Related Manuals for DeVilbiss EasyFit SilkGel
Summary of Contents for DeVilbiss EasyFit SilkGel
- Page 1 ® EasyFit SilkGel ® EasyFit SilkGel Full Face Mask 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
Table of Contents Table of Contents Introduction Intended use ................ 4 Contraindications ..............5 Side effects ................5 Duty to provide instruction ............ 5 Safety Warnings in this document ........... 6 Safety information ..............7 General information ............. 9 Product description Overview ................ - Page 3 Table of Contents Cleaning instructions Clean mask ................ 30 Tips ..................32 Change of patient .............. 32 Disposal Troubleshooting Item List Complete System ..............34 Replacement Cushions ............34 Replacement Headgear ............34 Parts and Accessories ............35 Instructions ................ 35 Technical data Specifications ..............
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Page 4: Introduction
All information and instructions in these instructions for use have been compiled based on the current valid standards and regulations, the latest state-of-the-art technology and our long- standing experience and knowledge in the field. DeVilbiss accepts no liability in the following circumstances: •... -
Page 5: Contraindications
Introduction 1.2 Contraindications Use of this device may be contraindicated under the following conditions: Erosions and ulcerations, skin allergies, skin rashes on the face, pressure points on the face, claustrophobia, anxiety, deformities of the face or nasopharynx, ingestion of drugs which may induce vomiting, the necessity for immediate intubation. -
Page 6: Safety
Safety Safety Read these instructions for use carefully. They are an essential part of the mask and must be available at all times. 2.1 Warnings in this document Warnings indicate information relevant to safety. Within instructions, you will find warnings in front of a step which contains a hazard to persons or objects. -
Page 7: Safety Information
Safety Indicates material hazards. If you do not follow this instruction, material damage may result. Indicates useful tips within procedures. 2.2 Safety information 2.2.1 Warnings Risk of injury from the supply of oxygen! Oxygen can become deposited in clothing, bed linen and hair. In conjunction with smoking, open flame and electrical equipment, it can cause fires and explosions. - Page 8 Safety Risk of injury from re-inhaling CO If the mask is used incorrectly, CO may be re-inhaled. The flow of air from the therapy device serves, among other things, to remove the exhaled air from the mask and tube. If the therapy device is not switched on, there is a risk of re-inhalation.
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Page 9: General Information
Safety 2.2.2 Cautions Risk of injury from oxygen therapy! Oxygen therapies can lead to side effects if incorrectly used/ metered. Only administer oxygen following prescription by a physician. Follow the instructions for use of the oxygen system and the therapy device. -
Page 10: Product Description
Product description • To prevent an infection, bacterial contamination or functional impairments, follow the instructions in the section entitled “Cleaning instructions” (see 5, p. 30). Inappropriate cleaning procedures, unsuitable cleaning agents and infrequent cleaning can result in an infection or bacterial contamination and can impede the functioning of the mask. - Page 11 Product description Designation Description The headgear is used to secure the mask on the head. Headgear for ® EasyFit SilkGel Full Face Mask The forehead cushion acts as a pillow between the forehead support and the head. It ensures that the Forehead cushion forehead support lies softly against the head and that little pressure is applied.
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Page 12: Compatible Devices
Product description Description Designation The mask cushion acts as a pillow between the mask frame and the face. It ensures that the mask frame Mask cushion lies softly against the face and that little pressure is applied. The tube anchoring strap is used to fix the device tube Tube anchoring to the side or the top of the headgear if you want to strap... -
Page 13: Exhalation System
Product description 3.3 Exhalation system The mask has an integrated exhalation system. The retaining ring 6 and mask frame 10 are shaped so that a gap forms between these parts. The exhaled air can escape through this gap. The specific geometry of the parts ensures that the rotating sleeve cannot seal this gap when it is pushed into place. -
Page 14: Anti-Asphyxia Valve
Product description 3.4 Anti-asphyxia valve The mask also has an anti-asphyxia valve 8. The antiasphyxia valve has an opening to the atmosphere through which you can inhale ambient air if the therapy device fails. As long as the therapy device is in operation, the membrane is forced against the opening by the air flow and seals it. -
Page 15: Ports For Pressure Measurement
Product description 3.5 Ports for pressure measurement The mask has two ports 5 which you can use for measuring pressure or for supplying oxygen. If you are not using the ports, seal them using the cap in order to achieve therapy pressure. ®... -
Page 16: Operation
Operation Operation 4.1 Apply mask 1. Unfasten the bottom headgear clip on the mask. 2. Pull headgear 1 over your head and place the mask on the face. 3. Attach headgear clip 11 to the mask. ® EasyFit SilkGel Full Face Mask... -
Page 17: Remove Mask
Operation 4. If the breathing tube is to be routed over the head: attach the tube to the headgear using tube anchoring strap 13. 4.2 Remove mask 1. Unfasten the bottom headgear clip 11 on the mask. 2. Disconnect mask tube from the ventilation tube of the therapy device. -
Page 18: Adjust Mask
Operation 4.3 Adjust mask 1. Keep the top tabs of coarse adjustment component 4 depressed. 2. Push fine adjustment component 3 into one of the three engaged positions. 3. If you need to adapt the height of forehead cushion 1: rotate fine adjustment component 3 through 180°. - Page 19 Operation 4. Keep the bottom tabs of coarse adjustment component 4 depressed. 5. Push coarse adjustment component 4 into one of the three engaged positions (marked 1, 2 and 3) of the mask frame. 6. Apply mask (see "4.1 Apply mask" page 16). 7.
