carina_instructions_for_use_sw_3-2n_edition_5_march.pdf
Page 1
Instructions for use
Carina
WARNING
To properly use this medical device,
read and comply with these instructions for use.
Sub-Acute Care Ventilator
Software 3.2n
Page 2
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
™
MEDIBUS.X
Virex
®
®
Dräger
Dräger
Diversey
BIPAP1)
1)
2
Trademark used under license
Instructions for use Carina SW 3.2n
Page 3
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
Page 4
Target groups
Duties of the operating organization
The tasks described in this document specify the
requirements that have to be met by each respective target group.
Reprocessing personnel
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).
–
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
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
Service personnel
Task
Requirement
Installation
Specialist knowledge in
electrical engineering and
mechanics
Basic service work
(inspection)
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
Page 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 . . . . . . . . . . . . . . . . . . . . .
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 . . . . . . . . . .
Preparing Carina . . . . . . . . . . . . . . . . . . . . . . .
Carina with trolley . . . . . . . . . . . . . . . . . . . . . . .
Safety information on breathing circuits and
additional components . . . . . . . . . . . . . . . . . . .
Using bacterial filters . . . . . . . . . . . . . . . . . . . .
Connecting breathing circuits . . . . . . . . . . . . . .
Connecting the breathing gas humidifier . . . . .
Preparing Aeroneb Pro medication nebulizer. .
Connecting the power supply . . . . . . . . . . . . . .
Connecting the gas supply . . . . . . . . . . . . . . . .
Connecting the nurse call . . . . . . . . . . . . . . . . .
Using the MEDIBUS or MEDIBUS.X
protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intrahospital patient transport . . . . . . . . . . . . . .
34
34
36
39
40
41
43
47
48
50
51
53
54
Getting started . . . . . . . . . . . . . . . . . . . . . . . . 57
Safety information on getting started . . . . . . . .
Powering on the device . . . . . . . . . . . . . . . . . .
Checking readiness for operation. . . . . . . . . . .
Selecting the application mode. . . . . . . . . . . . .
Instructions for use Carina SW 3.2n
58
58
59
62
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
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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
Page 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 . . . . . .
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . .
Not for use in areas of explosion hazard . . . . .
Connected devices . . . . . . . . . . . . . . . . . . . . . .
Device combinations . . . . . . . . . . . . . . . . . . . .
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient monitoring. . . . . . . . . . . . . . . . . . . . . . .
Functional safety . . . . . . . . . . . . . . . . . . . . . . .
Electromagnetic compatibility (EMC) . . . . . . . .
Disposable products . . . . . . . . . . . . . . . . . . . . .
Sterile accessories . . . . . . . . . . . . . . . . . . . . . .
Installing accessories . . . . . . . . . . . . . . . . . . . .
Storing the instructions for use . . . . . . . . . . . . .
8
8
8
9
9
9
9
9
10
10
11
11
11
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
Page 8
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
Page 9
For your safety and that of your patients
Not for use in areas of explosion hazard
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 mixtures are likely to occur.
Connected devices
WARNING
Risk of electric shock and of device malfunction
Patient safety
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.
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
Page 10
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
Page 11
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
Page 12
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
Page 13
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
Page 14
For your safety and that of your patients
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 voltage (SELV) to the connections for the serial port
and the nurse call.
Monitoring ventilation
Backup ventilation with an independent
manual ventilation device
WARNING
Risk of patient injury
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
Page 15
Application
Application
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Definition of sub-acute care . . . . . . . . . . . . . 16
Instructions for use Carina SW 3.2n
15
Page 16
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
Page 17
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 . . . . . . . . . . . . . . . . . . . . .
Breathing circuits . . . . . . . . . . . . . . . . . . . . . . .
Monitoring functions . . . . . . . . . . . . . . . . . . . . .
Gas supply . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . .
Data transfer. . . . . . . . . . . . . . . . . . . . . . . . . . .
Medication nebulization . . . . . . . . . . . . . . . . . .
Trolley. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bed and wall mountings . . . . . . . . . . . . . . . . . .
21
21
21
22
22
22
22
22
22
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 23
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Instructions for use Carina SW 3.2n
17
Page 18
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
Page 19
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
Page 20
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
Page 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.
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.
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 inspiratory tidal volume of the patient.
– VC-SIMV, VC-AC and SPN-CPAP/PS (VG)
control the calculated inspiratory tidal volume of
the patient.
Instructions for use Carina SW 3.2n
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
21
Page 22
Overview
Patient monitoring is supported by setting the following 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
Trolley
Carina can be placed on a trolley.
An optional gas cylinder holder can be attached to
the trolley.
Bed and wall mountings
Gas supply
An internal turbine supplies Carina with ambient air.
Optional bed and wall mountings are available for
fixing Carina to a bed or wall.
O2 supply
–
High Pressure Oxygen (HPO) from the central
gas supply system or from compressed gas cylinders
–
Low Pressure Oxygen (LPO) from an external
low-pressure oxygen source, e.g., O2 concentrator
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.
