Lowenstein Medical prisma20C Installation and operating manual

EN Service and repair manual for type WM 100 TD and WM 100 TH devices
Sleep therapy devices
prisma20C prisma25S-C
prisma20A prisma25ST
prismaCR prismaLAB
prisma25S prismaAQUA
prisma30ST prisma30ST-C

2EN WM 100 TD and WM 100 TH
WM 67971b 09/2017
Table of Contents
Table of Contents
1 Introduction ................................................. 3
1.1 About this document ...................................................... 3
1.2 Navigation in this document ............................................ 3
1.3 Function ......................................................................... 4
1.4 Warnings in this document .............................................. 5
2 Product description ..................................... 6
2.1 Therapy device overview ................................................. 6
2.2 Display ........................................................................... 7
2.3 Symbols on the display .................................................. 10
2.4 Components ................................................................. 12
2.5 Accessories ................................................................... 13
2.6 Labels and symbols ....................................................... 14
3 Maintenance ............................................... 20
3.1 General information ...................................................... 20
3.2 Intervals ....................................................................... 20
3.3 Changing the filter ........................................................ 20
4 Hygienic preparation ................................. 22
4.1 General information ...................................................... 22
4.2 Hygienic preparation of the therapy device .................... 22
4.3 Hygienic preparation of the respiratory air humidifier ..... 28
5 Final test ..................................................... 29
5.1 General information ...................................................... 29
5.2 Service mode ................................................................ 29
5.3 Preparation for testing .................................................. 32
5.4 Performing a function check .......................................... 32
5.5 Checking the display and the function of the keys .......... 36
5.6 Checking the SD card .................................................... 36
6 Faults ........................................................... 37
6.1 Respiratory air humidifier faults ..................................... 37
6.2 Display messages .......................................................... 37
6.3 Error memory ................................................................ 38
7 Repairs ........................................................ 41
7.1 General information ...................................................... 41
7.2 Opening the therapy device ........................................... 41
7.3 Closing the therapy device ............................................ 43
7.4 Replacing the mainboard .............................................. 44
7.5 Replacing the display .................................................... 49
7.6 Replacing the fan .......................................................... 51
7.7 Replacing the parts of the housing ................................ 55
7.8 Replacing the battery on the mainboard ........................ 58
8 Storage and disposal ................................. 59
8.1 Storage ......................................................................... 59
8.2 Disposal ........................................................................ 59
9 Replacement parts ..................................... 60
9.1 Replacement parts list ................................................... 60
9.2 Service sets ................................................................... 61
10 Components and accessories ................... 63
11 Required auxiliary equipment ................. 64
11.1 Tools ............................................................................ 64
11.2 Test equipment ............................................................. 64
11.3 Disinfectant .................................................................. 64
12 Technical data ............................................ 65
12.1 Technical data of therapy device ................................... 65
12.2 Technical data of power supply unit .............................. 69
12.3 Technical data of respiratory air humidifier .................... 69
12.4 Pressure volume curve .................................................. 70
12.5 Pneumatic system diagram ........................................... 71
12.6 Separation distances ..................................................... 71
13 Test record ................................................. 72
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WM 67971b 09/2017
WM 100 TD and WM 100 TH EN 3
1 Introduction
1 Introduction
1.1 About this document
The aim of this service and repair manual is to familiarize you with the
device in terms of function, technology, maintenance and repairs. This
enables you to:
• provide instructions for customers
• rectify faults
• perform function checks
• carry out repairs
However, please observe the following:
• You are responsible for all repairs carried out by yourself and
for the repair warranty!
• Only use original spare parts from Löwenstein Medical.
• Please observe the accompanying documentation
(instructions for use).
If you have any queries or feedback, please contact our Technical
Service team:
T: [phone]
E: [email protected]
1.2 Navigation in this document
The buttons below provide a quick way to navigate through this
document:
• To view the last page you looked at, click the Back button.
Example: If you are on page 30 and the last page you viewed was
page 20, clicking the Back button will take you back to page 20.
• To return to the page you were viewing prior to clicking the Back
button, click the Forward button.
