Weinmann homecare SOMNOsoft + WM 24600 Manual

1
SOMNO soft +
CPAP Device with softPAP Exhalation Relief
and Therapy Monitoring SOMNO soft +
CPAP-apparat med utandningshälp softPAP
och behandlingskontroll SOMNO soft +
CPAP-apparat med udåndingshjælp softPAP
og terapikontrol SOMNO soft + WM 24600
SOMNO soft + with SOMNO click
SOMNO soft + med SOMNO click
SOMNO soft + med SOMNO click WM 24610
SOMNO soft + with SOMNO click 300
SOMNO soft + med SOMNO click 300
SOMNO soft + med SOMNO click 300 WM 24675
Description and Operating Instructions
Apparatbeskrivning och bruksanvisning
Apparatbeskrivelse och brugsanvisning

English 2
Svenska 40
Dansk 78

SOMNOsoft +
1 hPa 1 cmH
2
O
DC-AC WANDLER
DC-AC INVERTER
IN
OUT
Overview / Översikt / Oversigt
SOMNO soft +
21
1
3
6
11
12
8
13
5 4
15
7
14
10
17
22
23
18
26
25
24
28
30
29
31
34
32
2
9
33
20
19
27
16

2 Legend
English
1. Legend
1 SOMNO soft +
2 Bacteria filter
3 Connecting cord
4 Serial interface
5 Control panel and display
6 Connection for humidifier
7 Unit outlet
8 Stopper (2x)
9 Drying adapter
10 Adapter
11 Pressure measurement tube
12 Hose system
13 Exhalation system
14 Mask
15 Cap
16 Softstart time
17 Total running time / daily therapy time
18 Change filter
19 softPAP mode activated
20 Therapy pressure
21 LC display
22 Humidifier activated
23 Service
24 On / off switch
25 Softstart button
26 Humidifier button (level 1-6)
27 Humidifier indicator lamp
28 Filter compartment cover, air inlet
29 Supply connection
30 Rating plate
31 Carrying bag
32 Inverter
33 O2connection valve
34 SOMNOclick/SOMNOclick 300

Contents 3
Contents
1. Legend . . . . . . . . . . . . . . . . . . . . . . . 2
2. Description . . . . . . . . . . . . . . . . . . . . 4
2.1 Uses . . . . . . . . . . . . . . . . . . . . . . . . 4
2.2 Description of function . . . . . . . . . . 4
3. Safety instructions . . . . . . . . . . . . . . 6
3.1 Safety rules. . . . . . . . . . . . . . . . . . . 6
3.2 Contra-indications . . . . . . . . . . . . . 7
3.3 Side-effects. . . . . . . . . . . . . . . . . . . 8
3.4 Special symbols on the device. . . . . 9
4. Preparing for use . . . . . . . . . . . . . . 10
4.1 Setting up and connecting the
device. . . . . . . . . . . . . . . . . . . . . . 10
4.2 Exhalation system . . . . . . . . . . . . . 11
4.3 Putting on the mask . . . . . . . . . . . 11
4.4 Humidifier . . . . . . . . . . . . . . . . . . 11
4.5 Bacteria filter . . . . . . . . . . . . . . . . 12
4.6 Oxygen delivery . . . . . . . . . . . . . . 12
5. Operation . . . . . . . . . . . . . . . . . . . . 13
5.1 Exhalation relief softPAP . . . . . . . . 13
5.2 Auto switch-on. . . . . . . . . . . . . . . 14
5.3 Using SOMNOsoft + . . . . . . . . . . . 15
5.4 Softstart setting . . . . . . . . . . . . . . 16
5.5 Setting the humidifier. . . . . . . . . . 16
5.6 After use . . . . . . . . . . . . . . . . . . . 16
5.7 Reading therapy time . . . . . . . . . . 17
5.8 Reading therapy data . . . . . . . . . . 18
5.9 Travelling with SOMNOsoft + . . . . 18
6. Hygienic preparation . . . . . . . . . . .19
6.1 Intervals . . . . . . . . . . . . . . . . . . . . 19
6.2 Cleaning . . . . . . . . . . . . . . . . . . . 19
6.3 Disinfection and sterilization. . . . . 21
6.4 Change of patient . . . . . . . . . . . . 22
7. Functional check . . . . . . . . . . . . . . .23
7.1 Intervals . . . . . . . . . . . . . . . . . . . . 23
7.2 Performing the check. . . . . . . . . . 23
8. Troubleshooting . . . . . . . . . . . . . . .24
9. Servicing . . . . . . . . . . . . . . . . . . . . .25
9.1 Intervals . . . . . . . . . . . . . . . . . . . . 25
9.2 Filter change . . . . . . . . . . . . . . . . 26
9.3 Changing the pressure
measurement tube. . . . . . . . . . . . 27
9.4 Disposal . . . . . . . . . . . . . . . . . . . . 27
10. Product and accessories . . . . . . . . .28
10.1 Standard product. . . . . . . . . . . . . 28
10.2 Accessories . . . . . . . . . . . . . . . . . 29
10.3 Spare parts. . . . . . . . . . . . . . . . . . 32
11. Technical data . . . . . . . . . . . . . . . . .33
11.1 Specifications. . . . . . . . . . . . . . . . 33
11.2 Pressure-volume curve . . . . . . . . . 35
11.3 Safe distances . . . . . . . . . . . . . . . 36
12. Warranty . . . . . . . . . . . . . . . . . . . . .37
13. Index . . . . . . . . . . . . . . . . . . . . . . . .39

