Carina Instructions for Use Sw 3.2n Edition 5 March 2017

Typographical conventions 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 different 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.

Screen reproductions The reproductions of screen content in the instructions for use can differ from the content actually shown on the screen.

Use of terms Dräger uses the term "accessory" not only for accessories in the sense given by IEC 60601-1, but also for consumables, removable parts, and attached parts.

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

Trademarks Trademark AutoFlow

Trademark owner

®

Dräger

®

Dräger

Carina

SyncPlus

®

Dräger

VentStar®

Dräger

DrägerService ™

®

Dräger

MEDIBUS.X

Dräger

®

Diversey

Virex

BIPAP1) 1)

2

Trademark used under license

Instructions for use Carina SW 3.2n

Safety information definitions WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate 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.

Instructions for use Carina SW 3.2n

3

Target groups

Duties of the operating organization

Reprocessing personnel

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

Task

Requirement

Reprocessing

Specialist knowledge in the reprocessing of medical devices

The operating organization of this product must ensure the following: The target group has the required qualifications (e.g., has undergone specialist training or acquired specialist knowledge through experience).

Service personnel

–

The target group has been trained to perform the task.

Basic service work (inspection)

–

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 Task

Requirement

Use of the product in Specialist medical knowlaccordance with the edge in ventilation intended use Specialist medical knowledge in the use of the product

Task

Requirement

Installation

Specialist knowledge in electrical engineering and mechanics Experience in the servicing of medical devices

Specialized service personnel Task

Requirement

Installation

Specialist knowledge in electrical engineering and mechanics

Basic and complex service work (inspection, maintenance, repair)

Experience in the servicing of medical devices Experience in complex service work on this product

Dräger recommends arranging a service contract with DrägerService.

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

4

Instructions for use Carina SW 3.2n

Contents

Contents Target groups...

4

For your safety and that of your patients. . .

7

General safety information... 8 Product-specific safety information... 12 Application... 15 Intended use... 16 Definition of sub-acute care... 16 Overview... 17 Carina basic device... Trolley... Range of functions... Abbreviations... Symbols...

18 20 21 23 25

Operating concept... 27 Operating and display unit... 28 Screen... 29 Assembly and preparation... 33 Safety information for preparation... 34 Preparing Carina... 34 Carina with trolley... 36 Safety information on breathing circuits and additional components... 39 Using bacterial filters... 40 Connecting breathing circuits... 41 Connecting the breathing gas humidifier... 43 Preparing Aeroneb Pro medication nebulizer. . 47 Connecting the power supply... 48 Connecting the gas supply... 50 Connecting the nurse call... 51 Using the MEDIBUS or MEDIBUS.X protocol... 53 Intrahospital patient transport... 54 Getting started... 57 Safety information on getting started... 58 Powering on the device... 58 Checking readiness for operation... 59 Selecting the application mode... 62 Instructions for use Carina SW 3.2n

Setting the O2 supply... Starting ventilation...

62 63

Operation...

65

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

66 67 69 70 71 72 73 73 77 78

Alarms...

81

78 79

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

87

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

88 88 89 91 91 91 93 93 93 94

Problem solving...

95

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

5

Contents

Reprocessing... 105 Dismantling... 106 Information on reprocessing... 107 Classifications for reprocessing... 108 Validated reprocessing procedures... 109 Reprocessing non-critical components... 109 Reprocessing semi-critical components... 110 After reprocessing... 110 Maintenance... 111 Overview... 112 Inspection... 113 Preventive maintenance... 114 Repair... 114 Replacing the inlet filter... 115 Charging the internal battery... 115 Disposal... 117 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 Technical data... 121 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 Trolley... 134 Alarm system of Carina... 135 Alarm delays... 136 EMC declaration... 137 Connections to IT networks... 139 Principles of operation... 141 Pneumatic function description... 142 Description of the ventilation modes... 145 Additional settings for ventilation... 155 Therapy types... 159 Additional functions... 160 Volume measurement... 162 Index... 163 6

Instructions for use Carina SW 3.2n

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... 8 Maintenance... 8 Accessories... 8 Not for use in areas of explosion hazard... 9 Connected devices... 9 Device combinations... 9 Patient safety... 9 Patient monitoring... 9 Functional safety... 10 Electromagnetic compatibility (EMC)... 10 Disposable products... 11 Sterile accessories... 11 Installing accessories... 11 Storing the instructions for use... 11 Product-specific safety information... 12 Monitoring ventilation... 14 Backup ventilation with an independent manual ventilation device... 14

Instructions for use Carina SW 3.2n

7

For your safety and that of your patients

General safety information The following WARNING and CAUTION statements apply to general operation of the medical device. 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 device.

