EN Instructions for Use for devices of type WM 090 TD
prisma SMART
prisma SOFT
Sleep therapy devices
Contents
Contents
1 Introduction 4
1.1 Intended use ............................................................................................. 4
1.2 Description of function ............................................................................. 4
1.3 User qualifications ..................................................................................... 4
1.4 Indications ................................................................................................ 4
1.5 Contraindications ...................................................................................... 5
1.6 Side effects ............................................................................................... 5
2 Safety 6
2.1 Safety information .................................................................................... 6
2.2 General information .................................................................................. 6
2.3 Warnings in this document ....................................................................... 8
3 Product description 9
3.1 Overview .................................................................................................. 9
3.2 Operating states ..................................................................................... 10
3.3 Control panel .......................................................................................... 10
3.4 Symbols in the display ............................................................................. 11
3.5 Accessories ............................................................................................. 12
4 Preparation and operation 13
4.1 Set up and connect the device ................................................................ 13
4.2 Start therapy ........................................................................................... 15
4.3 End therapy/switch off device ................................................................. 15
4.4 Set humidifier ......................................................................................... 15
4.5 Performing the mask test ........................................................................ 16
4.6 Switch softSTART on and off ................................................................... 17
4.7 Use SD card (optional) ............................................................................. 18
5 Menu settings 19
5.1 Function of the keys ................................................................................ 19
5.2 Settings menu ......................................................................................... 19
5.3 Info menu/read out operating hours ....................................................... 21
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Contents
6 Hygiene treatment 22
6.1 General information ................................................................................ 22
6.2 Cleaning intervals ................................................................................... 22
6.3 Hygiene treatment for device .................................................................. 23
6.4 Hygiene treatment for breathing tube ..................................................... 25
7 Function check 25
8 Troubleshooting 26
8.1 Device faults ........................................................................................... 26
8.2 Display messages .................................................................................... 27
9 Servicing 28
10 Storage 28
11 Disposal 28
12 Appendix 29
12.1Technical data ......................................................................................... 29
12.2Marks and symbols ................................................................................. 33
12.3Scope of supply ...................................................................................... 35
12.4Accessories and replacement parts .......................................................... 36
12.5Warranty ................................................................................................ 36
12.6Declaration of conformity ....................................................................... 36
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1 Introduction
1 Introduction
1.1 Intended use
Devices of the WM 090 TD type are pressure-controlled, non-invasive, non-lifesupporting therapy devices for treating sleep-related breathing disorders (SRBDs) using
a mask. The devices are used on persons weighing 30 kg or more. CPAP mode can be
used on persons aged 3 years upwards. The device may only be used on a physician's
instructions. (auto)CPAP mode provides positive airway pressure for treating
obstructive sleep apnea in patients who breathe spontaneously. Devices of the
WM 090 TD type are used in clinical facilities and in the domestic environment. In the
domestic environment, the devices also accompany the owner on trips away.
1.2 Description of function
A blower takes in ambient air through a filter and pumps it to the patient at therapy
pressure through the patient circuit and the patient/ventilator interface. The user
interface is for displaying and setting the available parameters. Therapy data are saved
on the SD card and can be evaluated using PC software.
1.3 User qualifications
The person operating the device is referred to in these Instructions for Use as the user.
A patient, on the other hand, is the person receiving the therapy.
As an owner/operator or user you must be familiar with the operation of this medical
device. The owner/operator is responsible for ensuring the compatibility of the device
and of all the components or accessories connected to the patient before use.
When the device is handed over to the patient, as the attending physician or medical
specialist you must provide instruction in the function of the device.
1.4 Indications
prisma SOFT
CPAP therapy device for treating patients with obstructive sleep apnea with a constant
pressure requirement.
prisma SMART
APAP therapy device for treating patients with obstructive sleep apnea with a variable
pressure requirement. Therapy pressure adapts automatically to the patient's pressure
requirement.
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1 Introduction
1.5 Contraindications
The following contraindications are known - in the individual case, responsibility for
deciding whether to use the device rests with the attending physician. Threatening
situations have not ever been observed.
Cardiac decompensation, severe cardiac arrhythmias, severe hypotension, especially in
combination with intravascular volume depletion, severe epistaxis, high risk of
barotrauma, severe lung disease (e.g. COPD), pneumothorax or pneumomediastinum,
pneumoencephalus, head injury, status following brain surgery and following surgical
procedures on the hypophysis or middle or inner ear, acute inflammation of the nasal
sinuses (sinusitis), middle ear infection (otitis media) or perforated eardrum,
dehydration.