4Description
2. Description
2.1 Uses
SOMNOsoft + is an nCPAP device for treating sleep-related respiratory disorders.
• SOMNOsoft + generates positive airway pressure (PAP).
• The softPAP mode increases patient comfort by means of a brief pressure
reduction during the transition from inhalation to exhalation.
• SOMNOsoft + recognises respiratory events. This permits efficient
therapy control.
• While the patient is asleep, the airways are braced by the air pressure
generated.
• Airway pressure is administered by means of a mask.
• SOMNOsoft +can be used both in CPAP mode and in softPAP mode for
individuals aged 12 years or more.
Caution!
SOMNOsoft + can reliably prevent closure of the airways only if the therapy pressure
specific to the patient and prescribed by a doctor has been determined, e.g. in a sleep
laboratory.
SOMNOsoft + is not suitable for use as a life-support system.
2.2 Description of function
SOMNOsoft +works on the principle of an electrically powered flow generator delivering
an electronically controlled constant pressure level.
• A radial fan draws in ambient air through a filter and conveys it to the
device outlet port. From here the air flows through the hose system and
the mask to the patient.
• The airway pressure is registered via the pressure measurement tube in
the mask.
• The pressure present in the mask is shown in the LC display. The micro-
processor-controlled flow generator regulates the pressure at the set
value.

Description 5
• In softPAP mode the respiratory flow curve is analysed continuously to
ensure timely recognition of the transition between inhalation and exha-
lation. Before the transition to exhalation the therapy pressure is reduced
to make it easier to breathe out. The size of this pressure reduction can
be set in two stages: “slight” (stage 1) and “normal” (stage 2). This in-
creases patient comfort. Before the next inhalation phase, the pressure
is raised to the therapy figure once again.
•If apnoea or valid flow limitations occur while the patient is sleeping, the
softPAP mode is automatically deactivated for the relevant period. If the
respiratory frequency is too high, the softPAP mode is also temporarily
deactivated. However, the therapy pressure remains reduced during this
period.
•The device also records a respiratory flow signal that can be output to a
PSG system or read off with the aid of SOMNOsupport. SOMNOsoft +
recognises apnoea, hypopnoea and resipiratory flow limitations. This
permits efficient therapy control.
• The exhalation system before the mask prevents accumulation of CO2-
enriched expired air in the hose system.
•An automatic Softstart system is provided to enable the patient to go to
sleep more easily. When this is switched on, the pressure is reduced to
the Softstart pressure set by the doctor. The therapy pressure then grad-
ually increases to the set value. The period for the pressure rise can be set
in 5-minute steps between 0 and 30 minutes. The automatic Softstart
system can be locked out by the physician.
• Auto switch-on can be activated on the SOMNOsoft +. The device can
then be switched on by breathing into the mask. If there is no pressure
for about 5 seconds (e.g. because the mask is taken off), the
SOMNOsoft + switches off automatically.
• Following a power failure and resumption of the power supply, the sta-
tus of SOMNOsoft +is the same as it was before the power failure. The
stored data remain preserved.