Strictly follow these instructions for use s

WARNING Risk of incorrect operation and of incorrect use Any use of the medical device requires full understanding and strict observation of all sections of these instructions for use. The medical 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 labels. Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use.

Maintenance WARNING Risk of medical device failure and of patient injury The medical device must be inspected and serviced regularly by service personnel. Repair and complex maintenance carried out on the medical device must be performed by experts. If the above is not complied with, medical device failure and patient injury may occur. Observe chapter "Maintenance". Dräger recommends that a service contract is obtained with DrägerService and that all repairs are performed by DrägerService. For maintenance Dräger recommends the use of authentic Dräger repair parts.

Accessories WARNING Risk due to incompatible accessories Dräger has tested only the compatibility of accessories listed in the current list of accessories. 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.

8

Instructions for use Carina SW 3.2n

For your safety and that of your patients

Not for use in areas of explosion hazard

Patient safety

WARNING Risk of fire

The design of the medical device, the accompanying documentation, and the labeling on the medical device are based on the assumption that the purchase and the use of the medical device are restricted to persons familiar with the most important inherent characteristics of the medical device.

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

Connected devices WARNING Risk of electric shock and of device malfunction

Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device. The instructions for use do not contain any information on the following points: –

Risks that are obvious to users

Electrical connections to equipment not listed in these instructions for use or these assembly instructions must only be made when approved by each respective manufacturer.

–

Consequences of obvious improper use of the medical device

–

Potentially negative effects on patients with different underlying diseases

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

Medical device modification or misuse can be dangerous.

Device combinations This device can be operated in combination with other Dräger devices or with devices from thirdparty manufacturers. Observe the accompanying documents for the individual devices.

CAUTION Risk of patient injury Do not make therapeutic decisions based solely on individual measured values and monitoring parameters.

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

Patient monitoring

Device combinations that are approved by Dräger meet the requirements of the following standards: – IEC 60601-1, 2nd edition (general requirements for safety) – IEC 60601-1-1 (device combinations) – IEC 60601-1-2 (electromagnetic compatibility) – IEC 60601-1-4 (software-controlled functions) – IEC 60601-1-8 (alarm systems)

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

Instructions for use Carina SW 3.2n

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.

The responsibility for selecting the best level of patient monitoring lies solely with the user of the medical device.

9

For your safety and that of your patients

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 electromagnetic compatibility. Observe the EMC information during installation and initial operation. For further information, see the following section: ''EMC declaration'' (page 137). Portable and mobile high-frequency communication equipment can affect medical electrical equipment.

10

WARNING Risk due to electromagnetic interference Malfunctions that endanger the patient may occur if no protective measures against electrostatic discharge are employed in the following situations: – When touching the pins of connectors that carry the ESD warning symbol. – When establishing connections with these connectors. To prevent malfunctions, observe the following measures and train the relevant personnel: – Observe the ESD protective measures. Such measures may include wearing antistatic clothing and shoes, touching a potential equalization pin before and while making the connection, or using electrically insulating and antistatic gloves. – Observe the requirements for the electromagnetic environment. Observe the following section: "Electromagnetic immunity" (page 137). The medical device may only be used adjacent to or stacked with other devices when the configuration 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.

Instructions for use Carina SW 3.2n

For your safety and that of your patients

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 sufficient separation distance, see "Recommended separation distances from mobile high-frequency communication equipment" on page 138. Maintain a separation distance of at least 30 cm (1 ft) to wireless communication equipment.

Disposable products WARNING Risk of injury to patients due to failure of accessories

Installing accessories CAUTION Risk of device failure Install accessories to the basic device in accordance with the instructions for use of the basic device. Make sure that there is a safe connection to the basic device. Strictly observe instructions for use and assembly instructions.

Storing the instructions for use CAUTION Risk of incorrect use The instructions for use must be kept in an accessible location for users.

Disposable products were developed, tested and manufactured for single use only. Reuse, reprocessing, or sterilization can lead to a failure of accessories and cause injury to the patient. Do not reuse, reprocess or sterilize disposable products.

Sterile accessories 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.

Instructions for use Carina SW 3.2n

11

For your safety and that of your patients

Product-specific safety information WARNING Risk of patient injury

WARNING Risk of fire

The device may not be used for the acute inpatient 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.

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

WARNING Risk of incorrect use

If highly flammable substances are used for disinfection, adequate airing must be ensured.

