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Summary of Contents for Weinmann SOMNOcomfort 2e
- Page 1 SOMNOcomfort 2e SOMNOaqua CPAP unit from SN 65000 SOMNOcomfort 2e SOMNOcomfort 2e with SOMNOaqua Description of the equipment and instructions for use...
- Page 2 Overview SOMNOcomfort 2e 1 Bacteria filter 12 Headgear 2 Power supply cable 11 Mask 3 Power pack 10 Exhalation 5 Cover system 4 Humidifier 9 Breathing hose Adapter 6 Serial interface 7 Unit outlet 13 Humidifier activated 14 Softstart time...
- Page 3 Legend Bacteria filter Softstart time Used to protect the patient from bacteria, partic- This symbol appears when the softstart time is set ularly if the unit is being used by a number of or the softstart is activated. patients. Automatic switch on/off Power supply cable The symbol "A"...
- Page 4 SOMNOaqua (optional) 32 Filling cap 31 Upper part 30 Lower part 26 Heater 29 Outlet 27 Inlet connections connections 28 Pressure gland Legend Heater Outlet connections Heats the water in the humidifier. This humidifies The humidified air flows from here through the the air.
- Page 5 Special markings on the unit Symbol Meaning SOMNOcomfort 2e: Unit inlet: allows air at room temperature to enter Unit outlet: air escapes with 4 - 20 hPa Side connection socket: Connection for setting the therapy parameters with SOMNOadjust WM 23930 and WEINMANNsupport WM 93305 by specialist staff or to control the O connection valve, WM 24042.
- Page 6 Symbol Meaning Do not dispose of unit as domestic waste Serial number of the unit Type of protection against electric shock: unit of protection class II CE 0197 symbol: confirms that the product conforms to the applicable European directives. IPX1 Protection against ingress of water (drips) Labeling on the packaging of the therapy device Symbol...
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Page 7: Table Of Contents
5.4 Descaling the SOMNOaqua . . 28 1.1 Intended use 5.5 Disinfecting the SOMNOcomfort 2e ..8 SOMNOcomfort 2e..28 1.2 SOMNOaqua intended use ..8 5.6 Disinfecting the SOMNOaqua . -
Page 8: Description Of Equipment
The SOMNOaqua humidifier is an optional accessory for the Weinmann SOMNOcomfort 2e therapy unit. The SOMNOaqua humidifier is used to heat the air flow created by the SOMNOcomfort 2e and to increase its humidity. This will prevent the patient's upper airways drying out during the therapy. -
Page 9: Functional Description Somnocomfort 2E
1.3 Functional description SOMNOcomfort 2e SOMNOcomfort 2e operates according to the principle of an electrically driven flow gen- erator, with the pressure level being controlled electronically. • A fan draws in ambient air via a filter and conveys it to the unit outlet. -
Page 10: Somnoaqua
The amount of humidity released can be adjusted using the buttons on the Weinmann therapy unit. The output of the heater rods and consequent- ly the temperature of the water in the humidifier chamber is controlled electronically by the Weinmann unit. -
Page 11: Safety Instructions
Maintain a safe distance between the SOMNOcomfort 2e and equip- ment that emits HF radiation (e.g. mobile phones). This unit may other- wise malfunction (see page 42). If the SOMNOcomfort 2e interferes with other devices (e.g. a radio), move the SOMNOcomfort 2e further away. - Page 12 Transport/Accessories/Spare Parts/Repair Caution! • Do not transport (or tilt) the SOMNOcomfort 2e with the humidifier in- stalled. Tilting might cause water remaining in the humidifier to run into the SOMNOcomfort 2e and damage it. • Only have checks and repair work carried out by Weinmann or specialist staff.
