Weinmann SOMNOcomfort 2e Technisches Dokument

SOMNOcomfort 2e

SOMNOaqua

CPAP unit

from SN 65000

SOMNOcomfort 2e

SOMNOcomfort 2e with SOMNOaqua

Description of the equipment and instructions for use

HiTRON

electronics

corporation

MODEL:XXY78-12345-c

PowerSupplyfor MedicalUse only

100-240V~

1.OA

60/50Hz

24V---2.1

InputOutput

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

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

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

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

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

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

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

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

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.

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