Weinmann SOMNOsmart 2 User manual

SOMNO smart
2
Smart PAP-device / smart PAP-apparat /
smart PAP-apparat SOMNO smart 2
SOMNO smart 2 with / med / med
SOMNO click 300
Description and instructions for use
Apparatbeskrivning och bruksanvisning
Apparatbeskrivelse och brugsanvisning

English 2
Svenska 48
Dansk 94

21
P
ini
DC-AC WANDLER
DC-AC INVERTER
IN
OUT
Overview / Översikt / Oversigt
SOMNO smart 2
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15
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25
24
28 t
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32
2
9
33
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2EN
English
Contents
Contents . . . . . . . . . . . . . . . . . . . . 2
Legend . . . . . . . . . . . . . . . . . . . . . 3
1. Description . . . . . . . . . . . . . . . . . . . 4
1.1 Purpose . . . . . . . . . . . . . . . . . 4
1.2 Function . . . . . . . . . . . . . . . . 5
2. Safety Instructions . . . . . . . . . . . . . . 8
2.1 Safety regulations . . . . . . . . . . 8
2.2 Contraindications . . . . . . . . . 10
2.3 Side effects . . . . . . . . . . . . . 11
2.4 Labelling . . . . . . . . . . . . . . . 12
3. Setup of Equipment . . . . . . . . . . . . 14
3.1 Set up and connect unit . . . . . 14
3.2 Exhalation system . . . . . . . . . 15
3.3 Fitting mask . . . . . . . . . . . . . 15
3.4 Humidifier . . . . . . . . . . . . . . 16
3.5 Bacteria filter . . . . . . . . . . . . 16
3.6 Oxygen supply. . . . . . . . . . . 16
4. Operation . . . . . . . . . . . . . . . . . . .17
4.1 Exhalation relief softPAP (from
software version 6.0). . . . . . . 17
4.2 Automatic on / off switching
system. . . . . . . . . . . . . . . . . 18
4.3 SOMNOsmart 2: Startup . . . . 21
4.4 (Soft)Start setting . . . . . . . . . . 23
4.5 Set humidifier . . . . . . . . . . . . 23
4.6 After usage . . . . . . . . . . . . . 24
4.7 Reading therapy time. . . . . . . 25
4.8 Reading the therapy record. . . 26
4.9 Travelling with
SOMNOsmart 2 . . . . . . . . . 26
5. Hygienic preparation . . . . . . . . . . .27
5.1 Intervals . . . . . . . . . . . . . . . .27
5.2 Cleaning . . . . . . . . . . . . . . .28
5.3 Disinfection, Sterilization . . . . .30
5.4 Change in patients. . . . . . . . .32
6. Functional Check . . . . . . . . . . . . . .33
6.1 Intervals . . . . . . . . . . . . . . . .33
6.2 Method . . . . . . . . . . . . . . . .33
7. Malfunctions and Rectification . . . .34
8. Maintenance . . . . . . . . . . . . . . . . .36
8.1 Intervals . . . . . . . . . . . . . . . .36
8.2 Filter change. . . . . . . . . . . . .37
8.3 Change pressure measurement
tube . . . . . . . . . . . . . . . . . .38
8.4 Disposal. . . . . . . . . . . . . . . .39
9. Scope of Supply . . . . . . . . . . . . . .40
9.1 Standard scope of supply . . . .40
9.2 Accessories and spare parts . .40
10. Technical Data . . . . . . . . . . . . . . . .41
10.1 Specifications. . . . . . . . . . . .41
10.2 Pressure-volume curve. . . . . . .44
10.3 Safe distances . . . . . . . . . . .44
11. Warranty . . . . . . . . . . . . . . . . . . .45
12. Index . . . . . . . . . . . . . . . . . . . . . .46
13. Declaration of conformity . . . . . . .47

3
EN
Legend
1SOMNOsmart 2
2Bacteria filter
3Connecting cord
4Serial interface
5Control panel and display
6Connection for humidifier
7Unit outlet
8Stopper (2x)
9Drying adapter
10 Adapter
11 Pressure measurement tube
12 Hose system
13 Exhalation system
14 Mask
15 Cap
16 (Soft)Start time
17 Total running time / daily therapy time
18 Change filter
19 Pressure rise/fall and 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

