Weinmann SOMNOvent CR User manual

SOMNOvent C R
CS therapy device with autoTriLevel principle
SOMNOvent C R
SOMNOvent CR with SOMNOclick 300
SOMNOvent C R 230 V
Device description and instructions for use
with devices as of serial number 10.000
or firmware version 5.0

Contents 3
EN
Contents
1. Overview . . . . . . . . . . . . . . . . . . . 4
1.1 Markings on the device . . . . . . . . . 6
1.2 Markings on the pack . . . . . . . . . . . 7
1.3 Safety information in this manual . . 8
2. Description of device . . . . . . . . . 9
2.1 Intended use. . . . . . . . . . . . . . . . . . 9
2.2 Description of function . . . . . . . . . . 9
3. Safety information . . . . . . . . . . 11
3.1 Safety instructions . . . . . . . . . . . . 11
3.2 Contraindications . . . . . . . . . . . . . 13
3.3 Side effects. . . . . . . . . . . . . . . . . . 14
4. Set up device . . . . . . . . . . . . . . . 15
4.1 Set up and connect the
SOMNOvent CR . . . . . . . . . . . . . . 15
4.2 For operation without a respiratory
humidifier. . . . . . . . . . . . . . . . . . . 16
4.3 For operation with respiratory
humidifier. . . . . . . . . . . . . . . . . . . 16
4.4 Breathing mask. . . . . . . . . . . . . . . 17
4.5 Connect other accessories . . . . . . 18
5. Operation . . . . . . . . . . . . . . . . . 19
5.1 Patient menu . . . . . . . . . . . . . . . . 19
5.2 Read out therapy time . . . . . . . . . 20
5.3 Automatic on/off . . . . . . . . . . . . . 21
5.4 Softstart setting . . . . . . . . . . . . . . 22
5.5 Set SOMNOclick 300. . . . . . . . . . . 23
5.6 Operating the therapy device . . . . 24
5.7 After use . . . . . . . . . . . . . . . . . . . 26
5.8 Traveling with therapy devices . . . 27
6. Hygiene treatment . . . . . . . . . . 28
6.1 Intervals . . . . . . . . . . . . . . . . . . . . 28
6.2 Breathing tube . . . . . . . . . . . . . . . 29
6.3 Clean the housing of the
SOMNOvent CR . . . . . . . . . . . . . . 30
6.4 Clean coarse dust filter,
change fine filter . . . . . . . . . . . . . 31
6.5 Accessories . . . . . . . . . . . . . . . . . . 32
6.6 Disinfect the SOMNOvent CR . . . . 32
6.7 Change in patients . . . . . . . . . . . . 33
7. Function check . . . . . . . . . . . . . 34
7.1 Intervals . . . . . . . . . . . . . . . . . . . . 34
7.2 Function check SOMNOvent CR . . 34
7.3 Function check SOMNOclick 300 . 34
8. Troubleshooting . . . . . . . . . . . . 35
8.1 SOMNOvent CR . . . . . . . . . . . . . . 35
9. Servicing . . . . . . . . . . . . . . . . . . 37
9.1 Intervals . . . . . . . . . . . . . . . . . . . . 37
9.2 Scope of service . . . . . . . . . . . . . . 37
9.3 Change pressure measuring tube. 37
10. Disposal . . . . . . . . . . . . . . . . . . . 38
11. Scope of supply . . . . . . . . . . . . 39
11.1 Standard scope of supply . . . . . . . 39
11.2 Accessories and spare parts . . . . . 40
12. Technical data . . . . . . . . . . . . . . 41
12.1 Specifications. . . . . . . . . . . . . . . . 41
12.2 Pressure/volume curve . . . . . . . . . 45
12.3 Safety distances . . . . . . . . . . . . . . 45
13. Warranty . . . . . . . . . . . . . . . . . . 46
14. EC Declaration of conformity . 47
15. Glossary . . . . . . . . . . . . . . . . . . 48
16. Index . . . . . . . . . . . . . . . . . . . . . 50

4Overview
EN
1. Overview
SOMNOvent C R
3Power cord
12 Tube system
13 Exhalation
system
7Device outlet port with
pressure measuring connector
4Serial port
15 Headband
14 Breathing
mask
10 Adapter
25 Humidifier key
with LED
24 Softstart key 22 On/Off key
(standby)/ESC
27 Filter compartment
lid, air inlet
26 Device information plate
28 Power connection
30 Carrying bag
29 Inverter
2Bacteria filter
31 O2supply valve
32 Respiratory humidifier
SOMNOclick 300
1SOMNOvent C R
5Control panel and displays
6Connector for respiratory humidifier
9Drying adapter
8Sealing plug
11 Pressure measuring tube
20 Respiratory humidifier
activated
21 Service symbol
17 Filter change symbol
19 Therapy
pressure
18 Inspiration/Exhalation
display/Set parameter
16 Softstart active
23 Menu key

