Weinmann SOMNOcomfort 2e Technical Document

SOMNOcomfort 2e
SOMNOaqua
CPAP unit
from SN 65000
SOMNOcomfort 2e
SOMNOcomfort 2e with SOMNOaqua
Description of the equipment and instructions for use

e
H
HiTRON
electronics
corporation
MODEL:XXY78-12345-c
PowerSupplyfor MedicalUse only
100-240V~
1.OA
60/50Hz
24V---2.1
InputOutput
CE
e
13 Humidifier activated
Overview
SOMNOcomfort 2e
2Power supply
cable
9Breathing hose
10 Exhalation
system
7Unit outlet
6Serial interface
12 Headgear
5Cover
11 Mask
8Adapter
14 Softstart time
15 Automatic
switch on/off
16 Therapy pressure 19 Humidifier button
18 Softstart button
17 On/off switch
(stand-by)
20 Filter compartment cover, air inlet
25 Nameplate 24 Supply connection
21 Carry case
22 DC adapter
1Bacteria filter
23 O2connection valve
3Power pack
4Humidifier

Overview 3
EN
Legend
1 Bacteria filter
Used to protect the patient from bacteria, partic-
ularly if the unit is being used by a number of
patients.
2 Power supply cable
Connects the power pack to the power supply.
3 Power pack
Used to supply power to the unit.
4 Humidifier
Used to heat and humidify the air flow created by
the therapy unit.
5 Cover
Connects the unit outlet with the humidifier con-
nection. Is required if a humidifier is not being
used.
6 Serial interface
Connects the therapy device to devices for setting
and evaluating therapy data or to the O2supply
valve.
7 Unit outlet
The air flows from here via the breathing hose
and mask to the patient.
8 Adapter
Connects the breathing hose to the unit outlet.
9 Breathing hose
The air flows through the breathing hose to the
mask.
10 Exhalation system (accessory)
Exhalation air containing carbon dioxide is
diverted here during the therapy.
11 Mask (accessory)
The mask is used to provide the patient with air at
the required therapy pressure.
12 Headgear (accessory)
Helps locate the mask correctly and securely.
13 Humidifier activated
This symbol appears when the humidifier is in op-
eration. The current humidity level is displayed.
14 Softstart time
This symbol appears when the softstart time is set
or the softstart is activated.
15 Automatic switch on/off
The symbol "A" (automatic) appears when the
Automatic switch on/off is active. The symbol
"M" (manual) appears when the Automatic
switch on/off is inactive.
16 Therapy pressure
The therapy pressure is shown in hPa
(hectoPascal). 1 hPa = 1 mbar = 1 cm H2O.
17 On/off switch (stand-by)
Switches the therapy unit on and off.
18 Softstart button
Activates the softstart or sets the softstart time
(5 - 30 minutes in 5 minute steps)
19 Humidifier button
Activates the humidifier or sets the humidifier
level (6 levels).
20 Filter compartment cover, air inlet
Covers and securely locates the coarse and fine
dust filters.
21 Carry case
For carrying the therapy unit.
22 DC adapter (accessory)
For operating the therapy unit via a DC socket
(12 - 24 V).
23 O2connection valve (accessory)
For introducing oxygen into the mask.
24 Supply connection
This is the connection for the external power pack
or DC adapter.
25 Nameplate
Provides information about the unit, e.g. serial
number and year built.

