Weinmann Homecare CPAP 20e User manual

CPAP 20e
CLICK 2
CPAP unit
Aparato CPAP
CPAP 20e WM 27320
CLICK 2 WM 27330
Description of the equipment and instructions for use
Descripción del aparato e instrucciones de manejo

English 4
Español 52

4 Overview
English
Overview
13 Humidifier activated
CPAP 20e
12 Power supply cable
4 Breathing hose
3 Exhalation system
5 Unit outlet
7 Serial interface
1 Head gear
2 Mask
15 Maintenance symbol
14 Softstart time
17 Therapy pressure
16 Change filter symbol
20 Humidifier button
19 Softstart button
18 On/off switch
(stand-by)
8 Air inlet
10 Unit plaque
9 Supply connection
24 Carry case 23 DC adapter 12 - 24 V 21 Bacteria filter
25 O
2
connection valve
11 Power supply
22 Humidifier
6 Humidifier connection

Overview 5
Legend
1 Head gear (Accessories)
Helps locate the mask correctly and securely.
2 Mask (Accessories)
The mask is used to provide the patient with air at
the required therapy pressure.
3 Exhalation system (Accessories)
Exhalation air containing carbon dioxide is
diverted here during the therapy.
4 Breathing hose
The air flows through the breathing hose to the
mask.
5 Unit outlet
The air flows from here via the breathing hose
and mask to the patient.
6 Humidifier connection
Used to connect the CLICK 2 humidifier (supplied
as an accessory).
7 Serial interface
Used exclusively to connect to devices for
visualization and evaluation of therapy data.
8 Air inlet
Securely positions the coarse and fine dust filters.
9 Supply connection
This is the connection for the external power
supply or DC adapter.
10 Unit plaque
Provides information about the unit, e.g. serial
number and year built.
11 Power supply
Used to supply power to the unit.
12 Power supply cable
Connects the power supply to the power supply.
13 Humidifier activated
This symbol appears when the humidifier is in
operation. The current humidity level is displayed.
14 Softstart time
This symbol appears when the softstart time is set
or the softstart is activated.
15 Maintenance symbol
This symbol appears every 10,000 operating
hours. The unit must then be serviced.
16 Change filter symbol
This symbol appears every 250 operating hours.
The fine filter must then be changed.
17 Therapy pressure
The therapy pressure is shown in hPa
(hectoPascal). 1 hPa = 1 mbar ≈1 cm H2O.
18 On/off switch (stand-by)
Switches the therapy unit on and off.
19 Softstart button
Activates the softstart or sets the softstart time
(5 - 30 minutes in 5 minute increments)
20 Humidifier button
Activates the humidifier or sets the humidifier
level (6 levels).
21 Bacteria filter (Accessories)
Used to protect the patient from bacteria,
particularly if the unit is being used by a number
of patients.
22 Humidifier (Optional)
Used to heat and humidify the air flow created by
the therapy unit.
23 DC adapter 12 - 24 V (Accessories)
For operating the therapy unit via a DC socket
(12 - 24 V).
24 Carry case (Accessories)
For carrying the therapy unit.
25 O2connection valve (Accessories)
For introducing oxygen into the mask.

6Overview
Legend
26 Filling cap
For filling the humidifier.
27 Upper part
Closes the humidifier, contains the filling cap.
28 Outlet connections
From here the moistened air flows into the
breathing hose.
29 Lower part
Contains approximately 280 ml water.
30 Closures
Used to shut off the pressure gland during
preparatory hygienic operations.
31 Heater
Heats the water in the humidifier. This humidifies
the air.
32 Inlet connections
The air flows from the therapy unit into the
humidifier.
33 Bellows
Dries the CLICK 2.
32 Inlet connections
28 Outlet
connections
27 Upper part
31 Heater
26 Filling cap
30 Closures
29 Lower part
CLICK 2 (optional)
33 Bellows