1.6 Side effects
When using the device, the following undesired side effects may occur in short-term
or long-term use: pressure points from the mask and the forehead cushion on the face,
reddening of the facial skin, dry throat, mouth, nose, feeling of pressure in the sinuses,
irritated mucous membrane in the eyes, gastrointestinal insufflation of air
("bloating"), nosebleeds, reduced auditory capacity.
These are general side effects not attributable specifically to use of devices of the
WM 090 TD
type.
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2 Safety
2 Safety
2.1 Safety information
2.1.1
Handling the device, the components and the accessories
If the device is damaged or its function is restricted, patients, users and people in the vicinity
may be injured.
⇒ Only operate the device and its components if they are externally undamaged.
⇒ Perform a function check at regular intervals (see "7 Function check", page 25).
⇒ Only operate device within the specified ambient conditions (see "12.1 Technical
data", page 29).
⇒ Do not reuse disposables. Disposables may be contaminated and/or their function may
be impaired.
⇒ Water and dirt in the device may damage the device.
⇒ Only transport the device with the cover fitted.
⇒ Transport the device in the associated carrying bag.
⇒ Do not transport or tilt the device with the humidifier full.
⇒ Use the gray air filter.
⇒ Use the white pollen filter (optional accessory) if required.
2.1.2
Energy supply
Operating the device outside the specified energy supply may injure the user and damage
the device.
⇒ Operate the device only with the power supply unit provided on voltages from 100 V
to 240 V.
⇒ Use the DC adapter for operation on voltages of 12 V or 24 V.
⇒ Keep access to the power supply connector and the power supply free at all times.
2.1.3
Handling oxygen
Supplying oxygen without a special safety device can lead to fire and injure people.
⇒ Follow the Instructions for Use for the oxygen supply system.
⇒ Set up oxygen sources at a distance of over 1 m from the device.
⇒ At the end of therapy, shut off the oxygen supply and allow the device to run on briefly
to flush residual oxygen out of the device.
2.2 General information
• The use of third-party articles may lead to incompatibility with the device. In such
cases, please be aware that any claim under warranty and liability will be void if neither
the accessories nor the genuine replacement parts recommended in the Instructions
for Use are used.
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2 Safety
• Have measures such as repairs, servicing and maintenance work carried out by the
manufacturer or by specialists expressly so authorized by the manufacturer.
• Connect only the devices and modules permitted in accordance with these Instructions
for Use. The devices must meet the product standard applicable to them. Non-medical
equipment should be positioned away from the patient's vicinity.
• The device is subject to special precautions with regard to EMC (electromagnetic
compatibility). Maintain the recommended safety distances (see "12.1.5 Safety
distances", page 33) between the device and devices which emit high-frequency
radiation (e.g. cellphones) to prevent malfunctions.
• In combination with the device itself, the use of tube heating will generate a slightly
higher temperature at the patient connection opening.
• The operator is responsible for ensuring that the setting of the therapeutic pressure
has been determined for each patient individually with the device configuration to be
used.
• The operator should regularly assess the effectiveness of the therapeutic settings.
• To prevent infection or bacterial contamination, follow the section about hygiene
treatment (see "6 Hygiene treatment", page 22).
• Keep therapy device and accessories away from children and pets. Store therapy
device in transportation case when not in use or being transported.
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2.3 Warnings in this document
Warnings indicate information relevant to safety.
Within procedures, you will find warnings in front of a step which contains a hazard
to persons or objects.
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 do not follow this instruction, mild
or moderate injuries may result
Note!
Indicates a harmful situation. If you do not follow this
instruction, material damage may result.
Indicates useful information within procedures.
2 Safety
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3 Product description
1
2
3
4
5
6
7
8
9
12
10
11
13
3 Product description
3.1 Overview
1 Humidifier connection with cover
2 Release catch
3 Control panel with display
4 Interface for connecting the communication module
5 Handle
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6 Filter compartment
7 Connection for power supply cable
8 Breathing tube with connection for mask
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3 Product description
p
r
i
s
m
a
S
M
A
R
T
1
2
3
4
5
9 SD card slot
10 Power supply unit
11 SD card
12 Power cord
13 Device outlet port
3.2 Operating states
• On: therapy is running.
