Page 1
SOMNOvent CR CS therapy device with autoTriLevel principle SOMNOvent CR SOMNOvent CR with SOMNOclick 300 SOMNOvent CR 230 V Device description and instructions for use with devices as of serial number 10.000 or firmware version 5.0...
1. Overview SOMNOvent CR 2 Bacteria filter 15 Headband 3 Power cord 9 Drying adapter 14 Breathing mask 1 SOMNOvent CR 13 Exhalation 8 Sealing plug system 10 Adapter 12 Tube system 4 Serial port 11 Pressure measuring tube 7 Device outlet port with...
Page 5
This symbol appears after every 250 operating For controlling and monitoring the hours or if the filter is blocked. The fine filter then SOMNOvent CR and connected accessories. has to be changed. 6 Connector for respiratory humidifier 18 Inspiration/Exhalation display/Set...
25 Humidifier key with LED 28 Power connection For activating/deactivating the respiratory This is where the power cord is connected to the humidifier, for setting the humidifier stage during optional inverter at the device end. therapy (press and hold key) and for increasing an 29 Inverter (accessory) adjustable value.
Device information plate 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.
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. Overview...
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.
Page 10
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.
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.
Page 12
• 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.
• 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.
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 •...
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.
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.
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.
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.
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.
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.
Each therapy day begins and ends at 12 noon. Data recorded from 0 (midnight) to 12 (noon) are assigned to the previous calendar day in each case. 5.3 Automatic on/off If the automatic system is activated, you can switch the SOMNOvent CR on and off using the pressure in the mask. Note: When the device is switched on, you can view the current setting via the patient menu, but you cannot change it.
Automatic system activated As soon as a patient breathes into the mask (pressure > 0.5 hPa), the AVto SOMNOvent CR switches on automatically. When the mask is removed, the device switches off automatically after 5 seconds. Automatic system deactivated AVto The device can only be switched on by pressing the on/off key.
5.5 Set SOMNOclick 300 Using a respiratory humidifier prevents the upper airways of the patient drying out during therapy. Six humidifier stages can be set (1 = low heating output to 6 = maximum heating output). The most favorable setting for you will depend on room temperature and humidity, so the ideal setting will vary with the season and ambient conditions.
Switch off respiratory humidifier You have two options for switching off the respiratory humidifier: – Press the humidifier key on the therapy device. The humidifier symbol in the display goes out. The therapy device remains switched – press the on/off key of your therapy device. The respiratory humidifier and the therapy device are both switched off.
If the automatic system is activated, you can switch on the SOMNOvent CR by taking one breath into the mask. Total therapy time appears in the display for approx. 3 seconds. The flow generator starts to pump air through the breathing tube and the air flow can be felt at the mask.
Respiratory phase The symbol is displayed during inspiration phases. The symbol is displayed during exhalation phases. Switch off device – To switch off the device, press the on/off key. Daily therapy time appears in the display for approx. 3 seconds. If the automatic system is activated, the device switches off automatically 5 seconds after the mask has been removed.
Save energy With the mains unit and in standby mode (standby), the SOMNOvent CR uses approx. 4 W. The device does not have a power switch. To save electricity, you can remove the plug of the power cord from the power socket during the day.
Clean coarse dust filter. Section 6.4 Check fine filter. Change if required. Section 6.4 Check breathing tube. Clean if required. Section 6.2 Wipe down the housing of the SOMNOvent CR. Section 6.3 Weekly Wash headgear/headband. associated instructions for use Hygiene treatment...
Every 6 months Change pressure measuring tube Section 9.3 Replace breathing mask and exhalation system. Every 12 months Replace breathing tube. Replace headgear/headband. Disinfect the SOMNOvent CR Section 6.6 Disinfect the SOMNOclick 300 As required associated instructions for use If necessary, hygiene treatment Section 6.7...
Dry breathing tube You can dry the breathing tube completely with the aid of the SOMNOvent CR. To do so, proceed as follows: Status: device switched off. 1. Remove the respiratory humidifier if necessary. 2. Remove the plug from the pressure measuring tube.
3. Clean the filter compartment lid under running water until there are no residues. Then dry it carefully. The SOMNOvent CR must be completely dry before being started up. 6.4 Clean coarse dust filter, change fine filter 1. Remove the filter compartment lid on the rear of the device.
Caution! Ensure that no liquids get into the device through the pressure measuring connector, otherwise there may be malfunctions. The housing and the power cord of the SOMNOvent CR are cleaned simply by wiping with disinfectant. Breathing tube ®...
