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Instructions for use Carina Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc- tions for use.

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Page 1: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

Instructions for use

Carina

Sub-Acute Care VentilatorSoftware 3.2n

WARNING To properly use this medical device, read and comply with these instruc-tions for use.

Page 2: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

2 Instructions for use Carina SW 3.2n

Typographical conventions

Any text shown on the screen and any labeling on the device are printed in bold italics, for example, PEEP, Air.

Screen reproductions

The reproductions of screen content in the instruc-tions for use can differ from the content actually shown on the screen.

Use of terms

Dräger uses the term "accessory" not only for ac-cessories in the sense given by IEC 60601-1, but also for consumables, removable parts, and at-tached parts.

Trademarks

1 Consecutive numbers indicate steps of action, with the numbering restarting with "1" for each new sequence of actions.

Bullet points indicate individual actions or differ-ent options for action.

– Dashes indicate the listing of data, options, or objects.

(A) Letters in parentheses refer to elements in the related illustration.

A Letters in illustrations denote elements referred to in the text.

Trademark Trademark owner

AutoFlow® Dräger

Carina® Dräger

SyncPlus® Dräger

VentStar® Dräger

DrägerService® Dräger

MEDIBUS.X™ Dräger

Virex® Diversey

BIPAP1)

1) Trademark used under license

Page 3: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

Instructions for use Carina SW 3.2n 3

Safety information definitions

WARNING

A WARNING statement provides important in-formation about a potentially hazardous situa-tion which, if not avoided, could result in death or serious injury.

CAUTION

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

NOTE

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

Page 4: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

4 Instructions for use Carina SW 3.2n

Target groups

Duties of the operating organization

The tasks described in this document specify the requirements that have to be met by each respec-tive target group.

The operating organization of this product must en-sure the following:

– The target group has the required qualifications (e.g., has undergone specialist training or ac-quired specialist knowledge through experi-ence).

– The target group has been trained to perform the task.

– The target group has read and understood the chapters required to perform the task.

Description of the target groups

The target groups may only perform the following tasks if they meet the corresponding requirements.

User

Reprocessing personnel

Service personnel

Specialized service personnel

Dräger recommends arranging a service contract with DrägerService.

Abbreviations and symbols

For explanations refer to sections "Abbreviations" and "Symbols" in chapter "Overview".

Task Requirement

Use of the product in accordance with the intended use

Specialist medical knowl-edge in ventilation

Specialist medical knowl-edge in the use of the prod-uct

Task Requirement

Reprocessing Specialist knowledge in the reprocessing of medical devices

Task Requirement

Installation Specialist knowledge in electrical engineering and mechanics

Experience in the servicing of medical devices

Basic service work (inspection)

Task Requirement

Installation Specialist knowledge in electrical engineering and mechanics

Experience in the servicing of medical devices

Experience in complex ser-vice work on this product

Basic and complex service work (in-spection, mainte-nance, repair)

Page 5: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

Instructions for use Carina SW 3.2n 5

Contents

Contents

Target groups . . . . . . . . . . . . . . . . . . . . . . . . . . 4

For your safety and that of your patients. . . 7

General safety information . . . . . . . . . . . . . . . . 8Product-specific safety information. . . . . . . . . . 12

Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 16Definition of sub-acute care . . . . . . . . . . . . . . . 16

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Carina basic device . . . . . . . . . . . . . . . . . . . . . 18Trolley. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20Range of functions . . . . . . . . . . . . . . . . . . . . . . 21Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 23Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Operating concept . . . . . . . . . . . . . . . . . . . . . 27

Operating and display unit . . . . . . . . . . . . . . . . 28Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Assembly and preparation . . . . . . . . . . . . . . 33

Safety information for preparation . . . . . . . . . . 34Preparing Carina . . . . . . . . . . . . . . . . . . . . . . . 34Carina with trolley. . . . . . . . . . . . . . . . . . . . . . . 36Safety information on breathing circuits and additional components . . . . . . . . . . . . . . . . . . . 39Using bacterial filters . . . . . . . . . . . . . . . . . . . . 40Connecting breathing circuits . . . . . . . . . . . . . . 41Connecting the breathing gas humidifier . . . . . 43Preparing Aeroneb Pro medication nebulizer. . 47Connecting the power supply . . . . . . . . . . . . . . 48Connecting the gas supply . . . . . . . . . . . . . . . . 50Connecting the nurse call . . . . . . . . . . . . . . . . . 51Using the MEDIBUS or MEDIBUS.X protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Intrahospital patient transport . . . . . . . . . . . . . . 54

Getting started . . . . . . . . . . . . . . . . . . . . . . . . 57

Safety information on getting started . . . . . . . . 58Powering on the device . . . . . . . . . . . . . . . . . . 58Checking readiness for operation. . . . . . . . . . . 59Selecting the application mode. . . . . . . . . . . . . 62

Setting the O2 supply . . . . . . . . . . . . . . . . . . . 62Starting ventilation . . . . . . . . . . . . . . . . . . . . . . 63

Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Safety information on ventilation . . . . . . . . . . . 66Setting ventilation . . . . . . . . . . . . . . . . . . . . . . 67Non-invasive ventilation (NIV) . . . . . . . . . . . . . 69Using apnea ventilation . . . . . . . . . . . . . . . . . . 70Using the AutoAdapt function . . . . . . . . . . . . . 71Displaying setting and measured values. . . . . 72Locking keys . . . . . . . . . . . . . . . . . . . . . . . . . . 73Low Pressure Oxygen (LPO) . . . . . . . . . . . . . 73Standby mode . . . . . . . . . . . . . . . . . . . . . . . . . 77Ending operation . . . . . . . . . . . . . . . . . . . . . . . 78Taking the device out of service for an extended period. . . . . . . . . . . . . . . . . . . . . . . . 78Improving the display accuracy of the charge state of the internal battery . . . . . . . . . 79

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Display of alarms. . . . . . . . . . . . . . . . . . . . . . . 82Setting the alarm limits . . . . . . . . . . . . . . . . . . 84Suppressing the acoustic alarm signal and the nurse call . . . . . . . . . . . . . . . . . . . . . . . . . . 86

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

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88Opening the configuration menu . . . . . . . . . . . 88Service menu . . . . . . . . . . . . . . . . . . . . . . . . . 89Setting the alarm volume. . . . . . . . . . . . . . . . . 91Setting the acoustic alarm signal. . . . . . . . . . . 91Selecting the screen display . . . . . . . . . . . . . . 91Selecting the application mode . . . . . . . . . . . . 93Selecting the O2 supply. . . . . . . . . . . . . . . . . . 93Selecting Ti or I:E . . . . . . . . . . . . . . . . . . . . . . 93Setting the night mode . . . . . . . . . . . . . . . . . . 94

Problem solving . . . . . . . . . . . . . . . . . . . . . . 95

Failure of the power supply . . . . . . . . . . . . . . . 96Failure of the gas supply . . . . . . . . . . . . . . . . . 96Alarm – Cause – Remedy . . . . . . . . . . . . . . . . 97Emergency ventilation . . . . . . . . . . . . . . . . . . . 103

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Contents

6 Instructions for use Carina SW 3.2n

Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . 105

Dismantling. . . . . . . . . . . . . . . . . . . . . . . . . . . . 106Information on reprocessing. . . . . . . . . . . . . . . 107Classifications for reprocessing . . . . . . . . . . . . 108Validated reprocessing procedures . . . . . . . . . 109Reprocessing non-critical components. . . . . . . 109Reprocessing semi-critical components . . . . . . 110After reprocessing . . . . . . . . . . . . . . . . . . . . . . 110

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 111

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113Preventive maintenance. . . . . . . . . . . . . . . . . . 114Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114Replacing the inlet filter . . . . . . . . . . . . . . . . . . 115Charging the internal battery . . . . . . . . . . . . . . 115

Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

Safety information for disposal . . . . . . . . . . . . . 118Disposal of packaging material . . . . . . . . . . . . 118Disposal of batteries. . . . . . . . . . . . . . . . . . . . . 118Disposal of inlet filters . . . . . . . . . . . . . . . . . . . 119Disposal of the Medical Device . . . . . . . . . . . . 119

Technical data. . . . . . . . . . . . . . . . . . . . . . . . . 121

Ambient conditions . . . . . . . . . . . . . . . . . . . . . . 122Setting values. . . . . . . . . . . . . . . . . . . . . . . . . . 122Performance characteristics. . . . . . . . . . . . . . . 124Displayed measured values . . . . . . . . . . . . . . . 127Monitoring functions . . . . . . . . . . . . . . . . . . . . . 129Operating data characteristics . . . . . . . . . . . . . 130Factory-set ventilation parameters . . . . . . . . . . 133Trolley. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134Alarm system of Carina . . . . . . . . . . . . . . . . . . 135Alarm delays. . . . . . . . . . . . . . . . . . . . . . . . . . . 136EMC declaration. . . . . . . . . . . . . . . . . . . . . . . . 137Connections to IT networks . . . . . . . . . . . . . . . 139

Principles of operation . . . . . . . . . . . . . . . . . 141

Pneumatic function description . . . . . . . . . . . . 142Description of the ventilation modes . . . . . . . . 145Additional settings for ventilation . . . . . . . . . . . 155Therapy types. . . . . . . . . . . . . . . . . . . . . . . . . . 159Additional functions . . . . . . . . . . . . . . . . . . . . . 160Volume measurement . . . . . . . . . . . . . . . . . . . 162

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

Page 7: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

Instructions for use Carina SW 3.2n 7

For your safety and that of your patients

For your safety and that of your patients

General safety information . . . . . . . . . . . . . . 8

Strictly follow these instructions for use . . . . . . 8Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . 8Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Not for use in areas of explosion hazard . . . . . 9Connected devices. . . . . . . . . . . . . . . . . . . . . . 9Device combinations . . . . . . . . . . . . . . . . . . . . 9Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . 9Patient monitoring. . . . . . . . . . . . . . . . . . . . . . . 9Functional safety . . . . . . . . . . . . . . . . . . . . . . . 10Electromagnetic compatibility (EMC) . . . . . . . . 10Disposable products . . . . . . . . . . . . . . . . . . . . . 11Sterile accessories . . . . . . . . . . . . . . . . . . . . . . 11Installing accessories . . . . . . . . . . . . . . . . . . . . 11Storing the instructions for use . . . . . . . . . . . . . 11

Product-specific safety information . . . . . . . 12

Monitoring ventilation . . . . . . . . . . . . . . . . . . . . 14Backup ventilation with an independent manual ventilation device . . . . . . . . . . . . . . . . . 14

Page 8: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

For your safety and that of your patients

8 Instructions for use Carina SW 3.2n

General safety information

The following WARNING and CAUTION state-ments apply to general operation of the medical de-vice.

WARNING and CAUTION statements specific to subsystems or particular features of the medical device appear in the respective sections of these instructions for use or in the instructions for use of another product being used with this medical de-vice.

Strictly follow these instructions for use

s

Maintenance

Accessories

WARNING

Risk of incorrect operation and of incorrect use

Any use of the medical device requires full un-derstanding and strict observation of all sec-tions of these instructions for use. The medi-cal device must only be used for the purpose specified under "Intended use" on page 16 and in conjunction with appropriate patient monitoring (see page 9).

Strictly observe all WARNING and CAUTION statements throughout these instructions for use and all statements on medical device la-bels. Failure to observe these safety informa-tion statements constitutes a use of the medi-cal device that is inconsistent with its intended use.

WARNING

Risk of medical device failure and of patient injury

The medical device must be inspected and serviced regularly by service personnel. Re-pair and complex maintenance carried out on the medical device must be performed by ex-perts.

If the above is not complied with, medical de-vice failure and patient injury may occur. Ob-serve chapter "Maintenance".

Dräger recommends that a service contract is obtained with DrägerService and that all re-pairs are performed by DrägerService. For maintenance Dräger recommends the use of authentic Dräger repair parts.

WARNING

Risk due to incompatible accessories

Dräger has tested only the compatibility of ac-cessories listed in the current list of accesso-ries. If other, incompatible accessories are used, there is a risk of patient injury due to medical device failure.

Dräger recommends that the medical device is only used together with accessories listed in the current list of accessories.

Page 9: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

Instructions for use Carina SW 3.2n 9

For your safety and that of your patients

Not for use in areas of explosion hazard

Connected devices

Device combinations

This device can be operated in combination with other Dräger devices or with devices from third-party manufacturers. Observe the accompanying documents for the individual devices.

If a device combination is not approved by Dräger, the safety and correct functioning of the individual devices may be compromised. The owner must en-sure that the device combination complies with the applicable editions of the relevant standards for medical devices.

Device combinations that are approved by Dräger meet the requirements of the following standards: – IEC 60601-1, 2nd edition (general require-

ments for safety)– IEC 60601-1-1 (device combinations)– IEC 60601-1-2 (electromagnetic compatibil-

ity)– IEC 60601-1-4 (software-controlled func-

tions)– IEC 60601-1-8 (alarm systems)

Patient safety

The design of the medical device, the accompany-ing documentation, and the labeling on the medical device are based on the assumption that the pur-chase and the use of the medical device are re-stricted to persons familiar with the most important inherent characteristics of the medical device.

Instructions and WARNING and CAUTION state-ments are therefore largely limited to the specifics of the Dräger medical device.

The instructions for use do not contain any informa-tion on the following points:

– Risks that are obvious to users

– Consequences of obvious improper use of the medical device

– Potentially negative effects on patients with dif-ferent underlying diseases

Medical device modification or misuse can be dan-gerous.

Patient monitoring

The user of the medical device is responsible for choosing a suitable patient monitoring system that provides appropriate information on medical device performance and patient condition.

Patient safety may be achieved by a wide variety of means ranging from electronic surveillance of med-ical device performance and patient condition to simple, direct observation of clinical signs.

The responsibility for selecting the best level of pa-tient monitoring lies solely with the user of the med-ical device.

WARNING

Risk of fire

The medical device is not approved for use in areas where oxygen concentrations above 25 Vol% or combustible or explosive gas mix-tures are likely to occur.

WARNING

Risk of electric shock and of device malfunc-tion

Electrical connections to equipment not listed in these instructions for use or these assem-bly instructions must only be made when ap-proved by each respective manufacturer.

Before operating the medical device, strictly comply with the instructions for use of all con-nected devices or device combinations.

CAUTION

Risk of patient injury

Do not make therapeutic decisions based solely on individual measured values and monitoring pa-rameters.

Page 10: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

For your safety and that of your patients

10 Instructions for use Carina SW 3.2n

Functional safety

The essential performance consists in controlled and monitored patient ventilation. The user defines settings for the following monitoring functions:

– Minimum inspiratory ventilation flow

– Maximum airway pressure

If a set limit is exceeded, the device generates a corresponding alarm.

The medical device is equipped with basic safety features to reduce the possibility of patient injury while the cause of an alarm is remedied.

Electromagnetic compatibility (EMC)

Medical electrical equipment is subject to special precautionary measures concerning electromag-netic compatibility. Observe the EMC information during installation and initial operation. For further information, see the following section: ''EMC decla-ration'' (page 137).

Portable and mobile high-frequency communica-tion equipment can affect medical electrical equip-ment.

The medical device may only be used adjacent to or stacked with other devices when the configura-tion is approved by Dräger. If adjacent or stacked use of non-approved configurations is inevitable, verify normal operation of the medical device in the configuration in which it will be used. In any case, strictly observe the instructions for use of the other devices.

WARNING

Risk due to electromagnetic interference

Malfunctions that endanger the patient may occur if no protective measures against elec-trostatic discharge are employed in the follow-ing situations:– When touching the pins of connectors that

carry the ESD warning symbol.– When establishing connections with these

connectors.

To prevent malfunctions, observe the follow-ing measures and train the relevant person-nel:– Observe the ESD protective measures.

Such measures may include wearing anti-static clothing and shoes, touching a po-tential equalization pin before and while making the connection, or using electrical-ly insulating and antistatic gloves.

– Observe the requirements for the electro-magnetic environment. Observe the fol-lowing section: "Electromagnetic immuni-ty" (page 137).

Page 11: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

Instructions for use Carina SW 3.2n 11

For your safety and that of your patients

Disposable products

Sterile accessories

Installing accessories

Strictly observe instructions for use and assembly instructions.

Storing the instructions for use

WARNING

Risk due to electromagnetic fields

Electromagnetic fields may interfere with the device function and consequently endanger the patient.

Only use high-frequency devices at a suffi-cient separation distance, see "Recommend-ed separation distances from mobile high-fre-quency communication equipment" on page 138.

Maintain a separation distance of at least 30 cm (1 ft) to wireless communication equip-ment.

WARNING

Risk of injury to patients due to failure of ac-cessories

Disposable products were developed, tested and manufactured for single use only. Reuse, reprocessing, or sterilization can lead to a fail-ure of accessories and cause injury to the pa-tient.

Do not reuse, reprocess or sterilize dispos-able products.

CAUTION

Risk of medical device failure and of patient injury

Do not use sterile-packaged accessories if the packaging has been opened, is damaged, or if there are other signs of non-sterility.

CAUTION

Risk of device failure

Install accessories to the basic device in accord-ance with the instructions for use of the basic de-vice. Make sure that there is a safe connection to the basic device.

CAUTION

Risk of incorrect use

The instructions for use must be kept in an acces-sible location for users.

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For your safety and that of your patients

12 Instructions for use Carina SW 3.2n

Product-specific safety information

WARNING

Risk of patient injury

The device may not be used for the acute inpa-tient treatment of unstable patients that have to be ventilated with extensive, continuous monitoring in accordance with IEC 60601-2-12 or ISO 80601-2-12.

WARNING

Risk of incorrect use

This medical device is only intended to be used by the target group "users".

WARNING

Risk of malfunctions

Prohibited modifications to the medical de-vice lead to malfunctions.

This medical device must not be modified without permission from the manufacturer.

WARNING

Risk of patient injury

Penetrating liquid may cause malfunction of or damage to the device, which may endanger the patient.

Do not place any containers with liquid on or above the device.Make sure that no liquids penetrate the device during surface disinfection.

WARNING

Risk of fire

Do not use the medical device in conjunction with flammable gases or flammable solutions that can mix with air, oxygen or nitrous oxide, or other sources of ignition since the medical device could ignite.

Do not allow the medical device to come into contact with sources of ignition.

WARNING

Risk of fire

If medications or other substances based on flammable solvents such as, e.g., alcohol, reach the breathing circuit, there is a risk of fire.

If highly flammable substances are used for disinfection, adequate airing must be en-sured.

WARNING

Risk of fire

Due to oxygen enrichment in the ambient air, the medical device can ignite. Medical device malfunctions can increase the O2 concentra-tion in the ambient air.

Only use the medical device in adequately ventilated rooms.

WARNING

Risk of fire

Do not use a defibrillator at the same time as additional oxygen is administered.

WARNING

Risk of patient injury

Magnetic fields may affect the correct opera-tion of the medical device.

Do not use the medical device in the vicinity of nuclear magnetic resonance scanners (MRI, NMR, NMI).

WARNING

Risk of patient injury

Hyperbaric chambers may impair correct functioning of the medical device.

Do not use the medical device in hyperbaric chambers.

Page 13: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

Instructions for use Carina SW 3.2n 13

For your safety and that of your patients

WARNING

Risk of patient injury

If patients are dependent on ventilation, one of the following parameters must be monitored:– Expiratory tidal volume– Expiratory minute volume– End-tidal expiratory CO2 concentration

If no patient monitoring is implemented, no alarm will be generated in case of insufficient patient ventilation.

Use suitable external monitors.

WARNING

Risk of increased CO2 rebreathing

If a breathing circuit with a leakage valve is used, the flushing out of CO2 may be reduced, e.g., by the accumulation of secretions in the leakage valve, without being noticed.

Check the leakage valves regularly and re-place them if necessary. Use suitable patient monitoring (capnogra-phy) to detect increased CO2 rebreathing.

WARNING

Risk of patient injury

If the inspiratory oxygen concentration differs from the ambient air concentration, monitor-ing of the inspiratory oxygen concentration with adjustable high and low alarm limits is needed.

Connect an external oxygen monitor comply-ing with ISO 21647 or ISO 80601-2-55 to the breathing circuit. Otherwise no alarm will be generated if the actual inspiratory oxygen concentration differs from the set oxygen con-centration.

WARNING

Risk of patient injury

Because of the restricted monitoring func-tions (no internal monitoring of the expiratory minute volume), the device may not detect a disconnection of the breathing hose or the pi-lot line. This can occur particularly with low PEEP values and the use of filters with high re-sistance.

Only use the filters listed in the current list of accessories.

CAUTION

Risk of patient injury

The device can apply a maximum of 120 L/min of pure oxygen. If a high O2 concentration with a ventilation flow above 120 L/min is set, this O2 concentration may not be reached.

Use external O2 monitoring or reduce leakage.

CAUTION

Risk of overheating of the medical device

Sources of heat such as direct sunlight, radiant heaters, or spotlights may cause the medical de-vice to overheat.

Keep the medical device away from heat sources. Only use the medical device in adequately venti-lated rooms.

CAUTION

Risk of toppling over

Do not tilt the device more than 15° while in use to ensure that it cannot topple over. When the device is on the trolley, do not tilt the trolley more than 10°.

Page 14: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

For your safety and that of your patients

14 Instructions for use Carina SW 3.2n

Monitoring ventilation

The built-in monitoring facilities monitor the follow-ing parameters:– Airway pressure– Inspiratory minute volume– Applied minute volume (without leakage com-

pensation)– Apnea alarm time– Disconnection time– Mean airway pressure– Respiratory rate– Leakage minute volume

Changes in these parameters may be caused by:– Acute changes in the patient's condition– Incorrect settings and faulty handling– Device malfunctions– Failure of power and gas supplies

If the built-in monitoring fails, use substitute moni-toring.

Backup ventilation with an independent manual ventilation device

CAUTION

Risk of electric shock

If a faulty device without safety extra-low voltage (SELV) is connected to the medical device, there is a risk of electric shock from the housing of the medical device.

Only connect devices with safety extra-low volt-age (SELV) to the connections for the serial port and the nurse call.

WARNING

Risk of patient injury

If a fault is detected in the medical device, its life-support functions may no longer be as-sured.

Ventilation of the patient using an independ-ent ventilation device must be started without delay, if necessary with PEEP and/or an in-creased inspiratory O2 concentration (e.g., with a manual resuscitator).

Page 15: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

Instructions for use Carina SW 3.2n 15

Application

Application

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Definition of sub-acute care . . . . . . . . . . . . . 16

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Application

16 Instructions for use Carina SW 3.2n

Intended use

Carina is a long-term ventilator for patients who are dependent on ventilators or who require respiratory support.

– For treatment of sub-acute care patients in hos-pital or medical rooms.

– For non-invasive and invasive ventilation.

– For patients with at least 100 mL tidal volume.

– The device is intended for use by qualified med-ical personnel only.

Definition of sub-acute care*

Sub-acute care is comprehensive inpatient treat-ment of the following types of patients:

– Patients who were an acute case because of in-jury, disease or deterioration of their disease condition

– Patients with a defined course of treatment

– Patients who are stable and require diagnostic and invasive procedures but not intensive treat-ment

The status of the patients requires:

– Medical supervision with frequent consultations

– Professional nursing care

– Complex medical and/or rehabilitation care

Sub-acute care is implemented to discharge pa-tients into their accustomed environment or to transfer them to a lower level of care.

* 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

Page 17: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

Instructions for use Carina SW 3.2n 17

Overview

Overview

Carina basic device . . . . . . . . . . . . . . . . . . . . 18

Top . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Bottom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Patient connection panel (front) . . . . . . . . . . . . 19Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Bed and wall mountings . . . . . . . . . . . . . . . . . . 20

Range of functions . . . . . . . . . . . . . . . . . . . . . 21

Ventilation functions . . . . . . . . . . . . . . . . . . . . . 21Breathing circuits . . . . . . . . . . . . . . . . . . . . . . . 21Monitoring functions . . . . . . . . . . . . . . . . . . . . . 21Gas supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . 22Data transfer. . . . . . . . . . . . . . . . . . . . . . . . . . . 22Medication nebulization . . . . . . . . . . . . . . . . . . 22Trolley. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Bed and wall mountings . . . . . . . . . . . . . . . . . . 22

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 23

Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Page 18: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

Overview

18 Instructions for use Carina SW 3.2n

Carina basic device

Top

A Handle

B Screen for displaying application-specific infor-mation for ventilation

C Keys for selecting functions and ventilation pa-rameters

D Rotary knob for setting and confirming functions and parameters

E Audio paused 2 min. key – To suppress the acoustic alarm signal for a

maximum of 2 minutes– To suppress alarm generation by the nurse

call for a maximum of 2 minutes– To indicate the alarm priority (alarm LED)

F LED for displaying the power supply

G Start/Standby key for switching between standby and ventilation

H Select Menu key for opening the menus:– Ventilation settings– Alarms– Measured values– Configuration– Locking

Bottom

I Switch for selecting breathing circuit with leakage valve or breathing circuit with expira-tory valve, protected by sliding cover

00

0

Alarm LED flashes red Warning

Alarm LED flashes yellow Caution

Alarm LED lights yellow Note

A

B

C

DEF

GH

LED is green

External power supply (mains or external battery)

The internal battery is charged.

LED flashes green

External power supply (mains or external battery)

The internal battery is being charged.

LED off Internal battery

00

1

I

K

L

J

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Instructions for use Carina SW 3.2n 19

Overview

J Rating plate

K No function

L 4 holes for positioning the device on the trolley

Patient connection panel (front)

A Inspiratory port (connection for breathing hose)

B Emergency air inlet and oxygen overflow

C Connection for pilot line (for breathing circuit with expiratory valve)

Rear

D Ventilation slots

E RS232 COM port for data transfer (MEDIBUS, MEDIBUS.X)

F No function

G Inlet filter (HEPA filter)

H HPO port for O2 compressed gas hose

I LPO port for low pressure for connecting an ox-ygen source, e.g., O2 concentrator

J Power switch for switching on or off

K Ventilation slots

L Connection for external battery (no longer fitted from 2017 onwards)

M Connection for power cable

N No function

O Connection for nurse call

CAUTION

Risk of malfunctions

Only service personnel may perform the change between a breathing circuit with leakage valve and a breathing circuit with expiratory valve.