• Standby: blower is off, but immediately operational if the On/off key is pressed briefly.
Settings can be made on the device when it is in standby mode.
• Off: the device is de-energized. No settings can be made and the display remains dark.
3.3 Control panel
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1 key*
2 key*
3 On/Off key*
4 Menu key*
5 softSTART key*
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3 Product description
The keys of the device may have different functions. If there is a symbol above the key in
*
the display, the key adopts the function of the symbol in question. If there is no symbol
above the key, the key retains its original function.
3.4 Symbols in the display
SYMBOL DESCRIPTION
Orange symbol: expert area active.
White symbol: parameters enabled for patient.
Parameter is disabled for patient.
Info menu
Settings menu
SoftSTART symbol
Green symbol: SD card inserted. When the symbol is flashing, data
are being written to the SD card.
Orange symbol: SD card fault
Leak display. Mask or tube leaking.
White symbol: Humidifier connected.
Green symbol: Humidifier switched on.
Back to start screen
Cancel
Forward one menu item
Back one menu item
Confirms the current selection.
Selection adopted successfully.
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3.5 Accessories
2
3
1
1 Humidifier
2 Pollen filter (white)
3 12-24 V DC adapter
3 Product description
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4 Preparation and operation
4 Preparation and operation
4.1 Set up and connect the device
Risk of injury due to contaminated or infected patient circuit!
A contaminated or infected patient circuit may transmit contamination or infections
to the next patient.
⇒ Do not reprocess disposable patient circuits.
⇒ Subject reusable patient circuits to the correct hygiene treatment.
Material damage from overheating!
Excessive temperatures may lead to the device overheating and damage the device.
⇒ Do not cover device and power supply unit with textiles (e.g. bedclothes).
⇒ Do not operate device in the vicinity of a radiator.
⇒ Do not expose device to direct sunlight.
⇒ Do not operate device in the carrying bag.
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1. Connect the power supply unit to the device.
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4 Preparation and operation
2. Connect the power cord to the power supply unit and the socket.
The operating hours of the device are displayed briefly. The device switches to
standby.
Risk of injury if breathing tube routed incorrectly!
An incorrectly routed breathing tube may injure the patient.
⇒ Never wrap the breathing tube around the neck.
⇒ Do not crush the breathing tube.
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3. Push breathing tube onto the device outlet port.
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4 Preparation and operation
Risk of suffocation if full-face masks without an exhalation system are used!
If full-face masks without an exhalation system are used, the CO
concentration may
2
rise to critical values and put the patient at risk.
⇒ Use full-face masks with an external exhalation system if there is no integrated
exhalation system.
⇒ Follow the Instructions for Use for the exhalation system.
4. Connect the mask to the breathing tube (see Instructions for Use for the breathing
mask).
The proper position and arrangement of the mask on the face of the patient is
critical for uniform use of the device.
4.2 Start therapy
Requirement
Device is set up and connected (see "4.1 Set up and connect the device", page 13).
1. If the display is dark: press any key briefly.
The device switches to standby.
2. Briefly press the On/off key .
or
If the autoSTART function is activated: breathe into the mask.
Current therapy pressure appears in the display. Therapy starts.
For more information on autoSTART (see "5 Menu settings", page 19).
4.3 End therapy/switch off device
1. Briefly press the On/off key .
or
If the autoSTART function is activated: remove mask.
The device displays the therapy hours for the current day and then switches to
standby.
To save energy, you can disconnect the plug from the socket during the day.
4.4 Set humidifier
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Requirement
Humidifier is connected and filled with water (see Instructions for Use for humidifier).
The humidifier symbol can be seen in the display.
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1. Start therapy (see "4.2 Start therapy", page 15).
The humidifier switches on automatically. The humidifier symbol goes green .
2. To increase the humidifier stage: press the key.
3. To decrease the humidifier stage: press the key.
4. To switch off the humidifier: press the key until
• The humidifier stage suitable for you depends on room temperature and
humidity. If you have dry airways in the morning, heating output is set too low.
If condensation has formed in the breathing tube in the morning, heating
output is set too high.
• When the water level in the humidifier is too low, the device switches off the
humidifier automatically.
• If the humidifier symbol is flashing, you need to fill the humidifier with water
(see Instructions for Use for humidifier).
