe inspiratory side will reduce the noiselevel. The noise level can vary betweendifferent helmets.

Do not use nebulizers.

Do not use humidified ventilation gas as thiswill cause condensation on the helmetwalls.

Do not use the Y-sensor measuring option.

Do not use the CO2 option.

The two versions of the disposable, single-useY Sensor —Adult (1) and Infant (2)—are shownin the figure above. The Infant sensor includesan adaptor for use with the neonate CO2

adapter.



10.1 INTRODUCTION

This chapter lists and describes alarms anderror messages both for CO2 Analyzer

calibration and technical problems. The listsalso suggest actions in response to themessages.

WARNING! Always disconnect the patientfrom the ventilator when performingoperations that increase risk to the patient,such as replacing the O2 cell.

CAUTION: Do not lift or disconnect theexpiratory cassette when the ventilator isoperating; instead, you may do this inStandby mode.

Note: Most technical errors require theattention of a service technician.


| 10 | System messages |

10.2 HIGH PRIORITY ALARMS

RemediesPossible causesAlarm Message

Check patient and breathing system.Check ventilator settings.

Preset or default alarm limit exceeded.Time between two consecutiveinspiratory efforts exceeds the set alarmlimit.

Apnea

Check the Edi Catheter position.Backup ventilation is active due to lowEdi signal.

Backup ventilation(Edi low)

Refer to service.Remove water from tubing and checkhumidifier settings, e.g., relative humidity.Check heater wires in humidifier (ifpresent).Check connections of tubing andexpiratory cassette.

Problems with patient tubing orexpiratory pressure transducer.Disconnected pressure transducer(expiratory or inspiratory).Blocked pressure transducer (expiratoryor inspiratory).Water in expiratory limb of ventilator.Wet or clogged bacteria filter.Excessive leakage.

Check tubing

Check the Edi Catheter position.Backup ventilation is active due to invalidEdi signal.

Check catheterposition/Edi invalid

Check the Edi Catheter position.Backup ventilation is active due tointerference of the ECG signal with theEdi signal.

Check catheterposition/RR and HRcoupling

Insert the Edi Module.NAVA mode is activated when no EdiModule is connected.

Edi monitoring notactive

Connect the expiratory cassette.Replace the expiratory cassette.Perform a Pre-use check if a newexpiratory cassette is inserted.

The expiratory cassette is disconnectedor not connected properly.

Expiratory cassettedisconnected

Check patient and breathing system.Check trigger sensitivity setting.Check alarm limit settings.

Preset or default alarm limit exceeded.Increased patient activity.Ventilator self-triggering (autocycling).Improper alarm limit setting.

Expiratory MinuteVolume: High

Check patientCheck cuff pressure.Check patient breathing system (performleakage test if necessary). Check pausetime and graphics to verify.Consider increased ventilatory supportfor the patient.

Preset or default alarm limit exceeded.Note: This alarm also works as a patientdisconnect alarm.Low spontaneous patient breathingactivity.Leakage around the cuff.Leakage in the patient breathing system.Improper alarm setting.

Expiratory MinuteVolume: Low (Alsosee note at the endof this table)




Check the gas connections.Air/HeO2 and O2 supply is below 2.0 kPax 100.Air/HeO2 and O2 gas supplydisconnected.

Gas supplypressures: Low

Check patient and breathing system.Check ventilator settings.Contact a service technician.

Constant high airway pressure for morethan 15 seconds (PEEP + 15 cmH2O).

High continuouspressure

Check patient and breathing system.Check mask/ prongs size and patient fit.Check the helmet leakage.

Leakage too high. The mask / prongs /helmet may not be adjusted properly forthe patient or may be the wrong size.

Leakage out ofrange (A highpriority alarm whenNIV disconnect flowis enabled). Seesection Mediumpriority alarms.

Insert a new battery module or connectto AC power

Less than 10 minutes left of batteryoperating time.

Limited batterycapacity

If possible, connect to AC power supply.Replace and discard all batteries if thismessage appears even when batteriesare fully charged.

Battery voltage too low. Cannotguarantee continued ventilator operation.

Low battery voltage

Change the nebulizer.Contact a service technician.

Technical problem with nebulizerhardware.Temperature too high.

Nebulizer hardwareerror

Connect to AC power.Insert charged battery modules.

Less than 3 minutes left of batteryoperation.

No battery capacity


The ventilator has switched betweensupported and backup ventilation fourtimes in two minutes.The patient has only triggered a singlebreath to interrupt each of twoconsecutive backup periods

No consistentpatient effort


An apnea has caused the ventilator toswitch to backup ventilation.

No patient effort

Check O2 cell / sensor and connection.

Note: If O2 sensor is being used, makesure O2 sensor software is installed.

O2 cell / sensor missing or disconnected.O2 cell / sensorfailure

Check air/HeO2 supply

Perform a Pre-use check.Perform O2 cell adaptation.

Measured O2 concentration exceeds theset value by more than 5 Vol.%.Gas supply or air line disconnected.No supply from wall outlet.The air gas module is disconnected.If no gas is available, then both expiratoryand safety valves will open.

O2 concentration:High




Check O2 supply line.

Perform a Pre-use check.Perform O2 cell adaptation.

Measured O2 concentration is below theset value by more than 5 Vol.% orconcentration is below 18 Vol.% whichis independent of operator settings.Gas delivered in O2 supply line is not O2.

O2 sensor faulty or exhausted.

O2 cell uncalibrated.

O2/oxygen gas module faulty.

O2 concentration:Low

Check patient and breathing system.Check ventilator settings and alarmlimits.

Airway pressure exceeds preset UpperPressure Limit.Kinked or blocked tubing.Mucus or secretion plug in endotrachealtube or in airways.Patient coughing or fighting ventilator.Inspiratory flow rate too high.Improper alarm setting.Blocked expiratory filter.

Paw high

CAUTION: If airwaypressure rises6 cmH2O above setupper pressurelimit, the safetyvalve opens. Thesafety valve alsoopens if systempressure exceeds117 ±7 cmH2O.

Check the Edi Catheter position.Check/adjust the trigger settings.Change ventilation mode.

The measured Edi signal is completelyout of phase compared with the pressureand flow signals generated by thepatient.

Pneumatic-Edi outof synch

Restart the ventilator and perform aPre-use check.Contact a service technician.

Software error.Restart ventilator!

Contact a service technician.During Pre-use check the system foundproblems with the opening pressure forthe safety valve.

Safety valve testfailed

Restart the ventilator and perform aPre-use check.Check ventilator settings.

Software error, memory corrupt.Settings lost;Restart ventilator

Perform a Pre-use check.Change the expiratory cassette andperform a Pre-use check.Contact a service technician.

Technical problem with the expiratorycassette.

Technical error inExpiratory cassette

Restart the ventilator, perform a Pre-usecheck and check all settings.Contact a service technician.

Ventilator settings lost.Technical error:Restart ventilator

Check patient and breathing system.Time in waiting position is exceeded.Patient is not connected to the ventilatoror leakage is excessive.

Time in waitingposition exceeds2 min.

Check the Edi Catheter position.The measured Edi signal is completelyout of phase compared with the pressureand flow signals generated by thepatient.

Unreliable Edisignal



See the following Note.

Note: Considerable leakage may occuraround the endotracheal tube if it isuncuffed. The combination of small tidalvolumes, leakage around the tube, andactivated compliance compensation maytrigger the Low Expiratory Minute Volumealarm due to a very low expiratory flowpassing from the patient through theexpiratory channel. By observing thedifference between the Vti and Vte valuespresented on the user interface, a leakagecan be detected and its extent easilycontrolled. The first time an unacceptablylarge leakage occurs around the tube,correct this problem to avoid triggering theLow Expiratory Minute Volume alarm. If theleakage persists, either adjust the alarmlimit down to its lowest level (10 ml) orpermanently silence the alarm (seepage 184)—if this step is clinicallyappropriate. Finally, if the leakage still hasnot been remedied, deactivate thecompliance compensation to avoidtriggering the alarm. If the compliancecompensation is deactivated while inPressure Control, Pressure Support, orSIMV (Pressure Control) ventilation modes,then no further settings need to be adjusted.However, in volume-related modes, the setvolumes must be adjusted.



10.3 MEDIUM PRIORITY ALARMS


Check the gas supply lines. Perform aPre-use check.Contact a service technician.

Air supply pressure above 6.5 kPa x100 (94 psi)Air supply pressure at gas inlet is toohigh.

Air supply pressure:High

Check and connect gas supply lines.Perform a Pre-use check.

Air supply pressure below2.0 kPa x 100 (29 psi)Air supply pressure at gas inlet is too low.Gas supply line disconnected.Note: This alarm can be permanentlysilenced (Audio off) when activated.

Air supply pressure:Low

Contact a service technician.Technical problems (hardware orsoftware) with the external alarmfunction.

Alarm outputconnection error

Connect to AC power to use the ServoUltra Nebulizer.Check the connection to AC power.

