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WARNINGFor a full understanding of the per-formance characteristics of this medical device, the user should carefully read these Instructions for Use before use of the medical device.

Instructions for Use

Carina

Sub-Acute Care VentilatorSoftware 3.n

2 Instructions for Use Carina SW 3.n

Working with these Instructions for Use

In the header – the subject of the main chapter To help you find your way around quickly.

On each page – the instructions for use Combining text with illustrations. The information is translated directly into actions to enable the user to learn "hands-on" how to use the Carina ventilator.

Left-hand column – the textProvides explanations and guides the user clearly and ergonomically with brief directions for using the product. Dots indicate the steps to be followed whilst num-bers refer to the illustration and indicate the sequence.Font style, e.g. »Start/Standby«, »MVi«, indicates buttons, device labels and messages on the screen.

Right-hand column – the illustrationProvides a link with the text and serves as a guide to the ventilator. Points mentioned in the text are emphasized and non-essential information is omit-ted.Screen displays guide the user and confirm the steps to be followed.

107

Operation


Setting ventilation modesSwitching on, Carina shows the ventilation mode last set along with the set parameters.

Calling up the ventilation settings menu1 Press »Select Menu« button.

2 Press the »Settings« button and the ventilation mode last set is indicated.

Changing the ventilation mode3 Press button for the ventilation mode.

Select and confirm the ventilation mode using the rotary knob.

Carina can use the following ventilation modes:– VC-SIMV– PC-BIPAP– PC-AC– SPN-PS (VG)– SPN-CPAP

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507

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506

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Instructions for Use Carina SW 3.n 3

Trademarks– AutoFlow® – Carina®

– SyncPlus®

are registered trademarks of Dräger.

– BIPAP*

– Virex® is a registred trademark of JohnsonDiversery.

Definitions

* Trademark Used Under Licence

WARNINGA WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTIONA CAUTION statement provides important infor-mation about a potentially hazardous situation which, if not avoided, may result in minor or mode-rate injury to the user or patient or in damage to the medical device or other property.

NOTEA NOTE provides additional information intended to avoid inconvenience during operation.


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Contents

Contents

Working with these Instructions for Use . . . . . 2

Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

For Your Safety and That of Your Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

General WARNINGS and CAUTIONS . . . . . . . . 10

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

System Overview . . . . . . . . . . . . . . . . . . . . . . . 15

Main functions . . . . . . . . . . . . . . . . . . . . . . . . . . 16Control panel, top . . . . . . . . . . . . . . . . . . . . . . . . 18Carina underside . . . . . . . . . . . . . . . . . . . . . . . . 18Front connection block . . . . . . . . . . . . . . . . . . . . 19Rear connection block . . . . . . . . . . . . . . . . . . . . 19Trolley 1-63 cm, Trolley 1-78 cm . . . . . . . . . . . . 20Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Operating concept . . . . . . . . . . . . . . . . . . . . . . 25

Control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . 26Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Setting ventilation mode . . . . . . . . . . . . . . . . . . . 28Setting ventilation parameters . . . . . . . . . . . . . . 28Calling up menus . . . . . . . . . . . . . . . . . . . . . . . . 29

Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Information on preparation . . . . . . . . . . . . . . . . . 32Fitting the inlet filter . . . . . . . . . . . . . . . . . . . . . . 32Positioning Carina . . . . . . . . . . . . . . . . . . . . . . . 32Carina with trolley . . . . . . . . . . . . . . . . . . . . . . . . 33Information on using bacterial filters, HME systems and hose systems . . . . . . . . . . . . . . . . 39Connecting a hose system . . . . . . . . . . . . . . . . . 40Connecting a respiratory gas humidifier . . . . . . . 43Preparing the Aeroneb Pro nebuliser . . . . . . . . . 46Connecting to the power supply . . . . . . . . . . . . . 47O2 supply, connect . . . . . . . . . . . . . . . . . . . . . . . 50Connecting to the nurse call system. . . . . . . . . . 52MEDIBUS interface . . . . . . . . . . . . . . . . . . . . . . 53Position of the user. . . . . . . . . . . . . . . . . . . . . . . 53

Start-up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Information on start-up . . . . . . . . . . . . . . . . . . . 56Switching on Carina . . . . . . . . . . . . . . . . . . . . . 56Checking readiness for operation . . . . . . . . . . . 57Selecting an application method . . . . . . . . . . . . 59Setting the O2 supply . . . . . . . . . . . . . . . . . . . . 60

Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Setting ventilation modes . . . . . . . . . . . . . . . . . 62Setting ventilation parameters. . . . . . . . . . . . . . 63Starting ventilation . . . . . . . . . . . . . . . . . . . . . . . 63VC-SIMV AF . . . . . . . . . . . . . . . . . . . . . . . . . . . 64PC-BIPAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66PC-AC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68SPN-PS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70SPN-CPAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72Apnoea ventilation. . . . . . . . . . . . . . . . . . . . . . . 73Volume guarantee . . . . . . . . . . . . . . . . . . . . . . 74NIV – Non-invasive Ventilation . . . . . . . . . . . . . 75LPO – Low Pressure Oxygen mode . . . . . . . . . 77Locking buttons . . . . . . . . . . . . . . . . . . . . . . . . . 80Terminating ventilation. . . . . . . . . . . . . . . . . . . . 81Switching off the device . . . . . . . . . . . . . . . . . . 81Improve displayed accuracy of the charging capacity of the internal battery . . . . . . . . . . . . . 82

Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Setting alarm limits . . . . . . . . . . . . . . . . . . . . . . 84In the event of an alarm. . . . . . . . . . . . . . . . . . . 85Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . 86Suppressing the alarm tone . . . . . . . . . . . . . . . 86Alarm after battery discharge . . . . . . . . . . . . . . 86

Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Carina Configuration . . . . . . . . . . . . . . . . . . . . . 88Service menu . . . . . . . . . . . . . . . . . . . . . . . . . . 89Setting volume of the alarm tone. . . . . . . . . . . . 91Setting the alarm tone . . . . . . . . . . . . . . . . . . . . 91Selecting screen display . . . . . . . . . . . . . . . . . . 92Selecting display for 2 measured values. . . . . . 93Selecting an application method . . . . . . . . . . . . 93Switching LPO mode on/off . . . . . . . . . . . . . . . . 93Selecting Ti or I:E . . . . . . . . . . . . . . . . . . . . . . . 94Setting the night screen. . . . . . . . . . . . . . . . . . . 94


Contents

Fault – Cause – Remedy . . . . . . . . . . . . . . . . . 95

Fault – Cause – Remedy . . . . . . . . . . . . . . . . . . 96Displaying technical alarm causes . . . . . . . . . . 101Rescue Ventilation . . . . . . . . . . . . . . . . . . . . . . 101

Cleaning, Disinfection and Sterilisation. . . . 103

General information on cleaning, disinfection and sterilisation . . . . . . . . . . . . . . . 104Care list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105Dismantling the components . . . . . . . . . . . . . . 105Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106Wipe disinfection . . . . . . . . . . . . . . . . . . . . . . . 106Wipe disinfection with Virex Tb. . . . . . . . . . . . . 106Damp heat disinfection. . . . . . . . . . . . . . . . . . . 106Autoclave sterilisation at 134 °C. . . . . . . . . . . . 106Reprocessing of accessories . . . . . . . . . . . . . . 106Before reusing on patient . . . . . . . . . . . . . . . . . 106

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Maintenance intervals . . . . . . . . . . . . . . . . . . . 108Replacing the inlet filter . . . . . . . . . . . . . . . . . . 109Taking the device out of operation for a lengthy period . . . . . . . . . . . . . . . . . . . . . . . . 109Visual inspection of accessories. . . . . . . . . . . . 110

Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

Disposing of the internal battery. . . . . . . . . . . . 112Disposing of the inlet filter . . . . . . . . . . . . . . . . 112Disposing of the device . . . . . . . . . . . . . . . . . . 112

Technical Data . . . . . . . . . . . . . . . . . . . . . . . . 113

Ambient conditions . . . . . . . . . . . . . . . . . . . . . . 114Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114Performance data. . . . . . . . . . . . . . . . . . . . . . . 115Measurement displays . . . . . . . . . . . . . . . . . . . 115Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116Operating data . . . . . . . . . . . . . . . . . . . . . . . . . 117Classification . . . . . . . . . . . . . . . . . . . . . . . . . . 118Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . 118Trolley. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118Hose systems. . . . . . . . . . . . . . . . . . . . . . . . . . 119EMC Declaration . . . . . . . . . . . . . . . . . . . . . . . 120

Description . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

Mode of operation . . . . . . . . . . . . . . . . . . . . . . 126VC-SIMV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

PC-BIPAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132PC-AC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133SPN-PS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134SPN-CPAP . . . . . . . . . . . . . . . . . . . . . . . . . . . 135Tube (Invasive ventilation) . . . . . . . . . . . . . . . 135Mask ventilation (Non-invasive ventilation) . . . 136SyncPlus . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138Volume Guarantee (VG) . . . . . . . . . . . . . . . . . 138Volume measurement . . . . . . . . . . . . . . . . . . 139AutoRamp . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141


For Your Safety and That of Your Patients


Strictly follow these Instructions for Use. . . . . . . . 8Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Safe connection with other electrical equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Patient monitoring. . . . . . . . . . . . . . . . . . . . . . . . . 8Functional safety . . . . . . . . . . . . . . . . . . . . . . . . . 9

General WARNINGS and CAUTIONS . . . . . . . 10

Note on EMC/ESD risk for the device function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Adequate monitoring of ventilation . . . . . . . . . . . 11Back-up ventilation with an independent manual ventilation device . . . . . . . . . . . . . . . . . . 12



Strictly follow these Instructions for Use

Maintenance

Accessories

Safe connection with other electrical equipment

Patient safety The design of the medical device, the accompany-ing literature, and the labeling on the medical device take into consideration that the purchase and use of the medical device are restricted to trained professionals, and that certain inherent characteristics of the medical device are known to the trained operator. Instructions, warnings, and caution statements are limited, therefore, largely to the specifics of the Dräger design. This publication excludes references to various hazards which are obvious to a medical profes-sional and operator of this medical device, to the consequences of medical device misuse, and to potentially adverse effects in patients with abnor-mal conditions. Medical device modification or mis-use can be dangerous.

Patient monitoringThe operators of the medical device are responsi-ble for choosing appropriate safety monitoring that supplies adequate information on medical device performance and patient condition. Patient safety may be achieved through a wide variety of means ranging from electronic surveillance of medical device performance and patient condition, to sim-ple, direct observation of clinical signs.The responsibility for the selection of the best level of patient monitoring lies solely with the medical device operator.

WARNINGAny use of the medical device requires full understanding and strict observation of all portions of these instructions. The medical device is only to be used for the purpose spec-ified under "Intended Use" on page 14 and in conjunction with appropriate patient monitor-ing (see page 11). Strictly observe all WARN-ING and CAUTION statements throughout these instructions for Use and all statements on medical device labels.

WARNINGThe medical device must be inspected and serviced regularly by properly trained service personnel. Repair of the medical device may also only be carried out by properly trained service per-sonnel. Dräger Medical recommends that a service contract be obtained with DrägerService and that all repairs also be carried out by them. Dräger Medical recommends that only authen-tic Dräger Medical repair parts be used for maintenance. Otherwise the correct function-ing of the medical device may be compro-mised.See chapter "Maintenance".

WARNINGOnly the accessories indicated on the list of accessories 90 38 969 (1st edition or higher) have been tested and approved to be used with the medical device. Accordingly it is strongly recommended that only these acces-sories be used in conjunction with the specific medical device. Otherwise the correct func-tioning of the medical device may be compro-mised.

WARNINGElectrical connections to equipment which is not listed in these Instructions for Use should only be made following consultation with the respective manufacturers. Equipment mal-function may result with the risk of patient injury.



Functional safetyThe essential performance consists in controlled and monitored patient ventilation with user-defined settings for the monitoring functions– minimum inspiratory breathing gas flow,– maximum airway pressure,or, if one of the limits set is exceeded, by an appro-priate alarm. The medical device is equipped with basic safety features to reduce the possibility of patient injury while the cause of an alarm is reme-died.



General WARNINGS and CAUTIONSThe following WARNINGS and CAUTIONS apply to general operation of the device. WARNINGS and CAUTIONS specific to subsystems or particular features appear with those topics in later sections of these Instructions for Use or in the Instructions for Use of any product being used with this device.

WARNINGIt is the medical user's responsibility to select the appropriate ventilation mode for the patient's underlying disorder. Despite all the ventilator adjustments to ensure that the ven-tilation setting is optimally suited to the condi-tion of the patient, the user must take the patient's respiratory status and general state of health into account.

WARNINGOnly use the device under the supervision of qualified medical personnel so that in the event of a malfunction assistance is on hand immediately.

WARNINGOperation prohibited in potentially explosive atmospheres! The device is not approved for operation in potentially explosive atmos-pheres.

WARNINGDo not use the device in conjunction with flammable gases or anaesthetic agents – fire hazard!

WARNINGMedications or other substances based on flammable solvents such as alcohol must not be introduced into the hose system. Fire haz-ard!If highly flammable substances are used for disinfection, adequate ventilation must be ensured.

WARNINGDo not use the device during magnetic reso-nance (MRI, NMR, NMI)! Device operation may be affected, thus placing the patient at risk.

WARNINGDo not use the device in hyperbaric cham-bers!Device operation may be affected, thus plac-ing the patient at risk.

WARNINGOperation of the device can be impaired by the use of high-frequency electrosurgical units, defibrillators and shortwave therapy devices, thus endangering the patient.

WARNINGDo not use any antistatic or conductive Venti-lation hoses. Risk of electric shock and fire hazard due to oxygen.

CAUTIONTo prevent the device from tipping over, only use Carina up to a maximum inclination of 15°!

CAUTIONTo combine Carina with other products the opera-tor must secure the equipment appropriately in accordance with the relevant basic requirements of Directive 93/42/EEC.

CAUTIONObserve the following for ventilation when moving through the hospital: Do not place Carina on the bed. Prevent Carina from dropping. Secure accessories.

WARNINGDo not use the device in rooms at tempera-tures above 35 °C (95 °F) or below 5 °C (41 °F). Risk of lung damage, especially in the case of tracheotomized patients.



Note on EMC/ESD risk for the device functionGeneral information on electromagnetic compatibil-ity (EMC) pursuant to international EMC standard IEC 60601-1-2:Electromedical devices are subject to special pre-cautionary measures concerning electromagnetic compatibility (EMC) and must be installed and put into operation in accordance with the EMC informa-tion provided on page 120.Portable, mobile RF communications equipment can affect medical electrical equipment.

Adequate monitoring of ventilation The patient monitoring system integrated into Carina monitors the following parameters: – Airway pressure Paw– Inspiratory minute volume MVi– Delivered minute volume MV (without leakage

compensation)– Apnoea time Tapn

– Inspiratory tidal volume VTi (not in SPN-CPAP)– Delivered tidal volume VT (without leakage

compensation) (not in SPN-CPAP)– PEEP– Mean pressure Pmean

– Frequency f – I:E

Changes in these parameters can be caused by: – acute change in the condition of the patient – adjusting and handling errors – device errors – failure of power and gas supplies If there is a fault in the integrated patient monitoring system use separate measuring equipment.

CAUTIONOnly use the device in well ventilated rooms to prevent over heating of the device.

CAUTIONDo not expose the device to direct sunlight to pre-vent over heating of the device.

WARNINGOnly operate Carina with an inlet filter (HEPA) to prevent infection and dusting patient.

WARNINGIf inspiratory oxygen concentration differs from ambient air concentration, monitoring of inspiratory oxygen concentration with adjust-able high and low alarm limits is needed. Con-nect external monitor to hose system in accordance with ISO 21647. Otherwise no alarm will be activated if actual inspiratory oxygen concentration differs from set oxygen concentration.

WARNINGPatients depending on ventilation need either monitoring of expiratory tidal volume, or mon-itoring of expiratory minute volume, or moni-toring of endtidal expiratory CO2 concentration. Connect appropriate external monitor to hose system. Otherwise no alarm will be activated, if patient's ventilation deteriorates.

CAUTIONDue to Carina's limited monitoring functionality (no internal monitoring of expiratory minute vol-ume), Carina is not always able to detect a dis-connection of the hose system or pilot line! Especially in cases when low PEEP values and filters with high resistance are used. Use only fil-ters listed in the separate accessories list, or con-nect appropriate external monitor!

WARNINGIn the case of patients who require a high O2 concentration ensure that there is an emer-gency supply of oxygen available, e.g. in O2 cylinders.

WARNINGDo not operate a defibrillator while supplying oxygen. Fire hazard!



Back-up ventilation with an independent manual ventilation device

WARNINGIf a fault is detected in Carina so that its life-support functions are no longer assured, ven-tilation using an independent ventilation device must be started without delay – if nec-essary with PEEP and/or an increased inspir-atory O2 concentration (e.g. with the Resutator MR 100).


Intended Use

Intended Use

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Sub-acute care definition . . . . . . . . . . . . . . . . . . 14

Intended Use


Intended UseCarina – long-term ventilator for ventilator-depend-ent patients or ventilator-assisted patients.– For treatment of sub-acute care patients in hos-

pital or medical rooms.– For invasive ventilation or non-invasive ventila-

tion.– For patients with a tidal volume of at least

100 mL.– For use by qualified medical personnel.

Sub-acute care definition*

Sub-acute care is comprehensive, inpatient care for patients who:– Have had an acute event resulting from injury,

illness or exacerbation of a desease process;– Have a determined course of treatment;– Though stable, require diagnostics or invasive

procedures, but not intensive procedures requiring an acute level of care.

The severity of the patient’s condition requires:– Active physician direction with frequent on-site

visits;– Professional nurse care;– Complex medical and/or rehabilitative care.

Typically sub-acute care is designed to return patients to the community or transition them to a lower level of care.

WARNINGNot intended for acute inpatient care of non-stabilized patients who require ventilation with comprehensive continuous monitoring according to IEC 60601-2-12 or EN 794-1.

* References:National Association of Subacute and Post Acute Care (NASPAC)The American Health Care Association (AHCA)The Joint Commission on Accreditation of Healthcare Organizations (JCAHO)FDA Consumer magazine September-October 1999


System Overview

System Overview

Main functions . . . . . . . . . . . . . . . . . . . . . . . . . 16

Ventilation modes . . . . . . . . . . . . . . . . . . . . . . . . 16Supplements. . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Hose systems. . . . . . . . . . . . . . . . . . . . . . . . . . . 16Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Gas supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17MEDIBUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Trolley. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Control panel, top . . . . . . . . . . . . . . . . . . . . . . . 18

Carina underside . . . . . . . . . . . . . . . . . . . . . . . 18

Front connection block . . . . . . . . . . . . . . . . . . 19

Rear connection block . . . . . . . . . . . . . . . . . . . 19

Trolley 1-63 cm, Trolley 1-78 cm . . . . . . . . . . . 20

Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 22


System Overview

Main functions

Ventilation modesVC-SIMV AFVolume Control – Synchronized Intermittent Man-datory Ventilation – AutoFlowIntermittent triggered mechanical ventilation (vol-ume-controlled) in conjunction with spontaneous breathing. With AutoFlow function for optimisation of inspiration flow.