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Page 13: Contraindications
4 l/min. If excessive quantities are supplied, there is a risk of fire. 2.2 Contraindications The SOMNOcomfort 2e should not be used with certain diseases or only with particular caution. In each case the decision whether to use SOMNOcomfort 2e for therapy lies with the doctor in charge. This includes: •... -
Page 14: Side Effects
2.3 Side effects When using SOMNOcomfort 2e the following undesirable side effects may occur during short-term and long-term usage: • pressure points on the face caused by the mask and the forehead padding; • reddening of the skin on face;... -
Page 15: Setup Of Equipment
The unit may overheat, resulting in insufficient therapy delivery and damage to the unit. Plug the power supply cable into the supply connection of the SOMNOcomfort 2e. Then plug the power pack into a socket outlet (using the power supply cable). -
Page 16: Fitting The Mask
Note • The device automatically compensates for differences in air pressure (e.g. as a result of great altitude). 3.2 Fitting the mask Adjust the forehead support of the mask (if present). Connect the headgear to the mask. Position the mask. Adjust the headgear so that the bulge of the mask only results in low pressure to prevent pressure points on the face. - Page 17 Open the filling cap of the humidifier. Fill the humidifier up to the mark "max " with distilled water. If no distilled water is available, low calcium boiled water can be used instead (but not as a rule!). Check that the heater rod does not scale up (see “5.4 Des- caling the SOMNOaqua”...
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Page 18: Accessories
This application must be prescribed by the doctor in charge. To prevent oxygen entering the therapy unit, the SOMNOcomfort 2e automatically gener- ates a therapy pressure of at least 5 hPa when an oxygen connection valve is attached. You must under all circumstances follow the safety instructions for handling oxygen as well as the operating instructions for the oxygen valve and the oxygen unit used. -
Page 19: Operation
If a button is not pressed for 5 seconds, the current setting is saved. When the automatic system is activated, you can switch SOMNOcomfort 2e on and off using the on/off switch or using the pressure available in the mask. -
Page 20: Somnocomfort 2E Startup
Feed the breathing hose away from your head. Never place the breathing hose around your neck. 3. Press the on/off switch. If the automatic system is ac- tivated, you can also switch on SOMNOcomfort 2e with a breath. The therapy period will appear for approx. 3 seconds in the display. - Page 21 Press the humidifier button on your therapy unit. The humidifier symbol and the humidification level display (level 4 in this case) are shown in the display of the therapy unit. Humidifier button Setting the heating level Make sure your therapy unit is switched on. Press the humidifier button for approx.
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Page 22: Softstart Setting
The softstart settings are saved when the unit is switched off. Whenever SOMNOcomfort 2e is started up, it automatically starts in softstart mode if this was switched on. Softstart can be switched on and off at any time by pressing the softstart button 4.5 After usage... -
Page 23: Read Off Therapy Duration
The stored values and settings will not be lost. 4.6 Read off therapy duration SOMNOcomfort 2e saves the data from 366 days and the associated therapyduration. You can display the following values: •... -
Page 24: Travelling With Therapy Units
Use the on/off switch in the same way to return to the current date. If a button is not pressed for 10 seconds, the total operating time will appear for 3 seconds. This display then disappears and "0" reappears in the display. 4.7 Travelling with therapy units To transport the therapy unit over long distances, it should be packed in the carry case (included with the unit). -
Page 25: Hygienic Preparation
– change the fine filter once a month depending on soiling. • Regularly wipe clean the housing of the SOMNOcomfort 2e and the power pack. • The breathing hose should be cleaned according to the level of soiling, however at least once a month. Replace it every 12 months. - Page 26 Hang up the hose and allow to drip to prevent moisture from getting into the SOMNOcomfort 2e. The breathing hose is dried completely with the help of SOMNOcomfort 2e. If necessary, remove the humidifier and fit the cover. Insert the breathing hose adapter into the unit outlet.