Ventilator is running on batteries and theServo Ultra Nebulizer is disabled toreduce power consumption.

Battery mode!Nebulizer switchedoff

Check the connection to AC power.AC power interrupted.Battery operation

Check the alarm limits.The persistent memory has corruptcontents.

Check alarm limits

Check default alarm limits.Contact a service technician.

Problems in internal memory for defaultalarm limits.

Check default alarmlimits

Check sensor connection to patientbreathing system.Change the Y Sensor.

Y Sensor is not connected to the patientbreathing system or Y Sensor is notworking properly.

Check Y Sensor

Unplug and reinsert the module.Change the module.Contact a service technician.

Hardware error in the CO2 Analyzermodule.

CO2 module error

Insert the CO2 Analyzer module.CO2 Analyzer module is not properlyinserted.

CO2 moduleunplugged

Connect the sensor to the CO2 Analyzermodule.

CO2 capnostat sensor is not attached.CO2 sensordisconnected

Unplug and reinsert the capnostatsensor.Calibrate the capnostat sensor.Change the capnostat sensor.Contact a service technician.

Hardware error in CO2 capnostat sensor.The values in the capnostat memoryfailed the internal test.

CO2 sensor error

Make sure the capnostat sensor is notexposed to extreme heat (heat lamp,incubator etc.).Replace the capnostat sensor.

Possible hardware error. The capnostatsensor temperature is higher than 50oC

CO2 sensortemperature toohigh




Change capnostat sensor and/or module.Contact a service technician.

The capnostat sensor does not reachoperating temperature.

CO2 sensortemperature toolow

Check patient and breathing system.Check mask/ prongs size and patient fit.Check alarm settings.

Preset or default alarm exceeded.CPAP High/Low

Check patient circuit.Check ventilator settings.

Hypoventilation. Leakage with high biasflow. CO2 sensor, Y-piece, HME.

etCO2 high

Check patient circuit.

Check ventilator settings.

Hyperventilation. Leakage with high biasflow. CO2 sensor, Y-piece, HME.

etCO2 low

Perform a Pre-use check.Expiratory cassette has been exchangedduring operation. Pre-use check notperformed after exchange.

Exp. cassetteexchanged

Change ventilator settings.Combination of settings exceeds theallowable inspiration flow range.

Inspiratory flowoverrange

Check fan operation.Check the operating temperature.Clean the fan filter in the patient unit.

Temperature inside the ventilator is toohigh.

Internaltemperature: High

Check the gas supply lines. Perform aPre-use check.Contact a service technician.

HeO2 supply pressure above 6.5 kPa x100 (94 psi)HeO2 supply pressure at gas inlet is toohigh.

HeO2 supplypressure: High


HeO2 supply pressure below 2.0 kPa x100 (29 psi)HeO2 supply pressure at gas inlet is toolow.Note: This alarm can be permanentlysilenced (Audio off) when activated.

HeO2 supplypressure: Low

Check that the Heliox adapter is properlyconnected to the Air inlet.If the problem persists contact a servicetechnician

Measured HeO2 pressure above3.5 kPa x 100 (50 psi)

Check Helioxadapter



Leakage out ofrange (A mediumpriority alarm whenNIV disconnect flowis disabled). Seesection High priorityalarms.

Connect the nebulizer.Change the connection cable.

The nebulizer is disconnected duringnebulization.Technical problem with connection cable.

Nebulizerdisconnected




Restart the nebulizer.Check buffer liquid level.Change the nebulizer.Change connection cable.Contact a service technician.

Technical problem with nebulizerhardware.Temperature too high.Not enough buffer liquid.Technical problem with connection cable.

Nebulizer hardwareerror

Turn off the nebulizer and restart whencool.

Temperature too high.Nebulizer inhibiteddue to overheating

Check the gas supply lines.Perform a Pre-use check.Contact a service technician.

O2 supply pressure above 6.5 kPa x 100.

O2 supply pressure at gas inlet is toohigh.

O2 supply pressure:High


O2 supply pressure below 2.0 kPa x 100.

O2 supply pressure at gas inlet is too low.

Gas supply line disconnected.This alarm can be permanently silenced(Audio off) when activated.

O2 supply pressure:Low

Check control cable.Contact a service technician.

No communication between userinterface and patient unit.

Panel disconnected

Check patient breathing system.Check patient connection (cuffpressure/tracheal tube size).Perform a Pre-use check.Check ventilator settings.Check alarm settings.

The measured end expiratory pressureis above the preset or default alarm limitfor three consecutive breaths.

PEEP High

Check patient breathing system.Check patient connection (cuffpressure/tracheal tube size).Perform a Pre-use check.Check alarm settings.

The measured end expiratory pressureis below the preset or default alarm limitfor three consecutive breaths.Setting the alarm to zero turns the alarmoff.Leakage in patient breathing system.Leakage at patient connection (cuff,tracheal tube).

PEEP Low

Check ventilator settings.It is not possible to reach the Set volumein PRVC and VS due to restrictionsimposed by the set upper pressure limit.Set high pressure alarm limit; this limitsthe regulatory pressure used in PRVC orVS

Regulation pressurelimited

Remove one of the CO2 Analyzermodules.

Two CO2 Analyzer modules areconnected at the same time.

Remove one CO2module

Check gas supply.If more than one minute passes withoutthe set gas type being identified.

Requested gas typenot connected

Attend to the patient.Check the trigger setting.

Respiratory frequency too high.Auto triggering.

Respiratory Rate:High




Attend to the patient.Check trigger setting.Check inspiratory cycle-off setting.

Respiratory frequency too low.Trigger sensitivity setting incorrect.Large tidal volume.

Respiratory Rate:Low

Check the adjustment for the inspiratorytidal volume.

Setting causing larger volume thanallowed for the selected category.Limited adjustment of excessive tidalvolume.

VT inspiratoryoverrange

Check patient category setting.Check Y Sensor

Y Sensor does not match the selectedpatient category

Y Sensor mismatch

Insert the Y Sensor module.Y Sensor module is not properly inserted.Y Sensor Moduledisconnected

Remove one of the Y Sensor modules.Two Y Sensor modules are connectedat the same time.

Remove one YSensor Module

Unplug and reinsert the module.Change the module.Contact a service technician.

Hardware error in the Y Sensormeasuring module.

Y Sensor Moduleerror

Make sure the Y Sensor module is notexposed to extreme heat.Change the module.Contact a service technician.

Possible hardware error.The Y Sensor module temperature ishigher than 60oC.

Y Sensor Moduletemp high

Connect the sensor to the Y Sensormodule.

Y Sensor is not attached.Y Sensordisconnected

Insert the Edi Module.Edi Module is not properly inserted.Edi Moduledisconnected

Unplug and re-insert the Edi Module.Change the Edi Module.Contact a service technician.

Hardware error in the Edi Module.Edi Module error

Connect the Edi Catheter properly.Edi Catheter is not properly connected.No Edi Catheterconnected

Perform the Edi Module Test.Replace the Edi Catheter.

Error in the Edi Catheter.Edi Catheter error

Check the Edi Catheter position.The Edi Catheter is not placed properlyinside the patient.

No Edi signaldetected

Check the Edi Catheter position.Adjust the Edi trigger setting.Change ventilation mode.

The measured Edi activity is low duringNAVA ventilation.

Edi activity low

Remove one Edi ModuleTwo Edi Modules are connected at thesame time.

Remove one EdiModule



10.4 LOW PRIORITY ALARMS

RemediesPossible causesAlarm message



Leakage fractiontoo high

Check screen and knobs.Contact a service technician.

Screen or knob has been pressed formore than one minute. Screen or knobhardware time out.

Touch screen orknob press timeexceeded

10.5 CO2 ANALYSER: CALIBRATION ERROR MESSAGES (OPTION)

RemediesDescriptionMessage

Perform a verification calibration.Contact a service technician.

An error was detected during theverification calibration (adapter zero). Theairway adapter is occluded or CO2 gasis present in the adapter. The calibrationwas cancelled and old cell zeroparameters were not restored.

Adapter zero: Failed

Perform a cell zero calibration.Contact a service technician.

An error was found during cell zerocalibration. The calibration was cancelledand old cell zero parameters were notrestored.

CO2 cell zero failed

Clean the capnostat sensor windows.Replace the capnostat sensor.

The capnostat sensor is faulty or thereis an optical blockage of the capnostatsensor windows.

Verification againstReference cell:Failed



10.6 TECHNICAL ERRORMESSAGES

RemediesCausesError code number


Technical problem, identified by the errorcode xxxx.

xxxx (General)

Contact a service technician.Internal power error.1 - 6, 29, 10001

Contact a service technician.Control system error7, 10-12, 16

Contact a service technician.Battery information error43

Check that the loudspeaker outlet is notobstructed. Restart the ventilator andperform a Pre-use check.Contact a service technician.

