Prisma VENT
Prisma VENT
WM 120 TD
prisma VENT30
prisma VENT30-C
prisma VENT40
prisma VENT50
Ventilators
Contents
Contents
1 Introduction 3 7 Repair 36
1.1 About this document ...................................... 3 7.1 General information ...................................... 36
1.2 Navigation in this document ............................ 3 7.2 Open therapy device ..................................... 36
1.3 Warnings in this document .............................. 4 7.3 Close therapy device ..................................... 39
2 Product description 5 7.4 Replacing the valve control board (only
prisma VENT50) ............................................. 41
2.1 Overview ......................................................... 5
7.5 Replacing the internal battery ........................ 44
2.2 Control panel .................................................. 7
7.6 Replacing the pressure build-up valve (only
2.3 Symbols in the display ..................................... 7
prisma VENT50) ............................................. 47
2.4 Description of function .................................... 9
7.7 Replace main board ....................................... 49
2.5 Navigating in the device ................................ 11
7.8 Replacing the knob/encoder .......................... 53
3 Servicing 12 7.9 Replace front wall of housing with display ..... 55
3.1 General information ...................................... 12 7.10 Replace central part of housing ..................... 55
3.2 Intervals ........................................................ 12 7.11 Replace blower .............................................. 58
3.3 Change filters ................................................ 12 7.12 Replace power supply unit and its
3.4 Perform firmware update .............................. 13 connecting cable ........................................... 61
4 Hygiene treatment 14 7.13 Replace rear of housing ................................. 63
4.1 General information ...................................... 14 8 Storage and disposal 64
4.2 Hygiene treatment for therapy device ............ 14 8.1 Storage ......................................................... 64
4.3 Hygiene treatment for humidifier .................. 20 8.2 Disposal ........................................................ 64
5 Final check 21 9 Replacement parts 65
5.1 General information ...................................... 21 9.1 Replacement parts list .................................... 65
5.2 Activating service mode ................................. 21 9.2 Service sets .................................................... 67
5.3 Conduct test ................................................. 24 10 Components and accessories 69
5.4 Perform function check/TSC in line with §11
of the MP BetreibV [German law governing the 11 Auxiliary equipment required 70
owners of medical devices] ............................ 25 11.1 Tools ............................................................. 70
11.2 Test equipment ............................................. 70
6 Faults 31
11.3 Disinfectants ................................................. 70
6.1 Humidifier faults ............................................ 31
6.2 Display messages ........................................... 31
6.3 Fault memory ................................................ 32
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2 | EN
1 Introduction
1 Introduction
1.1 About this document
The objective of these Servicing and Repair Instructions is to familiarize
you with the function, technology, servicing and repair of the device.
This will allow you to:
• Eliminate faults
• Perform function checks
• Perform repairs
Observe the information below when doing so.
• Repairs/servicing work may only be carried out by
Löwenstein Medical or by expert trained specialists with a
valid certificate. You are responsible for repairs carried out
yourself and for guaranteeing them!
• Use only genuine Löwenstein Medical replacement parts.
• Comply with accompanying documents (Instructions for
Use).
If you have any questions or feedback, please contact our Technical
Service team:
T: +49 40 54 70 2-100
e-mail: [email protected]
EN |3
1 Introduction
Danger!
Indicates an unusually significant hazardous situation. If you ignore this
instruction, severe irreversible injuries or death will result.
Warning!
Indicates an unusually significant hazardous situation. If you ignore this
instruction, severe irreversible or fatal injuries may result.
Caution!
Indicates a hazard. If you ignore this instruction, mild or moderate
injuries may result.
Notice!
Indicates a harmful situation. If you ignore this instruction, material
damage may result.
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2 Product description
2 Product description
2.1 Overview
2.1.1 prisma VENT30, prisma VENT30-C,
prisma VENT40
2
1
4
3 5
13 6
14
15 12
11 7
9 8
17
16
10
EN |5
2 Product description
2
1
4
3 5
6
14
15
13
16
12 7
9 8
10
11
18
17
6 | EN
2 Product description
1
10
9
2
8 Enter 3
7 5 4
6
1 Alarm acknowledgment key - mutes an alarm for 2 minutes
2 LIAM key (only present on prisma VENT50)
3 Dial for navigating in the menu
4 Function keys - have different functions
5 Monitor key for switching between different screen views
6 Home key - switches the view back to the start screen
7 Power supply indicator
8 On/off key
9 Humidifier key
10 Program key for selecting preconfigured programs
EN |7
2 Product description
SYMBOL DESCRIPTION
prisma2CLOUD module connected
SD card inserted.