4Description
EN
1. Description
1.1 Purpose
SOMNOsmart 2 is a smartPAP appliance for treating
sleep-related respiratory disorders.
• SOMNOsmart 2 creates a “Positive Airway
Pressure” (PAP).
• SOMNOsmart 2 is a self-regulating appliance.
SOMNOsmart 2 identifies respiratory events and
varies the respiratory pressure accordingly.
• The air pressure generated supports the patient’s
air passages during sleep.
• The air pressure is administered through a mask.
• SOMNOsmart 2 can be used for persons aged
12 and over.
•SOMNOsmart 2 from software version 6.0;
generally from device no. 10,000:
The softPAP mode increases patient comfort by
means of a brief pressure reduction during the tran-
sition from inhalation to exhalation.
Important! SOMNOsmart 2 can prevent blockage of the air pas-
sages reliably only if the upper and lower pressure lim-
its prescribed for the individual patient by a doctor
have been determined in, for example, a sleep
laboratory.
SOMNOsmart 2 is not suitable for life-support use.

Description 5
EN
1.2 Function
SOMNOsmart 2 works on the principle of an
electrically powered flow generator, and delivers an
electronically controlled constant pressure level.
• A radial fan draws in ambient air through a filter
and delivers it to the outlet port. From here the air
flows through the hose system and the mask to the
patient.
•An oscillation generator creates a slight pneumatic
sinusoidal oscillation in the air flow produced by
the device.
• The airway and oscillation pressure is registered
via the pressure measurement tube in the mask
• The current oscillation pressure reading is com-
pared with an average value and the preceding
values. This evaluation of the oscillation pressure
makes it possible to identify any significant
change in airway resistance and hence to in-
crease or reduce the therapy pressure via the flow
generator.
• The pressure present in the mask is shown in the
LC display. The microprocessor-controlled flow
generator regulates the pressure at the value
determined.
• The device also records a respiratory flow signal
that can be output to a PSG system or read off with
the aid of WEINMANNsupport. This makes it
possible to identify apnoea, hypopnoea and
respiratory flow limitations.
•The expiration system before the mask prevents ac-
cumulation of CO2-enriched expired air in the tube
system.

6Description
EN
•An automatic ON/OFF switching system can be
activated in the SOMNOsmart 2. This allows the
appliance to be switched on by breathing out into
the mask. If there is no pressure for about 5 sec-
onds (e.g. because the mask has slipped off dur-
ing the night), the SOMNOsmart 2 switches itself
off automatically.
• Following a power failure and resumption of the
power supply, the status of SOMNOsmart 2 is the
same as it was before the power failure. The
stored data remain preserved.
•There are two functions to facilitate falling asleep:
(Soft)start or start pressure function.
•(Soft)start function: when the device is switched on,
pressure is set to the (Soft)start pressure specified by
the doctor. The pressure limits then slowly rise to
specified values. The duration of the rise is adjust-
able. This function is suitable for patients who find
high pressure unpleasant when they are awake.
From software version 6.0,
the following option is also
available:
•Start pressure function: pressure remains at the set
value during the start time. After the start time has
expired, pressure is reduced to the lower pressure
limit. This function is suitable for patients who find
low pressure unpleasant when they are awake or
who require a high pressure rapidly after they fall
asleep.
• In softPAP mode, the respiratory flow curve is sub-
jected to continuous evaluation so that transitions
between inspiration and exhalation can be detect-
ed early. Therapy pressure is reduced before the
transition to exhalation to relieve exhalation. The
extent of the drop can be set to two levels: "slight”
(Level 1) and "normal” (Level 2). This increases pa-
tient comfort. Before the next inspiration starts,
pressure is raised to the therapy value again.

Description 7
EN
• If apnoeas or valid flow limitations occur during
sleep, softPAP mode is automatically deactivated
for the relevant period. If respiratory rate is too
high, softPAP mode is likewise deactivated tempo-
rarily. However, therapy pressure remains re-
duced during this period.
• In full-face mode, therapy is supported by a full-
face mask. Adaptation of pressure in response to
respiratory events is modified during this process.

8Safety Instructions
EN
2. Safety Instructions
2.1 Safety regulations
Read these operating instructions carefully. They are
part of the appliance and must be kept available at all
times. Use SOMNOsmart 2 for the designated pur-
pose only (see “1.1 Purpose” 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 supply voltage of the unit complies
with your supply voltage. The unit is designed for
voltages of 115 V and 230 V. One of these
voltages is detected automatically. With 12 V DC
or 24 V DC use an inverter available as an
accessory.
•Caution with oxygen: When using oxygen during
night-time therapy smoking and open fire are not
permitted. There is the risk of fire. The oxygen may
be deposited in the clothing, bed linen or the hair.
It is only removed when the room is ventilated
thoroughly.
•The supply of oxygen is only permitted with the use
of the O2connection valve WM 24042.
•As regards oxygen please make sure you observe
the safety information included in the instructions
for your oxygen system.