Audible alarm/ loudspeaker error28, 20004

Contact a service technician.Internal clock error41

Contact a service technician.Internal communication error25, 33-35, 50,10002, 20001

Contact a service technician.Barometer error38-39

Contact a service technician.Alarm output connection error46

Contact a service technician.Timeout error8-9, 48-49


Backup audible alarm error22, 24, 27

Contact a service technician.Backlight error20002

Check the user interface buttons.Contact a service technician.

Membrane button error20003

Contact a service technician.Technical problem with On/Off switch.51

Contact a service technician.O2 sensor not compatible with Helioxoption

52

Contact a service technician.Exp. flow meter PC board not compatiblewith Heliox option.

53

Contact a service technician.Exp. flow meter error40001


Other error40, 42, 44, 45, 50,54, 10003, 20005



11.1 INTRODUCTION

The ventilator will always start up with thestored Start-Up Configuration. The Start-UpConfiguration can be edited, copied, andsaved.

You can edit the following Start-UpConfiguration settings:

Patient category (Adult or Infant)

Type of ventilation - invasive or non-invasive(NIV)

Volume setting

Breath cycle setting

Pre/post oxygenation concentration aboveset O2 concentration (%)

Option to deactivate backup ventilation(Disabled or Enabled)

NIV disconnect function (High flow, Lowflow or Disabled)

Extended leakage test during pre-use check

This section provides instructions foraccessing and editing the start-upconfiguration, changing the patient category,and changing the type of ventilation.

11.2 ACCESS THE START-UPCONFIGURATION

SVX-9046

Note: The ventilator must be in Standbymode.


2. Press the Biomed pad and enter theaccess code (the factory setting is 1973).

The Biomed submenu consists of the followingtouchpads:

Service

Edit configuration

Copy configuration

Set date and clock

Change access code

Start Remote Service

To alter ventilator settings, press theappropriate touchpad and follow on-screeninstructions.


| 11 | Start-up configuration |

11.3 EDIT THE START-UPCONFIGURATION

To edit the Start-up Configuration.1. Press the Edit configuration touchpad in

the Biomed submenu.

2. Press the Start-up configuration touchpad.

3. Press the touchpad for desired start-upsetting.

4. Press Next to continue to ventilation modesettings.

5. Press the appropriate touchpad to changethe settings.

Note: Press Restore mode settings torestore factory default settings.

6. Press Next to view a summary of thestart-up configuration.

7. Press Accept to save the start-up settings.

Note: The ventilator must be restarted toactivate the new settings.

11.3.1 PROCEDURE DIAGRAM: EDIT THESTART-UP CONFIGURATION


| Start-up configuration | 11 |

11.4 START MCARE REMOTESERVICE

Connect the network cable between theSERVO-i Ventilator System (1) and the dockingstation.

WARNING! Only use network equipmentthat has been installed by a MAQUETrepresentative.

CAUTION: When using the MCare RemoteService function, install the network cableso that there is no risk of anyone trippingover it.

Activate the MCare Remote Service functionby pressing the Start MCare Remote Servicetouchpad (2) in the Biomed window.

2

SVX-9045

The following message appears in Standbymode (3) - MCare Remote Service is activated.Make sure the network cable is connected andProgress: Waiting for transfer...., followed bySending log files.

SVX-9042

3

1

When the transfer is finished, the messageThe file transfer is completed. MCare RemoteService will be deactivated. Disconnect thenetwork cable.

Accept the dialog by pressing OK and theMCare Remote Service is deactivated.

WARNING! Always disconnect the networkcable before starting ventilation.

Note: The SERVO-i Ventilator System isprepared for the MCare Remote servicefunctionality, although additional equipmentis needed to utilise this function. Pleasecontact your sales and servicerepresentative for more details.


| 11 | Start-up configuration |

12.1 SYSTEM

12.1.1 GENERAL

This device complies with requirements ofMedical Device Directive 93/42/EEC.

StandardsEN/IEC 60601-1, GB9706.1 (Class 1,Type B), continuous operation

EN/IEC 60601-2-12, GB9706.28

EN 794-1

Electromagnetic compatibility (EMC)According to EN/IEC 60601-1-2, 2nd edition(2001)

As regards immunity, MAQUET haveperformed an extended test of 30V/m.

The EMC declaration: Information to theResponsible Organization is available fromMAQUET.

Patient Range (kg)Adult weight: 10 - 250

Infant weight: 0.5 - 30

NIV (PC + PS) Infant weight: 3 - 30

NIV Nasal CPAP Infant weight: 0.5 - 10

IP classificationIP 20

12.1.2 OPERATING CONDITIONS

Operating Temperature range: +10 to +40°C

Relative humidity: 15 to 95%non-condensing

Atmospheric pressure: 660 to 1060 hPa

Lowest pressure in patient circuit:-400 cmH2O

ImpactPeak acceleration: 15 g

Pulse duration: 6 ms

Number of impacts:1000

12.1.3 NON OPERATING CONDITIONS

Storage temperature: -25 to +60°C (-13 to140°F)

Storage relative humidity: < 95%.

Storage atmospheric pressure: 470 —1060 hPa


| 12 | Technical data |

12.1.4 POWER SUPPLY

Power supply, automatic range selection100-120V, 220-240V, AC 50-60Hz

Allowed fluctuations + 10% from nominalvoltage.

Battery backup2– 6 battery modules rechargeable 12 V,5A, 3.5 Ah each.

Recharge time approximately 3 h/battery(up to 12 hours if battery is completelydischarged)

Battery backup time approximately 3 h,when using 6 batteries.

External 12V DC12.0V - 15.0V DC, 10A

Type of connector is stated in the ServiceManual.

CAUTION: When using external 12V DC,at least two installed Battery modules arerequired to ensure proper operation.

Max power consumptionAt 110-120V: 2A, 190VA, 140W.

At 220- 240V: 1A, 190VA, 140W.



12.2 VENTILATOR

12.2.1 GENERAL

Dimensions (mm)User Interface: W 355 x D 53 x H 295

Patient Unit: W 300 x D 205 x H 415

Weight, approximate (kg)Total: 20

User Interface: 5

Patient Unit: 15

Triggering methodFlow and pressure

12.2.2 GAS SUPPLY

Gas qualitySupplied gases shall meet the requirementsfor medical grade gases according toapplicable standards.

Maximum levels:Air

H2O < 7 g/m3

Oil < 0.5 mg/m3

Chlorine: must not be detectable 2

O2

H2O < 20 mg/m3

Oil < 0.3 mg/m3

HeO2

H2O < 100 mg/m3

Inlet gasAir/O2

Pressure: 2.0 – 6.5 kPa x 100 (29 – 94 psi)

max 60 l/min

HeO2

Pressure: 3.4 – 6.5 kPa x 100 (49 – 94 psi)

max 60 l/min

Connection standards availableAGA, DISS, NIST, or French.

12.2.3 PATIENT SYSTEM CONNECTORS

Conical fittings (mm)Male 22 and female 15, in accordance withISO 5356-1.

Gas exhaust port (mm)Male 30 cone.

12.2.4 USER INTERFACE

Attaches to the mobile cart, a table, railing, or15-30 mm diameter pipe.

2. If the compressed air is generated by a liquid ring compressor there is a potential risk of chlorine in the supplied

air.



12.3 STANDARD CONDITIONSPECIFICATION

Error ranges in this document assume thefollowing standard conditions and the worstcase, i.e. all errors are summarized positive.Statistically 95% of all values will be within 2/3of the given error.

Ambient pressure: 101.3 kPa

Room temperature: 20 ºC

Dry gases in patient system

Inlet pressure: 4.3 kPa x 100

Pre-use check performed on a warmed upventilator

Default settings unless otherwise specified

In SERVO-i Ventilator System all measured,preset and indicated flows and volumes arereferenced to ambient pressure at +21°C(AP21).

Pre-use check performed with 99 %oxygen content in O2 supply.

Pre-use check performed with 21 ± 0.5%oxygen content in air/HeO2 supply (to

ensure specified O2 monitoring accuracy).

12.4 INSPIRATORY CHANNEL

Pressure dropMaximum: 6 cmH2O at a flow of 1 l/s

Internal compressible factorMaximum: 0.1 ml/cmH2O

Gas delivery systemMicroprocessor controlled valves

Gas delivery deviceFlow range:

Adult: 0-3.3 l/s

Infant: 0-0.55 l/s

Inaccuracy ±5% or ± 0.1 ml/s

Maximum pressure setting:Adult: 120 cmH2O

Infant: 80 cmH2O

Inaccuracy ±5% or ± 1 cmH2O 3

NIV max. leakage compensation levelAdult: 65 l/min

Infant: 25 l/min

Infant Nasal CPAP: 10 l/min

3. at RR < 100 b/min



O2 concentrationSetting range: 21 - 100%

Inaccuracy ± 3 vol%.

Add ± 2 vol% inaccuracy when HeO2 is

used.