Overview 5
EN
Key
2 Bacteria filter (accessory)
For protecting the patient from bacteria, in
particular when the device is used by several
patients.
3Powercord
For connecting the device to the power supply.
4 Serial port
For connecting to devices or computers for
setting, displaying and evaluating therapy data
and for connecting the O2supply valve.
5 Control panel and displays
For controlling and monitoring the
SOMNOvent CR and connected accessories.
6 Connector for respiratory humidifier
For connecting the SOMNOclick 300 to the
therapy device.
7 Device outlet port with pressure
measuring connector
The respiratory air flows from here via breathing
tube and breathing mask to the patient.
8 Sealing plug
For sealing the pressure measuring tube during
cleaning.
9 Drying adapter
Required for drying the tube system with the
SOMNOvent C R .
10 Adapter
For connecting the breathing tube to the device
outlet port.
11 Pressure measuring tube
For measuring prevailing pressure in the breathing
mask.
12 Tube system
The air flows through the tube system to the
mask. The tube system consists of creased tube,
pressure measuring tube and adapter.
13 Exhalation system (accessory)
The carbon dioxide-enriched exhalation air
escapes here during therapy.
14 Breathing mask (accessory)
The patient is supplied with respiratory air at the
required therapy pressure via the breathing mask.
15 Headband (accessory)
For correct and reliable positioning of the
breathing mask.
16 Softstart active
This symbol appears when the Softstart time is set
or Softstart is activated.
17 Filter change symbol
This symbol appears after every 250 operating
hours or if the filter is blocked. The fine filter then
has to be changed.
18 Inspiration/Exhalation display/Set
parameter
The up arrow illuminates during inspiration, the
down arrow during exhalation.
Both arrows come on when a value can be
amended using the + or - key.
19 Therapy pressure
The therapy pressure is displayed in hPa
(hectoPascals). 1 hPa = 1 mbar 1 cm H2O.
20 Respiratory humidifier activated
This symbol appears when the humidifier is in
operation. The set humidifier stage is displayed.
21 Service symbol
This symbol appears after every 5000 operating
hours. The device then needs servicing.
22 On/Off key (standby)/ESC
For switching the therapy device on and off and
for exiting a menu.
23 Menu key
For opening the patient menu and for scrolling to
the next value of the patient menu.
24 Softstart key
For activating/deactivating Softstart, for calling up
the Softstart setting (press and hold key during
therapy) and for reducing a value which can be
set.

6Overview
EN
25 Humidifier key with LED
For activating/deactivating the respiratory
humidifier, for setting the humidifier stage during
therapy (press and hold key) and for increasing an
adjustable value. The LED comes on when the
humidifier is connected and switched on.
26 Device information plate
Provides information about the device, such as
serial number and year of manufacture, for
example.
27 Filter compartment lid, air inlet
For covering and securely positioning the coarse
dust and fine filters.
28 Power connection
This is where the power cord is connected to the
optional inverter at the device end.
29 Inverter (accessory)
For operating the therapy device via a direct-
current socket (12/24 V).
30 Carrying bag
For transporting the therapy device.
31 O2supply valve (accessory)
For introducing oxygen into the breathing mask.
32 Respiratory humidifier
SOMNOclick 300
For heating and humidifying the current of air
generated by the therapy device.
1.1 Markings on the device
33 34 35 36
Symbol Significance
33 Device inlet: inlet for ambient air at room temperature
34 Follow the instructions for use!
Connection for respiratory humidifier SOMNOclick 300 WM 24372.
35 Device outlet: ambient air outlet at 4 - 20 hPa
36 Connection for setting therapy parameters with the SOMNOadjust
WM 23930, for reading out the course of therapy with
WEINMANNsupport WM 93305 by professional staff or for
controlling O2supply valve WM 24042. Max. current consumption
163 mA.
Analog output for therapy pressure, flow and leakage (0 V to
1.0 V DC).

Overview 7
EN
Device information plate
1.2 Markings on the pack
Symbol Significance
Year of manufacture
Degree of protection against electric shock: device Type B
Do not dispose of the device with domestic waste!
Follow the associated instructions for use!
Serial number of device
CE 0197 symbol: Confirms that the product conforms to the
applicable European directives.
IPX1 Protection against ingress of water (drips)
Type of protection against electric shock: device protection class II
Fulfilled standard ISO 17510-1
Symbol Significance
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
SN
-20

8Overview
EN
1.3 Safety information in this manual
Safety instructions are marked in this instruction manual as follows:
Warning!
Warns of risk of injury and potential material damage.
Caution!
Warns of material damage and potentially false therapy results.
Note:
Contains useful tips.