PC-ACPressure Control – Assist ControlPressure-assisted spontaneous breathing with fixed inspiration time.

PC-BIPAPPressure Control – Biphasic Positive Airway Pres-surePressure-controlled ventilation in conjunction with free spontaneous breathing during the entire breathing cycle.

SPN-PS (VG)Spontaneous – Pressure Support (Volume Guarantee)Pressure-assisted spontaneous breathing with selectable volume guarantee function

SPN-CPAPSpontaneous Continuous Positive Airway PressureSpontaneous breathing with continuous positive airway pressure

SupplementsApnoea ventilationFor automatically switching to volume-controlled, mandatory ventilation in the event of apnoea. If apnoea occurs, Carina gives an alarm after the set alarm time and starts ventilation at the predeter-mined volume.

TriggerFor the ventilation of spontaneously breathing patients, synchronising ventilation with spontane-ous breathing.

SyncPlus For leak compensation.

RampVariable rise in pressure from the lower pressure level to the upper pressure level.

VGVolume GuaranteeVG ensures that patients receive a defined tidal vol-ume even during pressure-assisted ventilation (SPN-PS).

Hose systemsHose system with leak valve (LeakV) for mask or tube application method– Automatic leakage compensation– MVi and VTi represents the calculated inspira-

tory patient volume– VC-SIMV AF and SPN-PS (VG) control the cal-

culated inspiratory patient volume

Hose system with expiratory valve (ExpV) for tube application method– No leakage compensation– MV and VT represents the delivered volume– VC-SIMV AF and SPN-PS (VG) control the

delivered volume

MonitoringThe following parameters are monitored:– Airway pressure Paw– Inspiratory minute volume MVi, MV– Breathing frequency f

The following are indicated as measured values:– Airway pressure PIP– Airway pressure Pmean– Airway pressure PEEP– Inspiratory minute volume MVi, MV– Inspiratory tidal volume VTi, VT (not in

SPN-CPAP)– Breathing frequency f– Leak minute volume MVleak

The following are represented as curves:– Flow (t)– Paw (t)


System Overview

The following are displayed as a bar graph:– Airway pressure

Display of:– Log book for technical alarms– List of measured values– List of set values

Monitoring of the patient is assisted by adjustment of the alarm limits:– Airway pressure Paw high– Pressure limitation Pmax

– Minute volume MV high, MV low– Breathing frequency f high– Tdisconn (disconnect alarm for mask ventilation)– Apnoea time Tapn

Gas supplyHPO – High Pressure Oxygen modeFor O2 supply to Carina from the central gas supply or from a O2 gas cylinder.LPO – Low Pressure Oxygen mode For O2 supply to Carina from a mobile oxygen source, separate from a central high-pressure O2 supply.

Power supply– Mains voltage 100 to 240 V, 50/60 Hz– Internal battery– External battery (optional)Active power supply is indicated on the screen.

Interfaces– RS 232 serial port for data communication– Nurse call system

MEDIBUSSoftware protocol for the transfer of data between Carina and an external medical or non-medical device (e. g. patient monitors or computers for data management systems) via an RS 232 interface, see "MEDIBUS for Dräger Intensive Care Devices" (90 28 329) and "MEDIBUS for Carina" (90 39 037).All transferred data are for information only and should not be used as basis for diagnostic or ther-apeutic decisions.

To protect the patient and the user against electrical hazards, it is essential that all systems consisting of medical devices as well as other electrical devices which are not restricted to computers, printers etc., are only assembled by trained personnel. The system must meet the requirements of the IEC/EN 60601-1-1 and IEC/EN 60601-1-2 standards.

TrolleyCarina can be positioned on a trolley.

System Overview


Control panel, top1 Carrying handle2 Screen for application-specific information on

ventilation3 Buttons for selecting functions and ventilation

parameters 4 Centre rotary knob for setting and confirming

functions and parameters5 »Audio paused 2 min.« button for suppressing

the alarm tone for 2 minutes and for visual indication of alarm status: red = warning, yellow = caution

6 LED for indicating power supply:LED lit = External power supply (mains/external battery), internal battery is chargedLED flashes = External power supply (mains/external battery), internal battery is being chargedLED off = battery operation

7 »Start/Standby« button to switch between standby and ventilation

8 »Select Menu« button to open the menus for ventilation settings, alarms, measured values, configuration, interlock

Carina underside9 Switch for hose system with leak valve or hose

system with expiratory valve masked by sliding cover (not illustrated)

10 Base humidifier (accessory, currently not fitted)11 Holes for positioning on the trolley (4 off)

CAUTIONSwitching between a hose system with leak valve and a hose system with expiratory valve must be carried out by properly trained personnel only! Risk of malfunction!

000

1

45

2

3876

001

9

10

11


System Overview

Front connection block1 Ventilation hose connection2 Emergency air inlet and oxygen overflow3 Connection for control hose (for hose system

with expiratory valve)

Rear connection block4 Not assigned5 Connection for nurse call system6 RS 232 serial port for data communication

(MEDIBUS)7 Not assigned8 Inlet filter (HEPA filter)9 Connection for HPO oxygen supply10 Connection for LPO oxygen supply11 Mains switch12 Connection for external battery13 Power cable connection

002

1

2

3

003

4 5 6 7

8

9

10

111213

System Overview


Trolley 1-63 cm, Trolley 1-78 cm1 Carina bracket2 Standard rail grip3 Universal bracket with standard rail, optional4 Trolley column5 Pedastal6 Red locking lever of the column mount closed

(under pedestal)7 Dual rollers with locking brakes, 4 each8 Battery holder, optional

077

1

2

3

4

76

5

8


System Overview

Symbols

Mains switch ON

Mains switch OFF

Connection for nurse call system

Data port

Power supply display

Standby mode ON/OFF

Turn off audible alarm

Connection for control hose (for hose system with expiratory valve)

Hose system with expiratory valve

Hose system with leak valve

Ventilation hose connection

Power supply – internal battery

Power supply – external battery

Power supply – mains

Charge of internal battery: 90 to 100 %





* Patient effort detection

Menu button

Lower alarm limit

Upper alarm limit

Temperature limitation

int

ext

Menu 1

Menu 2

Menu 3

Observe the Instructions for Use!

Gas inlet (emergency air inlet)

Gas outlet (oxygen overflow)

Disposal information

Protection class type BF

Manufacturer symbol

123

123

123


System Overview

Abbreviations

Abbreviation ExplanationApn. Vent. Apnoea ventilation

AutoFlow Automatic optimisation of inspi-ration flow

bpm Breaths per minuteVentilation strokes per minute

BTPS Body Temperature, Pressure, SaturatedMeasurements related to condi-tions of the patient's lungs, body temperature 37 °C, ambient pressure, watervapor-saturated gas

C Compliance

Δ Psupp Pressure support setting Psupp in relation to PEEP

EMC Electromagnetic compatibility

etCO2 End-expiratory CO2 concentra-tion

ExpV Hose system with expiratory valve

f Breathing frequency

FiO2 Inspiratory O2 concentration

HEPA High Efficiency Particulate Air

HPO High Pressure Oxygen O2 supply to Carina via the O2 high-pressure inlet

I:E Ratio of inspiration time to expi-ration time

LeakV Hose system with leak valve

LPO Low Pressure Oxygen O2 supply to Carina via the O2 low-pressure inlet

MEDIBUS Dräger communication protocol for medical equipment

Mask Mask ventilation

MV Minute volume = product of set-tings VT and f (VT x f)

MVi Inspiratory minute volume

MVleak Leakage minute volume

NIV Non-invasive ventilation (mask ventilation)

Pa Pascal, unit of pressure1 mbar = 100 Pa = 1 hPa1 bar = 100 kPa = 1000 hPa

Paw Airway pressure

Paw high Airway pressure high

PC-AC Pressure Control – Assist ControlPressure-assisted spontaneous breathing

PC-BIPAP Pressure Control – Biphasic Pos-itive Airway PressureSpontaneous breathing with con-tinuously positive airway pres-sure at two different pressure levels

PEEP Positive end expiratory pressure

Pinsp Upper pressure level setting in Pressure Control mode

PIP Measured inspiratory peak pres-sure

Pmax Maximum permitted airway pres-sure setting

Pmean Mean airway pressure

Psupp Pressure support setting, abso-lute value

R Resistance

Ramp Pressure rise time

SPN-CPAP Spontaneous Continuous Posi-tive Airway PressureSpontaneous breathing at contin-uously positive pressure

SPN-PS Spontaneous Pressure SupportPressure-assisted spontaneous breathing

Tapn Apnoea time (time before apnoea ventilation starts)

Abbreviation Explanation


System Overview

Tdisconn Delay time for »Airway pressure low !!!« alarm

Te Expiration time

Ti Inspiration time setting

Ti max Maximum inspiration time setting

Tube Tube ventilation (invasive ventilation)

UMDNS Universal Medical Device Nomenclature SystemNomenclature for medical devices

VC-SIMV Volume Control – Synchronized Intermittent Mandatory Ventila-tionSynchronized Intermittent Man-datory Ventilation (volume-con-trolled)

VG Volume Guarantee

VT Tidal volume setting

VTi Inspiratory tidal volume

Abbreviation Explanation


Operating concept

Operating concept

Control panel . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Centre rotary knob . . . . . . . . . . . . . . . . . . . . . . . 26Buttons with a fixed function. . . . . . . . . . . . . . . . 26Buttons for calling up functions and ventilation parameters . . . . . . . . . . . . . . . . . . . . 26Power supply display . . . . . . . . . . . . . . . . . . . . . 26Dwell time without inputs . . . . . . . . . . . . . . . . . . 26

Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Layout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Colour concept . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Setting ventilation mode . . . . . . . . . . . . . . . . . 28

Setting ventilation parameters . . . . . . . . . . . . 28

Calling up menus . . . . . . . . . . . . . . . . . . . . . . . 29

Expanding menus. . . . . . . . . . . . . . . . . . . . . . . . 29The following menus can be selected . . . . . . . . 29

Operating concept


Control panel

Centre rotary knob1 For setting and confirming functions and venti-

lation parameters. To set the value, turn rotary knob.To confirm, press rotary knob.

Buttons with a fixed function2 »Audio paused 2 min.« button for switching off

the alarm tone for 2 minutes.3 »Select Menu« button to call up the menus

(ventilation settings, alarms, measured values, configuration, interlock).

4 »Start/Standby« button to switch between standby and ventilation.

Buttons for calling up functions and ventilation parameters5 Pressing the button opens the relevant function

displayed on the screen or the relevant ventila-tion parameter.

Power supply display6 Green LED

Dwell time without inputsIf a changed setting or selection is not confirmed with the rotary knob for more than 30 seconds, the previous state is reactivated.

Flashing: External power supply is connected (mains/external battery), internal battery is being charged.

Lit: External power supply is connected (mains/external battery), internal battery is fully charged.

Off: External power supply is not connected, device is being operated from a battery.

076

1

2

4

3

6

5


Operating concept

Screen

Layout1 Alarm line for indicating audible alarm switched

off and alarm message2 Status line for current device settings3 Display for real-time waveforms of flow and

pressure or bar display for pressure and 4 measured values

4 Display for 2 measured values, configurable5 Information line, e.g. for information if the set

range limit has been reached6 Display of functions and ventilation parameters

– activated with the relevant function key

Status line for displaying current device settings2.1 LPO oxygen supply 2.2 Power supply (not illustrated)

2.3 Charge of internal battery 2.4 Hose system – expiratory valve or leak valve2.5 Application method – tube or mask2.6 Set ventilation mode (VC-SIMV, PC-BIPAP,

PC-AC, SPN-PS, SPN-CPAP)2.7 Patient effort detection (VC-SIMV, PC-BIPAP,

PC-AC, SPN-PS)

Internal battery

External battery

Mains

500

1

2

3

4

5

6

555*

2.1 2.2 2.3 2.4 2.5 2.6 2.7int

ext

Operating concept


Display of relevant ventilation parameters1 When setting a ventilation parameter the rele-

vant ventilation values calculated by Carina are indicated in the display field for »Value 1«. When the setting has been confirmed, the dis-play field closes.

Colour concept

Setting ventilation mode2 Press button for the ventilation mode displayed.

To select ventilation mode, turn rotary knob.To confirm, press rotary knob.

Setting ventilation parameters3 Press button for the ventilation parameter.

4 To set the value, turn rotary knob. To confirm, press rotary knob.

Yellow Function/parameter selected, not yet confirmed

Dark green Button can be usedFunction/parameter confirmed

Grey Function/parameter cannot be used

501

1

506

2

508

3

080

4


Operating concept

Calling up menus1 Press »Select Menu« button. All the menus are

shown.

2 Press the button for the relevant menu.

The functions and parameters of the menu selected are displayed, e.g. »Vent.Set« menu.

Expanding menus3 In the case of menus with more than 4 or 8 func-

tions/parameters the other functions/parame-ters can be activated by pressing the or

button. The active menu is indicated by the white bar: Menu 1, Menu 2, Menu 3.

The following menus can be selected– »Vent.Set« menu for the ventilation settings, for

a detailed description see page 62.– »Alarms« menu for displaying and setting the

alarm limits, for a detailed description see page 84.

– »Values« menu for displaying the set values and measured values in the current ventilation mode, for a detailed description see page 80.

– »Config.« menu for setting device and ventila-tion parameters, for a detailed description see page 88.

– »Un-Locked/Locked« menu for locking the buttons to prevent them from being pressed accidentally, for a detailed description see page 80.

035

1

507

2

5063

123

123


Preparation

Preparation

Information on preparation . . . . . . . . . . . . . . . 32

Fitting the inlet filter . . . . . . . . . . . . . . . . . . . . . 32

Positioning Carina . . . . . . . . . . . . . . . . . . . . . . 32

Stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Carina with trolley . . . . . . . . . . . . . . . . . . . . . . 33

Position Carina on the trolley . . . . . . . . . . . . . . . 34Attach universal bracket with standard rail . . . . . 35Attaching accessories to the standard rail . . . . . 35Attaching battery holder . . . . . . . . . . . . . . . . . . . 36External battery pack . . . . . . . . . . . . . . . . . . . . . 36Use in the hospital . . . . . . . . . . . . . . . . . . . . . . . 37

Information on using bacterial filters, HME systems and hose systems . . . . . . . . . . 39

Fitting the bacterial filter . . . . . . . . . . . . . . . . . . . 39Observe when using heat and moisture exchangers (HMEs) . . . . . . . . . . . . . . . . . . . . . . 39Hose systems. . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Connecting a hose system . . . . . . . . . . . . . . . 40

Hose system with leak valve . . . . . . . . . . . . . . . 41Hose system with expiratory valve . . . . . . . . . . . 41Attaching the hinged arm . . . . . . . . . . . . . . . . . . 42

Connecting a respiratory gas humidifier . . . . 43

Respiratory gas humidifier without inspiratory heater . . . . . . . . . . . . . . . . . . . . . . . . 44Respiratory gas humidifier with inspiratory heater . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Preparing the Aeroneb Pro nebuliser . . . . . . . 46

Connecting to the power supply. . . . . . . . . . . 47

For mains operation . . . . . . . . . . . . . . . . . . . . . . 47External battery connection . . . . . . . . . . . . . . . . 48External battery for 3rd party connection . . . . . . 48Internal battery . . . . . . . . . . . . . . . . . . . . . . . . . . 49

O2 supply, connect . . . . . . . . . . . . . . . . . . . . . . 50

HPO – High Pressure Oxygen mode . . . . . . . . . 51LPO – Low Pressure Oxygen mode. . . . . . . . . . 51

Connecting to the nurse call system. . . . . . . 52

MEDIBUS interface . . . . . . . . . . . . . . . . . . . . . 53

Position of the user . . . . . . . . . . . . . . . . . . . . . 53

Preparation


Information on preparationBefore every use, reprocess Carina and all the accessories according to the information in the Instructions for Use, see page 103. Comply with the hospital's hygiene regulations!

Fitting the inlet filterUnpack the inlet filter.1 Insert the inlet filter at the bottom, 2 swivel it in and3 press at the top until its snaps into place.

Positioning CarinaPlace Carina on a flat, stable surface.Keep the cooling air vents on the underside of Carina free.Keep the emergency air inlet and oxygen over-flow free.Keep a clearance of at least 20 cm all round free for air supply. Do not cover the device!

WARNINGThe distance between the back of the device and any large obstruction or the wall of the room must not be less than 20 cm. Fire hazard due to high concentration of oxygen.

WARNINGDo not place the device on the bed. Pillows and blankets can affect the supply of air!

023

2 3

1


Preparation

StabilityTo prevent the device from tipping over, only use Carina up to a maximum inclination of 15°!

Carina with trolleyUse Dräger trolley "Trolley 1-63 cm" or "Trolley 1-78 cm" only.

Before use, check readiness for operation of the trolley:1 Red locking lever of the column mount closed,2 Attachments such as standard rail grip or

universal bracket firmly secured,3 Locking levers of the Carina holder closed,4 Rubber elements of device mounts in perfect

condition.

007

077

1

33

2

4

Preparation


Position Carina on the trolleyOpen both locks.

1 Red areas must be visible.

Hold Carina with both hands and place the holes in the underside of the device over the mounting pins. Move Carina in parallel with the base plate of the device mount until Carina comes to rest on the base plate.

Close both locks – the red surfaces should not be visible. Only touch the grip part of the locks.Check Carina to make sure it is secure.Observe the maximum payload! See "Trolley" on page 118.

WARNINGOnly touch the grip part of the locks.Risk of trapping fingers at the lock!

085

005

1 1

006


Preparation

Attach universal bracket with standard railAttach right side of holder to right side of column.

1 Make sure the nose of the universal bracket is completely behind the revolving edge.

2 Attach the left side of the holder to the left side of the column. Make sure the nose of the uni-versal bracket is completely behind the revolv-ing edge.

3 For level adjustment use the plate on the upper side of the universal bracket.

4 Level the universal bracket.5 Secure adjusting lever.

Height Adjustment5 Release adjusting lever and adjust height of

universal bracket.Level universal bracket.Retighten adjusting lever.

Attaching accessories to the standard railAttach accessory to the standard rail. Observe the maximum payload! See "Trolley" on page 118.

CAUTIONCheck tension of universal bracket: The universal bracket must be securely seated on the column. Otherwise the universal bracket may loosen.

086

1

087

2

3

088

4

5

Preparation


Attaching battery holder1 Press the locks inwards to open.2 Open the door of the battery holder.

Position the battery holder against the column.Attach the battery holder. Use the four provided bolts.Tighten the four bolts. Use the provided Allen key.Make sure the battery holder is firmly attached.

External battery pack1 Press the locks inwards to open.2 Open the door of the battery holder.3 Slide in the external battery pack.

Close the door of the battery holder.

