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