00

2

A

B

C

00

3

DEF

G

HIJKL

M

NO

Page 20: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

Overview

20 Instructions for use Carina SW 3.2n

Trolley

A Carina holder

B Standard rail handle

C Trolley column

D Battery holder, optional

E Universal holder with standard rail, optional

F Base

G Red locking lever for column holder (under base)

H Double castors with locking brake, set of 4

I Gas cylinder holder, optional

Bed and wall mountings

The bed and wall mountings are optional accesso-ries.

A Clamp with threaded handle

B Spacer with 2 buffers

C Carina holder

07

7

A

B

C

E

G

F

D

H

09

811

7

I

Wall mounting Bed mounting

A

B

C

Page 21: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

Instructions for use Carina SW 3.2n 21

Overview

Range of functions

Ventilation functions

For a detailed description of the ventilation modes and the extended settings see chapter Principles of operation. Abbreviations see page 23.

Application modes

– Non-invasive ventilation (NIV)– Invasive ventilation (Tube)

Ventilation modes

Volume-controlled ventilation:– VC-SIMV– VC-AC (optional)

Pressure-controlled ventilation:– PC-BIPAP– PC-AC

Support of spontaneous breathing:– SPN-CPAP/PS (VG)

Additional settings for ventilation

– Apnea ventilation– Trigger– Ramp– Volume Guarantee– AutoAdapt

Breathing circuits

Breathing circuit with leakage valve (LeakV) for mask or tube ventilation:– Automatic leakage compensation– MVi and VTi correspond to the calculated inspir-

atory tidal volume of the patient.– VC-SIMV, VC-AC and SPN-CPAP/PS (VG)

control the calculated inspiratory tidal volume of the patient.

Breathing circuit with expiratory valve (ExpV) for tube ventilation:– No leakage compensation– MV and VT correspond to the applied volume.– VC-SIMV, VC-AC and SPN-CPAP/PS (VG)

control the applied volume.

Monitoring functions

The following parameters are monitored:– Airway pressure Paw– Inspiratory minute volume MVi– Applied minute volume MV (without leakage

compensation)– Apnea alarm time Tapn– Disconnection time Tdiscon– Mean airway pressure Pmean– Respiratory rate RR– Leakage minute volume MVleak

The following measured values are displayed:– Peak inspiratory pressure PIP– Mean airway pressure Pmean– Positive end-expiratory pressure PEEP– Inspiratory minute volume MVi, MV– Inspiratory tidal volume VTi, VT– Respiratory rate RR– Leakage minute volume MVleak– Adjustment time in AutoAdapt Tadpt

The following waveforms are displayed:– Flow– Pressure

The following is displayed as a bar graph:– Pressure

Display of:– Logbook for technical alarms– Measured value list– Set value list

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Overview

22 Instructions for use Carina SW 3.2n

Patient monitoring is supported by setting the fol-lowing alarm limits:– Airway pressure Paw high– Minute volume MV high, MV low– Respiratory rate RR high– Time until disconnection alarm Tdiscon– Apnea alarm time Tapn

Gas supply

An internal turbine supplies Carina with ambient air.

O2 supply

– High Pressure Oxygen (HPO) from the central gas supply system or from compressed gas cyl-inders

– Low Pressure Oxygen (LPO) from an external low-pressure oxygen source, e.g., O2 concen-trator

Power supply

– Mains power supply 100 to 240 V and 50/60 Hz– Internal battery– External battery (optional)

The active power supply is displayed on the screen.

Data transfer

The RS232 COM port can be used for data transfer via the MEDIBUS or MEDIBUS.X protocol.

Medication nebulization

An external medication nebulizer is also optionally available.

Trolley

Carina can be placed on a trolley.

An optional gas cylinder holder can be attached to the trolley.

Bed and wall mountings

Optional bed and wall mountings are available for fixing Carina to a bed or wall.

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Instructions for use Carina SW 3.2n 23

Overview

Abbreviations

Abbreviation Explanation

%PIF Percentage of the peak inspiratory flow

Apn.Vent. Apnea ventilation

Aut.Adapt Function AutoAdapt in SPN-CPAP/PS, generates a linear pres-sure increase over a defined period to accustom patients slowly to ven-tilation.

AutoFlow Automatic optimization of inspira-tory flow

BF Insulation class Body Floating

BTPS Body Temperature Pressure Satu-rated, measured values based on the condition of the patient’s lungs, body temperature 37 °C (98.6 °F), atmospheric pressure, water va-por-saturated gas

C Compliance

cm H2O Unit of measurement for pressure

DC Direct current

ΔPSadpt Start-up value of relative pressure support in AutoAdapt

ΔPsupp Pressure support relative to PEEP

DSSS Direct Sequence Spread Spectrum, spread-spectrum technology

EBP External battery pack

EMC Electromagnetic compatibility

ESD Electrostatic Discharge, Electrostatic discharge

etCO2 End-tidal CO2 concentration

ExpV Breathing circuit with expiratory valve

FHSS Frequency Hopping Spread Spec-trum

FiO2 Inspiratory O2 concentration

HEPA High Efficiency Particulate Air

HME Heat Moisture Exchanger, heat and moisture exchanger

hPa Hectopascal, unit of measurement for pressure1 hPa = 1 mbar = approx. 1 cm H2O

HPO High Pressure Oxygen, high-pres-sure O2 supply from the central gas supply system or an O2 com-pressed gas cylinder

I:E Ratio of inspiratory time to expiratory time

LeakV Breathing circuit with leakage valve

LPO Low Pressure Oxygen, O2 supply from an external low-pressure oxy-gen source, e.g., O2 concentrator

mbar Millibar, unit of pressure (1 mbar = approx. 1 cm H2O)

MEDIBUS Dräger communication protocol for medical devices

MEDIBUS.X Dräger communication protocol with simplified data structure for communication between devices

MRT Magnetic Resonance Tomography

MV Minute Volume, product of the set values VT and RR (VT x RR)

MVi Inspiratory minute volume

MVleak Leakage minute volume

NIV Non-Invasive Ventilation (mask ventilation)

NMI Nuclear Magnetic Imaging, nuclear spin tomography

NMR Nuclear Magnetic Resonance, magnetic resonance

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

Abbreviation Explanation

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Overview

24 Instructions for use Carina SW 3.2n

Paw Airway pressure

Paw high Airway pressure high

PC-AC Pressure Control – Assist Control, assisted-controlled, pressure-con-trolled ventilation with backup res-piratory rate

PC-BIPAP Pressure Control – Biphasic Posi-tive Airway Pressure, spontaneous breathing under continuous posi-tive airway pressure with 2 different pressure levels

PEEP Positive end-expiratory pressure

PEEPadp Start-up value of PEEP in AutoAdapt

PIF Peak Inspiratory Flow

Pinsp Set value of upper pressure level in pressure-controlled ventilation modes

PIP Peak Inspiratory Pressure, meas-ured peak inspiratory pressure

Pmax Maximum allowed airway pressure

Pmean Mean airway pressure

PS Pressure Support

Psupp Set value of pressure support, ab-solute

R Resistance

Ramp Pressure rise time

RR Respiratory rate

RR high Upper alarm limit for respiratory rate

RRapn Respiratory rate of apnea ventila-tion (set value)

SELV Safety Extra Low Voltage

SPN-CPAP/PS

Spontaneous – Continuous Posi-tive Airway Pressure/Pressure Support, spontaneous breathing with continuous positive pressure level and with or without pressure support

Abbreviation Explanation

T0...90 Response time: time that a sensor requires to display 90 % of the new signal value after a change of the signal.

Tadpt Time in AutoAdapt until the thera-peutic pressure level is reached

Tapn Apnea alarm time (time until apnea ventilation starts or an apnea alarm is triggered)

Tdiscon Delay time to alarm Airway pres-sure low !!!

Te Expiratory time

Ti Set value of inspiratory time

Timax Maximum inspiratory time during pressure support

Tube Tube ventilation (invasive ventila-tion)

UMDNS Universal Medical Device Nomen-clature System, nomenclature for medical devices

VC-AC Volume Control – Assist Control, assisted-controlled, volume-con-trolled ventilation with fixed inspira-tory flow and backup frequency with AutoFlow

VC-SIMV Volume Control – Synchronized In-termittent Mandatory Ventilation with AutoFlow (volume-controlled)

VG Volume Guarantee

VT Tidal volume

VTapn Tidal volume with apnea ventilation

VTi Inspiratory tidal volume

Abbreviation Explanation

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Instructions for use Carina SW 3.2n 25

Overview

Symbols

Symbol Explanation

Device switched on

Device switched off

Nurse call

Data interface (RS232 COM port)

Power supply display

Start/Standby keyStandby mode on/off

Select Menu key

Audio paused 2 min. key To suppress the acoustic alarm sig-nal and alarm generation by the nurse call for a maximum of 2 minutes

Indication of Audio paused 2 min. Acoustic alarm signal and alarm generation by the nurse call sup-pressed for a maximum of 2 minutes

Alarm limit switched off

Connection for pilot line (for breath-ing circuit with expiratory valve)

Breathing circuit with expiratory valve

Breathing circuit with leakage valve

Inspiratory port (connection for breathing hose)

Power supply – internal battery

Power supply – external battery

Mains power supply

Charge state of internal battery 90 to 100 %

int

ext

Charge state of internal battery 75 to 89 %

Charge state of internal battery 50 to 74 %

Charge state of internal battery 30 to 49 %

Charge state of internal battery 0 to 29 %

^ Spontaneous breathing activity by the patient

Menu 1

Menu 2

Menu 3

Menu 4

Upper alarm limit

Lower alarm limit

Caution: Observe important safety information and precautions in the instructions for use.

Observe the instructions for use

Warning! Strictly follow these in-structions for use

Nominal weight and maximum weight (for information, see chapter "Technical data")

Gas inlet (emergency air inlet)

Gas outlet (oxygen overflow)

Information on disposal

BF type application mode

Symbol Explanation

1234

1234

1234

1234

nom. 22 kg (48.5 lbs)

max. 63 kg (139 lbs)

Page 26: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

Overview

26 Instructions for use Carina SW 3.2n

Manufacturer

Manufacturing date

ESD warning symbol on device

ESD warning symbol

Degree of protection against water penetration

Material and revision number of the medical device

Serial number of the device

No function

No function

Protection Class II

Do not reuse

Do not use if packaging damaged!

Use by

Not made with natural rubber latex

Non-sterile

Relative humidity

Ambient pressure

Temperature limitation

Keep away from oil and grease

Keep away from sunlight

Lot number

Keep dry

Symbol Explanation

IPX1

REF

SN

NON STERILE

LOT

Alternating voltage

Direct voltage

Symbol Explanation

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Instructions for use Carina SW 3.2n 27

Operating concept

Operating concept

Operating and display unit . . . . . . . . . . . . . . 28

Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Structure of the screen . . . . . . . . . . . . . . . . . . . 29Status line for current device settings. . . . . . . . 29Color coding . . . . . . . . . . . . . . . . . . . . . . . . . . . 30Opening menu . . . . . . . . . . . . . . . . . . . . . . . . . 30Expanding menus. . . . . . . . . . . . . . . . . . . . . . . 30Setting ventilation modes . . . . . . . . . . . . . . . . . 31Setting ventilation parameters . . . . . . . . . . . . . 31Exceeding the set limit of a ventilation parameter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31Display of associated ventilation parameters . . 31

Page 28: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

Operating concept

28 Instructions for use Carina SW 3.2n

Operating and display unit

A Screen for displaying application-specific infor-mation for ventilation

B Keys for selecting functions and ventilation pa-rameters

Press key to open the associated function or the associated ventilation parameter on the screen.

C Rotary knob for setting and confirming functions and parameters

Set: Turn the rotary knob.

Confirm: Push the rotary knob.

D Audio paused 2 min. key – To suppress the acoustic alarm signal for a

maximum of 2 minutes– To suppress alarm generation by the nurse

call for a maximum of 2 minutes– To indicate the alarm priority (alarm LED)

E LED for displaying the power supply

F Start/Standby key for switching between standby and ventilationThe key contains a green LED, which flashes in standby mode and remains steady while venti-lation is active.

G Select Menu key for opening the menus:– Ventilation settings– Alarms– Measured values– Configuration– Locking

Hold time without input

If a modified setting or selection is left for more than 30 seconds without the rotary knob being pressed, the previous status becomes active again.

07

6

A

B

C

DE

F

G

Alarm LED flashes red Warning

Alarm LED flashes yellow Caution

Alarm LED lights yellow Note

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Instructions for use Carina SW 3.2n 29

Operating concept

Screen

Structure of the screen

A Alarm line with the following information:– Symbol for suppressed acoustic alarm sig-

nal or symbol for deactivated alarm limit – Alarm message

B Status line for current device settings.

C Display for real-time waveforms of flow and pressure or bar graph for pressure and 4 measured values

D Display for 2 measured values (value 1, value 2), configurable

E Information line, e.g., for information when the limit of the setting range is reached.

F Display of functions and ventilation parameters. The display is activated by the associated key.

Status line for current device settings

A When configured, display of LPO if the O2 sup-ply comes from a low-pressure oxygen supply. If LPO is not displayed, the O2 supply is from a HPO supply.

B Power supply:– Internal battery – External battery – Mains power

C Charge state of internal battery

D Breathing circuit:– Expiratory valve ExpV– Leakage valve LeakV

E Application mode:– NIV – Tube

F Set ventilation mode:– VC-SIMV– VC-AC– PC-BIPAP– PC-AC– SPN-CPAP/PS

G Display for detection of spontaneous breathing activity

50

03

AB

C

D

E

F

Check settings !!

NIVLeakV SPN-CPAP/PS

Flow

Pressure

L/min

mbar

211

NIVLeakV SPN-CPAP/PS

A B C D E F G

intext

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Operating concept

30 Instructions for use Carina SW 3.2n

Color coding

Opening menu

1 Press the Select Menu (A) key. All menus are displayed (B).

2 Press the key of the corresponding menu (C).

3 The functions and parameters of the selected menu are displayed (B).

The following menus can be selected:

– Vent.set. for ventilation settings, for detailed description see page 67

– Alarms menu for display and setting alarm lim-its, for detailed description see page 81

– Values menu for displaying set values and measured values in the current ventilation mode, for detailed description see page 72

– Config. menu for setting device and ventilation parameters, for detailed description see page 87

– Not Locked/Locked for locking keys to prevent accidental actuation, for detailed description see page 73

Expanding menus

Additional functions or parameters are activated with the (A) key. The active menu is displayed by a white bar.

Menu 1:

Menu 2:

Menu 3:

Menu 4:

Color Meaning

Dark green Key can be actuated

Function or parameter activated

Yellow Key selected

Function or parameter selected but not yet confirmed with rotary knob

Gray Key cannot be actuated

Function or parameter cannot be selected

Light green Key can be actuated

In the main menu for opening ad-ditional menus

03

5

A

B B B B B

C C C C C

10

8

3

A

1234

1234

1234

1234

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Instructions for use Carina SW 3.2n 31

Operating concept

Setting ventilation modes

1 Press (A) for the ventilation mode. The color changes to yellow.

2 To set the ventilation mode turn the rotary knob (B).

3 To confirm the ventilation mode push the rotary knob (B). The color of the key changes to dark green.

Setting ventilation parameters

1 Set ventilation mode.

2 Press (C) for the applicable ventilation parame-ter. The color changes to yellow.

3 To set the value turn the rotary knob (B).

4 To confirm the value push the rotary knob (B). The color of the key changes to dark green.

Exceeding the set limit of a ventilation parameter

If a setting limit of a ventilation parameter is reached, the device displays a message in the in-formation line (A).

1 Set the ventilation parameter named in the message and confirm with the rotary knob.

2 The setting limit of the ventilation parameter can now be exceeded. Set ventilation parameter ac-cordingly and confirm with the rotary knob.

Display of associated ventilation param-eters

If a ventilation parameter (B) is set, the associated ventilation values are shown in the display (A). The display is closed after confirmation of the setting.

08

00

80

A

B

B

C C C

10

811

5

3

A

A

B

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32 Instructions for use Carina SW 3.2n

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Instructions for use Carina SW 3.2n 33

Assembly and preparation

Assembly and preparation

Safety information for preparation . . . . . . . . 34

Preparing Carina. . . . . . . . . . . . . . . . . . . . . . . 34

Installing the inlet filter . . . . . . . . . . . . . . . . . . . 34Positioning Carina . . . . . . . . . . . . . . . . . . . . . . 34

Carina with trolley . . . . . . . . . . . . . . . . . . . . . 36

Checking the trolley's readiness for operation before using it . . . . . . . . . . . . . . . . . . 36Positioning the device on the trolley. . . . . . . . . 36Attaching accessories to the trolley . . . . . . . . . 37Attaching the battery holder . . . . . . . . . . . . . . . 38Inserting the external battery . . . . . . . . . . . . . . 38Preparing the gas cylinder holder. . . . . . . . . . . 38Preparing bed and wall holders . . . . . . . . . . . . 39

Safety information on breathing circuits and additional components . . . . . . . . . . . . . . 39

Using bacterial filters . . . . . . . . . . . . . . . . . . . 40

Connecting breathing circuits. . . . . . . . . . . . 41

Safety information for connecting breathing circuits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Breathing circuit with leakage valve . . . . . . . . . 42Breathing circuit with expiratory valve . . . . . . . 42Fixing the hinged arm. . . . . . . . . . . . . . . . . . . . 43

Connecting the breathing gas humidifier . . 43

Safety information for connecting the breathing gas humidifier . . . . . . . . . . . . . . . . . . 43Attaching the breathing gas humidifier . . . . . . . 44Breathing gas humidifier with inspiratory hose heater. . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Breathing gas humidifier without inspiratory hose heater. . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Passive humidifier . . . . . . . . . . . . . . . . . . . . . . 46

Preparing Aeroneb Pro medication nebulizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Connecting the power supply . . . . . . . . . . . . 48

Safety information for power supply . . . . . . . . . 48

Mains power supply. . . . . . . . . . . . . . . . . . . . . 48Power supply from the external battery. . . . . . 49Power supply from the internal battery . . . . . . 49

Connecting the gas supply . . . . . . . . . . . . . 50

Connecting the O2 supply . . . . . . . . . . . . . . . . 50

Connecting the nurse call . . . . . . . . . . . . . . 51

Safety information for using the nurse call . . . 52Connecting the nurse call . . . . . . . . . . . . . . . . 52

Using the MEDIBUS or MEDIBUS.X protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Connecting an external device for MEDIBUS or MEDIBUS.X . . . . . . . . . . . . . . . . 53

Intrahospital patient transport . . . . . . . . . . . 54

Safety information for intrahospital patient transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54Increasing the toppling stability . . . . . . . . . . . . 54Moving the trolley . . . . . . . . . . . . . . . . . . . . . . 55

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Assembly and preparation

34 Instructions for use Carina SW 3.2n

Safety information for preparation

Preparing Carina

Installing the inlet filter

1 Remove the inlet filter from the packaging.

2 Insert the inlet filter (A) into the holder from be-low, fold it up and push it into the holder (B) until it locks into position.

Positioning Carina

WARNING

Risk of personal injury

If medical devices are not reprocessed, there is an increased risk of infection to both hospi-tal staff and patients.

Before each use, reprocess the device and all accessories in accordance with the instruc-tions for use, see "Reprocessing list" on page 110. Observe the hospital hygiene regu-lations.

WARNING

Risk of damage to device or personal injury

If the device is not securely fastened, the de-vice can fall down.

Securely fasten the device. Check for secure fit.

02

3

A

B

WARNING

Risk of fire

Due to oxygen enrichment in the ambient air, the medical device can ignite.

A distance of at least 10 cm (3.9 in) must be maintained between the rear of the medical device and the walls or large obstacles.

WARNING

Risk of overheating of the device

Pillows and blankets will block air feed.

Do not place the device on the patient's bed.

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Instructions for use Carina SW 3.2n 35

Assembly and preparation

1 Place Carina on a horizontal, stable surface.

2 Keep ventilation slots (A) clear.

3 Keep emergency air inlet and oxygen overflow (B) clear.

Toppling stability

Do not tilt the device more than 15° while in use to ensure that it cannot topple over.

09

50

99

00

7

A

B

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Assembly and preparation

36 Instructions for use Carina SW 3.2n

Carina with trolley

Use the Dräger trolley 1 (63 cm) or trolley 1 (78 cm) only.

Checking the trolley's readiness for op-eration before using it

1 The red locking lever of the column holder (A) is locked.

2 Accessories such as the standard rail handle (B) or universal holder with standard rail (B) are firmly attached.

3 The locking levers of the Carina holder (C) are closed.

4 The rubber components (D) of the device holder are in good condition.

Positioning the device on the trolley

1 Open both locking levers (A).

2 Red areas (B) must be visible.

07

7

A

B

C

D

08

5

WARNING

Risk of jamming fingers

Touch the locking levers on the handle only.

00

50

06

A

A

B B

C

D

D

E

E

F

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Instructions for use Carina SW 3.2n 37

Assembly and preparation

3 Hold Carina (C) with both hands and position the holes in the bottom of the device (D) on the locating pins (E).

4 Move Carina parallel to the base plate (F) of the device holder until it is resting safely on the base plate.

5 Lock both locking levers: red areas are no longer visible. Touch the locking levers on the handle only.

6 Check that Carina is firmly seated.

Observe the maximum load, see "Trolley" on page 134.

Attaching accessories to the trolley

Attaching the universal holder with standard rail

1 Position the right side of the holder on the right side of the column. Make sure that the catch (A) of the universal holder is completely behind the alignment aid.

2 Position the left side of the holder on the left side of the column. Make sure that the catch (B) of the universal holder is completely behind the alignment aid.

3 Use the template (C) on the top of the universal holder to ensure that it is horizontal.

4 Align the universal holder so it is horizontal.

5 Tighten the adjusting screw (D).

Height adjustment

Loosen the adjusting screw and adjust the height of the universal holder. Align the univer-sal holder horizontally and tighten the adjusting screw.

Placing accessories on the standard rail

Place accessories on the standard rail. Observe the maximum load. See "Trolley" on page 134.

08

60

87

A

B C

08

8

WARNING

Risk of damange to the device and of patient injury

If the universal holder is not tightly fastened to the column, it may come loose.

Check that the universal holder is tightly fas-tened by pulling on it.

D

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Assembly and preparation

38 Instructions for use Carina SW 3.2n

Attaching the battery holder

1 Press the locks (A) together and open the flap (B).

2 Hold the battery holder to the holes (C) in the trolley column. Screw the battery holder in place with the 4 included screws.

3 Tighten all 4 screws. Use the included Allen key for this.

4 Make sure that the battery holder is tightly fas-tened.

Inserting the external battery

1 Press the locks (A) together and open the flap (B).

2 Insert the external battery (C) into the battery holder.

3 Close the flap (B).

Preparing the gas cylinder holder

Available only with the gas cylinder holder option.

Gas cylinders of the following sizes can be at-tached:

08

90

90

C

B

A

A

C

A

A

B

WARNING

Risk of damage to device or personal injury

If the Velcro fasteners holding the gas cylin-ders are too short, the gas cylinders may fall down.

The length of the Velcro fasteners must match the circumference of the gas cylinders. If nec-essary, have the correct Velcro fastener in-stalled by service personnel.

Diameter 80 to 160 mm (3.15 to 6.3 in)

Length 420 to 870 mm (16.54 to 34.25 in)

WARNING

Risk of damage to gas cylinders during trans-port

Install gas cylinders so the pressure reducers are clear and do not project from the side of the trolley.

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Instructions for use Carina SW 3.2n 39

Assembly and preparation

1 Place the gas cylinders into the mountings (A) of the gas cylinder holder.

2 Secure each cylinder with 2 Velcro fasteners (B).

3 Observe the maximum load of 12 kg (27 lbs) for each side of the gas cylinder holder, see the medical device label on the gas cylinder holder.

Preparing bed and wall holders

Prepare the bed and wall holders as directed by the instructions for use for the bed and wall holders (9053157).

Safety information on breathing circuits and additional components

Additional components in the breathing circuit or components that deviate from the standard breath-ing circuit may significantly increase the inspiratory and expiratory resistance values above the require-ments imposed by standards (for example, bacteria filters, HME). The device cannot directly monitor re-sistance in the patient connection.

For this reason:

Check the patient state and the volume values of the device more frequently.

Observe the instructions for use for the filters and components.

09

6

A A

BB

BB

09

7

CAUTION

Increased compliance or resistance

Additional components in the breathing circuit such as bacterial filters or HME increase the dead space and result in an increase of compliance or resistance.

When using additional components, particular care and monitoring are required.

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Assembly and preparation

40 Instructions for use Carina SW 3.2n

Note the following for a passive humidifier

A heat and moisture exchanger (HME) for a pas-sive humidifier may significantly increase the resist-ance at the patient connection. An increase in re-sistance will result in increased breathing effort with spontaneous breathing or increased trigger effort with assisted breathing. Under unfavorable circum-stances this may result in unwanted intrinsic PEEP. The device cannot directly monitor resistance in the patient connection.

For this reason:

Check the patient state and the volume values of the device more frequently.

Observe the instructions for use for the HME.

Do not use additional inspiratory bacterial filters with a heat and moisture exchanger with filter function.

Using bacterial filters

Fit the bacterial filter onto the inspiratory port.

WARNING

Increased resistance

If an HME and a breathing gas humidifier/med-ication nebulizer are used at the same time, re-sistance can increase.

Use either an HME or a breathing gas humidi-fier/medication nebulizer.

WARNING

Increased resistance

When using a heat and moisture exchanger in environments with high relative humidity, the resistance may be significantly increased. In some cases the device may not detect a dis-connection in this situation.

Assess the necessity of using the HME under these conditions or connect an appropriate external monitor to the breathing circuit.

WARNING

Risk of infection

Do not operate the device without an inlet fil-ter (HEPA filter) to prevent infection of the pa-tient and to ensure dust-free operation.

WARNING

Risk of infection

If no inspiratory bacterial filter is used, the pa-tient can be infected by aspirated ambient air.