4Overview
EN
Legend
26 Heater
Heats the water in the humidifier. This humidifies
the air.
27 Inlet connections
The air flows from the therapy unit into the
humidifier.
28 Pressure gland
Measures the present therapy pressure.
29 Outlet connections
The humidified air flows from here through the
unit outlet into the breathing hose.
30 Lower part
Holds approx. 300ml water.
31 Upper part
Closes the humidifier, contains the filling cap.
32 Filling cap
For filling the humidifier.
27 Inlet connections
29 Outlet
connections
31 Upper part
26 Heater
32 Filling cap
30 Lower part
SOMNOaqua (optional)
28 Pressure gland

Overview 5
EN
Special markings on the unit
Symbol Meaning
SOMNOcomfort 2e:
Unit inlet: allows air at room temperature to enter
Unit outlet: air escapes with 4 - 20 hPa
Side connection socket:
Connection for setting the therapy parameters with SOMNOadjust
WM 23930 and WEINMANNsupport WM 93305 by specialist staff or
to control the O2connection valve, WM 24042. Max. current
consumption 163 mA.
SOMNOaqua (optional)
Do not use the humidifier on patients whose airways have been bypassed
Unit is heated! Do not touch the heater rod.
SN Serial number of humidifier
Degree of protection against electric shock: device type BF
Do not dispose of unit as domestic waste
Year built
CE 0197 symbol: confirms that the product conforms to the applicable
European directives.
24 V DC 24 V DC
Signs on the unit:
Year built
Unit type B

6Overview
EN
Labeling on the packaging of the therapy device
Labeling on the packaging of the breathing tube
Do not dispose of unit as domestic waste
SN Serial number of the unit
Type of protection against electric shock: unit of protection class II
CE 0197 symbol: confirms that the product conforms to the applicable
European directives.
IPX1 Protection against ingress of water (drips)
Symbol Meaning
Permitted storage temperature: -40°C to +70°C
CE 0197 symbol: confirms that the product conforms to the applicable
European directives.
Permitted storage humidity: max. 95% relative humidity.
Protect device from wet
Fragile
Symbol Meaning
Use only for a single patient.
Symbol Meaning

Contents 7
EN
Contents
1. Description of Equipment . . . . . . . . 8
1.1 Intended use
SOMNOcomfort 2e . . . . . . . . . . 8
1.2 SOMNOaqua intended use . . . . 8
1.3 Functional description
SOMNOcomfort 2e . . . . . . . . . . 9
1.4 Functional description
SOMNOaqua. . . . . . . . . . . . . . 10
2. Safety Instructions . . . . . . . . . . . . . 11
2.1 Safety instructions. . . . . . . . . . 11
2.2 Contraindications . . . . . . . . . . 13
2.3 Side effects . . . . . . . . . . . . . . . 14
3. Setup of Equipment . . . . . . . . . . . . 15
3.1 Setting up and connecting the
SOMNOcomfort 2e . . . . . . . . . 15
3.2 Fitting the mask . . . . . . . . . . . 16
3.3 Filling and connecting the
SOMNOaqua. . . . . . . . . . . . . . 16
3.4 Accessories . . . . . . . . . . . . . . . 18
4. Operation . . . . . . . . . . . . . . . . . . . . . 19
4.1 Automatic switch on/off . . . . . 19
4.2 SOMNOcomfort 2e startup . . . 20
4.3 SOMNOaqua setting . . . . . . . . 20
4.4 Softstart setting . . . . . . . . . . . 22
4.5 After usage . . . . . . . . . . . . . . . 22
4.6 Read off therapy duration . . . . 23
4.7 Travelling with therapy units . . 24
5. Hygienic preparation . . . . . . . . . . . 25
5.1 Intervals . . . . . . . . . . . . . . . . . 25
5.2 Cleaning SOMNOcomfort 2e. . 25
5.3 Cleaning the SOMNOaqua . . . 27
5.4 Descaling the SOMNOaqua . . 28
5.5 Disinfecting the
SOMNOcomfort 2e. . . . . . . . . 28
5.6 Disinfecting the SOMNOaqua . 29
5.7 Multiple patient use
SOMNOcomfort 2e. . . . . . . . . 30
5.8 Multiple patient use
SOMNOaqua . . . . . . . . . . . . . 30
6. Functional checks . . . . . . . . . . . . . .31
6.1 Intervals . . . . . . . . . . . . . . . . . 31
6.2 Function check of
SOMNOcomfort 2e. . . . . . . . . 31
6.3 Function check of
SOMNOaqua . . . . . . . . . . . . . 32
7. Malfunctions and Rectification . . .33
7.1 SOMNOcomfort 2e. . . . . . . . . 33
7.2 SOMNOaqua . . . . . . . . . . . . . 34
8. Maintenance . . . . . . . . . . . . . . . . . .36
9. Disposal . . . . . . . . . . . . . . . . . . . . . .36
10. Scope of supply . . . . . . . . . . . . . . . .37
10.1 Standard scope of supply . . . . 37
10.2 Accessories and spare parts . . 37
11. Technical data . . . . . . . . . . . . . . . . .38
11.1 Specifications . . . . . . . . . . . . . 38
11.2 Pneumatic diagram . . . . . . . . 42
11.3 Safety distances . . . . . . . . . . . 42
12. Warranty . . . . . . . . . . . . . . . . . . . . .43
13. Declaration of conformity . . . . . . .43
13. Index . . . . . . . . . . . . . . . . . . . . . . . . .44