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Page 27: Cleaning The Somnoaqua
Cleaning the coarse dust filter/changing the fine filter Remove the filter compartment cover on the rear of the unit. Remove the coarse dust filter and clean under clear running water until no residues remain. Replace the fine filter if necessary, as it cannot be cleaned. -
Page 28: Descaling The Somnoaqua
Finally, dry all parts carefully. 5.5 Disinfecting the SOMNOcomfort 2e If necessary, for example after an infectious illness or if the unit has become unusually con- taminated, you can also disinfect the housing, the power supply cable, the breathing hose, and the humidifier. -
Page 29: Disinfecting The Somnoaqua
Make sure no liquid gets into the housing via the pressure measurement port. This may cause the unit to malfunction. The housing, power pack and power supply cable of the SOMNOcomfort 2e are cleaned by being simply wiped Pressure measurement port over with disinfectant. Breathing hose •... -
Page 30: Multiple Patient Use Somnocomfort 2E
If the unit is to be utilised for another patient without using a bacteria filter, it must under- go a hygiene treatment beforehand. This has to be carried out by Weinmann or a dealer. The procedure used for the hygiene treatment is described in the inspection sheet and the service and repair instructions for SOMNOcomfort 2e. -
Page 31: Functional Checks
6. Functional checks 6.1 Intervals Carry out a functional check on the SOMNOcomfort 2e and the SOMNOaqua at least every 6 months. If you find a defect during the functional check, do not use the unit until the defect has been remedied. -
Page 32: Function Check Of Somnoaqua
6.3 Function check of SOMNOaqua Perform a visual inspection of the plastic housing. If cracks/damage or severe soiling is evident, the plastic parts or seals must be replaced. Fill the humidifier up to the mark with water. Check whether the humidifier is leaking. Empty the water. -
Page 33: Malfunctions And Rectification
7. Malfunctions and Rectification If there are defects which cannot be rectified at once, please contact Weinmann or your dealer immediately to have the unit repaired. To avoid greater damage, do not use the unit. 7.1 SOMNOcomfort 2e Malfunctions Cause... -
Page 34: Somnoaqua
7.2 SOMNOaqua Malfunctions Cause Rectification Humidifier is not Switch on the air humidifier, see 4.3, activated. page 20. Humidifier does not warm up. Send the humidifier and the therapy Electronics defect. unit to your dealer for repair. The heater rod seal Replace the seal, see page 34. - Page 35 Replacing the housing lower part seal Open the humidifier by twisting the upper and lower parts against each other in an anti-clockwise direc- tion. Carefully take the sealing ring out of the groove in the lower part of the unit. Important! Take care to ensure that the groove in which the seal fits is not damaged.
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Page 36: Maintenance
8. Maintenance 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. Disposal To dispose of the unit properly, please contact a licensed and certified electronic waste disposal merchant. -
Page 37: Scope Of Supply
24403 10.2 Accessories and spare parts You can order accessories and spare parts separately if required. A current list of accesso- ries and spare parts can be ordered on the Internet at www.weinmann.de or via your dealer. Scope of supply... -
Page 38: Technical Data
11. Technical data 11.1 Specifications SOMNOcomfort 2e SOMNOcomfort 2e with SOMNOaqua Product class as per 93/42/EEC Dimensions WxHxD in 21 x 9 x 27 21 x 14 x 27 Weight approx. 1.7 kg approx. 1.9 kg (without water) Temperature range –... - Page 39 SOMNOcomfort 2e SOMNOcomfort 2e with SOMNOaqua Electromagnetic Test parameters and limit values can be obtained from the manufacturer if compatibility (EMC) as required. per EN 60601-1-2:2001 – radio interference EN 55011 B suppression – immunity to EN 61000-4 parts 2 to 6, part 11...
- Page 40 SOMNOcomfort 2e SOMNOcomfort 2e with SOMNOaqua Precision of dynamic pressure (short-term precision) with 10 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...
- Page 41 SOMNOaqua II a Product class as per 93/42/EEC Dimensions WxHxD in mm 140 x 100 x 121 Weight (without water) 300 g Temperature range – operation +5 ° C to +35 ° C – storage –40 ° C to +70 ° C Humid operation and storage ≤95 % relative humidity Ambient pressure range...
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Page 42: Pneumatic Diagram
Pressure sensor for patient pressure 11.3 Safety distances Recommended safety distances between portable and mobile HF telecommunications equipment (e.g. mobile phones) and SOMNOcomfort 2e or SOMNOaqua Safety distance dependent on transmission frequency Nominal output of HF equipment in m in W... -
Page 43: Warranty
None 13. Declaration of conformity Weinmann Geräte für Medizin GmbH + Co. KG declares herewith that the product com- plies 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... -
Page 44: Index
13. Index Keyword: page: Accessories Automatic switch on/off 9, 19, 20, 33 Automatic switch-on Cleaning Disinfection 25, 28 Drying exhalation Exhalation system: 18, 20, 23, 25, 31 Filter 25, 33, 40 Functional Check Humidifier 12, 18, 28, 37, 38 Inspection Malfunctions Mask 16, 20, 22, 23... - Page 48 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...
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