1. Overview Therapy device 1 Bacteria filter 14 Head strap 2 Power cord 8 Drying adapter 13 Breathing mask 12 Exhalation system 7 Sealing plug 9 Click adapter 11 Breathing tube 3 Serial port 10 Pressure measure- 4 Control panel and displays 6 Device outlet port with ment tube 5 Connection for respiratory air humidifier...
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Control panel 21 On/Off key 22 Menu key 24 Humidifier key 23 Softstart key with LED Accessories 28 Inverter 29 Carrying bag 30 O supply valve 27 Power supply connection 26 Filter compartment lid, air inlet 25 Device ID plate 31 SOMNOclick 300 respiratory air humidifier 1 Bacteria filter...
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9 Click adapter 21 On/Off key For connecting the breathing tube to the device For switching the therapy device on and off and outlet port. for exiting a menu. 10 Pressure measurement tube 22 Menu key For measuring the pressure prevailing in the For opening the Patient menu and for scrolling to breathing mask.
1.1 Markings on the therapy device Symbol Meaning Service label: indicates when the next service is required. Device inlet: inlet for ambient air at room temperature See instructions for use! Connection for SOMNOclick 300 respiratory air humidifier. Device outlet port: outlet for ambient air at 4 - 20 hPa Connection for adjusting therapy parameters using WEINMANNadjust PC software or SOMNOadjust remote setting for professional staff to read out the course of therapy using...
Device ID plate Symbol Meaning Year of manufacture Degree of protection against electric shock: device type B Do not dispose of the device in domestic waste! Follow the relevant instructions for use! Serial number of the device Type of protection against electric shock: device of protection class II CE marking: confirms that the device conforms to the applicable Eu- ropean directives.
2. Description of device 2.1 Intended use SOMNOvent auto-S SOMNOvent auto-S is an automatically-regulating BiLevel S therapy device with autoTriLevel principle and up to three pressure levels suitable for treating patients from the age of 12 with obstructive, mixed or complex sleep apnea and –...
Note To ensure successful therapy with SOMNOvent auto-ST, therapy mode, therapy objective and possibly other therapy parameters have to be determined and set accordingly by spe- cialist medical staff. 2.2 Description of function The therapy device has an electronically-controlled fan which draws in ambient air through a filter and pumps it to the fan outlet.
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The difference between IPAP and EPAP (PDIFF) can likewise be adapted automatically up to an upper limit which can be set. • T (can only be selected on SOMNOvent auto-ST). A minimum frequency for preventing central apneas can be set in S mode. The minimum respiratory frequency takes effect as a background frequency as soon as the patient breathes more slowly than set.
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If the power supply is interrupted and then restored, the therapy device will be in the state it was in before the interruption. Saved data are retained. Description of device...
3. Safety instructions Please read these instructions for use through carefully. They are a constituent part of the therapy device and must be available at all times. Use the therapy device only for the intended use described (see “2.1 Intended use” on Page 9).
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This must be performed by the manufacturer, Weinmann, or by an authorized specialist dealer.
Oxygen supply Warning! If oxygen is used during therapy, smoking and naked flames are prohibited. Risk of fire. Oxygen may accumulate in clothing, bed-linen or in hair. It can be removed only by thorough ventilation. Caution! Oxygen may only be supplied if O supply valve WM 24042 is used.
3.3 Side effects When using the therapy device, the following undesired side effects may occur in short- term or long-term use: • pressure points on the face from the nasal cannula and forehead cushion • reddening of facial skin • blocked nose •...
4. Device setup 4.1 Set up and connect therapy device Location – Place the therapy device on a flat surface, for example a bedside table or on the floor next to the bed. – Keep the rear of the therapy device a distance of at least 5 cm from the wall, as the air inlet is on the rear of the therapy device.
4.2 For operation without respiratory air humidifier 1. To remove the humidifier if required, pull this off the device outlet port from the front. 2. Push the breathing tube onto the click adapter for the device outlet port. 3. Plug the click adapter of the breathing tube into the de- vice outlet port of the therapy device.
Warning! Oronasal masks must be fitted with an emergency exhalation valve so that you can breathe through your nose or mouth even if the device fails. Oronasal masks with- out an emergency exhalation valve may not be used! External exhalation system On some masks, there is no integrated exhalation system.
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Oxygen supply Warning! For safety reasons (risk of fire), it is not permitted to supply oxygen directly to the breathing tube or to the breathing mask without a special safety device. If oxygen supply valve WM 24042 is used, up to 4 l/min oxygen can be supplied to the breath- ing mask.
