Siemens Drager medical Carina Instruction Manual

The Carina Guidelines are not a replacement or
substitute for the Instructions for Use.
Any use of the device requires full understanding
and strict observation of the Instructions for Use.
The user must be familiar with the device according
to the national and local laws and recommendations.
Carina Guidelines

Page
1 Table of contents 2
2 Intended Use Carina 3
3 What is what 4
3.1 Control panel, top 4
3.2 Carina underside 4
3.3 Front connection block 5
3.4 Rear connection block 5
3.5 Trolley 1-78 cm 6
3.6 Screen Layout 6
3.7 Status line for displaying current device settings 6
4 Preparation 7
4.1 Connecting electrical power 7
4.2 Connecting the oxygen supply 7
4.3 Setting up the ventilator breathing circuit 8
4.4 Powering up the ventilator 9
4.5 Ventilator setting 10
4.6 Setting alarm limit 11
4.7 Displaying set value and measured value 11
4.8 Configuration 12
4.9 Locking bottons 12
5 Alarm handling 13
5.1 In the event of alarm 13
5.2 Suppressing the alarm tone 13
6 Standby and switch OFF 14
6.1 Switching Carina to Standby 14
6.2 Switching OFF the device 14
7 Cleaning and maintenance 15
7.1 Cleaning intervals 15
7.2 Maintenance intervals 15
8 Alarm message Cause & Remedy 16
9 Accessories 18
9.1 Accessories for Carina 18
9.2 Mask cleaning 19
10 Preparation procedure 20
Table of contents

Intended Use
Carina – long-term ventilator for ventilator-
dependent patients or ventilator-assisted patients.
• For treatment of sub-acute care patients in
hospital or medical rooms.
• For invasive ventilation or non-invasive
ventilation.
• For patients with a tidal volume of at least 100 mL.
• For use by qualified medical personnel.
WARNING!
Not intended for acute inpatient care of
nonstabilized patients who require ventilation
with comprehensive continuous monitoring
according to IEC 60601-2-12 or EN 794-1.
Sub-acute care definition
Sub-acute care is comprehensive, inpatient care for
patients who:
• Have had an acute event resulting from injury,
illness or exacerbation of a decease process;
• Have a determined course of treatment;
• Though stable, require diagnostics or invasive
procedures, but not intensive procedures
requiring an acute level of care.
• The severity of the patient’s condition requires:
• Active physician direction with frequent
on-site visits;
• Professional nurse care;
• Complex medical and/or rehabilitative care.
Typically sub-acute care is designed to return
patients to the community or transition them to a
lower level of care.
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2 Intended Use

3 What is what
4
3.1 Control panel, top
Carrying handle
Screen
Buttons for functions and parameters
Rotary knob
Audio paused 2 min. button
LED for indicating power supply:
• LED lit = External power supply (mains/external
battery), internal battery is charged
• LED flashes = External power supply
(mains/external battery), internal battery
is being charged
• LED off = battery operation
»Start/Standby« button
»Select Menu« button
3.2 Carina underside
Switch for hose system with leak valve or hose
system with expiration valve masked by sliding cover
(not illustrated)
Future functions
Holes for positioning on the trolley (4 off)
3.3 Front connection block
Ventilation hose connection
Emergency air inlet and oxygen overflow
Connection for control hose
(for hose system with expiration valve)
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3 What is what
3.4 Rear connection block
Not assigned
Connection for nurse call system
RS 232 serial port (MEDIBUS)
Not assigned
Inlet filter (HEPA filter)
Connection for HPO oxygen supply
Connection for LPO oxygen supply
Mains switch
Connection for external battery
Power cable connection
3.5 Trolly
Carina bracket
Standard rail grip
Universal bracket
with standard rail, optional
Trolley column
Pedestal
Red locking lever of the
column mount closed
(under pedestal)
Dual rollers with locking
brakes, 4 each
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3 What is what
3.6 Screen layout
Alarm line for alarm message
Status line for current device settings
Display for real-time waveforms of flow and pressure
Display for 2 measured values, configurable
Information line
Display of ventilation parameters
3.7 Status line for displaying current device settings
LPO oxygen supply
Power supply
Charge of internal battery
Hose system – expiration valve or leak valve
Ventilation method – tube or mask
Set ventilation mode
Patient effort detection
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int Internal battery
ext External battery
Mains
1 2 3 4 5 6 7

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4 Preparation
4.1 Connecting electrical power
• Plug the ventilator power cable into device
AC power
• Secure with the wire clip.
• Insert the mains plug into a power socket.
• The LED flashes or lights up according to the
charge of the internal battery.
• If you are using an External battery or heated
humidifier, plug their power cord to AC power
as well.
4.2 Connecting the oxygen supply
• Screw the O2compressed gas hose onto the
HPO nozzle or tube from O2gas cylinder
onto the LPO nozzle of Carina.
• Supply with oxygen from the central supply
or from the O2gas cylinder/concentrator .
C
B
A
A
B
C