8Description of Equipment
EN
1. Description of Equipment
1.1 Intended use SOMNOcomfort 2e
SOMNOcomfort 2e is a CPAP unit (CPAP = Continuous Positive Airway Pressure) used to
treat sleep-related breathing disorders in patients from the age of 12 years.
No special knowledge or training is required in order to use the unit. All that is required is
instruction by a clinic or a medical practitioner.
Important!
SOMNOcomfort 2e can only reliably prevent airway closure when the CPAP pressure pre-
scribed by a doctor for the specific patient has been calculated, e.g. in a sleep laboratory.
SOMNOcomfort 2e is not designed for life support.
Only use the unit for the purposes described below.
1.2 SOMNOaqua intended use
The SOMNOaqua humidifier is an optional accessory for the Weinmann
SOMNOcomfort 2e therapy unit.
The SOMNOaqua humidifier is used to heat the air flow created by the SOMNOcomfort 2e
and to increase its humidity. This will prevent the patient's upper airways drying out during
the therapy.
SOMNOaqua can only be used with the SOMNOcomfort 2e therapy unit. Operation with
third-party devices is not permitted.
Only use the unit for the purposes described below.

Description of Equipment 9
EN
1.3 Functional description SOMNOcomfort 2e
SOMNOcomfort 2e operates according to the principle of an electrically driven flow gen-
erator, with the pressure level being controlled electronically.
• A fan draws in ambient air via a filter and conveys it to the unit outlet.
From here the air flows through the breathing hose and the mask to the
patient.
• A pressure sensor measures the pressure at the unit outlet and shows this
in the display. The microprocessor-controlled flow generator controls the
pressure to the set value and reduces fluctuations in pressure caused by
breathing.
• A softstart automatic system is installed to help the patient fall asleep
more easily. When the unit is switched on, the CPAP pressure starts at
the initial pressure selected by the doctor and is then slowly increased to
the setpoint pressure selected. The time of the pressure increase can be
adjusted between 5 and 30 minutes in 5-minute increments.
• Automatic switch on/off can be activated on SOMNOcomfort 2e. The
unit can then be switched on by breathing into the mask. If there is no
pressure for approx. 15 seconds (e.g. because the mask has been re-
moved), SOMNOcomfort 2e will switch off automatically.
• The therapy parameters are adjusted using the SOMNOadjust remote
control system or the WEINMANNsupport evaluation program.
•SOMNOcomfort 2e automatically saves all settings in the event of a pow-
er failure. This means that the unit does not need to be reset when power
is restored.

10 Description of Equipment
EN
1.4 Functional description SOMNOaqua
The humidifier works on the so-called overflow principle. The air coming from the therapy
unit passes over the surface of a heated water tank, increasing the relative humidity and
the temperature of the air flow. The amount of humidity released can be adjusted using
the buttons on the Weinmann therapy unit. The output of the heater rods and consequent-
ly the temperature of the water in the humidifier chamber is controlled electronically by the
Weinmann unit.
The water level can be checked whenever required through the window in the humidifier
chamber.