4.5 Performing the mask test
Requirement: Therapy is running.
1. Press menu button .
4 Preparation and operation
0
appears in the display.
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2. To start the mask test: Press .
The remaining time and the mask test pressure are displayed.
3. If necessary: Press or button to change the mask test pressure.
4. Check mask for leaks.
Proper mask location: Green checkmark.
Mediocre mask location: Leakage display turns orange.
Poor mask location: Leakage display flashes.
5. If necessary: Adjust mask.
6. Wait until the device has completed the mask test.
or
Press .
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4 Preparation and operation
4.6 Switch softSTART on and off
Requirement
Therapy is running. softSTART is activated by the physician.
If the soft start is activated, the device automatically turns on every time therapy is
started.
1. Press the softSTART key briefly to switch on softSTART manually.
Remaining time and the current softSTART pressure are displayed.
2. Press the softSTART key briefly to switch off softSTART.
• If you press the softSTART key when the device is on standby, the device
• To deactivate softSTART, set the softSTART time to
switches to the patient menu and you can adjust the softSTART time (see "5.2
Settings menu", page 19).
OFF
4.7 Use SD card (optional)
If an SD card is present, the device automatically saves the therapy data to the SD card.
An SD card is not required to operate the device.
Requirement
The device is on standby.
Loss of data if power is interrupted!
If the device is disconnected from the power supply during the save process, data may
be lost.
⇒ Leave the device connected to the power supply during the save process (SD card
symbol flashing).
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4 Preparation and operation
1. Push the SD card into the SD card slot until you hear it engage.
The SD card symbol appears in the display.
2. To remove it, press the SD card briefly and remove the SD card. In doing so, please
note: do not remove the SD card while the SD card symbol is flashing.
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5 Menu settings
5 Menu settings
5.1 Function of the keys
The keys of the device may have different functions. If there is a symbol above the key
in the display (e.g. above the softSTART key), the key adopts the function of the
symbol in question. If there is no symbol above the key (e.g. in the case of the
key), the key retains its original function.
5.2 Settings menu
5.2.1
Navigate in the menu
Requirement
The device is on standby.
1. Press the menu key .
2. To call up the settings menu: press .
3. Make settings in the menu.
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5 Menu settings
FUNCTION KEY DESCRIPTION
Scroll forward through menu
Scroll back through menu
Increase value
Reduce value
Confirm value
Discard value
Exit menu. Switch back to start screen.
5.2.2
Menu structure
You can set the following parameters if your physician has enabled them for you.
PARAMETER DESCRIPTION
Here you can set the time for which ventilation pressure rises to
softSTART (
therapy pressure during the softSTART. If this function cannot be
t
)
selected, it needs to be enabled by the physician or specialist
dealer.
ON
), the device can be switched on by a
OFF
to switch off this function.
autoSTART
If autoSTART is activated (
breath (> 0.5 hPa) being taken into the mask and switches off
automatically after 5 seconds without a breath being taken.
Switch autoSTART to
The device temporarily reduces therapy pressure in stages
before the transition to exhalation.
softPAP
softPAP breathing relief is suitable for patients who find it
unpleasant to exhale against a high pressure. Switch softPAP to
OFF
to deactivate this function.
Time You can set the current time here.
Format time
display
Here you can set whether the time is to be displayed in the form
24-h
0-24 (
clock) or 0-12 (
12-h
clock).
1
and 2
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5 Menu settings
5.3 Info menu/read out operating hours
Requirement
The device is on standby.
1. Press the menu key .
2. To call up the info menu: press .
3. Navigate to the desired value with the or keys:
DISPLAY MEANING
0000
1 d Operating hours for the last day.
7 d Operating hours for the last 7 days.
28 d Operating hours for the last 28 days.
182 d Operating hours for the last 182 days.
366 d Operating hours for the last 366 days.
h Total operating hours of the device
• Data are displayed only if they really are present in the device.
• Each therapy day begins and ends at 12 noon. Data recorded from midnight
to 12 noon are assigned to the previous calendar day.
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6 Hygiene treatment
6 Hygiene treatment
Risk of infection when the device is used again!
If the device is used by several patients, infections may be transmitted to the next
patient.
⇒ If the device is used again: have the device subjected to a hygiene treatment by
the manufacturer or an authorized specialist dealer.