Indicates respiratory status:
Arrow pointing upward: Inspiration
Arrow pointing downward: Exhalation
S: Spontaneous breath
T: Mandatory breath
Target volume switched on.
Battery fault
Alarm/alarms deactivated.
8 | EN
2 Product description
EN |9
2 Product description
2.4.4 Display
The display measuring 4.3" is for displaying all information. It is
permanently connected (bonded) to the front wall of the housing.
2.4.5 Blower
The blower is a radial blower with a finely-weighted fan wheel and a
3-phase motor with Hall sensors to detect speed continuously. The
blower is actuated by the main board, with blower speed dependent
on current pressure requirements and current leakage.
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2 Product description
EN | 11
3 Servicing
3 Servicing
3.1 General information
Servicing, safety checks [Sicherheitstechnische Kontrollen or STKs] and
maintenance measures such as servicing and repairs may only be
performed by the manufacturer or by specialists expressly so
authorized by the manufacturer.
3.2 Intervals
The therapy device is designed for a service life of 6 years.
Once these 6 years have elapsed, a complete final check (see "5 Final
check", page 21) should be performed.
In the event of use in accordance with purpose in line with the
Instructions for Use, the therapy device requires no maintenance.
In the event of use in accordance with purpose in line with the
Instructions for Use, the humidifier requires no maintenance.
If used and cleaned daily, the humidifier can be used for > 6 months.
In Germany, an STK [sicherheitstechnische Kontrolle or safety check] is
a legal requirement under §11 MPBetreibV [the German law governing
the owners of medical devices] and must be performed every 2 years
(see "5 Final check", page 21).
12 | EN
3 Servicing
EN | 13
4 Hygiene treatment
4 Hygiene treatment
4.1 General information
• This product may contain disposable items. Disposable items
are intended to be used only once. Therefore, use these items
only once and do not reprocess them. Reprocessing disposable
items may impair the functionality and safety of the product and
lead to unforeseeable reactions due to ageing, embrittlement,
wear, thermal load, the effects of chemical processes etc.
• Wear appropriate safety gear for the disinfecting process.
• Refer to the Instructions for Use for the disinfectant used.
• The Instructions for Use for the device, the components and the
accessories should also be followed.
• If there is evidence of contamination with critical germs (MRSA,
3Mrgn etc.) of the parts inside the device which carry air, the
device must be reprocessed in line with the Keredusy method or
disposed of. Reprocessing in line with the Keredusy method can be
performed up to 5 times (also in the course of regular processing).
Please follow the manufacturer's instructions for this process
(www.medizinservice-sachsen.de). Air filter WM 29651 and the
pollen filter (if present) must also be replaced. Once the Keredusy
method has been used 5 times, components must be replaced in
line with the set for change of patient, WM 15913.
14 | EN
4 Hygiene treatment
Requirement
The device was used with a bacteria filter.
1. Disinfect the following parts by wiping:
• Housing, handle and device outlet port
• Power cord
2. Replace the following parts:
• Breathing tube WM 24445
• Mask with headgear
• Carrying bag WM 29337
3. Set device to factory settings to clear all previous settings.
4. Clear therapy data.
5. Recommended: Perform a complete final check (see "5 Final
check", page 21).
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4 Hygiene treatment
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4 Hygiene treatment
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4 Hygiene treatment
Clean blower
1. Release decoupling tube 15 and spacer 54 from blower 53.
54
15
53
56
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4 Hygiene treatment
53
56
53
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4 Hygiene treatment
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5 Final check
5 Final check
5.1 General information
To simplify the test sequence, the therapy device has a programmed
step-by-step test. This is available in activated Service mode (see "5.4.2
Perform step-by-step test", page 25).
The step-by-step test comprises all the test steps necessary to check the
functionality of the therapy device.
The test sequence is independent of current therapy device settings,
i.e. patient parameters are retained unchanged.