Safety Instructions 9
EN
•Do not place the unit near a source of heating or
expose to direct sunlight as this may additionally
heat up the respiratory air and inside parts. This
might cause condensation to form in the humidifier
and to be deposited 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 inade-
quate therapy for the patient and damage to the
device.
Caution!
• Maintain a safe distance between
SOMNOsmart 2 and equipment that emits HF ra-
diation (e.g. mobile phones). Otherwise there is a
risk of malfunction (see page 44).
• To prevent infection or bacterial contamination
please comply with section “5. Hygienic prepara-
tion” on page 27.
Transport/Accessories/Spare Parts/
Repairs
Caution!
•Do not transport SOMNOsmart 2 with the humid-
ifier installed. Tilting might cause water remaining
in the humidifier to run into the SOMNOsmart 2
and damage it.
• Have all inspections and servicing work carried
out only by the manufacturer (Weinmann) or
expert personnel.
•If third-party items are used, functional failures may
occur and fitness for use may be restricted. Bio-
compatibility requirements may also not be met.
Please note that in such cases, any claim under
warranty and liability will be voided if neither the
accessories nor genuine replacement parts recom-
mended in the instructions for use are used.

10 Safety Instructions
EN
•Third-party masks may be used only after approval
by Weinmann.
•Make sure that the accessories used are complete
and suitable for the therapy in question. This ap-
plies particularly to the exhalation system. Other-
wise there is a risk of suffocation.
2.2 Contraindications
The SOMNOsmart 2 should not be used with certain
diseases or only with particular caution. In each case
the decision whether to use SOMNOsmart 2 for
therapy lies with the doctor in charge.
This includes:
• cardiac decompensation
• severe cardiac dysrhythmia
•severe hypotension, particular in conjunction with
intravascular volume depletion
• severe epistaxis
• high risk of barotrauma
• serious pulmonary diseases (e.g. COPD, pulmo-
nary emphysema)
• daytime hypoxaemia
•ventilatory insufficiency due to a cause other than
OSA
•noctural hypoxaemia of an origin other than OSA
(obesity-hypoventilation syndrome)
• pneumothorax or pneumomediastinum
• pneumo-encephalus
• cranial trauma

Safety Instructions 11
EN
•status after brain operation and surgical procedure
performed on hypophysis or middle or inner ear
•acute sinusitis, inflammation of the middle ear (oti-
tis media) or eardrum perforation
• dehydration
Threatening situations were not observed with
SOMNOsmart 2.
2.3 Side effects
When using SOMNOsmart 2 the following undesir-
able side effects may occur during short and long-term
usage:
• pressure points caused by the mask and the fore-
head padding on the face;
• reddening of skin on face;
• nasal congestion;
• dry nose;
• dry mouth in morning;
• feeling of pressure in sinuses;
• irritation of conjunctiva of eyes;
• gastrointestinal insufflation of air ("stomach
bloating");
• nosebleeds.

12 Safety Instructions
EN
2.4 Labelling
Special labelling on unit
Unit inlet Inlet of room air at ambient temperature
Service label: Indicates when the next service is required
Front socket Electrical connection for humidifier
Unit outlet Ambient air outlet at 4 – 18 hPa
Side connection
socket
Serial port for setting therapy parameters with SOMNOadjust WM 23930
or WEINMANNsupport WM 93305 and for medical staff to read off raw
data and compressed data on therapy history for up to 30 nights of therapy
or for controlling the O2switching valve WM 24042. Max. current con-
sumption 163 mA. Analogue outlet for therapy pressure, flow, leakage flow
and oscillation pressure (0 V to 1 V DC).
Labelling on the rating plate
Do not dispose of the device in domestic waste!
Protection class B
Type of protection against electric shock: unit of protection class II
CE 0197 symbol: Confirms that the product conforms to the applicable Euro-
pean directives

Safety Instructions 13
EN
Date of manufacture
IPX1 Degree of protection against penetration by water (drips)
SN Serial number of device
Labelling on the packaging
Confirms that the product conforms to the applicable European directives
Permitted temperature for storage: –20° C to +70° C
Permitted humidity for storage: maximum 95 % relative humidity
Protect unit from wet
Fragile
-20
+70