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Page 20: Disassemble Mask
Operation The hook-and-loop tab on top of the head is easiest to adjust by loosening the tab, gently pulling on the ends of the headgear with both hands and pushing the tab back down firmly. 4.4 Disassemble mask 1. Unfasten the headgear clip 11 to remove headgear 1. 2. - Page 21 Operation 3. Keep the bottom tabs of coarse adjustment component 4 depressed and remove it. 4. Keep the top tabs of coarse adjustment component 4 depressed and remove fine adjustment component 3. ® EasyFit SilkGel Full Face Mask...
- Page 22 Operation 5. Remove forehead cushion 2 from fine adjustment component 3 6. Take mask cushion 12 off mask frame 10. ® EasyFit SilkGel Full Face Mask...
- Page 23 Operation 7. Turn retaining ring 6 counterclockwise and remove it. 8. Take off elbow 7 through retaining ring 6. 9. Take rotating sleeve 9 off elbow 7. ® EasyFit SilkGel Full Face Mask...
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Page 24: Assemble Mask
Operation 10. Remove anti-asphyxia valve 8 from the elbow. 4.5 Assemble mask 1. Press the rotating sleeve 9 onto elbow 7. 2. Press elbow 7 into the retaining ring 6 until you hear it click into place. ® EasyFit SilkGel Full Face Mask... - Page 25 Operation 3. Press anti-asphyxia valve 8 onto the elbow. 4. Push retaining ring 6 and elbow 7 onto the mask frame. 5. Turn retaining ring 6 clockwise to hear it click into place. ® EasyFit SilkGel Full Face Mask...
- Page 26 Operation 6. Attach mask cushion 12 to mask frame 10. The centering aid helps you position the mask frame correctly. 7. Hook in the forehead cushion 2 on one side of the fine adjustment component 3 and pull over the other side. ®...
- Page 27 Operation 8. Push fine adjustment component 3 into one of the three engaged positions. 9. Keep the bottom tabs of coarse adjustment component 4 depressed and push coarse adjustment component 4 into one of the three engaged positions (marked 1, 2 and 3) of the mask frame.
- Page 28 Operation 10. If necessary, push the cap onto the pressure measurement ports 5. 11. Attach headgear clips 11 to the mask. ® EasyFit SilkGel Full Face Mask...
- Page 29 Operation You can tell whether the headgear is correctly attached by the hook-and-loop tabs. The hook-and-loop tabs on the forehead are light blue, those on the cheek are dark blue. ® EasyFit SilkGel Full Face Mask...
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Page 30: Cleaning Instructions
Cleaning instructions Cleaning instructions Risk of injury if cleaning is inadequate! Residues may block the mask, impair the integrated exhalation system and jeopardize the success of therapy. For patients with a compromised immune system or particular background of illness, disinfect mask parts daily following consultation with the physician. - Page 31 Cleaning instructions Part Daily Weekly Wash mask parts with warm water using ® Palmolive Ultra Original dishwashing liquid soap or a comparable mild detergent. When washing mask parts (except for mask cushion and forehead cushion), clean thoroughly with a cloth or a soft brush. Wash headgear by hand.
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Page 32: Tips
Disposal 5.2 Tips • You can wash all parts (except anti-asphyxia valve and headgear) in a dishwasher at 149 °F (65 °C). • Wash headgear before first use, as the color may run. • Handle the coating on the mask cushion and forehead cushion with care. -
Page 33: Troubleshooting
Troubleshooting Troubleshooting Problem Cause Remedy Pain in face due Mask is too tight. Loosen headgear slightly. to pressure. Modify position of forehead support. Mask is too loose. Tighten headgear slightly. Modify position of forehead support. Dry eyes. Mask does not fit. Use a different mask size. -
Page 34: Item List
Item List Item List 8.1 Complete System All masks are supplied fully assembled. Headgear and instructions for use DV67487 are included. Size Article no. DV97418 DV97428 DV97438 8.2 Replacement Cushions Article Article no. Mask cushion Size S DV97452 Mask cushion Size M DV97453 Mask cushion Size L DV97454... -
Page 35: Parts And Accessories
Item List 8.4 Parts and Accessories Article Article no. Ball-and-socket joint set (consisting of DV15857 retaining ring, elbow and rotating sleeve) Rotating sleeve DV97288 Cap for pressure measurement ports DV97213 Forehead support (including coarse adjustment component and fine DV15856 adjustment component) Tube anchoring strap DV97274 Carrying bag... -
Page 36: Technical Data
Technical data Technical data 9.1 Specifications Dimensions c. 4.21“ x 6.29“ x 4.17“ (W x H x D) (c. 107 mm x 160 mm x 106 mm) Weight c. 3.6 oz (102 g) Therapy pressure range 4 cm H O - 30 cm H (4 hPa - 30 hPa) Tube connection: tapered connection male Ø... - Page 37 Technical data Quoted two-figure noise emission value to ISO 4871: 16.5 dB(A) - sound pressure level 24.5 dB(A) - sound power level 3 dB(A) - uncertainty factor Switching pressure for anti-asphyxia valve 1 cm H2O ( 1 hPa) open ...
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Page 38: Materials
Technical data 9.2 Materials Mask part Material Cap for pressure measurement ports Silicone Mask cushion, forehead cushion Silicone and silicone gel, silicone coating Mask frame, elbow Polycarbonate Retaining ring, anti-asphyxia valve Polypropylene, TPE Headgear clip Polyoxymethylene Forehead support, rotating sleeve Polyamide Headgear Lycra, polyester, polyurethane, UBL loop...