Other service functions are furthermore available in Service mode (see
"5.2 Activating service mode", page 21).
• Perform a final check:
• After every service
• After every repair
• After every hygiene treatment
• In the final step of the step-by-step test, there is the option of
having an electronic test record generated in PDF format. The test
record can be saved on the SD card of the device.
• If you find faults or deviations from specified values during the final
check, do not use the therapy device again until the faults have
been rectified.
• Note that the final check is only possible from firmware version
1.3.0 upwards. Perform a firmware update if there is a lower
version of the firmware on the device (see "3.4 Perform firmware
update", page 13).
• Use the final check to troubleshoot. A summary of possible faults
can be found in the section entitled “Faults” (see "6 Faults", page
31).
• The auxiliary equipment required can be found in the section
entitled “Auxiliary equipment required” (see "11 Auxiliary
equipment required", page 70).
EN | 21
5 Final check
22 | EN
5 Final check
EN | 23
5 Final check
24 | EN
5 Final check
EN | 25
5 Final check
26 | EN
5 Final check
Requirement:
All the LEDs are off.
• Confirm the requirement with Yes.
The selection Buttons and LED test passed? is automatically
confirmed with Yes.
• Select Next.
10. Step 7: Test alarm.
• Select Start beeper test.
Requirement:
Alarms of varying volume are heard.
• Confirm Did you hear beeper with 4 tones? with Yes.
• Select Next.
• If no SD card present:
Insert SD card and select Start SD card test.
Requirement:
Display: SD card test status -> Passed
The selection SD card test passed? is automatically confirmed
with Yes.
• Select Next.
12. Step 9: Check PSG/system interface.
• Select Start PSG test.
Requirement:
Display: PSG UART test status -> Passed
(UART = Universal Asynchronous Receiver Transmitter)
The selection PSG test passed? is automatically confirmed with
Yes.
• Select Next.
• Select Next.
EN | 27
5 Final check
28 | EN
5 Final check
22. Disconnect the service connector from the therapy device to exit
the Service menu.
EN | 29
5 Final check
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6 Faults
6 Faults
If you are unable to eliminate faults immediately with the help of the
table, contact the manufacturer. To avoid exacerbating the damage,
do not continue operating the device.
EN | 31
6 Faults
FAULT
DESCRIPTION CAUSE REMEDY
NUMBER
101 Sensor fault Main board faulty Replace main board
102 Sensor fault Main board faulty Replace main board
Main board faulty Replace main board
103 Sensor fault
Device outlet port incorrectly assembled
Check device outlet port assembly
104 Sensor fault Main board faulty Replace main board
105 Sensor fault Main board faulty Replace main board
106 Sensor fault Main board faulty Replace main board
107 Sensor fault Main board faulty Replace main board
Set date and time so that the course of
Time not set
therapy is set correctly.
108 Real Time Clock fault
Battery on main board discharged Replace battery on main board
Main board faulty Replace main board
109 Real Time Clock fault Main board faulty Replace main board
110 Real Time Clock fault Main board faulty Replace main board
111 Real Time Clock fault Main board faulty Replace main board
Main board faulty Replace main board
113 Self-test fault
Blower faulty Replace blower
151 Sensor fault Main board faulty Replace main board
152 Sensor fault Main board faulty Replace main board
Main board faulty Replace main board
201 Blower speed fault
Blower faulty Replace blower
Main board faulty Replace main board
202 Blower speed fault
Blower faulty Replace blower
Main board faulty Replace main board
203 Sensor fault Pressure measurement tube kinked/ Check position of pressure measurement
blocked tube/remove blockage, replace tube
Main board faulty Replace main board
205 Voltage supply fault
Power supply unit faulty Replace power supply unit
Replace prismaCONNECT module
206 Module fault prismaCONNECT module module faulty
module
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6 Faults
FAULT
DESCRIPTION CAUSE REMEDY
NUMBER
Main board faulty Replace main board
PSG module faulty Replace PSG module
207 Module fault
prisma CHECK faulty Replace prisma CHECK
Connecting cable faulty Replace connecting cable
251 Blower speed fault Blower faulty Replace blower
Check tubing and position of pressure
Tubing for the pressure sensors faulty
252 Sensor fault measurement tubes
Main board faulty Replace main board
Main board faulty Replace main board
253 Sensor fault Pressure measurement tube kinked/ Check position of pressure measurement
blocked tube/remove blockage, replace tube
254 Flow fault Main board faulty Replace main board
Power supply
255 Main board faulty Replace main board
fault
Power supply
256 Main board faulty Replace main board
fault
Power supply