22
Instructions for use Carina SW 3.2n
Page 23
Overview
Abbreviations
Abbreviation Explanation
Abbreviation Explanation
%PIF
Percentage of the peak inspiratory
flow
HME
Heat Moisture Exchanger, heat
and moisture exchanger
Apn.Vent.
Apnea ventilation
hPa
Aut.Adapt
Function AutoAdapt in SPNCPAP/PS, generates a linear pressure increase over a defined period
to accustom patients slowly to ventilation.
Hectopascal, unit of measurement
for pressure
1 hPa = 1 mbar = approx. 1 cm
H2O
HPO
High Pressure Oxygen, high-pressure O2 supply from the central gas
supply system or an O2 compressed 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 oxygen 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
AutoFlow
Automatic optimization of inspiratory flow
BF
Insulation class Body Floating
BTPS
Body Temperature Pressure Saturated, measured values based on
the condition of the patient’s lungs,
body temperature 37 °C (98.6 °F),
atmospheric pressure, water vapor-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 Spectrum
FiO2
Inspiratory O2 concentration
HEPA
High Efficiency Particulate Air
Instructions for use Carina SW 3.2n
23
Page 24
Overview
Abbreviation Explanation
Abbreviation Explanation
Paw
Airway pressure
T0...90
Paw high
Airway pressure high
PC-AC
Pressure Control – Assist Control,
assisted-controlled, pressure-controlled ventilation with backup respiratory rate
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 therapeutic pressure level is reached
Pressure Control – Biphasic Positive Airway Pressure, spontaneous
breathing under continuous positive airway pressure with 2 different
pressure levels
Tapn
Apnea alarm time (time until apnea
ventilation starts or an apnea alarm
is triggered)
Tdiscon
Delay time to alarm Airway pressure low !!!
PEEP
Positive end-expiratory pressure
Te
Expiratory time
PEEPadp
Start-up value of PEEP in
AutoAdapt
Ti
Set value of inspiratory time
Timax
PIF
Peak Inspiratory Flow
Maximum inspiratory time during
pressure support
Pinsp
Set value of upper pressure level in
pressure-controlled ventilation
modes
Tube
Tube ventilation (invasive ventilation)
UMDNS
PIP
Peak Inspiratory Pressure, measured peak inspiratory pressure
Universal Medical Device Nomenclature System, nomenclature for
medical devices
Pmax
Maximum allowed airway pressure
VC-AC
Pmean
Mean airway pressure
PS
Pressure Support
Psupp
Set value of pressure support, absolute
Volume Control – Assist Control,
assisted-controlled, volume-controlled ventilation with fixed inspiratory flow and backup frequency
with AutoFlow
VC-SIMV
R
Resistance
Ramp
Pressure rise time
Volume Control – Synchronized Intermittent Mandatory Ventilation
with AutoFlow (volume-controlled)
RR
Respiratory rate
VG
Volume Guarantee
RR high
Upper alarm limit for respiratory
rate
VT
Tidal volume
VTapn
Tidal volume with apnea ventilation
RRapn
Respiratory rate of apnea ventilation (set value)
VTi
Inspiratory tidal volume
SELV
Safety Extra Low Voltage
SPNCPAP/PS
Spontaneous – Continuous Positive Airway Pressure/Pressure
Support, spontaneous breathing
with continuous positive pressure
level and with or without pressure
support
PC-BIPAP
24
Instructions for use Carina SW 3.2n
Page 25
Overview
Symbols
Symbol
Explanation
Symbol
Explanation
Device switched on
Charge state of internal battery 75
to 89 %
Device switched off
Charge state of internal battery 50
to 74 %
Nurse call
Charge state of internal battery 30
to 49 %
Data interface (RS232 COM port)
Charge state of internal battery 0 to
29 %
Power supply display
Start/Standby key
Standby mode on/off
Select Menu key
Audio paused 2 min. key
To suppress the acoustic alarm signal 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 suppressed for a maximum of
2 minutes
^
1
2
3
4
Menu 1
1
2
3
4
Menu 2
1
2
3
4
Menu 3
1
2
3
4
Menu 4
Upper alarm limit
Lower alarm limit
Caution: Observe important safety
information and precautions in the
instructions for use.
Alarm limit switched off
Connection for pilot line (for breathing circuit with expiratory valve)
Observe the instructions for use
Breathing circuit with expiratory
valve
Warning! Strictly follow these instructions for use
Breathing circuit with leakage valve
Inspiratory port (connection for
breathing hose)
int
Power supply – internal battery
ext
Power supply – external battery
Spontaneous breathing activity by
the patient
nom. 22 kg (48.5 lbs)
max. 63 kg (139 lbs)
Nominal weight and maximum
weight (for information, see chapter
"Technical data")
Gas inlet (emergency air inlet)
Gas outlet (oxygen overflow)
Mains power supply
Information on disposal
Charge state of internal battery 90
to 100 %
BF type application mode
Instructions for use Carina SW 3.2n
25