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Thank you for choosing
This product has been designed by the RDI department of SIBEL S.A.U. in cooperation
with the sleep units of the University Hospital Araba / Osakidetza (Vitoria, SPAIN) and
of the University Hospital Arnau de Vilanova (Lleida, SPAIN).
according to the European Medical Device Directive and with the best quality standards.
Revised
Date: 2018-09
Technical Director
EN 2
PRODUCT IN COMPLIANCE WITH MEDICAL DEVICE DIRECTIVE 93/42/EEC
(CLASS IIa).
!
Somnibel
somnibel
Somnibel
is manufactured
Approved
Date: 2018-09
Sales Director
User's Manual
534-800-MUM_Rev.1.05
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Summary of Contents for Sibelmed somnibel
- Page 1 User’s Manual PRODUCT IN COMPLIANCE WITH MEDICAL DEVICE DIRECTIVE 93/42/EEC (CLASS IIa). Thank you for choosing Somnibel This product has been designed by the RDI department of SIBEL S.A.U. in cooperation with the sleep units of the University Hospital Araba / Osakidetza (Vitoria, SPAIN) and of the University Hospital Arnau de Vilanova (Lleida, SPAIN).
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Page 2: Table Of Contents
3.1 SOMNIBEL FUNCTIONING ................. 13 3.2 COMPLIANCE ENHANCEMENT FUNCTION ............14 3.3 VISUAL INDICATIONS AND WARNINGS ............15 3.4 TRAVELLING WITH THE SOMNIBEL ................15 4. CLEANING INSTRUCTIONS ................. 16 5. TECHNICAL SPECIFICATIONS ................16 6. APPLICABLE DIRECTIVES AND STANDARDS ............18 7. -
Page 3: Safety
User’s Manual 1. SAFETY Somnibel is a new system for the treatment of patients with Sleep-Related Breathing Disorders (SRBD), mainly the Sleep Apnea-Hypopnea Syndrome (SAHS) or habitual snoring during sleep. It has been developed by the RDI Department of SIBEL S.A.U. with the collaboration of reference Health Centers and doctors specialized in Sleep Disorders. -
Page 4: Indications For Use
User’s Manual 1.2 INDICATIONS FOR USE It is well known that more than 50% of SAHS patients experience a worsening in the frequency and severity of respiratory events when sleeping in the supine position, compared to other body positions 1, 2, 3, 4 . -
Page 5: Warnings
User’s Manual must be adhered to the patient’s body, at the forehead or chest, by means of a specifically designed Somnibel disposable fastening adhesive. The fastening adhesive should not be placed onto injured skin. The patient should adopt a lying sleeping position (trunk inclination < 30º) while using the device. - Page 6 User’s Manual Accessories should be handled by their strongest parts, which are the connectors. They should also not get wet or exposed to very abrupt changes of temperature. Do not apply excessive stress to the accessories. In particular, avoid pulling or bending any part of the cables.
- Page 7 User’s Manual The device is not designed to work in an explosive environment or in the presence of flammable anesthetics or gases of any kind. MAY CAUSE EXPLOSION. The device should be used in an acoustic environment that allows the patient to sleep normally.