6Safety instructions
3. Safety instructions
3.1 Safety rules
Please read these operating instructions carefully. They are an integral part of the device
and must be kept available for reference at all times. Always use the device only for the
purpose described (see “2.1 Uses” on page 4).
For your own safety and that of your patients, and in accordance with the requirements of
Directive
93/42/EEC, please observe the following points:
Operating the appliance
Caution!
• Check that the mains voltage shown on the device matches your local
mains voltage. The device can run on a mains voltage of 115 V or 230 V.
It automatically adjusts to one of these voltages. For running on 12 V DC
or 24 V DC, use one of the power inverters which are available as an
accessory.
•Do not place the device close to heating systems (radiators etc.), and do
not expose it to direct sunlight, as this can cause additional heating of
the air for breathing and the internal parts of the device. This could result
in condensation forming in the humidifier and condensing out in the
hose system.
•Make sure the device is not covered by bedding etc. This would block the
air inlet and could cause the device to overheat. This could result in inad-
equate therapy for the patient and damage to the device.
Caution!
• Maintain a safe distance between SOMNOsoft + and equipment that
emits HF radiation (e.g. mobile phones). Otherwise there is a risk of
malfunction (see page 36).
• To prevent infection or bacterial contamination, please observe section
“6. Hygienic preparation” on page 19.

Safety instructions 7
Transport/Accessories/Spare Parts/Repairs
Caution!
• Do not transport the SOMNOsoft + with the humidifier attached. If it is
tilted, residual water from the humidifier can run into the SOMNOsoft +
and damage it.
• Always have inspections or repairs carried out by the manufacturer
(Weinmann) or expert personnel.
•Malfunctions and a lack of biocompatibility may result if third-party arti-
cles are used. Please note that in such cases all warranty entitlement and
liability claims shall be void where items other than the accessories rec-
ommended in the instructions for use or original spare parts are used.
• Third-party masks may only be used subject to approval by Weinmann.
Use of non-approved masks presents risks to the success of the therapy.
• Make sure that the accessories used are complete and suitable for the
therapy in question. This applies particularly to the exhalation system.
Otherwise there is a risk of suffocation.
Oxygen delivery
Warning!
•Smoking and open flames are prohibited if oxygen is used during thera-
py. There is a fire risk. The oxygen can accumulate in clothing, bedding
or hair. It can only be removed by airing thoroughly.
Caution!
• Oxygen delivery is only permitted when using the O2switching valve
WM 24042.
•With regard to oxygen, please be sure to observe the safety information
in the operating instructions for your oxygen delivery system.
3.2 Contra-indications
The SOMNOsoft +should not be used, or should only be used with special care, if the pa-
tient is suffering from certain disorders. In the individual case the decision on whether to
conduct therapy using the SOMNOsoft + is the responsibility of the attendant physician.
Such disorders include:
• Cardiac decompensation
• Severe disordered action of the heart

8Safety instructions
• Severe hypotonia, especially in conjunction with intravascular volume
depletion
• Severe epitaxia
• High risk of barotrauma
• Severe pulmonary disorders (e.g. COPD, pulmonary emphysema)
• Daytime hypoxaemia
• Respiratory insufficiency due to causes other than OSA
• Nocturnal hypoxaemia due to causes other than OSA (obstructive sleep
apnoea)
• Pneumothorax or pneumomediastinum
• Pneumoencephalus
• Cranial trauma
•Status following brain operation or following surgical procedures on the
pituitary gland or the middle or inner ear
• Acute sinusitis, otitis media or perforation of the eardrum
• Dehydration
No threatening situations have been observed with the SOMNOsoft + to date.
3.3 Side-effects
The following undesirable side-effects may occur during short and long-term use of the
SOMNOsoft +:
• Pressure sores on the face due to mask and forehead pad
• Redness of facial skin
• Blocked nose
• Dry nose
• Dry mouth in the morning
• Pressure sensation in sinuses
• Conjunctival irritation
• Gastrointestinal insufflation (“flatulence”)
• Nose bleeds

