Weinmann CPAP 20e Technical Document

CPAP 20e
CLICK 2
CPAP unit
Aparato CPAP
Description of the equipment and instructions for use
for devices from SN 65000
Descripción del aparato e instrucciones de manejo
para aparatos a partir del número de serie 65000

2Contents
EN
English
Contents
1. Description of unit . . . . . . . . . . . . . . 9
1.1 Intended use CPAP 20e . . . . . . 9
1.2 Intended use CLICK 2 . . . . . . . . 9
1.3 Functional description
CPAP 20e . . . . . . . . . . . . . . . . 10
1.4 Functional description
CLICK 2 . . . . . . . . . . . . . . . . . 10
2. Safety Instructions . . . . . . . . . . . . 11
2.1 Safety instructions . . . . . . . . . 11
2.2 Contraindications . . . . . . . . . . 13
2.3 Side effects. . . . . . . . . . . . . . . 14
3. Set up of equipment . . . . . . . . . . . 15
3.1 Setting up and connecting
the CPAP 20e . . . . . . . . . . . . . 15
3.2 Filling and connecting the
CLICK 2 . . . . . . . . . . . . . . . . . 16
3.3 Breathing mask. . . . . . . . . . . . 17
3.4 Connect other accessories . . . 18
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 . . . . . . . . 26
5.3 Cleaning CLICK 2. . . . . . . . . . 28
5.4 Descaling CLICK 2 . . . . . . . . . 30
5.5 Disinfection CPAP 20e . . . . . . 30
5.6 Disinfection CLICK 2 . . . . . . . 31
5.7 Multiple patient use
CPAP 20e. . . . . . . . . . . . . . . . 32
5.8 Multiple patient use CLICK 2 . 32
6. Functional check . . . . . . . . . . . . . . . 33
6.1 Intervals . . . . . . . . . . . . . . . . . 33
6.2 Function check of CPAP 20e . 33
6.3 Function check of CLICK 2 . . . 34
7. Malfunctions and Rectification . . 35
7.1 CPAP 20e. . . . . . . . . . . . . . . . 35
7.2 CLICK 2 . . . . . . . . . . . . . . . . . 36
8. Maintenance . . . . . . . . . . . . . . . . . . 38
9. Disposal . . . . . . . . . . . . . . . . . . . . . . 38
10. Scope of supply . . . . . . . . . . . . . . . 39
10.1 Standard scope of supply . . . . 39
10.2 Accessories and spare parts . . 39
11. Technical data . . . . . . . . . . . . . . . . . 40
11.1 Specifications. . . . . . . . . . . . . 40
11.2 Pneumatic diagram . . . . . . . . 44
11.3 Safety distances . . . . . . . . . . . 44
12. Warranty . . . . . . . . . . . . . . . . . . . . . 45
13. Declaration of Conformity . . . . . . 45
13. Index . . . . . . . . . . . . . . . . . . . . . . . . 46

Overview 3
EN
Overview
13 Humidifier activated
CPAP 20e
12 Power supply cable
4Breathing hose
3Exhalation system
5Unit outlet
7Serial interface
1Head gear
2Mask
14 Softstart time
15 Therapy pressure
18 Humidifier button
17 Softstart button
16 On/off switch
(stand-by)
8Air inlet
10 Unit plaque
9Supply connection
22 Carry case
21 DC adapter 12 - 24 V19 Bacteria filter
23 O2connection valve
11 Power supply
20 Humidifier
6Humidifier connection

4Overview
EN
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 visual-
ization 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 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 Therapy pressure
The therapy pressure is shown in hPa
(hectoPascal). 1 hPa = 1 mbar ≈1 cm H2O.
16 On/off switch (stand-by)
Switches the therapy unit on and off.
17 Softstart button
Activates the softstart or sets the softstart time
(5 - 30 minutes in 5 minute increments)
18 Humidifier button
Activates the humidifier or sets the humidifier
level (6 levels).
19 Bacteria filter (Accessories)
Used to protect the patient from bacteria, partic-
ularly if the unit is being used by a number of
patients.
20 Humidifier (Optional)
Used to heat and humidify the air flow created by
the therapy unit.
21 DC adapter 12 - 24 V (Accessories)
For operating the therapy unit via a DC socket
(12 - 24 V).
22 Carry case (Accessories)
For carrying the therapy unit.
23 O2connection valve (Accessories)
For introducing oxygen into the mask.