Inspiratory Minute VolumeAir/O2

AdultSetting range: 0.5 - 60 l/min

Inaccuracy ± 6% 4

InfantSetting range: 0.3 - 20 l/min

Inaccuracy ± 6% 5

HeO2/O2

AdultSetting range: 0.5 - 60 l/min

Inaccuracy + 10% 6

InfantSetting range: 0.3 - 20 l/min

Inaccuracy + 10% 7

Inspiratory Tidal VolumeAir/O2

AdultSetting range: 100 - 2000/4000 ml 8

Inaccuracy: + 7% 9

InfantSetting range: 2 - 350 ml

Inaccuracy: + 6% 10

HeO2/O2

AdultSetting range: 100 - 2000/4000 ml 11

Inaccuracy: + 10% 12

InfantSetting range: 2 - 350 ml

Inaccuracy: + 10% 13

4. at 2.5 - 60 l/min and set I:E<1:1

5. at 1 - 20 l/min and set I:E<1:1

6. at 2.5 - 60 l/min and set I:E<1:1

7. at 1 - 20 l/min and set I:E<1:1

8. 100 - 2000 (Adult), 100 - 4000 (Universal)

9. at 400 - 4000 ml and set I:E<1:1

10. at 20 - 350 ml and set I:E<1:1

11. 100 - 2000 (Adult), 100 - 4000 (Universal)

12. at 400 - 4000 ml and set I:E<1:1

13. at 20 - 350 ml and set I:E<1:1



12.5 EXPIRATORY CHANNEL

Pressure DropMaximum: 3 cmH2O at a flow of 1 l/s

Internal Compressible FactorMaximum: 0.1 ml/cmH2O

PEEP RegulationMicroprocessor controlled valve

PEEP setting range:PEEP setting range 0 - 50 cmH2O

Inaccuracy: + 5% or + 1 cmH2O 14

Expiratory Flow Measurements0 - 3.2 l/s

Rise time (flow of 0.05 - 3.2 l/s): <12 ms for10 - 90% response

12.6 MONITORING

Expiratory Minute VolumeAir/O2

AdultRange: 0 - 60 l/minInaccuracy: + 8% or + 0.15 l/min 15

NIV: + 10% 16

InfantRange: 0 - 20 l/min

Inaccuracy: + 8% or + 0.15 l/min 17

NIV: + 10% 18

NIV Nasal CPAP: + 25% or + 0.15 l/min 19

HeO2/O2

AdultRange: 0 - 60 l/minInaccuracy: + 15% or + 0.25 l/min 20

NIV: + 15% 21

InfantRange: 0 - 20 l/min

Inaccuracy: + 15% or + 0.25 l/min 22

NIV: + 15% 23

NIV Nasal CPAP: + 25% or + 0.25 l/min 24

14. at RR < 66 b/min

15. at RR <100 b/min

16. at constant leakage fraction <30%

17. at RR <100 b/min



20. at RR≤45 b/min


22. at RR ≤75 b/min





Expiratory Tidal VolumeAir/O2

AdultRange: 0 - 2000/4000 ml 25

Inaccuracy: + 8% or + 15 ml 26

Infant

Range: 0 - 350 ml


HeO2/O2

AdultRange: 0 - 2000/4000 ml 28


InfantRange: 0 - 350 ml


In the infant setting, tidal volume range involume controlled and volume supportedmodes is 2-350 ml. When the tidal volume isset below 5 ml, use of Y Sensor measuring isrecommended to optimize monitoring ofvolumes (not possible during HeO2 use).

O2 ConcentrationRange: 0 – 100%

Inaccuracy: + 3 vol% O2

The accuracy of the measurement isdependant on the oxygen content of thesupplied gases during the Pre-use check.

Add + 2 vol% O2 measuring tolerance if an

HeO2 gas deviating from 21% O2 content is

used for the Pre-use check (i.e. 80/20,78/22 HeO2)

An increased deviation in measured O2

concentration may be seen during HeO2

delivery in infant range.

Airway PressureRange: -40 - 160 cmH2O

Inaccuracy: + 5% or + 1 cmH2O

Supply PressureRange: 0 - 7 bar

Inaccuracy: + 5% or read value

FilteringPressure waveform: Low pass filtered (timeconstant 15 ms)

CO2 waveform: Low pass filtered (time

constant 15 ms)

25. 0-2000 (Adult), 0-4000 (Universal)

26. at Expiration time <4s and RR <100 b/min

27. at Expiration time <1 s and RR <100 b/min

28. 0-2000 (Adult), 0-4000 (Universal)

29. at Expiration time <4s and RR 45 b/min

30. at Expiration time <1.7s and RR 75 b/min



12.7 ALARMS

12.7.1 ALLOWED ALARM SETTINGS

Airway Pressure (Upper alarm limit)

Adult: 16 - 120 cmH2O


Airway Pressure in NIV (Upper alarm limit)

16 - 40 cmH2O

High Continuous Pressure (> 15 s)

Set PEEP level + 15 cmH2O

O2 ConcentrationAir: Set value ± 5 vol% or < 18 vol%

HeO2: Set value ± 7 vol% or < 18 vol%

Expired Minute Volume (Upper alarm limit)Adult: 0.5 – 60 l/min

Infant: 0.01 – 30 l/min

Expired Minute Volume (Lower alarm limit)Adult: 0.5 – 40 l/min

Infant: 0.01 – 20 l/min

ApneaAdult: 15 - 45 s

Infant: 5 - 45 s 31

Apnea audio delay (Infant only)0 - 30 s

Gas SupplyAir/O2: < 2.0 kPa x 100 or > 6.5 kPa x 100

HeO2: <2.0 kPa x 100 or > 6.5 kPa x 100

Respiratory Frequency1 – 160 b/min.

End Expiratory Pressure (Upper alarm limit)0 - 55 cmH2O

End Expiratory Pressure (Lower alarm limit)0 - 47 cmH2O 32

End-tidal CO2 (Upper and Lower limit)0.5-20%, 4-100 mmHg, 0.5-14 kPa 33

Nasal CPAP (Upper and Lower alarm limit)Infant: 0 - 25 cmH2O

31. The apnea alarm can be turned off in Nasal CPAP

32. Setting the alarm to 0 (zero) is equal to alarm off

33. In NIV low limit can be set to 0 (zero)



12.7.2 AUTOSET ALARM LIMITS -CONTROLLED MODES ONLY

High Airway PressureMean peak pressure +10 cmH2O or at least

35 cmH2O

Expiratory Minute Volume (Upper alarmlimit)+ 50%

Expiratory Minute Volume (Lower alarmlimit)- 50%

Respiratory Frequency (Upper alarm limit)+ 40%

Respiratory Frequency (Lower alarm limit)- 40%

End Expiratory Pressure (Upper alarm limit)Mean End Expiratory Pressure + 5 cmH2O

End Expiratory Pressure (Lower alarm limit)Mean End Expiratory Pressure - 3 cmH2O

End-tidal CO2 Concentration (Upper alarmlimit)+ 25%

End-tidal CO2 Concentration (Lower alarmlimit)- 25%

12.7.3 ALARMS MISCELLANEOUS

Audio Pause (Alarm silence/reset)Two-minute silence and reset of latchedalarms.



12.8 VENTILATION MODES

12.8.1 CONTROLLED VENTILATION

Pressure Control (PC)Pressure controlled ventilation.

Volume Control (VC)Volume controlled ventilation.

Pressure Regulated Volume Control (PRVC)Pressure regulated volume controlledventilation.

NIV Pressure ControlNoninvasive pressure controlled ventilation.

12.8.2 SUPPORTED VENTILATION

Volume Support (VS)Volume supported ventilation.

Pressure Support (PS)/CPAPPressure supported ventilation / Continuouspositive airway pressure ventilation.

NIV PSNoninvasive pressure supported ventilation.

Nasal CPAPNasal continuous positive airway pressureventilation.

NAVANeurally Adjusted Ventilatory Assist.

NIV NAVANon invasive ventilation neurally adjustedventilatory assist

12.8.3 COMBINED VENTILATION

SIMV (VC) + PSSynchronized intermittent mandatoryventilation based on volume controlledventilation with pressure support.

SIMV (PC) + PSSynchronized intermittent mandatoryventilation based on pressure controlledventilation with pressure support.

SIMV (PRVC) + PSSynchronized intermittent mandatoryventilation based on pressure regulatedvolume controlled ventilation with pressuresupport.

Bi-VentPressure controlled ventilation that allows thepatient the opportunity of unrestrictedspontaneous breathing.