Safety instructions 9
3.4 Special symbols on the device
Device inlet Inlet for room air at ambient temperature
Socket at front of
device Electrical connection for humidifier
Device outlet port Outlet for ambient air at 4 – 18 hPa
Connection on
side of device
Connection for setting the titration/therapy parameters with
SOMNOadjust WM 23930, for reading of therapy data with
SOMNOsupport WM 23975 by medical staff, or for controlling the O2
switching valve WM 24042. Maximum current consumption 163 mA.
Outlet for therapy pressure, flow and leakage flow (0 V to 1.0 V DC).
Rating plate
Do not dispose of appliance as domestic refuse!
Safety class B
Safety class II, total insulation
Year of manufacture

10 Preparing for use
4. Preparing for use
4.1 Setting up and connecting the device
1. Place the device on a level surface, e.g. on the bedside cupboard or on the floor beside
the bed.
Make sure there is a gap of at least 5 cm between the wall and the rear of the device,
as the air intake is at the rear.
Important
Do not cover up the device.
2. Run the power cord 3from the power connection 29 to a mains socket.
SOMNOsoft + automatically detects whether the mains supply is 115 V or 230 V and
switches automatically.
The display shows “0” for standby.
3. If the SOMNOsoft + is to be run on a voltage of 12 or
24 V DC, connect the power inverter 32 to a cigarette
lighter.
For this purpose, use either:
– Power inverter 12 V, WM 24131
– Power inverter 24 V, WM 24132
Use the power cord 3to connect the power socket of the power inverter to the power
connection 29 of the SOMNOsoft +.
4. Insert the adapter 10 for the hose system in the device
outlet port 7.
Note:
The appliance automatically compensates for differenc-
es in air pressure (e.g. due to high altitude).
DC-AC WANDLER
DC-AC INVERTER
IN
OUT

Preparing for use 11
4.2 Exhalation system
The coupling on the end of the corrugated hose has a di-
ameter of 19.5 mm and fits on a 22 mm standard conical
connection. Push the coupling onto the exhalation system.
The exhalation system enables you to breathe through
your nose or mouth if the device should fail. Full facial
masks must also be equipped with a safety valve. Remove
the mask as soon as possible. Check whether there is a
power failure. Consult the operating instructions for your
exhalation system 13.
4.3 Putting on the mask
1. Adjust the forehead pad of the mask (if it has one).
2. Attach the cap or headstraps to the mask.
3. Put the mask on.
4. To avoid pressure sores on the face, adjust the cap or headstraps so that the rim of the
mask only exerts slight pressure on the face.
For further details of the procedure, consult the operating instructions for the individual
mask.
4.4 Humidifier
If you use a humidifier 34, this is inserted between the
SOMNOsoft + 1and the hose system 12. The inlet connec-
tion stub and the electrical connection of the heating ele-
ment must face towards the SOMNOsoft +. Also observe
the operating instructions supplied.
13

12 Preparing for use
4.5 Bacteria filter
If the SOMNOsoft +is to be used for several patients (e.g.
in a hospital), the bacteria filter WM 24148 should be used
to protect against infection. It is inserted between tube
system and the SOMNOsoft +or humidifier. Also observe
the operating instructions supplied.
4.6 Oxygen delivery
For safety reasons (fire risk), direct introduction of oxygen
into the hose system or the mask without special safety fa-
cilities is not permitted. The oxygen switching valve
WM 24042 can be used to introduce up to 4 l/min of
oxygen into the hose system.
An oxygen concentrator (e.g. Oxymat), liquid oxygen or an oxygen cylinder with a suitable
pressure reducer may be used. This application must be prescribed by the attendant physi-
cian.
Be sure to observe the safety information regarding the use of oxygen and the operating
instructions for the oxygen switching valve and oxygen device used.