089

1

2

090

2

1

3


Preparation

Use in the hospital

WARNINGFor greater stability, move accessories into their optimal position for moving the trolley:

Move hinged arm to its smallest extension.Keep hoses as close to the trolley as pos-sible.Hang the humidifier on the trolley, do not attach to the device!

Otherwise there is a risk of falling.

CAUTIONThe maximum speed for moving the trolley is walking pace.There is a higher risk of it tilting over at thresholds, on uneven floors and on ramps. Reduce moving speed further.

CAUTIONDo not tilt the trolley (with accessories in the worst position) by more than 10°. Otherwise the tilt sta-bility is no longer assured.

CAUTIONWhen using Carina in combination with other products the equipment's owner must ensure that it is adequately secured in accordance with the relevant fundamental requirements of Directive 93/42/EEC.

CAUTIONWhen moving or repositioning the ventilator, ensure a firm grip on the handle, as there is a risk of tilting.

Preparation


Moving the trolley1 Release all four locking brakes.

2 Hold and move the trolley by gripping the stand-ard rail or the trolley column.

Parking the trolley 3 Engage all four locking brakes.

012

1

018

2

026

3


Preparation

Information on using bacterial filters, HME systems and hose systemsAny additional components in the breathing system and any components that do not belong to the standard hose system can substantially increase inspiratory and expiratory breathing resistance beyond the standard requirements (e.g. bacterial filter, HME). Breathing resistance in the patient connection port cannot be directly monitored by Carina.Therefore:

The condition of the patient and the ventilator’s measured values for air volume must be checked more frequently.Follow the Instructions for Use for the used filter and components.

Fitting the bacterial filter

Attach the bacterial filter to the ventilation hose connection point » «.

Observe when using heat and moisture exchangers (HMEs)If a heat and moisture exchanger (HME) is con-nected to the patient port, this can increase breath-ing resistance substantially. An increase in breathing resistance will in turn lead to greater effort in spontaneous breathing and/or greater trig-ger effort during assisted ventilation. Under unfa-vourable conditions, an increase in breathing resistance can lead to an unwanted intrinsic PEEP. This breathing resistance in the patient connection cannot be directly monitored by the ventilator.

Therefore:The condition of the patient and the ventilator's measured values for air volume must be checked more frequently.Follow the Instructions for Use of the heat and moisture exchanger (HME).

Position the filter near to the patient.

Hose systems

WARNINGAlways use an inspiratory bacterial filter or HME/F to reduce possible airborne or liquid-borne cross contamination of the device. Otherwise this can result in cross contamina-tion of the patient.

WARNINGDo not use the heat and moisture exchanger (HME) together with a medication nebuliser or humidifier! This can lead to a greater breath-ing resistance.

WARNINGUsing a HME at high relative ambient humidity can increase breathing resistance substan-tially. Carina might not indicate a disconnect situation under these circumstances! Please check the need of using a HME under these conditions or connect an appropriate external monitor to hose system.

NOTEWhen using a hose system with expiratory valve coupled with heat and moisture exchangers and filters, vibrations may occur during ventilation.

WARNINGThe inspiratory breathing gas is warmed by the built-in blower. To ensure appropriate cooling of the breathing gas, the total length of the inspiratory hoses must be not less than 1.2 m. If hoses are shorter, the temperature of the breathing gas may be too high and thus put the patient at risk.


Preparation

Connecting a hose system

For a detailed description of invasive ventilation, see page 135.

WARNINGMake sure that the selected hose system cor-responds to the device setting! Carina might not give an alarm when using an incorrect hose system. In such cases, meas-ured volumes can differ significantly from the actual volumes!

WARNINGDo not use antistatic or conductive hoses. The use of such materials increases the risk of an electric shock for the patient and the risk of fire breaking out due to oxygen.

WARNINGOnly use hoses and masks that conform to ISO 5356-1. Otherwise hoses might discon-nect during ventilation.

WARNINGRoute hoses safely. Eliminate the risk of stum-bling! Do not kink hoses! Keep the leak valve free for expiration!

NOTETo avoid contamination and soiling of the hose sys-tem, it should remain packaged until ready to be used.


Preparation

Hose system with leak valve 1 Open the sliding cover on the underside of

Carina.2 Using a coin, turn the switch to leak valve

» « until it is properly engaged.3 Close the sliding cover.

4 Connect the filter to socket » «.5 Connect the ventilation hose to the filter.6 Connect the leak valve to the nozzle on the ven-

tilation hose, making sure that the direction is correct.When using the disposable hose system VENTSTAR Carina LeakV (MP 00 312) the leak valve is included. Check that the hose system is displayed in the status line of the screen as follows: »LeakV«.

Hose system with expiratory valve1 Open the sliding cover on the underside of

Carina.2 Using a coin, turn the switch to expiratory valve

» « until it is properly engaged.3 Close the sliding cover.



014

1

3

2

015

4 65

016

1

32

Preparation


4 Connect the filter to socket » «.5 Connect the ventilation hose to the filter.6 Connect the expiratory valve to the nozzle of

the ventilation hose.When using the disposable hose system VENTSTAR Carina ExpV (MP 00 313) the expiratory valve is included.

7 Connect the pilot line of the expiratory valve to pilot hose socket » «.Check that the hose system is displayed in the status line of the screen as follows: »ExpV«.

Attaching the hinged armDräger recommends using a hinged arm to prevent the ventilation hose from kinking.

Attach the hinged arm to the universal rail of the trolley with the claw and screw tight.

017

657 4


Preparation

Connecting a respiratory gas humidifier

WARNINGInstall a water trap when using a respiratory gas humidifier. Otherwise the flow inside of the hoses can be blocked by condensed water.

WARNINGPlace the device and the respiratory gas humidifier on a stable, firm surface. Otherwise the humidifier might fall.

WARNINGDo not use a patient filter when using a respi-ratory gas humidifier. Risk of high resistance in hose system, which could lead to hypoventilation.

WARNINGOnly use distilled water for the respiratory gas humidifier. Risk of infection of the airways.

WARNINGWhen using a respiratory gas humidifier, do not use a heat and moisture exchanger (HME) at the same time! Risk of increased breathing resistance because of condensation.

WARNINGUse the F&P MR 810 respiratory gas humidi-fier only in conjunction with the »Mask/NIV« application method, as the apparatus is only approved for non-invasive ventilation and for flows >5 L/min. Observe the humidifier’s Instructions for Use. Risk of injury to the patient due to insufficient humidification dur-ing invasive ventilation.

Preparation


Respiratory gas humidifier without inspiratory heater For hose system with leak valve

Turn the switch to leak valve » «, see page 41.

1 Connect the filter to socket » «.2 Connect ventilation hoses, observing hose

lengths!3 Place the water trap vertically at the lowest

point of the hose connection.4 Connect the leak valve, making sure the direc-

tion is correct.

For hose system with expiratory valveTurn the switch to expiratory valve » «, see page 41.

1 Connect the filter to socket » «.2 Connect ventilation hoses, observing hose

lengths!3 Place the water trap vertically at the lowest

point of the hose connection.4 Connect the expiratory valve to the nozzle of

the ventilation hose.5 Connect the pilot line of the expiratory valve to

pilot hose socket » «.03

8

35 cm

60 cm60 cm

2 3

41

039

35 cm

60 cm

60 cm

2 3

45 1


Preparation

Respiratory gas humidifier with inspiratory heater For hose system with leak valve

Turn the switch to leak valve » «, see page 41.

1 Connect the filter to socket » «.2 Fit the ventilation hoses according to the

instructions for the respiratory gas humidifier, observing hose lengths.

3 Install the leak valve, making sure the direction is correct.

For hose system with expiratory valveTurn the switch to expiratory valve » «, see page 41.

1 Connect the filter to socket » «.2 Fit the ventilation hoses according to the

instructions for the respiratory gas humidifier, observing hose lengths.

3 Connect the expiratory valve to the nozzle of the ventilation hose.

4 Connect the pilot line of the expiratory valve to pilot hose socket » «.

040

40 cm

110 cm

2

1

3

041

40 cm

110 cm

1

2

3

4

Preparation


Preparing the Aeroneb Pro nebuliser

Position the nebuliser near to the patient.Observe the Instructions for Use of the neb-uliser being used!

WARNINGDuring medication nebulisation do not use a heat and moisture exchanger (HME). Risk of increased breathing resistance.

WARNINGDo not nebulise flammable medication, fire hazard!

081

30

15


Preparation

Connecting to the power supply

A stationery device can be supplied either from the mains or from an external battery. Both power sources charge the internal battery.If you are using the mains supply and a battery sup-ply at the same time, the power supply from the mains takes priority. The external battery supply is switched off. The internal battery is charged from the mains.

For mains operation100 to 240 V AC; 50 to 60 Hz; 1.7 to 1.1 A

1 Plug the power cable into the device and secure with the wire clip.

2 Insert the mains plug into a power socket.The LED flashes or lights up according to the charge of the internal battery.

CAUTIONMaintain a sufficiently charged external battery on hand, in the possible event of a power supply failure.

NOTERoute hoses safely to reduce the risk of tripping.

WARNINGIEC 60601-1-1, Edition 2004 (Safety of medical electrical systems):The use of portable multiway adapters is not allowed!

NOTEUse only power leads with connectors conforming with the EN 60320 C17 or C13 standards, and which can be secured with the wire clip and whose power leads conform with national requirements.

010

1 2

Preparation


External battery connection 1 Insert the DC connector in the Carina.2 Connect the external battery. Refer to the

Instructions for Use of the external battery.The external battery is not charged from the Carina mains supply!

External battery for 3rd party connection12 to 24 V DC (–10 % to +30 %); 6.3 to 3.2 AEnsure that the battery is connected with correct polarity!

1 Insert the plug.2 Connect a microfuse (6.3 A slow blow) to the

external battery.3 Connect the cable to the microfuse.

The LED flashes or lights up according to the charge of the internal battery.

The external battery is not charged from the Carina mains supply!

WARNINGMains-powered equipment must not be con-nected to the connection for an external bat-tery. Risk of electric shock or equipment damage.

CAUTIONAvoid high resistance in conjunction with the external battery by keeping the electrical connec-tors clean at all times to avoid insufficient power being delivered to the device.

CAUTIONThe external battery must always have sufficient capacity as directed in the Instructions for Use for the external battery.

092

External battery

011

- +

1

2

3


Preparation

Internal batteryIf the external power supply (mains/external bat-tery) should fail, Carina automatically switches over to supply from the internal battery.If the battery is fully charged, ventilation can be per-formed reliably for approx. 60 minutes without any external power supply (assuming average ventila-tion parameters and normal ambient conditions).

A completely discharged battery can be fully charged within a charging time of approx. 2 hours. Refer to "Maintenance of the internal battery" on page 110.The LED lights up.

WARNINGBefore transporting the device within the clinic check that the internal battery is suffi-ciently charged. Otherwise the correct func-tioning of the Carina may be compromised.

CAUTIONRecharge the battery if it has not been used for a lengthy period! Refer to "Maintenance of the inter-nal battery" on page 110.

NOTEIf charging and discharging cycles are incomplete, the charge capacity of the internal battery maybe displayed inaccurately.For improving the displayed accuracy, see page 82.


Preparation

O2 supply, connect

WARNINGKeep oil and grease away from all oxygen sup-ply components. Risk of explosion due to spontaneous combustion!

WARNINGSmoking and naked flames prohibited: fire hazard.

WARNINGIf inspiratory oxygen concentration differs from ambient air concentration, monitoring of inspiratory oxygen concentration with adjust-able high and low alarm limits is needed. Con-nect external monitor to hose system in accordance with ISO 21647. Otherwise no alarm will be activated if actual inspiratory oxygen concentration differs from set oxygen concentration.

WARNINGPatients depending on ventilation need either monitoring of expiratory tidal volume, or mon-itoring of expiratory minute volume, or moni-toring of endtidal expiratory CO2 concentration. Connect appropriate external monitor to hose system. Otherwise no alarm will be activated, if patient's ventilation deteriorates.

WARNINGIn the case of patients who require a high O2 concentration ensure that there is backup oxygen supply available, e.g. in O2 cylinders.

WARNINGMake sure there is adequate ventilation at the rear of Carina. Do not use an O2 source which supplies a flow in excess of 10 L/min. Switch off the source, e.g. an O2 concentrator if Carina is not in ventilation mode. Otherwise there is an increased risk of fire due to the concentration of oxygen when heat/ignition and fuel are present.


Preparation

HPO – High Pressure Oxygen modeFor O2 supply to Carina from the central gas supply or from a O2 gas cylinder.

Screw the O2 compressed gas hose onto the HPO nozzle of Carina. Supply with oxygen from the central supply or from the O2 gas cylinder.

LPO – Low Pressure Oxygen mode For O2 supply to Carina from a mobile oxygen source, separate from a central high-pressure O2 supply.1 Remove the cap from the LPO nozzle for O2

supply.2 Connect the O2 supply hose from the O2 source

to the LPO nozzle.3 Connect a flow control valve on the O2 cylinder

with pressure gauge or a concentrator. Observe the Instructions for Use for the O2 components.

WARNINGO2 compressed gas must be dust-free, oil-free and dry and its pressure should be between 2.7 and 6 bar (270 and 600 kPa). Risk of fire.

WARNINGOnly use O2 gas supplies with 100 % O2. Risk of incorrect FiO2 at patient.

021

022

21

3

Preparation


Connecting to the nurse call systemSocket on the back of Carina to transmit alarms to a central alarm system within the clinic.

Plug: AMP/Tyco 5-555237-3, 6-pinPin allocation:View of the wiring side of the open plug

1 N.O. contact (closes in the event of an alarm)2 Base3 N.C. contact (closed during normal operation)

Dräger makes the following recommendations for safety reasons: Use an N.C. contact so that any disconnection or cable break will trigger a nurse call.

Plug into the » « socket on the rear of the device.Check that the connected nurse call system is operating correctly.

Technical data of the nurse call system

WARNINGA nurse call system used in conjunction with Carina must conform to IEC 60601-1-8 and transmit alarms from Carina within 5 seconds. Risk of injury to patient if alarms are not timely transmitted to the nurse call system.

CAUTIONA nurse call system may only be connected by trained electrical staff!

CAUTIONCheck the nurse call system once a month.

Voltage max. 40 V AC/DC

Switching capacity max. 500 mA

Contact potential-free

025

1 2 3


Preparation

MEDIBUS interface

Use Dräger "Babylink Cable" 83 06 488.Insert the plug into the » « socket on the rear of Carina and screw tight.

Position of the userThe device is always operated from the side look-ing onto the hose connections as seen by the user.

CAUTIONThe data port (data transfer) may only be con-nected by EDP (Electronic Data Processing) staff trained in maintenance and repair.

020


Start-up

Start-up

Information on start-up . . . . . . . . . . . . . . . . . . 56

Switching on Carina . . . . . . . . . . . . . . . . . . . . . 56

Checking readiness for operation . . . . . . . . . 57

Connecting test lung. . . . . . . . . . . . . . . . . . . . . . 57Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Switching Carina to Standby. . . . . . . . . . . . . . . . 59

Selecting an application method . . . . . . . . . . 59

Selecting a mask . . . . . . . . . . . . . . . . . . . . . . . . 59Selecting a tube . . . . . . . . . . . . . . . . . . . . . . . . . 59

Setting the O2 supply . . . . . . . . . . . . . . . . . . . . 60

Placing the oxygen sensor . . . . . . . . . . . . . . . . . 60

Start-up


Information on start-upBefore starting up for the first time and after any lengthy period of storage always charge the inter-nal battery of Carina for at least 2 hours.

Switching on Carina 1 Set the mains switch to » «. Carina conducts

a self-test.

During the self-test the screen indicates the progress of the self-test.

CAUTIONThe Carina shall not be operated immediately fol-lowing storage or transport outside the recom-mended operating conditions. Otherwise there is a risk of malfunction. After prolonged storage at a temperature and humidity outside the operating range (refer to "Ambient conditions" on page 114), the device must be brought to ambient room tem-perature at the point of use for three hours before being used.

027

1

502


Start-up

The self test is followed by the screen showing the ventilation mode and parameters last set. The device is in standby mode.

Checking readiness for operationThis test must be conducted every time before the device is put into operation.The checklist on page 58 can be copied for docu-mentation purposes.

Tick off the test items in the copied checklist after a test item has been completed success-fully.

The following functions are checked:– Operation of LEDs, displays and alarm tone– Upper alarm limit for Paw– Disconnect alarm– Apnoea ventilation– Mains power failure alarm

Connecting test lungThe test lung consists of a mask manifold for con-necting, a catheter nozzle with a diameter of 7 mm for simulating the resistance of airways and a 2 L breathing bag 84 03 201 for simulating lung compliance.

Connect the mask manifold to the patient port.

CAUTIONUse the device only if all tests have been com-pleted successfully.

504

019


Start-up

Checklist

Action Observe Check1 Connect all necessary equipment: hoses,

cable, filter, etc.Equipment is connected correctly, refer to page 31.

2 Turn the main switch on. Carina performs a self-test, LEDs light up and alarm tone is given.

3 Check if the used hose system (leak valve or expiratory valve) conforms with the text in the status line.

»LeakV« for leak valve or »ExpV« for expir-atory valve is displayed in the status line.

4 Check if the used patient connection (tube or mask) conforms with the text in the status line.

»Mask« for mask or »Tube« for tube appli-cation method is displayed in the status line.

5 Connect the test lung to the hose system.

6 Make following settings:Mode PC-BIPAPSettings Pinsp 15 mbar

PEEP 5 mbarFiO2 21 %f 10 bpmTi/I:E 2 s/1:2Ramp 0.2 s

Alarms Paw high 20 mbarTdisconn 0 s

Press »Start/ Standby« button to start the ven-tilation and squeeze the test lung several times strongly during inspiration.

Each time the lung is compressed, expira-tion should be initiated instantly.

After the second compression on Pinsp level alarm tone starts and »Airway pressure high !!!« is displayed.

7 Confirm alarm, then disconnect the test lung from the hose system.

Alarm tone starts and »Airway pressure low !!!« is displayed.

8 Reconnect test lung and hose system.

9 Change following settings:Mode SPN-CPAPSettings Apn.Vent. onAlarm Tapn 5 sSteadily inflate and deflate the test lung tosimulate spontaneous breathing, thenstop simulation.

Without spontaneous breathing and after apnoea alarm time has elapsed, alarm »Apnoea ventilation !!!« is displayed. Apnoea ventilation starts.

10 Set ventilation mode to PC-BIPAP.

11 Disconnect device from all external power sup-plies.

Alarm tone starts and display indicates »External power failure !!«.

12 Reconnect the power supplies. Disconnect the test lung from the hose system.


Start-up

Switching Carina to StandbyPress »Start/Standby« button and confirm with rotary knob. Carina is in standby mode.LED in the button flashes.The screen displays »Standby – Patient not ventilated«.

Selecting an application methodIn the configuration menu set the method to »Mask« or »Tube«. Setting is only possible in standby mode and for hose systems with leak valve.

