Related Manuals for DeVilbiss Healthcare EasyFit SilkGel
Summary of Contents for DeVilbiss Healthcare EasyFit SilkGel
- Page 1 ® EasyFit SilkGel ® EasyFit SilkGel Nasal 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 ................ 5 Contraindications ..............5 Side effects ................5 Duty to provide instruction ............ 6 Safety Warnings in this document ........... 6 Safety information ..............7 General information ............. 9 Product description Overview ................ - Page 3 Table of Contents Cleaning instructions Clean mask ................ 28 Tips ..................30 Change of patient .............. 30 Disposal Troubleshooting Item List Complete System ..............32 Replacement Cushions ............32 Replacement Headgear ............32 Parts and Accessories ............33 Instructions ................ 33 Technical data Specifications ..............
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Page 4: Introduction
Introduction Introduction These instructions for use ensure that the mask is used safely and effectively. These instructions must be stored in an easily accessible place at all times. They must be read and understood prior to use. Liability limitations 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 longstanding experience and knowledge in the field. -
Page 5: Intended Use
Introduction 1.1 Intended use The Nasal Mask is intended for prescription use to be used during nasal CPAP or Bi-Level Positive Pressure therapy for adult patients (>30kg). 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: Duty To Provide Instruction
Safety 1.4 Duty to provide instruction Ensure that your doctor or home healthcare medical equipment provider instructs you in the use of the mask before beginning therapy. 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. -
Page 7: Safety Information
Safety Indicates an unusually great hazard. If you do not follow this instruction, severe irreversible or fatal injuries may result. Indicates a hazard. If you do not follow this instruction, mild or moderate injuries may result. Indicates material hazards. If you do not follow this instruction, material damage may result. - 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. 28). 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 Headgear for ® head. EasyFit SilkGel The forehead cushion acts as a pillow between the forehead support and the head. It ensures Forehead cushion that the 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 cushion mask frame lies softly against the face and that little pressure is applied. The tube anchoring strap is used to fix the device tube to the side or the top of the Tube anchoring strap headgear if you want to keep the device tube in... -
Page 13: Exhalation System
Product description 3.3 Exhalation system The mask has an integrated exhalation system. The retaining ring 6 and mask frame 9 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: Ports For Pressure Measurement
Product description 3.4 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 15: 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 10 to the mask. ® EasyFit SilkGel... -
Page 16: 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 12. 4.2 Remove mask 1. Unfasten the bottom headgear clip 10 on the mask. 2. Disconnect mask tube from the ventilation tube of the therapy device. -
Page 17: 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 18 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 15). 7.
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Page 19: 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 10 to remove headgear 1. 2. - Page 20 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...
- Page 21 Operation 5. Remove forehead cushion 2 from fine adjustment component 3 6. Take mask cushion 11 off mask frame 9. ® EasyFit SilkGel...
- Page 22 Operation 7. Turn retaining ring 6 counterclockwise and remove it. 8. Take off elbow 7 through retaining ring 6. 9. Take rotating sleeve 8 off elbow 7. ® EasyFit SilkGel...
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Page 23: Assemble Mask
Operation 4.5 Assemble mask 1. Press the rotating sleeve 8 onto elbow 7. 2. Press elbow 7 into the retaining ring 6 until you hear it click into place. 3. Push retaining ring 6 and elbow 7 onto the mask frame. 4. - Page 24 Operation 5. Attach mask cushion 11 to mask frame 9. The centering aid helps you position the mask frame correctly. 6. Hook in the forehead cushion 2 on one side of the fine adjustment component 3 and pull over the other side. ®...
- Page 25 Operation 7. Push fine adjustment component 3 into one of the three engaged positions. 8. 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 26 Operation 9. If necessary, push the cap onto the pressure measurement ports 5. 10. Attach headgear clips 10 to the mask. ® EasyFit SilkGel...
- Page 27 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...
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Page 28: 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 29 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 30: Tips
Disposal 5.2 Tips • You can wash all parts (except 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 31: 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 32: Item List
Item List Item List 8.1 Complete System All masks are supplied fully assembled. Headgear and instructions for use DV67485 are included. Size Article no. DV97318 DV97328 DV97338 8.2 Replacement Cushions Article Article no. Mask cushion Size S DV97352 Mask cushion Size M DV97353 Mask cushion Size L DV97354... -
Page 33: Parts And Accessories
Item List 8.4 Parts and Accessories Article Article no. Ball-and-socket joint set (consisting of DV15858 retaining ring, elbow and rotating sleeve) Rotating sleeve DV97288 Cap for pressure measurement ports DV97308 Forehead support (including coarse adjustment component and fine DV15856 adjustment component) Tube anchoring strap DV97213 Carrying bag... -
Page 34: Technical Data
Technical data Technical data 9.1 Specifications Dimensions c. 3.15“ x 5.11“ x 3.54“ (W x H x D) (c. 80 mm x 130 mm x 90 mm) Weight c. 3 oz (85 g) Therapy pressure range 4 cm H O - 30cm H (4 hPa - 30hPa) Tube connection: tapered connection male Ø... -
Page 35: Materials
Technical data Depending on size and variant The materials of the mask will age if they are exposed to aggressive detergents, for example. In individual cases, therefore, it may be necessary to replace mask parts sooner. The right to make design modifications is reserved. 9.2 Materials Mask part Material... -
Page 36: Characteristic Pressure/Flow Curve
Technical data 9.3 Characteristic pressure/flow curve The characteristic pressure/flow curve shows outlet flow rate as a function of therapy pressure. Outlet pressure at therapy device (cm H O/hPa) ® EasyFit SilkGel...
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