Weinmann homecare SOMNOvent auto-S with SOMNOclick 300 Manual Download | Manualshive

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EC Declaration of conformity

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EN

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

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Summary of Contents for homecare SOMNOvent auto-S with SOMNOclick 300

Page 1: ...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 firmw...

Page 2: ......

Page 3: ...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 3...

Page 4: ...lid air inlet 26 Device information plate 28 Power connection 30 Carrying bag 29 Inverter 2 Bacteria filter 31 O2 supply valve 32 Respiratory humidifier SOMNOclick 300 1 SOMNOvent CR 5 Control panel...

Page 5: ...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 access...

Page 6: ...ce via a direct current socket 12 24 V 30 Carrying bag For transporting the therapy device 31 O2 supply valve accessory For introducing oxygen into the breathing mask 32 Respiratory humidifier SOMNOcl...

Page 7: ...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...

Page 8: ...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 th...

Page 9: ...y 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 f...

Page 10: ...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...

Page 11: ...e 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...

Page 12: ...difier 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...

Page 13: ...y 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 c...

Page 14: ...term or long term use pressure points from the nasal cannula and the forehead cushion on the face reddening of facial skin blocked nose dry nose dry mouth in the morning feeling of pressure in the sin...

Page 15: ...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 connect...

Page 16: ...orwards 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 Ensu...

Page 17: ...mergency 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 sys...

Page 18: ...cularly 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 specia...

Page 19: ...hing 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 2...

Page 20: ...l 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 s...

Page 21: ...ystem 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 ch...

Page 22: ...keep the Softstart key depressed until the current setting appears 2 To change the time press the Softstart key or the humidifier key several times until the desired time is shown 3 To save the settin...

Page 23: ...use 2 Switch on the therapy device 3 Press the humidifier key on the therapy device The humidifier symbol and the humidifier stage Stage 3 in this case are shown in the display of the therapy device S...

Page 24: ...automatically and operated at the heating output of the previous therapy session Automatic off If the therapy device detects too low a filling level in the respiratory humidifier it switches the respi...

Page 25: ...mask and adjust the head bands if necessary 2 To cancel the mask test before 30 seconds have elapsed press the On Off button The therapy device is now ready to use Leakage indicator You can view the c...

Page 26: ...he mask has been removed 5 7 After use 1 Take off the headgear headband with the breathing mask 2 To switch off the device press the on off key or If the automatic system is activated the device switc...

Page 27: ...disconnecting the plug or interrupting the power supply at a switchable socket 5 8 Traveling with therapy devices To transport the therapy device a relatively long distance you should pack it in the...

Page 28: ...eable reactions as a result of ageing embrittlement wear thermal load the effects of chemical processes etc 6 1 Intervals Daily Clean breathing mask and exhalation system See associated instructions f...

Page 29: ...nd out using clean hot water 5 Shake the breathing tube thoroughly 6 Hang up the breathing tube and allow it to drip dry 7 Dry the breathing tube with the aid of the therapy device Monthly Replace fin...

Page 30: ...Press the On Off key and the Softstart key simultaneously The device now switches on and dries the breathing tube time 30 minutes The remaining time is shown in the display After the end of the dryin...

Page 31: ...der clean running water until there are no residues 3 Change the fine filter if required It cannot be cleaned 4 Allow the coarse dust filter to dry The coarse dust filter must be completely dry before...

Page 32: ...alin protect as a disinfectant Warning Risk of electric shock Before cleaning it is essential to pull the power cord out of the power connection and the power supply plug out of the socket Ensure that...

Page 33: ...Disinfecting and sterilizing in the relevant instructions for use 6 7 Change in patients If the unit is operated with a bacteria filter change the bacteria filter or sterilize the bacteria filter and...

Page 34: ...t pressure in the Patient menu to 12 hPa see Mask test on page 25 3 Switch the therapy device on The fan delivers air through the breathing tube to the breathing mask Current pressure is shown in the...

Page 35: ...hed on The Softstart function is deactivated Clarify with your doctor whether the Softstart function can be activated for your therapy Device does not switch off approx 5 seconds after the mask has be...

Page 36: ...36 Troubleshooting EN Servicing indicator illuminates Servicing required The device needs to be checked or serviced by Weinmann or an authorized dealer as soon as possible Fault Cause of fault Remedy...

Page 37: ...the creased tube from the adapter 2 Pull the pressure measuring tube out of the creased tube 3 Pull the pressure measuring tube off the adapter 4 Push the new pressure measuring tube onto the adapter...

Page 38: ...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 packa...

Page 39: ...ter WM 24097 Fine filter packed WM 23596 Instructions for use SOMNOvent CR WM 66321 Short instructions for use SOMNOvent CR WM 66331 Patient record WM 16162 Parts Order number SOMNOvent CR WM 24720 SO...

Page 40: ...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 Short instructions for use S...

Page 41: ...peration and storage 95 rh no condensation Air pressure range 600 1100 hPa allows operation at altitudes of up to 4000 m Automatic altitude compensation Diameter of breathing tube connection mask side...

Page 42: ...m the manufacturer if required EN 55011 B EN 61000 4 Parts 2 to 6 Part 11 Mean sound pressure level to EN ISO 17510 1 2002 at a distance of 1 m from the device in the patient position approx 31 dB A a...

Page 43: ...Pa 12 hPa 8 hPa 4 hPa 115 l min 110 l min 135 l min 130 l min 155 l min 150 l min 170 l min 165 l min 185 l min 180 l min Heating of respiratory air 2 5 C depending on heating stage Precision of dynam...

Page 44: ...p 0 3 hPa p 0 2 hPa p 0 2 hPa p 0 2 hPa p 0 3 hPa p 0 4 hPa Precision of dynamic pressure short term precision with 20 breaths min to EN ISO 17510 1 2009 at 4 hPa 8 hPa 12 hPa 16 hPa 20 hPa p 0 2 hPa...

Page 45: ...ble and mobile HF telecommunications devices e g mobile telephone and the SOMNOvent CR Nominal output of HF device in W Safety distance depending on transmission frequency in m 150 kHz 80 MHz 80 MHz 8...

Page 46: ...conditions can be downloaded from www weinmann de on the Internet We can also send you the warranty conditions on request In the event of a claim under warranty contact your specialist dealer Product...

Page 47: ...y Weinmann Ger te f r 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 Declarat...

Page 48: ...ressure i e the patient is continuously supplied with respiratory air at a constant slight pressure whilst asleep This is generally performed using a nasal cannula or full face mask This pneumatic bra...

Page 49: ...Glossary 49 EN Hypopnea A reduction in respiratory flow of at least 50 is called a hypopnea There are obstructive and central hypopneas...

Page 50: ...26 29 34 F Faults 35 Filter 35 44 Function check 34 L Location 15 M Maintenance 12 O Operating hours 21 Oxygen supply 13 18 P Patient menu 19 call up 19 exit 20 scroll 19 Power supply 15 Pressure meas...

Page 51: ......

Page 52: ...2 Hamburg Kronsaalsweg 40 D 22525 Hamburg T 49 0 40 5 47 02 0 F 49 0 40 5 47 02 461 E info weinmann de www weinmann de Center for Production Logistics Service Weinmann Ger te f r Medizin GmbH Co KG Si...

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