Example: If you were on page 20 and you clicked the Back button
to skip back to page 10, clicking the Forward button would return
you to page 20.
• Click the Contents button to go to the Table of Contents.
• Click the Previous Page button to go to the previous page.
• Click the Next Page button to go to the next page.
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4EN WM 100 TD and WM 100 TH
WM 67971b 09/2017
1 Introduction
1.3 Function
1.3.1 WM 100 TD therapy device
The fan in the therapy device sucks ambient air in through a filter,
compresses it, and routes it to the device outlet.
From here, the air flows through the hose system and the mask to the
patient. The exhalation system in front of the mask or optionally
integrated in the mask prevents CO2-enriched exhaled air from
collecting in the hose system. The therapy device determines and
analyzes the pressure and respiratory flow signal. This allows
respiratory events to be recognized.
The pressure sensor is connected to the device outlet via a hose,
allowing measurement of the pressure close to the device.
The flow sensor is connected to a flow element directly via 2 seals. The
flow element contains many lamellae, which create a laminar flow. The
laminar flow results in a pressure drop. The flow sensor calculates the
resulting differential pressure. With the aid of additional state
parameters, such as the absolute pressure, the flow sensor can also
determine the flow rate.
The device can function with one pressure level (CPAP) or with two or
three pressure levels (BILevel or inspiratory pressure, expiratory
pressure, and end-expiratory pressure). Depending on the version
employed, the pressure levels can be set automatically by the device
within preset limits, or they can be set manually. Depending on the
mode, the pressure can be continually applied at one level, or triggered
by the patient or applied with time controls. Pressure signals,
respiratory flow signals, and respiratory events can be saved and/or can
be output in analog form on a PSG system.
The therapy data are saved in the device and on an SD card for therapy
control.
The device is operated via an On/Off button and a touchscreen.
The prismaTS therapy software can be used to control the therapy
device remotely from a PC.
In the case of a power failure, the settings are retained and the therapy
is continued once the power supply is restored.
Mainboard
The mainboard forms the core of the therapy device. It contains
important components such as the flow and pressure sensors, memory
module, and controller. The controller is programmed with the
respective device firmware, which includes the whole algorithm for
device control.
In addition, the mainboard is also responsible for all the energy
management of the therapy device.
Touchscreen
The touchscreen is used to display all the information and, at the same
time, for operating and setting the therapy device. It is a resistive
touchscreen.
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WM 67971b 09/2017
WM 100 TD and WM 100 TH EN 5
1.4 Warnings in this document
Fan
The fan is a centrifugal fan with a precision-balanced fanwheel and a
3-phase motor with Hall effect sensors for continuous speed measure-
ment. The fan is controlled from the mainboard, and the fan speed de-
pends on the current pressure requirements and the current leakage.
1.3.2 WM 100 TH respiratory air humidifier
The heatable respiratory air humidifier functions on the so-called pass-
over principle. The air coming from the therapy device is routed across
the surface of a preheated water reservoir. This increases the relative
humidity and temperature of the air flow.
The humidifier level can be set individually using the buttons on the
therapy device.
The power of the heating element, and consequently the temperature
of the water in the humidifier chamber, is controlled electronically via
the therapy device.
The transparent window of the humidifier chamber makes it possible
to check the water level at any time.
1.4 Warnings in this document
Warnings are used to flag up safety-relevant information.
You will find a warning preceding any action that entails a hazard for
persons or equipment.
Warnings consist of
• the warning symbol (pictogram),
• a signal word designating the hazard level,
• information about the hazard
• instructions for avoiding the hazard.
The warnings appear in three hazard levels, depending on the degree
of danger:
Danger!
Designates an extremely dangerous situation. Failure to
observe this warning will lead to serious, irreversible injury,
or death.
Warning!
Designates an extremely dangerous situation. Failure to
observe this warning may lead to serious, irreversible, or
fatal injury.
Caution!
Designates a dangerous situation. Failure to observe this
warning may lead to minor or moderately serious injury.
Notice!
Indicates a harmful situation. Failure to observe this
warning may lead to damage to equipment.
Designates useful information relating to a particular
action.