Safety Instructions 11
EN
2. Safety Instructions
Please read these operating instructions through carefully. They form part of the equip-
ment and should be available at all times.
For your own safety, the safety of your patients, and to comply with the requirements of EU
Directive 93/42/EEC, please observe the following points.
2.1 Safety instructions
Operating the unit
Caution!
• The power pack supplied allows the unit to be operated at voltages be-
tween 115 V and 230 V. Check that your supply voltage falls within this
range. With a 12 V DC or 24 V DC supply, use the WM 24469 DC adapt-
er available as an accessory.
• Do not cover the unit or power pack. Do not use in the vicinity of a heater
or in direct sunlight. The unit may overheat, resulting in insufficient ther-
apy delivery and damage to the unit.
• Maintain a safe distance between the SOMNOcomfort 2e and equip-
ment that emits HF radiation (e.g. mobile phones). This unit may other-
wise malfunction (see page 42). If the SOMNOcomfort 2e interferes with
other devices (e.g. a radio), move the SOMNOcomfort 2e further away.
Caution!
• Do not use the therapy unit or humidifier if the unit is malfunctioning,
parts are damaged and/or the contact between the humidifier and the
heater rod is damp.
• The performance of the humidifier can be affected if it is used outside
the permitted temperature range.
• Observe the operating instructions for your mask.
• Please observe the section “5. Hygienic preparation” on page 25 to
avoid infection or bacterial contamination.

12 Safety Instructions
EN
Transport/Accessories/Spare Parts/Repair
Caution!
• Do not transport (or tilt) the SOMNOcomfort 2e with the humidifier in-
stalled. Tilting might cause water remaining in the humidifier to run into
the SOMNOcomfort 2e and damage it.
• Only have checks and repair work carried out by Weinmann or specialist
staff.
• If third-party items are used, functional failures may occur and fitness for
use may be restricted. Biocompatibility 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
recommended in the instructions for use are used.
Caution!
• Modifications to the SOMNOcomfort 2e and SOMNOaqua are not per-
mitted.
• Third-party masks may only be used after being approved by Weinmann.
Using unapproved masks may result in unsuccessful therapy.
• Please make sure that the accessories you use are complete and are suit-
able for the therapy. This particularly applies to the exhalation system.
The CO2content of the exhaled air may otherwise adversely affect your
breathing.
Oxygen supply
Warning!
• Do not smoke or use open fires if oxygen is being used during therapy.
There is a risk of fire! The oxygen may be deposited in clothing, bed lin-
en or in your hair. It can only be removed by ventilating the room thor-
oughly.
Caution!
• An oxygen supply is only permitted if the WM 24042 O2connection valve
is used. Valves of third-party manufacture may only be used following
authorization by the manufacturer, Weinmann. If unauthorized valves
are used, there is a risk of fire.
• On the topic of oxygen, it is essential to follow the safety instructions in
the instructions for use of your oxygen supply system and the 02oxygen
valve.

Safety Instructions 13
EN
• Oxygen must be supplied via the breathing mask. Supply via any other
point is not permitted. The quantity of oxygen supplied must not exceed
4 l/min. If excessive quantities are supplied, there is a risk of fire.
2.2 Contraindications
The SOMNOcomfort 2e should not be used with certain diseases or only with particular
caution. In each case the decision whether to use SOMNOcomfort 2e for therapy lies with
the doctor in charge.
This includes:
• cardiac decompensation
• severe cardiac dysrhythmia
• severe hypotension, particularly in conjunctions with intravascular vol-
ume depletion
• Severe epistaxis
• high risk of barotrauma
• ventilatory insufficiency due to a cause other than OSA
• nocturnal hypoxaemia of an origin other than OSA (obesity-
hypoventilation syndrome)
• pneumothorax or pneumomediastinum
• pneumo-encephalus
• cranial trauma
• status after brain operation and surgical procedure performed on
hypophysis or on middle or inner ear
• acute sinusitis, inflammation of the middle ear (otitis media) or eardrum
perforation
• dehydration
Threatening situations were not observed with SOMNOcomfort 2e.