AutomodeSupport modeControl modeVSVC <------ ------>PSPC <------ ------>VSPRVC <------ ------>



12.9 TREND FUNCTION

PpeakPeak Airway Pressure

PplatPause Airway Pressure

PmeanMean Airway Pressure

PEEPPositive End Expiratory Pressure

CPAPContinuous Positive Airway Pressure

RRspontSpontaneous breaths per minute

RRBreathing frequency

MVe spSpontaneous Exp. Minute Volume

MViInspired Minute Volume

MVeExpired Minute Volume

LeakageLeakage fraction (%)

VTiInspired Tidal Volume

VTeExpired Tidal Volume

eeEnd Expiratory Flow

O2Measured Oxygen Concentration

etCO2CO2 End Tidal Concentration

CO2CO2 Minute Elimination

VTCO2CO2 Tidal Elimination

CdynDynamic Characteristics

CstaticStatic Compliance

RiInspiratory Resistance

ReExpiratory Resistance

WOB vWork of Breathing ventilator

WOB pWork of Breathing patient

EElastance

P0.1P0.1

SBIShallow Breathing Index

Edi peakPeak Edi value

Edi minMinimum Edi value



12.10 OPEN LUNG TOOL TREND(OPTION)

EIP

PEEP

VTi

VTe

C dyn i

VTCO2 (optional CO2 Analyzer)

12.11 LOG FUNCTION

Event LogAlarms

Ventilator settings

Apnea periods

Immediate functions

Service LogTechnical alarms

Test results

Preventive maintenance

Service report history

Configuration log

12.12 IMMEDIATE FUNCTIONS

Oxygen Breaths100% for 1 minute.

Start BreathInitiation of 1 breath in all modes.

(In SIMV mode initiation of one mandatorybreath).

Pause HoldInspiratory or expiratory.

12.13 COMMUNICATION/INTERFACE

Serial PortRS-232C-isolated. For data communicationvia the Communication Interface Emulator(CIE).

Alarm Output Connection (Option)Isolated 4-pole modular connector forcommunication of high and medium priorityalarms. The alarm output connection optionis a non-guaranteed alarm in accordance withIEC60601-1-8. Max 40 V DC, Max 500 mA,Max 20 W.

Data Transfer via Ventilation Record CardFile format is Unicode (big endian). Requiredsoftware is Microsoft Excel 2000 with VisualBasic for applications.



12.14 SERVICE

WARNINGS!Preventive maintenance must beperformed by authorized personnel atleast once a year or after every 5000hours of operation. The Status menu onthe user interface shows the currentoperating time.

Service, repair and installation must beperformed by MAQUET authorizedpersonnel only.

All technical documentation is availablefor use by MAQUET-authorizedpersonnel.

Service mode should only be usedwithout a patient connected to theventilator.

CAUTION:Original parts from MAQUET must be used.

Battery module replacement, see page 35 forinformation.

12.15 SERVO ULTRA NEBULIZER(OPTION)

Patient UnitWeight, approximate (g): 125

Dimensions (mm): W60 x L108 x H105

Nebulizer T-Piece ConnectionsInlet/outlet:

22/15 mm outside/inside diameter

22 mm inside diameter, ISO standard

Infant patient tubing, nipple connectors:22/10 mm outside diameter

15/10 mm outside diameter

Internal Volume (ml)60

Ultrasonic Generator Frequency (MHz)2.4

Particle Size, approximate (water, µm)4.0, mass median diameter (MMD) measureddistally in endotracheal tube 8 mm insidediameter.



Output from nebulizer (water)Minimum water flux:

0.1 ml/min at gas flow 0.1l/s

0.3 ml/min at gas flow 0.5l/s

0.5 ml/min at gas flow 1.0l/s.

Buffer LiquidSterile water

Maximum Medication Temperature55º C (131º F)

Volume, medication cup (Maximum, ml)10

Noise level (Maximum, dBA)50, measured at 0.3 m distance

Connection Cable Length (m)2.0

Note: For information about the stand-aloneAeroneb Professional Nebulizer System,refer to accompanying documentation.

12.16 CO2 ANALYZER (OPTION)

GeneralStandard compliance: EN864, ISO9918.

Classification: Class I equipment(According to IEC 60 601-1/EN 60 601-1.Type BF.)

Size (mm)CO2 Analyzer module: 154 x 90 x 43

Sensor: 32.0 x 42.4 x 21.6

Weight (g)CO2 Analyzer module: 450

Sensor: 18

Airway adapter: 10

Connectors and CablesCO2 Analyzer module:15-pole D-sub female

connector

Sensor 20-pole: 2.4 m cable

Power sourceCO2 Analyzer module supply voltage: powered

from the SERVO-i Ventilator System

Power consumption< 8 W at 12V, during warm up;

< 6.5 W at 12V, during normal operation.



SensorPowered from the CO2 Analyzer module.

PerformanceMeasuring method:Mainstream, dual-wavelength, non-dispersiveinfrared.

Stability (within 8-hour period):0 to 100 mmHg ± 2 mmHg

0 to 13.3 kPa ± 0.3 kPa

0 to 13.2% ± 0.3% (at a barometricpressure of 1013 hPa).

Measuring range:0 to 100 mmHg CO2 partial pressure

0 to 13.3 kPa CO2 partial pressure

0 to 13.2% CO2 volume (at a barometric

pressure of 1013 hPa).

Accuracy0 to 40 mmHg ± 2mmHg

41 to 70 mmHg ± 5% of reading

71 to 100 mmHg ± 8% of reading

0 to 5.3 kPa ± 0.3 kPa

5.4 to 9.3 kPa ± 5% of reading

9.4 to 13.3 kPa ± 8% of reading

0 to 5.3% ± 0.3%

5.4 to 9.2% ± 5% of reading

9.3 to 13.2% ± 8% of reading

Measurement ConditionsCO2 minute elimination and CO2 tidal

elimination measurements are referenced tostandard temperature and pressure (STP).

Standard gas mixture of CO2, balance

saturated air at 33º C, barometric pressure1013 hPa, gas flow rate 2 l/mm, halogenatedhydrocarbons <5%.

Step response time<25 ms (10 to 90% step response)

Warm-up time30 s to initial CO2 indication

maximum 5 minutes to full specification.

Oxygen concentration compensationAutomatic. Values supplied from the SERVO-iVentilator System.

Barometric pressure compensationAutomatic. Values supplied from the SERVO-iVentilator System.

Digitizing Rate (Hz)87

Airway adapter dead spaceAdult <5 cm3

Infant <0.5 cm3



12.17 Y SENSOR MEASURING(OPTION)

Size (mm)Y Sensor Module: W 154 x L 90 x H 21

Y sensor adult Length: 84

Y sensor infant Length: 51

Weight (g)Y Sensor Module: 400

Y sensor adult: 10.5

Y sensor infant: 7.5

Sensor MaterialMakrolon polycarbonate

Tubing2.0 m Medical grade PVC

Power SourceY Sensor Module supply voltage: poweredfrom SERVO-i Ventilator System, < 5 W at 12V (normal operation)

Y Sensor Measuring PerformanceMeasuring method: Fixed orifice, differentialpressure

ParametersAirway pressure

Airway flow

Inspiratory Volume

Expiratory Volume

Measuring RangeAdult: 2 to 180 l/min

Infant: 0.125 to 40 l/min

Airway Adapter Dead SpaceAdult: < 9.0 ml

Infant: < 0.45 ml

12.18 NAVA (OPTION)

Size (mm)Edi Module: W 154 x L 90 x H 21

Cable (m)2.0 m

Edi Catheter size16 Fr

12 Fr

8 Fr 125 cm

8 Fr 100 cm

6 Fr 50 cm

6 Fr 49 cm



12.19 ACCESSORIES

12.19.1 MOBILE CART (OPTION)

Weight (kg)20

Dimensions (mm)W 542 x L 622 x H 1010

12.19.2 DRAWER KIT (OPTION)

Weight (kg)4.5


12.19.3 HOLDER (OPTION)

Weight (kg)3.5


12.19.4 SHELF BASE (OPTION)

Weight (kg)1.2


12.19.5 GAS CYLINDER RESTRAINER(OPTION)

Maximum loadTwo 5-liter bottles.

12.19.6 IV POLE (OPTION)

Maximum Load (total, kg)6

12.19.7 GAS TROLLEY (OPTION)

Maximum loadTwo 10-kg bottles

12.19.8 COMPRESSOR MINI (OPTION)

Dimensions (mm)W 430 x D 330 x H 250

Weight (approximate, kg/lbs)26/70

Power supply115 V AC, 60 Hz (single phase).

220–240 V AC, 50/60 Hz (single phase).

Compressor capacityContinuous flow at normal atmosphericpressure (approximately 1013 hPa) 30 l/min(expanded to ambient air pressure) at 3.5 kPax 100 (bar)/50 psi.



12.20 HEALTH AND ENVIRONMENT

12.20.1 POLLUTION CONTROL

This product complies with environmental protection use period as defined in People`s Republicof China Electronic Industry Standard SJ/T11364-2006.

Toxic or hazardous substances will not leakor mutate under normal operating conditionsfor 50 years.

12.20.2 HAZARDOUS SUBSTANCES

The following table shows the names and contents of toxic or hazardous substances in thisproduct as defined in People`s Republic of China Electronic Industry Standard SJ/T11364-2006.

Hazardous substances

PBDEPBBCr6+CdHgPbParts

00X000Metal parts

000000Plastic and polymeric parts

00000XElectrical components

000000LCD display

0: Indicates that this toxic or hazardous substance contained in all of the homogeneousmaterials for this part is below the limit and meets the requirement in SJ/T11363-2006.X: Indicates that this toxic or hazardous substance contained in at least one of thehomogeneous materials used for this part is above the limit requirement in SJ/T11363-2006.