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

WARNING Risk of fire

WARNING Risk of malfunctions

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

Prohibited modifications to the medical device 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

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

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.

WARNING Risk of patient injury

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

Do not use the medical device in hyperbaric chambers.

12

Hyperbaric chambers may impair correct functioning of the medical device.

Instructions for use Carina SW 3.2n

For your safety and that of your patients

WARNING Risk of patient injury

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

Because of the restricted monitoring functions (no internal monitoring of the expiratory minute volume), the device may not detect a disconnection of the breathing hose or the pilot line. This can occur particularly with low PEEP values and the use of filters with high resistance.

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 replace them if necessary. Use suitable patient monitoring (capnography) to detect increased CO2 rebreathing. WARNING Risk of patient injury If the inspiratory oxygen concentration differs from the ambient air concentration, monitoring of the inspiratory oxygen concentration with adjustable high and low alarm limits is needed. Connect an external oxygen monitor complying 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 concentration.

Instructions for use Carina SW 3.2n

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 device to overheat. Keep the medical device away from heat sources. Only use the medical device in adequately ventilated 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°.

13

For your safety and that of your patients

CAUTION Risk of electric shock

Backup ventilation with an independent manual ventilation device

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.

WARNING Risk of patient injury

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

Monitoring ventilation

If a fault is detected in the medical device, its life-support functions may no longer be assured. Ventilation of the patient using an independent ventilation device must be started without delay, if necessary with PEEP and/or an increased inspiratory O2 concentration (e.g., with a manual resuscitator).

The built-in monitoring facilities monitor the following parameters: – Airway pressure – Inspiratory minute volume – Applied minute volume (without leakage compensation) – 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 monitoring.

14

Instructions for use Carina SW 3.2n

Application

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

Instructions for use Carina SW 3.2n

15

Application

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 hospital 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 medical personnel only.

Definition of sub-acute care* Sub-acute care is comprehensive inpatient treatment of the following types of patients: –

Patients who were an acute case because of injury, 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 treatment

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 patients 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

16

Instructions for use Carina SW 3.2n

Overview

Overview Carina basic device... 18 Top... Bottom... Patient connection panel (front)... Rear...

18 18 19 19

Trolley... 20 Bed and wall mountings... 20 Range of functions... 21 Ventilation functions... 21 Breathing circuits... 21 Monitoring functions... 21 Gas supply... 22 Power supply... 22 Data transfer... 22 Medication nebulization... 22 Trolley... 22 Bed and wall mountings... 22 Abbreviations... 23 Symbols... 25

Instructions for use Carina SW 3.2n

17

Overview

Carina basic device

Top

F LED for displaying the power supply LED is green

A

External power supply (mains or external battery) The internal battery is charged.

B

LED flashes green

External power supply (mains or external battery)

LED off

Internal battery

The internal battery is being charged.

G Start/Standby key for switching between standby and ventilation

C

H G F

000

D E

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

A Handle B Screen for displaying application-specific information for ventilation

Bottom

C Keys for selecting functions and ventilation parameters D Rotary knob for setting and confirming functions and parameters

I

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)

18

Warning

Alarm LED flashes yellow

Caution

Alarm LED lights yellow

Note

K L I

001

Alarm LED flashes red

J

Switch for selecting breathing circuit with leakage valve or breathing circuit with expiratory valve, protected by sliding cover Instructions for use Carina SW 3.2n

Overview

J

Rear

Rating plate

K No function L 4 holes for positioning the device on the trolley CAUTION Risk of malfunctions

O N

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

D E F G

Patient connection panel (front)

003

M L

H I J K

D Ventilation slots

C

A

E RS232 COM port for data transfer (MEDIBUS, MEDIBUS.X) F No function G Inlet filter (HEPA filter) 002

B 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)

H HPO port for O2 compressed gas hose I

LPO port for low pressure for connecting an oxygen 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

Instructions for use Carina SW 3.2n

19

Overview

Trolley

A

I

B C 098

D I

E

Gas cylinder holder, optional

Bed and wall mountings

F

The bed and wall mountings are optional accessories.

A

077

H G A Carina holder B Standard rail handle C Trolley column

B

D Battery holder, optional E Universal holder with standard rail, optional F Base

H Double castors with locking brake, set of 4

C Wall mounting

Bed mounting 117

G Red locking lever for column holder (under base)

A Clamp with threaded handle B Spacer with 2 buffers C Carina holder

20

Instructions for use Carina SW 3.2n