14 Safety Instructions
EN
2.3 Side effects
When using SOMNOcomfort 2e the following undesirable side effects may occur during
short-term and long-term usage:
• pressure points on the face caused by the mask and the forehead
padding;
• reddening of the skin on face;
• nasal congestion;
•drynose;
• dry mouth in morning;
• feeling of pressure in sinuses;
• irritation of conjunctiva of eyes;
• gastrointestinal insufflation of air
("bloated stomach");
• nosebleeds.

Setup of Equipment 15
EN
3. Setup of Equipment
3.1 Setting up and connecting the SOMNOcomfort 2e
1. Set up the unit on a flat surface, e.g. on the bedside cabinet or on the floor next to
the bed.
Caution!
Do not cover the unit or power pack. Do not use in the vicinity of a heater or in direct
sunlight. The unit may overheat, resulting in insufficient therapy delivery and damage
to the unit.
2. Plug the power supply cable into the supply connection of the SOMNOcomfort 2e.
Then plug the power pack into a socket outlet (using the power supply cable).
The power pack automatically determines the
appropriate mains voltage (115 V - 230 V).
The display shows "0" for standby, together with "A"
or "M" according to the appropriate setting on the
automatic on/off switch
3. If SOMNOcomfort 2e is to be operated with a voltage
of 12 or 24 V DC, connect the WM 24469 DC adapt-
er (available as an option) instead of the power pack.
4. Plug the breathing hose into the socket outlet
adapter.
5. Lock the cover by pushing the breathing hose adapter
into the unit outlet until it latches in place.
Power pack
DC adapter

16 Setup of Equipment
EN
Note
• The device automatically compensates for differences in air pressure (e.g.
as a result of great altitude).
3.2 Fitting the mask
1. Adjust the forehead support of the mask (if present).
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 pressure points on the face.
For further instructions, please refer to the operating instructions for the relevant mask.
3.3 Filling and connecting the SOMNOaqua
Before using for the first time
Before using for the first time, rinse the humidifier with copious amounts of water (see “5.
Hygienic preparation” on page 25).
Filling the humidifier
Caution!
• Never overfill the humidifier, otherwise water may enter the therapy unit
and damage it.
• Do not fill the humidifier when it is connected to the therapy unit,
otherwise water may enter the therapy unit and damage it.
• Do not fill the humidifier with hot water as this may damage the housing
and heater rod, resulting in incorrect operation and insufficient therapy
delivery.
Note
• The use of aromatic additives, such as eucalyptus oil, may damage the
plastic parts of the humidifier.

Setup of Equipment 17
EN
1. Open the filling cap of the humidifier.
2. Fill the humidifier up to the mark "max " with
distilled water.
If no distilled water is available, low calcium boiled
water can be used instead (but not as a rule!). Check
that the heater rod does not scale up (see “5.4 Des-
caling the SOMNOaqua” on page 28).
3. Firmly close the humidifier with the filling cap.
4. After filling, check that the humidifier is not leaking.
Run your finger over the bottom of the humidifier or
place the humidifier on a piece of kitchen paper. Any
escaping water will then be easy to spot.
Adapting the humidifier
1. If necessary, detach the breathing hose from the ther-
apy unit by pushing in the catch on the adapter. Pull
the breathing hose and adapter off the unit outlet.
2. Push the cover sideways out of the humidifier stub on
the therapy unit.
3. Push the filled humidifier as far as it will go into the
stub on the unit.
4. Insert the breathing hose adapter into the outlet of
the therapy unit. Check that the locking catch is
pointing upwards and has latched into the groove in
the unit outlet.
max
max
H
2
O
max
e
click!