6.1 General information
• Wear appropriate safety gear for the disinfecting process.
• Refer to the Instructions for Use for the disinfectant used.
• Following a hygiene treatment by the authorized specialist dealer, the device is suitable
for using again with other patients.
6.2 Cleaning intervals
INTERVAL ACTION
Clean device (see "6.3 Hygiene treatment for device", page 23)
Weekly
Monthly
Every 6 months Replace air filter
Annually Replace breathing tube
As required
On change of
patient
Clean breathing tube (see "6.4 Hygiene treatment for breathing
tube", page 25)
Clean air filter (see "6.3.1 Clean air filter (gray filter)", page 24)
Replace pollen filter (see "6.3.2 Replace optional pollen filter (white
filter)", page 24)
In the clinical sphere: disinfect breathing tube (see "6.4 Hygiene
treatment for breathing tube", page 25)
Have specialist dealer perform a hygiene treatment on the device
before using it again.
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6 Hygiene treatment
6.3 Hygiene treatment for device
Risk of injury from electric shock!
Ingress of liquids may lead to a short-circuit, injure the user and damage the device.
⇒ Disconnect the device from the power supply before the hygiene treatment.
⇒ Do not immerse the device and components in liquids.
⇒ Do not pour liquids over the device and components.
1. Subject the device and components to a hygiene treatment in accordance with the
table below.
PART CLEANING DISINFECTING STERILIZATION
Housing including
device outlet port/
inlet
High-gloss surfaces
on the housing
Power cord and
power supply unit
Wipe down: use
water or mild
detergent
Wipe down: use
water or mild
detergent; do not use
microfiber cloths
Wipe down: use
water or mild
detergent
Disinfect by wiping
(recommended
products:
®
terralin
protect or
perform advanced
Alcohol EP)
Not permitted
2. Replace mask, breathing tube, air filter and pollen filter (if present).
3. Perform function check (see "7 Function check", page 25).
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6.3.1
1
2
1
Clean air filter (gray filter)
1. Clean air filter 1 under running water.
2. Allow air filter 1 to dry.
6.3.2
Replace optional pollen filter (white filter)
6 Hygiene treatment
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1. Remove air filter 1 .
2. Replace white pollen filter 2 .
3. Replace air filter 1 in the holder.
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7 Function check
6.4 Hygiene treatment for breathing tube
Risk of material damage as a result of ingress of liquids!
The device may be damaged by the ingress of liquids.
⇒ Use the breathing tube only when completely dry.
1. Subject the breathing tube to a hygiene treatment in accordance with the table
below.
CLEANING DISINFECTING STERILIZATION
With hot water and
detergent
2. Rinse off breathing tube with clean water and shake thoroughly.
3. Dry breathing tube.
If you use a heated breathing tube, see the Instructions for Use for the breathing
tube.
Disinfect by immersion
(Recommended product:
gigasept FF
®
)
Not permitted
7 Function check
Carry out a function check after each hygiene treatment and maintenance task, but at
least every 6 months.
1. Check device for external damage.
2. Check connectors and cables for external damage.
3. Check that components are correctly connected to the device.
4. Connect device to the power supply and switch it on (see "4.1 Set up and connect
the device", page 13).
5. If softSTART is active: press softSTART key to cancel softSTART.
6. Close the opening of the breathing mask.
7. Compare the pressure shown in the display with the prescribed pressure.
8. If one of the items is not OK or pressure deviates by > 1 hPa: do not use device and
contact your specialist dealer.
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8 Troubleshooting
8 Troubleshooting
If you are unable to remedy faults with the aid of the table, or in the event of
unexpected operation or an incident, contact the manufacturer or your authorized
specialist dealer. To avoid exacerbating the damage, do not continue operating the
device.
You can find an explanation of the symbols which may appear in the display in the
product description (see "3.4 Symbols in the display", page 11).
8.1 Device faults
FAULT/FAULT MESSAGE CAUSE REMEDY
No running noise, nothing
in the display.
Therapy cannot be started
by taking a breath.
Device does not switch off
after approx. 5 seconds
once mask is removed.
softSTART cannot be
switched on.
Device does not reach the
set target pressure.
No power supply.
autoSTART function not
activated.
autoSTART function may
be restricted in the case of
accessories with a high
resistance.
softSTART function is
disabled.
Air filter dirty.
Breathing mask leaking.