Use an inspiratory bacterial filter.

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Instructions for use Carina SW 3.2n 41

Assembly and preparation

Connecting breathing circuits

Safety information for connecting breathing circuits

WARNING

Risk of electric shock and fire

The use of antistatic or conductive breathing hoses increases the risk of electric shock to the patient and the risk of fire in an oxygen-en-riched environment.

Do not use antistatic or conductive breathing hoses.

WARNING

Risk of patient injury

If the hoses are disconnected from the device during ventilation, ventilation will be inter-rupted.

Position hoses safely. Avoid trip hazards. Do not kink hoses. Keep leakage valve free for ex-piration.

WARNING

Risk of patient injury

A component of the volume supplied by the device remains in the breathing circuit during ventilation. This component depends on the ratio of hose compliance to lung compliance. The device does not take account of the com-pliance of the breathing circuit.

The volume losses must be manually cor-rected. For additional information, see chapter "Volume losses during ventilation" on page 144.

WARNING

Risk of patient injury

If the incorrect breathing circuit is used, the volume measurements may be significantly different from the actual volume.

Make sure that the selected breathing circuit matches the device setting.

CAUTION

Risk of malfunctions

Only service personnel may perform the change between a breathing circuit with leakage valve and a breathing circuit with expiratory valve.

CAUTION

Risk of infection

Leave the breathing circuit in its packaging until just before use to keep contamination and dirt away.

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Assembly and preparation

42 Instructions for use Carina SW 3.2n

Breathing circuit with leakage valve

The leakage valve can be used for both non-inva-sive ventilation (NIV) and invasive ventilation (Tube).

Setting the switch to leakage valve

1 Open the sliding cover (A) on the bottom of the device.

2 Move the switch (B) to leakage valve with a coin until the switch locks.

3 Close the sliding cover.

Connecting the breathing circuit

4 Fit the bacterial filter (C) to the inspiratory port (D).

5 Connect the breathing hose (E) to the bacterial filter.

6 Fit the leakage valve (F) to the port on the breathing hose. Observe the direction.

When using the disposable breathing circuit VentStar Carina LeakV (MP00312) the leakage valve is permanently fixed to the breathing hose.

The status line on the screen shows LeakV.

Breathing circuit with expiratory valve

Setting the switch to expiratory valve

1 Open the sliding cover (A) on the bottom of the device.

2 Move the switch (B) to expiratory valve with a coin until the switch locks.

3 Close the sliding cover.

Connecting the breathing circuit

4 Fit the bacterial filter (C) to the inspiratory port (D).

5 Connect the breathing hose (E) to the bacterial filter.

6 Fix the expiratory valve (F) to the port on the breathing hose (E). Observe the direction.

When using the disposable breathing circuit VentStar Carina ExpV(MP00312) the leakage valve is permanently fixed to the breathing hose.

7 Connect the pilot line (G) to the pilot line plug (H).

01

40

15

21

2

B A

CD E F

LeakV SPN-CPAP/PSNIV

NOTE

The breathing circuit with expiratory valve must be used only for invasive ventilation (Tube).

01

60

17

B A

CH

FE

D

G

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Instructions for use Carina SW 3.2n 43

Assembly and preparation

The status line on the screen shows ExpV.

Fixing the hinged arm

To prevent the breathing hose from kinking, Dräger recommends the use of a hinged arm.

Attach the hinged arm with rail clamp to the uni-versal rail on the trolley and fix in position.

Connecting the breathing gas humidifier

Safety information for connecting the breathing gas humidifier

21

2ExpV PC-ACTube

WARNING

Risk of patient injury

When using a breathing gas humidifier with-out heated hoses condensate may increase the resistance.

Use a water trap.

WARNING

Risk of damange to the device and of patient injury

Position device and breathing gas humidifier on a flat, stable surface. Otherwise the breath-ing gas humidifier may fall down.

WARNING

Risk of patient injury

Increased resistance values may cause hy-poventilation.

When using a breathing gas humidifier do not use an additional heat and moisture ex-changer (HME).

WARNING

Risk of patient injury

When using active humidification the device may not detect a disconnection due to the re-stricted monitoring function.

Use suitable monitoring.

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Assembly and preparation

44 Instructions for use Carina SW 3.2n

Attaching the breathing gas humidifier

Prepare the breathing gas humidifier in accordance with the corresponding instructions for use. For the part numbers for the breathing gas humidifier see the separate list of accessories.

The breathing gas humidifier can be attached to the universal holder with standard rail.

Clamp the breathing gas humidifier to the standard rail (A) and screw firmly into place.

Breathing gas humidifier with inspira-tory hose heater

For breathing circuits with leakage valve

1 Set the switch to leakage valve , see page 42.

2 Fit the bacterial filter (A) to the inspiratory port (B).

3 Connect the breathing hose (C) to the bacterial filter and the breathing gas humidifier (D).

4 Connect the breathing hose (E) to the breathing gas humidifier (D).

5 If necessary, connect the thermometer (F). Ob-serve the instructions for use of the humidifier.

6 Connect the leakage valve (G). Observe the di-rection.

For breathing circuits with expiratory valve

1 Set the switch to expiratory valve , see page 42.

2 Fit the bacterial filter (A) to the inspiratory port (B).

3 Connect the breathing hose (C) to the bacterial filter and the breathing gas humidifier (D).

4 Connect the breathing hose (E) to the breathing gas humidifier (D).

5 If necessary, connect the thermometer (F). Ob-serve the instructions for use of the humidifier.

6 Connect the expiratory valve (G). Observe the direction.

7 Connect the pilot line (H) to the plug (I).

116

04

0A

A

G

B

CE

DF

04

1

E

G

H

I

AB

C

DF

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Instructions for use Carina SW 3.2n 45

Assembly and preparation

Breathing gas humidifier without inspir-atory hose heater

For breathing circuits with leakage valve

1 Set the switch to leakage valve , see page 42.

2 Fit the bacterial filter (A) to the inspiratory port (B).

3 Connect the breathing hose (C) to the bacterial filter and the breathing gas humidifier (D).

4 Connect the breathing hose (E) to the breathing gas humidifier (D) and the water trap (F). Con-nect another breathing hose (E) to the water trap.

5 Position the water trap (F) vertically at the low-est point of the hose connection.

6 Connect the leakage valve (G). Observe the di-rection.

For breathing circuits with expiratory valve

1 Set the switch to expiratory valve , see page 42.

2 Fit the bacterial filter (A) to the inspiratory port (B).

3 Connect the breathing hose (C) to the bacterial filter and the breathing gas humidifier (D).

4 Connect the breathing hose (E) to the breathing gas humidifier (D) and the water trap (F). Con-nect another breathing hose (E) to the water trap.

5 Position the water trap (F) vertically at the low-est point of the hose connection.

6 Connect the expiratory valve (G). Observe the direction.

7 Connect the pilot line (H) to the plug (I).

03

8

AB

DC

E E

F

G

03

9

AB

DC

E E

F

G

H

I

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Assembly and preparation

46 Instructions for use Carina SW 3.2n

Passive humidifier

For breathing circuits with leakage valve

1 Set the switch to leakage valve , see page 42.

2 Fit the bacterial filter (A) to the inspiratory port (B).

3 Connect the breathing hose (C) to the bacterial filter (A).

4 Fit the leakage valve (D) to the port on the breathing hose (C). Observe the direction.

When using the disposable breathing circuit VentStar Carina LeakV (MP00312) the leakage valve is permanently fixed to the breathing hose.

5 Fit the heat and moisture exchanger (E) to the leakage valve (D).

For breathing circuits with expiratory valve

1 Set the switch to expiratory valve , see page 42.

2 Fit the bacterial filter (A) to the inspiratory port (B).

3 Connect the breathing hose (C) to the bacterial filter (A).

4 Fix the expiratory valve (D) to the port on the breathing hose (C). Observe the direction.

When using the disposable breathing circuit VentStar Carina ExpV (MP00312) the leakage valve is permanently fixed to the breathing hose.

5 Fit the heat and moisture exchanger (E) to the expiratory valve (D).

6 Connect the pilot line (F) to the plug (G).

When using heat and moisture exchangers with filter

If a heat and moisture exchanger with filter function is used, the bacterial filter is not required.

CAUTION

Increased compliance or resistance

Additional components in the breathing circuit such as bacterial filters or HME increase the dead space and result in an increase of compliance or resistance.

When using additional components, particular care and monitoring are required.

119

A

C

B D E

12

0

AB C

D

F

G

E

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Instructions for use Carina SW 3.2n 47

Assembly and preparation

Preparing Aeroneb Pro medication nebulizer

Observe the instructions for use of the Aeroneb Pro nebulizer.

Observe the "Safety information on breathing circuits and additional components" on page 39.

WARNING

Increased resistance

If an HME and a medication nebulizer are used at the same time, resistance can increase.

During medication nebulization, do not use a HME.

WARNING

Risk of increased CO2 rebreathing

When using the breathing circuit with leakage valve, aerosols may cause deposits in the leakage valve. This will reduce the flow through the leakage valve.

Use suitable external patient monitoring (cap-nography) to detect increased CO2 rebreath-ing.

WARNING

Risk of increased CO2 rebreathing

Position the nebulizer between the inspiratory hose and expiratory valve or leakage valve to prevent increased dead space.

When using a medication nebulizer, use only single hoses with a separate valve (MP00220, MP00224).

08

1

30

15

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Assembly and preparation

48 Instructions for use Carina SW 3.2n

Connecting the power supply

Safety information for power supply

The device can be powered by the mains power supply or an external battery for stationary use. Both power sources charge the internal battery.

When the device is connected to both mains power supply and the external battery at the same time, the device is run on mains power. The external bat-tery connection is switched off. The internal battery is charged from the mains.

Mains power supply

The device is designed for connection to the hospi-tal's mains power supply. Connection characteris-tics, see "Operating data characteristics" on page 130.

1 Plug the power cable (A) into the socket (B) and secure it with the wire clip.

2 Insert the mains plug into the mains power socket (C).

The LED flashes or lights depending on the charge of the internal battery.

The device mains plug must be easily accessible to ensure that the device can be disconnected from the power supply at any time.

WARNING

Trip hazard

Position cables safely. Avoid trip hazards.

NOTE

Only use power cables with the following connec-tors:– The connector to the device conforms to the

IEC 60320-1 C17 or C13 standard and can be secured by a wire clip.

– The mains plug conforms to the national regu-lations.

01

0

A

B

C

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Instructions for use Carina SW 3.2n 49

Assembly and preparation

Power supply from the external battery

The optional external battery pack (EBP) is no lon-ger available since 2014.

Connecting the external battery

Observe the instructions for use for the external battery.

1 Plug the DC plug (A) into the socket (B) for the external battery.

2 Connect the DC cable to the external battery (C).

The LED flashes or lights depending on the charge of the internal battery.

The external battery pack (EBP) has an internal charger.

Power supply from the internal battery

If the external power supply fails (mains power sup-ply or external battery), the device automatically switches to the internal battery power supply. Ca-rina shows the alarm message External power failure !! for 2 minutes. Then the alarm message Int. battery activated ! is displayed.

With a fully charged battery, ventilation can be con-tinued reliably for approx. 60 minutes without an external power supply (with average ventilation val-ues and normal ambient conditions).

If the charge is less than 50 %, the alarm message Int. battery low ! is displayed. If the charge is less than 30 %, the alarm message Int. battery low !!! is displayed. At the end of the operating time, the alarm message Int. battery empty !!! is displayed. Restore the external power supply immediately to avoid any interruption in ventilation.

WARNING

Risk of patient or user injury and of device damage

Only connect external batteries included in the list of accessories. Do not connect mains-operated devices to the socket for the external battery (except the ex-ternal battery pack (EBP)).

NOTE

The external battery pack (EBP) is not charged via the Carina main connection.

09

2

A

CB

WARNING

Risk of patient injury

If the internal battery is discharged and the ex-ternal power supply fails, the device cannot ventilate.

Only start intrahospital transport if the internal battery is sufficiently charged.

CAUTION

Risk of self-discharge

Charge the internal battery if it has not been used for some time. See "Charging the internal battery" on page 115.

NOTE

Incomplete charging and discharging cycles may lead to an incorrect display of the charge state of the internal battery. Improve the display accuracy, see page 79.

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Assembly and preparation

50 Instructions for use Carina SW 3.2n

The ventilation settings and the alarm limits remain saved even in the event of a power supply failure.

A fully discharged battery will be fully recharged af-ter about 2 hours of charging. The LED lights.

Charging the internal battery, see page 115.

Connecting the gas supply

The device uses ambient air for ventilation, which is delivered by means of an internal turbine.

The O2 supply is provided by one of the following sources:– Central gas supply system (HPO mode)– Compressed gas cylinders (HPO mode)– Low-pressure oxygen supply (LPO mode)

Connecting the O2 supply

WARNING

Risk of explosion

Pressurized oxygen in conjunction with oil or grease may spontaneously ignite.

Do not bring any oxygen supply components into contact with oil and grease.

WARNING

Risk of patient injury

If compressed gases are used that are not ap-proved for medical uses, the proper function-ing of the device may be impaired.

Only use compressed gases approved for medical use. The compressed gases must be free of dust and oil particles and dry.

WARNING

Risk of patient injury

If the inspiratory oxygen concentration differs from the ambient air concentration, monitor-ing of the inspiratory oxygen concentration with adjustable high and low alarm limits is needed.

Connect an external oxygen monitor comply-ing with ISO 21647 or ISO 80601-2-55 to the breathing circuit. Otherwise no alarm will be generated if the actual inspiratory oxygen concentration differs from the set oxygen con-centration.

WARNING

Risk of patient injury

If patients are dependent on ventilation, one of the following parameters must be monitored:– Expiratory tidal volume– Expiratory minute volume– End-tidal expiratory CO2 concentration

If no patient monitoring is implemented, no alarm will be generated in case of insufficient patient ventilation.

Use suitable external monitors.

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Instructions for use Carina SW 3.2n 51

Assembly and preparation

Use external monitors to ensure that the oxygen dosage is accurate.

O2 supply from a central gas supply system

1 Screw the O2 compressed gas hose (A) to the HPO connection (B).

2 Plug the connector into the wall terminal unit for the central gas supply system.

O2 supply from compressed gas cylinders

If the central gas supply fails or is not available, O2 can be supplied from compressed gas cylinders.

O2 supply from low-pressure oxygen supply (LPO mode)

The O2 is supplied from an external low-pressure oxygen source, e.g., an O2 concentrator, see page 73.

Connecting the nurse call

The nurse call is used for transmitting high-priority alarms (warning) and medium-priority alarms (cau-tion) to a central hospital alarm system. Low-priority alarms (note) are not transmitted.

If the acoustic alarm signal on the device has failed, the nurse call will still be activated.

If, in the event of an alarm, the Audio paused 2 min. key is pressed, the acoustic alarm signal on the device and the nurse call are suppressed for 2 minutes. During this time, new alarms that occur are not signaled by the nurse call.

WARNING

Insufficient O2 supply

Patients who require an increased O2 concen-tration are at risk in the event of failure of the oxygen source.

Make sure there is an emergency oxygen sup-ply, e.g., O2 from compressed gas cylinders.

02

1

A

B

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Assembly and preparation

52 Instructions for use Carina SW 3.2n

Safety information for using the nurse call

Connecting the nurse call

Use only the nurse call cable 5704906 from Dräger. Observe corresponding instructions for use.

Have the nurse call cable connected to the line of the central hospital alarm system by service personnel.

Connecting the nurse call to the ventilator

1 Plug the nurse call plug (A) into the socket (B). Make sure that the plug audibly locks into posi-tion.

2 Check the correct operation of the connected nurse call system.

WARNING

Risk of nurse call failure

Carina can be integrated into a distributed alarm system by means of the nurse call inter-face. According to IEC 60601-1-8, this distrib-uted alarm system is not suitable for secure transmission of alarms. Thus data transfer by means of the nurse call is not a substitute for regular checking of the notifications on the device screen.

All display devices in this distributed alarm system must be provided with a warning which indicates that secure receipt of alarm signals cannot be ensured.

CAUTION

Risk of nurse call failure

A connection failure between the device and the central hospital alarm system may interrupt the transmission of information.

Regularly check the information on the screen of the device.

CAUTION

Risk due to limited patient monitoring

The nurse call does not forward all alarm mes-sages. Do not use the nurse call as the sole source of alarm information.

Regularly check the information on the screen of the device. Check alarms on the device directly.

CAUTION

Have the nurse call system connected by service personnel only.

CAUTION

Risk of electric shock

If a faulty device without safety extra-low voltage (SELV) is connected to the medical device, there is a risk of electric shock from the housing of the medical device.

Only connect devices with safety extra-low volt-age (SELV) to the connections for the serial port and the nurse call.

02

5

A

B

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Instructions for use Carina SW 3.2n 53

Assembly and preparation

Using the MEDIBUS or MEDIBUS.X protocol

MEDIBUS and MEDIBUS.X are software protocols for data transfer between Carina and other medical devices (e.g., patient monitors) or other devices (e.g., computers for data management systems).

Requirements for the combination of Carina and an external device, see "Device combinations" on page 9.

Observe software protocols

For MEDIBUS:

For MEDIBUS.X:

Connecting an external device for MEDIBUS or MEDIBUS.X

The port (RS232 COM port) is intended exclu-sively for connecting to devices with safety extra-low voltage (SELV).

Use only "Babylink cable" 8306488 from Dräger.

Connect the external device to the port (A).

MEDIBUS for Carina 9039037

Dräger RS 232 MEDIBUS, Protocol Definition

9028258

MEDIBUS.X, Rules and Standards for Implementation

9052607

MEDIBUS.X, Profile Definition for Data Communication V1.0

9052608

WARNING

Risk of patient injury

Data transmitted over the RS232 COM port are to be used only for information and are not in-tended as the sole basis for diagnostic or ther-apeutic decisions. The RS232 COM port is not intended for use with a distributed alarm sys-tem conforming to IEC60601-1-8.

WARNING

Risk of electric shock

If the connectors of the interface and the pa-tient are touched simultaneously, there is a risk of electric shock.

Do not simultaneously touch the connectors of the interface and the patient.

02

0

A

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Assembly and preparation

54 Instructions for use Carina SW 3.2n

Intrahospital patient transport

Safety information for intrahospital pa-tient transport

Increasing the toppling stability

To ensure that the device cannot topple over, the accessories must be moved to the most advanta-geous position:

– Set hinged arm to minimum extension.

– Attach hoses and cables as close as possible to the trolley.

– Attach breathing gas humidifier to the trolley, not the device.

WARNING

Risk of patient injury

Changes to the patient's condition or damage to the device during transport endanger the patient.

The patient must be monitored continuously by users.

WARNING

Risk of patient injury

If the internal battery is discharged and the ex-ternal power supply fails, the device cannot ventilate.

Only start intrahospital patient transport if the internal battery is sufficiently charged.

CAUTION

Risk of damage to device or personal injury

If Carina is placed on the bed when transporting patients, the device may fall down.

Do not place the device on the patient's bed.

CAUTION

Risk of toppling over

The medical device may topple over if incorrectly handled.

Do not tilt the trolley more than 10°.

Hold the device firmly by the handle to move or position it.

Move the trolley at walking speed only. The dan-ger of toppling over is greater at thresholds, on uneven surfaces and ramps. Reduce speed even more.

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Instructions for use Carina SW 3.2n 55

Assembly and preparation

Moving the trolley

1 Release all 4 locking brakes (A).

2 Hold and move the trolley by the standard rail handle (B) or the trolley column (C).

Parking the trolley

Lock all 4 locking brakes.

01

2

A

AA

A

B

C

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56 Instructions for use Carina SW 3.2n

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Instructions for use Carina SW 3.2n 57

Getting started

Getting started

Safety information on getting started. . . . . . 58

Requirements for getting started . . . . . . . . . . . 58

Powering on the device . . . . . . . . . . . . . . . . . 58

Checking readiness for operation . . . . . . . . 59

Connecting the test lung. . . . . . . . . . . . . . . . . . 59Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Selecting the application mode. . . . . . . . . . . 62

Setting the O2 supply . . . . . . . . . . . . . . . . . . . 62

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

Auto wake-up . . . . . . . . . . . . . . . . . . . . . . . . . . 63

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Getting started

58 Instructions for use Carina SW 3.2n

Safety information on getting started

Before getting started and after extended downtime charge the internal battery of the device for at least 2 hours.

Requirements for getting started

– Device is reprocessed and assembled ready for operation.

– Mains power supply or power supply with a charged battery is established.

– O2 supply is connected, if necessary.

Powering on the device

Set the power switch (A) to .

Carina runs the selftest. The screen shows the pro-gress display for the selftest.

After the selftest the screen shows the last defined ventilation mode and the last defined parameters. The device is in standby mode. The patient is not ventilated in standby mode.

WARNING

Risk of patient injury

Ventilation does not take place in standby mode. Patients connected to the device are endangered.

The device must only be set to standby mode when no patient is connected to the device.

CAUTION

Malfunctions from condensation

Condensation may form when the device is moved from a cold storage location to a warm en-vironment.

Only switch on the device once the condensation has dried.

02

7

A

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Instructions for use Carina SW 3.2n 59

Getting started

Checking readiness for operation

After the device is switched on or after the breath-ing circuit is changed, the operational readiness of the device must be verified by means of the device check.

The checklist on pages 60 and 61 can be copied for documentation purposes.

Check the test steps in the copied checklist once they have been successfully completed.

The following functions are tested:– LEDs, displays and alarm tone– Upper alarm limit Paw– Lower alarm limit Paw– Apnea ventilation

Connecting the test lung

Use only the test lungs specified in the list of acces-sories.

Connect the appropriate test lung to the breath-ing circuit.

CAUTION

Do not use the device unless the device check was successful.

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Getting started

60 Instructions for use Carina SW 3.2n

Checklist

Test step Measure Requirement Result

1 Assembly and preparation Make all connections: Connect breathing circuit, filters and test lung.Connect the power cable.

All components must be connected correctly, see chapter "Assembly and preparation".

2 Switch on the device Carina performs a selftest: The LED in the Start/Standby key flashes and the LED flashes or lights and an acoustic alarm signal sounds.

3 Compare the breathing cir-cuit (leakage valve or ex-piratory valve) with the dis-play in the status line.

The status line shows LeakV for leakage valve or ExpV for expiratory valve.

4 Check the application mode (Tube or NIV)

The status line shows NIV for non-invasive ventilation or Tube for invasive ventila-tion.

5 Check the Airway pres-sure high !!! alarm

Set the ventilation mode: PC-BIPAP

Optical alarm signals: The Airway pressure high !!! alarm message is dis-played and the Audio paused 2 min. alarm LED flashes red.

Acoustic alarm signal: High-priority alarm signal

Setting alarm limits:

Paw high:Tdiscon:

20 mbar0 s

Setting ventilation parameters:

PEEP: Pinsp: RR: Ti / I:E: Ramp:

5 mbar15 mbar13/min2 s / 1:1.30.2 s

Start ventilation by pressing the Start/Standby key. Squeeze the test lung together during in-spiration for 2 consecutive me-chanical breaths, so that the Paw high alarm limit is ex-ceeded.

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Instructions for use Carina SW 3.2n 61

Getting started

After the device check

Switch Carina to standby mode, see page 77.

6 Check the Airway pres-sure low !!! alarm

Confirm the Airway pressure high !!! alarm. Disconnect the test lung from the breathing circuit.

Optical alarm signals: The Airway pressure low !!! alarm message is dis-played and the Audio paused 2 min. alarm LED flashes red.

Acoustic alarm signal: High-priority alarm signal

7 Check apnea ventilation Connect the test lung to the breathing circuit.

Set the ventilation mode: SPN-CPAP/PS

After the apnea alarm time has elapsed:

Optical alarm signals: The Apnea Ventilation ! alarm message is displayed and the Audio paused 2 min. alarm LED lights yel-low.

Acoustic alarm signal: Low-priority alarm signal

Setting alarm limits:

Paw high:Tapn:

45 mbar5 s

Setting ventilation parameters:

Apn.Vent.: Pmax: VTapn:

On40 mbar500 mL

Simulate spontaneous breath-ing by squeezing the test lung. Then stop the breathing.

After a successful device check, Carina is ready for use with the patient.

Test step Measure Requirement Result

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Getting started

62 Instructions for use Carina SW 3.2n

Selecting the application mode

The device can be used for non-invasive ventilation (NIV) and ventilation of intubated patients (Tube).

The application mode is set in the configuration menu. The NIV application mode can only be set when LeakV is displayed in the status line on the screen.

Prerequisite: Carina is in standby mode

1 Press the Select Menu (A) key.

2 Press the Config. (B) key.

3 Press the (C) key.

4 In menu 2 press the Method (D) key.

5 In the display (E) select NIV or Tube by turning the rotary knob and push to confirm.

The selected application mode is displayed in the status line of the screen.

Additional information

Using NIV application mode, see "Non-invasive ventilation (NIV)" on page 69.

Setting the O2 supply

The device is factory-set to HPO mode. For the O2 supply in LPO mode see "Selecting the O2 supply" on page 93.

The device shows the O2 concentration set by the user, not the concentration currently supplied to the patient.

Dräger recommends the use of an external O2 monitor in the breathing circuit for measurement of the current O2 concentration.

Positioning the oxygen sensor

Position the sensor (A) of the oxygen monitor directly at the inspiratory port (B) of Carina.

Breathing circuit Application mode

With leakage valve NIV, Tube

With expiratory valve Tube

10

0

A

D B CE

1234

09

3

A

B

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Instructions for use Carina SW 3.2n 63

Getting started

Starting ventilation

Before using on the patient:

1 Check readiness for operation, see page 59.

2 Sett ventilation modes and ventilation parame-ters, see page 67.

3 Setting the alarm limits, see page 84.

Press the Start/Standby (A) key.

The start of ventilation is indicated by a single tone.

Auto wake-up

1 Connect the patient.

2 Carina starts ventilation on detection of the in-spiratory effort with the previously set ventila-tion settings.

3 Monitor the start of ventilation. Check the venti-lation settings and adjust if necessary.

03

4

A

WARNING

Risk of patient injury

After connecting the patient, monitor the start of ventilation. If the patient's inspiratory effort is not sufficient, the device cannot start venti-lation.