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6EN WM 100 TD and WM 100 TH
WM 67971b 09/2017
2 Product description
2 Product description
2.1 Therapy device overview
2-1 Therapy device
123 4 5
6
7
8
9
10
11
1213
No. Designation Description
1 Cover Covers the humidifier connection when no respiratory air humidifier is connected.
2 Unlocking button Allows the cover to be removed for connecting the humidifier prismaAQUA.
3 Display Allows operation of the therapy device and the respiratory air humidifier.
Displays settings and current values.
4 System interface Connects the therapy device to modules.
5 Handle Allows lifting and transporting of the therapy device.
6 Filter compartment in suction
section
Houses the air filter and, where applicable, the pollen filter. The respiratory air is sucked in here and the
dust particles are filtered out.
7 Power input Connects the therapy device to the power supply unit.
8 Mounting holes For attaching and securing a module to the therapy device.
9 SD card slot For inserting an SD card.The symbol on the display indicates the communication between the SD card and
the therapy device.
10 Micro USB port Used for point-to-point connection with a PC on which prismaTS is installed. Allows settings to be
changed on the therapy device and data to be exported.
11 On/Off button
Switches the therapy device on and off.
Switches the therapy device to standby mode.
Starts and stops the therapy.
12 Hose heater connection Electrical power supply connection for a heatable hose (only applies to devices as of serial number 5.000).
13 Device output Connection for the breathing tube, through which the patient is supplied with respiratory air.
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WM 67971b 09/2017
WM 100 TD and WM 100 TH EN 7
2.2 Display
2.2 Display
The information shown on the display depends on the current status
of the therapy device:
•Standby mode (no therapy in progress)
The clock is shown, as is the wake-up time if the alarm clock is set.
•Therapy mode (therapy in progress)
Therapy is in progress (see "2.2.2 Display in patient sector (Start
screen in Therapy mode)", page 8).
•Energy-saving mode
The therapy device is supplied with a very low level of power;
nothing is shown on the display. You can return to Standby mode
by pressing the On/Off button .
2.2.1 Display in patient sector
(Start screen in Standby mode)
2-2 Start screen in Standby mode
1
2
3
4
5
No. Designation Description
1 Info menu button Provides access to the info menu.
2 Alarm clock with wake-up time Alarm clock is set.
Displays the set wake-up time.
3 Menu button Provides access to the settings menus.
4 Dimmer button Dims the display.
5 Clock Displays the current time.
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8EN WM 100 TD and WM 100 TH
WM 67971b 09/2017
2 Product description
2.2.2 Display in patient sector
(Start screen in Therapy mode)
2-3 Start screen in Therapy mode
21
3
4
5
67
8
9
No. Designation Description
1 Clock Displays the current time.
2 SD card symbol The SD card is in the therapy device.
3 Info button Provides access to the info screen with detailed information on the therapy currently in progress.
4 Alarm clock with wake-up time Alarm clock is set.
Displays the set wake-up time.
5 softSTART button
Switches the softSTART function on or off.
Displays the time remaining.
If the softSTART is off, the set softSTART period is displayed.
If there is no softSTART button, the physician or authorized dealer has disabled this function.
6 Respiration status symbol Indicates the current respiration status.
7 Mask status symbol with leak
indicator Indicates how well the respiratory mask is positioned.
8 Humidifier button for respiratory
air humidifier prismaAQUA
Indicates that the respiratory air humidifier is connected and switched on.
Shows the set humidifier level of the respiratory air humidifier.
9 Function buttons for the
respiratory air humidifier Allow the humidifier level to be increased/decreased.
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WM 67971b 09/2017
WM 100 TD and WM 100 TH EN 9
2.2 Display
2.2.3 Display in the expert sector
2-4 Display in expert sector (screen in BILevel ST mode in Therapy
device mode)
Please note that the screens may differ slightly depending on the set
ventilation mode and device mode.
213
4
5
6
7
9
10
11
12
13
14
15
16
8
No. Designation Description
1PSG symbol prismaPSG module is not plugged in or there is no connection.
2CONNECT symbol prismaCONNECT is plugged in.
3Network symbol Network connection available.