Description of device 9
EN
2. Description of device
2.1 Intended use
SOMNOvent CR is an automatically-regulating CS therapy device with autoTriLevel
principle suitable for treating patients from the age of 12
•with periodic respiration or Cheyne-Stokes breathing (e.g. in
cardiac insufficiency)
•as well as central, mixed and complex sleep apnea.
The therapy device adapts ventilation automatically and continuously to the changing
requirements of the patient in question.
The SOMNOvent C R i s not suitable for life-support use on patients requiring ventilation.
Caution!
To ensure successful therapy with the SOMNOvent CR, the pressure limits prescribed
by the doctor and the background ventilation frequency must be determined and
adjusted accordingly in a sleep laboratory.
2.2 Description of function
The SOMNOvent CR has an electronically-controlled fan which takes in ambient air
through a filter and pumps it to the fan outlet. From here, the air flows through the tube
system and the breathing mask to the patient.
The SOMNOvent CR analyzes the pressure in the mask and the air flow to the patient and
detects from this sleep-related respiratory disorders such as Cheyne-Stokes breathing or
airway obstructions.
Depending on the events detected, the three pressure levels IPAP (pressure during
inspiration), EPAP (pressure at the start of exhalation) and EEPAP (pressure at the end of
exhalation) are automatically adapted to the current requirements of the patient.
• If respiratory volume drops, the device supports the patient's breathing
by continuously increasing IPAP/EPAP difference. In this way, ventilation
in Cheyne-Stokes breathing and in central or mixed sleep apnea
syndrome is normalized.

10 Description of device
EN
• In the case of apneas, the therapy device ventilates at a fixed respiratory
frequency or automatically at an individual frequency
• In the case of increasing respiratory volume, the IPAP/EPAP difference is
reduced to calm breathing.
• If obstructions (epochs with apneas, hypopneas, flow limitations or
snoring) are detected, EEPAP is increased to keep the airways open.
• In the case of normal breathing, pleasant exhalation relief is
administered. Before the transition to exhalation, therapy pressure is
reduced to relieve exhalation. This increases patient comfort. Before the
start of the next inspiration, pressure is increased back up to therapy
pressure. Pressure is slightly increased during inspiration.
The device stores data relating to therapy monitoring and adjustment, thus allowing
comprehensive analysis by the doctor.
Automatic Softstart is fitted to facilitate falling asleep. On switching on, pressure is reduced
to the Softstart pressure set by the doctor. Therapy pressure then slowly increases to the
specified value. The device does not react to respiratory disorders during the Softstart
phase.
The therapy device can be used to check whether the mask is correctly fitted. Leaks due to
a poorly-fitted mask often only occur at relatively high pressures. To check that the mask
is leaktight, it is possible to output a higher pressure during the first 30 seconds after the
therapy device is switched on. This pressure is adjustable.
A qualitative leakage display is available during therapy.
It is possible to activate automatic on/off on the SOMNOvent CR. The device can be
switched on by taking a breath into the mask and switches off automatically if not used.
If the power supply is interrupted and then restored, the SOMNOvent CR is in the condition
in which it was before the interruption. Stored data are retained.

Safety information 11
EN
3. Safety information
Please read these instructions for use carefully. They are a component of the device and
must be available at all times.
Use the device exclusively for the intended purpose (see “2.1 Intended use” on page 9)
described.
For your own safety and the safety of your patients and in accordance with the
requirements of Directive 93/42 EEC, follow the safety instructions below.
3.1 Safety instructions
Operating the device
Caution!
• Check whether the power supply of the device matches the power
supply in your home. The device can operate with voltages 115 V and
230 V. It automatically adapts to one of these voltages. Exception: the
SOMNOvent CR 230 V (WM 23470) can only operate with a voltage of
230 V. For operation on 12 V DC or 24 V DC, use an inverter which is
available as an accessory.
• The device must be connected to an easily accessible socket so that the
plug can be taken out quickly in the event of a fault.
• Do not set up the device close to a radiator and do not expose it to direct
sunlight, as this could heat up the respiratory air and also the internal
parts. This could cause condensation to form in the respiratory humidifier
which would then be deposited in the tube system.
• Do not cover the device with blankets etc.. The air inlet would be blocked
and the device could overheat. This may lead to inadequate therapy and
damage to the device.
• Maintain a safe distance between the SOMNOvent CR and devices which
emit HF radiation (e.g. mobile telephones) (see page 45), otherwise there
may be malfunctions.
• Do not operate the therapy device and the respiratory humidifier if the
device is not working properly, if parts are damaged and/or the
respiratory humidifier is wet at the contact of the heating element.