12.20.3 PHTHALATES

Parts of the following accessories for theSERVO-i Ventilator System contain thephthalate DEHP:

Edi Catheter with the following articlenumbers:66 71 275, 66 71 277, 66 71 280, 66 71 287,66 71 290 and 66 71 282

Y Sensor Adult and Y Sensor Neonate withthe following article numbers:66 70 660 and 66 70 662

The intended use of these devices includestreatment of children or treatment of pregnantor nursing women. DEHP is classifiedaccording to regulation (EC) No. 1272/2008of the European Parliament and of the councilof 16 December 2008 as a Category 2 hazardfor reproductive toxicants. This means thatDEHP is only suspected of being a humanreproductive toxicant. Evidence of this isquestionable. No phthalates can be transferredfrom the Y sensors to patients. Only thefeeding and sump connectors of the EdiCatheter contain DEHP. These are not in directcontact with the patient. Only a small part ofthe connectors is in direct contact with thefeeding solution during the actual feedingprocess.



12.21 BREATHING PARAMETERS

Setting rangeFactory set default values (Standardconfiguration)

Parameter

AdultInfantAdultInfant

ON/ OFFON/ OFFOFFOFFAutomode ON/OFF

7 - 123 – 1573Automode trigger timeout(s)

--20.5Bias flow (l/min)

1 - 150.5 - 1541Breath cycle time, SIMV (s)

4 - 100(4 - 150 inUniversal)

4 - 1501530CMV frequency (b/min)

ON/ OFFON/ OFFOFFOFFCompensate forcompliance

-2 - 20-5CPAP (cmH2O) in NIV NasalCPAP

0.1 – 2.00.1 – 2.00.50.5Edi Trigger (µV)

0-100%0-100%50%50%Flow trig sensitivity level(fraction of bias flow)

1:10 - 4:11:10 - 4:11:21:2I:E ratio

1:10 - 4:11:10 - 4:11:21:2I:E ratio in backup

1 - 701 - 703030Inspiratory cycle-off (% ofpeak flow)

10 - 7010 - 705030Inspiratory cycle-off (% ofpeak flow) in NIV

0 - 200 - 2055Inspiratory rise time (%)

0 - 0.40 - 0.20.150.15Inspiratory rise time (s)



Setting rangeFactory set defaultParameter


0 - 0.40 - 0.20.20.15Inspiratory rise time (s) inNIV

--3.30.56Maximum inspiratory flow(l/s)

--12080Maximum permittedabsolute pressure (cmH2O)

--3232Maximum permittedabsolute pressure in NIV(cmH2O)

0.5-600.3 - 207.52.0Minute Volume (l/min)

--PSPSMode (in NIV)

--VCPCMode (Invasive ventilation)

0.0 - 15.00.0 - 15.01.01.0NAVA level (cmH2O/µV)

ON/ OFFON/ OFFOFFOFFNebulizer

5 - 305 - 301010Nebulizer time (min)

0.0 - 15.00.0 - 15.00.50.5NAVA level in NIV(cmH2O/µV)

21 - 10021 - 1004040O2 concentration (%)

0 - 500 - 5055PEEP (cmH2O)

2 - 202 - 2055PEEP in NIV (cmH2O)

(PEEP+1) - 50(PEEP+1) - 501515Phigh (cmH2O)

-20 - 0-20 - 0--Press trig sensitivity level(cmH2O)





0 - (120 -PEEP)0 - (80 -PEEP)2020Pressure level above PEEP(cmH2O)

0 - (32-PEEP)0 - (32-PEEP)55Pressure level above PEEPin NIV (cmH2O)

5- (120 -PEEP)5- (80 -PEEP)2010Pressure level above PEEPin backup (cmH2O)

5 - (32 – PEEP)5 - (32 – PEEP)55Pressure level above PEEPin NIV backup (cmH2O)

0 - (120 -PEEP)0 - (80-PEEP)00PS above PEEP in Bivent(cmH2O)

0 - (120 - PHigh)0 - (80-PHigh)00PS above Phigh in Bivent(cmH2O)

4 - 100(4 - 150 inUniversal)

4 - 1501530Resp rate in backup

1 - 601 - 60520SIMV frequency (b/min)

0.2 - 100.2 - 1021Thigh (s)

0.1 - 50.1 - 50.90.5Ti (s)

0.1 - 50.1 - 50.90.5Ti in backup (s)

100 - 2000(100 - 4000 inUniversal)

2 – 35050080Tidal Volume (ml)

100 - 2000(100 - 4000 inUniversal)

2 – 35050080Tidal volume in backup (ml)

0 – 300 – 301010Tpause (%)

0 - 1.50 - 1.50.40.2Tpause (s)

0.2 - 100.2 - 1021TPEEP (s)

10- 2500.5 - 30503Weight (kg)



12.22 ALARM LIMITS



16 -12016 - 904040Airway pressure, upper limit(cmH2O)

16 - 4016 - 402020Airway pressure, upper limit(cmH2O) in NIV

15 - 455 - 452010Apnea, time till alarm (s)

-0 - 25-7Nasal CPAP high limit(cmH2O)

-0 - 25-3Nasal CPAP lower limit(cmH2O) Note: Setting thealarm to zero turns off thealarm

0 - 550 - 551010End expiratory pressure,high limit (cmH2O)

0 - 470 - 4722End expiratory pressure,lower limit (cmH2O) Note:Setting the alarm to zeroturns off the alarm

etCO2 Lower alarm limit:

0.5 - 200.5 - 204.04.0%

4 - 1004 - 1003030mmHg

0.5 - 140.5 - 144.04.0kPa





etCO2 Lower alarm limit in NIV: Note: In NIV low limit can be set to 0 (zero).

0 - 200 - 204.04.0%

0 - 1000 - 1003030mmHg

0 - 140 - 144.04.0kPa

etCO2 Upper alarm limit:

0.5 - 200.5 - 206.56.5%

4 - 1004 - 1004949mmHg

0.5-140.5-146.56.5kPa

0.5 - 40.00.01-20.05.02.0Expired minute volume,lower limit (l/min)

0.5 - 60.00.01-30.040.05.0Expired minute volume,upper limit (l/min)

1 - 1601 - 160520Respiratory frequency,lower limit (b/min)

1 - 1601 - 1603050Respiratory frequency,upper limit (b/min)

Default values are set:

restarting the ventilator

admitting a new patient

changing type of ventilation (option)

changing patient category (option)

the ventilator has been totally without power for more than 2 minutes.

Always make sure relevant values are set.



13 DEFINITIONS

b/min—Breaths per minute

Bias flow—The continuous flow during theexpiratory phase

Breath cycle time—Total cycle time permandatory breath in SIMV (inspiratory + pause+ expiratory). Set in seconds.

Cdyn—Dynamic characteristics

CMV—Controlled Mechanical Ventilation

CPAP—Continuous Positive Airway Pressure

Cstatic—Static compliance, respiratorysystem

E—Elastance

Edi—Electrical activity of the diaphragm

Edi Catheter—A single-use feeding tube withmeasuring electrodes.

Edi Trigger—The level of Edi signal wheninspiration is started.

etCO2—End tidal carbon dioxide

concentration

Expiratory hold—Manual closure ofinspiration and expiration valves afterexpiration (max. 30 seconds). Measures TotalPEEP.

Flow sensitivity level—The flow that thepatient must inhale to open the ventilator for,and start, an inspiration (fraction of the biasflow).The trigger functionality is set for eitherpressure or flow sensitivity.

HME—Heat and moisture exchanger

I:E—Inspiration to Expiration ratio (only duringcontrolled ventilation)

IED—The distance between the Edi Catheterelectrodes

Inspiratory hold—Manual closure ofinspiration and expiration valves afterinspiration (max. 30 seconds). Measuresplateau pressure.

Inspiratory cycle-off—Fraction of maximumflow at which inspiration should switch toexpiration (%)

Inspiratory rise time—Time to full inspiratoryflow or pressure at the start of each breath,as a percentage or in seconds of the breathcycle time (% or s)

Leakage - leakage in relation to inspiratoryflow (%)

Minute Volume—Volume per minute or targetvolume (l)

MVe—expiratory Minute Volume

MVe sp—Spontaneous expiratory minutevolume

MVe sp / MVe—The ratio of spontaneousexpired minute volume to total expired minutevolume (only applicable in Bi-Vent)

MVi—inspiratory Minute Volume

NAVA—Neurally Adjusted Ventilatory Assist.

NAVA level—The relation between measuredEdi signal and pressure assist provided.

NIV—Noninvasive Ventilation


| Definitions | 13 |

NIV NAVA — Non Invasive Ventilation NeurallyAdjusted Ventilatory Assist

NVT—Neuro Ventilatory Tool.

O2—Oxygen concentration in vol.%

O2 breaths—100% oxygen for one minute.