Overview 7
Special markings on the unit
Symbol Meaning
CPAP 20e:
34 Unit outlet: air escapes with 4 - 20 hPa
35 Please use the appropriate User Guide!
Connector for respiratory humidifier CLICK 2 WM 27330.
36
Please use the appropriate User Guide!
Connection for power supply WM 24480 or DC adapter WM 24469, to
operate the therapy units using a DC socket (12 - 24 V)
37 DC voltage
38 Unit inlet: allows air at room temperature to enter
39
Please use the appropriate User Guide!
Connection for setting the therapy parameters with SOMNOadjust
WM 23930 and SOMNOsupport WM 23975 by specialist staff or to control
the O2connection valve, WM 24042. Max. current consumption 163 mA.
CLICK 2 (optional):
40 Unit is hot! Do not touch the heater rod.
34
CPAP 20e
CLICK 2
39
3736 38
40
41
35

8Overview
Unit plaques
Markings on the packaging
41 Do not use the humidifier on patients whose airways have been bypassed
Year built
Level of protection from electric shock: Unit type B
Do not dispose of the unit as household waste
Please use the appropriate User Guide!
SN Unit serial number
Type of protection from electric shock: Unit of protection class II
Symbol Meaning
Permitted temperature for storage: -20˚C to + 70˚C
% 0-95 Permitted humidity for storage: max. 95 % relative humidity.
Symbol Meaning
-20

Contents 9
Contents
1. Description of unit . . . . . . . . . . . . . 10
1.1 Intended use CPAP 20e . . . . . . . . 10
1.2 Intended use CLICK 2 . . . . . . . . . . 10
1.3 Functional description CPAP 20e. . 11
1.4 Functional description CLICK 2 . . . 11
2. Safety Instructions . . . . . . . . . . . . . 12
2.1 Safety instructions . . . . . . . . . . . . 12
2.2 Contraindications . . . . . . . . . . . . . 14
2.3 Side effects. . . . . . . . . . . . . . . . . . 15
3. Set up of equipment . . . . . . . . . . . . 16
3.1 Setting up and connecting the
CPAP 20e . . . . . . . . . . . . . . . . . . . 16
3.2 Filling and connecting the
CLICK 2 . . . . . . . . . . . . . . . . . . . . 17
3.3 Breathing mask. . . . . . . . . . . . . . . 18
3.4 Connect other accessories . . . . . . 19
4. Operation . . . . . . . . . . . . . . . . . . . . 20
4.1 CPAP 20e startup . . . . . . . . . . . . . 20
4.2 CLICK 2 setting. . . . . . . . . . . . . . . 21
4.3 Softstart setting . . . . . . . . . . . . . . 22
4.4 After usage. . . . . . . . . . . . . . . . . . 23
4.5 Read off therapy duration. . . . . . . 23
4.6 Traveling with therapy units . . . . . 24
5. Hygienic preparation . . . . . . . . . . . 25
5.1 Intervals . . . . . . . . . . . . . . . . . . . . 25
5.2 Cleaning CPAP 20e. . . . . . . . . . . . 25
5.3 Cleaning CLICK 2 . . . . . . . . . . . . . 27
5.4 Descaling CLICK 2 . . . . . . . . . . . . 29
5.5 Disinfection CPAP 20e . . . . . . . . . 29
5.6 Disinfection CLICK 2 . . . . . . . . . . 30
5.7 Multiple patient use CPAP 20e. . . 30
5.8 Multiple patient use CLICK 2 . . . . 31
6. Functional check . . . . . . . . . . . . . . .32
6.1 Intervals . . . . . . . . . . . . . . . . . . . . 32
6.2 Function check of CPAP 20e . . . . 32
6.3 Function check of CLICK 2 . . . . . . 33
7. Malfunctions and Rectification . . . .34
7.1 CPAP 20e . . . . . . . . . . . . . . . . . . 34
7.2 CLICK 2 . . . . . . . . . . . . . . . . . . . . 35
8. Maintenance . . . . . . . . . . . . . . . . . .37
8.1 Intervals . . . . . . . . . . . . . . . . . . . . 37
8.2 Maintenance includes the
following: . . . . . . . . . . . . . . . . . . 37
9. Disposal . . . . . . . . . . . . . . . . . . . . . .37
10. Scope of supply . . . . . . . . . . . . . . . .38
10.1 Standard scope of supply . . . . . . . 38
10.2 Accessories . . . . . . . . . . . . . . . . . 38
10.3 Replacement parts CPAP 20e . . . . 41
10.4 Replacement parts CLICK 2 . . . . . 41
11. Technical data . . . . . . . . . . . . . . . . .42
11.1 Specifications. . . . . . . . . . . . . . . . 42
11.2 Pneumatic diagram . . . . . . . . . . . 45
11.3 Safety distances . . . . . . . . . . . . . . 46
12. Warranty . . . . . . . . . . . . . . . . . . . . .47
13. Index . . . . . . . . . . . . . . . . . . . . . . . .48
14. Declaration of Conformity . . . . . . .49