4Mask test button Starts the mask test and stops it prematurely.
Shows the remaining time in seconds.
5softSTART button Switches the softSTART on and off.
Shows the set/remaining softSTART time in minutes.
6Lock button Exits the settings menus and locks the parameter setting function.
7Menu button Gives access to the settings menus (only available after login).
8VT display Displays the tidal volume. Please note that if an oxygen supply unit is used, the supplied quantity of
oxygen is not taken into consideration.
9Hose diameter display Displays the diameter of the breathing tube used.
10 Info fields Display the set therapy parameters. (They can be changed here following login).
11 Respiration status symbol Indicates the current respiration status.
12 Mask status symbol with leak
indicator Displays how well the respiratory mask is positioned and the extent of any leak.
13 Actual pressure display Shows the actual pressure.
14 rAMV display / MV display Shows the relative or absolute respiratory minute volume (not available in CPAP or APAP mode).
15 Ventilation mode display Displays the set ventilation mode.
Allows selection of another ventilation mode.
16 Expert sector symbol Shows that the expert sector is open and it is possible to set the parameters.
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10 EN WM 100 TD and WM 100 TH
WM 67971b 09/2017
2 Product description
2.3 Symbols on the display
Symbol Designation Description
Device status symbols (shown on the top line of the display)
Access symbol
The expert sector is open and the parameters can be set.
The expert sector is open and the settings are locked. It is not possible to configure
parameter settings.
Bacteria filter symbol Bacteria filter is connected and active.
Filter change symbol Air filter replacement required. (Symbol only appears when air filter replacement is
active).
Maintenance symbol Maintenance required (symbol only appears when maintenance function is active).
USB symbol USB connection
Connect symbol prismaCONNECT module is plugged in.
(Green symbol)
prisma2CLOUD symbol
(Gray symbol)
prisma2CLOUD module is plugged in.
No connection to prisma2CLOUD module established.
PSG symbol
prismaPSG module is plugged in.
No connection to prismaPSG module established.
Network symbol
Network connection available.
No network connection available.
SD card symbol
SD card in SD card slot.
Symbol flashes: Data is being saved to the SD card.
Respiratory air humidifier
symbol
Respiratory air humidifier is connected and switched off. The last set humidifier level
is displayed.
Respiratory air humidifier is connected and switched on. The currently set humidifier
level is displayed.
Respiratory air humidifier is connected and empty of water.
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WM 67971b 09/2017
WM 100 TD and WM 100 TH EN 11
2.3 Symbols on the display
Alarm clock symbol Alarm clock is set.
If no alarm clock symbol is shown: the alarm clock is off.
Respiration status symbol
Displays the respiration status:
S=spontaneous
T=timed
Arrow pointing upward: Inspiration
Arrow pointing downward: Expiration
Apnea
Mask status symbol with leak
indicator symbol
Mask position is good, no leaks
Mask is not well positioned, considerable leaks, the efficacy of the therapy is not
guaranteed
Hose diameter symbol Indicates the diameter of the hose in mm.
Menu level symbol Shows the menu level that you are currently in:
The more green dots, the deeper you are in the menu structure.
Alarm window
Alarm symbol Low-priority alarm triggered.
(Black symbol)
Mute symbol
(Orange symbol)
Indicates that the acoustic signal for an alarm can be muted.
Acoustic signal for alarm is muted.
Symbol Designation Description
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12 EN WM 100 TD and WM 100 TH
WM 67971b 09/2017
2 Product description
2.4 Components
2-5 Components
1234
5
6
7
8
9
No. Designation Description
1 Respiratory mask Supplies the respiratory air to the patient.
2 Power supply unit with connection
cable
Supplies power to the device.
Connects the power supply unit to the therapy device.
3 Power supply cable Connects the power supply unit to the power socket.
4 prismaCONNECT module Creates the connection between the therapy device and PC and between the therapy device
and prismaPSG module.
5 prismaPSG module Used to convert digital signals from the therapy device into analog data.
6 PSG connection cable Connects the therapy device to the prismaPSG module.
7 Breathing tube with 19 mm diameter Connects the therapy device to the respiratory mask.
8 SD card Records therapy data.
9 Exhalation system If the mask does not feature an integrated expiratory system, the exhaled air escapes here
during the therapy.