14 Setup of Equipment
EN
3. Setup of Equipment
3.1 Set up and connect unit
1. Set up the unit on a flat surface, e.g. on a bedside
cabinet or on the floor next to the bed.
Keep a space of min. 5 cm between the rear of
the unit and the wall as the air inlet is on the rear
of the unit.
Important! Do not cover the unit.
2. Connect the power supply cable 3to the supply
connection 29 and a socket outlet.
SOMNOsmart 2 automatically detects whether
115 V or 230 V has been connected and switch-
es over automatically.
The display shows "0" for standby.
3. If SOMNOsmart 2 is to be operated with a volt-
age of 12 or 24 V DC, connect the inverter 32 to
a cigarette lighter.
To do so either use an:
– inverter 12 V WM 24131
– inverter 24 V WM 24132
Connect the outlet of the inverter and the supply
connection 29 of SOMNOsmart 2 using the pow-
er supply cable 3.
4. Please insert the adapter 10 of the hose system into
the unit outlet 7.
Note:
The appliance automatically compensates for dif-
ferences in air pressure (e.g. due to high altitude).
DC-AC WANDLER
DC-AC INVERTER
IN
OUT

Setup of Equipment 15
EN
3.2 Exhalation system
The sleeve at the end of the creased hose has a
diameter of 19.5 mm and fits over a 22 mm standard
cone. Place the sleeve on the exhalation system.
The exhalation system allows you to breathe through
the nose or mouth if the unit malfunctions. Full facial
masks must also be equipped with a safety valve. Re-
move the mask as soon as possible. First check wheth-
er a power failure has occurred. Please observe the
operating instructions for your exhalation system 13.
3.3 Fitting mask
1. Adjust the forehead support of the mask
(if provided).
2. Connect the headgear to the mask.
3. Position the mask.
4. Adjust the headgear so that the bulge of the mask
only results in low pressure to prevent causing pres-
sure points on the face.
Please refer to the operating instructions for the relevant
mask for further procedure.
13

16 Setup of Equipment
EN
3.4 Humidifier
When using the humidifier 34 it is positioned between
SOMNOsmart 2 1and the hose system 12. For this
the inlet connection stub and the electrical connection
of the heating element have to be aligned with the
SOMNOsmart 2. When doing so, please also ob-
serve the operating instructions included.
3.5 Bacteria filter
If SOMNOsmart 2 is to be used by several patients
(e.g. at hospital), the bacteria filter WM 24148
should be used to protect against infection. It is in-
stalled between the hose system and SOMNOsmart 2
or humidifier. When doing so, please also observe the
operating instructions included.
3.6 Oxygen supply
For safety reasons (risk of fire) the direct introduction of
oxygen into the hose system or the mask without any
special protective device is not permitted. However,
the supply of up to 4 l/min. oxygen to the hose system
is possible when using the oxygen connection valve
WM 24042. 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 doctor in charge.
You must also follow the safety instructions for handling
oxygen without fail as well as the operating instructions
for the oxygen valve and the oxygen unit used.

Operation 17
EN
4. Operation
4.1 Exhalation relief softPAP (from software version 6.0)
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 SOMNOsmart 2 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 de-
sired softPAP stage “soft 1” or “soft 2”ap-
pears 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 dis-
appears and the display again shows “0”.
Deactivating softPAP
soft 0 = softPAP off
soft 1 = softPAP slight
soft 2 = softPAP normal
1. With the SOMNOsmart 2 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.

18 Operation
EN
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 dis-
appears and the display again shows “0”.
4.2 Automatic on / off switching system
Activate automatic system
(up to and including software version 5.0)
A 0 = Automatic system not
activated
A 1 = Automatic system
activated
1. With the SOMNOsmart 2 switched off press the
softstart button 25 until the current setting “A 0”
appears in the display.
2. Press the on / off switch 24 to change the setting
to “A 1“.
If a button is not operated for 5 seconds, the display
will disappear and ”0” will reappear.
When the automatic system is activated, you can
switch SOMNOsmart 2 on and off using the on / off
switch 24 or using the pressure available in the mask.
• SOMNOsmart 2 is switched on automatically as
soon as the patient breathes into the mask
(pressure > 0,5 hPa).
•If the mask is removed, the unit will switch off after
5 seconds.
•If an oronasal mask with integrated emergency ex-
halation system is used, the device does not switch
on/off automatically even if setting “A” is selec-
ted. The emergency exhalation valve of the mask
means that the device cannot detect the pressure
change required for switching.