Selecting a maskPress »Select Menu« button.Press »Config.« button.Press » « button.Press »Method« button.Select and confirm »Mask« with rotary knob.

Selecting a tubePress »Select Menu« button.Press »Config.« button.Press » « button.Press »Method« button.Select and confirm »Tube« with rotary knob.

034

123

505

123

509

Start-up


Setting the O2 supplyCarina has been set to HPO mode by the manufac-turer.For LPO mode, configure LPO, see page 78.

Dräger recommends the use of an external oxygen monitor add to the patient circuit to measure the actual oxygen concentration. Carina displays the concentration set by the user, but does not denote the actual concentration delivered to the patient.

Placing the oxygen sensor The oxygen sensor for the oxygen monitor should be placed directly at the patient connection port of Carina, before the mask or tube.

093


Operation

Operation

Setting ventilation modes . . . . . . . . . . . . . . . . 62

Calling up the ventilation settings menu. . . . . . . 62Changing the ventilation mode. . . . . . . . . . . . . . 62

Setting ventilation parameters . . . . . . . . . . . . 63

Values set on delivery. . . . . . . . . . . . . . . . . . . . . 63

Starting ventilation . . . . . . . . . . . . . . . . . . . . . . 63

VC-SIMV AF. . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Setting ranges . . . . . . . . . . . . . . . . . . . . . . . . . . 65

PC-BIPAP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Setting ranges . . . . . . . . . . . . . . . . . . . . . . . . . . 67

PC-AC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Setting ranges . . . . . . . . . . . . . . . . . . . . . . . . . . 69

SPN-PS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Setting ranges . . . . . . . . . . . . . . . . . . . . . . . . . . 71

SPN-CPAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Setting ranges . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Apnoea ventilation . . . . . . . . . . . . . . . . . . . . . . 73

Switching on apnoea ventilation. . . . . . . . . . . . . 73

Volume guarantee. . . . . . . . . . . . . . . . . . . . . . . 74

Switching on VG. . . . . . . . . . . . . . . . . . . . . . . . . 74

NIV – Non-invasive Ventilation . . . . . . . . . . . . 75

Using mask ventilation . . . . . . . . . . . . . . . . . . . . 75Selecting the »Mask« application method . . . . . 76Setting ventilation parameters . . . . . . . . . . . . . . 76Automatic leak compensation of the triggers . . . 76Selecting the »Tube« application method . . . . . 76

LPO – Low Pressure Oxygen mode . . . . . . . . 77

Setting LPO mode . . . . . . . . . . . . . . . . . . . . . . . 78Setting O2 concentration . . . . . . . . . . . . . . . . . . 78Switching off LPO mode . . . . . . . . . . . . . . . . . . . 78Chart for operation with expiratory valve (MP 00 313) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Chart for operation with leak valve (MP 00 312). . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Locking buttons . . . . . . . . . . . . . . . . . . . . . . . 80

Terminating ventilation . . . . . . . . . . . . . . . . . . 81

Switching off the device . . . . . . . . . . . . . . . . . 81

Improve displayed accuracy of the charging capacity of the internal battery . . . 82

Operation


Setting ventilation modesSwitching on, Carina shows the ventilation mode last set along with the set parameters.

Calling up the ventilation settings menu1 Press »Select Menu« button.

2 Press the »Vent.Set« button and the ventilation mode last set is indicated.

Changing the ventilation mode3 Press button for the ventilation mode.

Select and confirm the ventilation mode using the rotary knob.

Carina can use the following ventilation modes:– VC-SIMV– PC-BIPAP– PC-AC– SPN-PS (VG)– SPN-CPAP

035

1

507

2

506

3


Operation

Setting ventilation parameters1 Press button for the ventilation parameter

required. Select the value using the rotary knob and con-firm.

Values set on delivery

Once the ventilation parameters have been set they remain intact when the device is switched off.

Starting ventilationPress the »Start/Standby« button.

Carina ventilates at the ventilation parameters set. The screen shows the current ventilation wave-forms and values. For configuration of the screen display, see page 92.

Ventilation mode PC-AC

VT 500 mL

Pinsp 15 mbar

PEEP 3 mbar

FiO2 40 %

f 15 bpm

Ti 1.3 s

Ti max 4 s

I:E 1:2

Δ Psupp 12 mbar

CPAP 3 mbar

Ramp Auto

VG Off

Trigger Normal

Apnoea ventilation On

518

1

034

Operation


VC-SIMV AFVolume Control – Synchronized Intermittent Man-datory Ventilation AutoFlow

Volume-controlled ventilation with fixed mandatory minute volume MV, set with tidal volume VT and frequency f. Between the mandatory ventilation strokes the patient can breathe spontaneously.AutoFlow – Automatic optimisation of inspiration flow to deliver the set tidal volume avoiding pres-sure peaks.

Suitable for patients with insufficient spontaneous breathing or for patients who are undergoing with-drawal by gradually reducing the mandatory portion of total minute volume.

Set ventilation sample for VC-SIMV with the but-tons for ventilation parameters: – Tidal volume »VT«– Positive end expiratory pressure »PEEP«– O2 Concentration »FiO2«– Sensitivity of »Trigger« (for synchronising man-

datory ventilation strokes) – Frequency »f«– Inspiration time »Ti« or »I:E« (configurable, see

page 94)– Pressure rise time »Ramp«– Maximum airway pressure »Pmax«

Non-invasive ventilation with a hose system with leak valve – using the »Mask« application method, see page 75.Setting alarm limits, see page 84.

WARNINGBe especially careful when setting small volumes due to the risk of dead space ventila-tion to the patient. Volume compensation is required, see page 128.

WARNINGIn VC-SIMV and SPN-PS VG mode it is not pos-sible to guarantee volumes if there is a sub-stantial leak (e.g. due to a leaky mask).

036

Flow

Paw

Ti

fT=

PEEPPIP

Ramp high Ramp low

t

t

1 Trigger window

without spontane-ous breathing

with spontaneous breathing

519

520

521


Operation

Setting ranges

Ventilation parameter Setting rangeTidal volume VT [mL] 100 to 2000

PEEP [mbar] 3 to 20

Inspiratory O2 concentration FiO2 [%] 21 to 100

Trigger sensitivity Trigger Off/Normal/Sensitive

Frequency f [bpm] 5 to 50

Inspiration time Ti [sec] or I:E

0.3 to 81:39 to 2:1

Ramp rise time Ramp [sec] Auto/0.1 to 2.0

Pressure limitation Pmax [mbar] LeakV: 5 to 40

ExpV: 5 to 50

Operation


PC-BIPAPPressure Control – Biphasic Positive Airway Pressure

Pressure-controlled ventilation in conjunction with free spontaneous breathing during the entire breathing cycle. The mandatory portion of total minute volume MV is adjusted with inspiration pres-sure Pinsp, PEEP and frequency f.

Suitable for patients without spontaneous breath-ing, to spontaneous breathing patients before extu-bation. Withdrawal by gradually reducing the mandatory portion of total minute volume MV.

Set PC-BIPAP with the buttons for the ventilation parameters:– Inspiration pressure »Pinsp«– Positive end expiratory pressure »PEEP«– O2 concentration »FiO2«– Sensitivity of »Trigger« (for synchronising

spontaneous breathing)– Frequency »f«– Inspiration time »Ti« or »I:E« (configurable, see

page 94)– Pressure rise time »Ramp«


036

Flow

Paw

Ti

fT=

PEEPPinsp

Ramp high Ramp low

t

t

1 Trigger window



522

523


Operation

Setting ranges

Ventilation parameter Setting rangeInspiration pressure Pinsp* [mbar]

* Only values can be set which are 2 mbar above the set PEEP value

LeakV: 5 to 40

ExpV: 5 to 50

PEEP** [mbar]

** An increase in PEEP value necessitates an increase in the Pinsp value when a min-imum difference of 2 mbar has been reached

3 to 20





0.3 to 81:39 to 2:1


Operation


PC-ACPressure Control – Assist ControlPressure-controlled, assisted ventilationEvery inspiratory effort of the patient on PEEP level triggers a synchronized mandatory breath.

Set PC-AC with the buttons for the ventilation parameters:– Inspiration pressure »Pinsp«– Positive end expiratory pressure »PEEP«– O2 concentration »FiO2«– Sensitivity of »Trigger« (for synchronising

spontaneous breathing)– Frequency »f«– Inspiration time »Ti« or »I:E« (configurable, see

page 94)– Pressure rise time »Ramp«


037

Flow

Paw

Ti

PEEP PinspRamp high Ramp low

t

t

f1

Trigger window



524

525


Operation

Setting ranges

Ventilation parameter Setting rangeInspiration pressure Pinsp* [mbar]

* Only values can be set which are 2 mbar above the set PEEP value

LeakV: 5 to 40

ExpV: 5 to 50

PEEP** [mbar]

** An increase in PEEP value necessitates an increase in the Pinsp value when a min-imum difference of 2 mbar has been reached

3 to 20





0.3 to 81:39 to 2:1


Operation


SPN-PS Spontaneous Pressure SupportFor patients with sufficient spontaneous breathing.

Spontaneous breathing at an increased pressure level to raise the functional residual capacity. Spon-taneous breathing can be supported with Pressure Support.

Set SPN-PS with the buttons for the ventilation parameters:– Pressure support »Δ Psupp«– Positive end expiratory pressure »PEEP«– O2 concentration »FiO2«– Sensitivity of »Trigger« (for synchronising

spontaneous breathing)– Maximum inspiration time »Ti max« – Pressure rise time »Ramp«

SPN-PS can be expanded with the following venti-lation parameters:– Apnoea ventilation, see page 73.– Volume guarantee, see page 74.With apnoea Ventilation or volume guarantee switched on:

Set pressure limitation »Pmax«.


526

527

528


Operation

Setting ranges

Ventilation parameter Setting rangePressure support Δ Psupp [mbar] LeakV: 2 to 40 (with PEEP)

ExpV: 2 to 50 (with PEEP)

PEEP [mbar] 3 to 20


Trigger sensitivity Trigger Normal/Sensitive

Maximum inspiration time Ti max [sec] 0.4 to 10.0


Apnoea ventilation Apn. Vent. On/Off

Volume guarantee VG On/Off

Pressure limitation Pmax* [mbar]

* Only with apnoea ventilation or volume guarantee switched on

LeakV: 5 to 40

ExpV: 5 to 50

Operation


SPN-CPAPSpontaneous Continuous Positive Airway Pressure

Suitable for patients with sufficient spontaneous breathing. Spontaneous breathing at an increased pressure level to raise the functional residual capacity.

Set CPAP with the buttons for the ventilation parameters:– Positive end expiratory pressure »CPAP«– O2 concentration »FiO2«

SPN-CPAP can be expanded with the following ventilation parameters:– Apnoea ventilation, see page 73.With apnoea Ventilation switched on:

Set pressure limitation »Pmax«.


Setting ranges

Ventilation parameter Setting rangeCPAP [mbar] 3 to 20


Apnoea ventilation Apn. Vent. On/Off

Pressure limitation Pmax* [mbar]

* Only with apnoea Ventilation or volume guarantee switched on

LeakV: 5 to 40

ExpV: 5 to 50

529

530


Operation

Apnoea ventilationFor automatically switching to volume-controlled, mandatory ventilation (VC-SIMV) in the event of apnoea.Can be switched on in ventilation modes SPN-PS and SPN-CPAP.The device gives an alarm »Apnoea ventila-tion!!!« if there has been no adequate inspiratory gas delivery within the set apnoea time Tapn (to set apnoea alarm time, see page 84).

Carina starts ventilation in VC-SIMV mode at the set ventilation parameters, see page 64.

Carina terminates apnoea ventilation when the patient has successfully triggered at least 5 ventila-tion strokes per minute. Carina switches back to the previous ventilation mode.

Switching on apnoea ventilationFor ventilation mode SPN-PS in menu 3,for ventilation mode SPN-CPAP in menu 2:

Press »Apn. Vent« button.Select and confirm »On« with rotary knob. To set apnoea alarm time, see page 84.Set pressure limitation »Pmax«.

To switch off: Select »Off« and confirm.

VTapn setting parameter is based on volume setting mode (VC-SIMV or VG).fapn setting parameter is based on mandatory mode setting (VC-SIMV, PC-AC or PC-BIPAP).

CAUTIONIn case of an apnoea situation, Carina only can give the alarm message »Apnoea ventila-tion!!!«, if apnoea ventilation is switched on. A separate apnoea alarm is not available. Please make sure to switch on apnoea ventilation.

042

Tapn1fFlow

Paw

Apnoea alarm time

t

t

PEEP

Spontaneous breathing with pressure support

Start of apnoea Ventilation

530

Operation


Volume guarantee Can be switched on in ventilation mode SPN-PS.Tidal volume guaranteeInspiratory plateau pressure is automatically regu-lated between Pmax and PEEP in such a way that the set tidal volume VT is applied.

Set volume guarantee with the parameters: – Tidal volume »VT«– Pressure limitation »Pmax«

Switching on VGIn menu 3 press the »VG« button.Select and confirm »On« with rotary knob. Set Pmax.

Set VT.

To switch off: Select »Off« and confirm.

WARNINGSet Pmax in such a way that critical airway pressures are avoided.

WARNINGIn VC-SIMV and SPN-PS VG mode it is not pos-sible to guarantee volumes if there is a sub-stantial leak (e.g. due to a leaky mask).

534

556


Operation

NIV – Non-invasive Ventilation Mask ventilation is only possible in combination with a hose system with leak valve.

Using mask ventilationFor a detailed description of mask ventilation, see page 136.

WARNINGThe full-face mask, which covers the entire nose and mouth or the total-face mask, which covers the entire face, should not be used on patients who are uncooperative, obtunded, unresponsive, or unable to remove the mask. There is a risk of CO2 re-breathing in case of a device failure. Danger for the patient!

WARNINGNever leave the mask on patient while Carina is not ventilating. There is a risk of CO2 re-breathing in case of no ventilation.

WARNINGRemove the mask immediately if ventilation fails. There is a risk of CO2 re-breathing in case of a device failure.

WARNINGThe operator should instruct the patient how to remove the mask. There is a risk of CO2 re-breathing in case of a device failure.

WARNINGIn general, as inspiratory time increases, the potential for CO2 re-breathing increases. A higher inspiratory time decreases exhalation time, allowing less CO2 to be purged from the circuit before the next cycle. In such circum-stances, higher tidal volumes further increases the volume of CO2 re-breathed by the patient.

WARNINGAn intubated patient must not be ventilated in »Mask« mode! A leakage may lead to a temporary change of the delivered volume to the patient.

WARNINGIn the »Mask« application method the alarm concept is adapted to mask ventilation. Only use on patients who have sufficient spontane-ous breathing. Risk to ventilated patient without appropriate alarm monitoring.

WARNINGDead space increases when using masks. Observe the instructions provided by the mask manufacturer! A too high dead space may lead to too high etCO2 of the patient.

WARNINGAvoid high airway pressures, risk of aspira-tion!

WARNINGAfter switching from the »Mask« to »Tube« application method check the alarm limits! Risk to ventilated patient without appropriate alarm monitoring.

WARNINGMasks with Anti-Asphyxia Valve and air-venti-lation holes (vented mask) are not recom-mended for use with Carina. Only use a mask with standard elbow (non-vented mask) and the Dräger leakage valve hose system, other-wise accuracy of volume measurement will not be kept during ventilation.

Operation


In the »Mask« application method all the ventilation modes are available for selection.

Selecting the »Mask« application methodSwitch Carina to standby mode.Press »Select Menu« button.Press »Config.« button.Press » « button.Press »Method« button.Select and confirm »Mask« with rotary knob. The status line shows »Mask«.

Setting ventilation parametersPerform as described for the »Tube« applica-tion method.

Automatic leak compensation of the triggersCarina compensates leaks for the detection of a trigger initiated by the patient. If leaks are higher than 50 L/min, an alarm is given. For further description see page 138.

Selecting the »Tube« application methodSwitch Carina to standby mode.Press »Select Menu« button.Press »Config.« button.Press » « button.Press »Method« button.Select and confirm »Tube« with rotary knob.The status line shows »Tube«.

Set alarm limits for the »Tube« application method.

123

505

123

509


Operation

LPO – Low Pressure Oxygen mode

For further description of LPO see page 127.

WARNINGOnly connect O2 sources which meet the fol-lowing conditions:O2 flow: 10 L/min max.O2 pressure: max. 500 hPa.The O2 source must be approved for medical purposes and suitable for supplying the patient directly.Risk of infection, risk of failure of LPO supply.

WARNINGObserve the Instructions for Use for the oxy-gen components! Risk of fire.

WARNINGMake sure there is adequate ventilation at the rear of Carina. Do not use an O2 source which supplies a flow in excess of 10 L/min. Switch off the source, e.g. an O2 concentrator if Carina is not in ventilation mode. Otherwise there is an increased risk of fire due to the concentration of oxygen when heat/ignition and fuel are present.

WARNINGOnly operate an O2 concentrator without a humidifier! If the O2 concentrator has a humid-ifier system, it is essential to empty or remove it before starting up. Otherwise humidified oxygen supply could damage the Carina.

NOTEOnly hose systems approved for medical pur-poses and for use with oxygen are to be used between Carina and the O2 source.

NOTEAutomatic O2 control of Carina is not in operation in LPO mode. The O2 concentration can only be set via the following parameters:– For leak valve: as a function of Pmean and

LPO flow– For expiratory valve: as a function of minute

volume and LPO flow

NOTEIf O2 is simultaneously supplied from the central gas supply or a gas cylinder and from the O2 con-centrator, LPO supply is prevented.

WARNINGIf inspiratory oxygen concentration differs from ambient air concentration, monitoring of inspiratory oxygen concentration with adjust-able high and low alarm limits is needed. Con-nect external monitor to hose system in accordance with ISO 21647. Otherwise no alarm is activated if actual inspiratory oxygen concentration differs from set oxygen concentration.

WARNINGIn the event of an LPO source failure, ensure that an emergency oxygen supply (e.g. oxy-gen cylinders), is provided for patients requir-ing a higher O2 concentration level.

CAUTIONWhen the oxygen supply to the device is insuffi-cient (example: LPO hose kinked) the patient will not receive increased oxygen levels via LPO. In this case no alarm will be given. In the case of patients who require a high O2 concentration, an external O2 monitor must be connected.

Operation


Setting LPO modeSwitch Carina to standby mode.Press »Select Menu« button.Press »Config.« button.Press » « button.Press »LPO« button.Select and confirm »On« with rotary knob.

The status line on the screen shows »LPO«.

Setting O2 concentrationSet oxygen flow at the flow control valve in accordance with medical prescription:max. 500 hPa at 10 L/minDuring periods when the ventilator is not being used, close off the O2 supply to prevent excess oxygen from escaping.

The patient’s O2 concentration is influenced by:– the hose system used– O2 concentration delivered by the O2 concen-

trator used– set O2 flow on the O2 concentrator (LPO flow)– administered minute volume on Carina (MV)– mean airway pressure PmeanThe O2 concentration for the patient is set at the defined ventilation parameters only using flow reg-ulation at the flow control valve or at the O2 concen-trator. Use charts to estimate flow control, see page 79.