Check that the power cord
is securely connected.
Check function of socket.
Activate autoSTART
function.
Contact your specialist
dealer.
Ask the physician whether
the function can be
enabled.
Clean air filter. If necessary:
replace filter (see "6
Hygiene treatment", page
22).
Adjust headgear so that
the mask is tight.
If necessary, replace faulty
mask.
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8 Troubleshooting
8.2 Display messages
If the message Err (xxx) appears in the display, look in the table for the error code
displayed. Remedy the error in accordance with the description.
ERROR CODE CAUSE REMEDY
(108)
(204)
(601), (610) or
(609)
Device has lost the
saved time.
Humidifier not
working properly.
Faulty SD card
(603) SD card full
Leak on humidifier or
(701)
at the cover on the
side
All other error
codes
Electronics problems
Contact specialist dealer and have device
repaired.
Remove humidifier from device and reconnect it.
If the message continues to be displayed,
contact an authorized specialist dealer and
have the device and the humidifier checked.
Remove and reinsert SD card. If the message
persists, replace the SD card.
Delete data from the SD card/Use new SD
card.
Remove humidifier or side cover from device
and re-connect.
If the message continues to be displayed,
contact an authorized specialist dealer and
have the device and the humidifier checked.
Disconnect the device from the power supply
and reconnect it (see 4.1, p.13).
If the message continues to be displayed,
contact an authorized specialist dealer and
have the device and the humidifier checked.
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9 Servicing
The device is designed for a service life of 6 years.
If used in accordance with the intended use, the device requires no servicing during
this period.
If the device is used beyond this period, it needs checking by an authorized specialist
dealer.
10 Storage
Store the device under the specified ambient conditions. Clean the device before
storing it.
11 Disposal
Do not dispose of the product or any rechargeable batteries with
domestic waste. To dispose of properly, contact a licensed, certified
electronic 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.
9 Servicing
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12 Appendix
12 Appendix
12.1 Technical data
12.1.1
Device
SPECIFICATION DEVICE
Product class to 93/42/EEC IIa
Dimensions W x H x D in cm 17 x 13.5 x 18
Weight 1.34 kg
Temperature range
- operation
- storage
Rel. humidity, non-condensing
for
- operation
- storage
Air pressure range
Connection diameter of
breathing tube in mm
Power capacity Max. 40 VA
System interface
Current consumption in
operation (therapy)
230 V
115 V
on standby
230 V
115 V
Classification to DIN EN 606011-11:
class of protection against
electric shock
degree of protection against
electric shock
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protection against damaging
ingress of water and solids
+5 °C to +40 °C
-25 °C to +70 °C
10% to 93%
10% to 95%
700 hPa to 1060 hPa, corresponds to an altitude of 3000
m above mean sea level
19.5 (fits standard tapered connector)
24 V DC
Max. 5 VA
0.13 A
0.22 A
0.036 A
0.053 A
Protection class II
Type BF
IP21
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SPECIFICATION DEVICE
Classification to DIN EN 606011:
Continuous duty
duty cycle
Application part Breathing mask
Electromagnetic compatibility
(EMC) to DIN EN 60601-1-2
Radio interference suppression
Radio interference immunity
Mean sound pressure level/
operation to ISO 80601-2-70
Mean sound pressure level/
operation to ISO 80601-2-70
with humidifier
Test parameters and limit values can be obtained from
the manufacturer on request.