Option—Optional, add-on functionality oraccessory

P—Pressure

P0.1—Indicator for respiratory drive

Pause time—Time for no flow or pressuredelivery (%)

PC—Pressure Control

PEEP—Positive end expiratory pressure(cmH2O)

PEEPtot— Set PEEP + Intrinsic PEEP

Paw—Airway pressure

Ppeak—Maximum inspiratory pressure

Phigh—High pressure level

Pmean—Mean airway pressure

Pplat—Pressure during end-inspiratory pause

PRVC—Pressure-regulated volume control

PS—Pressure support

PS above Phigh—Inspiratory pressuresupport level for breaths triggered during theThigh period in Bi-Vent (cmH2O)

PS above PEEP—Inspiratory pressure supportlevel for breaths triggered during the TPEEPperiod in Bi-Vent (cmH2O)

Re—expiratory resistance

RH—Relative humidity

Respiratory Rate—Rate of controlledmandatory breaths or used for calculatingtarget volume (b/min)

Ri—inspiratory resistance

RR—Respiratory rate

Service card—Field service software card

SIMV—Synchronized Intermittent MandatoryVentilation

SIMV rate—Rate of controlled mandatorybreaths (b/min)

Start breath—Manually triggered set breath

T—Time

Tc—Time constant

Ti—Inspiration time

Ti/Ttot—Duty cycle or ratio of inspiration timeto total breathing cycle time (only duringspontaneous breathing)

Tidal Volume—Volume per breath or targetvolume (ml)

Thigh—Time at Phigh level in Bi-Vent (s)

TPEEP—Time at PEEP level in Bi-Vent (s)

—Flow

CO2—CO2 Minute elimination

ee—End expiratory flow

leak—Leakage flow (l/min)


| 13 | Definitions |

Ventilation record card—Documentation card

VTCO2—CO2 tidal elimination

Va—Alveolar ventilation

VC—Volume Control

VDaw—Airway dead space

VS—Volume Support

VTA—Alveolar Tidal Volume

VTe—Expiratory Tidal Volume

VTi—Inspiratory Tidal Volume


| Definitions | 13 |


| 13 | Definitions |

14.1 FIXED KEYS

Audio pause (Silence or pre-silence alarms)

By pressing Autoset in controlled modesof ventilation the alarm limits areautomatically set for:

PressureVolumeResp. RatePEEPCO2

Note: Autoset is not possible in NIV.

In spontaneous modes an alarm settingfor apnea time is available.

Alarm profile setup. Possible selections:Pressure (upper)Minute volume (lower and upper)Respiratory rate (lower and upper)End expiratory pressure (lower andupper)Alarm sound level (10-100%)End tidal CO2 (lower and upper)

Note: In NIV the alarm sound can bepermanently silenced (audio off).

Alarm profile

The Save key can be used to either:copy screen, orsave one recording (10 s before and 10 s after pressing the key)

Save

The trend graph appears when the Trend key is pressed. Data can be recordedover a period of time up to 24 hours. The time resolution is displayed in the trendgraph.

Trends

Function is not implemented.

The Neural access key opens a menu with the following choices:Edi Catheter positioningNAVA previewNeuro Vent. ToolNVT scales

Neural access


| 14 | Appendix • User interface |

14.2 SPECIAL FUNCTION KEYS

The ventilator will initiate a new breath cycle according to the current ventilatorsettings.

Start breaths

This function allows 100% oxygen to be given for 1 minute. After this time theoxygen concentration will return to the pre-set value. The oxygen breaths can beinterrupted by pressing the O2 breaths fixed key during the 1 minute interval.

Note: If O2 breaths is activated during the pre- or post-oxygenation phase inSuction Support the procedure will be discontinued.

O2 breaths

Expiratory hold is activated by manually pressing the Exp. hold key. The maximumtime is 30 seconds. The inspiratory and expiratory valves close after expiration.This function can provide an exact measurement of the end expiratory lungpressure. It can be used for static compliance measurement and to determine thetotal PEEP.

Note: Expiratory hold is not available in Nasal CPAP.

Exp. hold

Inspiratory hold is activated by pressing the Insp. hold key. The maximum time is30 seconds. The inspiratory and expiratory valves close after expiration. Thisfunction can provide an exact measurement of the end inspiratory lung pressure.It can be used during x-ray or to determine Plateau pressure, or static compliancecalculation.

Note: Inspiratory hold is not available in Nasal CPAP.

Insp. hold



14.3 QUICK ACCESS KEY

This function allows the user to disconnect the patient from the ventilator and turnsoff the alarms (for apnea, minute volume, frequency alarm, check tubing, low PEEP)during suction support.

Note: Suction support is not available when NIV or O2 breaths are activated.

Suction Support

Loops are graphs that show two measured values: one measured value (x-axis)against another measured value (y-axis). Loops are updated breath by breath.

Two loops are available:volume-pressureflow-volume

Note: A reference loop can be saved by the user.

Loops

Waveform scalingPressure scalingFlow scaleVolume scaleCO2 scale

These four scales are set to automatic scaling, by default.The sweep speed (mm/s) can be set to 5, 10 or 20 mm/s (default).

Waveform scales

Possibility to increase the space for viewing the waveform curves. This means thatmore detailed information can be viewed.

Waveformconfiguration

The Open Lung Tool assists in alveolar recruitment procedures. The screen givesinformation about End inspiratory pressure (EIP) and PEEP. inspiratory andexpiratory Tidal Volume as well as Dynamic Compliance (Cdyn i).

Note: Open Lung Tool is not available in NIV.

Open Lung Tool

Open Lung ToolScales



14.4 MAIN SCREEN KEY

Mainscreen

The Main screen fixed key will return you to the Main screen, cancelling currentwork, from wherever you are in the Menu/dialog windows.

Main screen



14.5 MENU KEY

Alarm profile setupAlarm

By pressing Autoset in controlledmodes of ventilation the alarmlimits are automatically set for:

PressureVolumeResp. RatePEEPCO2

Note: Autoset is not possiblein NIV.

In spontaneous modes an alarmsetting for apnea time is available.

Alarm profile setup. Possibleselections:

Pressure (upper)Minute volume (lower andupper)Respiratory rate (lower andupper)End expiratory pressure (lowerand upper)Alarm sound level (10-100%)End tidal CO2 (lower andupper)

Note: In NIV the alarm soundcan be permanently silenced(audio off).

Alarm:Profile

This shows alarms that have been activated. The list is in alphabeticalorder.

Alarm:History

Audio pause (Silence or pre-silence alarms)Alarm:

Review

Review trends, recorded waveforms, event log or configuration.Review:TrendsReview:Recorded waveformsReview:Event logReview:View configuration



Options

CO2 calibration, Edi Module testOptions:CO2 calibrationOptions:Edi module test

Compensate

Under "Compliance" it is possible to activate or deactivate circuitcompliance compensation. Under "Gas type" it is possible tocompensate the system for HeO2/Air.

Compensate:Compliance

Copy

Copy data (event log, recordings, trends, OLT data, Start-upconfiguration) to PC Card.

Copy:Copy data

Copy screen to PC Card.Copy:Copy screen

Biomed

Biomed(standby mode)

Measured O2 concentration will be adapted in relation to set value.Biomed:O2 cell adaptation(only during ventilation)

Locks all user input functions on the User Interface. Press Mainscreen fixed key to unlock.

Panel lock

Available in SERVO-i Ventilator System, Universal only. Switchesbetween Adult and Infant patient category.

Change patient category(only during ventilation)



14.6 BIOMED MENU (STANDBYMODE)

Biomed

Enter code 1973 to access Biomed menus. The access code can bechanged by the user.

Display Event logs. Possible selections:latest logsselected time interval

Service:Event logAlarmsVentilator settingsFunctions

Display service logs. Possible selections:21 latest logsselected time interval

Service:Service logTechnical alarmsTest resultsPreventive maintenanceService report historyInstallation log

Enters a date for the preventative maintenance into the service log.Service:Report PM

Reset of breath counter in expiratory cassette.Service:Replaced Expmembrane

User default configuration setup.Edit configurationAlarm sound levelAdult alarm limitsInfant alarm limitsDisplayed valuesNIV adult alarmNIV infant alarmStartup configuration



Copy configuration to/from PC card.Copy configuration

Date and time setup.Set date and clock

Change access code to Biomed menu.Change access code

Starts MCare Remote Service functionStart MCare Remote Service



14.7 SCREEN TOUCHPADS

When the soft key for a selected ventilation mode is pressed, awindow appears with the valid settings for this mode. The windowhas an Accept soft key and a Cancel soft key. When the Accept softkey is pressed the ventilator starts to ventilate with the new settings.If the Cancel soft key is pressed this window will disappear and theventilator will continue to ventilate with the original settings. Tosupport the clinician in adjusting settings some values, derived fromsettings, are shown in the upper right field of the set ventilation modewindow e.g. inspiration time in seconds, calculated inspiratory flow.

Mode Xxxxx

The touchpad Automode selects the Automode function. When thepatient is breathing spontaneously:

The green indicator is litThe ventilation mode text goes from grey to black.