Ventilation must then be started manually.

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64 Instructions for use Carina SW 3.2n

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Instructions for use Carina SW 3.2n 65

Operation

Operation

Safety information on ventilation . . . . . . . . . 66

Setting ventilation . . . . . . . . . . . . . . . . . . . . . 67

Setting ventilation modes . . . . . . . . . . . . . . . . . 67Setting ventilation parameters . . . . . . . . . . . . . 67Setting ranges for ventilation . . . . . . . . . . . . . . 68

Non-invasive ventilation (NIV). . . . . . . . . . . . 69

Safety Information . . . . . . . . . . . . . . . . . . . . . . 69Using non-invasive ventilation . . . . . . . . . . . . . 70

Using apnea ventilation . . . . . . . . . . . . . . . . . 70

Activating apnea ventilation . . . . . . . . . . . . . . . 70Switching off apnea ventilation . . . . . . . . . . . . . 71

Using the AutoAdapt function. . . . . . . . . . . . 71

Activating AutoAdapt . . . . . . . . . . . . . . . . . . . . 71Canceling AutoAdapt . . . . . . . . . . . . . . . . . . . . 72

Displaying setting and measured values . . . 72

Locking keys. . . . . . . . . . . . . . . . . . . . . . . . . . 73

Low Pressure Oxygen (LPO) . . . . . . . . . . . . . 73

Safety information for LPO . . . . . . . . . . . . . . . . 73Connecting the O2 concentrator to Carina . . . . 74Setting LPO mode . . . . . . . . . . . . . . . . . . . . . . 75Setting the O2 concentration . . . . . . . . . . . . . . 75Switching off the LPO supply . . . . . . . . . . . . . . 77

Standby mode . . . . . . . . . . . . . . . . . . . . . . . . . 77

Activating standby mode . . . . . . . . . . . . . . . . . 77Continuing ventilation . . . . . . . . . . . . . . . . . . . . 78

Ending operation . . . . . . . . . . . . . . . . . . . . . . 78

Taking the device out of service for an extended period . . . . . . . . . . . . . . . . . . . . . . . 78

Taking the device out of service . . . . . . . . . . . . 78Storing the device. . . . . . . . . . . . . . . . . . . . . . . 78

Improving the display accuracy of the charge state of the internal battery. . . . . . . . 79

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Operation

66 Instructions for use Carina SW 3.2n

Safety information on ventilation

WARNING

Risk of patient injury

A component of the volume supplied by the device remains in the breathing circuit during ventilation. This component depends on the ratio of hose compliance to lung compliance. The device does not take account of the com-pliance of the breathing circuit.

The volume losses must be manually cor-rected. For additional information, see chapter "Volume losses during ventilation" on page 144.

WARNING

Risk of increased CO2 rebreathing

The risk of dead space ventilation is increased when setting small volumes.

Observe the patient very closely.

WARNING

Risk of insufficient ventilation

Leakages may cause the applied volume to be less that the set volume.

Prevent leakages.

WARNING

Risk of patient injury

Critical airway pressures may result with Vol-ume Guarantee.

Set Pmax accordingly.

CAUTION

The Apnea !!! alarm is only displayed in an apnea situation if apnea monitoring is activated.

Set the apnea alarm time Tapn.

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Instructions for use Carina SW 3.2n 67

Operation

Setting ventilation

The section describes how ventilation modes and ventilation parameters are set. The factory default ventilation parameters and setting ranges are listed.

For the detailed description of the ventilation modes and parameters see section Description of the ventilation modes, page 145.

Setting ventilation modes

1 Press the Select Menu (A) key.

2 Press the Vent.set. (B) key. The last set venti-lation mode is displayed (C).

3 Press (B) for the ventilation mode.

4 Select the ventilation mode by turning the rotary knob (D) and push to confirm.

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

After switching on, the device displays the last set ventilation mode with the set ventilation parame-ters.

Setting ventilation parameters

Prerequisite: Carina displays the last set ventilation mode.

1 Press (A) for the applicable ventilation parame-ter.

2 Set the value by turning the rotary knob (B) and push to confirm.

3 Display other ventilation parameters, e.g., Apn.Vent. and VG, with the key (C). Set venti-lation parameters as described under step 1 and 2.

Set ventilation parameters are retained even when the device is switched off.

Factory-set ventilation parameters, see page 133.

Start ventilation, see page 63.

10

1

A

B

D

C

10

2

A A A

B

C

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Operation

68 Instructions for use Carina SW 3.2n

Setting ranges for ventilation

Ventilationparameter

Ventilation mode

VC-SIMV VC-AC PC-BIPAP PC-AC SPN-CPAP/PS (VG)

VT1) [mL]

1) For SPN-CPAP/PS the following applies: Only with activated Volume Guarantee VG.

100 to 2000 100 to 2000 – – 100 to 2000

Pinsp2) [mbar, cm H2O]

2) For PC-BIPAP and PC-AC the following applies: Only Pinsp values that are at least 2 mbar above the set PEEP value can be set.

– – LeakV: 5 to 40ExpV: 5 to 50

LeakV: 5 to 40ExpV: 5 to 50

PEEP [mbar, cm H2O]

3 to 20 3 to 20 3 to 20 3 to 20 3 to 20

FiO23) [%]

3) Only with HPO O2 supply.

21 to 100 21 to 100 21 to 100 21 to 100 21 to 100

Trigger Off, Normal, Sensitiv.

Off, Normal, Sensitiv.

Off, Normal, Sensitiv.

Off, Normal, Sensitiv.

Normal, Sensitiv.

RR [/min] 5 to 50 5 to 50 5 to 50 5 to 50 –

Ti4) [s]or I:E

4) For VC-SIMV/PS and PC-BIPAP/PS the following applies: The maximum inspiratory time Timax for pressure-supported breaths is derived from Ti, see page 150.

0.3 to 81:39 to 2:1

0.3 to 81:39 to 2:1

0.3 to 81:39 to 2:1

0.3 to 81:39 to 2:1

Ramp Auto/0.1 to 2.0 Auto/0.1 to 2.0 Auto/0.1 to 2.0 Auto/0.1 to 2.0 Auto/0.1 to 2.0

Pmax5) [mbar, cm H2O]

5) For SPN-CPAP/PS (VG) the following applies: Only with activated apnea ventilation or activated Volume Guarantee VG.

LeakV: 5 to 40ExpV: 5 to 50

LeakV: 5 to 40ExpV: 5 to 50

– – LeakV: 5 to 40ExpV: 5 to 50

ΔPsupp6) [mbar, cm H2O]

6) For SPN-CPAP/PS the following applies: Only with deactivated Volume Guarantee VG. For PC-BIPAP and VC-SIMV the following applies: only with trigger activated

LeakV: 0 to 37ExpV: 0 to 47

– LeakV: 0 to 37ExpV: 0 to 47

– LeakV: 0 to 37ExpV: 0 to 47

Timax [s] – – – – 0.4 to 10.0

Apn.Vent. – – – – On, Off

RRapn7) [/min]

7) Only with apnea ventilation activated.

– – – – 5 to 50

VTapn7) [mL] – – – – 100 to 2000

VG – – – – On, Off

Aut.Adapt8)

8) Only in NIV application mode with Volume Guarantee VG deactivated.

– – – – On, Off

Tadpt 9) [min]

9) Only with Aut.Adapt function activated.

– – – – 5 to 120

PEEPadp9) [mbar, cm H2O]

– – – – 3 to 20

ΔPSadpt9) [mbar, cm H2O]

– – – – 0 to 37

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Instructions for use Carina SW 3.2n 69

Operation

Additional information

Configuring the display for Ti or I:E, see page 93.

Using non-invasive ventilation, see page 69.

Using apnea ventilation, see page 70.

Using AutoAdapt, see page 71.

Setting the alarm limits, see page 84.

Non-invasive ventilation (NIV)

This chapter describes the use of non-invasive ven-tilation in the NIV application mode.

All ventilation modes can be selected in the NIV ap-plication mode.

Safety Information

WARNING

Risk of patient injury

If a device fails, there is the risk of CO2 re-breathing.

Do not use masks that cover the entire face or the nose and mouth for patients who are unco-operative, partially conscious, apathetic or un-able to remove the mask.

WARNING

Risk of patient injury

Without ventilation there is a risk of CO2 re-breathing. If the device is not ventilating, the mask must not remain on the patient.

Instruct the patient on how to remove the mask.

WARNING

Risk of patient injury

When the inspiratory time is extended, the risk of CO2 rebreathing is increased. When the in-spiratory time is longer, the expiratory time is reduced, which means that less CO2 is re-moved from the breathing circuit before the next respiratory cycle. Under these conditions the volume of CO2 rebreathed by the patient is further increased with increased tidal volume.

Adjust the I:E ratio.

WARNING

Risk of patient injury

Use of masks increases the dead space. If the dead space is too high, the patient's etCO2 concentration may be increased.

Observe the mask manufacturer's instruc-tions.

WARNING

Risk of aspiration

Danger of aspiration due to high airway pres-sures.

Avoid high airway pressures.

NOTE

Masks with anti-asphyxia valve and exhalation ports (airflow masks) are not recommended for use with Carina. Use only masks with standard el-bows (not airflow masks). Otherwise the accuracy of the volume measurement may be impaired.

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Operation

70 Instructions for use Carina SW 3.2n

Using non-invasive ventilation

1 Select the NIV application mode. See "Select-ing the application mode" on page 62.

2 Select the ventilation mode and set the ventila-tion parameters. See "Setting ventilation" on page 67.

3 Set the alarm limits. See "Setting the alarm lim-its" on page 84.

Automatic leakage compensation of the trigger

The device automatically adjusts the trigger thresh-olds to the current leakage situation. An alarm is triggered if the patient leakage exceeds 60 L/min.

For more descriptions, see "Volume losses during ventilation" on page 144.

Flow reduction (Anti Air Shower)

The device reduces the inspiratory flow when the mask is removed. If inspiratory effort is detected or the mask is put on again, the ventilation will con-tinue with the previous settings.

To turn the function on and off, see chapter "Config-uring the flow reduction (Anti Air Shower)" on page 90.

Using apnea ventilation

Activating apnea ventilation

Prerequisites: – SPN-CPAP/PS ventilation mode is activated.– The Vent.set. menu is opened. – The apnea alarm time is set.

1 Press the (A) key twice. Menu 3 is set.

2 Press the Apn.Vent. (B) key. Select (F) On by turning the rotary knob and push to confirm.

3 Set RRapn (C) and VTapn (D) ventilation pa-rameters. See "Setting ventilation" on page 67.

Additional information

Setting the alarm limits, see page 84.

If apnea monitoring is switched off, there is no ap-nea ventilation. Switching off apnea monitoring, see page 84.

Description of apnea ventilation, see page 155.

12

2

ABC D

F

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Instructions for use Carina SW 3.2n 71

Operation

Switching off apnea ventilation 1 Press the (A) key twice. Menu 3 is set.

2 Press the Apn.Vent. (B) key. Select Off by turn-ing the rotary knob (C) and push to confirm.

The device ventilates with the previous ventilation parameters.

Using the AutoAdapt function

The AutoAdapt function is used to adjust mask-ventilated patients slowly to the therapeutic pres-sure level.

Activating AutoAdapt

Prerequisites: – NIV application mode is selected.– Volume Guarantee VG is deactivated.– SPN-CPAP/PS ventilation mode is activated.– The Vent.set. menu is opened.

1 Press the (A) key three times. Menu 4 is set.

2 Press the key for Aut.Adapt (B). Select On by turning the rotary knob (F) and push to confirm.

The AutoAdapt function is activated. The parame-ters of the AutoAdapt function are displayed:

– ΔPSadpt (C)

– PEEPadp (D)

– Tadpt (E)

3 Press the key of the corresponding parameter. Select the value by turning the rotary knob (F) and push to confirm.

The ventilation parameters can be modified at any time. AutoAdapt executes the initial adaptation with reference to the modified ventilation parameters.

12

2

AB

C

12

2

ABC D E

F

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Operation

72 Instructions for use Carina SW 3.2n

Canceling AutoAdapt

1 Press the (A) key three times. Menu 4 is set.

2 Press the key for Aut.Adapt (B). Select Off by turning the rotary knob (F) and push to confirm.

The device ventilates with the previous ventilation parameters.

Displaying setting and measured values

Prerequisite: Carina is in ventilation mode.

1 Press the Select Menu (A) key.

2 Press the Values (B) key.

The device shows the following on the screen:– Bar graph for pressure (C)– Set values (D)– Measured values (E)

Measured values depending on the valve in use

10

31

04

B

A

C

D E

Valve Volume measured values

LeakV MVi, VTi, MVleak1)

1) MVleak always shows the total leakage, consisting of pa-tient leakage and valve leakage.

ExpV MV, VT, - -2)

2) MVleak is always at - - because no leakage is measured and compensated.

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Instructions for use Carina SW 3.2n 73

Operation

Locking keys

All keys can be locked to prevent accidental actua-tion (except for the Audio paused 2 min. key).

1 Press the Select Menu (A) key.

2 Keep the Not Locked key (B) pressed until the following occurs:– An acoustic signal sounds 3 times.– The color of the key changes to red and

Locked is displayed.

The message Key lock activated is displayed in the alarm line.

Unlocking keys

Press the Locked key.

Low Pressure Oxygen (LPO)

Safety information for LPO

10

5

A

B

WARNING

Risk of infection and insufficient O2 supply

If the oxygen source is not suitable for direct supply to the patient, there is a risk of infec-tion and the LPO supply may fail.

Only connect oxygen sources that are ap-proved for medical use and that meet the fol-lowing conditions:– O2 flow: max. 10 L/min– O2 pressure: max. 0.5 bar (500 hPa or

7.25 psi)

WARNING

Risk of fire

Due to oxygen enrichment in the ambient air, the medical device can ignite.

Ensure sufficient ventilation at the rear of the device. Do not use any oxygen source that delivers a flow exceeding 10 L/min. If the device is not in ventilation mode, switch off the oxygen source, e.g., O2 concentrator.

WARNING

Risk of patient injury

Moist oxygen may affect the function of the device.

Only operate an O2 concentrator without hu-midifier. Drain or remove a humidity system on the O2 concentrator before use.

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Operation

74 Instructions for use Carina SW 3.2n

Observe the instructions for use of the oxygen source used, e.g., the O2 concentrator.

Connecting the O2 concentrator to Carina

1 Remove the protective cap (A) from the LPO connection (B).

2 Connect the O2 supply hose (C) to the LPO connection.

3 Connect the O2 supply hose to the oxygen source (D). Observe the instructions for use for the O2 concentrator.

WARNING

Missing O2 supply

Patients who require an increased O2 concen-tration are at risk in the event of failure of the oxygen source.

Make sure there is an emergency oxygen sup-ply, e.g., O2 from compressed gas cylinders.

CAUTION

Insufficient O2 supply

If the O2 supply is insufficient (e.g., because of a kinked LPO hose), the patient will not receive the increased O2 concentration from the LPO supply. In this case an alarm is not triggered.

In the case of patients who require an increased O2 concentration use external O2 monitoring.

WARNING

Risk of patient injury

The patient will be at risk if unapproved hose systems are used between the device and the oxygen supply.

Only use hoses approved for medical use and for use with oxygen.

NOTE

The automatic O2 mixing of the device does not operate in LPO mode. The O2 concentration can only be set by the following parameters:– For leakage valve: as a function of Pmean and

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

volume and LPO flow

NOTE

If O2 is supplied simultaneously from the central gas supply or gas cylinder and from the O2 con-centrator the LPO feed will be blocked.

02

2

A B

C

D

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Instructions for use Carina SW 3.2n 75

Operation

Setting LPO mode

Prerequisite: Carina is in standby mode.

1 Press the Select Menu (A) key.

2 Press the Config. (B) key.

3 Press the (C) key.

4 In menu 2 press the O2 suppl. (D) key.

5 Select LPO (E) by turning the rotary knob and push to confirm.

LPO is shown in the status line of the screen.

Setting the O2 concentration

Set the O2 flow at the O2 concentrator as di-rected by the doctor: max. 10 L/min at an O2 pressure of max. 0.5 bar (500 hPa or 7.25 psi).

In ventilation intervals stop the O2 feed to pre-vent escape of excess oxygen.

The O2 concentration reaching the patient is influ-enced by the following factors:– Breathing circuit in use– The O2 concentration delivered by the O2 con-

centrator used– Specified O2 flow at the O2 concentrator (LPO

flow)– Applied minute volume (MV)– Mean airway pressure Pmean

The O2 concentration for the patient at specified ventilation parameters is only set via the flow con-trol at the O2 concentrator. Use diagrams to esti-mate the flow control, see page 76.

The use of an external O2 monitor to measure the current O2 concentration simplifies the process of setting the O2 concentrator exactly to the desired O2 concentration.

10

6

A

CD B

F

E

1234

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Operation

76 Instructions for use Carina SW 3.2n

Diagram for operation with expiratory valve (MP00313)

Diagram for operation with leakage valve (MP00312)

07

90

78

Minute volume in L/min

FiO2 as a function of minute volume and LPO flow

2.5 L/min O2

5 L/min O2

10 L/min O2

Mean airway pressure in mbar (cm H2O)

FiO2 as a function of Pmean and LPO flow

2.5 L/min O2

5 L/min O2

10 L/min O2

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Instructions for use Carina SW 3.2n 77

Operation

Switching off the LPO supply

1 Switch Carina to standby mode.

2 Press the Select Menu (A) key.

3 Press the Config. (B) key.

4 Press the (C) key.

5 In menu 2 press the O2 suppl. (D) key.

6 Select HPO (E) by turning the rotary knob and push to confirm.

7 Disconnect the LPO gas supply.

8 Connect HPO supply if necessary.

Standby mode

If the standby mode is activated, ventilation is inter-rupted. Switch to standby mode for the following ac-tions:– Keeping Carina ready for operation while the

patient is absent– Changing the application mode– Performing a device check– Switching off Carina

Activating standby mode

1 Press the Start/Standby (A) key.

The message Confirm with rotary knob – Standby is displayed. A single tone sounds.

2 To confirm the standby mode, push the rotary knob (B).

Carina is in standby mode. The LED in the (A) key flashes. The message Standby activated and the alarm message Standby – Patient not ventilated are displayed on the screen.

10

6

A

CD B

F

E

NOTE

If an O2 flow greater than 10 L/min is supplied to the device, switch off the LPO mode. Reduce the O2 flow and switch on LPO mode again.

1234

WARNING

Risk of patient injury

Ventilation does not take place in standby mode. Patients connected to the device are endangered.

The device must only be set to standby mode when no patient is connected to the device.

03

4

AB

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Operation

78 Instructions for use Carina SW 3.2n

Continuing ventilation

1 Press the Start/Standby (A) key.

2 Check the ventilation settings of the patient. Change ventilation settings if required, see page 67.

For automatic continuation of ventilation with Auto wake-up, see page 63.

Ending operation

Prerequisite: Carina is in standby mode. Set the power switch (A) to . The device switches off.

The device cannot be switched off during ventila-tion. The device displays the Set standby to shut-off !! alarm message.

The internal battery is still charged when the device is switched off.

Taking the device out of service for an extended period

Taking the device out of service

1 Switch off the device.

2 Disconnect cables and hoses.

3 Dispose of single-use components and prepare new single-use components.

4 Clean and disinfect reusable components.

Storing the device

Store the device only with a fully charged internal battery and under permissible ambient conditions, see page 122.

02

7

A

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Instructions for use Carina SW 3.2n 79

Operation

Improving the display accuracy of the charge state of the internal battery

Inaccuracy is indicated when the message Battery indication not reliable ! is displayed on the screen.

Improving the display accuracy

1 Connect the power cable. The internal battery is charged, the LED flashes.

2 Charge the internal battery completely until the LED remains steady.

3 Disconnect the power cable and, if applicable, the cable from the external battery, from the de-vice. The LED is off. Connect the test lung and operate the device in a mandatory ventila-tion mode (VC-SIMV, PC-AC, or PC-BIPAP) un-til it switches automatically to standby mode. Do not interrupt the battery discharging proce-dure.

4 Leave the device in standby mode until it shuts down and the power supply failure alarm is gen-erated.

5 Set the power switch to .

6 Connect the power cable again. The internal battery is charged, the LED flashes. Charge the internal battery completely until the LED remains steady. Do not interrupt the charging process.

If there is no improvement, inform DrägerService.

NOTE

Incomplete charging and discharging cycles may lead to an incorrect display of the charge state of the internal battery.

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80 Instructions for use Carina SW 3.2n

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Instructions for use Carina SW 3.2n 81

Alarms

Alarms

Display of alarms . . . . . . . . . . . . . . . . . . . . . . 82

Visual alarm signals . . . . . . . . . . . . . . . . . . . . . 82Acoustic alarm signals . . . . . . . . . . . . . . . . . . . 82Alarm priorities . . . . . . . . . . . . . . . . . . . . . . . . . 83Confirming alarms . . . . . . . . . . . . . . . . . . . . . . 83

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

Opening the Alarms menu . . . . . . . . . . . . . . . . 84Alarm limits and setting ranges . . . . . . . . . . . . 84Switching off alarm limits . . . . . . . . . . . . . . . . . 85

Suppressing the acoustic alarm signal and the nurse call . . . . . . . . . . . . . . . . . . . . . . 86

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Alarms

82 Instructions for use Carina SW 3.2n

Display of alarms

Alarms are signaled optically and acoustically ac-cording to their alarm priority.

Visual alarm signals

Carina displays the following visual alarm signals:

– The alarm message is displayed in the alarm line (A), e.g.:

– The alarm LED Audio paused 2 min. flashes or lights depending on the alarm priority.

Acoustic alarm signals

The device generates different alarm signals for acoustic indication of alarms.

The acoustic alarm signal can be configured by ser-vice personnel and experts in the Service > Bi-omed menu.

Standard setting

Dräger setting

Failure of the acoustic alarm signal

If the loudspeaker for the acoustic alarm signal (main alarm) fails due to a defect, the alarm signals will be generated by the loudspeaker for the auxil-iary alarm.

Power supply failure alarm

If the power supply fails completely, the device gen-erates an alarm in the form of a continuous tone, see page 96.

21

2

Alarm prior-ity

Acoustic alarm signal

Repetition

High 2x 5 tones Every 13 seconds

Medium 3 tones Every 10 seconds

Low 1 tone No repetition

A Inlet filter missing !!

Alarm prior-ity

Acoustic alarm signal

Repetition

High 2x 5 tones Every 6 sec-onds

Medium 3 tones Every 6 sec-onds

Low 1 tone No repetition

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Instructions for use Carina SW 3.2n 83

Alarms

Alarm priorities

The background color of the alarm line indicates the priority of the active alarm. The priority of alarm messages is also displayed by exclamation marks.

The alarm with the highest priority is signaled vis-ually and acoustically.

For a list of causes and remedies, see "Alarm – Cause – Remedy" on page 97.

Confirming alarms

The following alarms must be confirmed:

– Airway pressure high !!!

– Check settings !!

– Invalid date !

To confirm, press the rotary knob.

Color of the alarm line

Priority of the alarm message Behavior of the alarm LED

Action required

Red back-ground color

Warning !!! Alarm with high prior-ity

Alarm LED flashes red

Immediate action re-quired to avert acute danger

Yellow back-ground color

Caution !! Alarm with medium priority

Alarm LED flashes yellow

Quick action required to avert danger

Blue back-ground color

Note ! Alarm with low prior-ity

Alarm LED lights yellow

Attention and action re-quired

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Alarms

84 Instructions for use Carina SW 3.2n

Setting the alarm limits

When the device is switched on, the most recently set alarm limits are always applied.

Opening the Alarms menu

1 Press the Select Menu (A) key.

2 Press the Alarms (B) key.

The device shows the defined alarm limits.

Alarm limits and setting ranges

In the following table, the alarm limits are listed with the setting ranges.

The set values for the alarm limits are retained even if the electrical power supply is interrupted.

To set the alarm limits

1 Touch the corresponding key for the alarm limit.

2 Set the value by turning the rotary knob and push to confirm.

WARNING

Risk of patient injury

If the alarm limits are not adapted to the pa-tient and the required therapy, the patient may be endangered.

Set the alarm limits accordingly.

CAUTION

Risk of patient injury due to incorrect settings

If several identical or similar devices are used in the same care area, the alarm limits of the devices can be configured differently and therefore be un-suitable for the current patient.

Check the alarm limits and adapt them to the cur-rent patient and the required therapy. Make sure that extreme or disabled alarm limits do not render the alarm system useless.

10

9

A

B2

13

(C) Upper alarm limit

(D) Current measured value

(E) Lower alarm limit

Alarm limit Setting range Factory set-ting

Paw 10 to 55 mbar 25 mbar

MV 2 to 60 L/min 15 L/min

MV 0.1 to 39 L/min 3 L/min

RR high 10 to 74/min, Off 20/min

Tapn 5 to 60 s, Off1)

1) If the Tapn alarm limit is set to Off, no apnea monitoring or apnea ventilation will be performed. Tapn can only be set to Off if the apnea ventilation has been switched off beforehand.

15 s

Tdiscon NIV: 0, 15, 30, 60, 90, 120 sTube: 0, 15, 30, 60 s

15 s

C

D

E

Paw MV RR high Tapn Tdiscon

ssmbar L/min /min

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Instructions for use Carina SW 3.2n 85

Alarms

Exceeding the setting limit

The device limits specific alarm limits to a setting limit.

1 Confirm the setting limit with the rotary knob.

Or

2 Set the parameter named in the message and confirm with the rotary knob.

The set limit can be exceeded.

Switching off alarm limits

The following alarm limits can be switched off:– RR high – Tapn

To switch off the alarm limit

1 Touch the corresponding key for the alarm limit.

2 Set the highest value that can be set by turning the rotary knob and push to confirm.

3 Turn the rotary knob further until Off is dis-played and push to confirm.

The alarm limit is switched off.

Carina displays the symbol (A) in the alarm line.