4.3 Setting up the ventilator breathing circuit
Select hose system Leak valve system or expiration
valve system
Open the sliding cover on the underside of Carina.
Using a coin, turn the switch to your hose system
Close the sliding cover.
Leak valve hose system:
Connect the filter to socket.
Connect the ventilation hose: VentStar Carina LV
(MP00312) to filter.
The hose system is displayed on the status line of the
screen as follows: »LeakV«.
or:
Expiration valve hose system:
Connect the filter to socket.
Connect the ventilation hose: VentStar Carina EV
(MP00313) to filter
Connect the pilot line of the expiration valve to
pilot hose socket.
The hose system is displayed on the status line of the
screen as follows: »ExpV«.
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4 Preparation
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4 Preparation
4.4 Powering up the ventilator
Carina switching on
Set the mains switch to
Carina conducts a self-test.
During the self-test the screen indicates the
progress of the self-test.
That is followed by the screen showing the
ventilation mode and parameters last set.
The device is in standby mode.
Starting ventilation
Press the »Start/Standby« key.
Carina ventilates at the ventilation parameters set.
The screen shows the current ventilation waveforms
and values. For configuration of the screen display,
see page 86 Instruction for Use.
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2

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4 Preparation
VC-SIMV AF Volume Control – Synchronized Intermittent Mandatory
Ventilation
AF - AutoFlow
Trigger can be switched OFF VC-CMV
PC-BIPAP*Pressure Control – Biphasic Positive Airway Pressure
Trigger can be switched OFF PC-CMV
PC-AC Pressure-controlled, assisted ventilation
SPN-PS Spontaneous - Pressure Support
For patients with sufficient spontaneous breathing.
Volume guarantee VG can be switched on in ventilation mode SPN-PS.
Tidal volume guarantee
SPN-CPAP Spontaneous - Continuous Positive Airway Pressure
Apnoea ventilation For automatically switching to volume-controlled,
mandatory ventilation (VC-SIMV AF) in the event
of apnoea.
Only on SPN-PS and SPN-CPAP
* Trademark used under license
4.5 Ventilator settings
Vent.
Settings Alarms Values Config. Un
locked
Push „Menu“ key

11
4 Preparation
4.6 Setting alarm limits
The current measured value is
displayed between the upper and
lower alarm limits.
4.7 Displaying set values
and measured values
Measured values, set values and
pressure curve are displayed.
The screen displays:
•Settings
• Measured values
• graphic representation of Paw
NOTE:
Measured Frequency on VC-SIMV and PC-BIPAP
displays only mandatory breaths per minute.
(Spontaneous breaths are not counted)
Alarm Setting range
Paw high 10 to 55 mbar
MVi high 2 to 40 L/min
MVi low 0.1 to 39 L/min
f high 10 to 50 bpm
Tapnea 5 to 60 seconds
Tdisconn Mask: 0, 15, 30, 60, 90, 120 sec.
Tube: 0, 15, 30, 60 sec.
Vent.
Settings Alarms Values Config. Un
locked
Vent.
Settings Alarms Values Config. Un
locked

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4 Preparation
4.8 Configuration
The configuration menu shows the configurable
functions and parameters:
4.9 Locking buttons
All the buttons (apart from the »Audio paused 2 min.«
button) can be locked in order to prevent them from
being pressed accidentally.
Locking: Press the »Un-Locked« button and keep it
pressed until the colour of the button switches to red
and the button indicates »Locked«.
Unlocking: Press the »Locked«
button, thus unlocking the buttons.
1st page Service: for system and contact information and log book
(Password:12345)
Volume: adjustable from 1 to 5
Tone: default tone or Dräger tone can be selected
Screen: adjustable for displaying curves or values
2nd page Set value: for selecting measured values to display value 1 and value 2
Method: for setting mask or tube ventilation
LPO: for setting LPO oxygen supply
Ti / I : E: for selecting the setting used for Ti or I : E ratio
3rd Page Night: for switching on the screen in night screen mode
after 3min. display
Vent.
Settings Alarms Values Config. Un
locked
Vent.
Settings Alarms Values Config. Un
locked
Vent.
Settings Alarms Values Config. Locked

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5 Alarm handling
5.1 In the event of an alarm
If the alarm message, e.g. »MV high !!«, appears in the
alarm line on the screen.
Carina assigns the message an appropriate level of
priority.
Red !!! = Alarm Message with the highest priority
Yellow !! = Important Message with medium priority
Yellow ! = Note Message with low priority
5.2 Suppressing the alarm tone
for up to 2 minutes:
Press »Audio paused 2 min.« key.
The alarm tone is suppressed for approx. 2 minutes.
The symbol of silent alarm is displayed on the
screen. If an alarm with a higher or equal priority
occurs during the period when the alarm tone is
suppressed, the alarm tone sounds again.
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MV high !!

