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Summary of Contents for DeVilbiss Healthcare SOMNOplus
- Page 1 SOMNOplus SOMNOplus Nasal Mask Device Description and Instructions for Use Caution: Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician. Latex-free...
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Page 2: Table Of Contents
Contents 1. Overview ....3 2. Device Description ....4 2.1 Intended use . -
Page 3: Overview
1. Overview SOMNOplus (with WEINMANNstrap) 2 Mask cushion 3 Forehead cushion 4 Forehead support 5 Support 6 Port caps 7 Mask frame 1 Head gear 8 Elbow 9 Exhalation 10 Exhalation slot connector 13 EasyClip 11 Hose 12 Rotating sleeve... -
Page 4: Device Description
2. Device Description 2.1 Intended use The Weinmann SOMNOplus is intended for prescrip- tion use to be used during nasal CPAP or Bi-level Pos- itive Pressure therapy for adult patients (>66 pounds or 30 kg). 2.2 Functional description The nasal mask and the headgear are attached over your nose so that the flow of air from the therapy de- vice is routed through the nasal mask to the nose. -
Page 5: Safety Instructions
• Patients with obstructive and restrictive lung diseas- es should be examined on an individual basis dur- ing use of the SOMNOplus, for example with regard to re-inhalation of CO Safety instructions... - Page 6 • The SOMNOplus has an integrated exhalation system. Do not connect any other exhalation sys- tem or exhalation valve to the nasal mask. • Only put the nasal mask over your face for a pro- longed period when the therapy device is switched on.
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Page 7: Side Effects
• Malfunctions and a lack of biocompatibility may result if third-party articles are used. Please bear in mind that in these cases any warranty entitlement and liability shall lapse where the accessories rec- ommended in the instructions for use or original spare parts are not utilized. -
Page 8: Operation
4. Operation Some users may prefer to clean the mask and the headgear before using it for the first time (See chap- ter“5. Cleaning Instructions” on page 14). 4.1 Assembling and adjusting forehead support The forehead support is made up of a support and a forehead cushion. -
Page 9: Disassembling Forehead Support
4.2 Disassembling forehead support Loosen the forehead support by pressing on the clamp on the mask frame (Fig. C). Pull forehead cushion off support. 4.3 Adjusting headgear When you first apply the nasal mask with the head- gear, it is a good idea to ask another person for help. 1. - Page 10 4. Adjust the headgear with the aid of the hook-and- loop closures so that the mask seals on the face but is not too tight (Fig. E). WEINMANNstrap only: The WEINMANNstrap headgear provides the fol- lowing options for you to do this (Fig. F): –...
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Page 11: Connecting The Mask To A Therapy Device
4.4 Connecting the mask to a therapy device Push the hose of your therapy device onto the rotating sleeve (Fig. G). In doing so, ensure that there is a se- cure, airtight connection to the hose. The connection should not come loose as a result of therapy pressure. If you wish to interrupt therapy briefly, you can pull the rotating sleeve out of the elbow. -
Page 12: Using The Mask With Humidifiers
Please be sure to read the instructions for use for your humidifier and your therapy device. 4.7 Pressure measurement SOMNOplus is supplied with two ports. They can be used for external pressure measurement. If only one port is required, turn the connection up- wards (Fig. -
Page 13: Disassembling The Mask
4.9 Disassembling the mask 1. Remove the headgear from the nasal mask. 2. Loosen the forehead support from the mask frame by pressing on the clamp. Pull the forehead cush- ion off the support. 3. Pull the mask cushion off the mask frame and re- move the seal for the ports. -
Page 14: Cleaning Instructions
5. Cleaning Instructions 5.1 Schedule Note: Wash the headgear before using for the first time, as the color might run. Daily Please clean the nasal mask after every usage as de- scribed in item “5.2 Procedures allowed“ under “Man- ual Cleaning“. For cleaning purposes we recommend taking the mask apart as described above. -
Page 15: Procedures Allowed
5.2 Procedures allowed The following procedures are allowed: Procedures Parts Mask cushion Forehead cushion Port caps Mask frame Support Elbow Rotating sleeve Headgear Clean in warm water, free of residues with a Manual Cleaning mild detergent as for dishwashing. Carefully rinse the parts with clear water. Dry all parts thoroughly after cleaning. - Page 16 Warning For patients with a weakened immune system or a special medical history daily disinfection or steril- ization may be necessary. In this case, please consult your physician. Cleaning Instructions...
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Page 17: Functional Checks
6. Functional Checks Carry out a visual check once per week. If the mask cushion is no longer airtight due to cracks or splits, replace it with a new one. Yellowing of the mask cushion does not indicate malfunction or dam- age. -
Page 18: Troubleshooting
7. Troubleshooting Problem Cause Remedy In the Loosen the headgear a bit. morning you Change the position of the have pain The nasal mask forehead support on the mask from is too tight. frame. If necessary, select a pressure on different support size for the your face. -
Page 19: Scope Of Supply
All masks are supplied fully assembled and consist of mask cushion, mask frame, port caps, forehead sup- port (sizes 1-4, size 3 already assembled), exhalation connector, headgear, instructions for use. Description Item No. SOMNOplus‚ size XS WM 25800 SOMNOplus‚ size S WM 25810 SOMNOplus‚ size M WM 25820 SOMNOplus‚... -
Page 20: Mask Frame
Description Item No. Headgear (WEINMANNstrap/HEADstrap), WM 26375 Universal Size Forehead support (sizes 1-4, size 3 already WM 25160 assembled) Forehead cushion WM 15700 Forehead support size 1 WM 15701 Forehead support size 2 WM 15702 Forehead support size 3 WM 15703 Forehead support size 4 WM 15704 Exhalation connector... -
Page 21: Technical Data
9. Technical Data 9.1 Specifications Dimensions (WxHxD): approx. 3,25“ x 5,5“ x 3,5“ mm Weight: approx. 1,9 oz. Therapy pressure range: 4 to 30 cm H 22 mm conical connector in Hose connector: accordance with ISO 5356-1 Port for pressure measurement Ø... -
Page 22: Materials
9.2 Materials Components Material Mask cushion Silicone Elbow Polycarbonate Rotating sleeve Polycarbonate Port caps Silicone Forehead cushion Silicone Support Polypropylene Spandex, Polyester, Polyurethane, WEINMANNstrap headgear Nylon, Cotton, Polyamide Nylon, Spandex, Polyurethane, HEADstrap headgear Polyester/Lycra Polyoxymethylene, Polyethylene, EasyClip Polyamide/Nylon All individual parts of the nasal mask are latex-free. 9.3 Characteristic pressure/flow graph The characteristic pressure/flow graph shows outlet flow as a function of therapy pressure. -
Page 23: Warranty
10. Warranty DeVilbiss warrants that on delivery your SOMNOplus mask system including its components: mask cushion, mask frame, elbow, port caps, forehead cushion, sup- port, exhalation connector and headgear is free from defects in material and workmaship. Patents US 6,926,004; US 5,715,814 and other US patents pending. - Page 24 +49/40/5 47 02-461 E-mail: info@weinmann.de Internet www.weinmann.de Manufactured for: DeVilbiss Healthcare LLC 100 DeVilbiss Drive Somerset, Pennsylvania, 15501 Phone: 814.443.4881 Internet www.devilbisshealthcare.com © 2012 DeVilbiss Healthcare LLC 09.12. All Rights Reserved. ® ® DeVilbiss and EasyFit are registered trademarks of DeVilbiss Healthcare.
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