If an acoustic alarm signal is suppressed at the same time, the following symbols are displayed al-ternately:– Symbol indicating switched off alarm limits – Symbol indicating suppressed acoustic alarm

signals

WARNING

Risk of patient injury

When alarm limits are switched off, Carina cannot monitor the patient.

Alarm limits may only be switched off if the safety of the patient is not jeopardized by the absence of an alarm.

21

2A Standby activated

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Alarms

86 Instructions for use Carina SW 3.2n

Suppressing the acoustic alarm signal and the nurse call

The following actions are possible with the Audio paused 2 min. key:

– Suppressing the acoustic alarm signal for a maximum of 2 minutes

– Suppressing alarm generation by the nurse call for a maximum of 2 minutes

If an alarm with the same or higher priority arises during this time, the acoustic alarm signal sounds once. Alarm generation by the nurse call will not be activated.

If the cause of the alarm is not rectified after a max-imum of 2 minutes:– The acoustic alarm signal is initiated again.– Alarm generation by the nurse call is initiated

again.

Press the Audio paused 2 min. (A) key.

The acoustic alarm signal and alarm generation by the nurse call are suppressed for a maximum of 2 minutes.

The device displays the (B) symbol in the alarm line.

To reactivate the alarm signal and alarm generation by the nurse call before the suppression time has elapsed:

Press the Audio paused 2 min. (A) key again.

NOTE

For the Airway pressure low !!! alarm, the acoustic alarm signal and alarm generation by the nurse call can be suppressed for a maximum of 1 minute only.

05

72

12

A

B Inlet filter missing !!

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Instructions for use Carina SW 3.2n 87

Configuration

Configuration

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Opening the configuration menu . . . . . . . . . 88

Setting parameters . . . . . . . . . . . . . . . . . . . . . . 89

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

Opening the Service menu. . . . . . . . . . . . . . . . 89Displaying the system information . . . . . . . . . . 89Displaying the contact information . . . . . . . . . . 90Displaying the logbook . . . . . . . . . . . . . . . . . . . 90

Setting the alarm volume. . . . . . . . . . . . . . . . 91

Setting the acoustic alarm signal . . . . . . . . . 91

Selecting the screen display . . . . . . . . . . . . . 91

Screen display Curves . . . . . . . . . . . . . . . . . . . 92Measured values screen display . . . . . . . . . . . 92Configuring the display for measured values . . 92

Selecting the application mode. . . . . . . . . . . 93

Selecting the O2 supply . . . . . . . . . . . . . . . . . 93

Selecting Ti or I:E . . . . . . . . . . . . . . . . . . . . . . 93

Setting the night mode. . . . . . . . . . . . . . . . . . 94

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Configuration

88 Instructions for use Carina SW 3.2n

Overview

The following settings can be made in the Config. menu:– Service

– System time– Language– MEDIBUS protocol– Flow reduction (Anti Air Shower)

– Alarm volume– Screen display of waveforms and measured

values– Setting of measured value display– O2 supply with LPO mode or HPO mode

– Selection between non-invasive ventilation (NIV) and invasive ventilation (Tube)

– Selection of setting of Ti or I:E– Night mode On/Off

Settings made in the Config. menu are retained when the device is switched off.

The following information about the device can be called in the Config. menu under Service:– System information– Information on contacting DrägerService– Logbook for technical alarm messages

Opening the configuration menu

1 Press the Select Menu (A) key.

2 Press the Config. (B) key.

The configuration menu shows the configurable functions and parameters.

To display additional configurable parameters:

3 Press the (C) key.

110

A

B C

1234

Menu 1 Service For system information, con-tact information, logbookadditional settings

Volume Alarm volume adjustable from 1 to 5

Screen For selection of the display of waveforms or values

Menu 2 Set value

For selection of the meas-ured values for the display of Value 1 and Value 2

Method For selection of non-invasive ventilation or invasive venti-lation

O2 suppl.

For selection of the O2 sup-ply with LPO or HPO

Ti / I:E For selection of the used set-ting for Ti or I:E ratio

Menu 3 Night For switching night mode on or off

1234

1234

1234

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Instructions for use Carina SW 3.2n 89

Configuration

Setting parameters

1 Press the key for the function or parameter.

2 Set the value by turning the rotary knob and push to confirm.

Service menu

The Service menu is protected by a password.

The password can only be changed by DrägerService. A forgotten password can be re-stored by DrägerService. The factory default pass-word is 1, 2, 3, 4, 5.

Opening the Service menu

Prerequisite: The Config. menu is opened.

1 Press the Service key.

2 Press 1, 2, 3, 4, 5 in succession.

3 Push the rotary knob. The password is con-firmed.

Carina shows the functions of the service menu:

– Syst.info (system information)– For display of device data– For setting the system time– For setting the current language

– Contact to display contact information for the customer

– Logbook to display technical alarm messages

Displaying the system information

Prerequisite: The Service menu is opened.

Press the Syst.info key.

The following system information is displayed:– Serial number– Software version

– Hardware version– Operating hours

– Ventilation– Standby– Turbine– Cooling

– System time– Language– Operating voltages– Next service date– MEDIBUS protocol– Flow reduction (Anti Air Shower)

Setting the system time

The system time can only be set in standby mode.

After opening the system information menu, the current system time is shown in white.

Positions of system time:– year-month-day– hours:minutes:seconds

Push the rotary knob to highlight the first posi-tion (year). Set the year by turning the rotary knob and push to confirm. The next position is highlighted.

Set all other positions. The system time is up-dated when the last position (seconds) has been confirmed.

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Configuration

90 Instructions for use Carina SW 3.2n

Setting the language

The language can only be set in standby mode.

Select the line Language by turning the rotary knob and push to confirm.

Select the desired language by turning the ro-tary knob and push to confirm.

Setting the software protocol

The software protocol for data transfer can only be set in standby mode.

Select the line Protocol with the rotary knob.

Set MEDIBUS or MEDIBUS.X by turning the ro-tary knob and push to confirm.

Configuring the flow reduction (Anti Air Shower)

The function can only be set in standby mode.

Select the line Anti Air Shower by turning the rotary knob and push to confirm.

Set On or Off by turning the rotary knob and push to confirm.

Displaying the contact information

Prerequisite: The Service menu is open.

Press the Contact key.

The following information for contacting DrägerService is displayed:– Organization– Telephone number– Customer ID– City

Displaying the logbook

Prerequisite: The Service menu is open.

Press the Logbook key.

The logbook shows the technical alarms as infor-mation for the service. Technical alarm messages are only available in English. Only the technical alarms from the last 48 hours are displayed on the device. The complete logbook can be downloaded or reviewed by specialized service personnel.

Once there are more than approx. 500 logbook en-tries, the oldest entries will be overwritten.

The entries in the logbook are preserved even after the device is switched off and on again, and after a power failure of any duration.

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Instructions for use Carina SW 3.2n 91

Configuration

Setting the alarm volume

The minimum alarm volume can be configured by service personnel and experts in the Service > Bi-omed menu.

Prerequisite: The Config. menu is opened.

1 Press the Volume key.

2 Set the value from 1 to 5 by turning the rotary knob and push to confirm.

The specific alarm volume is set.

Setting the acoustic alarm signal

The acoustic alarm signal (Standard or Dräger) can be configured by service personnel and experts in the Service > Biomed menu.

Selecting the screen display

Prerequisite: The Config. menu is opened.

1 Press the Screen key.

2 Select Curves or Measure by turning the rotary knob and push to confirm.

The current setting is shown in the Screen key.

WARNING

Failure to hear alarm signals in a noisy envi-ronment

Alarm situations will not be noticed.

Set the volume of alarm signals so that they can be perceived.

NOTE

When setting the alarm volume (Volume), the user will no longer be able to set the level below the minimum volume set in the Service > Biomed menu.

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Configuration

92 Instructions for use Carina SW 3.2n

Screen display Curves

A Flow waveform in real time

B Pressure waveform in real time

C Value 1 field, configurable measured-value dis-play

D Value 2 field, configurable measured-value dis-play

Measured values screen display

A Pressure waveform as bar graph

B 4 Fields for measured values:– MVi (MV)– VTi (VT)

– RR– PIP

C Value 1 field, configurable measured-value dis-play

D Value 2 field, configurable measured-value dis-play

Configuring the display for measured values

The following measured values can be selected for the Value 1 and Value 2 fields:– Off (no display of a measured value)– PIP– VTi (VT)– RR– PEEP– MVi (MV)– MVleak– Pmean– Tadpt

It is not possible to select the same measured val-ues for Value 1 and Value 2.

Selecting measured values

Prerequisite: The Config. menu is opened.

1 Press the key.

2 In menu 2 press the Set value button.

3 Press the Value 1 key.

4 Select the measured value by turning the rotary knob and push to confirm.

5 Select the measured value for Value 2 in the same way.

112

111

A

B

C D

A

B

BB

C D

B

1234

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Instructions for use Carina SW 3.2n 93

Configuration

Selecting the application mode

The application mode can only be selected in standby mode. The NIV application mode can only be selected if LeakV is displayed in the status line on the screen.

Prerequisite: The Config. menu is opened.

1 Press the key.

2 In menu 2 press the Method key.

3 Select NIV or Tube by turning the rotary knob and push to confirm.

The selected application mode is displayed in the status line of the screen.

Selecting the O2 supply

The O2 supply can only be set in standby mode.

Prerequisite: The Config. menu is opened.

1 Press the key.

2 In menu 2 press the O2 suppl. key.

3 Select LPO or HPO by turning the rotary knob and push to confirm.

If LPO has been selected, LPO is displayed in the status line on the screen.

Selecting Ti or I:E

Prerequisite: The Config. menu is opened.

1 Press the key.

2 In menu 2 press the Ti / I:E key.

3 Select Ti or I:E by turning the rotary knob and push to confirm.

1234

1234

1234

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Configuration

94 Instructions for use Carina SW 3.2n

Setting the night mode

Prerequisite: The Config. menu is opened.

1 Press the key twice.

2 In menu 3 press the Night key.

3 Select On by turning the rotary knob and push to confirm.

If the device is not actuated when night mode is set and no alarm is displayed, the screen switches off after 130 seconds. If the device is actuated or an alarm is active, the screen is switched on immedi-ately.

To switch off

Select Off by turning the rotary knob and push to confirm.

1234

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Instructions for use Carina SW 3.2n 95

Problem solving

Problem solving

Failure of the power supply. . . . . . . . . . . . . . 96

Failure of the gas supply . . . . . . . . . . . . . . . . 96

Alarm – Cause – Remedy. . . . . . . . . . . . . . . . 97

Additional messages on the screen . . . . . . . . . 103

Emergency ventilation . . . . . . . . . . . . . . . . . . 103

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Problem solving

96 Instructions for use Carina SW 3.2n

Failure of the power supply

If the external power supply fails (mains power sup-ply or external battery), the device automatically switches to the internal battery power supply. If the battery is fully charged, the device can continue to operate for about 60 minutes.

If the power supply fails completely, the device trig-gers a power supply failure alarm (continuous tone). The ventilation settings and the alarm limits remain saved even in the event of a power supply failure.

Restore the power supply immediately, see page 48.

Or:

Disconnect the patient from the device and im-mediately resume ventilation using another, in-dependent ventilator.

Failure of the gas supply

If the O2 supply fails, the device replaces the miss-ing O2 portion with ambient air and generates an alarm. The minute volume remains constant. The inspiratory O2 concentration falls to 21 Vol%.

If the patient requires a higher O2 concentration:

Restore the O2 supply immediately.

If the turbine fails:

The device can no longer ventilate.

Disconnect the patient from the device and im-mediately resume ventilation using another, in-dependent ventilator.

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Instructions for use Carina SW 3.2n 97

Problem solving

Alarm – Cause – Remedy

The alarm messages are displayed in the alarm line of the screen as long as the alarm is active.

If multiple faults occur simultaneously, the highest priority alarm is displayed.

The priority of the alarm messages is marked by dif-ferent background colors and with exclamation marks after the alarm message. See chapter "Alarm priorities" on page 83.

The alarm classifications by internal priority num-bers are listed in the following table. The most criti-cal alarm is assigned the number 5. As the num-bers get higher, the priority of the alarms is reduced.

In the following table, the alarm messages are listed in alphabetical order. If an alarm occurs, the table helps to identify causes and remedies. The different causes and remedies should be worked through in the order listed until the alarm has been resolved.

Alarm texts in parentheses indicate technical alarms that are entered in the logbook. The entries for technical alarms in the logbook are only availa-ble in English.

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Problem solving

98 Instructions for use Carina SW 3.2n

Alarm message Internal priority number

Cause Remedy

Airway pressure high !!! 200 The overpressure alarm may be triggered by sustained coughing.

Confirm the alarm message by pressing the rotary knob. Check patient condition, check breathing pattern, correct alarm limit if necessary.

Airway pressure low !!! 202 This fault is only reported af-ter the defined time Tdiscon.A connection is disconnected in the breathing circuit. Venti-lation is not possible.

Restore correct seating of mask, hoses, filters, and other components.

Apnea !!! 207 No spontaneous breathing by patient

Check the patient’s condition. Use controlled ventilation, if re-quired.

Stenosis Check tube. Check the breath-ing circuit.

Apnea Ventilation ! 456 The device has detected a respiratory arrest in the SPN-CPAP/PS or SPN-CPAP mode and is applying con-trolled apnea ventilation ac-cording to the settings until spontaneous breathing re-starts.

Apply controlled ventilation or extend apnea alarm time Tapn.

Auto reset !!!

(Auto reset !!!)

5 to 60 Internal system malfunction The device restarts. Ventilation is continued. After 3 attempts the device stops ventilation. Disconnect the patient from the device and immediately re-sume ventilation using an-other, independent ventilator.

Inform DrägerService.

AutoAdapt active ! 507 AutoAdapt function is active. If it is not required, switch off the function. Otherwise wait for the Tadpt time.

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Instructions for use Carina SW 3.2n 99

Problem solving

Breath. circuit incorrect !!! 270 Breathing circuit without leak-age valve connected, al-though Carina is set to "breathing circuit with leak-age valve".

Connect breathing circuit with leakage valve or set Carina to "breathing circuit with expira-tory valve" with the switch on the bottom.

The leakage valve is partially or completely blocked.

Connect new breathing circuit with leakage valve or replace leakage valve.

Check settings !!

(Check settings !!)

318 Loss of saved settings. The device is operating with the default settings.

Confirm the alarm message by pressing the rotary knob. Use a substitute device. Inform DrägerService.

Continuous Paw high !!! 95 Expiratory valve blocked or breathing circuit kinked.

Check expiratory valve and breathing circuit.

Continuous Paw low !!! 243 Air feed blocked. High leak-age in breathing circuit or pa-tient disconnected.

Make sure air feed is free. With free air feed: check mask, hoses, filters, and other com-ponents for blockages and leakages.

Device malfunction Use a substitute device. Inform DrägerService.

Device failure !!!

(Device failure !!!)

45 to 70 The device has detected a technical problem. Ventilation has failed.

Disconnect the patient from the device and immediately re-sume ventilation using an-other, independent ventilator.

Inform DrägerService.

Disconnection / Leakage ! 450 Disconnection of breathing hose or high leakage de-tected. After the disconnec-tion alarm the device delivers a constant flow (if the Anti Air Shower function is switched on). After repair of the leak-age, the device automatically continues to operate with the previous ventilation settings.

Check mask, filters, and other components for leakages and loose connections.

Alarm message Internal priority number

Cause Remedy

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Problem solving

100 Instructions for use Carina SW 3.2n

External power failure !! 420 The device has no external power supply.

Check mains power supply or external battery.

Failure of mains power supply Connect external battery.

The external battery is flat. Connect the mains power sup-ply. Charge the external bat-tery.

HPO supply insufficient !!! 214 HPO supply faulty or not available.

Check O2 compressed gas supply.

Inlet filter missing !! 430 Inlet filter has been removed or is incorrectly installed.

Insert inlet filter. Check that the inlet filter is correctly installed.

Insp. temperature high !!!

(Insp. temperature high !!!)

235 Breathing gas temperature above 40 °C

Ensure free air feed at inlet fil-ter. Remove blockages from breathing circuit and breathing circuit connections (foreign bodies, kinked hoses). Lower the ambient temperature.

Int. battery activated ! 457 Device is being powered by the internal battery due to the absence of mains supply or a discharged external battery.

Restore mains power supply or power supply by charged external battery.

Int. battery empty !!! 76 The operating time with power supply from the inter-nal battery has elapsed. The device switches to standby mode.

Restore mains power supply or power supply by charged external battery immediately.

Int. battery low ! 454 Battery charge has fallen be-low 50 %.

Restore mains power supply or power supply by charged external battery.

Int. battery low !!! 225 Battery charge has fallen be-low 30 %.

Restore mains power supply or power supply by charged external battery.

Int. temperature high !!!

(Int. temperature high !!!)

143 The device has overheated for external reasons.

Ensure free air feed at inlet fil-ter. Remove blockages from breathing circuit and breathing circuit connections (foreign bodies, kinked hoses). Lower the ambient temperature.

Alarm message Internal priority number

Cause Remedy

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Instructions for use Carina SW 3.2n 101

Problem solving

Invalid date ! 460 The date setting is incorrect. Confirm the alarm message by pressing the rotary knob. Cor-rect date. Inform DrägerService.

Key overused !!!

(Key overused !!!)

175 Key pressed too often. Check the function of the keys.

Large leakage ! 452 The breathing circuit or mask is leaking. Note: Only dis-played after the 3rd breath.

Check mask, filters, and other components for leakages and loose connections.

Leakage valve blocked !!! 265 Low flow because of deposits in leakage valve, Risk of CO2 rebreathing.

Replace leakage valve.

LPO pressure high !! 410 LPO is set although O2 com-pressed gas supply (HPO) is connected.

Disconnect O2 compressed gas supply (HPO) or set HPO.

MEDIBUS !

(MEDIBUS !)

462 An unexpectedly large amount of data is being re-ceived over the RS232 COM port.

Check the external device on the RS232 COM port.

MV high !! 414 The upper alarm limit of the minute volume has been ex-ceeded.

Check patient condition, check breathing pattern, correct alarm limit if necessary.

Leakage in breathing system Make sure that the breathing system is leakage-free.

Device malfunction Disconnect the patient from the device and immediately re-sume ventilation using an-other, independent ventilator. Inform DrägerService.

MV low !!! 209 The lower alarm limit of the minute volume has been ex-ceeded.

Check patient condition, check breathing pattern, correct alarm limit if necessary.

Device malfunction Disconnect the patient from the device and immediately re-sume ventilation using an-other, independent ventilator. Inform DrägerService.

O2 calibration failed !

(O2 calibration failed !)

458 Calibration of O2 dosing is faulty.

Inform DrägerService.

Alarm message Internal priority number

Cause Remedy

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Problem solving

102 Instructions for use Carina SW 3.2n

Pilot line disconnected !!! 205 A connection of the pilot line is disconnected. (Breathing circuit with expiratory valve only.) Ventilation function is faulty.

Make sure that the pilot line is tightly connected at both ends.

Rescue ventilation !!!

(Rescue ventilation !!!)

80 to 93 The device has a technical problem and switches to emergency mode. Ventilation is not optimum.

Ensure free air feed at inlet fil-ter. Remove blockages from breathing circuit and breathing circuit connections (foreign bodies, kinked hoses).

Use a substitute device. Inform DrägerService.

RR high !!! 260 Patient is breathing at a high rate. The alarm limit of the respiratory rate has been ex-ceeded.

Check patient condition, check breathing pattern, correct alarm limit if necessary.

Set standby to shut-off !! 425 Illegal attempt to switch off the device at the power switch during ventilation.

Terminate ventilation first, then switch off the device.

Technical alarm !!!

(Technical alarm !!!)

95 to 290 The device has a technical problem, e.g., breathing gas temperature sensor faulty.

Use substitute device.

If the device cannot be switched off, disconnect the O2 compressed gas hose from the central supply and then switch off the device. Inform DrägerService.

Technical alarm !!

(Technical alarm !!)

300 to 390 The device has a technical problem. This alarm has no influence on the ventilation function, e.g., faulty key.

Use a substitute device. Inform DrägerService.

VT not reached, Pmax ! 455 The measured VT is lower than the defined VT and the maximum allowable pressure is reached.

Check setting of Pmax and VT.

Alarm message Internal priority number

Cause Remedy

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Instructions for use Carina SW 3.2n 103

Problem solving

Additional messages on the screen

Emergency ventilation

In the event of a technical fault, e.g., a pressure sensor fault, the device switches to emergency ventilation at 21 Vol% FiO2. The turbine maintains controlled ventilation at the required ventilation pressure even in the event of sensor faults.

Emergency ventilation is a pressure-controlled ven-tilation with reduced quality. The trigger function is deactivated. Volume Guarantee is no longer avail-able. Functions are not monitored.

Message Cause Remedy

Battery indication not relia-ble !

Battery display is inaccurate. Improve the accuracy, see page 79.

If there is no improvement, inform DrägerService.

Standby activated The device is in standby mode, there is no ventilation.

Start ventilation: Press the Start/Standby key.

Key lock activated Locked function is active. Press the Locked key again.

WARNING

Risk of patient injury

If a fault is detected in the medical device, its life-support functions may no longer be as-sured.

Ventilation of the patient using an independ-ent ventilation device must be started without delay, if necessary with PEEP and/or an in-creased inspiratory O2 concentration e.g., with a manual resuscitator).

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Reprocessing

Reprocessing

Dismantling . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Before dismantling . . . . . . . . . . . . . . . . . . . . . . 106Removing breathing hoses. . . . . . . . . . . . . . . . 106Dismantling accessories. . . . . . . . . . . . . . . . . . 106

Information on reprocessing. . . . . . . . . . . . . 107

Information on disinfectants . . . . . . . . . . . . . . . 107Safety Information . . . . . . . . . . . . . . . . . . . . . . 107

Classifications for reprocessing. . . . . . . . . . 108

Classification of medical devices . . . . . . . . . . . 108Classification of the device-specific components . . . . . . . . . . . . . . . . . . . . . . . . . . . 108

Validated reprocessing procedures . . . . . . . 109

Reprocessing non-critical components . . . . 109

Surface disinfection with cleaning . . . . . . . . . . 109

Reprocessing semi-critical components . . . 110

Machine cleaning with thermal disinfection . . . 110Steam sterilization . . . . . . . . . . . . . . . . . . . . . . 110Special reprocessing measures . . . . . . . . . . . . 110

After reprocessing . . . . . . . . . . . . . . . . . . . . . 110

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Reprocessing

106 Instructions for use Carina SW 3.2n

Dismantling

Before dismantling

1 Switch off the device and any additional devices and disconnect their power plugs.

2 Drain the water traps and breathing hoses.

3 Drain the water container of the breathing gas humidifier.

Removing breathing hoses

1 Remove the expiratory valve or leakage valve as required. Remove the pilot line of the expira-tory valve.

2 Remove the breathing hoses. Drain conden-sate from the breathing hoses.

3 If fitted: Pull the water trap from the breathing hoses.

4 Pull the water trap container from the water trap. Drain the water trap.

5 Pull the bacterial filter from the inspiratory port.

Dispose of disposable products and reprocess reusable breathing hoses in accordance with the corresponding instructions for use.

Dismantling accessories

Dismantle and reprocess the breathing gas hu-midifier and the medication nebulizer in accord-ance with the corresponding instructions for use.

Dismantle and dispose of the bacterial filter and HME in accordance with the corresponding in-structions for use.

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Reprocessing

Information on reprocessing

The instructions for reprocessing meet the require-ments of ISO17664:2004.

Information on disinfectants

Use disinfectants that are nationally approved and are suitable for the particular reprocessing procedure.

Safety Information

WARNING

Risk of infection

Reusable products must be reprocessed, oth-erwise there is an increased risk of infection and their correct functioning may be impaired.– Observe the hospital hygiene regulations.– Use validated procedures for reprocess-

ing.– Reprocess reusable products after every

use.– Follow the manufacturers' instructions for

cleaning agents and disinfectants.

CAUTION

Risk of defective products

Signs of wear may appear on reusable products, e.g., cracks, deformations, discoloration or peel-ing.

Check the products for signs of wear and replace them if necessary.

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Reprocessing

108 Instructions for use Carina SW 3.2n

Classifications for reprocessing

Classification of medical devices

Medical devices and their components are classi-fied according to the type of application and the risk resulting from it.

Classification of the device-specific components

Observe the instructions for use for the compo-nents.

Non-critical

– Carina basic device– Trolley with accessories– O2 supply hose– Hinged arm– Bed and wall mountings

Semi-critical B

– Reusable water trap

Classification Definition

Non-critical Components that merely come into contact with intact skin.

Semi-critical Components that carry breathing gas or come into contact with mucous mem-branes or pathologically altered skin.

Semi-critical A No special requirements regarding reprocessing

Semi-critical B Increased requirements regarding reprocessing

Critical Components that penetrate skin or mucous membranes, or come into contact with blood

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Instructions for use Carina SW 3.2n 109

Reprocessing

Validated reprocessing procedures

The suitable reprocessing procedures result from the classification.

The effectiveness of the reprocessing procedures listed has been validated by independent laborato-ries which are certified to ISO 17025.

At the time of validation, the following reprocessing procedures were effective and compatible with the materials used.

Reprocessing non-critical components

Surface disinfection with cleaning 1 Remove soiling immediately. To remove, use a cloth moistened with disinfectant.

2 Perform surface disinfection.

3 After the contact time has elapsed, remove dis-infectant residue.

4 Check the product for visible contamination. Repeat steps 1 to 4 as required.

5 Check product for visible damage and replace it if necessary.

Classification Procedure Agent Manufac-turer

Concen-tration

Contact time

Tempera-ture

Non-critical Surface disinfection with cleaning

Virex TB Diversey Dosing and contact time as specified by manufacturer

Semi-critical A and B

Machine cleaning

followed by thermal disinfection

Neodisher MediClean

Dr. Weigert Dosing and contact time as specified by manufacturer

– – – 10 min 93 °C (199.4 °F)

Steam sterilization – – – 5 min 134 °C (273.2 °F)

WARNING

Risk from penetrating liquid

Penetrating liquid my cause the following:– Damage to the device– Electric shock at switch-on– Device malfunctions

Make sure that no liquid penetrates into the device.