EN 55011 B
IEC 61000-4 Parts 2 to 6, Part 11, Part 8
IEC 61000-3 Parts 2 and 3
approx. 26 db(A) at 10 hPa (corresponds to a sound
power level of 34 db(A))
approx. 27.5 db(A) at 10 hPa (corresponds to a sound
power level of 35.5 db(A))
CPAP operating pressure range 4 hPa to 20 hPa
Pressure accuracy 0.5 hPa ± 3% of the measured value
P lim
the event of a fault)
Maximum flow rate to ISO
80601-2-70
Test pressures:
4 hPa
8 hPa
12 hPa
16 hPa
20 hPa
(maximum pressure in
max
<
40 hPa
Pressure measured at the
patient connection opening
at a flow rate of 40 l/min
3.9 hPa
7.8 hPa
11.8 hPa
15.8 hPa
19.7 hPa
Mean flow rate prevailing
at the patient connection
opening
160 l/min*
155 l/min*
130 l/min*
130 l/min*
115 l/min**
At an ambient pressure of 700 hPa, the values drop by
* -10 %
** - 50 %
Heating of respiratory air Max. +3 °C
Stability of dynamic pressure
(short-term precision) at 10
With breathing tube, with
humidifier
With breathing tube,
without humidifier
breaths/min to ISO 80601-2-70
at
4 hPa
8 hPa
12 hPa
16 hPa
20 hPa
Δp ≤ 0.3 hPa
Δp ≤ 0.4 hPa
Δp ≤ 0.6 hPa
Δp ≤ 0.5 hPa
Δp ≤ 0.7 hPa
Δp ≤ 0.3 hPa
Δp ≤ 0.4 hPa
Δp ≤ 0.4 hPa
Δp ≤ 0.5 hPa
Δp ≤ 0.6 hPa
12 Appendix
30 | EN
WM 68201a 06/2016
12 Appendix
SPECIFICATION DEVICE
Stability of dynamic pressure
(short-term precision) at 15
With breathing tube, with
humidifier
breaths/min to ISO 80601-2-70
at
4 hPa
8 hPa
12 hPa
16 hPa
20 hPa
Stability of dynamic pressure
(short-term precision) at 20
Δp ≤ 0.4 hPa
Δp ≤ 0.5 hPa
Δp ≤ 0.6 hPa
Δp ≤ 0.8 hPa
Δp ≤ 0.8 hPa
With breathing tube, with
humidifier
breaths/min to ISO 80601-2-70
at
4 hPa
8 hPa
12 hPa
16 hPa
20 hPa
Δp ≤ 0.6 hPa
Δp ≤ 0.7 hPa
Δp ≤ 0.8 hPa
Δp ≤ 1.0 hPa
Δp ≤ 1.1 hPa*
*At 700 hPa ambient pressure
Stability of static pressure
(long-term precision) to
Δp < 0.25 hPa
ISO 80601-2-70
Recommended maximum
additional oxygen flow rate
Pollen filter
up to 1 μm
up to 0.3 μm
15 l/min
Filter class E10
≥ 99.5 %
≥ 85 %
Service life of pollen filter approx. 250 h
SD card
Memory size 2 GB to 32 GB can be used, interface
compatible with SD physical layer version 2.0
With breathing tube,
without humidifier
Δp ≤ 0.4 hPa
Δp ≤ 0.5 hPa
Δp ≤ 0.6 hPa
Δp ≤ 0.7 hPa
Δp ≤ 0.8 hPa
With breathing tube,
without humidifier
Δp ≤ 0.6 hPa
Δp ≤ 0.8 hPa
Δp ≤ 0.8 hPa
Δp ≤ 1.0 hPa
Δp ≤ 0.9 hPa*
Δp ≤ 1.6 hPa
TOLERANCES FOR MEASURED VALUES
Pressure:
± 0.75 % from measured value or
± 0.1 hPa
Flow rate: ± 2 % from actual value
Temperature: ± 0.3
°C
Noise pressure level and noise power level ± 2 dB(A)
WM 68201a 06/2016
The right to make design modifications is reserved.
All flow rate and volume values determined under STPD conditions.
All parts of the device are free from latex.
EN | 31
12 Appendix
Air filter
Ambient air inlet
Blower
Optional
humidifier
Pressure sensor
for patient pressure
Breathing tube
Exhalation
system
Patient/ventilator
interface
O2 pressure
source
Flow adjuster
Devices of the WM 090 TD type use the following open-source software:
FreeRTOS.org
The software of this device contains code which is subject to the GPL. You can see the
GPL source code and the GPL on request.