Overview 5
EN
Legend
24 Filling cap
For filling the humidifier.
25 Upper part
Closes the humidifier, contains the filling cap.
26 Outlet connections
From here the moistened air flows into the
breathing hose.
27 Lower part
Contains approximately 280 ml water.
28 Closures
Used to shut off the pressure gland during
preparatory hygienic operations.
29 Heater
Heats the water in the humidifier. This humidifies
the air.
30 Inlet connections
The air flows from the therapy unit into the
humidifier.
31 Bellows
Dries the CLICK 2.
30 Inlet connections
26 Outlet
connections
25 Upper part
29 Heater
24 Filling cap
28 Closures
27 Lower part
CLICK 2 (optional)
31 Bellows

6Overview
EN
Special markings on the unit
Symbol Meaning
CPAP 20e:
32 Unit outlet: air escapes with 4 - 20 hPa
33 Please use the appropriate User Guide!
Connector for respiratory humidifier CLICK 2 WM 27330.
34 DC voltage
35
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)
36 Unit inlet: allows air at room temperature to enter
37
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):
38 Unit is hot! Do not touch the heater rod.
32
CPAP 20e
CLICK 2
37
3534 36
38
39
33

Overview 7
EN
Unit plaques
Markings on the packaging of the therapy device
39 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!
Type of protection from 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)
SN Unit serial number
Symbol Meaning
Permitted temperature for storage: -20°C to + 70°C
Permitted humidity for storage: max. 95 % relative humidity.
CE 0197 symbol: Confirms that the product conforms to the applicable
European directives.
Protect device from wet
Fragile
Symbol Meaning
-20

8Overview
EN
Labeling on the packaging of the breathing tube
Symbol Meaning
Use only for a single patient

Description of unit 9
EN
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.

10 Description of unit
EN
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-con-
trolled 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 pres-
sure 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 re-
mote 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 re-
leased can be adjusted using the buttons on the Weinmann therapy unit. The out-
put of the heater rods and consequently 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.

Safety Instructions 11
EN
2. Safety Instructions
Please read these operating instructions through carefully. They form part of the
equipment and should be available at all times.
For your own safety, the safety of your patients, and to comply with the require-
ments 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 volt-
ages between 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 adapter 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 insufficient 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 other-
wise malfunction (see page 44). 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 malfunc-
tioning, parts are damaged and/or the contact between the
humidifier and the heater rod is damp.

12 Safety Instructions
EN
• 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.
Transport/Accessories/Spare Parts/Repair
Caution!
• Do not transport (or tilt) the CPAP 20e with the humidifier in-
stalled. Tilting 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.
• If third-party items are used, functional failures may occur and fit-
ness 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 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 suitable for the therapy. This particularly applies to the exha-
lation 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

Safety Instructions 13
EN
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 O2
connection 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 instruc-
tions in the instructions for use of your oxygen supply system and
the 02oxygen valve.
• 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
CPAP 20e should be used with particular caution or not at all with some diseases.
In individual cases. It is up to the doctor supervising treatment to decide whether
use is indicated. In such cases, use needs to be tightly controlled and the risk
weighed up against the benefits.
This implies:
• Acute cardiac decompensation
• Severe cardiac arrhythmias, atrial fibrillation with reduced filling
of the right ventricle.
• Insufficiency of the right heart or other pulmonary hypertension
• Severe hypotension, especially in combination with intravascular
volume depletion
• High risk of barotraumas
• Bullous lung emphysema
• Severe deyhdration

14 Safety Instructions
EN
• Severe epistaxis (nosebleeds)
• Acute sinusitis, otitis media or perforated eardrum
• Pneumothorax or pneumomediastinum
• Pneumoencephalus
• Severe skull trauma
• Status following brain surgery and following surgical intervention
on the pituitary gland or the middle/ inner ear.
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
padding
• reddening of facial skin
• nasal congestion
•drynose
• dry mouth in morning
• feeling of pressure in the sinuses
• irritation of conjunctiva of eyes
• gastrointestinal insufflation
(“wind”)
• nosebleeds

Set up of equipment 15
EN
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
appropriate 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 dif-
ferences in air pressure (e.g. as a result of great
altitude).
Power
supply
DC adapter

16 Set up of equipment
EN
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
housing and heating rod resulting in incorrect operation and in-
sufficient therapy delivery.
Note
• The use of aromatic additives, such as eucalyptus oil, may dam-
age 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 calci-
um 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 30).
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
24

Set up of equipment 17
EN
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 heating rod must be directed towards to
the sleep apnea unit. Take care to engage the
lock.
3. Connect the corrugated tube to the outlet con-
nections 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 rel-
evant 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 fail-
ure. Full-face masks without an emergency exhalation valve may not be
used!
Locking catch

18 Set up of equipment
EN
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 re-
quired on these masks. Follow the instructions for use of your exhaled air system.
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
breathing 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 pro-
tect 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.

Set up of equipment 19
EN
Oxygen supply
For safety reasons (risk of fire) the direct introduction
of oxygen into the breathing hose or the mask with-
out 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 gener-
ates a therapy pressure of at least 5 hPa when an oxygen connection valve is at-
tached. You must always follow the safety instructions for handling oxygen as
well as the operating instructions for the oxygen valve and the oxygen unit used.

20 Operation
EN
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 17.
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).