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Reprocessing

110 Instructions for use Carina SW 3.2n

Reprocessing semi-critical components

For medical devices and components that are clas-sified as semi-critical B, the following procedure has been selected:

– Machine cleaning with thermal disinfection

Steam sterilization can be performed in addition.

Special measures must be carried out on medical devices and components that are classified as semi-critical B. Further information can be found in section "Special reprocessing measures" on page 110.

Machine cleaning with thermal disinfec-tion

Use a washer-disinfector that meets the require-ments of EN ISO 15883. Dräger recommends the use of a cart for anesthesia accessories and venti-lation accessories. Observe instructions for use of the washer-disinfector.

1 Position the product securely in the basket. En-sure the following:– All surfaces and interior spaces can be com-

pletely flushed.– The water can drain off freely.

2 Use suitable cleaning agent.

3 Select a suitable program.

4 Use demineralized water for the final rinsing.

5 After the cycle has ended, check the product for visible soiling. If necessary, repeat the cycle or perform manual cleaning and disinfection by im-mersion.

6 Check product for visible damage and replace it if necessary.

7 Allow the product to dry completely.

Steam sterilization

Use a steam sterilizer that meets the requirements of DIN EN 285. Dräger recommends steam sterili-zation with fractionated vacuum.

Prerequisite: The product is cleaned and disin-fected.

1 Sterilize the product.

2 Check product for visible damage and replace it if necessary.

Special reprocessing measures

Water traps

Keep spring-loaded valves open during reprocess-ing.

After reprocessing

Preparations before reusing

Assemble and prepare the device for operation, see chapter "Assembly and preparation".

Check readiness for operation, see chapter "Getting started".

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Instructions for use Carina SW 3.2n 111

Maintenance

Maintenance

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Definition of maintenance concepts . . . . . . . . . 112

Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Safety checks . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Preventive maintenance . . . . . . . . . . . . . . . . 114

Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

Replacing the inlet filter. . . . . . . . . . . . . . . . . 115

Charging the internal battery . . . . . . . . . . . . 115

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Maintenance

112 Instructions for use Carina SW 3.2n

Overview

This chapter describes the maintenance measures required to maintain the proper functioning of the medical device. Maintenance measures must be performed by the personnel responsible.

Only carry out maintenance work when no patient is connected to the device.

Definition of maintenance concepts

CAUTION

Risk of infection

Users and service personnel can become in-fected with pathogenic germs.

Disinfect and clean device or device parts before any maintenance measures and also before re-turning the medical device for repair.

WARNING

Risk of electric shock

Current-carrying components are located un-der the cover.– Do not remove the cover.– Maintenance measures must be performed

by the personnel responsible. Dräger rec-ommends DrägerService to perform these measures.

CAUTION

Risk of electric shock

The batteries must be replaced by specialized service personnel.

Concept Definition

Maintenance All measures (inspection, preventive maintenance, repair) intended to maintain and restore the functional condition of a medical device

Inspection Measures intended to determine and assess the actual state of a medical device

Preventive mainte-nance

Recurrent specified measures intended to maintain the functional condition of a medical device

Repair Measures intended to restore the functional condition of a medical device after a device malfunction

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Instructions for use Carina SW 3.2n 113

Maintenance

Inspection

Perform inspections at regular intervals and ob-serve the following specifications.

Safety checks

Safety checks are no substitute for preventive maintenance measures (including preventive re-placement of wear parts) as identified by the man-ufacturer.

1 Check accompanying documents:– Instructions for use are available

2 Perform a functional test of the following fea-tures according to the instructions for use:– Readiness for operation– Checking the function of accessories

3 Check that the device combination is in good condition:– All labels are complete and legible– There is no visible damage

4 Using the instructions for use, check that all components and accessories needed to use the product are available.

5 Check the electrical safety according to IEC 62353.

6 Check safety features:– Correct functioning of the pneumatic safety

valve (overpressure): Pressure 55 to 66 mbar (or hPa or cm H2O)

– Correct functioning of the emergency breathing valve (underpressure): Opening pressure –5 to 0 mbar (or hPa or cm H2O)

– Correct functioning of the External power failure !! alarm

7 Check the functions:– Leakage– O2 delivery– Condition of the ELCO printed circuit board

Checks Interval Personnel responsible

Inspection Every 12 months Service personnel

Safety checks Every 12 months Service personnel

CAUTION

Risk of medical device failure

If safety checks are not performed on a regular basis, the proper operation of the medical device can be compromised.

Perform safety checks at the indicated intervals.

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Maintenance

114 Instructions for use Carina SW 3.2n

Preventive maintenance

The following table shows the preventive mainte-nance intervals:

Repair

Dräger recommends that all repairs are carried out by DrägerService and that only authentic Dräger repair parts are used.

WARNING

Risk of faulty components

Device failure is possible due to wear or mate-rial fatigue of the components.

To maintain the proper operation of all compo-nents, this device must undergo inspection and preventive maintenance at specified inter-vals.

Component Interval Measure Personnel responsi-ble

Inlet filter (HEPA filter) Every 6 months or as specified by hospital regulations

Replace, see page 115 Users

Internal battery (NiMH battery)

Every 3 years Replace Specialized service personnel

Interior of device Every 3 years Visual inspection, clean and replace affected parts if nec-essary

Specialized service personnel

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Instructions for use Carina SW 3.2n 115

Maintenance

Replacing the inlet filter

When the inlet filter is removed, the alarm message Inlet filter missing !! is displayed.

1 Unlock the inlet filter (A), fold it down and re-move it from the holder (B).

Disposal see page 119.

2 Remove the new inlet filter from the packaging.

3 Insert the inlet filter (A) into the holder from be-low, fold it up and push it into the holder (B) until it locks into position.

Charging the internal battery

The internal battery has no memory effect, but will lose capacity due to self-discharge. With an exter-nal power supply (mains power or external battery), the internal battery is automatically recharged at regular intervals.

Charge regularly depending on the ambient tem-perature:– at –20 to +35 °C every 3 months – at +35 to +55 °C once a month

WARNING

Risk of infection

Do not operate the device without the inlet fil-ter.

03

0A

B

02

3

A

B

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Disposal

Disposal

Safety information for disposal. . . . . . . . . . . 118

Disposal of packaging material. . . . . . . . . . . 118

Disposal of batteries . . . . . . . . . . . . . . . . . . . 118

Disposal of inlet filters . . . . . . . . . . . . . . . . . . 119

Disposal of the Medical Device . . . . . . . . . . . 119

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Disposal

118 Instructions for use Carina SW 3.2n

Safety information for disposal

For countries subject to EU Directive 2002/96/EC

This device is subject to EU Directive 2002/96/EC (WEEE). In order to comply with its registration ac-cording to this directive, this device may not be dis-

posed of at municipal collection points for waste electrical and electronic equipment. Dräger has au-thorized a company to collect and dispose of this device. To initiate collection or for further informa-tion, visit Dräger on the Internet at www.drae-ger.com. Use the Search function with the keyword "WEEE" to find the relevant information. If access to Dräger's website is not possible, contact the local Dräger Organization.

Disposal of packaging material

Dispose of the packaging material of the device and the accessories listed in the list of accessories in accordance with the applicable laws and regula-tions.

Disposal of batteries

The medical device contains batteries with toxic substances. In the Federal Republic of Germany: The user is obliged by the ordinance on the return and disposal of used batteries to return batteries which contain toxic substances either to the manufacturer/sales outlet or to a collection center operated by public waste disposal corporations. The battery contained in the device must therefore be removed by spe-cialized service personnel before disposing of the device. In countries other than the Federal Repub-lic of Germany, the respective national regulations must be observed.

CAUTION

Risk of infection

The device and its components must be disin-fected and cleaned before disposal.

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Disposal

Disposal of inlet filters

Dispose of filters with municipal waste.

Disposal of the Medical Device

At the end of its service life:

Consult the relevant waste disposal company for appropriate disposal.

Observe the applicable laws and regulations.

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Technical data

Technical data

Ambient conditions . . . . . . . . . . . . . . . . . . . . 122

Setting values . . . . . . . . . . . . . . . . . . . . . . . . . 122

Performance characteristics . . . . . . . . . . . . . 124

Displayed measured values . . . . . . . . . . . . . 127

Monitoring functions . . . . . . . . . . . . . . . . . . . 129

Operating data characteristics . . . . . . . . . . . 130

Factory-set ventilation parameters . . . . . . . . 133

Settings for typical ventilation. . . . . . . . . . . . . . 133

Trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Alarm system of Carina . . . . . . . . . . . . . . . . . 135

Alarm delays . . . . . . . . . . . . . . . . . . . . . . . . . . 136

EMC declaration . . . . . . . . . . . . . . . . . . . . . . . 137

General information . . . . . . . . . . . . . . . . . . . . . 137Electromagnetic environment . . . . . . . . . . . . . . 137Electromagnetic immunity . . . . . . . . . . . . . . . . 137Recommended separation distances from mobile high-frequency communication equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Connections to IT networks . . . . . . . . . . . . . 139

Information on connecting to the IT network . . 139

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Technical data

122 Instructions for use Carina SW 3.2n

Ambient conditions

During operation

Temperature 5 to 35 °C (41 to 95 °F)

Ambient pressure 900 to 1100 hPa (13.1 to 16 psi)From 700 to 900 hPa (10.2 to 13.1 psi), reduced functionality in terms of maximum flow and pres-sure delivery

Relative humidity 5 to 95 %, non-condensing

Altitude Max. 3000 m (9842 ft)

During storage and transport

Temperature (up to 1 day) –20 to 60 °C (–4 to 140 °F)

Temperature (up to 1 month) –20 to 55 °C (–4 to 131 °F)

Temperature (up to 3 months) –20 to 35 °C (–4 to 95 °F)

Ambient pressure 500 to 1100 hPa (7.3 to 16 psi)

Relative humidity 5 to 95 %, non-condensing

The ambient conditions may be further restricted, depending on the accessories used. Observe cor-responding instructions for use.

Setting values

Ventilation systems Breathing circuit with leakage valveBreathing circuit with controlled expiratory valve

Ventilation modes VC-SIMV, VC-AC, PC-BIPAP, PC-AC, SPN-CPAP/PS (VG)

Tidal volume VT

Range 100 to 2000 mL, BTPS

Resolution 10 mL

Positive end-expiratory pressure PEEP

Range 3 to 20 mbar (or hPa or cm H2O)

Resolution 1 mbar (or hPa or cm H2O)

Pressure limitation Pmax

Range (leakage valve) 5 to 40 mbar (or hPa or cm H2O)

Range (expiratory valve) 5 to 50 mbar (or hPa or cm H2O)

Resolution 1 mbar (or hPa or cm H2O)

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Technical data

Inspiratory pressure Pinsp

Only values from PEEP + 2 mbar can be set

Range (leakage valve) 5 to 40 mbar (or hPa or cm H2O)

Range (expiratory valve) 5 to 50 mbar (or hPa or cm H2O)

Resolution 1 mbar (or hPa or cm H2O)

Pressure support ΔPsupp

Range (leakage valve) 0 to 37 mbar (or hPa or cm H2O) Condition: PEEP + ΔPsupp ≤40 mbar (or hPa or cm H2O)

Range (expiratory valve) 0 to 47 mbar (or hPa or cm H2O)Condition: PEEP + ΔPsupp ≤50 mbar (or hPa or cm H2O)

Resolution 1 mbar (or hPa or cm H2O)

Respiratory rate RR

Range 5 to 50/min

Resolution 1/min

Inspiratory time Ti

Range 0.3 to 8 s

Resolution 0.1 s

Maximum inspiratory time for supported breaths Timax

Range 0.4 to 10 s

Resolution 0.1 s

Ratio of inspiratory time to expiratory time I:E

Range 1:39 to 2:1

Resolution 0.1

Pressure rise time Ramp

Range Auto (The device calculates the optimum value from the measured respiratory rate)0.1 to 2.0 s

Resolution 0.1 s

Trigger sensitivity Trigger

Range Off, Normal, Sensitiv.

Apnea ventilation Apn.Vent.

Range On, Off

Respiratory rate with apnea ventilation RRapn

Range 5 to 50/min

Resolution 1/min

Setting values (cont.)

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Technical data

124 Instructions for use Carina SW 3.2n

Tidal volume with apnea ventilation VTapn

Range 100 to 2000 mL, BTPS

Resolution 10 mL

Volume Guarantee VG

Range On, Off

Inspiratory O2 concentration (in HPO mode) FiO2

Range 21 to 100 %

Resolution 1 %

AutoAdapt Aut.Adapt

Range On, Off

Positive end-expiratory pressure with AutoAdapt PEEPadp

Range 3 to 20 mbar (or hPa or cm H2O)

Resolution 1 mbar (or hPa or cm H2O)

Pressure support with AutoAdapt ΔPSadpt

Range 0 to 37 mbar (or hPa or cm H2O)

Resolution 1 mbar (or hPa or cm H2O)

Time in AutoAdapt Tadpt

Range 5 to 120 min

Resolution 1 min

Performance characteristics

Control principle Time-controlled or flow-controlled and pressure-controlled or volume-controlled

Supply system for patient flow Turbine

Maximum continuous inspiratory flow 180 L/min, BTPS (of which max. 120 L/min with 100 % O2)

Device resistance during device failure

The resistance is specified for the breathing circuit, i.e., between the emergency breathing valve (un-derpressure), the expiratory valve, and the patient connection. The specified resistances take the breathing gas humidifier in account where neces-sary but not additional accessories such as bacte-rial filters or HMEs. See the applicable instructions for use for these components for the resistance.

Setting values (cont.)

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Instructions for use Carina SW 3.2n 125

Technical data

Inspiratory resistance (adults) at 60 L/min

MP00312 breathing circuit <3.5 mbar (or hPa or cm H2O)

MP00313 breathing circuit <4 mbar (or hPa or cm H2O)

5704962 breathing circuit <4 mbar (or hPa or cm H2O)

2166046 breathing circuit with MP00224 leakage valve

<4 mbar (or hPa or cm H2O)

2166046 breathing circuit with MP00220 expiratory valve

<4.5 mbar (or hPa or cm H2O)

F&P RT219 breathing circuit with MP00224 leakage valve

<4 mbar (or hPa or cm H2O)

F&P RT219 breathing circuit with MP00220 expiratory valve

<5.5 mbar (or hPa or cm H2O)

2165619 breathing hose with 8412217 hu-midifier chamber, 2 x 2165627 breathing hose, 8404985 water trap and MP00224 leakage valve

<4.5 mbar (or hPa or cm H2O)

2165619 breathing hose with 8412217 hu-midifier chamber, 2 x 2165627 breathing hose, 8404985 water trap and MP00220 expiratory valve

<5.5 mbar (or hPa or cm H2O)

Inspiratory resistance (pediatric patients) at 30 L/min

MP00312 breathing circuit <2 mbar (or hPa or cm H2O)

MP00313 breathing circuit <3.5 mbar (or hPa or cm H2O)

5704962 breathing circuit <3.5 mbar (or hPa or cm H2O)

2166046 breathing circuit with MP00224 leakage valve

<2 mbar (or hPa or cm H2O)

2166046 breathing circuit with MP00220 expiratory valve

<3.5 mbar (or hPa or cm H2O)

F&P RT219 breathing circuit with MP00224 leakage valve

<2 mbar (or hPa or cm H2O)

F&P RT219 breathing circuit with MP0022Z expiratory valve

<3.5 mbar (or hPa or cm H2O)

2165619 breathing hose with 8412217 hu-midifier chamber, 2 x 2165627 breathing hose, 8404985 water trap and MP00224 leakage valve

<2 mbar (or hPa or cm H2O)

Performance characteristics (cont.)

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Technical data

126 Instructions for use Carina SW 3.2n

2165619 breathing hose with 8412217 hu-midifier chamber, 2 x 2165627 breathing hose, 8404985 water trap and MP00220 expiratory valve

<4 mbar (or hPa or cm H2O)

Expiratory resistance (adults) at 60 L/min

MP00312 breathing circuit <5 mbar (or hPa or cm H2O)

MP00313 breathing circuit <5 mbar (or hPa or cm H2O)

5704962 breathing circuit <5 mbar (or hPa or cm H2O)

2166046 breathing circuit with MP00224 leakage valve

<5 mbar (or hPa or cm H2O)

2166046 breathing circuit with MP00220 expiratory valve

<5 mbar (or hPa or cm H2O)

F&P RT219 breathing circuit with MP00224 leakage valve

<5 mbar (or hPa or cm H2O)

F&P RT219 breathing circuit with MP00220 expiratory valve

<5 mbar (or hPa or cm H2O)

2165619 breathing hose with 8412217 hu-midifier chamber, 2 x 2165627 breathing hose, 8404985 water trap and MP00224 leakage valve

<5.5 mbar (or hPa or cm H2O)

2165619 breathing hose with 8412217 hu-midifier chamber, 2 x 2165627 breathing hose, 8404985 water trap and MP00220 expiratory valve

<4 mbar (or hPa or cm H2O)

Expiratory resistance (pediatric patients) at 30 L/min

MP00312 breathing circuit <2 mbar (or hPa or cm H2O)

MP00313 breathing circuit <2.5 mbar (or hPa or cm H2O)

5704962 breathing circuit <2.5 mbar (or hPa or cm H2O)

2166046 breathing circuit with MP00224 leakage valve

<2 mbar (or hPa or cm H2O)

2166046 breathing circuit with MP00220 expiratory valve

<2.5 mbar (or hPa or cm H2O)

F&P RT219 breathing circuit with MP00224 leakage valve

<2 mbar (or hPa or cm H2O)

F&P RT219 breathing circuit with MP00220 expiratory valve

<2.5 mbar (or hPa or cm H2O)

Performance characteristics (cont.)

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Technical data

2165619 breathing hose with 8412217 hu-midifier chamber, 2 x 2165627 breathing hose, 8404985 water trap and MP00224 leakage valve

<2 mbar (or hPa or cm H2O)

2165619 breathing hose with 8412217 hu-midifier chamber, 2 x 2165627 breathing hose, 8404985 water trap and MP00220 expiratory valve

<2 mbar (or hPa or cm H2O)

Safety valve Opens breathing system in case of fault

Safety valve (overpressure) Restricts the airway pressure to 60 mbar (or hPa or cm H2O)

Emergency breathing valve (underpressure) Restricts the airway pressure to –3 mbar (or hPa or cm H2O)

Displayed measured values

Peak inspiratory pressure PIP

Range 0 to 68 mbar (or hPa or cm H2O)

Resolution 1 mbar (or hPa or cm H2O)

Accuracy ±(8 % of measured value +1.2 mbar) when using MP00312, MP00313 breathing circuits (without leakages)

Positive end-expiratory pressure PEEP

Range 0 to 25 mbar (or hPa or cm H2O)

Resolution 1 mbar (or hPa or cm H2O)

Accuracy ±(8 % of measured value +1.2 mbar) when using MP00312, MP00313 breathing circuits (without leakages)

Inspiratory tidal volume VTi, VT

Range 0 to 4.0 L, BTPS

Resolution 1 mL

Accuracy ±10 % of measured value or ±20 mL, whichever is greater (without leakage, and taking account of hose compliance correction, "Volume losses during ventilation" on page 144)

Performance characteristics (cont.)

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Technical data

128 Instructions for use Carina SW 3.2n

Respiratory rate RR

Range 0 to 75/min

Resolution 1/min

Accuracy ±1/min

T0...90 approx. 60 seconds

Mean airway pressure Pmean

Range 0 to 68 mbar (or hPa or cm H2O)

Resolution 0.1 mbar (or hPa or cm H2O)

Accuracy ±(8 % of measured value +1.2 mbar) when using MP00312, MP00313 breathing circuits (without leakages)

Minute volume MVi, MV

Range 0 to 60 L/min, BTPS

Resolution 0.1 L/min

Accuracy ±10 % of measured value or ±0.6 L/min, whichever is greater (without leakage, and taking account of hose compliance correction, "Volume losses during ventilation" on page 144)

T0...90 approx. 35 s

Leakage minute volume MVleak

Range 0 to 99 L/min, BTPS

Resolution 0.1 L/min

Accuracy ±10 % of measured value or ±0.6 L/min, whichever is greater (without leakage, and taking account of hose compliance correction, "Volume losses during ventilation" on page 144)

T0...90 Approx. 35 s

Adjustment time in AutoAdapt Tadpt

Range 0 to 120 min

Resolution 1 min

Accuracy 1 min

Airway pressure waveform display Pressure

Range 0 to 80 mbar (or hPa or cm H2O)

Flow waveform display Flow

Range –160 to +160 L/min

Airway pressure bar graph Pressure

Range 0 to 60 mbar (or hPa or cm H2O)

Displayed measured values (cont.)

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Technical data

Monitoring functions

Sound pressure level LPA of the alarm signals, measured according to IEC60601-1-8 and A1:2012:Defined user's operating location: Front of device at 1 m (39 in) distance and 1.5 m (59 in) height.

Acoustic alarm signal, standard setting (according to IEC 60601-1-8)

Range for high-priority alarms approx. 73 dB (A) to approx. 78 dB (A)

Range for medium-priority alarms approx. 68 dB (A) to approx. 76 dB (A)

Range for low-priority alarms approx. 53 dB (A) to approx. 73 dB (A)

Step size Can be set in 5 steps

Acoustic alarm signal/ Dräger setting (common acoustic alarm signal for Dräger ventilators)

Range for high-priority alarms approx. 67 dB (A) to approx. 81 dB (A)

Range for medium-priority alarms approx. 68 dB (A) to approx. 83 dB (A)

Range for low-priority alarms approx. 65 dB (A) to approx. 78 dB (A)

Step size Can be set in 5 steps

Power supply failure alarm and auxiliary alarm approx. 60 dB (A)

Inspiratory minute volume MV

Alarm for upper alarm limit If the upper alarm limit has been exceeded

Range 2 to 60 L/min

Resolution 0.1 L/min

Alarm for lower alarm limit If the lower alarm limit has been exceeded

Range 0.1 to 39 L/min

Resolution 0.1 L/min

Airway pressure Paw

Alarm for upper alarm limit If the alarm limit has been exceeded

Range 10 to 55 mbar (or hPa or cm H2O)

Resolution 1 mbar (or hPa or cm H2O)

Delay time to alarm Airway pressure low !!! Tdiscon

Non-invasive ventilation (NIV) 0, 15, 30, 60, 90, 120 s

Invasive ventilation (Tube) 0, 15, 30, 60 s

Respiratory rate RR high

Alarm If the alarm limit has been exceeded for one minute

Range 10 to 74/min, Off

Resolution 1/min

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Technical data

130 Instructions for use Carina SW 3.2n

Apnea alarm time Tapn

Alarm If no breathing activity has been detected

Range 5 to 60 s, Off

Resolution 1 s

Operating data characteristics

Power supply

Mains power 100 V to 240 V AC, 50/60 Hz

Power consumption At 100 V AC max. 1.1 AAt 240 V AC max. 0.5 A

Maximum power consumption (operation, charging internal battery)

90 W

Typical power consumption (operation, not charging internal battery)

35 W

Internal battery

Type NiMH enclosed, maintenance-free

Nominal capacity 2.5 Ah

Charging time 130 Minutes

Operating time 60 minutes with typical ventilation and ambient temperature 25 °C (77 °F), see page 133

Remaining operating time At least 3 minutes (time between generation of Int. battery low !!! alarm and failure of power supply)

Service life Depends on maintenance of internal battery

External battery 12 to 24 V DC (–10 to +30 %), 6.3 to 3.2 AThe optional external battery pack (EBP) is no lon-ger available since 2014.

External battery pack (EBP) with internal charger

Observe corresponding instructions for use.The external battery pack (EBP) is a component of the Carina medical system.

Gas supply

HPO

O2 operating pressure 2.7 bar to 6 bar270 kPa to 600 kPa40 psi to 87 psi

O2 flow 0 to 120 L/min

O2 connection Country-specific

Monitoring functions (cont.)

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Technical data

Dew point 5 K below ambient temperature

Oil content <0.1 mg/m3

Particle size Dust-free O2 flow (filtered with pore size <1 µm)

LPO

O2 operating pressure 0 bar to 0.5 bar0 kPa to 50 kPa0 psi to 7.25 psi

O2 flow 0 to 10 L/min

Connector hose Max. ∅ 7 mm (0.27 in)

O2 humidity Without condensation

Noise emission of device during ventilation at typi-cal setting (mean sound pressure level Leq (A)) (see page 133)

40 dB (A)

Dimensions of basic device (width x height x depth)

175 x 275 x 385 mm (6.9 x 10.8 x 15.2 in)

Weight of basic device 5.5 kg (12.1 lbs)

Heating of breathing gases in device Typically 2 K, max. 5 K

Screen TFT color screen 14.5 cm (5.7 in)

Device outputs

Digital output RS232 COM port, interface for MEDIBUS or MEDIBUS.X protocol

MEDIBUS protocol

Baud rate 9600 baud

Data bits 8

Parity None

Stop bit 1

MEDIBUS.X protocol

Baud rate 19200 baud

Data bits 8

Parity Even

Stop bit 1

Pin assignment

Pin 2 RXD

Pin 3 TXD

Pin 5 GND

Operating data characteristics (cont.)

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Technical data

132 Instructions for use Carina SW 3.2n

Electrical isolation The output is galvanically isolated from the device electronics. The check voltage for the electrical iso-lation is 1500 V.

Nurse call system

Connection 5704906 cable only

Switching contacts Potential-free

Input voltage Max. 40 V AC/DC

Input current Max. 500 mA

Alarm delay <0.5 s

Cable assignment in alarm-free status

Cable 2 (normally open): whiteCable 3 (common connection): yellowCable 4 (normally closed): brown

Electrical isolation The output is galvanically isolated from the device electronics. The check voltage for the electrical iso-lation is 1500 V.

Electromagnetic compatibility (EMC) Tested in accordance with IEC 60601-1-2

Protection classes

Basic device II, as per IEC 60601-1

Application part Type BF

Degree of protection against penetration of liquids and particles

IP X1

Classification in accordance with Directive 93/42/EEC, Annex IX

II b

UMDNS code – Universal Medical Device Nomen-clature System – Nomenclature for medical de-vices

14-355

GMDN code – Global Medical Device Nomencla-ture – Worldwide nomenclature for medical de-vices

42411

Operating data characteristics (cont.)