Automode

When the admit patient function is activated the clinician can enteror amend patient details:

date of admissionpatient nameidentity number height

weightdate of birth

Admit patient

The Nebulizer function turns the nebulizer on or off. It is possible toset the duration of nebulization between 5 and 30 minutes. Thedefault time is 10 minutes.

During nebulization the remaining time is displayed in the nebulizertouchpad.

The nebulizer is automatically disabled during battery operation.

Nebulizer



In the Status function, an icon displays which power source iscurrently active i.e. Mains, Ext. 12 V, or battery. When one or morebatteries are in use, information about remaining time is alsodisplayed. When the Status touchpad is activated a windows appearsdisplaying the status of:

Status of CO2 module (if used)General system informationStatus of O2 cell/sensor Status of Y Sensor module (if

used)Status of Expiratory cassetteInstalled optionsStatus of batteriesStatus of Pre-use check

StatusGeneralO2 cell/sensor

Exp. cassetteBatteriesModulesInstalled optionsPre-use check

Additional settings

Press the Additional settings touchpad to see the settings availablefor the current mode.

Vital parameters are set using the Direct Access Knobs.

The bar below the numeric value is a graphical representation of thechosen value and gives information about the parameter ranges.

the bar is white if your setting is within what is generally consideredsafe rangesthe bar turns yellow if your setting is slightly beyond what isgenerally considered safe rangesthe bar turns red if your setting is significantly beyond what isgenerally considered safe ranges

I:E/Insp. times

The trigger sensitivity bar is colored based on the setting:the bar is green for a normal setting for flow triggeringthe bar is red when there is a risk of self-triggeringthe bar is white when pressure triggering is selected.

Trigger

This pad will be visible in supported ventilation modes.Backup ventilation

This is an area of the screen which shows which showsmeasured/calculated numerical values.

Three pages with values are available. By pressing Additional valuesit is possible to scroll between the pages.

Note: In NIV, only one page is available.

Additional values



15 INDEX

AAbbreviations 247see Definitions

Accessories 191Activity instruction 36Additional settings 56, 261Additional values 62, 261Adult alarm limit 258Adult range

Air/O2 227, 228HeO2/O2 227, 228

Aeroneb Professional Nebulizer System 193AGA adapter 147Alarm output connection 29, 179, 233Alarm output connection option, test 44Alarm profile 40see Set alarm limits

AlarmsAlarm (technical data) 229Alarm limit 53, 186, 252Audio off 20, 184Autoset 230High priority alarms 181, 207History 256Low priority alarms 181Medium priority alarms 179, 181, 211Permanently silencing 183Pre-silencing alarms 183

Alarm settings 244Alarm sound level 53, 258Appendix

Fixed keys 252Main screen key 255Menu key 256Quick access key 254Screen touch pads 260Special function keys 253

Audio pause 20, 181, 182, 183, 230Automatic gas identification 149

Automode 79, 107

BBackup ventilation 128Battery

Charge indicator 36Data 35Module 34

Battery status 35Battery status window 36Before use 9, 154Biomed 258Bi-Vent 79, 119Breath cycle time 86Brief device description 6

CCautions 8Change access code 259Cleaning and Maintenance 7CO2 Analyzer 197, 235CO2 Analyzer

Calibration 199Components 198Use guidelines 198

Combined ventilation 231Communication/Interface 233Compressor Mini 238Connections and labels 17, 27Copy

Patient data 71, 72Copy configuration 218, 258, 259

DDefault values 241, 245Definitions 247Dimensions

Compressor Mini 238Drawer kit 238Holder 238Mobile Cart 238


| Index | 15 |

Shelf base 238Direct access knob 23Displayed values 258Disposable parts 155DISS adapters 148Drawer kit 238

EEdi Catheter 155, 163, 164, 165Edi Catheter

Before inserting 163Inserting 164Positioning 165Symbols 156

Edi module 162Edi module

Function check 162Insert into patient unit 162

Edit configuration 219, 258EMC 222Event log 66Expiratory cassette 26Expiratory channel 227Expiratory hold 247External 12 V 223External patient monitoring 146Extra flow and extra breaths 76

FFace mask 122Factory set default 241Fisher & Paykel

Humidifier 192Fixed keys 22Flow/Volume in focus 76Flow sensitivity level 247French adapter 147

GGas cylinder restrainer 238Gas mismatch 149Gas supply 224

Gas Trolley 238

HHeliox

Changing gas type 148HeO2 connection 147

Heliox adapters 145Helmet 146, 203, 204HeO2 icon 149High priority alarms 207History 256Holders

Gas cylinder restrainer 238IV Pole 238Shelf base 238

HumidifierFischer & Paykel 192Teleflex Medical 192

II:E ratio 135I:E ratio/inspiration time 88Important 8Infant alarm limits 258Infant range

Air/O2 227, 228HeO2/O2 227, 228

Informative text message 19, 37Inspiration time 136Inspiratory channel 225Inspiratory cycle-off 86Inspiratory hold 141Inspiratory rise time 85Intended use 6Intended user 6Internal tests 42Invasive ventilation 54

LLoops 67Low priority alarms 215


| 15 | Index |

MMain rotary dial 22Main screen key 255Mandatory breath 111, 112Mandatory ventilation (SIMV) 79Measured value boxes 62Measured values 62Medium priority alarms 211Menu key 25Minute volume 49Mobile cart 30, 238

NNasal CPAP 78, 126Nasal mask 122NAVA 153, 170NAVA

Components 157Edi Catheter 155Functional description 158General 154Overview 156Set NAVA level 169Workflow 161

NebulizerAeroneb ProfessionalNebulizer System 193Servo Ultra Nebulizer 194

Neuro ventilatory tool 175NIST adapter 147NIV 122NIV

Adult alarm 258Backup ventilation 132Infant alarm 258Nasal CPAP 126Pressure control 124Pressure support 125

NIV NAVA 173Non Invasive Ventilation 122Non-operating conditions 222

OO2 breaths 140O2 cell 59O2 sensor 59Operating conditions 222Options 13Options/Accessories 191

PPanel lock 257Patient breathing system 43Patient category 55Patient circuit test 48Patient data 49Patient range 203Patient unit

Connections and labels 27Gas flow 29

Pause time (T pause) 136PEEP 87Power supply 10Pressure and Volume in focus 76Pressure Control 78, 97Pressure Control

Controlled ventilation 97Pressure Control (NIV) 231Pressure control + Pressure support 117Pressure in focus 76Pressure Support (NIV) 231Pre-use check 40Pre-use check tests 40Previous mode 89PRVC 77, 91PRVC

Controlled ventilation 91

QQuick access key

Loops 254Scales 143


| Index | 15 |

RRemote Service 220Respiration cycle 160Respiratory rate 89Review 256

SService 7Service Log 7SERVO-i

Adult 13Infant 13Universal 13

Servo Ultra Nebulizer 194Set alarm limits 53Set up and start ventilation

NAVA 170NIV NAVA 173

Shelf base 238Software version 9Special functions

Fixed keys 139Spontaneous breathing/CPAP 107Standards 222Standby 124, 256Start breath 139Start-up configuration 217Status 26Suction support 57Support arm 9Symbols

Patient unit 27User interface 17

TTechnical error messages 216The system

Technical data 221Tidal volume 248Timing 76Touch screen 21Trends 68

Trigg. Flow 82Trigger

Indication 20Stronger patient effort 84Trigger sensitivity 82Weak patient effort 84

Trigg Pressure 82Troubleshooting

Medium priority alarms 211Technical errors 206

Type of ventilation 51

UUser Interface

Connections and labels 17

VVentilation

Automode 79Basic functionality 77Bi-Vent 79, 119Combined modes 79Controlled ventilation 231Extra flow and extra breaths 76Heliox 145I:E ratio/inspiration time 88Implementation 76Mandatory breath 111Modes of ventilation 80Parameters 135, 159Pressure Control 97Pressure Support 78PRVC 77, 91Settings 241, 244Set ventilation mode 51Supported ventilation 100, 103Timing 76Volume Support 100

Ventilation record cardCopy patient data 72Copy screen data 71

Ventilator 16


| 15 | Index |

Ventilatory 75Volume Control

Controlled ventilation 94Volume Support 100

WWarnings 8Water trap 192Waveform 64, 69Waveform configuration 254Waveform scales 65, 254Weight 224Workflow 40

YY sensor 201


| Index | 15 |


| 15 | Index |

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For local contact:Please visit our websitewww.maquet.com

GETINGE GROUP is a leading global provider of products andsystems that contribute to quality enhancement and cost efficiencywithin healthcare and life sciences. We operate under the threebrands of ArjoHuntleigh, GETINGE and MAQUET. ArjoHuntleighfocuses on patient mobility and wound management solutions.GETINGE provides solutions for infection control within healthcareand contamination prevention within life sciences. MAQUETspecializes in solutions, therapies and products for surgicalinterventions and intensive care.

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