5. Operation The therapy device is operated with the aid of the four keys on the control panel. A “Patient menu” allows a variety of functions and settings in standby mode (therapy de- vice switched off) or during therapy (therapy device switched on). Some of these functions can also be called up directly by a key command as an alternative to going through the Patient menu.
5.1 Patient menu 1. To call up the Patient menu, press the menu key briefly. Total therapy time is displayed. 2. To scroll through the Patient menu and switch to the next parameter, press the Menu key again. Key command Parameter Display Value range...
5.2 Read out therapy time The therapy device stores therapy data from 366 days. 1. Call up the Patient menu with the device switched off. Total therapy time is displayed. 2. To call up the data for a different day or a different period, press the + or – keys. The following displays appear consecutively (numerical values are examples): 11 d mean value for all therapy days (11 days in the example)
Activate/deactivate Auto On/Off Status: therapy device is switched off. 1. Call up the Patient menu and scroll to the setting for Auto On/Off. 2. Press the Softstart key (+) or the Humidifier key (-) until the desired setting appears in the display.
test Pressure for mask test: 16 hPa 16. 0 test Pressure for mask test: 20 hPa 20. 0 3. To exit the Patient menu, press the On/Off/ESC key. Alternatively, if you press no key for 30 seconds, the Patient menu closes automatically. 5.5 Softstart setting To facilitate falling asleep, specialist staff may set a pressure which deviates from the opti- mum therapy pressure.
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al setting depends on season and ambient conditions. Under “normal” conditions, pre-set humidifier stage 3 is adequate. If temperature is 23 °C and humidity is 70 %, humidification of 100 % can be achieved with humidifier stage 6 and a flow rate of 20 l/min. Switch on respiratory air humidifier 1.
The respiratory air humidifier is switched off together with the therapy device. If you switch the therapy device back on, the respiratory air humidifier is automatically switched back on and operated at the heat output of the previous therapy. Auto off If the therapy device detects too low a filling level in the respiratory air humidifier, it switch- es off the respiratory air humidifier within 15 minutes.
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Mask test When the mask test is activated, the higher pressure set is output for 30 seconds (8 hPa in the example). 1. Check that the mask is leaktight and adapt the head strap if necessary. 2. To cancel the mask test before the 30 seconds have expired, press the On/Off key.
Switch off therapy device – To switch off the therapy device, press the On/Off key. Daily therapy time appears in the display for approx. 3 seconds. Alternatively, if Auto On/Off is activated, the therapy device switches off 5 seconds after the mask has been removed.
5.9 Travel with the therapy device To transport the therapy device over a relatively long distance, you should pack it in the carrying bag (included in the scope of the supply for the therapy device). In the carrying bag you should pack: •...
6. Hygiene treatment Note • Follow the instructions regarding the hygiene treatment of the accesso- ries (exhalation system, breathing mask, headgear/head strap) in the rel- evant instructions for use. This product may contain disposable items. Disposable items are in- • tended to be used only once.
As required Disinfect therapy device Section 6.6 Disinfect SOMNOclick 300 See associated instructions for use On change of Hygiene treatment if required Section 6.7 patient Change particulate filter of bacteria filter. See associated instructions for use 6.2 Breathing tube Caution! The breathing tube may only be used again after cleaning once it is completely dry.
5. To start the drying process, press the Menu key until dr0:30 appears in the display. Press the Softstart key to start the drying process. Alternatively, press the On/Off key and the Softstart key simultaneously. The therapy device now switches on and dries the breathing tube (time: 30 minutes). The remaining time is shown in the display.
6.4 Clean coarse dust filter/change fine filter 1. Remove the filter compartment lid on the rear of the device. 2. Remove the coarse dust filter and clean it under clean running water until there are no residues. 3. Replace the fine filter if necessary. It cannot be cleaned. 4.
6.6 Disinfect therapy device If required, e.g. following infectious diseases or unusual contamination, you can also dis- infect the housing, the power cord and the breathing tube. Follow the instructions for use for the disinfectant used. It is recommended that suitable gloves (e.g. household or dispos- able gloves) are used for disinfecting.
• If the therapy device has been used without a bacteria filter, the therapy device must be subjected to a hygiene treatment before it can be used for another patient. This must be performed by the manufacturer, Weinmann, or by an authorized specialist dealer.