2

3

4

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Technical data

Settings for typical ventilation

Factory-set ventilation parameters

Ventilation mode PC-AC

VT 500 mL

Pinsp 15 mbar (or hPa or cm H2O)

PEEP 3 mbar (or hPa or cm H2O)

FiO2 40 %

RR 15/min

Ti 1.3 s

Timax 4 s

I:E 1:2

ΔPsupp 5 mbar (or hPa or cm H2O)

Ramp Auto

Pmax 15 mbar (or hPa or cm H2O)

VG Off

Trigger Normal

Apnea ventilation On

RRapn 15/min

VTapn 500 mL

Anti Air Shower On

Night mode Off

Aut.Adapt Off

Ventilation mode PC-BIPAP

Pinsp 15 mbar (or hPa or cm H2O)

PEEP 5 mbar (or hPa or cm H2O)

RR 12/min

Ramp Auto

I:E 1 : 1

FiO2 40 %

O2 suppl. HPO

Operating temperature 25 °C (77 °F)

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Technical data

134 Instructions for use Carina SW 3.2n

Trolley

Dimensions with Carina holder (height x width x depth)

Trolley 1 (63 cm) 730 x 570 x 670 mm(28.7 x 22.4 x 26.4 in)

Trolley 1 (78 cm) 880 x 570 x 670 mm(34.7 x 22.4 x 26.4 in)

Weight

Nominal weight (weight of basic device, hinged arm and trolley)

22 kg (48.5 lbs)

Maximum weight (permitted maximum total weight)

63 kg (139 lbs)

Weight without load

Trolley 1 (63 cm) 13.8 kg (30.4 lbs)

Trolley 1 (78 cm) 14.8 kg (32.6 lbs)

Trolley load

Maximum load for accessories 43 kg (94.8 lbs)

Load can consist of:

Gas cylinder holder (2 gas cylinders) Up to 24 kg (52.9 lbs)

Standard rail handle Up to 10 kg (22 lbs)

Universal holder with standard rail Up to 10 kg (22 lbs)

Battery holder with external battery pack (EBP)

10.5 kg (23.2 lbs)

Classification in accordance with Directive 93/42/EEC, Annex IX

I

UMDNS code Universal Medical Device Nomenclature System – Nomenclature for medical devices

10-635

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Technical data

Alarm system of Carina

The alarm system of Carina meets the require-ments of the IEC 60601-1-8 standard.

The optical and acoustic alarm signals include:

– Flashing or permanently lit LEDs

– On-screen display of alarm messages

– Acoustic main alarm and acoustic auxiliary alarm (also used as power supply failure alarm).

The alarm system is designed so that the user can recognize the alarm messages from a distance of 1 m (39 in). The specified volume levels for the alarm signal apply to a distance of 1 m (39 in) in front of the device and at a height of 1.5 m (59 in). For information on the volume levels of the acoustic main alarm for the individual alarm priorities, see chapter "Monitoring functions" on page 129.

The alarm system does not feature any configur-able alarm presets or default alarm presets. For the factory settings for the alarm limits, see page 84.

Carina has a nurse call interface which can be used for a distributed alarm system. According to IEC 60601-1-8, this distributed alarm system is not suitable for secure transmission of alarms. Thus data transfer by means of the nurse call is not a substitute for regular checking of the notifications on the device screen. Each device in the alarm sys-tem connected to this interface must be labeled with a warning that the connected device does not guarantee secure reception of the alarm signals.

The alarms are indicated acoustically and optically by the device without any additional delay immedi-ately after an alarm condition has been detected.

According to IEC 60601-1-8, when there are multi-ple simultaneously active alarms with the same pri-ority, the intelligent Carina alarm system displays the one with the highest urgency on the screen.

The list of alarm conditions and their priorities can be found in the chapter "Alarm – Cause – Remedy".

All the alarm limits that can be set by the user are shown in the Alarms menu. For a description of alarm system operation, see chapter "Alarms".

The acoustic alarm signal and alarms transmitted via the nurse call can be suppressed for a maxi-mum of 2 minutes with the Audio paused 2 min. key, see chapter "Suppressing the acoustic alarm signal and the nurse call" on page 86. A deacti-vated alarm signal is indicated by a corresponding symbol in the alarm line on the screen. If an alarm of higher priority occurs during this time, the acous-tic alarm signal sounds once, thus informing the user about the alarm.

The alarm system is activated when Carina is started. After the selftest the screen shows the last defined ventilation mode and the last defined venti-lation parameters. The device is in standby mode.

Before using the device on a patient, observe the chapter "Getting started".

During operation, all alarm limits and ventilation pa-rameters are permanently saved and are immedi-ately available after a restart.

Individual alarm conditions can be deactivated by the user under certain conditions, see chapter "Set-ting the alarm limits" on page 84. Deactivated alarm signals are indicated by a corresponding symbol in the alarm line on the screen.

Operation is terminated by activating standby mode, see chapter "Standby mode" on page 77. The device is then switched off, see chapter "End-ing operation" on page 78.

NOTE

Some alarm conditions are based on time-de-pendent parameters and are not detected imme-diately. For additional information, see chapter "Alarm delays" on page 136.

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Technical data

136 Instructions for use Carina SW 3.2n

Alarm delays

Alarms are not displayed immediately when the alarm limit is exceeded.

Alarm Delay time

Airway pressure high !!! If the alarm limit is exceeded in 2 consecutive breathing phases

Airway pressure low !!! >Tdiscon + 5 s

Apnea !!! After Tapn has elapsed, if a time has been set for Tapn

Apnea Ventilation ! After Tapn has elapsed, if a time has been set for Tapn

Breath. circuit incorrect !!! >37 s

Continuous Paw high !!! >15 s

Continuous Paw low !!! >30 s (at least 3 breaths)

HPO supply insufficient !!! >30 s

Large leakage ! If the permissible patient leakage is exceeded from the 11th breathing phase

LPO pressure high !! If the alarm limit is exceeded in 2 consecutive breathing phases

MV low !!! 60 s at start of ventilation and after reset of the alarm Airway pressure low !!!

RR high !!! 60 s

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Instructions for use Carina SW 3.2n 137

Technical data

EMC declaration

General information

The device was tested for electromagnetic compat-ibility using accessories from the list of accessories. Other accessories may only be used if they do not compromise the electromagnetic compatibility. The use of non-compliant accessories may result in in-creased electromagnetic emissions or decreased electromagnetic immunity of the device.

The device may be used in the direct vicinity of oth-er devices only if Dräger has authorized this device arrangement. If no authorization has been given by Dräger, it must be ensured that the device functions correctly in the desired arrangement before using it. The instructions for use for the other devices must be followed.

Electromagnetic environment

The emissions from this device were tested in the following frequency ranges:

Electromagnetic immunity

This device may only be used in environments specified in section "Intended use" on page 16.

Emissions Compliance

Conducted emissions Class B, group 1 (150 kHz to 30 MHz)

Radiated emissions Class B, group 1 (30 MHz to 1 GHz)

Harmonic emissions Requirement is met

Voltage fluctuation emissions (flicker) Requirement is met

Immunity against Test level

Electrostatic discharge (ESD) (IEC 61000-4-2) Contact discharge: ±8 kV

Air discharge: ±15 kV

Fast transient electrical disturbances (bursts) (IEC 61000-4-4)

Power cable: ±2 kV

Longer input/output lines: ±1 kV

Impulse voltages (surges) (IEC 61000-4-5) Voltage, external conductor – external conductor: ±1 kV

Voltage, external conductor – protective ground con-ductor: ±2 kV

Magnetic fields at a mains frequency of 50 Hz (IEC 61000-4-8)

30 A/m

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Technical data

138 Instructions for use Carina SW 3.2n

Recommended separation distances from mobile high-frequency communication equipment

In order to attain the full functional integrity of this device, a separation distance of at least 1.0 m (3.3 ft) is required between the device and wireless high-frequency communication equipment.

Voltage dips and short interruptions in the supply voltage (IEC 61000-4-11)

30% to 100%, 10 ms to 5 s, different phase angles

Radiated high-frequency disturbances (IEC 61000-4-3)

80 MHz to 2.7 GHz: 10 V/m

Conducted high-frequency disturbances (IEC 61000-4-6)

150 kHz to 80 MHz: 3 V, ISM bands and amateur ra-dio bands: 6 V

Electromagnetic fields in the vicinity of wireless high-frequency communication equipment

Diverse frequencies from 385 MHz to 5785 MHz: 9 V/m to 28 V/m

WARNING

Risk due to insufficient separation distance

If mobile high-frequency communication equipment is used too close to this device, malfunctions that put the patient at risk may occur.

Maintain a separation distance of at least 0.3 m (1.0 ft) between this device, including the cables, and high-frequency communica-tion equipment.

Immunity against Test level

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Technical data

Connections to IT networks

In an IT network, data can be exchanged by means of wired or wireless technologies. IT networks in-clude all data interfaces (e.g., RS232, LAN, USB, printer interface) that are described in standards and conventions.

During operation, this device can exchange infor-mation with other devices using IT networks, and supports the following functions:

– Display of waveforms and parameters

– Signaling of alarms

– Transfer of device settings and patient data

– Service mode, access to logbooks

Connecting this device to a network that incorpo-rates other devices, or making subsequent changes to that network, may result in new risks for patients, users, and third parties. Before the device is connected to the network or the network is changed, these risks must be identified, analyzed, and evaluated and appropriate measures taken.

Examples of subsequent changes to the network:

– Changing the network configuration

– Removing devices from the network

– Adding other devices to the network

– Performing upgrades or updates to devices that are connected to the network

Information on connecting to the IT net-work

Prerequisites

This device may only be connected to the network by service personnel. The IT representative for the hospital must be consulted beforehand.

The following documents must be observed:

– Documents accompanying this device

– Descriptions of the network interface

– Description of network-based alarm systems

Dräger recommends compliance with IEC 80001-1 (Risk Management for IT Networks with Medical Devices).

Serial interfaces

The following interfaces are supported:

– RS232 interfaces conforming to EIA RS-232 (CCITT V.24/V.28) for the following applica-tions:– MEDIBUS, MEDIBUS.X– Connections to medical devices from third-

party manufacturers

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Technical data

140 Instructions for use Carina SW 3.2n

Consequences of using an unsuitable network

If the network does not meet the requirements, dan-gerous situations may result. The following situa-tions may occur with this device:

– Due to an insecure distributed alarm system:– Alarms are not transmitted.– Alarms or data are transmitted with delays.– False alarms are triggered.

– During an interruption to the network connec-tion:– Alarms are not transmitted.– Suppressed alarms or alarm tones are not

reactivated, but remain suppressed.

– Without a firewall and anti-virus software:– Data are not protected.– Device settings are altered.– The device generates false alarms or no

alarms at all.

– Data are not sent, are sent incompletely or are sent to the wrong device.

– Patient data are intercepted, corrupted or dam-aged.

– Data have incorrect time-stamps.

– Overloading of the device due to a very high network load (e.g., as a result of Denial-Of-Ser-vice attacks) may result in temporary deactiva-tion of the interface.

Required electrical characteristics of con-nected devices and networks

The serial interface is only suitable for connecting devices or networks that have a nominal voltage of 24 V DC maximum on the network side and meet the requirements of one of the following standards:

– IEC 60950-1: Ungrounded SELV circuits

– IEC 60601-1 (as of 2nd edition): Touchable secondary circuits

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Instructions for use Carina SW 3.2n 141

Principles of operation

Principles of operation

Pneumatic function description . . . . . . . . . . 142

Functional units . . . . . . . . . . . . . . . . . . . . . . . . 142Volume losses during ventilation . . . . . . . . . . . 144

Description of the ventilation modes . . . . . . 145

VC-SIMV. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145VC-AC (optional) . . . . . . . . . . . . . . . . . . . . . . . 147PC-BIPAP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149PC-AC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151SPN-CPAP/PS . . . . . . . . . . . . . . . . . . . . . . . . . 152

Additional settings for ventilation . . . . . . . . 155

Apnea ventilation . . . . . . . . . . . . . . . . . . . . . . . 155Trigger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156Pressure rise ramp . . . . . . . . . . . . . . . . . . . . . . 157AutoAdapt. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158

Therapy types . . . . . . . . . . . . . . . . . . . . . . . . . 159

Non-invasive ventilation . . . . . . . . . . . . . . . . . . 159Invasive ventilation . . . . . . . . . . . . . . . . . . . . . . 159

Additional functions. . . . . . . . . . . . . . . . . . . . 160

Flow reduction (Anti Air Shower) . . . . . . . . . . . 160SyncPlus® . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

Volume measurement . . . . . . . . . . . . . . . . . . 162

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Principles of operation

142 Instructions for use Carina SW 3.2n

Pneumatic function description

Functional units

1 Air inlet

2 Turbine

3 Measuring unit

4 Expiratory valve

5 Leakage valve

6 Oxygen dosing unit

7 Oxygen measuring unit

8 Oxygen port LPO

9 Oxygen port HPO

The ambient air passes through the inlet filter (HEPA filter) (F1) and is compressed in the turbine (2). The pressure depends on the processor-con-trolled turbine speed. The low mass of the turbine impeller allows fast speed changes and high flow dynamics. The compressed air is sent to the meas-uring unit (3) through a venturi (R2). The pressure differential generated there is measured by the flow sensor (DPS1) and used to regulate the flow.

The measured values of the first pressure sensor (PS1) and the second pressure sensor (PS2) are used to control the ventilation pressure. The calcu-lation includes: specified setting values, ventilation algorithms and characteristics of the original Dräger breathing hoses (pressure loss by flow re-sistance). Volume losses and pressure losses of unknown components (third-party manufacturers) cannot be taken into account (see "Volume losses during ventilation" on page 144) and must be com-pensated by manual adjustment of the ventilation parameters. The leakage flow is continuously cal-culated from the flow and pressure values. The tidal volume is maintained at a constant level. During ex-piration the turbine supplies a slight counter-pres-sure for establishment of the defined PEEP.

The breathing gas temperature is monitored by the sensors (AT1 and AT2). Increases in temperature trigger an alarm message.

The connected breathing circuit (with controlled ex-piratory valve or leakage valve) is defined at the switch valve (V1) in the measuring unit (3).

113

H P Ocontro lboard

S ensorboard

6

73

P atien t

M oto rb low er1

C V 1

F1

C V 2

p ilo t line fo r exp . va lve

4

C V 4

5R 1

(e.g . S ilen tF low )

C V 3In le tlabyrin th

O utle tlabyrin th

8

P S 1E

p

P S 2E

p

D P S 1

R 2

EΔp

A T2

E V LV

A T1

V 2V 3

F3

V 5

F6

F59R 4

D P S 3E

Δp

C V 6

C V 8

V 6

V 7

C V 9

2 V 1

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Instructions for use Carina SW 3.2n 143

Principles of operation

Operation with controlled expiratory valve (4): dur-ing inspiration the pressure in the pilot line closes the expiratory valve. During expiration the pressure drop in the pilot line opens the expiratory valve to discharge the expiratory air.

Operation with leakage valve (5): the expiratory air of the patient is discharged through the leakage valve.

Oxygen admixture HPO

The desired FiO2 value can be set in the menu. The O2 is fed in via the high-pressure O2 inlet (9). The oxygen passes through a filter (F5) that removes impurities that could adversely affect the operation of the downstream components. The oxygen enters the electrically controlled O2 proportional valve (V5), which controls the O2 flow. The oxygen passes into the O2 measuring unit (7) through a venturi (R4). The resulting pressure differential is a control parameter for the O2 flow. It is measured by the O2 flow sensor (DPS3) and the result is used to regulate the O2 proportional valve (V5). The admix-ture to ambient air is in the turbine (2).

Oxygen admixture LPO

The system is switched to low-pressure oxygen in the menu. Oxygen is fed in through the low-pres-sure oxygen inlet (8). The oxygen passes through a filter (F6) that removes impurities that could ad-versely affect the operation of the downstream components. The oxygen enters the electrically controlled O2 proportional valve (V5), which is fully opened for operation with low-pressure oxygen. The O2 flow is not regulated. The admixture to am-bient air is in the turbine (2).

Check valves

The check valves (CV6 and CV8) prevent oxygen from escaping from an unused O2 inlet. The check valves also prevent high-pressure oxygen from flowing to the low-pressure O2 source if both sources are connected at the same time. One check valve (CV9) restricts the pressure in the low-pressure O2 inlet to <1 bar by discharging excess oxygen to the ambient air.

Safety

All sensors are duplicated and are monitored inde-pendently. A sensor failure triggers an alarm mes-sage and automatically switches the device to emergency ventilation, see "Emergency ventila-tion" on page 103.

Safety valves

The safety valve (overpressure) (CV3) restricts the airway pressure to 60 mbar (or hPa or cm H2O).

The emergency breathing valve (underpressure) (CV2) restricts the airway pressure to –3 mbar (or hPa or cm H2O).

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Principles of operation

144 Instructions for use Carina SW 3.2n

Volume losses during ventilation

A component of the volume supplied by the device remains in the breathing circuit during ventilation. This component depends on the ratio of hose com-pliance to lung compliance. The device does not in-

clude the compliance of the breathing circuit in the calculation of the displayed tidal volume VT. The volume losses must be manually corrected.

According to the pressure differentials (Pinsp –PEEP or PIP – PEEP) the specified tidal volume VT must be increased by the volume defined in the table.

Example

The patient is ventilated at the following settings:– 8418655 breathing circuit– Pinsp = 25 mbar (25 cm H2O)– PEEP = 5 mbar (5 cm H2O)

Volume loss not compensated by the device: 60 mL

The tidal volume VT must be manually increased by 60 mL to ensure that the patient receives the re-quired volume.

Part number MP00312 MP00313 5704962 8418655 2166046 2165627/ 2165619

Breathing cir-cuit

Disposable Disposable Disposable Disposable Reusable Reusable

1.5 m (59 in) with leakage valve

1.5 m (59 in) with expira-tory valve

2.0 m (79 in) with expira-tory valve

0.5 m (20 in) with humidi-fier cham-ber MR290, 1.5 m (59 in) with hose heater

1.5 m (59 in) 0.35 m (14 in) with humidi-fier chamber MR370, 2 x 0.60 m (24 in) and water trap

Active humidi-fication

No No No Yes No Yes

VTloss [mL] at ΔP1)[mbar]

1) ΔP = Pinsp – PEEP or PIP – PEEP

5 3 3 4 15 2 5

10 6 6 8 30 3 10

15 9 9 12 45 5 15

20 12 12 16 60 7 20

25 16 15 20 75 9 25

30 19 18 24 90 10 30

35 22 21 28 105 12 35

40 25 24 32 120 14 40

45 28 27 36 135 15 45

50 31 30 40 150 17 50

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Instructions for use Carina SW 3.2n 145

Principles of operation

Description of the ventilation modes

VC-SIMV

Volume Control – Synchronized Intermittent Man-datory Ventilation

Intermittent, triggered, volume-controlled ventila-tion, allowing spontaneous breathing during the ex-piratory phase with AutoFlow and pressure sup-port.

Volume-controlled ventilation

The tidal volume of the mandatory breaths is deter-mined by the volume VT. The duration of the inspir-atory phase of a mandatory breath is determined by Ti. The pressure rise is determined by the Ramp setting. The peak inspiratory pressure PIP is limited by the Pmax setting.

Synchronization

The mandatory breaths can be triggered by the pa-tient's inspiratory effort on PEEP level.

A mandatory breath can only be triggered within a "trigger window" by the flow trigger in synchrony with the patient's inspiratory effort. This prevents the mandatory breath being applied during expira-tion.

The trigger window has a maximum duration of 5 seconds. For expiratory times shorter than 5 seconds, the trigger window covers the entire ex-piratory time minus a refractory period of 500 ms to the beginning of the expiration.

The synchronization of the mandatory breath re-duces the expiratory time.

03

6

Paw

PEEP

1

Ti

Flow RR

t

t

Without spontaneous breathing

With spontaneous breathing

Trigger window

Pressure support

Fast pressure rise

Slow pressure rise

PmaxPIP

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Principles of operation

146 Instructions for use Carina SW 3.2n

The device extends the following expiratory time or spontaneous breathing time by the missing time. This prevents an increase of the mandatory res-piratory rate. The number of mandatory breaths is determined by the respiratory rate RR.

Pressure support

During spontaneous breathing on PEEP level, the patient can be supported with ΔPsupp. Every in-spiratory effort of the patient on PEEP level that meets the trigger criteria triggers a pressure-sup-ported breath. By setting the trigger level, the pa-tient’s inspiratory efforts are synchronized. The time, number, and duration of pressure-supported breaths is determined by the patient's spontaneous breathing.

As in all pressure-controlled ventilation modes, the tidal volume supplied depends on the difference in pressure ΔPsupp, the lung mechanics (resistance and compliance) and the patient's respiratory drive. The pressure rise from the lower pressure level PEEP to the upper pressure level Psupp is defined with the Ramp setting.

The pressure support is terminated as soon as the inspiratory flow falls below a specific proportion of the maximum inspiratory flow.

The pressure support is also terminated as soon as the duration of support exceeds a maximum inspir-atory time Timax. The maximum inspiratory time is limited to 130 % of Ti or a maximum of 4 seconds.

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Instructions for use Carina SW 3.2n 147

Principles of operation

VC-AC (optional)

Volume Control – Assist Control

Assisted-controlled, volume-controlled ventilation with fixed inspiratory flow and backup frequency with AutoFlow.

Volume-controlled ventilation

The tidal volume of the mandatory breaths is deter-mined by the volume VT. The duration of the inspir-atory phase of a mandatory breath is determined by Ti. The pressure rise is determined by the Ramp setting. The peak inspiratory pressure PIP is limited by the Pmax setting.

Assisted-controlled ventilation

Every inspiratory effort of the patient on PEEP level triggers a synchronized mandatory breath. Thus, the time and number of mandatory breaths are de-termined by the patient. The trigger window covers the expiratory time minus a refractory period at the beginning of the expiration. The expiratory time is determined by the respiratory rate RR and the in-spiratory time Ti.

A non-synchronized mandatory breath is triggered at the latest at the end of the expiratory time (backup respiratory rate).

The minimal number of mandatory breaths is deter-mined by the respiratory rate RR.

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Principles of operation

148 Instructions for use Carina SW 3.2n

AutoFlow

The AutoFlow function is always activated in the VC-SIMV and VC-AC ventilation modes.

With AutoFlow, the inspiratory flow automatically adapts to the changes in lung conditions (C, R) and the requirement for spontaneous breathing of the patient.

Always set the Paw high and pressure limitation Pmax alarm limits to limit any rise in airway pressure when the compliance changes.

Typically, the selected inspiratory time Ti is much longer than the lung filling time. The peak inspira-tory pressure PIP corresponds to the minimum value calculated from the tidal volume VT and com-pliance of the lungs.

The device automatically controls the inspiratory flow so that there is no pressure peak caused by the resistances of the tube and the airways. The peak inspiratory pressure PIP changes as the com-pliance changes, as is normal with constant-vol-ume breaths.

With AutoFlow these changes occur from breath to breath (NIV: maximum 1 mbar steps; tube: maxi-mum 3 mbar steps). The maximum peak inspira-tory pressure PIP is determined by the pressure limitation Pmax.

If the tidal volume VT is reached (inspiratory flow = 0) before the inspiratory time Ti has expired, the pa-tient can inhale and exhale at the level of the peak inspiratory pressure PIP during the remaining in-spiratory time.

If the patient inhales or exhales during the manda-tory inspiration, the peak inspiratory pressure PIP does not change during this breath, only the inspir-atory and expiratory flow adjust to the patient's re-quirements. The individually applied tidal volume VT may deviate from the set tidal volume VT in in-dividual breaths, but a constant tidal volume VT is applied over time.

04

4

Paw

PEEP

RR1

tTi

t

Without spontaneous breathing

With spontaneous breathing

Flow VT

Te

PawPmax

Fast pressure rise

Slow pressure rise

PIP

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Principles of operation

PC-BIPAP

Pressure Control – Biphasic Positive Airway Pres-sure

Intermittent, triggered, pressure-controlled ventila-tion allowing spontaneous breathing (open system) during the entire respiratory cycle and pressure support

Pressure-controlled ventilation

The upper pressure level is determined by Pinsp.

The duration of the inspiratory phase of a manda-tory breath is determined by Ti. As in all pressure-controlled ventilation modes, the tidal volume sup-plied depends on the difference in pressure "Pinsp – PEEP", the lung mechanics (resistance and com-pliance) and the patient's respiratory drive. The pressure rise from the lower pressure level PEEP to the upper pressure level Pinsp is defined with the Ramp setting.

Synchronization

The mandatory breaths can be triggered by the pa-tient's inspiratory effort on PEEP level. The manda-tory breaths can be synchronized with the inspira-tory efforts of the patient by setting the trigger level.

A mandatory breath can only be triggered within a "trigger window" by the flow trigger in synchrony with the patient's inspiratory effort. This prevents the mandatory breath being applied during sponta-neous expiration.

03

6

Paw

PEEP

1

Fast pressure rise

Ti

Flow RR

t

t

Pinsp

Without spontaneous breathing

With spontaneous breathing

Trigger window

Pressure support

Slow pressure rise

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Principles of operation

150 Instructions for use Carina SW 3.2n

The trigger window has a maximum duration of 5 seconds. For expiratory times shorter than 5 seconds, the trigger window covers the entire ex-piratory time minus a refractory period of 500 ms to the beginning of the expiration. The synchroniza-tion of the mandatory breath reduces the expiratory time.

The device extends the following expiratory time or spontaneous breathing time by the missing time. This prevents an increase of the mandatory res-piratory rate. The number of mandatory breaths is determined by the respiratory rate RR.

Pressure support

During spontaneous breathing on PEEP level, the patient can be supported with ΔPsupp. Every in-spiratory effort of the patient on PEEP level that meets the trigger criteria triggers a pressure-sup-ported breath. By setting the trigger level, the pa-tient’s inspiratory efforts are synchronized. The time, number, and duration of pressure-supported breaths is determined by the patient's spontaneous breathing.