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6 Standy-by and Switch OFF
6.1 Switching Carina to Standby
Press »Start/Standby« key for approx. 3 seconds
– Carina is in standby mode.
LED in the key flashes.
The alarm line shows »Standby activated«.
6.2 Switching off the device
Switch Carina to standby.
Set the mains switch to
Carina is switched off.
Carina cannot be switched off during ventilation.
Carina signals »Switch off via standby!!«
The internal battery is also charged when the device
is switched off.
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7 Cleaning and maintenance
Part Time schedule Activity
Carina basic unit Per patient Wipe outside
Trolley, hinged arm Per patient Wipe outside
HPO hose
Silicon hose Per patient/ weekly Immerse if possible
Reusable water trap Sterilise hot steam 134°C /10 min
Cleaning and disinfection
machine 93°C /10 min
VentStar Carina LV Per patient / weekly Replace
(MP00312)
VentStar Carina EV Per patient / weekly Replace
(MP00313)
Leakage valve Per patient Replace
7.1 Cleaning intervals
Disposable component: Please follow the instructions from the factory. Please
change disposable component weekly or in accordance with the rules specified
or applicable for your hospital.
7.2 Maintenance intervals
Clean and disinfect equipment and/or components before any maintenance
procedures and before returning for repair.
UUsseessuurrffaacceeddiissiinnffeeccttaanntt::
• Aldehydes • Quaternary ammonium compounds
TTooaavvooiiddtthheeppoossssiibbiilliittyyooffddaammaaggeettoommaatteerriiaall––ddoonnoottuusseeaannyyddiissiinnffeeccttaannttssbbaasseeddoonn::
• Alkylamine-based compounds • Strong organic acids
• Phenol-based compounds • Oxygen-releasing compounds
• Halogen-releasing compounds
Part Time schedule Activity
Nurse call (if applied) Per month Test
HEPA filter 6 monthly Replace
Internal Battery 3 monthly Recharge battery
(if not used temporarily) To be replaced by NiMH batteries should be disposed
technicians after 3 years. of as special waste
Technical and safety Annually Device check
inspections by service

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8 Alarm message Cause & Remedy
Error message Cause Remedy
Airway pressure high !!! The excess pressure alarm can be Check condition of patient,
caused by continuous coughing. check ventilation pattern, correct
alarm limit if necessary.
Airway pressure low !!! A connection has become detached. Make sure the hoses, filters and
other components are secure again.
Check the setting of Tdisconn.
High frequency !!! Patient is breathing at a high Check condition of patient,
spontaneous frequency, therefore check ventilation pattern, correct
the monitored overall frequency alarm limit if necessary.
is too high.
MV high !! The minute volume has exceeded Check condition of patient and
the upper alarm limit. ventilation pattern, correct alarm
Leak in breathing system. limit if necessary.
MV low !!! The minute volume has exceeded Check condition of patient and
the lower alarm limit. ventilation pattern, correct alarm
Leak in breathing system. limit if necessary.
Apnoea ventilation !!! The device has detected respiratory Apply controlled ventilation or
arrest in SPN-PS or SPN-CPAP mode extend apnoea alarm time Tapnea.
and will ventilate under control in
VC-SIMV mode until Spontaneous
breathing resumes.
8.1 Trouble shooting tips: Clinical related alarms
Error message Cause Remedy
Disconnection/high After the leakage alarm, Carina Check hoses, filters and other
leakage ! delivers a low constant flow at components to make sure the
PEEP level. When the leak has connections are not leaking
been eliminated, Carina and are secure.
Automatically resumes operation at
the previous ventilation settings.
Large leakage !!! Note: This is only displayed Check hoses, filters and other
after the 3rd ventilation stroke. components to make sure the
The hose system is leaking. connections are not leaking
and are secure.
Insufficient O
2
/LPO O
2
supply is too low . Check the HPO and LPO settings
set? ! Carina is working in LPO or HPO in the Configuration menu
mode if the O
2
-compressed In HPO mode: Check central
gas connection is not correct. gas supply.
Inlet filter missing !! The inlet filter has been removed Insert inlet filter.
or is not inserted correctly. Check that the inlet filter is secure.
8.2 Trouble shooting tips: Functional related alarms
These tips are not a replacement for the Instructions for use.

