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EN Instructions for Use with devices as of serial number 65,000
SOMNOvent auto-S/ST
automatic BiLevel S/ST therapy device with
autoTriLevel principle
SOMNOvent auto-S
SOMNOvent auto-S with SOMNOclick 300
SOMNOvent auto-S 230 V
SOMNOvent auto-ST
SOMNOvent auto-ST with
SOMNOclick 300
SOMNOvent auto-ST 230 V
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Table of Contents
Related Manuals for Lowenstein Medical SOMNOvent auto-S
Summary of Contents for Lowenstein Medical SOMNOvent auto-S
- Page 1 EN Instructions for Use with devices as of serial number 65,000 SOMNOvent auto-S/ST automatic BiLevel S/ST therapy device with autoTriLevel principle SOMNOvent auto-S SOMNOvent auto-S with SOMNOclick 300 SOMNOvent auto-S 230 V SOMNOvent auto-ST SOMNOvent auto-ST with SOMNOclick 300 SOMNOvent auto-ST 230 V...
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Page 2: Table Of Contents
Contents Overview ....3 Change of patient ... . 33 Markings on the therapy device . . 6 Function check . -
Page 3: Overview
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... - Page 4 Control panel 19 On/Off key 20 Menu key 22 Humidifier key 21 Softstart key with LED Accessories 26 Inverter 27 Carrying bag 28 O supply valve 25 Power supply connection 24 Filter compartment lid, air inlet 23 Device ID plate 29 SOMNOclick 300 respiratory air humidifier 1 Bacteria filter...
- Page 5 9 Click adapter 21 Softstart key For connecting the breathing tube to the device For activating/deactivating Softstart, for calling up outlet port. Softstart settings and for reducing an adjustable value. 10 Pressure measurement tube 22 Humidifier key with LED For measuring the pressure prevailing in the breathing mask.
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Page 6: Markings On The Therapy Device
1.1 Markings on the therapy device Symbol Meaning 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... -
Page 7: Markings On The Packaging
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. -
Page 8: Description Of Device
SOMNOvent auto-S is not suitable for life-support purposes on patients requiring ventilation. Note To ensure successful therapy with SOMNOvent auto-S, it is important to determine and set accordingly therapy mode, pressure limits and minimum respiratory frequency. SOMNOvent auto-ST SOMNOvent auto-ST is an automatically-regulating BiLevel ST therapy device with... -
Page 9: Description Of Function
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 specialist 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. - Page 10 • 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. One of three therapy objectives can be set in ST mode.
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Page 11: Safety Instructions
The therapy device can operate with the voltages 115 V and 230 V. It automatically adjusts to one of these voltages. Exception: the SOMNOvent auto-S/ST 230 V (WM 29210 / WM 29410) can only operate with a voltage of 230 V. Use the inverter available as an accessory for operation with 12 V DC or 24 V DC. - Page 12 • Follow the instructions for use for your breathing mask. • Follow the section entitled “6. Hygiene treatment” on page 29 to pre- vent an infection or bacterial contamination. • If the therapy device is intended for use by several patients, a bacteria fil- ter should be used to protect against infections.
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Page 13: Contraindications
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. -
Page 14: Side Effects
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 •... -
Page 15: Device Setup
The therapy device automatically detects whether 115 V or 230 V are connected and automatically switches. Exception: the SOMNOvent auto-S/ST 230 V (WM 29210 /WM 29410) can only operate with a voltage of 230 V. -
Page 16: For Operation Without Respiratory Air Humidifier
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. -
Page 17: Connect Other Accessories
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. - Page 18 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.
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Page 19: Operation
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. -
Page 20: 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... -
Page 21: Read Out Therapy Time
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): mean value for all therapy days (11 days in the example) 11 d... -
Page 22: Mask Test
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. -
Page 23: Softstart Setting
Pressure for mask test: 16 hPa test 16. 0 Pressure for mask test: 20 hPa test 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. - Page 24 ideal 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.
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Page 25: Operate Therapy Device
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. - Page 26 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.
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Page 27: After Use
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. -
Page 28: Travel With The Therapy Device
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: •... -
Page 29: Hygiene Treatment
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. -
Page 30: Breathing Tube
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. -
Page 31: Clean Housing
4. Push the click adapter of the breathing tube into the device outlet port or if necessary, onto the red drying adapter. 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. -
Page 32: Clean Coarse Dust Filter/Change Fine Filter
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. -
Page 33: Change Of Patient
Ensure that no liquids penetrate the therapy device. Never immerse the therapy de- vice in disinfectants or other liquids, otherwise this may lead to damage to the ther- apy device and thus to a hazard to users and patients. Caution! Ensure that no liquids penetrate the therapy device via the pressure measurement connection, otherwise there may be malfunctions. -
Page 34: Function Check
7. Function check 7.1 Intervals Perform a function check on both the therapy device and on SOMNOclick 300 at least every 6 months. Warning! If you find faults during the function check, you may not use the devices again until the faults have been eliminated. -
Page 35: Troubleshooting
8. Troubleshooting If you are unable to remedy faults with the aid of the table, or in the event of unexpected operation or an incident, contact your authorized specialist dealer to have the device re- paired. Do not continue operating the device to prevent greater damage. Cause of Fault Remedy... - Page 36 Cause of Fault Remedy fault Voltage too Therapy can continue without restriction. Inform Err r low. Internal your dealer. clock (RTC) now longer being sup- plied with power. Therapy device not HF sources Increase the distance between devices emitting working properly radiation and the therapy device.
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Page 37: Servicing
9. Servicing The device is designed for a service life of 5 years. When used in accordance with purpose and in accordance with the instructions for use, the device requires no maintenance during this period. 9.1 Change pressure measurement tube 1. -
Page 38: Scope Of Supply
Power cord WM 24133 Coarse dust filter WM 24097 Fine filter, packed WM 23596 Instructions for use WM 66941 SOMNOvent auto-S with SOMNOclick 300 WM 29250 Parts Order number SOMNOvent auto-S WM 29205 SOMNOclick 300 WM 24375 Instructions for use for SOMNOclick 300... - Page 39 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 66941 SOMNOvent auto-ST with SOMNOclick 300 WM 29450...
- Page 40 Power cord WM 24133 Coarse dust filter WM 24097 Fine filter, packed WM 23596 Instructions for use WM 66941 SOMNOvent auto-S 230 V with SOMNOclick 300 WM 29260 Parts Order number SOMNOvent auto-S 230 V WM 29210 SOMNOclick 300 WM 24375...
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Page 41: Accessories And Spare Parts
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 66941... -
Page 42: Technical Data
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... - Page 43 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...
- Page 44 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...
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Page 45: Pressure/Volume Curve
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. -
Page 46: Pneumatic Diagram
12.3 Pneumatic diagram pressure source Flow rate adjuster Optional (max. 1.5 bar) up to max. 4 l/min valve Patient mask Input Optional Optional Breathing tube with Filter humidifier bacteria filter 1.8 m for ambient air exhalation system Pressure Pressure sensor for measurement patient pressure tube... -
Page 47: Warranty
13. Warranty Löwenstein Medical gives the customer a limited manufacturer warranty on new original Löwenstein Medical products and any replacement part fitted by Löwenstein Medical 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. The warranty conditions are available on the website of the manufacturer. - Page 48 Löwenstein Medical Technology GmbH + Co. KG Kronsaalsweg 40 22525 Hamburg, Germany T: +49 40 54702-0 F: +49 40 54702-461 www.loewensteinmedical.de...
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