Switching off LPO modeSwitch device to standby mode.Press »Select Menu« button.Press »Config.« button.Press » « button.Press »LPO« button.Select and confirm »Off« with rotary knob.

Disconnect LPO gas supply.

535

123

123


Operation

Chart for operation with expiratory valve (MP 00 313)

Chart for operation with leak valve (MP 00 312)

079

,

Minute volume in L/min

FiO2 as a function of minute volume and LPO flow

078

,

Mean airway pressure in mbar

FiO2 as a function of Pmean and LPO flow

Operation


Displaying set values and measured valuesMeasured values, set values and pressure curve are displayed.1 Press »Select Menu« button.

2 Press »Values« button (only available during operation).

The screen displays:– Settings– Measured values– graphic representation of Paw

Locking buttons All the buttons (apart from the »Audio paused 2 min.« button) can be locked in order to prevent them from being pressed accidentally.

Press »Select Menu« button.3 Press the »Un-Locked« button and keep it

pressed until the colour of the button switches to red and the button indicates »Locked«.

Unlocking:Press the »Locked« button to unlock again.

NOTEMeasured Frequency on VC-SIMV and PC-BIPAP displays only mandatory breaths per minute.(Spontaneous breaths is not counted)

035

1

507

2

539

507

3

554


Operation

Terminating ventilationPress the »Start/Standby« button and confirm with rotary knob. Carina has terminated ventila-tion and is in standby mode.LED in the button flashes. The screen shows »Standby – Patient not ventilated«.

Switching off the device Switch Carina to standby.

1 Set the mains switch to » «. Carina is switched off.

Carina cannot be switched off during ventilation. Carina signals »Set standby to shut-off !!«

The internal battery is also charged when the device is switched off. To disconnect from the mains and terminate charg-ing:

Disconnect mains plug.

034

027

1

Operation


Improve displayed accuracy of the charging capacity of the internal battery

If the internal indication accuracy is not reliable enough the following message will appear:»Battery indication not reliable !«

Improving the display accuracy:Connect power cable. The internal battery is charging, the LED flashes.Charge internal battery completely, the LED remains illuminated.Disconnect the power cable from the unit. Con-nect test lung and operate the Carina in manda-tory ventilation mode (VC-SIMV, PC-AC or PC-BIPAP) until the battery is completely dis-charged. The LED is no longer illuminated. Carina stops ventilation. Do not interrupt the discharging process!Set the mains switch to off » «.Reconnect the power cable. The internal bat-tery is charging, the LED flashes. Charge internal battery completely (at least 4 hours), the LED remains continually illuminated. Do not interrupt the charging process!

If there is still no improvement, call DrägerService.

NOTEIf charging and discharging cycles are incom-plete, the charging capacity of the internal battery may be displayed inaccurately.


Monitoring

Monitoring

Setting alarm limits . . . . . . . . . . . . . . . . . . . . . 84

In the event of an alarm . . . . . . . . . . . . . . . . . . 85

More than one alarm at the same time. . . . . . . . 86

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . 86

Suppressing the alarm tone . . . . . . . . . . . . . . 86

Alarm after battery discharge . . . . . . . . . . . . . 86

Monitoring


Setting alarm limits1 Press »Select Menu« button.

2 Press »Alarms« button.

Carina displays the alarm limits set.

The current measured value is displayed between the upper and lower alarm limits.

To set:Press the appropriate button. Select the value using the rotary knob and con-firm.

= Upper alarm limit

= Lower alarm limit

Alarm limit

Setting range Value set on delivery

Paw high 10 to 55 mbar 25 mbar

MV high 2 to 40 L/min 15 L/min

MV low 0.1 to 39 L/min 3 L/min

f high 10 to 50 bpm 20 bpm

Tapn 5 to 60 seconds 15 seconds

Tdisconn Mask: 0, 15, 30, 60, 90, 120 secondsTube: 0, 15, 30, 60 seconds

15 seconds

WARNINGSet the alarm limits according to the patient's condition. Alarm conditions that are not adapted to the patient may lead to no or false alarms.

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Monitoring

Extreme settings

Certain ventilation parameters are limited by Carina to a threshold value. Extreme values can only be set after confirmation by pressing the rotary knob.

In the event of an alarmIf the alarm message, e.g. »MV high !!«, appears in the alarm line on the screen.

Carina assigns the message an appropriate level of priority. The message is displayed on a different-coloured background and the text is highlighted with exclamation marks according to priority. An alarm tone sequence is generated. The alarm tone can be configured, see page 91.1 The LED in the »Audio paused 2 min.« button

flashes or lights up red or yellow.

Alarm with the highest priority Message appears on a red background and is high-lighted with three exclamation marks.Example: »MV low !!!«Carina generates a five-tone sequence which is sounded twice and repeated every 13 seconds.The LED in the »Audio paused 2 min.« button flashes red.

Alarm with medium priorityMessage appears on a yellow background and is highlighted with two exclamation marks.Example: »MV high !!«Carina generates a three-tone sequence which is repeated every 10 seconds. The LED in the »Audio paused 2 min.« button flashes yellow.

Alarm with low priority Message appears with no background and is high-lighted with one exclamation mark.Example: »Int. battery low !«Carina generates a single-tone sequence which is repeated at intervals of one minute.The LED in the »Audio paused 2 min.« button lights up yellow.

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More than one alarm at the same timeIf more than one alarm occurs at the same time, the alarm with the higher priority is displayed. When the cause has been remedied, the alarm with the lower priority is displayed.

TroubleshootingUse the "Fault – Cause – Remedy" list, see page 95.

The alarm tone stops when the fault has been rem-edied. The message in the alarm line on the screen goes out.

Suppressing the alarm tonefor up to 2 minutes: 1 Press »Audio paused 2 min.« button.

The alarm tone is suppressed for approx. 2 minutes.2 The symbol is displayed on the screen.

If you wish to reactivate the audible alarm before the end of this time:

Press »Audio paused 2 min.« button again.

If an alarm with a higher or equal priority occurs during the period when the alarm tone is sup-pressed, the alarm tone sounds again.

Alarm after battery dischargeAlarms remain in the memory even after the battery has become completely discharged and they are displayed again when the battery has been charged.

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Configuration

Configuration

Carina Configuration . . . . . . . . . . . . . . . . . . . . 88

Calling up the »Config.« menu . . . . . . . . . . . . . . 88

Service menu . . . . . . . . . . . . . . . . . . . . . . . . . . 89

Opening the Service menu. . . . . . . . . . . . . . . . . 89Displaying system information . . . . . . . . . . . . . . 90Setting system time . . . . . . . . . . . . . . . . . . . . . . 90Setting the language. . . . . . . . . . . . . . . . . . . . . . 91Displaying contact information . . . . . . . . . . . . . . 91Displaying the log book . . . . . . . . . . . . . . . . . . . 91

Setting volume of the alarm tone . . . . . . . . . . 91

Setting the alarm tone . . . . . . . . . . . . . . . . . . . 91

Selecting screen display . . . . . . . . . . . . . . . . . 92

Selecting display for 2 measured values . . . . 93

Selecting an application method . . . . . . . . . . 93

Switching LPO mode on/off. . . . . . . . . . . . . . . 93

Selecting Ti or I:E . . . . . . . . . . . . . . . . . . . . . . . 94

Setting the night screen. . . . . . . . . . . . . . . . . . 94

Configuration


Carina ConfigurationThe following settings for application can be made under »Config.«:– Volume and type of alarm tone– Language, date and time – Screen display of curves and measured values– LPO mode on/off– Selection of mask or tube ventilation– Selection of the Ti or I:E setting– Night screen on/off

The settings performed under »Config.« remain stored when the device is switched off.

The following information on the device can be called up under »Config.«:– System information– Information on how to contact DrägerService – Log book for technical alarm messages

Calling up the »Config.« menu1 Press »Select Menu« button.

2 Press »Config.« button. 03

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Configuration

The configuration menu shows the configurable functions and parameters:– Service for system and contact information and

log book– Volume – adjustable from 1 to 5– Tone – default tone or Dräger tone can be

selected– Screen – adjustable for displaying curves or val-

ues– Set value – for selecting measured values to

display value 1 and value 2– Method – for setting mask or tube ventilation

(only possible in standby mode)– LPO – for setting LPO oxygen supply– Ti / I:E – for selecting the setting used for Ti or

I:E ratio – Night – for switching on the screen in night time

mode

To set:Press the appropriate button for function or parameter.Select the value using the rotary knob and con-firm.

Service menuThe »Service« menu is password-protected. The password can only be changed by DrägerService. If you have forgotten the password, it can be reconstructed by DrägerService.

Opening the Service menu1 Press the »Service« button. Carina prompts

you to enter the password.

Press buttons 1, 2, 3, 4 and 5 one after the other.Press the rotary knob to confirm the password.

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Configuration


Carina displays the functions of the Service menu:– System Information – for displaying device data

and for setting system time and the current lan-guage

– Contact – for displaying contact information for the customer

– Log book – for displaying technical alarm mes-sages

Displaying system informationPress »Syst.info« button. The system informa-tion is displayed.

Setting system timeThe system time can be changed only on standby setting.After opening system information the current sys-tem time is highlighted in white. Elements of system time: year-month-day hours:minutes:seconds

Press the rotary knob to highlight the first ele-ment (year). Set and confirm with the rotary knob. The next element (month) is highlighted. Set all the elements. Confirm the last element to update system time.

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Configuration

Setting the languageThe language can be changed only on standby set-ting.

On the »system information« screen, select the »current language« line by rotating the knob and confirming. The language is high-lighted.

Set the appropriate language using the rotary knob and confirm.

Displaying contact informationPress »Contact« button. Information on how to contact DrägerService.

Displaying the log bookPress »Logbook« button. The log book shows the technical alarms as information for servicing purposes. Technical alarm messages are avail-able only in English.

Setting volume of the alarm tone

1 Press »Volume« button.Set value from 1 to 5 and confirm. The volume selected is displayed.

Setting the alarm tone2 Press »Sound« button.

WARNINGSet an adequate alarm tone volume so that it may be easily heard!

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Configuration


Select Dräger tone or the default tone and con-firm. The tone selected is displayed.

Selecting screen displayThe screen display can be set: 1 Press »Screen« button.

Select »Curves« or »Measure« and confirm. The current setting is displayed in the button.

2 Pressure curve as a bar chart, 4 measured val-ues and 2 configurable measured values. To configure the measured value display see page 93.

3 Flow and pressure curve in real time and 2 con-figurable measured values. To configure the measured value display see page 93.

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Configuration

Selecting display for 2 measured valuesValue 1 and value 2 are freely selectable for the dis-play.1 Value 1: Off, PIP, VTi (VT), f, PEEP, MVi (MV),

MVleak, Pmean2 Value 2: Off, PIP, VTi (VT), f, PEEP, MVi (MV),

MVleak, PmeanThe measurements for value 1 and value 2 cannot be identical.

3 In menu 2: Press »Set value« button.

Press »Value 1« button. Select display and confirm.Press »Value 2« button. Select display and confirm.

Selecting an application methodTo switch Carina to standby see page 59.

4 In menu 2, press the »Method« button.Select and confirm »Mask« or »Tube« with rotary knob.

The application method selected is displayed in the status line on the screen.The »Mask« application method is only available for hose systems with leak valve.

Switching LPO mode on/offTo switch Carina to standby see page 59.

5 In menu 2, press the »LPO« button. To switch on:

Select and confirm »On« with rotary knob.The status line on the screen shows »LPO«.To switch off:

Select and confirm »Off« with rotary knob.

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Configuration


Selecting Ti or I:ESet I:E (time ratio of inspiration to expiration) or inspiration time Ti.1 Press »Ti / I:E« button.

Select »Ti« or »I:E« and confirm.

Setting the night screenIf the device is set to »Night« screen and it is not operated for 3 minutes or no alarm has occurred, the screen switches off. The screen is switched back on again as soon as any action is performed on the device.2 In menu 3, press the »Night« button.To switch on:

Select night mode »On« and confirm.To switch off:

Select night mode »Off« and confirm.

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Fault – Cause – Remedy


Fault – Cause – Remedy . . . . . . . . . . . . . . . . . 96

Displaying technical alarm causes . . . . . . . . 101

Rescue Ventilation . . . . . . . . . . . . . . . . . . . . . 101



Fault – Cause – RemedyCarina displays alarm messages in hierarchical order in the alarm line on the screen.

If two faults are detected at the same time, the more critical fault is displayed. The priority of alarm messages is indicated by dif-ferent background colours and with exclamation marks after the message:

The table lists the messages in alphabetical order. The table is designed to provide assistance in the event of an alarm for locating the cause and reme-dying it quickly. The various causes and remedies should be worked through in the order listed until the problem has been remedied.

Red !!! = Alarm High-priority alarm message

Yellow !! = Caution Medium-priority alarm message

Yellow ! = Note Low-priority alarm message

Error message Cause RemedyAirway pressure high !!! Note: This is only displayed

after the 2nd ventilation stroke. The excess pressure alarm can be caused by continuous coughing.

Check condition of patient, check ventilation pattern, cor-rect alarm limit if necessary.

Airway pressure low !!! A connection has become detached in the hose system. Ventilation not possible!

Make sure the hoses, filters and other components are secure again.

Apnoea ventilation !!! The device has detected respi-ratory arrest in SPN-PS or SPN-CPAP mode and will ven-tilate under control in VC-SIMV mode until spontaneous breathing resumes.

Apply controlled ventilation orextend apnoea alarm time Tapn.

Auto Reset(in log book »Auto Reset !!!«)

!!! Internal system fault. The device performs a restart. Ventilation continues. After 3 attempts the device stops ventilation. Disconnect the patient from Carina and con-tinue ventilation immediately using a different, separate ven-tilator. Call DrägerService.



Battery indication not reliable ! Battery indication is not relia-ble.

Proceed the action on page 82.If the problem persists call DrägerService.

Blower overheated(in log book »Blower over-heated !!!«)

!!! The blower has overheated. The device is operating at reduced output. Ventilation is not optimal.

Make sure air is being supplied to the device. If there is a free supply of air: Use a replace-ment device. Call DrägerService.

Check settings(in log book »Check settings !!«)

!! Loss of saved settings. Carina operates with the default set-tings.

Confirm with rotary knob. Use a replacement device. Call DrägerService.

Continuous Paw high(in log book »Continuous Paw high !!!«)

!!! Expiratory valve obstructed. Check expiratory valve.

Continuous Paw low(in log book »Continuous Paw low !!!«)

!!! Note: This error is only sig-nalled after 5 to 30 seconds. Air supply blocked. The ventila-tion function is not optimal. Hose system blocked or leak-ing.

Make sure there is a free sup-ply of air. If there is a free sup-ply of air: Check the hose system, filters and other com-ponents for free-flow and leaks. Use a replacement device. Call DrägerService.

Device failure(in log book »Device failure !!!«)

!!! The device has a fatal techni-cal problem. Ventilation has failed.

Immediately disconnect the patient from Carina and con-tinue ventilation using a differ-ent ventilator.If the device cannot be turned off, remove the O2 hose from the central supply and then turn off the device.Call DrägerService.

Disconnection/high leakage ! Disconnection of the hose or large leakage is detected. After the leakage alarm, Carina delivers a low constant flow at PEEP level. When the leak has been eliminated, Carina auto-matically resumes operation at the previous ventilation set-tings.

Check hoses, filters and other components to make sure the connections are not leaking and are secure.

Error message Cause Remedy



External power failure !! The device has no external power supply.

Check the mains supply or DC power supply.

The mains plug or DC plug is loose.

Insert the mains plug or DC plug properly at both ends.

The mains cable or DC cable has a break.

Change the cable.

Mains power failure. Connect a replacement bat-tery.

The external battery is flat. Connect to the mains. Charge external battery.

High frequency !!! Patient is breathing at a high spontaneous frequency, there-fore the monitored overall fre-quency is too high. The alarm is not active in ventilation mode PC-BIPAP and VC-SIMV.


Hose system incorrect !!! Only for a hose system with leak valve. The hose system connected does not correspond to the device setting.

Use the correct hose system. Or:

Correct the device setting.

Inlet filter missing !! The inlet filter has been removed or is not inserted cor-rectly.

Insert inlet filter. Check that the inlet filter is secure.

Insp. temperature high(in log book »Insp. temperature high !!!«)

!!! Breathing gas temperature above 40 °C.

Make sure the ambient temper-ature drops.

Int. battery activated ! Owing to the lack of an external power supply (mains or exter-nal battery) the device is being supplied from the internal bat-tery.

Reconnect the mains voltage or supply from a charged exter-nal battery.

Int. battery empty !!! Owing to the lack of an external power supply (mains or exter-nal battery) the device is being supplied from the internal bat-tery. The operating time with supply from the internal battery has expired.

Connect ventilator immediately to mains power supply or to a fully charged external battery.




Int. battery low !!! Battery charge has dropped to below 25 %.

Charge the battery: connect external power supply.

Int. battery low ! Battery charge has dropped to below 50 %.

Charge the battery: connect external power supply.

Mains voltage or external DC voltage present: internal bat-tery is not yet sufficiently charged.

Continue charging the battery.

Insufficient O2 / LPO set? !!! HPO O2 supply is too low or LPO source is used and does not correspond to the device setting.

Check the HPO and LPO set-tings in the Configuration menu.In HPO mode: Check central gas supply.

Int. temperature high(in log book »Int. temperature high !!!«)

!!! The device is overheated owing to external influences.

Make sure there is a free sup-ply of air to the inlet filter. Remove any obstructions (for-eign bodies, kinked hoses) from the hose connections and hose system. Reduce ambient temperature.

Invalid date ! The date setting is incorrect. Correct the date. Call DrägerService.

Key locked »Locked« function is acti-vated.

Press the »Locked« button again, thus making it possible to use the buttons.

Key overused(in log book »Key overused«)

!!! Button pressed too frequently. Check operation of the buttons.

Large leakage !!! The hose system is leaking. Note: This is only displayed after the 3rd ventilation stroke. Alarm is not active in ventila-tion mode SPN-CPAP.

Check hoses, filters and other components to make sure the connections are not leaking and are secure.

LPO pressure high !! LPO setting is »On«although O2 (HPO) is con-nected.

Disconnect O2 (HPO)or set LPO »Off«.




MV high !! The minute volume has exceeded the upper alarm limit.


Leakage in breathing system. Ensure that breathing system is leak-proof.

Device malfunction. Disconnect the patient from Carina and continue ventilation immediately using a different, separate ventilator. Call DrägerService.

MV low !!! The lower alarm limit for minute volume has been exceeded.


Leakage in breathing system. Ensure that breathing system is leak-proof.

Device malfunction. Disconnect the patient from Carina and continue ventilation using a different, separate ven-tilator.Call DrägerService.

O2 calibration failed ! O2 calibration failed. Call DrägerService.