Accessories To disinfect/sterilize the exhalation system, the breathing mask and the respiratory humidifier SOMNOclick 300, see the chapter entitled "Disinfecting and sterilizing" in the relevant instructions for use. 6.7 Change in patients If the unit is operated with a bacteria filter: •...
7. Function check 7.1 Intervals Perform a function check on both the SOMNOvent CR and on the SOMNOclick 300 at least every 6 months. Warning! If you discover faults during the function check, you may not use the devices again until the faults have been rectified.
8. Troubleshooting If faults occur which cannot be eliminated at once, contact the manufacturer, Weinmann, or your dealer immediately to have the device repaired. Do not continue operating the device in order to prevent even greater damage. 8.1 SOMNOvent CR...
Page 36
Fault Cause of fault Remedy Servicing indicator Servicing required The device needs to be checked or serviced illuminates. by Weinmann or an authorized dealer as soon as possible. Troubleshooting...
Section 6.4 Complete test of function see Section 7. Hygiene treatment of the device Send device to Weinmann Replace any defective parts Send device to Weinmann 9.3 Change pressure measuring tube 1. Release the sleeve on the creased tube from the adapter.
10. Disposal Do not dispose of the device with domestic waste. To dispose of the device properly, contact a licensed, certified electronic scrap disposal merchant. This address is available from your Environment Officer or from your local authority. The device packaging (cardboard and inserts) can be disposed of in paper recycling facilities.
WM 24775 Tube system WM 24130 Drying adapter WM 24203 Carrying bag WM 23717 Power cord WM 24133 Coarse dust filter WM 24097 Fine filter, packed WM 23596 Instructions for use SOMNOvent CR 230 V WM 66321 Scope of supply...
WM 16162 11.2 Accessories and spare parts You can order accessories and spare parts separately if required. A current list of accessories and spare parts can be ordered on the Internet at www.weinmann.de or via your dealer. Scope of supply...
12. Technical data 12.1 Specifications SOMNOvent CR with SOMNOvent CR SOMNOclick 300 Product class to 93/42/EEC Dimensions WxHxD 18 x 9 x 32 18 x 9 x 44 in cm Weight approx. 3.4 kg approx. 3.6 kg (excl. water) Temperature range +5 °C to +35 °C...
Page 42
SOMNOvent CR with SOMNOvent CR SOMNOclick 300 Classification as per EN 60601-1 – type of protection Protection class II from elec. shock – level of protection Type B from elec. shock – protection from IPX0 damaging ingress of water Operating mode...
Page 43
SOMNOvent CR with SOMNOvent CR SOMNOclick 300 Maximum flow rate to EN ISO 17510- 1:2002 at : 20 hPa 115 l/min 100 l/min 13.5 hPa 150 l/min 135 l/min 6.5 hPa 175 l/min 160 l/min 0 hPa 195 l/min 180 l/min Tolerance ±15 l/min...
Page 44
SOMNOvent CR with SOMNOvent CR SOMNOclick 300 Precision of dynamic pressure (short-term precision) with 15 breaths/min to EN ISO 17510-1:2009 at 4 hPa Δp = 0,2 hPa Δp = 0,2 hPa 8 hPa Δp = 0,2 hPa Δp = 0,2 hPa 12 hPa Δp = 0,2 hPa...
12.2 Pressure/volume curve 12.3 Safety distances Recommended safety distances between portable and mobile HF telecommunications devices (e.g. mobile telephone) and the SOMNOvent CR Safety distance depending on transmission frequency Nominal output of HF device in m in W 150 kHz - 80 MHz 80 MHz - 800 MHz 800 MHz –...
13. Warranty Weinmann gives the customer a limited manufacturer warranty on new original Weinmann products and any replacement part fitted by Weinmann in accordance with the warranty conditions applicable to the product in question and in accordance with the warranty periods from date of purchase as listed below.
14. EC Declaration of conformity Weinmann Geräte für Medizin GmbH + Co. KG declares herewith that the product complies fully with the respective regulations of the Medical Device Directive 93/42/EEC. The unabridged text of the Declaration of Conformity can be found on our website at www.weinmann.de...
15. Glossary Apnea A cessation of external respiration lasting at least 10 seconds is called a respiratory cessation or apnea. The apnea is usually ended by a waking reaction of the body. This interrupts sleep and reduces its recovery function. A distinction is made between obstructive apneas in which respiration is prevented by an obstruction of the upper airways and central apneas in which the respiratory drive...
Page 49
Hypopnea A reduction in respiratory flow of at least 50 % is called a hypopnea. There are obstructive and central hypopneas. Glossary...