257 Main board faulty Replace main board
fault
Power supply
258 Main board faulty Replace main board
fault
Power supply
259 Main board faulty Replace main board
fault
Humidifier faulty Replace humidifier
260 Humidifier fault
Main board faulty Replace main board
Humidifier faulty Replace humidifier
261 Humidifier fault
Main board faulty Replace main board
500 Controller fault Main board faulty Replace main board
501 Controller fault Main board faulty Replace main board
Send therapy device to the manufacturer
502 Initialization fault Further investigation required
or replace main board
Send therapy device to the manufacturer
504 Initialization fault Further investigation required
or replace main board
Send therapy device to the manufacturer
505 Initialization fault Further investigation required
or replace main board
Send therapy device to the manufacturer
507 Initialization fault Further investigation required
or replace main board
Send therapy device to the manufacturer
508 Initialization fault Further investigation required
or replace main board
Send therapy device to the manufacturer
509 Initialization fault Further investigation required
or replace main board
Send therapy device to the manufacturer
510 Initialization fault Further investigation required
or replace main board
550 Battery fault Battery capacity < 5% Connect the device to the power supply
551 Battery fault Battery capacity < 10% Connect the device to the power supply.
552 Battery fault Battery faulty Replace battery
553 Battery fault Battery not present Fit battery
Third-party battery Fit genuine battery
554 Battery fault
Battery faulty Replace battery
Operate device at an ambient
555 Battery fault Battery temperature on limit value
temperature of 5 °C to 40 °C
Operate device at an ambient
556 Battery fault Battery temperature too high
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temperature of 5 °C to 40 °C
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6 Faults
FAULT
DESCRIPTION CAUSE REMEDY
NUMBER
Connect the device to the power supply.
557 Battery fault Battery stored for too long If fault is still being displayed after 8 h,
replace battery
558 Battery fault Battery cannot be charged Replace battery
Battery cannot be charged due to high Operate device at an ambient
559 Battery fault
temperature temperature of 5 °C to 40 °C
Battery cannot be charged due to low Operate device at an ambient
560 Battery fault
temperature temperature of 5 °C to 40 °C
561 Battery fault Battery service life at an end Replace battery
Power supply
580 All power supplies have failed Provide power supply
fault
Power supply Press alarm acknowledgment key. The
581 Device in battery mode
fault device is in battery mode.
Power supply Battery on main board Replace battery on main
582
fault discharged board
Power supply
583 Main board faulty Replace main board
fault
Humidifier or cover not connected
Connect humidifier or cover correctly
without leaks
Main board faulty Replace main board
Pressure measurement
701 Pressure measurement tube not
section fault Connect pressure measurement tube
connected
Pressure measurement tube kinked/ Check position of pressure measurement
blocked tube/remove blockage, replace tube
Check position of breathing tube or
Breathing tube kinked
replace breathing tube
Device outlet port blocked Remove blockage at device outlet port
702 Flow section fault
Main board faulty Replace main board
Assembly fault Check flow section assembly
Restrictor faulty Replace restrictor
Remove blockage in intake area or
Intake area blocked
703 Flow section fault replace air filter
Blower faulty Replace blower
Humidifier or cover not connected
Connect humidifier or cover correctly
without leaks
Main board faulty Replace main board
Power supply
751 Pressure measurement tube not
fault Connect pressure measurement tube
connected
Pressure measurement tube kinked/ Check position of pressure measurement
blocked tube/remove blockage, replace tube
Check connection from device to the
752 VBS fault Disconnection for > 2 min. patient/ventilator interface at the patient
via the breathing tube
753 VBS fault Leakage too low Check exhalation system
Fault as a consequence of 701, 203, 751,
754 Remedy primary fault
253, 252
SpO2 alarms active and no SpO2 module Deactivate SpO2/pulse alarms or
793 Module fault
present when ventilation starts reconnect Prisma Check
Further investigation Send therapy device to the manufacturer
801 Controller fault
required or replace main board
Further investigation Send therapy device to the manufacturer
802 Controller fault
required or replace main board
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6 Faults
FAULT
DESCRIPTION CAUSE REMEDY
NUMBER
Further investigation Send therapy device to the manufacturer
805 Controller fault
required or replace main board
Further investigation Send therapy device to the manufacturer