Rescue Ventilation(in log book »Rescue Ventila-tion !!!«)

!!! The device has a technical problem and switches to emer-gency operation. Ventilation is not optimal.

Make sure there is a free sup-ply of air to the inlet filter. Remove any obstructions (for-eign bodies, kinked hoses) from the hose connections and hose system.

Use a replacement device. Call DrägerService.

Pilot line disconnected !!! A connection of the pilot hose has become detached. (Only for a system with an expiratory valve) No ventilation is possi-ble!

Make sure the pilot hose is secure at both ends.Check to avoid huge leakage.

Pmax limit reached ! The VT measured is lower than the VT set. The maximum per-missible pressure range has been reached.

Check the range of Pmax. Check the setting for VT.

Set standby to shut-off !! Impermissible attempt to switch off the device at the main switch during ventilation.

Terminate ventilation first, then switch off the device.




Displaying technical alarm causesCarina saves technical alarms in the log book as information for servicing purposes. See "Displaying the log book" on page 91.

Rescue Ventilation

In the event of a technical fault, e.g. pressure sen-sor error, Carina switches to rescue ventilation. The dynamically controlled blower maintains controlled ventilation at the necessary ventilation pressure even if sensors have failed.

Rescue ventilation is pressure-controlled ventila-tion (PC-BIPAP) at reduced quality. The trigger function is deactivated. There is no longer any vol-ume guarantee. Functions are no longer monitored.

Standby activated The device is ready for opera-tion. Ventilation is in standby mode.

To start ventilation: press the »Start/Standby« button.

Technical alarm(in log book »Technical Alarm !!«)

!! The device has a technical problem. This alarm does not affect to the breathing function, e.g. hard key defect.

Use a replacement device. Call DrägerService.

Technical alarm(in log book »Technical Alarm !!!«)

!!! The device has a technical problem. This alarm does not affect to the breathing function, e.g. temperature sensor defect.

Use a replacement device. If the device cannot be turned off, remove the O2 hose from the central supply and then turn off the device. Call DrägerService.

WARNINGIn the event of rescue ventilation the Carina ceases to ventilate the patient adequately, ventilation must be continued without delay by using an independent ventilation device – if necessary with PEEP and/or an increased inspiratory O2 concentration (e.g. with the Resutator MR 100).



Cleaning, Disinfection and Sterilisation


General information on cleaning, disinfection and sterilisation. . . . . . . . . . . . . 104

Care list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Dismantling the components . . . . . . . . . . . . 105

Respiratory gas humidifier, medication nebulizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105Ventilation hoses . . . . . . . . . . . . . . . . . . . . . . . 105

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Wipe disinfection . . . . . . . . . . . . . . . . . . . . . . 106

Wipe disinfection with Virex Tb . . . . . . . . . . 106

Damp heat disinfection . . . . . . . . . . . . . . . . . 106

Autoclave sterilisation at 134 °C . . . . . . . . . . 106

Reprocessing of accessories . . . . . . . . . . . . 106

Before reusing on patient . . . . . . . . . . . . . . . 106



General information on cleaning, disinfection and sterilisation

Comply with the hospital's hygiene regulations!Clean the device after every patient.Whenever the Carina device, trolley, hinged arm or gas supply hoses have been contami-nated or potentially contaminated with body flu-ids disinfect their surfaces with a suitable disinfectant e.g. Virex Tb.

In the case of disposable components, observe the manufacturer's recommendations. Replace dispos-able components weekly or according to hospital regulations.

WARNINGIn case of potential contamination with body fluids, clean and disinfect the device. Wear protective clothing, goggles, disposable gloves etc. Risk of infection for hospital staff and other patients.

WARNINGPersonnel should take precautions to avoid direct contact with chemical disinfectants and they should always be used in well-ventilated areas. Material Safety Data Sheets (MSDS) should be readily available in the event of accidental exposure.

WARNINGDo not sterilise parts in ethylene oxide!Ethylene oxide can diffuse into the parts.Health hazard!

WARNINGPenetrating liquid may lead to failure of the device or damage to the device and endanger the patient! Do not spray the disinfectant directly on the unit. Only disinfect parts by wiping and make sure no liquids penetrate into the device.



Care list

Dismantling the componentsSwitch off the device and respiratory gas humidifier.Disconnect mains plug.

1 Drain condensate from water traps.2 Drain the water container of the humidifier.

Remove expiratory valve or leak valve. Remove pilot line of the expiratory valve.Remove the inlet filter of the basic device.

Respiratory gas humidifier, medication nebulizer

Dismantle according to the relevant instructions for use.

Ventilation hosesRemove from the nozzles.To remove the ventilation hoses, always hold them at the connection sleeves and not the spiral ribbing!Otherwise the spiral ribbing may become detached, e.g. at the connection sleeve, or the hose can be torn out of the sleeve.Drain condensate from ventilation hoses.Disinfect and clean ventilation hoses, water traps and their removed collecting jars.

What Cleanable components

How oftenRecommended cleaning intervals

How

Carina basic device per patient Dismantle, clean and if applicable wipe disinfect

TrolleyCompressed gas hoseHinged arm

per patient Dismantle, clean and if applicable wipe disinfect

Reusable ventilation hosesReusable water trap

per patient/weekly Dismantle, clean and disinfect in the cleaning and disinfection machine at 93 °C/10 minutes with detergents only. Hot steam sterilisation at 134 °C.

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CleaningWipe surfaces with a clean, damp lint-free cloth. Do not use corrosive detergents.Aged or accumulated deposits should not be scraped off, but should instead be softened with warm soap solution and then removed. Wipe until all deposits are visually removed and allow to dry completely.

Wipe disinfectionUse preparations from the group of surface disin-fectants for disinfection. Due to material compatibil-ity, preparations based on these active ingredients are suitable:– aldehydes– quaternary ammonium compounds.

To avoid the possibility of damage to material, do not use any disinfectants based on:– alkylamine-based compounds– phenol-based compounds– halogen-releasing compounds– strong organic acids– oxygen-releasing compounds.

Disinfectants often contain, besides their main active agents, additives that can also damage materials.

Inquiries should be referred to the supplier or manufacturer of the disinfectant/cleaning agent.

The disinfectant in sufficient concentrations at the correct temperature must remain in contact with the surfaces for a specific period of time to allow pene-tration of all the microbial cell walls and deactiva-tion. The concentration, temperature, and exposure times are different for each disinfectant and the dis-infectant manufacturer's directions for use must be followed carefully.

Chemical disinfectants should not be mixed with each other or with detergents, since this may inac-tivate their disinfecting properties or create noxious fumes. Items should be dry to prevent dilution of the disinfectant.

Wipe disinfection with Virex TbThis procedure is applicable for Virex Tb. When using Virex Tb or other disinfectants strictly follow the disinfectant manufacturer's instructions.

Clean the surfaces according to the cleaning instructions.Wipe down the surfaces with a clean sponge or cloth soaked with Virex Tb. Use sufficient disin-fectant to saturate the surface and remain wet for 3 minutes (for low level disinfection).Remove Virex Tb residues with a second sponge, cloth or paper towel.

Damp heat disinfection93 °C/10 minutes; in the cleaning/disinfecting machine with detergent only!– Ventilation hoses– Water traps and collecting jars

Autoclave sterilisation at 134 °C– Ventilation hoses– Water traps and collecting jars

Reprocessing of accessoriesFor reprocessing of the following accessories, refer to the accompanying Instructions for Use:– Medication nebulizer– Respiratory gas humidifier– Leak valve

Before reusing on patientAssemble the device as described in the chap-ter "Preparation" on page 31.Check readiness for operation, see page 57.


Maintenance

Maintenance

Maintenance intervals . . . . . . . . . . . . . . . . . . 108

Replacing the inlet filter. . . . . . . . . . . . . . . . . 109

Taking the device out of operation for a lengthy period . . . . . . . . . . . . . . . . . . . . . . . 109

Taking the device out of service . . . . . . . . . . . . 109Storing the device. . . . . . . . . . . . . . . . . . . . . . . 109Maintenance of the internal battery . . . . . . . . . 110

Visual inspection of accessories . . . . . . . . . 110

Maintenance


Maintenance intervalsClean and disinfect equipment and/or compo-nents before any maintenance procedures and before returning for repair.

Inlet filter (HEPA filter) Replace after 6 months or in accordance with hospital-specific regulations, page 109. For disposal see page 112.

NiMH battery To be replaced by technicians after 3 years.NiMH batteries should be disposed of as spe-cial waste, see page 112.

Blower Annual inspection by technicians.Device inspection and maintenance Annual inspection by technicians.

Only original Dräger parts should be used.


Maintenance

Replacing the inlet filter

When the inlet filter is removed the »Inlet filter missing !!« alarm is displayed.

1 Unlock the inlet filter, fold it down and remove it from the holder. For disposal see page 112.

2 Insert a new inlet filter, swivel it in and3 press at the top until its snaps into place.

Taking the device out of operation for a lengthy period

Taking the device out of serviceSwitch off the device.Disconnect cables and hoses.Discard any disposable components and obtain new disposable components. Clean and disinfect reusable components. Remove inlet filter, discard and obtain a new inlet filter.

Storing the deviceOnly store the device under permissible ambient conditions (see chapter "Technical Data" on page 113).

WARNINGDo not operate the device without an inlet fil-ter: risk of infection!

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Maintenance


Maintenance of the internal batteryThe battery has no memory effect.If the battery is not used regularly it discharges. Charge at regular intervals depending on ambient temperature:Every 3 months for –20 to +35 °C Every month for +35 to +55 °C Charge the battery more frequently at higher tem-peratures.

Visual inspection of accessories

CAUTIONEven accessories designed to be reused (e.g. after reprocessing) have a limited service life. Due to a number of factors connected with handling and reprocessing (e.g. disinfectant residues can attack the material more intensely during auto-claving), increased wear can occur and the serv-ice life can be markedly shortened. These parts must be replaced if signs of wear become visible, such as cracks, deformation, discoloration, peel-ing, etc.


Disposal

Disposal

Disposing of the internal battery . . . . . . . . . 112

Disposing of the inlet filter . . . . . . . . . . . . . . 112

Disposing of the device . . . . . . . . . . . . . . . . . 112

Disposal


Disposing of the internal batteryDo not throw onto a fire, risk of explosion!Do not open by force, risk of acid burns!

NiMH batteries are special waste:dispose according to relevant national waste disposal regulations.

For information consult your environment agency, local government offices or appropriate waste dis-posal companies.

Disposing of the inlet filterDispose of the filter with domestic waste.

Disposing of the deviceAt the end of the service life

Dispose of the device according to national waste disposal regulations,

orhave the device disposed of by a suitable waste disposal company.

For information consult your environment agency and local government offices.

For countries subject to EU Directive 2002/96/EC:This device falls under the scope of EU Directive 2002/96/EC (WEEE). It is not registered for use in private households, and may not be disposed of at municipal collection points for waste electrical and electronic equipment.Dräger Medical has authorised a company to han-dle legal disposal of this device. For further information please contact your national Dräger Medical Organisation.


Technical Data

Technical Data

Ambient conditions . . . . . . . . . . . . . . . . . . . . 114

Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

Performance data . . . . . . . . . . . . . . . . . . . . . . 115

Measurement displays . . . . . . . . . . . . . . . . . . 115

Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116

Operating data . . . . . . . . . . . . . . . . . . . . . . . . 117

Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . 117Gas supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

Classification . . . . . . . . . . . . . . . . . . . . . . . . . 118

Relevant standards. . . . . . . . . . . . . . . . . . . . . . 118

Connections . . . . . . . . . . . . . . . . . . . . . . . . . . 118

Trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

Hose systems . . . . . . . . . . . . . . . . . . . . . . . . . 119

EMC Declaration . . . . . . . . . . . . . . . . . . . . . . . 120

General information . . . . . . . . . . . . . . . . . . . . . 120Electromagnetic emissions. . . . . . . . . . . . . . . . 121Electromagnetic immunity . . . . . . . . . . . . . . . . 121Recommended separation distances . . . . . . . . 123


Technical Data

Ambient conditions During operation

Temperature +5 to +35 °CAtmospheric pressure 900 to 1100 hPa

reduced functionality at 700 to 900 hPaRel. humidity 5 to 95 % non-condensing

In storage and transportationTemperature (up to 1 day) –20 to +60 °CTemperature (up to 1 month) –20 to +55 °CTemperature (up to 6 months) –20 to +45 °CTemperature (over 6 months) –20 to +35 °CAtmospheric pressure 500 to 1100 hPaRel. humidity 5 to 95 % non-condensing

SettingsVentilation systems single-hose system with leak valve (MP 00 312) (disposable)

single-hose system with controlled expiratory valve (MP 00 313) (disposable)

Ventilation modes VC-SIMVPC-BIPAPPC-ACSPN-PS (VG)SPN-CPAP

Tidal volume VT 100 to 2000 mL, BTPSResolution 10 mL

PEEPRange 3 to 20 mbarResolution 1 mbar

Pressure limitation Pmax 5 to 50 mbarResolution 1 mbar

Inspiration pressure Pinsp Only values higher than PEEP + 2 mbar can be setLeak valve 5 to 40 mbarExpiratory valve 5 to 50 mbarResolution 1 mbar

Pressure Support ΔPsupp Only values higher than PEEP + 2 mbar can be setLeak valve 2 to 40 mbar (with PEEP)Expiratory valve 2 to 50 mbar (with PEEP)Resolution 1 mbar

CPAPRange 3 to 20 mbarResolution 1 mbar

Ventilation frequency f 5 to 50 bpmResolution 1 bpm


Technical Data

Inspiration time Ti 0.3 to 8 secondsResolution 0.1 second

Inspiration/expiration ratio I:E 1:39 to 2:1Ramp rise time Ramp Auto (device uses the measured breathing rate to calculate

the optimum value)0.1 to 2.0 seconds

Resolution 0.1 secondTrigger sensitivity Trigger Off, Normal, SensitiveApnoea ventilation Apn. Vent. On, OffVolume guarantee VG On, OffInspiratory O2 concentration FiO2 21 to 100 %

Resolution 1 %

Performance dataControl principle Time-controlled, volume-controlled and pressure-controlledDevice compliance

Inspiratory resistance <4.5 mbar at 60 L/min; <3.5 mbar at 30 L/minExpiration resistance <6.5 mbar at 60 L/min; <4.0 mbar at 30 L/min

Safety valves Open the breathing system in the event of a faultOverpresssure Opens above 60 mbarVacuum Opens below –3 mbar

Supply system for patient flow High dynamic blowerMax. inspiratory flow 180 L/min at 21 Vol.% O2 and normal ambient conditions

120 L/min at 100 Vol.% O2 and normal ambient conditions

Measurement displaysInspiratory peak pressure PIPPos. end exp. pressure PEEPMean airway pressure Pmean

Range 0 to 80 mbarResolution 1 mbarAccuracy ±(8 % of the measurement + 1.2 mbar) (with defined hose system

and a bacterial filter)Minute volume MVi, MV

Range 0 to 40 L/min, BTPSResolution 0.1 L/minAccuracy ±10 % of the measurement or ±0.6 L/min, the higher value applying

(without leakages)T0...90 approx. 35 s

Breathing frequency fRange 0 to 80 bpmResolution 1 bpmAccuracy ±1 bpmT0...90 approx. 60 s

Technical Data


Inspiratory tidal volume VTi, VTRange 0 to 4000 mL, BTPSResolution 1 mLAccuracy ±10 % of the measured value (without leakages)

Waveform displayAirway pressure Pressure (t) 0 to 80 mbarFlow (t) –160 to +160 L/min

Bar graph displayAirway pressure Pressure 0 to 60 mbar

MonitoringInspiratory minute volume MV

Alarm upper alarm limit If the upper alarm limit has been exceeded.Setting range 2 to 40 L/min, in 0.1 L/min incrementsAlarm lower alarm limit If the lower alarm limit has been exceeded.Setting range 0.1 to 39 L/min, in 0.1 L/min increments

Airway pressure PawAlarm upper alarm limit If the "Paw high" value has been exceeded.Setting range 10 to 55 mbar, in 1 mbar increments

Delay time Tdisconn Mask ventilation 0, 15, 30, 60, 90, 120 secondsTube ventilation 0, 15, 30, 60 seconds

Apnoea alarm time TapnAlarm If no respiratory activity is detected.Setting range 5 to 60 seconds, adjustable in 1 second increments.

Breathing frequency f highAlarm If the alarm limit has been exceeded for 1 minute. Setting range 10 to 50 bpm


Technical Data

Operating dataPower supplyMains 100 to 240 V AC (–20 to +10 %); 50 to 60 Hz; 1.7 to 1.1 AInternal battery

Charging capacity 2.5 AhType NiMHCharging time 130 minutesOperating time 60 minutes (at average ventilation parameters and normal

ambient conditions)Remaining operating time 3 minutes (time between loss of all power and generating of

»Int. battery low !!!« alarm)Service life Dependent on battery care

External battery connectionInput voltage 12 to 24 V DC (–10 % to +30 %); 6.3 to 3.2 A

External battery EBP Multin Hittech BV – Observe the relevant instructions for use!Input voltage 100 to 240 V AC (50 to 60 Hz); 0.6 to 0.5 AOutput voltage 24 V DC (–15 % to +25 %); 0 to 5 ACharging time 10 hours from an empty battery to a fully charged battery –

only charge indoors!Operating time 8 hours (at average ventilation parameters and normal ambi-

ent conditions)Type Lead battery

Gas supplyHPO

O2 service pressure 2.7 to 6 bar (270 to 600 kPa)O2 flow 0 to 120 L/minConnection thread O2 Country-specificRequired composition of gas Medically pure (as per European Pharmacopoeia)

LPOO2 operating pressure 0 to 500 mbar (0 to 500 hPa)O2 flow 0 to 10 L/minConnecting hose max. ø 7 mm (inside diameter)O2 humidity Non-condensing

Dimensions W x H x D without accessories

175 x 275 x 385 mm

Weight without accessories 5,5 kgNoise max. 40 dBA (at 10 hPa) measured from the position of the

userSound pressure alarm tones 65 to 80 dBA (adjustable)Heat (warming of respiratory gases) typical 2 °C, max. 5 °C

Technical Data


Screen TFT color screen 13.7 cm (5.4 inch)

ClassificationClassification in accordance with Direc-tive 93/42/EEC Appendix IX

IIb

Protection class II, acc. to IEC 60601-1Connection block Type BF Electromagnetic compatibility EMC tested according to IEC 60601-1-2: 2001UMDNS codeUniversal Medical Device Nomenclature System – Nomenclature for Medical Products

14-355

Relevant standardsISO 10651-2 Ventilators for medical use: particular requirements for basic

safety (Carina coupled with O2- and etCO2 monitoring)IEC 60601-1 Medical electrical devices – part 1: General requirements for

safety (IEC 601-1: 1988, A1: 1991, A2: 1995)IEC 60601-1-2 Medical electrical devices – part 1: General requirements for

safety – 2nd supplementary standard: Electromagnetic com-patibility – requirements and testing (IEC 60601-1-2: 2001, A1: 2004)

ConnectionsNurse call system max. 40 V AC/DC, max. 500 mA (potential-free, safety extra-

low voltage, isolated from mains voltage)Data port RS 232

TrolleyDimensions with Carina bracket (height x width x depth)

Trolley 1-63 cm 730 mm x 570 mm x 670 mmTrolley 1-78 cm 880 mm x 570 mm x 670 mm

Weight without extra loadTrolley 1-63 cm 13.8 kg Trolley 1-78 cm 14.8 kg

Extra loadCarina bracket 5 kgStandard rail grip 10 kgUniversal bracket with standard rail 10 kgBattery holder with external battery 10.5 kg

Maximum extra load 36 kgClassification in accordance with Direc-tive 93/42/EEC Appendix IX

I

UMDNS code 10-635


Technical Data

Hose systemsAmbient conditions

Temperature during operation 10 to 40 °CTemperature during storage –20 to 60 °CAtmospheric pressure 500 to 1100 hPaRel. humidity 5 to 95 % non-condensing

Performance DataResistance at 60 L/min <2 mbarCompliance <1.5 mL/mbarLeakage (for MP 00 312 without leak valve)

<25 mL/min

Classification in accordance with Direc-tive 93/42/EEC Appendix IX

for MP 00 312 IIafor MP 00 313 IIb

UMDNS code 14-238Materials for MP 00 312 (VENTSTAR Carina LeakV)

Hose Ethylene Vinyl AcetateConnector PolypropyleneLeak valve Polycarbonate

Materials for MP 00 313 (VENTSTAR Carina ExpV)

Hose Ethylene Vinyl AcetateConnector (on device) PolypropyleneConnector (on patient side) PolycarbonateExpiratory valve Polyethylene, High- and Low Densitiy Polyethylene, Butadi-

ene Styrene, Polypropylene, Methylen ChloridePilot line Polyvinyl Chloride

Technical Data


EMC Declaration

General informationThe EMC conformity of Carina includes the use of the following external cables and accessories:

Additionally, accessories may be used which do not affect EMC compliance, if no other interfere with the use of them. The non-observance may result in increased emissions or decreased immunity of Carina.The Carina should not be used adjacent to or stacked with other equipment; if adjacent or stacked use is inevitable, Carina should be observed to verify normal operation in the configu-ration in which it will be used.