10 Description of unit
1. Description of unit
1.1 Intended use CPAP 20e
CPAP 20e 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.
Caution!
CPAP 20e can only reliably prevent airway closure when the CPAP pressure prescribed
by a doctor for the specific patient has been calculated, e.g. in a sleep laboratory.
CPAP 20e is not designed for life support.
Only use the unit for the purposes described below.
1.2 Intended use CLICK 2
The CLICK 2 humidifier is an optional accessory for the Weinmann CPAP 20e therapy unit.
The CLICK 2 humidifier is used to heat the air flow created by the CPAP 20e and to increase
its humidity. This will prevent the patient's upper airways drying out during the therapy.
CLICK 2 can only be used with the CPAP 20e therapy unit. Operation with third-party
devices is not permitted.
Only use the unit for the purposes described below.

Description of unit 11
1.3 Functional description CPAP 20e
CPAP 20e operates according to the principle of an electrically driven flow generator, 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 upcoming pressure at the unit outlet and
shows this on 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.
• The therapy parameters are adjusted using the SOMNOadjust remote
control system or the SOMNOsupport evaluation program.
• CPAP 20e automatically saves all settings in the event of a power failure.
This means that the unit does not need to be reset when power is
restored.
1.4 Functional description CLICK 2
The humidifier works on the so-called overflow principle. The air coming from the therapy
unit is conveyed across 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 us-
ing the buttons on the Weinmann therapy unit. The output of the heater rods and conse-
quently the temperature of the water in the humidifier chamber is controlled electronically
by the Weinmann unit.
The water level can be checked at any time through the window in the humidifier chamber.

12 Safety Instructions
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 supply 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.
• CPAP 20e must be connected to an easily accessible socket so that the
mains plug can be quickly removed in the event of a power failure.
• Do not cover the unit or power supply. Do not use in the vicinity of a
heater or in direct sunlight. The unit may overheat, resulting in insuffi-
cient therapy delivery and damage to the unit.
• Maintain a safe distance between the CPAP 20e and equipment that
emits HF radiation (e.g. mobile phones). This unit may otherwise mal-
function (see page 46). If CPAP 20e interferes with other equipment (e.g.
a radio), put the CPAP 20e further away from the equipment.
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.

Safety Instructions 13
Transport/Accessories/Spare Parts/Repair
Caution!
•Do not transport (or tilt) the CPAP 20e with the humidifier installed. Tilt-
ing might cause water remaining in the humidifier to run into the
CPAP 20e and damage it.
•Only have checks and repair work carried out by Weinmann or specialist
staff.
•Malfunctions and a lack of biocompatibility may result if third-party arti-
cles are used. Please bear in mind that in these cases any warranty enti-
tlement and liability shall lapse where the accessories recommended in
the instructions for use or original spare parts are not utilized.
Caution!
• Modifications to the CPAP 20e and CLICK 2 are not permitted.
•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!
•There is a risk of fire! Do not smoke or use open fires if oxygen is being
used during therapy. The oxygen may be deposited in clothing, bed linen
or in your hair and can only be removed by thorough ventilation.
Caution!
•An oxygen supply is only permitted if the WM 24042 O2connection valve
is used.
•As regards oxygen, please make sure you observe the safety instructions
included in the instructions for your oxygen system.

14 Safety Instructions
2.2 Contraindications
The CPAP 20e should not be used with certain diseases or only with particular caution. In
each case the decision whether to use CPAP 20e for therapy lies with the doctor in charge.
These include:
• cardiac decompensation
• severe heart arrhythmia
•severe hypotension, particularly in conjunction with intravascular volume
depletion
• severe epistaxis
• high risk of barotrauma
• ventilatory insufficiency due to a cause other than OSA
• nocturnal hypoxemia due to a cause other than OSA (obesity
hypoventilation syndrome)
• pneumothorax or pneumomediastinum
• pneumo-encephalus
• head injury
• status after brain operation and surgical procedure performed on
hypophysis or on middle or inner ear
• acute inflammation of the sinuses (sinusitis), middle ear inflammation
(otitis media) or perforated eardrum
• dehydration
Threatening situations were not observed with CPAP 20e.