806 Controller fault
required or replace main board
Further investigation Send therapy device to the manufacturer
809 Controller fault
required or replace main board
Further investigation Send therapy device to the manufacturer
810 Controller fault
required or replace main board
Further investigation Send therapy device to the manufacturer
811 Controller fault
required or replace main board
Further investigation Send therapy device to the manufacturer
821 Initialization fault
required or replace main board
Further investigation Send therapy device to the manufacturer
824 Initialization fault
required or replace main board
Further investigation Send therapy device to the manufacturer
851 Controller fault
required or replace main board
Further investigation Send therapy device to the manufacturer
852 Controller fault
required or replace main board
Further investigation Send therapy device to the manufacturer
853 Controller fault
required or replace main board
Further investigation Send therapy device to the manufacturer
854 Controller fault
required or replace main board
Further investigation Send therapy device to the manufacturer
860 Controller fault
required or replace main board
Further investigation Send therapy device to the manufacturer
861 Controller fault
required or replace main board
Further investigation Send therapy device to the manufacturer
862 Controller fault
required or replace main board
If only listed in the service files, no further
Delay when firmware is started
action is required
870 Controller fault
Further investigation Send therapy device to the manufacturer
required or replace main board
Further investigation Send therapy device to the manufacturer
871 Controller fault
required or replace main board
Further investigation Send therapy device to the manufacturer
872 Controller fault
required or replace main board
Further investigation Send therapy device to the manufacturer
880 Controller fault
required or replace main board
Further investigation Send therapy device to the manufacturer
897 Update fault
required or replace main board
Further investigation Send therapy device to the manufacturer
898 Update fault
required or replace main board
Update SD card removed before files Insert update SD card again and restart
899 Update fault
could be copied update
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7 Repair
7 Repair
7.1 General information
• Follow the Instructions for Use and the Service and Repair
Instructions when carrying out repairs. Follow the safety
instructions in the Instructions for Use in particular.
• Perform repairs only at an ESD workstation.
• Make sure the workstation is clean.
• Only perform repairs described in these Service and Repair
Instructions.
• Perform a final check after any repair (see "5 Final check", page
21).
• Use only genuine Löwenstein Medical replacement parts.
• The auxiliary equipment required can be found in the section
entitled “Auxiliary equipment required”.
• The item numbers in this section are identical to the item numbers
in the section entitled “Replacement parts”.
• Use a sorting aid for screws and washers.
1. Press the catch key and remove cover 7/humidifier from the
therapy device sideways.
7
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7 Repair
2. Place the device on the table so that the rear of the housing 1 faces
4 downwards.
29 3. Undo the two screws 29 of front panel 4 on the underside of the
device.
4. Take panel 4 off upwards.
5. If present: Remove internal battery (see "7.5.1 Removing the
internal battery", page 44).
29
3
7. Place the device on its underside and remove the 2 plugs 45 on the
rear of the device.
8. Undo 2 screws 29.
29 45
45
29
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7 Repair
9. Swivel the front of the device 3 away upwards and lay the device
3
on its rear 1.
20
11.Only prisma VENT50: Detach tube connection for double patient
circuit pressure measurement/PEEP control 21 to the tube
connectors.
20
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7 Repair
20
EN | 39
7 Repair
4. Hold the front of housing 3 up against the top edge of the blower
box and join both parts together. In doing so, please note:
3
• The cable guide and guidance for the pressure-side tube must
be correct.
• The sealing ring for the rear of the housing 38 must engage in
the device outlet port.
38
5. Place the device on its underside and insert the 2 screws 29 on the
rear of the device and tighten them up.
6. Insert 2 plugs 45.
29 45
45
29
3
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7 Repair
4 10. Place the device on its rear 1 and insert and tighten the 2 screws
29 29 on the underside of the device.
EN | 41
7 Repair
20
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7 Repair
20
2. Connect the tube marked blue to the sensor B400 and the tube
without marking to the sensor B401.