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Page 8: Disposal Of Electrical And Electronic Devices By Domestic Users In The European Union
User’s Manual DISPOSAL OF ELECTRICAL AND ELECTRONIC DEVICES BY DOMESTIC USERS IN THE EUROPEAN UNION Somnibel Never dispose in the household trash, since it contains a Lithium-Polymer battery and electronic components. It must be disposed properly and may need to be recycled in accordance with the statutory requirements in your country. -
Page 9: Installation Instructions
• Internal rechargeable battery: > 3 nights (10h/night) • ADHESIVE USER’S MANUAL • Visual indicator of battery status • Initial self-test 2.2 PACKING LIST CODE 08768 QTY. 1 SOMNIBEL POSITIONAL THERAPY DEVICE CODE 08754 QTY. 1 Somnibel USER’S MANUAL Visual Adhesive... -
Page 10: Instructions For Use
User’s Manual 3. INSTRUCTIONS FOR USE Clip one fastening adhesive to attention “click” indications of the device after Somnibel device until you hear a turn ON (consult section VISUAL “click” (the light blinks 3 times in INDICATIONS AND WARNINGS). -
Page 11: Somnibel Functioning
3.1 SOMNIBEL FUNCTIONING Somnibel is automatically turned ON when the fastening adhesive is clipped to the device. At the beginning, the device performs a self-test for checking its correct functioning. - Page 12 User’s Manual 3.2 COMPLIANCE ENHANCEMENT SETTINGS Somnibel device includes additional features for enhancing patient compliance to the positional therapy. These features are configured with default parameters, as follows: Default Settings Description Enhancement value EasySleep Time between device ON and activation of stimulus if...
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Page 13: Visual Indications And Warnings
User’s Manual 3.3 VISUAL INDICATIONS AND WARNINGS TURN ON 10 s RUNNING 0.5 s TURN OFF LOW BATTERY Connect the device to the mains with the battery charger. CHARGING The light turns OFF when the device is fully charged. -
Page 14: Travelling With The Somnibel
User’s Manual 3.4 TRAVELLING WITH THE SOMNIBEL Do not throw the packaging after using the device. It can be used for device transportation. Somnibel Somnibel If you need to travel, you can bring your with you for continuing your treatment. -
Page 15: Technical Specifications
User’s Manual 5. TECHNICAL SPECIFICATIONS Somnibel Useful life 3 years Size (L x W x H) 51.9 x 31.7 x 14.5 ± 0.5 mm Weight 16.8 ± 1.0 gr Internal rechargeable Lithium-Polymer battery (> 3 nights @ 10h/night) Power supply... - Page 16 User’s Manual Somnibel Auto-adjusting Stimulus Levels 0%, 25%, 50%, 75%, 100% (< 110 dB) EasySleep Delay 15 min Supine Delay 30 secs Stimulus Increase Period 60 secs Time at Maximum Power 20 min. Supine threshold angle 45º Visual indications (Note 5)
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Page 17: Applicable Directives And Standards
User’s Manual 6. APPLICABLE DIRECTIVES AND STANDARDS • European directive concerning medical devices 93/42/EEC • Rohs Directive: 2011/65/EU. • Waste disposal according to WEEE Directive 2012/19/UE. • Regulation EC 1272/2008 on classification, labeling and packaging of substances and mixtures (REACH). -
Page 18: Symbols
User’s Manual 7. SYMBOLS MANUFACTURER (manufacture date, DIRECT CURRENT ATMOSPHERIC name and address of the manufacturer) PRESSURE LIMITATION IP22 (SEE SECTION WARNINGS) DATE OF MANUFACTURE HUMIDITY DEVICE UPRIGHT POSITION LIMITATION CATALOGUE NUMBER BATCH CODE SERIAL NUMBER KEEP DRY USE BY DATE ... -
Page 19: Bibliography
User’s Manual 8. BIBLIOGRAPHY 1. Review by Veasey SC, Guilleminault C, Strohl KP et al. Medical Therapy for Obstructive Sleep Apnea: A Review by the Medical Therapy for Obstructive Sleep Apnea Task Force of the Standards of Practice Committee of the American Academy of Sleep Medicine. -
Page 20: Annex 1: Electromagnetic Compatibility
User’s Manual Annex 1: ELECTROMAGNETIC COMPATIBILITY Guidance and manufacturer’s declaration – electromagnetic emissions Somnibel is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment. - Page 21 RF compliance level above, Somnibel. should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such reorienting or relocating Somnibel. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
- Page 22 User’s Manual Recommended separation distances between portable and mobile RF communications equipment and Somnibel can help prevent electromagnetic interference by maintaining a Somnibel Somnibel is intended for use in an electronic environment in which radiated RF disturbances are controlled. The costumer or the user of...
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