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WM 67971b 09/2017
WM 100 TD and WM 100 TH EN 13
2.5 Accessories
2.5 Accessories
2-6 Accessories
213
86
5
791011
12
4
No. Designation Description
1 Breathing tube with 15 mm
diameter Connects the therapy device to the respiratory mask.
2 Pollen filter (white filter) Filters the suctioned respiratory air and prevents the ingress of fine dust particles, pollen and fungal
spores. Recommended for patients with allergies.
3 Heatable hose Avoids condensation in the breathing tube (only applies to devices as of serial number 5.000).
4 Inverter Enables operation of the device via a DC power socket (12 V/24 V).
Respiratory air humidifier prismaAQUA
5 Top of humidifier Seals the respiratory air humidifier.
6 Humidifier insert Prevents water from escaping.
7 Base of humidifier Holds the water for humidifying the respiratory air.
8 Lower grip recess For opening the respiratory air humidifier.
9 Input Connects the therapy device to the respiratory air humidifier.
10 Output Connects the respiratory air humidifier to the device output.
11 Heating element Heats the water in the respiratory air humidifier.
12 Upper grip recess For lifting and transporting the respiratory air humidifier.
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14 EN WM 100 TD and WM 100 TH
WM 67971b 09/2017
2 Product description
2.6 Labels and symbols
2.6.1 Labels on the therapy device
2-7 Labels on the therapy device
1 2
3
4
56
89
7
No. Symbol Description
Type plate on the right side of the therapy device
1
SN Serial number of the therapy device
Year of manufacture
Labels and symbols on the therapy device
2 , 8 Consult instructions for use
3 Device inlet: inlet for room air at ambient temperature
4 Follow the instructions for use
5 Slot for SD card
6 USB port
7 Indicates the On/Off button
9 Device output: Outlet for room air at 4 hPa to 30 hPa (depending on type of device)
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WM 67971b 09/2017
WM 100 TD and WM 100 TH EN 15
2.6 Labels and symbols
2.6.2 Labels on the respiratory air humidifier
r
2-8 Labels on the respiratory air humidifier
Type plate on the underside of the therapy device
TYPE: WM 100 TD Type designation of the therapy device
37V 37 V DC
IP21 IP protection class: Degree of protection against ingress of dangerous parts and solid foreign bodies. The
device is protected against dripping water.
Degree of protection against electric shock: Protection class II device
Do not dispose of device in household waste
Suitable for use in airplanes. Complies with RTCA/DO-160G chapter 21, Category M.
Degree of protection against electric shock: Type BF device
Manufacturer
CE mark (confirms that the product complies with the applicable European directives)
No. Symbol Description
1
2
No. Symbol Description
1 Fill with water
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16 EN WM 100 TD and WM 100 TH
WM 67971b 09/2017
2 Product description
2.6.3 Labels on the type plate of the power supply
unit
2 Respiratory air humidifier is heated. Do not touch the element!
Labels and symbols on the underside
Do not dispose of device in household waste
CE mark (confirms that the product complies with the applicable European directives)
32 V DC 32-volt direct current
Degree of protection against electric shock: Type BF device
IP21 IP protection class: Degree of protection against ingress of dangerous parts and solid foreign bodies.The device
is protected against dripping water.
>PC< Material designation: Polycarbonate
Date of manufacture (month/year)
Type: WM100TH Type designation: Device in the WM 100 TH series
Consult instructions for use
SN Serial number
No. Symbol Description
Symbol Description
Input: 100-240 V,
50-400 Hz, 1.5 A Input voltage: 100-240 V, 50-400 Hz, 1.5 A
Output: 37 V
2.43 A Output voltage 37 V DC 2.43 A
GOST-R certification (confirms that the product complies with the applicable Russian directives)
China RoHS label (confirms that the product does not emit toxic substances for the number of years indicated)
PSE mark (confirms that the product complies with the applicable Japanese directives)
Only intended for indoor use.