As in all pressure-controlled ventilation modes, the tidal volume supplied depends on the difference in pressure ΔPsupp, the lung mechanics (resistance and compliance) and the patient's respiratory drive. The pressure rise from the lower pressure level PEEP to the upper pressure level Psupp is defined with the Ramp setting.

The pressure support is terminated as soon as the inspiratory flow falls below a specific proportion of the maximum inspiratory flow.

The pressure support is also terminated as soon as the duration of support exceeds a maximum inspir-atory time Timax. The maximum inspiratory time is limited to 130 % of Ti or a maximum of 4 seconds.

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Instructions for use Carina SW 3.2n 151

Principles of operation

PC-AC

Pressure Control – Assist Control

Assisted-controlled, pressure-controlled ventilation allowing spontaneous breathing during the entire respiratory cycle and back-up respiratory rate

Pressure-controlled ventilation

The upper pressure level is determined by Pinsp. The duration of the inspiratory phase of a manda-tory breath is determined by Ti. As in all pressure-controlled ventilation modes, the tidal volume sup-plied depends on the difference in pressure "Pinsp – PEEP", the lung mechanics (resistance and com-pliance) and the patient's respiratory drive. The pressure rise from the lower pressure level PEEP to the upper pressure level Pinsp is defined with the Ramp setting.

Assisted-controlled ventilation

Every inspiratory effort of the patient on PEEP level triggers a synchronized mandatory breath. Thus, the time and number of mandatory breaths are de-termined by the patient. The trigger window covers the expiratory time minus a refractory period at the beginning of the expiration. The expiratory time is determined by the respiratory rate RR and the in-spiratory time Ti.

A non-synchronized mandatory breath is triggered at the latest at the end of the expiratory time (backup respiratory rate).

The minimal number of mandatory breaths is deter-mined by the respiratory rate RR.

03

7

Paw

PEEP

1

Ti

Slow pressure rise

Flow

t

t

Pinsp

Without spontaneous breathing With spontaneous breathing

Trigger window

RR

Fast pressure rise

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Principles of operation

152 Instructions for use Carina SW 3.2n

SPN-CPAP/PS

Spontaneous – Continuous Positive Airway Pres-sure/Pressure Support

Spontaneous breathing with continuous positive pressure level and with or without pressure support

During spontaneous breathing on PEEP level, the patient can be supported with ΔPsupp. Every in-spiratory effort of the patient on PEEP level that meets the trigger criteria triggers a pressure-sup-ported breath. The time, number, and duration of pressure-supported breaths is determined by the patient's spontaneous breathing.

As in all pressure-controlled ventilation modes, the tidal volume supplied depends on the difference in pressure ΔPsupp, the lung mechanics (resistance and compliance) and the patient's respiratory drive.

The pressure rise from the lower pressure level PEEP to the upper pressure level Psupp is defined with the Ramp setting.

21

4

Paw

Flow

t

t

PEEP

Spontaneous breathing with pressure support

Slow pressure rise

Fast pressure rise

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Instructions for use Carina SW 3.2n 153

Principles of operation

The pressure support is terminated as soon as the inspiratory flow falls below a specific proportion of the maximum inspiratory flow. The proportion of the maximum inspiratory flow is defined with the trigger criterion. The pressure support is also terminated as soon as the duration of support exceeds the maximum inspiratory time Timax.

When the pressure support is not switched on, the patient's spontaneous breathing is supported by the PEEP value set.

04

7

Paw

PEEP

Inspira-tory flow

Pressure rise

End of inspiration

ΔPsuppabove PEEP

Start of inspiration

Timax

t

t

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Principles of operation

154 Instructions for use Carina SW 3.2n

Volume Guarantee

The expanded ventilation setting VG enables a vol-ume guarantee in the SPN-CPAP/PS mode.

With VG every inspiratory effort of the patient on PEEP level that meets the trigger criteria triggers a volume-supported breath. By setting the trigger level, the patient’s inspiratory efforts are synchro-nized. The time, number, and duration of volume-supported breaths is determined by the patient's spontaneous breathing. The pressure rise is deter-mined by the Ramp setting.

The volume-supported breath is terminated as soon as the inspiratory flow falls below a specific proportion of the maximum inspiratory flow.

The proportion of the maximum inspiratory flow is defined with the trigger criterion.

The volume-supported breath is also terminated as soon as the duration of support exceeds a maxi-mum inspiratory time Timax.

The set tidal volume of the supported breath is reached via the automatically selected pressure level of the volume support.

With volume support the support pressure automat-ically adapts to the changes in lung conditions (re-sistance and compliance) and the requirement for spontaneous breathing of the patient.

The maximum applied pressure is limited by the Pmax set value. The difference between the alarm limit Paw high and the set value Pmax is at least 5 mbar (5 cm H2O).

Always set the alarm limits Paw high and pres-sure limitation Pmax to limit a rise of the airway pressure when compliance changes.

If the peak inspiratory pressure PIP reaches the pressure limit Pmax, the desired target volume cannot be applied. The device displays the mes-sage VT not reached, Pmax !. Set Pmax to the maximum allowable value. It is monitored from breath to breath. To reach the target volume, the peak inspiratory pressure PIP is adjusted by breath (NIV: in steps of maximum 1 mbar, tube: maximum 3 mbar steps). The basis for the adjustment is the tidal volume measured by the previous breaths.

21

0

t

t

Paw

Flow

PEEP

Inspiratory termination criterion

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Principles of operation

Additional settings for ventilation

Apnea ventilation

For switching over automatically to volume-con-trolled mandatory ventilation in case of apnea.

Apnea ventilation can be activated in SPN-CPAP/PS ventilation mode. If inspiratory gas is not supplied within the defined apnea alarm time Tapn, the device activates the Apnea Ventilation ! alarm. The device starts ventilation in volume-con-trolled mandatory ventilation.

The FiO2, PEEP and ΔPsupp ventilation parame-ters correspond to the current effective settings of SPN-CPAP/PS. The inspiratory time for apnea ven-tilation is determined from the set apnea respiratory rate RRapn and a fixed I:E ratio of 1:2. The tidal volume is determined with the VTapn setting.

If the patient has successfully triggered at least 5 breaths per minute, the device automatically ter-minates apnea ventilation. The device switches back to the previous ventilation mode.

If apnea ventilation is switched off, the Apnea !!! alarm is triggered in case of an apnea situation.

If apnea monitoring is switched off (Tapn alarm limit set to Off), there is no apnea alarm and no apnea ventilation.

Switching off apnea monitoring, see page 84.

Switching off apnea ventilation, see page 71.2

00

Spontaneous breathing with pressure support

Starting apnea ventilation

1Apnea alarm time Tapn RRapn

Paw

Flow

t

t

VTapn

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Principles of operation

156 Instructions for use Carina SW 3.2n

Trigger

The trigger is used to synchronize mandatory breaths with spontaneous breathing. The trigger is also used for triggering and terminating the sup-ported breaths with SPN-CPAP/PS, PC-BIPAP/PS and VC-SIMV/PS.

Carina uses 3 trigger criteria to detect the breathing effort of the patient:– Flow gradient (flow change rate)– Pressure– Flow

The following settings can be selected:– Off – Normal – Sensitiv.

Trigger criteria

The sensitivity in the detection of breaths and the termination criterion for pressure-supported or vol-ume-supported breaths are both changed with these settings. This means that the Sensitiv. trig-

ger setting compared with the Normal setting quickly triggers a breath and transitions early to ex-piration.

Termination criterion of supported breaths

Inspiratory criterion Expiratory criterion

Normal Sensitiv. Normal Sensitiv.

Flow gradient Major change Minor change Major change Minor change

Pressure [mbar or cm H2O]

0.6 to 1 0.6 to 1 Paw high Paw high

Flow [L/min] 11 to 7 8 to 4 30 %PIF 50 %PIF

20

8

Sensitiv. Normal

Flow Flow

30 %PIF

PIFPIF

50 %PIF

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Principles of operation

Pressure rise ramp

There are 2 options available for setting the Ramp pressure rise time:

– Time setting The steepness of the pressure rise from PEEP level to the inspiratory pressure can be adjusted for the needs of the patient.

– Setting the ramp to Auto (AutoRamp):The device automatically calculates the opti-mum value based on the measured respiratory rate.

AutoRamp

The device automatically sets the pressure rise to 70 % of the average inspiratory time of the patient.

The device does not detect trigger efforts of the pa-tient in patients without spontaneous breathing. The device provides the flow with a sinusoidal waveform.

The device detects the breathing efforts of the pa-tient in patients with triggered ventilation. Flow dos-ing is faster than with patients who are not breath-ing spontaneously.

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Principles of operation

158 Instructions for use Carina SW 3.2n

AutoAdapt

Extended function in ventilation mode SPN-CPAP/PS

To adjust mask-ventilated patients in SPN-CPAP/PS slowly to the therapeutic pressure level, the AutoAdapt function can be activated.

Over the time Tadpt , the pressures PEEPadp and ΔPSadpt are automatically increased in a linear manner until the PEEP and ΔPsupp therapeutic pressure levels are reached. The function is termi-nated when the time Tadpt elapses. The ventilation is continued in SPN-CPAP/PS with the defined PEEP and ΔPsupp values.

The ventilation parameters can be modified at any time. AutoAdapt executes the initial adaptation with reference to the modified ventilation parameters.

The maximum pressure change is 8 mbar/min (cm H2O/min). If the defined parameters require a greater pressure change, the Tadpt time is auto-matically adjusted. Thus the maximum pressure change of 8 mbar/min will not be exceeded.

Because the pressures remain below the therapeu-tic level during the Tadpt time, the patient condition must be continuously monitored. Set the alarm lim-its accordingly.

21

5

Paw

Flow

t

t

PEEP PEEPadp

Tadpt

ΔPSadpt ΔPsupp

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Principles of operation

Therapy types

Non-invasive ventilation

A mask connector without airflow must be used for combinations of leakage valve and nasal mask, mouth-nose mask or face mask.

Leakage is greater with non-invasive ventilation than with invasive ventilation. Therefore, trigger de-tection with automatic leakage detection is de-signed for these special conditions.

A breathing gas humidifier or a heat and moisture exchanger (HME) can be used for non-invasive ap-plications.

Information on CO2 rebreathing

With non-invasive ventilation CO2 rebreathing by the patient is possible under some conditions. If CO2 rebreathing represents a risk for the patient, alternative ventilation methods must be applied.

As the pressure in the breathing circuit is reduced, the risk of CO2 rebreathing increases. At low pres-sure the flow through the leakage valve is reduced, which means that it is possible that not all of the CO2 is discharged from the breathing circuit. Under these conditions the volume of CO2 rebreathed by the patient is further increased with increased tidal volume.

Invasive ventilation

With suitable patients the device can be used for in-vasive ventilation (tube ventilation). Note the follow-ing guidelines before use.

A breathing gas humidifier or a heat and moisture exchanger (HME) can be used for invasive applica-tions.

For information on configuration of the invasive breathing circuit and the accessories for normal op-eration see "Assembly and preparation".

Invasive ventilation with leakage valve

The breathing circuit uses a leakage valve for re-moval of expiratory gases.

WARNING

Risk of patient injury

If a device fails, there is the risk of CO2 re-breathing.

If ventilation fails, remove the mask immedi-ately. Instruct the patient on how to remove the mask if the device fails.

WARNING

Risk of patient injury

When the inspiratory time is extended, the risk of CO2 rebreathing is increased. When the in-spiratory time is longer, the expiratory time is reduced, which means that less CO2 is re-moved from the breathing circuit before the next respiratory cycle. Under these conditions the volume of CO2 rebreathed by the patient is further increased with increased tidal volume.

Adjusting I:E ratio.

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160 Instructions for use Carina SW 3.2n

As the pressure in the breathing circuit is reduced, the risk of CO2 rebreathing increases. At low pres-sure the flow through the leakage valve is reduced, which means that it is possible that not all of the CO2 is discharged from the breathing circuit.

If the device is not operating, insufficient CO2 is dis-charged from the breathing circuit via the leakage valve. In this case, the result will be CO2 rebreath-ing by the patient. Patients must not be connected to the device if it is not operating.

Invasive ventilation with expiratory valve

The breathing circuit is fitted with an expiratory valve. The exhaled expiratory gas flows directly into the environment through the expiratory valve even if the device is not operating. This prevents CO2 re-breathing.

If the device is not operating, there is no ventilation. Patients must not be connected to the device.

Additional functions

Flow reduction (Anti Air Shower)

Flow delivery is reduced if disconnection is de-tected. This convenience function supports the pa-tient when removing the mask. An unnecessarily high flow through the removed mask is prevented.

The Airway pressure low !!! alarm can be delayed by up to 120 seconds. The Tdiscon delay time can be set for this.

As soon as Carina has detected an inspiratory ef-fort with the aid of the trigger criteria or a reconnec-tion, ventilation will be continued with the previous settings. Trigger criteria, see page 156.

The Anti Air Shower function can be selected in the service menu. If the function is switched off, flow is not reduced even if a disconnection is detected, see page 90.

Application mode Delay time Tdiscon

Invasive ventilation 0 to 60 s

Non-invasive ventila-tion

0 to 120 s

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Principles of operation

SyncPlus®

SyncPlus is an automatic function for support of non-invasive ventilation.

SyncPlus is based on 3 main functions:– Multi-sense trigger– Automatic leakage compensation– Cycle learning technology

Multi-sense trigger

Carina uses 3 trigger criteria during inspiration and expiration to detect the breathing effort of the pa-tient:– Pressure– Flow – Flow gradient (flow change rate)

This increases the trigger sensitivity.

Automatic leakage compensation (breathing circuit with leakage valve)

The device measures the leakage from the leakage valve and also the degree of leakage in the breath-ing system. Then the device defines a new base for trigger detection based on the degree of leakage. This improves the trigger detection of the patient and optimizes ventilation. If a defined leakage is ex-ceeded, the Large leakage ! alarm is output.

Cycle learning technology

Carina "learns" the average spontaneous breathing cycle of the patient. This allows the time of sponta-neous breathing of the patient to be determined more easily. Then the device sets the maximum trigger sensitivity for the previously determined breathing component. This function enables high sensitivity and prevents incorrect triggering.

The trigger criteria of the leakage situation are ad-justed during ventilation.

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Principles of operation

162 Instructions for use Carina SW 3.2n

Volume measurement

Breathing circuit with leakage valve

The displayed values for VTi and MVi show the vol-ume applied to the patient's lung. The displayed values are calculated over several spontaneous breaths.

VTi, MVi are derived from the total applied volume, less the total leakage through the leakage valve and patient system. The leakage is displayed as MVleak.

Breathing circuit with expiratory valve

The displayed values for VT and MV show the total volume applied by the device.

CAUTION

Before making clinical decisions based on the dis-played values VTi and MVi, it is important to en-sure that the measurement is not affected by leak-ages.

NOTE

Carina cannot automatically compensate for hose compliance.

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Instructions for use Carina SW 3.2n 163

Index

Index

A

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Acoustic alarm signal

Suppressing . . . . . . . . . . . . . . . . . . . . . . . . . 86Additional settings . . . . . . . . . . . . . . . . . . . . . . . 21Aeroneb Pro . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Alarm – Cause – Remedy . . . . . . . . . . . . . . . . . 97Alarm delay . . . . . . . . . . . . . . . . . . . . . . . . . . . 136Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Alarm priorities . . . . . . . . . . . . . . . . . . . . . . . 83Displaying . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Ambient conditions . . . . . . . . . . . . . . . . . . . . . 122Anti Air Shower . . . . . . . . . . . . . . . . . . . . . 90, 160Apnea ventilation . . . . . . . . . . . . . . . . . . . . . . . 155

Using . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Application mode

Selecting . . . . . . . . . . . . . . . . . . . . . . . . . . . 62Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Auto wake-up . . . . . . . . . . . . . . . . . . . . . . . . . . . 63AutoAdapt . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158

Using . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71AutoFlow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148Automatic leakage compensation . . . . . . . . . . . 70AutoRamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

B

Battery holder . . . . . . . . . . . . . . . . . . . . . . . . . . 38Bed and wall mountings . . . . . . . . . . . . . . . 20, 22Breathing circuit . . . . . . . . . . . . . . . . . . . . . . . . . 21

Connecting . . . . . . . . . . . . . . . . . . . . . . . . . . 41Removing . . . . . . . . . . . . . . . . . . . . . . . . . . 106with expiratory valve . . . . . . . . . . . . . . . . . . 42with leakage valve . . . . . . . . . . . . . . . . . . . . 42

Breathing gas humidifier . . . . . . . . . . . . . . . . . . 43with inspiratory hose heater . . . . . . . . . . . . . 44without inspiratory hose heater . . . . . . . . . . 45

C

Central gas supply system . . . . . . . . . . . . . . . . 51Checking readiness for operation . . . . . . . . . . . 59CO2 rebreathing . . . . . . . . . . . . . . . . . . . . 69, 159Color coding . . . . . . . . . . . . . . . . . . . . . . . . . . . 30Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Opening menu . . . . . . . . . . . . . . . . . . . . . . . 88

Contact information . . . . . . . . . . . . . . . . . . . . . 90Continuing ventilation . . . . . . . . . . . . . . . . . . . . 78Cycle learning technology . . . . . . . . . . . . . . . 161

D

Data transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Description . . . . . . . . . . . . . . . . . . . . . . . . . . . 141Device

Positioning . . . . . . . . . . . . . . . . . . . . . . . . . 34Storing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78Taking out of service . . . . . . . . . . . . . . . . . . 78

Device check . . . . . . . . . . . . . . . . . . . . . . . . . . 59Diagram

Operation with expiratory valve . . . . . . . . . 76Operation with leakage valve . . . . . . . . . . . 76

Disconnection time . . . . . . . . . . . . . . . . . . . . . . 21Dismantling . . . . . . . . . . . . . . . . . . . . . . . . . . . 106Display accuracy . . . . . . . . . . . . . . . . . . . . . . . 79Displayed measured values . . . . . . . . . . . . . . 127Displaying setting and measured values . . . . . 72Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117Disposal of batteries . . . . . . . . . . . . . . . . . . . . 118Disposal of the Medical Device . . . . . . . . . . . 119

E

Electromagnetic compatibility . . . . . . . . . . . . . . 10EMC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10, 137Emergency ventilation . . . . . . . . . . . . . . . . . . 103Expiratory valve . . . . . . . . . . . . . . . . . . . . . . . . 42External battery . . . . . . . . . . . . . . . . . . . . . 19, 38

F

Factory settings . . . . . . . . . . . . . . . . . . . . . . . 133Fixing hinged arm . . . . . . . . . . . . . . . . . . . . . . . 43Flow reduction . . . . . . . . . . . . . . . . . . . . . . . . 160Functional units . . . . . . . . . . . . . . . . . . . . . . . 142

G

Gas cylinder holder . . . . . . . . . . . . . . . . . . . . . 38Gas supply . . . . . . . . . . . . . . . . . . . . . . 18, 22, 50

Central gas supply system . . . . . . . . . . . . . 51from compressed gas cylinders . . . . . . . . . 51Low Pressure Oxygen . . . . . . . . . . . . . . . . 51

Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . 57

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Index

164 Instructions for use Carina SW 3.2n

H

HEPA filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19HMEs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40HPO mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Selecting . . . . . . . . . . . . . . . . . . . . . . . . . . . 93HPO port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

I

Inlet filterDisposal . . . . . . . . . . . . . . . . . . . . . . . . . . . 119Installing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Replacing . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113Installing the bacterial filter . . . . . . . . . . . . . . . . 40Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Internal battery . . . . . . . . . . . . . . . . . . . . . . . . . 49

Charging . . . . . . . . . . . . . . . . . . . . . . . . . . 115Display accuracy of the charge state . . . . . . 79

Invasive ventilation . . . . . . . . . . . . . . . . . . 21, 159IT networks . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

L

Leakage valve . . . . . . . . . . . . . . . . . . . . . . . . . . 42Locking keys . . . . . . . . . . . . . . . . . . . . . . . . . . . 73Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90LPO mode

Selecting . . . . . . . . . . . . . . . . . . . . . . . . . . . 93Using . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

LPO port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

M

Mains power supply . . . . . . . . . . . . . . . . . . . . . . 48Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 8, 111Manual ventilation device . . . . . . . . . . . . . . . . . 14Mean airway pressure . . . . . . . . . . . . . . . . . . . . 76Measured values . . . . . . . . . . . . . . . . . . . . . . . 127Medication nebulization . . . . . . . . . . . . . . . . . . . 22Medication nebulizer . . . . . . . . . . . . . . . . . . . . . 47Menu

Extending . . . . . . . . . . . . . . . . . . . . . . . . . . . 30Opening . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Monitoring functions . . . . . . . . . . . . . . . . . . . . 129Multi-sense trigger . . . . . . . . . . . . . . . . . . . . . . 161

N

Night mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94NIV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69Non-Invasive Ventilation . . . . . . . . . . . . . . 69, 159

Nurse call . . . . . . . . . . . . . . . . . . . . . . . . . . 19, 51

O

O2 concentrator . . . . . . . . . . . . . . . . . . . . . . . . 74O2 supply . . . . . . . . . . . . . . . . . . . . . . . . . . 50, 62Operating and display unit . . . . . . . . . . . . . . . . 28Operating concept . . . . . . . . . . . . . . . . . . . . . . 27Operating data characteristics . . . . . . . . . . . . 130Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Ending . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

P

Passive humidifier . . . . . . . . . . . . . . . . . . . 40, 46Patient connection panel . . . . . . . . . . . . . . . . . 19Patient monitoring . . . . . . . . . . . . . . . . . . . . . . . 9PC-AC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151PC-BIPAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149Performance characteristics . . . . . . . . . . . . . . 124Pneumatic function description . . . . . . . . . . . 142Power on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Power supply . . . . . . . . . . . . . . . . . . . . . . . 22, 48

External battery . . . . . . . . . . . . . . . . . . . . . 49Internal battery . . . . . . . . . . . . . . . . . . . . . . 49Mains power supply . . . . . . . . . . . . . . . . . . 48

Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Preventive maintenance . . . . . . . . . . . . . . . . . 114Problem Solving . . . . . . . . . . . . . . . . . . . . . . . . 95

R

Ramp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157Range of functions . . . . . . . . . . . . . . . . . . . . . . 21Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . 105

Classifications . . . . . . . . . . . . . . . . . . . . . . 108Non-critical components . . . . . . . . . . . . . . 109Semi-critical components . . . . . . . . . . . . . 110

Reprocessing personnel . . . . . . . . . . . . . . . . . . . 4RS232 COM port . . . . . . . . . . . . . . . . . . . . . . . 19

S

Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Safety checks . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Screen display . . . . . . . . . . . . . . . . . . . . . . . . . 91

Measured values . . . . . . . . . . . . . . . . . . . . 92Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . 92

Select Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Service menu . . . . . . . . . . . . . . . . . . . . . . . . . . 89

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Index

Service personnel . . . . . . . . . . . . . . . . . . . . . . . . 4Specialized . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Setting language . . . . . . . . . . . . . . . . . . . . . . . . 90Setting ranges . . . . . . . . . . . . . . . . . . . . . . . . . . 68Setting the alarm limits . . . . . . . . . . . . . . . . . . . 84Setting values . . . . . . . . . . . . . . . . . . . . . . . . . 122Software protocol . . . . . . . . . . . . . . . . . . . . . . . . 53SPN-CPAP/PS . . . . . . . . . . . . . . . . . . . . . . . . 152Standby mode . . . . . . . . . . . . . . . . . . . . . . . . . . 77Start/Standby . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Status line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Sub-acute care . . . . . . . . . . . . . . . . . . . . . . . . . 16Subacute Care . . . . . . . . . . . . . . . . . . . . . . . . . . 16Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23System information . . . . . . . . . . . . . . . . . . . . . . 89

T

Target groups . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Technical causes of alarms . . . . . . . . . . . . . . . 103Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . 121Toppling stability . . . . . . . . . . . . . . . . . . . . . . . . 35Transport of patients . . . . . . . . . . . . . . . . . . . . . 54Trigger . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70, 156Trigger criteria . . . . . . . . . . . . . . . . . . . . . . . . . 156Trolley . . . . . . . . . . . . . . . . . . . 20, 22, 36, 55, 134Turbine . . . . . . . . . . . . . . . . . . . . . . . . . . 103, 142Typical ventilation . . . . . . . . . . . . . . . . . . . . . . 133

U

User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

V

VC-AC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147VC-SIMV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145Ventilation functions . . . . . . . . . . . . . . . . . . . . . 21Ventilation mode

Setting . . . . . . . . . . . . . . . . . . . . . . . . . . 31, 67Ventilation parameters

Factory settings . . . . . . . . . . . . . . . . . . . . . 133Setting . . . . . . . . . . . . . . . . . . . . . . . . . . 31, 67Setting ranges . . . . . . . . . . . . . . . . . . . . . . . 68

Volume Guarantee . . . . . . . . . . . . . . . . . . . . . 154Volume losses . . . . . . . . . . . . . . . . . . . . . . . . . 144Volume measurement . . . . . . . . . . . . . . . . . . . 162

Page 166: Instructions for use Carina€¦ · Sub-Acute Care Ventilator Software 3.2n WARNING To properly use this medical device, read and comply with these instruc-tions for use. 2 Instructions

These instructions for use apply only to the fol-lowing device with the specified serial number:Carina SW 3.2n If no serial number has been filled in by Dräger, these instructions for use are provided for gen-eral information only and are not intended for use with any specific medical device.These instructions for use are provided for customer information only and are only updated or exchanged upon customer request.

Directive 93/42/EECconcerning Medical Devices

Manufacturer

Drägerwerk AG & Co. KGaAMoislinger Allee 53 – 55D-23542 LübeckGermany+49 451 8 82-0

FAX +49 451 8 82-20 80http://www.draeger.com

9053706 – GA 5665.710 en© Drägerwerk AG & Co. KGaAEdition: 5 – 2017-03(Edition: 1 – 2012-06)Dräger reserves the right to make modifications to the device without prior notice.