3. Insert valve control board 28. Pay attention to the correct position
of the tubes and connecting cables.
29
Secure with 2 screws 29.
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7 Repair
1
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7 Repair
1. Connect the battery to the connection line and insert it into the
battery compartment.
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7 Repair
29
4 4. Place the device on its rear 1 and insert and tighten the 2 screws 29
29 on the underside of the device.
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7 Repair
62
64
29
62
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7 Repair
63
62
63
62
64
29
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7 Repair
62
EN | 49
7 Repair
9. Lift the main board at the side and release the ribbon cable for
display 16 on the underside of the main board.
10. Remove the main board from the front of the device.
16
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7 Repair
16
cover for the
system interface
EN | 51
7 Repair
If required If the message Code 113 appears on the therapy device after the main
board has been replaced, complete the following steps:
9. Activate Service mode: Connect service connector WM 29917 to
the system interface.
10. Connect the power supply unit to the therapy device and provide
a power supply.
The Service menu opens after approximately 3 seconds.
11. Select the Date, time, reminders field.
52 | EN
7 Repair
35
36
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7 Repair
36
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7 Repair
17
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7 Repair
5. Only prisma VENT50: Removing the valve control board (see "7.4.1
31 Removing the valve control board", page 41).
6. Undo and remove 3 screws 31.
7. Undo and remove 3 screws 30.
8. Remove the central part of the housing from the rear of the device.
9. Only prisma VENT50: Remove pressure drop valve 66.
10. Only prisma VENT50: Remove pressure build-up valve (see "7.6.1
Removing the pressure build-up valve", page 47).
11. Remove blower (see "7.11.1 Remove blower", page 58).
30
12. Remove connection line of battery main board 14 from the old
central part of housing.
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7 Repair
5. Place central part of housing on the rear of the device and fix in
31 position on rear with 3 screws 31.
6. Fix central part of housing in position at the front with 3 screws 30.
30
14
61
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7 Repair
17
39
53
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7 Repair
53
39
54
15
53
15
53
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7 Repair
53
39
39
53
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7 Repair
10
26
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7 Repair
2
3 7. Undo and remove 2 screws 29 from power supply input
connector 10 on the rear of the housing 1.
1 8. Pull power supply input connector out of the rear of the housing 1.
29
10
29
10
26
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7 Repair
EN | 63
8 Storage and disposal
8.2 Disposal
Do not dispose of the product with domestic waste.
To dispose of properly, contact a licensed, certified
electronics scrap disposal merchant. This address is
available from your Environment Officer or from
your local authority.
The device packaging (cardboard and inserts) can
be disposed of in paper recycling facilities.
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9 Replacement parts
9 Replacement parts
9.1 Replacement parts list
The item numbers in this section are identical to the item numbers in
the sections entitled “Hygiene treatment” and “Repair”.
EN | 65
9 Replacement parts
66 | EN
9 Replacement parts
EN | 67
9 Replacement parts
POSI-
TION DESIGNATION ITEM NUMBER
71 Insulating element 3 WM 29663
72 Insulating element 4 WM 29664
Set, insulating elements for central part of housing
73 Insulating element 6 WM 29666
74 Insulating element 7 WM 29667
75 Insulating element 8 WM 29668
76 Insulating element 9 WM 29669
SET FOR CHANGE OF PATIENT WM 100 TH WM 29974
77 Humidifier insert WM 29683
78 Lower part of humidifier WM 29682
79 O-ring 8-1.5 WM 1145/190
80 Label, set for change of patient WM 77161
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10 Components and accessories
EN | 69
11 Auxiliary equipment required
11.3 Disinfectants
• terralin® protect
• gigasept FF® (new)
• MIKROZID LIQUID
can be ordered from:
Schülke & Mayr GmbH
Robert-Koch-Str. 2
22851 Norderstedt, Germany
Tel.: +49 40 52 100-0
Fax: +49 40 52 100-318
Internet: www.schuelkemayr.de
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Löwenstein Medical
Technology GmbH + Co. KG
Kronsaalsweg 40
22525 Hamburg, Germany
T: +49 40 5 47 02 - 100
F: +49 40 5 47 02 - 476
www.loewensteinmedical.de