Operation 13
5. Operation
5.1 Exhalation relief softPAP
If your physician has enabled the softPAP function, you can choose between two softPAP
stages or deactivate the softPAP function.
Selecting softPAP stage
soft 0 = softPAP off
soft 1 = softPAP slight
soft 2 = softPAP normal
1. With the SOMNOsoft +switched off, press the Softstart
button 25 until the current softPAP setting flashes in
the display.
If the current softPAP setting does not flash, your physician has disabled it. In this case
you cannot change the setting.
2. Press the On/Off button 24 repeatedly until the desired softPAP stage “soft 1” or
“soft 2”appears in the display.
The setting “soft 1” reduces the therapy pressure slightly during exhalation, while
“soft 2” (normal) reduces it further.
If no button is pressed for 5 seconds, this display disappears and the display again shows
“0”.
Deactivating softPAP
soft 0 = softPAP off
soft 1 = softPAP slight
soft 2 = softPAP normal
1. With the SOMNOsoft +switched off, press the Softstart
button 25 until the current setting “soft 1” or
“soft 2” flashes in the display.
If the current softPAP setting does not flash, your physician has disabled it. In this case
you cannot change the setting.
2. Press the On/Off button 24 repeatedly until “soft 0” appears in the display. The
exhalation relief is now deactivated.
If no button is pressed for 5 seconds, this display disappears and the display again shows
“0”.

14 Operation
5.2 Auto switch-on
Activating auto switch-on
A 0 = Auto deactivated
A 1 = Auto activated
1. With the SOMNOsoft +switched off, press the Softstart
button 25 until the current setting for the softPAP ex-
halation relief (soft 1, soft 2 or soft 0) flashes in
the display.
2. Release the Softstart button 25.
3. Briefly press the humidifier button 26 while the softPAP setting is shown in the display.
The current auto switch-on setting “A 0” flashes in the display.
4. Press the On/Off button 24 to change the setting to “A 1”.
If no button is pressed for 5 seconds, this display disappears and the display again shows
“0”.
If auto switch-on is activated, you can switch the SOMNOsoft + on or off by means of
either the On/Off button 24 or the pressure in the mask.
Note:
If an oronasal mask with integrated emergency exhalation system is used, the device does
not switch on/off automatically even if setting “A” is selected. The anti-asphyxia valve of
the mask means that the device is unable to detect the change in pressure required for
switching.
• SOMNOsoft +will now be switched on automatically as soon as breath-
ing through the mask starts (pressure > 0.5 hPa).
• When the mask is removed, the device switches off after 5 seconds.
Deactivating auto switch-on
A 0 = Auto deactivated
A 1 = Auto activated
1. With the SOMNOsoft +switched off, press the Softstart
button 25 until the current setting for the softPAP ex-
halation relief (soft 1, soft 2 or soft 0) flashes in
the display.
2. Press the humidifier button 26 while the softPAP setting is shown in the display. The
current auto switch-on setting “A 1” flashes in the display.
3. Press the On/Off button 24 to change the setting to “A 0”.
If no button is pressed for 5 seconds, this display disappears and the display again shows “0”.
If auto switch-on is deactivated, you can only switch the SOMNOsoft + on and off by
means of the On/Off button 24.

Operation 15
If the device is not used for 15 minutes, it switches off automatically.
5.3 Using SOMNOsoft +
Always use an exhalation system. The exhalation system allows the spent air containing car-
bon dioxide (CO2) to escape from the mask. Without an exhalation system the CO2con-
centration in the mask and hose would rise to critical levels and hinder your breathing.
The exhalation system must always be fitted in the immediate vicinity of the mask.
Some mask systems have an integrated exhalation system. These do not require a separate
exhalation system. Please read the operating instructions for the mask in question.
1. If the mask does not possess an integrated expiration system, fit the expiration system
13 onto the end of the hose system 12.
2. Connect the hose system 12 including exhalation sys-
tem 13 to the mask 14 (conical connection). Observe
the operating instructions for the mask and/or exhala-
tion systems.
3. Press the on/off button 24. If auto switch-on is activat-
ed, you can put the mask on and switch the
SOMNOsoft + on simply by breathing.
The total therapy duration 17 appears in the LC display
21 for approx. 3 seconds. The flow generator starts to
deliver air through the hose system.
If Softstart is preset, the Softstart indicator 16 lights up
and the Softstart time appears in the LC display 21. The
LC display 21 also shows the current pressure.
If the softPAP exhalation relief is activated (Soft 1 or soft 2), the symbol appears
in the display.
If you press the humidifier button 26 when no humidifier is attached, the SOMNOsoft +
automatically switches this function off again.
The SOMNOsoft + is now ready for use.
13
12
14