Degree of protection against electric shock: Protection class II device
Do not dispose of device in household waste
CE mark (confirms that the product complies with the applicable European directives)
IP21 IP protection class: Degree of protection against ingress of dangerous parts and solid foreign bodies.The device is
protected against dripping water.
29657#XXXX Serial number
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WM 67971b 09/2017
WM 100 TD and WM 100 TH EN 17
2.6 Labels and symbols
2.6.4 Labels on the therapy device packaging
2.6.5 Labels on the breathing tube packaging
2.6.6 Viewing the therapy data and device
information in the Expert Info menu
In the Expert Info menu you can view information about the therapy
quality (compliance, leaks, AHI, pressure statistics in ventilation modes
with automatic pressure adaptation) of a selectable period of time, the
required pressure, and general information about the device and
network.
Requirement • The therapy device is in Standby mode.
• The expert sector is open.
1. Press the info button .
2. If necessary: To view therapy data from a night other than the
previous night, select the desired date in the list .
3. If necessary: To view a longer period of time, navigate to the second
screen .
Symbol Description
Permissible storage temperature: -25°C to +70°C
Permissible storage humidity: 15% to 93% relative humidity
Symbol Description
For use on one patient only!
25
°C
%
%
3
1
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18 EN WM 100 TD and WM 100 TH
WM 67971b 09/2017
2 Product description
4. Select the required period.
5. Navigate back with the arrow key.
6. To view detailed information about the leakage, press the Leakage
field.
7. To view detailed information about the apnea–hypopnea index
(AHI) and respiratory parameters, press the AHI field.
8. In some modes there are also additional pages displaying the
required pressures and statistical parameters on respiratory rate and
volume. If present: Use to navigate to the second and third
screens.
9. To view the device information, navigate using the arrow keys
and and press the Device field.
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WM 67971b 09/2017
WM 100 TD and WM 100 TH EN 19
2.6 Labels and symbols
10.To exit the info menu, press the Home button .
Result The therapy data and device information are called up.
Abbreviation Description
DV Device version
SN Serial number
HW Hardware version
FW Firmware version
PM Not relevant, internal developer information
MC Not relevant, internal developer information
SID System identification of the device
N1
Therapy hours without artifacts or open mask. This counter is
reset when therapy data in the device are deleted or the device
is reset to the factory settings.
N2
Therapy hours with respiratory air humidifier (without artifacts or
open mask). This counter is reset when therapy data in the
device are deleted or the device is reset to the factory settings.
N3
Patient operating hours: Period of use including artifacts and
open mask.This counter is reset when therapy data in the device
are deleted or the device is reset to the factory settings.
N4 Fan running time. Determines the age of the device and cannot
be reset.
FU
Date of first therapy. In combination with the current counter
readings, you can use this to determine the compliance, for
example the daily usage. This is especially important when
therapy data in the device have been deleted since the last
compliance check. In this case, you can see the date of the first
therapy after the data were deleted and can reconstruct the
compliance as of this date.
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20 EN WM 100 TD and WM 100 TH
WM 67971b 09/2017
3 Maintenance
3 Maintenance
3.1 General information
Maintenance, safety checks, inspections and repairs must only be
carried out by the manufacturer or a technician specifically authorized
by the manufacturer.
3.2 Intervals
The therapy device is designed to have a useful service life of 6 years.
Once these 6 years have elapsed, a complete final test must be
performed (see "5 Final test", page 29).
If the therapy device is used for its intended purpose, in accordance
with the instructions for use, it does not require any maintenance.
If the respiratory air humidifier is used for its intended purpose, in
accordance with the instructions for use, it does not require any
maintenance.
3.3 Changing the filter
1. Remove the air filter WM 29651.
2. If present: Remove the pollen filter WM 29652.
3. Insert new pollen filter WM 29652.
4. Insert new air filter WM 29651.
Resetting the filter change interval
You need to set the filter change interval to zero if you have changed
the air filter and the reminder for the air filter change is active.
1. Switch on the therapy device.
2. To open the expert sector, hold the info button down for > 4
seconds.
3. Press the menu button .
4. Press the Reset field.
5. Press Reset air filter.
6. Press Changed.
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