12 Safety information
EN
• The performance of the respiratory humidifier may change if the device
is operated outside the permitted ambient temperatures.
• Please also see the instructions for use for your breathing mask.
• Please observe Section “6. Hygiene treatment” on page 28 to prevent
infection or bacterial contamination.
• If the SOMNOvent CR is intended for use by several patients, a bacteria
filter should be used to protect against infections. It is inserted between
the breathing tube with adapter and the device outlet port. If the device
is to be used for another patient without a bacteria filter being used,it
must be subjected to a hygiene treatment beforehand. This should be
performed by the manufacturer, Weinmann, or an authorized dealer.
Transport
Caution!
Do not transport the SOMNOvent CR with the respiratory humidifier fitted. If the
device rests at an angle, residual water from the respiratory humidifier may run into
the SOMNOvent CR and damage it.
Accessories/replacement parts
Caution!
• 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.
• Masks of third-party manufacture may only be use following
authorization by the manufacturer, Weinmann. Using unauthorized
masks jeopardizes the success of therapy.
• Ensure that accessories used for therapy are suitable and complete. This
applies to the exhalation system in particular. Otherwise the CO2content
in the exhalation air may impede your breathing and there is a risk of
suffocation.
Maintenance
Caution!
• Have servicing and repair work carried out only by the manufacturer,
Weinmann, or professionals.

Safety information 13
EN
• Modifications to the SOMNOvent CR and the SOMNOclick 300 are not
permitted.
Oxygen supply
Warning!
If you use oxygen during treatment, smoking and naked flames are forbidden. Risk
of fire! The oxygen can accumulate in clothing, bed linen or hair. It can only be
removed by thorough ventilation.
Caution!
Oxygen supply is permitted only when using O2supply valve WM 24042. On the
topic of oxygen, it is essential to follow the safety instructions in the instructions for
use of your oxygen supply system.
3.2 Contraindications
The therapy device should be used with particular caution or not at all with some diseases.
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
• Severe epistaxis (nosebleeds)
• Acute sinusitis, otitis media or perforated eardrum
• Pneumothorax or pneumomediastinum
• Pneumoencephalus
• Severe skull trauma

14 Safety information
EN
• Status following brain surgery and following surgical intervention on the
pituitary gland or the middle/ inner ear.
3.3 Side effects
When using the SOMNOvent CR, the following undesired side effects may occur in short-
term or long-term use:
• pressure points from the nasal cannula and the forehead cushion on the
face
• reddening of facial skin
• blocked nose
•drynose
• dry mouth in the morning
• feeling of pressure in the sinuses
• irritated mucous membrane in the eyes
• gastrointestinal insufflation of air ("bloating")
• nosebleeds
Note:
These side effects are general side effects of therapy with a CPAP device and not
attributable specifically to use of the SOMNOvent C R .

Set up device 15
EN
4. Set up device
4.1 Set up and connect the SOMNOvent CR
Location
– Set up the device on a flat surface, e.g. on a bedside cabinet or on the floor next to the
bed.
– Maintain a distance of at least 5 cm between the wall and the rear of the device, as the
air inlet is at the rear of the device.
Caution!
Do not cover the device with blankets etc.. Do not operate it close to a radiator or in
direct sunlight. The device could overheat. This may lead to inadequate therapy and
damage to the device.
Power supply
1. Use the power cord to connect the power connector of
the SOMNOvent CR to a socket.
SOMNOvent CR automatically detects whether 115 V
or 230 V are connected and switches automatically.
Exception: the SOMNOvent CR 230 V (WM 23470)
can only operate with a voltage of 230 V.
In the display, "0" appears for standby.
2. If the SOMNOvent CR is to be operated at a voltage of
12 or 24 V DC, connect the inverter to a cigarette
lighter socket.
The options for doing this are either:
• inverter 12 V WM 24131
• inverter 24 V WM 24132
Use the power cord to connect the power connector of
the SOMNOvent CR to the power supply socket of the
inverter.

