Dräger Carina User manual

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 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
1Consecutive 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.
ALetters 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

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.

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)

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 . . . . . . . . . . . . . . . . 8
Product-specific safety information. . . . . . . . . . 12
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Definition of sub-acute care . . . . . . . . . . . . . . . 16
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Carina basic device . . . . . . . . . . . . . . . . . . . . . 18
Trolley. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Range of functions . . . . . . . . . . . . . . . . . . . . . . 21
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
Setting the O2supply . . . . . . . . . . . . . . . . . . . 62
Starting ventilation . . . . . . . . . . . . . . . . . . . . . . 63
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Safety information on ventilation . . . . . . . . . . . 66
Setting ventilation . . . . . . . . . . . . . . . . . . . . . . 67
Non-invasive ventilation (NIV) . . . . . . . . . . . . . 69
Using apnea ventilation . . . . . . . . . . . . . . . . . . 70
Using the AutoAdapt function . . . . . . . . . . . . . 71
Displaying setting and measured values . . . . . 72
Locking keys . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Low Pressure Oxygen (LPO) . . . . . . . . . . . . . 73
Standby mode . . . . . . . . . . . . . . . . . . . . . . . . . 77
Ending operation . . . . . . . . . . . . . . . . . . . . . . . 78
Taking the device out of service for an
extended period. . . . . . . . . . . . . . . . . . . . . . . . 78
Improving the display accuracy of the
charge state of the internal battery . . . . . . . . . 79
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Display of alarms. . . . . . . . . . . . . . . . . . . . . . . 82
Setting the alarm limits . . . . . . . . . . . . . . . . . . 84
Suppressing the acoustic alarm signal and
the nurse call . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Configuration. . . . . . . . . . . . . . . . . . . . . . . . . 87
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Opening the configuration menu . . . . . . . . . . . 88
Service menu . . . . . . . . . . . . . . . . . . . . . . . . . 89
Setting the alarm volume. . . . . . . . . . . . . . . . . 91
Setting the acoustic alarm signal. . . . . . . . . . . 91
Selecting the screen display . . . . . . . . . . . . . . 91
Selecting the application mode . . . . . . . . . . . . 93
Selecting the O2supply. . . . . . . . . . . . . . . . . . 93
Selecting Ti or I:E . . . . . . . . . . . . . . . . . . . . . . 93
Setting the night mode . . . . . . . . . . . . . . . . . . 94
Problem solving . . . . . . . . . . . . . . . . . . . . . . 95
Failure of the power supply . . . . . . . . . . . . . . . 96
Failure of the gas supply . . . . . . . . . . . . . . . . . 96
Alarm – Cause – Remedy . . . . . . . . . . . . . . . . 97
Emergency ventilation . . . . . . . . . . . . . . . . . . . 103

Contents
6 Instructions for use Carina SW 3.2n
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

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 . . . . . . 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

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.

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.

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).

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.

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 O2concentra-
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.

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 CO2concentration
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 CO2rebreathing
If a breathing circuit with a leakage valve is
used, the flushing out of CO2may 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 CO2rebreathing.
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 O2concentration with a
ventilation flow above 120 L/min is set, this O2
concentration may not be reached.
Use external O2monitoring 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°.

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 O2concentration (e.g.,
with a manual resuscitator).

Instructions for use Carina SW 3.2n 15
Application
Application
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Definition of sub-acute care . . . . . . . . . . . . . 16

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

Instructions for use Carina SW 3.2n 17
Overview
Overview
Carina basic device . . . . . . . . . . . . . . . . . . . . 18
Top . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Bottom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Patient connection panel (front) . . . . . . . . . . . . 19
Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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

Overview
18 Instructions for use Carina SW 3.2n
Carina basic device
Top
AHandle
BScreen for displaying application-specific infor-
mation for ventilation
CKeys for selecting functions and ventilation pa-
rameters
DRotary knob for setting and confirming functions
and parameters
EAudio 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)
FLED for displaying the power supply
GStart/Standby key for switching between
standby and ventilation
HSelect Menu key for opening the menus:
– Ventilation settings
– Alarms
– Measured values
– Configuration
– Locking
Bottom
ISwitch for selecting breathing circuit with
leakage valve or breathing circuit with expira-
tory valve, protected by sliding cover
000
Alarm LED flashes red Warning
Alarm LED flashes yellow Caution
Alarm LED lights yellow Note
A
B
C
D
E
F
G
H
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
001
I
K
L
J

Instructions for use Carina SW 3.2n 19
Overview
JRating plate
KNo function
L4 holes for positioning the device on the trolley
Patient connection panel (front)
AInspiratory port (connection for breathing hose)
BEmergency air inlet and oxygen overflow
CConnection for pilot line (for breathing circuit
with expiratory valve)
Rear
DVentilation slots
ERS232 COM port for data transfer (MEDIBUS,
MEDIBUS.X)
FNo function
GInlet filter (HEPA filter)
HHPO port for O2compressed gas hose
ILPO port for low pressure for connecting an ox-
ygen source, e.g., O2concentrator
JPower switch for switching on or off
KVentilation slots
LConnection for external battery (no longer fitted
from 2017 onwards)
MConnection for power cable
NNo function
OConnection 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.
002
A
B
C
003
D
E
F
G
H
I
J
K
L
M
N
O

Overview
20 Instructions for use Carina SW 3.2n
Trolley
ACarina holder
BStandard rail handle
CTrolley column
DBattery holder, optional
EUniversal holder with standard rail, optional
FBase
GRed locking lever for column holder (under
base)
HDouble castors with locking brake, set of 4
IGas cylinder holder, optional
Bed and wall mountings
The bed and wall mountings are optional accesso-
ries.
AClamp with threaded handle
BSpacer with 2 buffers
CCarina holder
077
A
B
C
E
G
F
D
H
098117
I
Wall mounting Bed mounting
A
B
C