Description Order-No.DC-cable S, 1.75 m 84 14 048

Cable mains Euro CL II, 2.5 m 57 30 042

Power cable Switzerland, 3 m, 10 A

18 51 691

Power cable Italy, 3 m, 10 A 18 55 344

Power cable Great Britain, 3 m, 10 A

18 51 713

Power cable Australia, 3 m, 10 A 18 51 705

Babylink cable BL.8000, 3 m 83 06 488


Technical Data

Electromagnetic emissionsCarina is intended for use in the electromagnetic environment specified below. The customer or the user of the Carina should assure that it is used in such an environment.

Information regarding electromagnetic emissions (IEC 60601-1-2: 2001, table 201)

Electromagnetic immunityCarina is intended for use in the electromagnetic environment specified below. The customer or the user of the Carina should assure that it is used in such an environment.

Emissions Compliance according to Electromagnetic environmentRadio frequency emission (CISPR 11)

Group 1 Carina uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class B Carina is suitable for use in all estab-lishments, including domestic estab-lishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic pur-poses.

Harmonic emissions (IEC 61000-3-2)

Class A

Voltage fluctuations/flicker (IEC 61000-3-3)

Complies

Immunity against IEC 60601-1-2 test level

Compliance level (of Carina)

Electromagnetic environment

Electrostatic discharge (IEC 61000-4-2)

Contact discharge: ±6 kV

±8 kV Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humid-ity should be at least 30 %.

Air discharge: ±8 kV

±15 kV

Electrical fast transient/bursts (IEC 61000-4-4)

Power supply lines: ±2 kV

±2 kV Mains power quality should be that of a typical commercial or hospital envi-ronment.Longer input/ out-

put lines: ±1 kV±1 kV

Surge on AC mains lines (IEC 61000-4-5)

Common mode: ±2 kV

±2 kV Mains power quality should be that of a typical commercial or hospital envi-ronment.Differential mode:

±1 kV±1 kV

Technical Data


Information regarding electromagnetic emissions (IEC 60601-1-2: 2001, table 202, 203 and 204)

Power frequency mag-netic field (50/60 Hz) (IEC 61000-4-8)

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Voltage dips and short interruptions on AC mains input lines (IEC 61000-4-11)

Dip >95 %, 0.5 periods

Dip >95 %, 0.5 periods

Mains power quality should be that of a typical commercial or hospital envi-ronment. If the user of the Carina requires continued operation during power mains interruptions, it is recom-mended that the Carina be powered from an uninterruptible power supply or a battery.

Dip 60 %, 5 periods

Dip 60 %, 5 periods

Dip 30 %, 25 periods

Dip 30 %, 25 periods

Dip >95 %, 5 seconds

Dip >95 %, 5 seconds

Radiated RF (IEC 61000-4-3)

80 MHz to 2.5 GHz: 10 V/m

10 V/m Recommended separation distance from portable and mobile RF transmit-ters with transmission power PEIRP to the Carina including its lines (1.84 m x √PEIRP)1

Conducted RF (IEC 61000-4-6)

150 kHz to 80 MHz outside ISM bands: 3 Vrms

10 Vrms Recommended separation distance from portable and mobile RF transmit-ters with transmission power PEIRP to the Carina including its lines (1.84 m x √PEIRP)1

150 kHz to 80 MHz outside ISM bands2: 10 Vrms

10 Vrms

1 For PEIRP the highest possible "equivalent isotropic radiated power" of the adjacent RF transmitter has to be inserted (value in Watt). Also in the vicinity of equipment marked with the symbol interference may occur. Field strengths from fixed, portable or mobile RF transmitters at the location of the equipment should be less than 3 V/m in the frequency range from 150 kHz to 2.5 GHz and less than 1 V/m above 2.5 GHz.

2 ISM bands in this frequency range are: 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; 40.66 MHz to 40.70 MHz.

Immunity against IEC 60601-1-2 test level

Compliance level (of Carina)

Electromagnetic environment


Technical Data

Recommended separation distances Recommended separation distances between port-able and mobile RF-telecommunication devices and the Carina.

Information regarding separation distances (IEC 60601-1-2: 2001, table 205 and 206)

Max. PEIRP (W) 3 V/m distance1 (m)

1 3 V/m distances to transmitters with frequencies from 150 kHz to 2.5 GHz, otherwise 1 V/m distance.

1 V/m distance1 (m) Examples0.001 0.06 0.17

0.003 0.10 0.30

0.010 0.18 0.55

0.030 0.32 0.95 e.g. WLAN 5250/ 5775 (Europe)

0.100 0.58 1.73 e.g. WLAN 2440 (Europe), Bluetooth

0.200 0.82 2.46 e.g. 5250 (not in Europe)

0.250 0.91 2.75 e.g. DECT devices

1.000 1.83 5.48 e.g. GSM 1800-/ GSM 1900-/ UMTS-mobiles, WLAN 5600 (not in Europe)

2.000 2.60 7.78 e.g. GSM 900 mobiles

3.000 3.16 9.49

10.000 5.80 17.30

100.000 18.30 54.80


Description

Description

Mode of operation . . . . . . . . . . . . . . . . . . . . . 126

Functional units . . . . . . . . . . . . . . . . . . . . . . . . 126Adding oxygen HPO. . . . . . . . . . . . . . . . . . . . . 127Adding oxygen LPO . . . . . . . . . . . . . . . . . . . . . 127Unidirectional valves. . . . . . . . . . . . . . . . . . . . . 127Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127Protective valves . . . . . . . . . . . . . . . . . . . . . . . 127Compensation of volume and pressure losses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

VC-SIMV. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

AutoFlow. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130Patient-oriented settings. . . . . . . . . . . . . . . . . . 131

PC-BIPAP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

PC-AC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

SPN-PS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

SPN-CPAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Tube (Invasive ventilation). . . . . . . . . . . . . . . 135

Mask ventilation (Non-invasive ventilation) . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

Information concerning CO2 re-breathing. . . . . 137

SyncPlus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Multi-sence trigger . . . . . . . . . . . . . . . . . . . . . . 138Automatic leakage compensation (hose system with leak valve). . . . . . . . . . . . . . . . . . . 138Cycle learning. . . . . . . . . . . . . . . . . . . . . . . . . . 138

Volume Guarantee (VG) . . . . . . . . . . . . . . . . . 138

Volume measurement . . . . . . . . . . . . . . . . . . 139

VTi (hose system with leak valve) . . . . . . . . . . 139VT (hose system with expiratory valve) . . . . . . 139MVi (hose system with leak valve) . . . . . . . . . . 139MV (hose system with expiratory valve) . . . . . . 139MVleak (hose system with leak valve). . . . . . . . 139Volume accuracy in case of leakages . . . . . . . 139

AutoRamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140


Description

Mode of operation

Functional units

1 Air inlet2 Blower3 Measuring unit4 Expiratory valve5 Leak valve6 Oxygen metering unit7 Oxygen measuring unit8 Oxygen connection LPO9 Oxygen connection HPO

The ambient air passes through the inlet filter (HEPA filter) (F1) and is compressed in the blower (2). The level of pressure depends on the proces-sor-controlled blower speed. The small mass of the blower wheel allows rapid speed changes and hence high flow dynamics. In the measuring unit (3) the compressed air is guided through a restriction (R2).The resulting difference in pressure is measured by the flow sensor (DPS1) and used for automatic flow control.

HPOcontrolboard

Sensorboard

6

73

Patient

Motorblower1

CV1

F1

CV2

pilot line for exp. valve

4

CV4

5R1

(e.g. SilentFlow)

CV3Inletlabyrinth

Outletlabyrinth

8

PS1E

p

PS2E

p

DPS1

R2

EΔp

AT2

EV LV

AT1

V2V3

F3

V5

F6

F59R4

DPS3E

Δp

CV6

CV8

V6

V7

CV9

2 V1


Description

The measured values of the first pressure sensor (PS1) and the second pressure sensor (PS2) are used to regulate ventilation pressure. The calcula-tion incorporates the following: set values, ventila-tion algorithms and characteristic of the original Dräger ventilation hoses (pressure loss due to flow resistance). Volume/pressure losses of unknown components (other makes) cannot be taken into consideration (See "Compensation of volume and pressure losses" on page 128.) and must be com-pensated by adjusting the ventilation parameters manually. The flow values and pressure values measured are used to continuously calculate leak-age flow. Tidal volume is kept constant. During expiration the blower delivers slight back pressure to build up the set PEEP or CPAP.

The temperature of the respiratory gas is monitored by the sensors (AT1 and AT2). Excess tempera-tures lead to an alarm message.

The hose system connected (with controlled expir-atory valve or leak valve) is defined in the measur-ing unit (3) at the changeover valve (V1). For operation with controlled expiratory valve (4): During inspiration the pressure in the pilot hose closes the expiratory valve. During expiration, the expiratory valve is opened by the pressure drop in the pilot hose in order to remove the expiration air.For operation with leak valve (5): The expiration air from the patient is removed via the leak valve.

Adding oxygen HPOThe desired FiO2 value can be set in the menu.The O2 supply is at the high-pressure O2 inlet (9). The oxygen passes through a filter (F5), which removes any impurities that might impair operation of downstream components. The oxygen arrives at the electrically controlled O2 proportional valve (V5), with which the O2 flow is regulated. In the O2 measuring unit (7) the oxygen is guided through a restriction (R4). The resulting difference in pressure is a measure of the amount of O2 flow and is measured by the O2 flow sensor (DPS3) and used to regulate the O2

proportional valve (V5). Adding to the respiratory air takes place in the blower (2).

Adding oxygen LPOThe switchover to low-pressure oxygen is per-formed in the menu.The oxygen is supplied at the low-pressure oxygen inlet (8). The oxygen passes through a filter (F6), which removes any impurities that might impair operation of downstream components. The oxygen arrives at the electrically controlled O2 proportional valve (V5), which is fully open for operation with low-pressure oxygen. Consequently, there is no regulation of O2 flow. Adding to the respiratory air takes place in the blower (2).

Unidirectional valvesThe unidirectional valves (CV6 and CV8) prevent the oxygen from escaping through an unused O2 inlet. The unidirectional valves also prevent the high-pressure oxygen from flowing to the low-pres-sure O2 source if both sources are connected at the same time.The unidirectional valve (CV9) restricts the pres-sure in the low-pressure O2 inlet to <1 bar by dis-charging excess oxygen to the ambient air.

SafetyAll the sensors are duplicated and are monitored separately. A sensor system failure leads to an alarm message and causes an automatic switcho-ver to emergency ventilation, see "Rescue Ventila-tion" on page 101.

Protective valvesThe overpressure protective valve (CV3) restricts airway pressure to <60 mbar.The underpressure protective valve (CV2) restricts airway pressure to >–3 mbar.

Description


Compensation of volume and pressure lossesCarina with hose system with leak valve compen-sates leakages from valve and patient.However, to compensate the volume loss due to the compliance of the different hose systems, con-sider the following table:

MVlost (minute volume lost) = VTlost (tidal volume lost) x f (frequency).

Hose system ΔP above PEEP

Volume loss (VTlost)

MP 00 312/21 65 643

5 mbar 4 mL

MP 00 312/21 65 643

10 mbar 7 mL

MP 00 312/21 65 643

15 mbar 11 mL

MP 00 313 5 mbar 4 mL

MP 00 313 10 mbar 7 mL

MP 00 313 15 mbar 11 mL

MP 00 313 20 mbar 14 mL

MP 00 313 25 mbar 17 mL


Description

VC-SIMVVolume Control – Synchronised Intermittent Man-datory Ventilation

Hybrid form of mandatory ventilation and spontane-ous breathing.

SIMV enables the patient to breathe spontaneously in regular prescribed cycles, with the mechanical mandatory ventilation strokes providing a minimum ventilation during the remaining cycles.

This minimum ventilation is predetermined by the two settings of tidal volume VT and frequency f, resulting from the product of VT x f. The ventilation pattern is defined with the ventila-tion parameters of tidal volume VT, frequency f, inspiration time Ti and ramp.

To prevent the mandatory ventilation stroke being applied during spontaneous expiration, the flow trigger of the device ensures that the mandatory ventilation stroke is triggered within a "trigger win-dow" with the spontaneous inspiration.The trigger window has a maximum length of 5 seconds. At expiration times of less than 5 seconds it covers the entire expiration time, minus a minimum expiration time of 500 ms.

Since synchronization of the mandatory ventilation stroke reduces the effective SIMV time and thus would undesirably increase the effective frequency, Carina extends the following spontaneous breath-ing time by the missing time difference ΔT. Exceed-ing the SIMV frequency is thus avoided. The factor f, responsible for minimum ventilation, remains constant, in addition to tidal volume VT.

046

Paw

Ramp Ramp

PEEP

Ti tTrigger-

window Spontaneousbreathing time Spontaneous

breathing time + ΔT

Synchronised manda-tory ventilation stroke

Set mand.cycle time 1

f

Set mand.cycle time 1

f

Unsynchronised mandatory ventilation stroke

Description


In the course of progressively weaning the patient from artificial ventilation, the ventilation frequency f is further reduced while the spontaneous breathing time is increased, so that the required total minute volume is supplied more and more by spontaneous breathing.

The ventilation frequency can be reduced to 5/min.

AutoFlowOn Carina, the AutoFlow function is always incor-porated in VC-SIMV ventilation mode.

With AutoFlow, the inspiration flow is automatically adjusted to changes in lung conditions (C, R) and to the spontaneous breathing demand of the patient.

Always set the alarm limits »Paw high« and pressure limitation »Pmax« in order to limit any rise in airway pressure or tidal volume VT if compliance has changed.

The selected inspiration time Ti is typically much longer than the fill time of the lung. The inspiration pressure PIP corresponds to the minimum value resulting from both tidal volume VT and compliance C of the lungs.

Carina automatically controls the inspiration flow so that there is no pressure peak due to the resist-ances of the tube and airways. As is usually the case with constant-volume ventilation strokes, inspiration pressure PIP alters according to changes in compliance C. With AutoFlow these changes occur in maximum increments of 1 mbar from ventilation stroke to ventilation stroke. Inspira-tion pressure PIP is set by the pressure limitation Pmax .If tidal volume VT is reached (inspiration flow = 0) before inspiration time Ti has elapsed, the patient can breathe in and out at the level of inspiration pressure PIP during the remaining inspiration time.

044

Paw

Ramp

PEEP

Paw

PIP Ramp

Ramp

Ti Te

f

low

t

t

Flow

highRamp

Pmax

VT

1

Without spontane-ous breathing

With spontaneous breathing


Description

If the patient breathes in or out during mandatory inspiration, inspiration pressure PIP does not change for that ventilation stroke – only inspiration flow and expiration flow adapt to patient demand. The individually administered tidal volume VT may differ from set tidal volume VT in single ventilation strokes but the tidal volume VT administered on average over time, is constant.

Initially, Carina administers the set tidal volume VT with a volume-controlled ventilation stroke. The inspiration pressure PIP determined for that venti-lation stroke is used by the AutoFlow function as a starting value for inspiration pressure.

Patient-oriented settingsThe start of mandatory inspiration can be synchro-nised with the patient's inhalation effort with the aid of the variable flow trigger. In VC-SIMV, PC-AC and PC-BIPAP, the flow trigger can be switched off com-pletely.

The abruptness of the pressure rise from PEEP level to inspiration level can be further adapted to the patient's requirements in VC-SIMV, PC-BIPAP, PC-AC and SPN-PS by using the Ramp ventilation parameter.

045

Flow VT

PEEP

PawPaw

t

t

PIP

Ti Te

f1



Description


PC-BIPAPPressure Control – Biphasic Positive Airway Pressure

This PC-BIPAP ventilation mode is pressure-con-trolled or time-controlled ventilation during which the patient can always breathe spontaneously. PC-BIPAP is thus often described as a time-control-led change between two pressure levels.

Controlled ventilation is achieved via a time-con-trolled pressure change which corresponds to pres-sure-controlled ventilation PC. However, the constant option of spontaneous breathing allows the transition from controlled breathing to inde-pendent spontaneous breathing to take place smoothly via the weaning phase, without requiring any change in ventilation mode. For good adapta-tion to the patient's spontaneous breathing behav-iour, the switch from the expiratory pressure level to the inspiratory pressure level is synchronised with the patient's spontaneous breathing.

The frequency of changes is also kept constant dur-ing synchronisation via a "trigger window" with a fixed position in time.

Recent clinical experience shows that this good adaptation to the spontaneous breathing of the patient results in less sedation requirement and thus a quicker return of the patient to complete spontaneous breathing.

As with all pressure-controlled ventilation modes, a non-fixed tidal volume VT is specified for the patient. Tidal volume is primarily the result of the pressure difference between the set points for PEEP and Pinsp.Changes in lung compliance and airways, as well as active breathing by the patient can lead to changes in tidal volume. This is a desired effect in this ventilation mode.