16 Set up device
EN
3. Plug the adapter of the tube system into the device
outlet port.
Note:
The appliance automatically compensates for differ-
ences in air pressure (e.g. due to high altitude).
4.2 For operation without a respiratory
humidifier
1. To disconnect the humidifier if required, pull it forwards
off the device outlet port.
2. Push the breathing tube onto the adapter for the device
outlet port.
3. Push the adapter of the breathing tube into the device
outlet port of the therapy device. Ensure in the process
that the locking latch points upwards and engages in
the groove of the device outlet port.
4.3 For operation with respiratory humidifier
Note:
Follow instructions relating to filling and adapting the respiratory humidifier
SOMNOclick 300 in the associated instructions for use.

Set up device 17
EN
4.4 Breathing mask
Put on breathing mask
1. Adjust the forehead support of the breathing mask (if provided).
2. Connect the headgear/headband to the mask.
3. Put on the mask.
4. Adjust the headgear/headband so that the bulge of the mask creates only low pressure
so as to prevent pressure points on the face.
Note:
Consult the instructions for use for the breathing mask in question for information
on how to proceed.
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 for the mask.
Warning!
Without an exhalation system, the CO2 concentration would rise to critical levels in
the mask and tube and thus inhibit your breathing. Risk of suffocation!
– Fit the external exhalation system between the
breathing mask and the breathing tube.

18 Set up device
EN
4.5 Connect other accessories
Bacteria filter
If the SOMNOvent CR is intended for use by several patients (e.g. in a hospital), a bacteria
filter should be used to prevent infections.
– Fit the bacteria filter between the breathing tube and
the adapter.
Caution!
• Pressure consistency and flow rate may be
reduced if a bacteria filter is used. If a bacteria
filter is connected, check the pressure.
• Follow the manufacturer's instructions,
particularly the expiry date of the filter.
Oxygen supply
Warning!
For safety reasons (risk of fire), it is not permitted to supply oxygen straight into the
breathing tube or the breathing mask without a special safety device. It is possible to
supply up to 4 l/min oxygen to the breathing mask using oxygen supply valve
WM 24042.
An oxygen concentrator (e.g. Oxymat), liquid oxygen or an oxygen cylinder with the
appropriate pressure-reducer on it can be used. This use must be prescribed by the doctor
in charge.
It is essential to follow the safety instructions for handling
oxygen as well as the instructions for use for the oxygen
valve and the oxygen device used.

Operation 19
EN
5. Operation
The SOMNOvent CR is operated with the aid of the four keys on the control panel.
A "Patient Menu" provides various functions and settings in standby mode (device
switched off) or during therapy (device switched on). As an alternative to the patient menu,
some of these functions can also be called up directly using a key command.
Patient menu in standby mode
• “5.2 Read out therapy time” on page 20
• “5.3 Automatic on/off” on page 21
• “5.4 Softstart setting” on page 22
• “5.5 Set SOMNOclick 300” on page 23
• “Dry breathing tube” on page 30
• “6.4 Clean coarse dust filter, change fine filter” on page 31
Patient menu during therapy
• “Leakage indicator” on page 25
• “5.3 Automatic on/off” on page 21
• “5.4 Softstart setting” on page 22
• “5.5 Set SOMNOclick 300” on page 23
5.1 Patient menu
1. To call up the patient menu, press the Menu key briefly. The first thing to be displayed
is total therapy time.
2. To scroll through the patient menu and switch to the next parameter, press the Menu
key again. If you keep the Menu key depressed, you scroll through the menu items
automatically.
Parameter Display Value range Key command
(alternative) Described in
Leakage LE small, medium,
large
Press the Menu button
briefly while the
device is switched on
Chapter 5.6 on
page 24

20 Operation
EN
3. To exit the patient menu, press the On/Off key/ESC.
or:
If you do not press any key for 30 seconds, you exit the patient menu automatically.
5.2 Read out therapy time
The SOMNOvent CR saves therapy data from 366 days.
1. Call up the patient menu. Total therapy time is displayed.
2. To call up the data for a different day or period, press the + or - keys. The following
displays appear consecutively (numerical values are examples):
Total therapy time
Total therapy time is displayed for a few seconds when the device is switched on.
Therapy time h–Chapter 5.2 on
page 20
Autostart AVto on
0FF –Chapter 5.3 on
page 21
Softstart time min 5 to 30
with device switched
on: press and
hold
Chapter 5.4 on
page 22
Humidifier stage 1 to 6
with device switched
on: press and
hold
Chapter 5.5 on
page 23
Drying mode dr 0:30 and press
simultaneously
Chapter 6.2 on
page 29
Change filter – Chapter 6.4 on
page 31
11 d mean value for all therapy days (11 days in the example)
23.02.for a particular day in the last 7 days, give the date (in the example, 23rd
February)
Parameter Display Value range Key command
(alternative) Described in