16 Operation
5.4 Softstart setting
If Softstart is activated on your device, the Softstart time can be selected in 5-minute steps
up to a maximum of 30 minutes.
1. Switch the SOMNOsoft + on and press the Softstart
button 25. Keep the button pressed until the display for
the Softstart time 16 starts flashing.
2. Press the Softstart button 25 repeatedly to increase the Softstart time in 5-minute steps.
The SOMNOsoft +increases the time up to the maximum of 30 minutes and then starts
again at the minimum time of 5 minutes.
If 4 seconds elapse without any button being pressed, the Softstart time displayed is
stored and the LC display stops flashing.
The Softstart settings are preserved even after the device is switched off. Whenever the
SOMNOsoft + is used, it automatically starts in Softstart mode if this was activated last
time.
Softstart can be switched on or off at any time by briefly pressing the Softstart button 25.
5.5 Setting the humidifier
Use the humidifier button 26 to switch the humidifier on
and off. When the humidifier is operating, the humidifier
indicator light 27 is on and the symbol appears in the
display.
To set the humidifer heating level, press the button 26 while the SOMNOsoft +is running
until the figure beside the symbol starts flashing. Every time you press the button 26
you alter the humidifier heating level by one step (from 1 to 6). The value displayed is stored
if 4 seconds elapse without any button being pressed.
For further details on setting the humidifier, please consult the relevant operating
instructions.
5.6 After use
1. Take off the cap or headstraps with the mask.
2. Press the On/Off button 24 to switch the device off. If auto switch-on was selected, the
device switches off automatically after about 5 seconds.

Operation 17
The date and the daily therapy duration appear briefly
in the display 21. After that, only “0” appears in the
display.
3. Detach the hose connection and the exhalation system
from the mask.
4. Clean the mask and the exhalation system (see “6.
Hygienic preparation” on page 19).
Important!
When in standby mode, SOMNOsoft + uses approx.
3.5 watt. To save electricity, you can remove the power
plug 3from the mains socket when the device is not in use.
The stored data and settings are preserved.
5.7 Reading therapy time
The SOMNOsoft +stores the data for 366 days and the associated therapy duration. You
can display the following figures:
• Total therapy time in hours,
• Average therapy duration per day
• Therapy duration for current day, showing date
Note:
A therapy day begins and ends at 12 noon. Data recorded from 12 midnight to 12 noon
are allocated to the previous calendar day.
The total therapy time is displayed for a few seconds when the device is switched on. To
read the other data, proceed as follows:
1. When switching off the device, keep the On/Off button 24 pressed until the total ther-
apy time (lower line) and the average daily therapy time (upper line) appear in the dis-
play.
2. Release the button. After a few seconds the display shows the date and the stored
therapy duration for the current day.





18 Operation
3. Press the Softstart button 25 to read the therapy duration for the preceding days.
Hold the button down longer to make the date change faster.
4. You can return to the current date by pressing the On/Off button 24.
If no button is pressed for 5 seconds, the total operating time (upper line) appears for
2 seconds. Then this display disappears and “0” appears in the display again.
5.8 Reading therapy data
SOMNOsoft + saves the following detailed data for up to 10 hours:
• Pressure
• Flow
• Leakage
• Relative breathing volume
• Respiratory events
The data for pressure, leakage and respiratory events (apnoea, hypopnoea, snoring etc.)
are stored in time-compressed form for the last 30 therapy days.
The data can only be read and analysed by medical staff with the aid of the evaluation
software SOMNOsupport.
5.9 Travelling with SOMNOsoft +
To transport the SOMNOsoft + for long distances, you should stow it in the carrying
bag 31.
1. Stow the device, power cord, hose system, masal mask including exhalation system and,
if appropriate, the humidifier in the carrying bag.
2. Close the zip fasteners of the carrying bag and adjust the shoulder strap to the right
length.
Important
Do not forget to take spare filters and the operating instructions with you, and include the
power inverter if needed.
If you want to take the SOMNOsoft +on board an aircraft as hand baggage, be sure to ask
your airline about all necessary formalities before checking in.