With the knowledge that the tidal volume and there-fore the minute volume are not constant, the alarm limits for minute volume must be adjusted with care.

036

Flow

Paw

Ti

fT=

PEEPPinsp

Trigger window

Ramp high Ramp low

t

t

1




Description

The display of calculated tidal volume VT is used to set the necessary difference between the two pres-sure levels.

As in VC-SIMV, the time pattern is set with the parameters of the basic setting for frequency f and inspiration time Ti. The resultant inspiration and expiration times are calculated by the device and displayed in the lower half of the screen below the curve setting. The lower pressure level is set with the parameter PEEP whilst the upper pressure level is set with the parameter Pinsp. The abruptness of pressure increase from the lower pressure level to the upper pressure level is determined with the »Ramp« setting. The transition from controlled ventilation via the weaning phase to fully spontaneous breathing is achieved by a grad-ual reduction of the inspiratory pressure Pinsp and/or frequency f.

PC-ACPressure Control – Assist ControlPressure-controlled, assisted ventilation

Used for all patients, from those unable to breathe spontaneously to those breathing spontaneously before being weaned off the ventilator.

The duration of Pinsp is determined by Ti. Sponta-neous breathing is possible at any time during ven-tilation.Each recognized inspiratory effort at the lower pres-sure level by the patient will trigger a synchronized inspiratory breath.The ventilator will start a non-synchronized inspira-tory breath at the latest after the inspiratory time fixed by f and Ti has elapsed.

037

Flow

Paw

Ti

PEEP PinspRamp high Ramp low

t

t

f1

Trigger window



Description


SPN-PS Spontaneous Pressure SupportFor pressure support of insufficient spontaneous breathing.

The function of the device in supporting insufficient spontaneous breathing is similar to that of the anaesthetist who manually assists and monitors the patient's spontaneous breathing by feeling the breathing bag.

The device takes over the inspiration work partially, however the patient retains control of spontaneous breathing.

The CPAP system supplies the spontaneously breathing patient with breathing gas, even with low inspiration efforts.

Pressure support PS is started when spontaneous inspiration flow reaches the set value of the flow trigger.

The device then generates a pressure increase, which is adjustable to patient breathing demand, up to the preselected PS pressure Δ Psupp above PEEP.

Flow supply can then be adjusted to suit the patient's individual requirements with »Ramp«.– With a steep ramp, Carina supports insufficient

spontaneous breathing on the part of the patient by providing high peak flow.

– With a flat ramp, Carina starts slowly at an even inspiration flow.

– With Auto setting on Ramp, the Carina deliv-eres the flow automatically at 70 % of inspira-tory time (average inspiratory time learned and identified by the device).

047

Paw

Insp.Flow

PEEP

t

t

Ti.max

Start of inspiration End of inspiration

Ramp

Δ Psupp above PEEP


Description

SPN-CPAPSpontaneous Continuous Positive Airway Pressure

Spontaneous breathing at a raised pressure level in order to increase the functional residual capacity (FRC).

Tube (Invasive ventilation) The Carina is used to provide invasive ventilation to the appropriate patients. The following guidelines should be considered prior to use.

Using invasive ventilationA heated humidification system or HME should always be used during invasive applications. The Carina invasive hose system configuration and accessories required for normal operation are illus-trated in chapter “Preparation”. See page 40 to 45.

In general, as circuit pressure decreases, the potential for CO2 re-breathing increases. Lower pressure produces less flow through the exhalation port, which may not purge all CO2 from the circuit to prevent re-breathing. The exhalation valve circuit system (VentStar Carina ExpV, MP 00 313 or Expi-ration Vent, MP 00 220) reduces the level of CO2 re-breathing compared to the level associated with VentStar Carina LeakV (MP 00 312) when low pressures are present.

Using invasive ventilation with VentStar Carina LeakV (MP 00 312)The Carina with the circuit offers a single limb cir-cuit and requires an intentional leak valve instead of an actively controlled exhalation valve to remove exhaled gases from the circuit. Therefore, never connect the device on the patient while Carina is not operating. When the Carina unit is not operat-ing, the VentStar Carina LeakV (MP 00 312) does not allow sufficient exhaust to eliminate CO2 from the circuit. Substantial CO2 re-breathing will occur.

094

CPAP

Paw

Flowt

t

Description


Using invasive ventilation with VentStar Carina ExpV (MP 00 313)This hose system has an expiratory valve. There-fore the exhaled gas runs through the expiratory valve instead of the inspiratory limb when the device is not operating.

Mask ventilation (Non-invasive ventilation)NIV (the mask ventilation)

In combination with the VentStar Carina LeakV (MP 00 312) and the full-face mask or the total-face mask, the user must use a non-vented (non-anti-asphyxia valve) connector to the mask.

With mask ventilation/non-invasive ventilation Carina provides a mode which is specifically designed for non-invasive ventilation with a nose or face mask. In non-invasive ventilation there are usually larger leaks than in tube ventilation. For this reason the automatic leak compensation trigger recognition is matched to these special condi-tions.The alarm and monitoring concept calls for greater attention on the part of the user.

WARNINGThe full-face mask, which covers the entire nose and mouth or the total-face mask, which covers the entire face, should not be used on patients who are uncooperative, obtunded, unresponsive, or unable to remove the mask. There is a risk of CO2 re-breathing in case of a device failure. Danger for the patient!


Description

Information concerning CO2 re-breathing

As with any ventilator used for NIV (mask ventila-tion) there are conditions under which patient CO2 re-breathing can occur while using the Carina ven-tilator. The following guidelines are provided to alert the user to these conditions and to suggest meth-ods for reducing the potential for CO2 re-breathing. If re-breathing is a significant concern for a particu-lar patient and these guidelines are not sufficient to acceptably reduce the potential for CO2 re-breath-ing, an alternative means of ventilation should be considered.

Never leave the mask on the patient while Carina is not operating. When the Carina unit is not operat-ing, the VentStar Carina LeakV (MP 00 312) does not allow sufficient exhaust to eliminate CO2 from the circuit. Substantial CO2 re-breathing will occur.

Patient monitoring should be performed initially and with each change in ventilator setting, circuit config-uration or patient condition to detect changes in respiratory status that may indicate excessive CO2 re-breathing.

In general, as circuit pressure decreases, the potential for CO2 re-breathing increases. Lower pressure produces less flow through the exhalation port, which may not purge all CO2 from the circuit to prevent re-breathing. Higher tidal volumes fur-ther increase the volume of CO2 re-breathed by the patient in such circumstances.

Reducing dead space can also lower potential CO2 re-breathing.

The »Airway pressure low !!!« alarm can be delayed by up to 60 seconds. For this reason, the delay time Tdisconn can be set from 0 to 60 seconds for tube ventilation and from 0 to 120 seconds for mask ventilation. At a setting of 15 seconds, for example, the patient can remove the mask for up to 15 seconds before Carina emits an alarm.

WARNINGNever leave the mask on patient while Carina is not ventilating. There is a risk of CO2 re-breathing in case of no ventilation. See below.

WARNINGRemove the mask immediately if ventilation fails. There is a risk of CO2 re-breathing in case of a device failure.

WARNINGThe operator should instruct the patient how to remove the mask. There is a risk of CO2 re-breathing in case of a device failure.

WARNINGIn general, as inspiratory time increases, the potential for CO2 re-breathing increases. A higher inspiratory time decreases exhalation time, allowing less CO2 to be purged from the circuit before the next cycle. In such circum-stances, higher tidal volumes further increases the volume of CO2 re-breathed by the patient.


Description

SyncPlus SyncPlus is an automatic function for supporting NIV (mask ventilation).This automatic technology are supported by 3 main features:– Multi-sence trigger– Automatic leakage compensation– Cycle learning

Multi-sence triggerCarina is using 3 triggering criteria for detecting patient breath effort for both inspiratory and expira-tory detection.– Pressure– Flow rate– Flow gradient (rate of change in flow)This mixture of triggering criteria helps to maintain the trigger sensitivity at a higher level.Flow gradient will often be 80 % as this is normally the fastest measurement criteria.

Automatic leakage compensation (hose system with leak valve)Carina is trying to detect the level of constant leak-age besides the leakage from leakage valve. Then Carina defines the new base line on the level of leakage. This function helps to reduce any missed triggering smoothing breath care for the patient. Technically, there is no limitation for leakage com-pensation. But the alarm »Large Leakage !!!« will occur, if a defined constant leakage flow level is exceeded. Alarm is not active in ventilation mode SPN-CPAP.

Cycle learningCarina is trying to learn the average cycle of patient spontaneous breath. This helps to predict the tim-ing of the patient's breath. The Carina then sets the highest sensitivity based on the timing of the patients end inspiratory breath. This function helps to keep high sensitivity and avoids missed trigger-ing for patients.

During ventilation with Carina, the trigger criteria in the »Mask« and »Tube« application methods are automatically compensated.

Volume Guarantee (VG) The ventilation mode extension VG allows for the volume support on SPN-PS mode. Carina controls inspiratory plateau pressure automatically, in order to deliver the set tidal volume. Changes in the mechanical properties of the respiratory system are compensated. Tidal volume of delivered breaths remains constant. VG is to be used with ventilation modes SPN-PS. Carina determines the pressure required for the set tidal volume with consideration of the lung condi-tions (compliance, resistance) and the patient's spontaneous breathing demand.The inspiratory pressure is limited by the alarm limit Paw high. The maximum pressure applied is limited by Pmax and therefore restricted to 5 mbar below the upper pres-sure limit Paw high. Always set Pmax and Paw high in order to generate an alarm in the event of an increase in airway pressure due to reduced compli-ance. Control of PIP is performed in the range from +2 mbar up to Pmax. The user determines the pres-sure the ventilator is allowed to apply via Pmax.

There is a situation where the ventilator will not be able to deliver the target volume:PIP is reached to Pmax. In this situation, Carina will display the message »Pmax limit reached !«. Pmax should be set on the maximum allowable value. The control operates in a breath-to-breath fashion. The volume delivered to the lung is calcu-lated based on the actual measured flow, pressure and average flow and pressure.Then, actual tidal volume is compared to the target volume and a new plateau pressure is then calcu-lated for the next breath. After a change in target volume, it will take between 5 to12 breaths before the corresponding inspiratory pressure has been reached.


Description

Volume measurement

VTi (hose system with leak valve)VTi value displayed on the screen is the volume of air delivered to the patient’s lungs (not in SPN-CPAP).VTi = total delivered volume – intentional leakage from leakage valve – additional leakageAdditional leakage is compensated by the device. Automatic leakage compensation require some breaths to display the connected VT value.

VT (hose system with expiratory valve)VT value displayed on the screen is the volume of air delivered by Carina without any leakage com-pensation (not in SPN-CPAP).VT = total delivered volume

MVi (hose system with leak valve)MVi value displayed on the screen is the averaged volume of air delivered to patient lungs.MVi = total delivered volume – intentional leakage from leakage valve – additional leakageAdditional leakage is compensated by the device. Automatic leakage compensation require some breaths to display the corrected MV value.

MV (hose system with expiratory valve)MV value displayed on the screen is the averaged volume of air delivered by Carina without any leak-age compensation.MV = total delivered volume

MVleak (hose system with leak valve)With a mask, breathing gas will frequently dis-charge to ambient air around mask. The Carina flow sensor is located inside the device near the inspiratory connection. During inspiration time, breathing gas will be lost after measurement at inspiratory side in the device. During expiration time, it will be lost before being measured. Therefore, tidal volume measured for inspiration (total delivered flow) will be larger than true tidal volume (air delivered to the lung), tidal volume for expiration will be smaller than total delivered flow. On average, the difference between inspiratory (air delivered to the lung) and expiratory flow is equal.

The gas volume that did not flow back through the sensor must have escaped through the leak.

Volume accuracy in case of leakagesDue to Carina's limited monitoring functionality (no internal monitoring of expiratory minute volume), Carina is not always able to accurately determine the amount of leakage. In volume guarantee mode (SPN-PS VG) and in volume control mode (VC-SIMV), the accuracy of the displayed values VTi and MVi and the actual tidal volume, as speci-fied in the chapter "Technical Data", can only be guaranteed if there are no leakages. This behavior is independent of the application method (mask or tube) used.

CAUTIONBefore making clinical decisions based on the VTi and MVi values displayed by Carina, make sure that no leakages impair the measurement.

Description


AutoRamp Ramp setting has 2 options– Time setting: The steepness of the pressure

rise from the PEEP level to the inspiration pres-sure level can be even more closely adapted to the needs of the patient in all ventilation mode except CPAP.

– Auto setting: Carina automatically calculates the optimum value from the registered breath-ing rate.

Non-spontaneous breathing patientDevice does not detect any trigger effort due to the non-spontaneous situation on patient.Carina is delivering the flow producing the shape of sine-curve pattern. The aim of sine curve is to dem-onstrate a normal breathing pattern.

Triggered breathingDevice will detect an effort of patient breath. Flow delivery will be faster than the situation described above.Ramp time is automatically defined by the device which is 70 % of the average inspiratory time of the patient.


Index

Index

AAbbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Aeroneb Pro nebuliser . . . . . . . . . . . . . . . . . . . . 46Alarm causes . . . . . . . . . . . . . . . . . . . . . . . . . . 101Alarm limits, . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84Alarm tone,

setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85Ambient conditions . . . . . . . . . . . . . . . . . . . . . 114Application method . . . . . . . . . . . . . . . . . . . . . . 59AutoFlow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130AutoRamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

BBacterial filter . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

CCare list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106Charging the battery . . . . . . . . . . . . . . . . . . . . . 49Checking readiness for operation . . . . . . . . . . . 57Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103Colour concept . . . . . . . . . . . . . . . . . . . . . . . . . 28Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . 87Configuration menu . . . . . . . . . . . . . . . . . . . . . . 88Connection block . . . . . . . . . . . . . . . . . . . . . . . . 19Contact information . . . . . . . . . . . . . . . . . . . . . . 91Control panel . . . . . . . . . . . . . . . . . . . . . . . . 18, 26

DDescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125Device data . . . . . . . . . . . . . . . . . . . . . . . 115, 117Dismantling . . . . . . . . . . . . . . . . . . . . . . . . . . . 105Displaying values . . . . . . . . . . . . . . . . . . . . . . . . 80Disposing of the device . . . . . . . . . . . . . . . . . . 112

EExternal battery . . . . . . . . . . . . . . . . . . . . . . . . . 48

FFault – Cause – Remedy . . . . . . . . . . . . . . . . . . 95

HHinged arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42HME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Hose system

connecting . . . . . . . . . . . . . . . . . . . . . . . . . 40with expiratory valve . . . . . . . . . . . . . . . . . . 41with leak valve . . . . . . . . . . . . . . . . . . . . . . 41

IInlet filter . . . . . . . . . . . . . . . . . . . . . . . . . . 52, 109Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . 13Internal battery

Display accuracy of the loading capacity . . 82Invasive ventilation

Description . . . . . . . . . . . . . . . . . . . . . . . . 135LLeak compensation . . . . . . . . . . . . . . . . . . . . . 76Locking function . . . . . . . . . . . . . . . . . . . . . . . . 80Log book . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91LPO Low Pressure Oxygen mode . . . . . . . . . . 77

MMaintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 107Maintenance intervals . . . . . . . . . . . . . . . . . . 108Manual ventilation device . . . . . . . . . . . . . . . . . 12Mask ventilation . . . . . . . . . . . . . . . . . . . . . . . . 75MEDIBUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . 11, 83Moving the trolley . . . . . . . . . . . . . . . . . . . . . . . 37

NNIV

Description of mask ventilation . . . . . . . . . 136Using mask ventilation . . . . . . . . . . . . . . . . 75

Nurse call . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

OO2 concentration . . . . . . . . . . . . . . . . . . . . . . . 78O2 supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50Operating concept . . . . . . . . . . . . . . . . . . . . . . 25Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

PPC-AC . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16, 68PC-BIPAP . . . . . . . . . . . . . . . . . . . . . . 16, 66, 132Placing the oxygen sensor . . . . . . . . . . . . . . . . 60Positioning Carina . . . . . . . . . . . . . . . . . . . . . . 32Power supply

connect . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47External battery . . . . . . . . . . . . . . . . . . . . . . 48Internal battery . . . . . . . . . . . . . . . . . . . . . . 49Mains operation . . . . . . . . . . . . . . . . . . . . . 47

Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31


Index

RRear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Respiratory gas humidifier . . . . . . . . . . . . . . . . . 43

with inspiratory heater . . . . . . . . . . . . . . . . . 45without inspiratory heater . . . . . . . . . . . . . . . 44

RS 232 interface . . . . . . . . . . . . . . . . . . . . . . . . 53

SSafety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

configuration . . . . . . . . . . . . . . . . . . . . . . . . 27Status line . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Selecting screen display . . . . . . . . . . . . . . . . . . 92Service menu . . . . . . . . . . . . . . . . . . . . . . . . . . 89Setting LPO mode . . . . . . . . . . . . . . . . . . . . . . . 78Setting system time . . . . . . . . . . . . . . . . . . . . . . 90Setting the language . . . . . . . . . . . . . . . . . . . . . 91Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114SPN-CPAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72SPN-PS . . . . . . . . . . . . . . . . . . . . . . . . 16, 70, 134Stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Standby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59Start-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55, 56Status line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109Sub-acute care . . . . . . . . . . . . . . . . . . . . . . . . . 14Supplements . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Switching off . . . . . . . . . . . . . . . . . . . . . . . . . . . 81Switching on . . . . . . . . . . . . . . . . . . . . . . . . . . . 56SyncPlus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138System overview . . . . . . . . . . . . . . . . . . . . . . . . 15

TTechnical Data . . . . . . . . . . . . . . . . . . . . . . . . 113Terminating ventilation . . . . . . . . . . . . . . . . . . . 81Trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

VVC-SIMV AF . . . . . . . . . . . . . . . . . . . . 16, 64, 129Ventilation hoses . . . . . . . . . . . . . . . . . . . . . . . 106Ventilation modes . . . . . . . . . . . . . . . . . . . . 16, 62Ventilation parameter . . . . . . . . . . . . . . . . . . . . 76Volume guarantee . . . . . . . . . . . . . . . . . . . 74, 138Volume measurement . . . . . . . . . . . . . . . . . . . 139

These Instructions for Use only apply toCarina SW 3.nwith the Serial No.:If no Serial No. has been filled in by Dräger, these Instructions for Use are provided for general information only and are not intended for use with any specific machine or device.This document is provided for customer information only, and will not be updated or exchanged without customer request.

Directive 93/42/EECconcerning Medical Devices

Manufacturer

Dräger Medical AG & Co. KG Moislinger Allee 53 – 55D-23542 LübeckGermany+49 451 8 82-0

FAX +49 451 8 82-20 80http://www.draeger.com

90 38 907 – GA 5665.700 en RI 12© Dräger Medical AG & Co. KG6th edition – December 2008 (1st edition – February 2006)Dräger reserves the right to make modifi-cations to the equipment without prior notice.

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