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8 Alarm message Cause & Remedy
Error message Cause Remedy
External power failure !! The device has no external Check the mains supply or DC
power supply. power supply.
The mains or DC plug is loose. Insert the mains plug or DC
plug properly at both ends.
The mains or DC cable has a break. Connect a replacement battery.
Mains power failure. Connect to the mains. Charge
The external battery is flat. external battery.
Int. battery activated ! Lack of an external power supply. Reconnect external power supply.
Int. battery low ! Battery charge: less than 50 % Charge the battery:
Connect external power supply.
Int. battery low !!! Battery charge: less than 25 % Charge the battery:
Connect external power supply.
Int. battery empty !!! Battery charge: less than 5 % Connect ventilator immediately to
The operating time with supply mains power supply or to a fully
from the internal battery has expired. charged external battery.
8.3 Trouble shooting tips: Battery related alarms
Error message Cause Remedy
Auto Reset !!! Internal system fault. The device performs a restart.
Ventilation continues. After 3
attempts the device stops ventilation.
Disconnect the patient from Carina
and continue ventilation immediately
using a different, separate ventilator.
Call DrägerService.
Technical alarm !! The device has a technical problem. Use a replacement device.
This Technical Failure does not affect Call DrägerService.
to the breathing function.
e.g. Hard key defect
Technical alarm !!! The device has a technical problem. Use a replacement device.
This Technical Failure might affect to Call DrägerService.
the breathing function.
e.g. Temperature sensor defect
Device failure !!! The device has a fatal technical Immediately disconnect the patient
problem. Device will immediately from Carina and continue ventilation
stop ventilation. e.g. Blower defect using a different ventilator.
If the device cannot be turned off,
remove the O
2
hose from the central
supply and then turn off the device.
Call DrägerService.
8.4 Trouble shooting tips: Technical failure alarms
These tips are not a replacement for the Instructions for use.

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9 Accessoires
Nr. Product Number Description
1 Ventstar Carina LeakV MP00312 Dispo. hose with leakage valve
Length: 150 cm, 5 pieces
2 Ventstar Carina ExpV MP00313 Dispo. hose with expiration valve
Length: 150 cm, 5 pieces
3 Filter CareStar 30 MP01770 For device protection
4 HEPA filter 5703105 Consumable parts for Carina
Exchange: Every 6month
5 NovaStar size L MP01581 Gel mask: Reusable
6 NovaStar size M MP01580 Gel mask: Reusable
7 NovaStar size S MP01579 Gel mask: Reusable
8 ClassicStar size L MP01575 Air cushion Mask
9 ClassicStar size M MP01574 Air cushion Mask
10 ClassicStar size S MP01573 Air cushion Mask
11 Two-side pump ball MP01590 To inflate ClassicStar Air cushion
12 Leak valve "silent flow" MP00224 Dispo. leakage valve, 5 pieces
13 Expiration valve MP00220 Dispo. expiration valve, 1 piece
14 Spiral hose E 150 cm 2165643 Reusable silicone hose: 150 cm
VentStarLV VentStarEV
CareStar
Pump ball
HEPA filter
NovaStar
9.1 Accessories for Carina
ClassicStar

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9 Accessoires
9.2 Mask cleaning
Headband:
• Separate the headband from the mask.
• Hand wash the headband in warm water using
pure soap.
• Rinse thoroughly in cold water and allow to dry
in the air, protected from direct sunlight.
Mask:
• Separate the headband from the mask.
• Soak the mask in enzymatic cleaning agent,
then rinse thoroughly in cold water and allow to
dry in the air, protected from direct sunlight.
Disinfection
Chemical disinfection:
Immerse the mask in one of the solutions listed
below for 15 minutes and then allow to dry,
protected from direct sunlight.
Gigasept®FF
Korsolex®extra
Korsolex®plus
Cidex®OPA
NOTE
Cleaning agents containing care or moisture
additives must not be used as
these leave residues.
NOTE
If adhesive substances are not removed, the mask
must be replaced.
NOTE
The headband cannot be disinfected or sterilized.
NOTE
The manufacturers specification must be observed
when using cleaning agents or disinfectants.
NovaStar

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9 Preparation procedure
Checklist
Aspect Measure Requirement Checked
System Prepare the device, HPO Hoses
configuration see chapter "Preparation", Electrical cables
as of page 32 Instructions for Use. HEPA Inlet filter
and components must
be connected properly.
Additional components
for example:
LPO hose
External battery
Set hose system: Leak valve, The hose system used must
page 40 Instructions for Use. be set correctly on the device.
Expiration valve, page 41 Filters
Instructions for Use. VentStar LV
(MP00312)
or
Filters
VentStar EV
(MP00313)
Pressure tube
Hygiene Take all hygiene precautions. Device, hoses, cables and
See "Cleaning" on page 102 components must be perfect
Instructions for Use. in terms of hygiene.
LEDs, check Switch on the device, LEDs light up
alarm tone see page 54 Instructions for Use.
Main switch
LED
LED
Safety Connect the test lung to the
hose system.
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After a successful check, Carina is ready for use on the patient.
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