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Technical data

EasyFit

SilkGel

DV6

7485

b 0

014

The right to make design modifications is reserved.

9.2 Materials

All parts of the mask are free from PVC. This device is not made
with natural rubber latex.

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.

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

Polypropylene, TPE

Headgear clip, rip-cord clip

Polyoxymethylene

Forehead support, rotating sleeve

Polyamide

Headgear

Lycra, polyester, polyurethane, UBL loop

Содержание EasyFit SilkGel

Страница 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...

Страница 2: ...o provide instruction 6 2 Safety 6 2 1 Warnings in this document 6 2 2 Safety information 7 2 3 General information 9 3 Product description 10 3 1 Overview 10 3 2 Compatible devices 12 3 3 Exhalation...

Страница 3: ...s 30 5 3 Change of patient 30 6 Disposal 30 7 Troubleshooting 31 8 Item List 32 8 1 Complete System 32 8 2 Replacement Cushions 32 8 3 Replacement Headgear 32 8 4 Parts and Accessories 33 8 5 Instruct...

Страница 4: ...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...

Страница 5: ...ty deformities of the face or nasopharynx ingestion of drugs which may induce vomiting the necessity for immediate intubation You should also observe the contraindications in the instructions for use...

Страница 6: ...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 Safety instructions consist...

Страница 7: ...nd explosions Do not smoke Avoid open flame Do not use electrically conductive tubes exception heated breathing tubes Indicates an unusually great hazard If you do not follow this instruction severe i...

Страница 8: ...the mask only within the quoted therapy pressure range Do not use mask on patients who cannot take off the mask independently or who tend to vomit This CPAP mask should be used only with CPAP systems...

Страница 9: ...breathe spontaneously Activate low pressure leakage alarms on therapy device Subject patients with obstructive and restrictive lung diseases to individual monitoring 2 3 General information If third p...

Страница 10: ...nts 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...

Страница 11: ...ead 4 Coarse adjustment component Coarse adjustment component enables you to modify the distance between the cushion and the forehead 5 Ports for pressure measurement with port cap A pressure measurem...

Страница 12: ...physician or provider so that the actual pressure in the mask corresponds to therapy pressure If your ventilation device has leakage or low pressure alarms set these so that an alarm is triggered as s...

Страница 13: ...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...

Страница 14: ...DV67485b 06 2014 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...

Страница 15: ...it SilkGel EN 15 DV67485b 06 2014 4 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 t...

Страница 16: ...ube 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 venti...

Страница 17: ...just 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 cushio...

Страница 18: ...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 Adjust headgear 1 with t...

Страница 19: ...adgear clip 10 to remove headgear 1 2 If necessary remove the cap for pressure measurement ports 5 The hook and loop tab on top of the head is easiest to adjust by loosening the tab gently pulling on...

Страница 20: ...syFit SilkGel DV67485b 06 2014 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...

Страница 21: ...Operation EasyFit SilkGel EN 21 DV67485b 06 2014 5 Remove forehead cushion 2 from fine adjustment component 3 6 Take mask cushion 11 off mask frame 9 2 3 11 9...

Страница 22: ...Operation 22 EN EasyFit SilkGel DV67485b 06 2014 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 6 6 8 7...

Страница 23: ...emble 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 Turn retain...

Страница 24: ...7485b 06 2014 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...

Страница 25: ...h 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 eng...

Страница 26: ...Operation 26 EN EasyFit SilkGel DV67485b 06 2014 9 If necessary push the cap onto the pressure measurement ports 5 10 Attach headgear clips 10 to the mask cap 5 10...

Страница 27: ...EasyFit SilkGel EN 27 DV67485b 06 2014 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 d...

Страница 28: ...xhalation 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 phys...

Страница 29: ...y Wash mask parts with warm water using Palmolive Ultra Original dishwashing liquid soap or a comparable mild detergent X When washing mask parts except for mask cushion and forehead cushion clean tho...

Страница 30: ...r suitable gloves e g disposable gloves during the cleaning procedure 5 3 Change of patient This mask system is approved for multiple patient use in a hospital or clinic environment such as sleep labo...

Страница 31: ...headgear slightly Modify position of forehead support Mask does not fit Use a different mask size Contact your equipment provider Therapy pressure is not reached Mask not adjusted correctly Readjust...

Страница 32: ...ions for use DV67485 are included 8 2 Replacement Cushions 8 3 Replacement Headgear Size Article no S DV97318 M DV97328 L DV97338 Article Article no Mask cushion Size S DV97352 Mask cushion Size M DV9...

Страница 33: ...elbow and rotating sleeve DV15858 Rotating sleeve DV97288 Cap for pressure measurement ports DV97308 Forehead support including coarse adjustment component and fine adjustment component DV15856 Tube...

Страница 34: ...ISO 5356 1 male 0 87 22 mm Pressure measurement ports 0 16 4 mm Temperature range Operation Storage 41 F to 104 F 5 C to 40 C 4 F to 158 F 20 C to 70 C Dead space Size S Size M Size L 80 ml 4 88 in 10...

Страница 35: ...age if they are exposed to aggressive detergents for example In individual cases therefore it may be necessary to replace mask parts sooner Mask part Material Cap for pressure measurement ports Silico...

Страница 36: ...pressure flow curve The characteristic pressure flow curve shows outlet flow rate as a function of therapy pressure Outlet pressure at therapy device cm H2O hPa Mean leakage flow rate l min 60 30 40...

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