5. Switch off the therapy device. Caution! If the values/functions quoted here are not met, send the therapy device to the manufacturer, Weinmann, or to an authorized specialist dealer for repair. 7.3 Function check of respiratory air humidifier Follow the relevant instructions for use.
8. Troubleshooting If there are faults which cannot be remedied at once, contact the manufacturer, Weinmann, or your specialist dealer immediately to have the device repaired. Do not continue operating the device to prevent greater damage. Cause of Fault Remedy...
Section 6.4 Complete function check see Section 7. Hygiene treatment of therapy device Send therapy device to Weinmann Replace any defective parts Send therapy device to Weinmann 9.3 Change pressure measurement tube 1. Release the sleeve of the creased tube from the click adapter.
10. Disposal Do not dispose of the therapy device in domestic waste. To dispose of the therapy device properly, contact an approved, certified electronics scrap dealer. You can ob- tain the address from your Environment Officer or your local authority. The device packaging (cardboard and inserts) can be disposed of in paper recycling facilities.
11. Scope of supply 11.1 Standard scope of supply SOMNOvent auto-S WM 29200 Parts Order number SOMNOvent auto-S, basic device WM 29205 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...
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SOMNOvent auto-ST WM 29400 Parts Order number SOMNOvent auto-ST, basic device WM 29405 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 WM 66971 Brief instructions for use WM 66981...
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SOMNOvent auto-S 230 V WM 29210 Parts Order number SOMNOvent auto-S 230 V, basic device WM 29215 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 WM 66971...
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SOMNOvent auto-ST 230 V WM 29410 Parts Order number SOMNOvent auto-ST 230 V, basic device WM 29415 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 WM 66971...
11.2 Accessories The following accessories can be ordered separately if required. Order Parts number 12 V inverter WM 24131 24 V inverter WM 24132 SOMNOclick 300 respiratory air humidifier WM 24375 SOMNOadjust WM 23930 remote setting software (for medical and technical professionals only) WEINMANNsupport WM 93305 evaluation software (for medical and technical professionals only)
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Order Parts number JOYCE GEL non-vented, size S WM 26162 JOYCE GEL non-vented, size M WM 26172 JOYCE GEL non-vented, size L WM 26182 JOYCE non-vented, size S WM 26160 JOYCE non-vented, size M WM 26170 JOYCE non-vented, size L WM 26180 JOYCE non-vented, size XL WM 26190...
12. Technical data 12.1 Specifications SOMNOvent auto-S/ST with SOMNOvent auto-S/ST 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 operation +5 °C to +35 °C storage...
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SOMNOvent auto-S/ST with SOMNOvent auto-S/ST SOMNOclick 300 Classification to EN 60601-1: 1990 +A1:1993 + A2:1995 Type of protection Protection class II against electric shock Degree of protection Type B against electric shock Protection against IPX0 damaging ingress of water Duty cycle Continuous duty Electromagnetic com- Test parameters and limit values can be obtained from the...
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SOMNOvent auto-S/ST with SOMNOvent auto-S/ST SOMNOclick 300 Max. CPAP pressure in the event of a fault < 36 hPa to EN ISO 17510 -1 Flow rate at max. speed at: 20 hPa 125 l/min 115 l/min 16 hPa 145 l/min 135 l/min 12 hPa 165 l/min...
SOMNOvent auto-S/ST with SOMNOvent auto-S/ST SOMNOclick 300 Long-term pressure consistency to Δp = 0.2 hPa Δp = 0.3 hPa EN 17510-1:2002 Fine filter, degree of separation up to 1 μm ≥ 99.5 % up to 0.3 μm ≥ 85 % Fine filter service life approx.
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. 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 un- abridged text of the Declaration of Conformity can be found on our website at www.weinmann.de...
15. Glossary Apnea If external breathing stops for at least 10 seconds, this is called apnea. Apnea is usually ended by a waking reaction in the body. This interrupts sleep and reduces its recovery function. A distinction is made between obstructive apneas, in which breathing is obstructed by closure of the upper air- ways, and central apneas, in which the respiratory drive stalls.
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Pressure during inspiration TriLevel A further development of the BiLevel system by Weinmann. As a higher pressure is required at the end of exhalation to prevent obstructions, this pressure may be set separately by a doctor or automatically adapted to the patient's current requirements by the device.
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Weinmann Geräte für Medizin GmbH + Co. KG P.O. Box 540268 D-22502 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 Geräte für Medizin GmbH + Co. KG Siebenstücken 14...