18 Setup of Equipment
EN
3.4 Accessories
External exhalation system
Should the unit fail, the exhalation system enables you to
breath through the nose or mouth. Full-face masks must
also be fitted with a safety valve. Remove the mask as
quickly as possible. First check whether there has been a
power failure. Follow the instructions for use of your ex-
haled air system.
Bacteria filter
If SOMNOcomfort 2e is to be used by several patients (e.g.
in a hospital), a bacteria filter should be used to protect
against infection. It is installed between the breathing
hose and the adapter. Using a bacteria filter can reduce
the pressure and flow rate.
Follow the manufacturer's instructions carefully, especially
with regard to the use-by date of the bacteria filter.
Oxygen supply
For safety reasons (risk of fire) the direct introduction of
oxygen into the breathing hose or the mask without any
special protective device is not permitted. However, the
supply of up to 4 l/min oxygen to the breathing mask 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.
To prevent oxygen entering the therapy unit, the SOMNOcomfort 2e automatically gener-
ates a therapy pressure of at least 5 hPa when an oxygen connection valve is attached. You
must under all circumstances follow the safety instructions for handling oxygen as well as
the operating instructions for the oxygen valve and the oxygen unit used.

Operation 19
EN
4. Operation
4.1 Automatic switch on/off
Activate automatic mode
M = manual
A = automatic
1. With the SOMNOcomfort 2e switched off, press the softstart button until the current
setting "M" starts to flash in the display.
2. Press the on/off switch to change the setting to "A".
If a button is not pressed for 5 seconds, the current setting is saved.
When the automatic system is activated, you can switch SOMNOcomfort 2e on and off
using the on/off switch or using the pressure available in the mask.
•SOMNOcomfort 2e 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 approx. 15 seconds.
Note:
If the JOYCE Full Face mask is used, the device does not switch on/off automatically,
even if setting "A" is selected. The emergency exhalation valve of the mask means that
the device cannot detect the pressure change required for switching.
Switch off automatic system
M = manual
A = automatic
1. With the SOMNOcomfort 2e switched off, press the softstart button until the current
setting "A" starts to flash in the display.
2. Press the on/off switch to change the setting to "M".
If a button is not pressed for 5 seconds, the current setting is saved.
When the automatic system is switched off, you can only switch SOMNOcomfort 2e on
and off using the on/off switch.
If the unit is not used for 15 minutes, it switches off automatically.

20 Operation
EN
4.2 SOMNOcomfort 2e startup
Always use an exhalation system. The exhalation system allows the used air containing car-
bon dioxide (CO2) to escape from the mask. Without an exhalation system the CO2con-
centration would rise to critical values in the mask and hose, thus hindering your breathing.
The exhalation system must always be installed in the immediate vicinity of the mask.
An exhalation system is already incorporated in some mask systems. In this case no sepa-
rate exhalation system is required. Please refer to the operating instructions for the relevant
mask.
1. If the mask has no integrated exhalation system, place the exhalation system on the
end of the breathing hose.
2. Connect the breathing hose including exhalation sys-
tem to the mask (plug cone). Please follow the rele-
vant operation instructions for the mask and
exhalation system.
Feed the breathing hose away from your head. Never
place the breathing hose around your neck.
3. Press the on/off switch. If the automatic system is ac-
tivated, you can also switch on SOMNOcomfort 2e
with a breath.
The therapy period will appear for approx. 3 seconds
in the display. The flow generator starts to convey air
through the breathing hose.
If softstart has been preselected, the softstart display will then light up and the
softstart time will appear in the display.
SOMNOcomfort 2e is now ready for operation.
4.3 SOMNOaqua setting
Switching on the humidifier
1. Fill up the humidifier and set up as described in “3.3 Filling and connecting the
SOMNOaqua” on page 16.
2. Switch on the therapy unit.