12.1.2
Technical data for power supply unit
SPECIFICATION POWER SUPPLY UNIT
Maximum output capacity 60 W
Input voltage 100 V - 240 V
Frequency 47 Hz - 63 Hz
12.1.3
Pressure/volume curve
p/V curve at AV = 0.5 l and f = 20/min
0.5
0.4
0.3
[l]
0.2
Volume
0.1
12.1.4
32 | EN
0
0.00 5.00 10.00 15.00 20.00
Pressure [hPa]
Pneumatic diagram
WM 68201a 06/2016
12 Appendix
1
2
3
4
5
6
8
7
9
12.1.5
Safety distances
RECOMMENDED SAFETY DISTANCES BETWEEN PORTABLE AND MOBILE HF
TELECOMMUNICATION DEVICES (E.G. CELLPHONES) AND THE DEVICE
Safety distance depending on transmission frequency in m
Nominal capacity
of HF device in W
0.01 0.04 0.12 0.12 0.23
0.1 0.11 0.38 0.38 0.73
1 0.35 1.20 1.20 2.30
10 1.10 3.80 3.80 7.27
100 3.50 12.00 12.00 23.00
150 kHz -
80 MHz outside
ISM bands
150 kHz -
80 MHz within
ISM bands
80 MHz 800 MHz
800 MHz -
12.2 Marks and symbols
12.2.1
Markings on the device
2.5 GHz
NO. SYMBOL DESCRIPTION
SN Serial number of the device
1
2 , 8 Follow Instructions for Use
WM 68201a 06/2016
3 Device inlet: ambient air inlet
Year of manufacture
EN | 33
NO. SYMBOL DESCRIPTION
4 Follow Instructions for Use
5 Slot for the SD card
6 USB connection (optional)
7 On/off: indicates the On/off key
DEVICE ID PLATE ON THE BOTTOM OF THE DEVICE
TYP Type designation of the device
IP21
Degree of protection against solid foreign bodies. Device is protected
against drips.
Degree of protection against electric shock: protection class II device
Do not dispose of device in domestic waste.
Suitable for use in aircraft. Meets RTCA/DO-160G Section 21, Category
M.
12 Appendix
34 | EN
Application part type BF
Manufacturer
CE symbol (confirms that the product conforms to the applicable
European directives)
WM 68201a 06/2016
12 Appendix
25
°C
%
%
5
1
0
12.2.2
Markings on the device ID plate of the power supply unit
SYMBOL DESCRIPTION
INPUT Input voltage
OUTPUT: Output voltage/direct voltage
Only intended for indoor use.
Degree of protection against electric shock: protection class II device
Do not dispose of device in domestic waste.
CE symbol (confirms that the product conforms to the applicable
European directives)
12.2.3
Markings on the packaging of the device and accessories
SYMBOL DESCRIPTION
Permitted storage temperature: -25 °C to +70 °C
Permitted humidity for storage:10 % to 95 % relative humidity
Use only for a single patient
12.3 Scope of supply
A current list of scopes of supply can be ordered on the website of the manufacturer
or through your specialist dealer.
The parts below are included in the standard scope of supply.
PART ITEM NUMBER
Basic device
Breathing tube WM 24445
Power cord WM 24133
Power supply unit WM 24480
WM 68201a 06/2016
Set, 2 air filters WM 29928
SD card WM 29794
Instructions for Use WM 68201
Varies depending on device
variant
EN | 35
12 Appendix
12.4 Accessories and replacement parts
A current list of accessories and replacement parts can be ordered on the internet site
of the manufacturer or through your authorized specialist dealer.
12.5 Warranty
Löwenstein Medical gives the customer a limited manufacturer warranty on a new
original Löwenstein Medical product and on any replacement part fitted by
Löwenstein Medical in accordance with the warranty conditions applicable to the
product in question and in accordance with the warranty periods from date of
purchase listed below. The warranty conditions are available on the website of the
manufacturer. We will also send you the warranty conditions on request.
In the event of a claim under warranty, contact your specialist dealer.
PRODUCT
Löwenstein Medical devices including accessories (except
masks) for sleep diagnosis, home ventilation, oxygen medicine
and emergency medicine
Masks including accessories, rechargeable batteries, batteries
(unless quoted differently in the technical documentation),
sensors, patient circuits
Disposable products None
WARRANTY
PERIODS
2 years
6 months
12.6 Declaration of conformity
Löwenstein Medical Technology GmbH + Co. KG, Kronsaalsweg 40, 22525 Hamburg,
Germany, the manufacturer of the devices described in these Instructions for Use,
hereby declares that the product complies with the relevant regulations of the Medical
Device Directive 93/42/EEC. The unabridged text of the Declaration of Conformity can
be found on the manufacturer's website.
36 | EN
WM 68201a 06/2016
WM 68201a 06/2016 EN
Löwenstein Medical
Technology GmbH + Co. KG
Kronsaalsweg 40
22525 Hamburg, Germany
T: +49 40 54702-0
F: +49 40 54702-461
www.loewensteinmedical.
de
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