Safety Instructions 15
2.3 Side effects
When using CPAP 20e 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 pad-
ding
• reddening of facial skin
• nasal congestion
• dry nose
• dry mouth in morning
• feeling of pressure in the sinuses
• irritation of conjunctiva of eyes
• gastrointestinal insufflation
(“wind”)
• nosebleeds

16 Set up of equipment
3. Set up of equipment
3.1 Setting up and connecting the CPAP 20e
1. Set up the unit on a flat surface, e.g. a bedside cabinet or on the floor next to the bed.
Caution!
Do not cover the unit or power supply. 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 CPAP 20e. Then plug the
power supply into a socket outlet (using the power supply cable).
The power supply automatically determines the appro-
priate mains voltage (115 V - 230 V).
If the CPAP 20e is to be operated with a voltage of
12 or 24 V DC, connect the WM 24469 DC adapter
(available as an option) instead of the power supply.
On the display „0“ appears to show it is ready for use.
3. Plug the breathing hose into the unit outlet.
Note:
The device automatically compensates for differences
in air pressure (e.g. as a result of great altitude).
Power
supply
DC adapter

Set up of equipment 17
3.2 Filling and connecting the CLICK 2
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!
•Do not fill the humidifier when it is connected to the therapy unit and do
not overfill above the maximum level, otherwise water may enter the
therapy unit. This can damage the unit.
•Do not fill the humidifier with hot water as this might damage the hous-
ing and heating rod resulting in incorrect operation and insufficient ther-
apy delivery.
Note
• The use of aromatic additives, such as eucalyptus oil, may damage the
plastic parts of the humidifier.
1. Open the filling cap of the humidifier.
2. Fill the humidifier up to the mark 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 Descaling
CLICK 2" on page 29).
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.
Fill level mark
26

18 Set up of equipment
Adapting the humidifier
1. If necessary, release the corrugated tubing from the
therapy unit.
2. Click the humidifier into position from the front onto
the sleep apnea unit. The inlet connection and the heat-
ing rod must be directed towards to the sleep apnea
unit. Take care to engage the lock.
3. Connect the corrugated tube to the outlet connections
of the humidifier.
4. To release the humidifier, press the locking catch and
withdraw it off the unit.
3.3 Breathing mask
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.
Note
For further instructions, please refer to the operating instructions for the relevant mask.
Warning!
Full-face masks must be equipped with an emergency exhalation valve so that you
can breathe through nose or mouth in the event of any device failure. Full-face masks
without an emergency exhalation valve may not be used!
External exhalation system
No exhalation system is integrated in some masks. In order for the used, carbon dioxide
(CO2)-enriched air to be able to escape, an external exhalation system is required on these
masks. Follow the instructions for use of your exhaled air system.
Locking catch

Set up of equipment 19
Warning!
Without an exhalation system the CO2concentration would rise to critical values in
the mask and hose, thus hindering your breathing. Risk of suffocation!
– Fit the external exhalation system between the breath-
ing mask and the breathing tube.
3.4 Connect other accessories
Bacteria filter
If the CPAP 20e is to be used by several patients (e.g. in a
hospital), a bacteria filter should be used to protect against
infection. It is inserted between the breathing tube and the
device outlet port. Using a bacteria filter can reduce the
pressure and flow rate.
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 WM 24042 oxygen connection
valve.
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 patient’s doctor.
To prevent oxygen entering the therapy unit, the CPAP 20e automatically generates a ther-
apy pressure of at least 5 hPa when an oxygen connection valve is attached. You must al-
ways follow the safety instructions for handling oxygen as well as the operating instructions
for the oxygen valve and the oxygen unit used.

20 Operation
4. Operation
4.1 CPAP 20e startup
Put on the mask
1. Put on the mask as described in Section “3.3 Breathing
mask” on page 18.
2. Connect the breathing hose to the mask (plug cone).
3. Feed the breathing hose away from your head.
Warning! Risk of injury!
Never place the breathing hose around your neck.
Switch on the device
1. Press the on/off switch.
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.
CPAP 20e is now ready for operation.
Note:
If the device is not used for 15 minutes, it will automatically switch off (only if the
therapy pressure is higher than 6hPa).