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.