DeVilbiss EasyFit SilkGel User manual

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

Table of Contents
2EN EasyFit®SilkGel Full Face Mask
DV67487b 06/2014
Table of Contents
1 Introduction 4
1.1 Intended use ........................................................................ 4
1.2 Contraindications ................................................................. 5
1.3 Side effects ........................................................................... 5
1.4 Duty to provide instruction .................................................... 5
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 system ............................................................... 13
3.4 Anti-asphyxia valve ............................................................. 14
3.5 Ports for pressure measurement .......................................... 15
4 Operation 16
4.1 Apply mask ........................................................................ 16
4.2 Remove mask ..................................................................... 17
4.3 Adjust mask ....................................................................... 18
4.4 Disassemble mask .............................................................. 20
4.5 Assemble mask .................................................................. 24

Table of Contents
EasyFit®SilkGel Full Face Mask EN 3
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5 Cleaning instructions 30
5.1 Clean mask ........................................................................ 30
5.2 Tips .................................................................................... 32
5.3 Change of patient .............................................................. 32
6 Disposal 32
7 Troubleshooting 33
8 Item List 34
8.1 Complete System ................................................................ 34
8.2 Replacement Cushions ....................................................... 34
8.3 Replacement Headgear ...................................................... 34
8.4 Parts and Accessories ......................................................... 35
8.5 Instructions ........................................................................ 35
9 Technical data 36
9.1 Specifications ..................................................................... 36
9.2 Materials ............................................................................ 38
9.3 Characteristic pressure/flow curve ....................................... 38

Introduction
4EN EasyFit®SilkGel Full Face Mask
DV67487b 06/2014
1 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 long-
standing experience and knowledge in the field. DeVilbiss accepts
no liability in the following circumstances:
• Failure to comply with these instructions for use
• Use other than the intended use
• Independently implemented alterations
• Technical alterations
1.1 Intended use
The EasyFit®SilkGel Full Face Mask is intended for adult patients
(>66 pounds or 30kg) prescribed continuous positive airway
pressure (CPAP) or bi-level therapy for multiple patient use in a
hospital or clinic environment after high-level disinfection and for
single-patient use in a home environment.

Introduction
EasyFit®SilkGel Full Face Mask EN 5
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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.
You should also observe the contraindications in the instructions for
use for your therapy device.
If you experience any of these symptoms, consult your doctor.
1.3 Side effects
The following side effects may occur during short-term or long-
term use: Blocked nose, dry nose, dry mouth in the morning, feeling
of pressure in the sinuses, irritated mucous membrane, skin rashes,
pressure points in the face, irritating noises when breathing.
If you experience any of these symptoms, consult your doctor.
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
6EN EasyFit®SilkGel Full Face Mask
DV67487b 06/2014
2 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.
Safety instructions consist of:
• The warning symbol (pictogram)
• A word to indicate the level of a hazard
• Information about the hazard and
• Instructions on how to avoid the hazard.
There are three levels of warning instruction, depending on the
degree of hazard.
Indicates an unusually great hazard. If you do not
follow this instruction, severe irreversible injuries
or death will result.
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.

Safety
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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.
Do not smoke.
Avoid open flame.
Do not use electrically-conductive tubes (exception: heated
breathing tubes).
Indicates material hazards. If you do not follow
this instruction, material damage may result.
Indicates useful tips within procedures.

Safety
8EN EasyFit®SilkGel Full Face Mask
DV67487b 06/2014
Risk of injury from re-inhaling CO2!
If the mask is used incorrectly, CO2may 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. In some circumstances,
this may lead to suffocation.
Do not seal the openings of the mask.
Only put mask on for a prolonged period if the therapy device
is running.
Use the mask only within the quoted therapy pressure range.
• The mask should not be worn if the anti-asphyxia valve is
damaged or missing. This valve ensures that CO2 rebreathing is
kept to a minimum in the event of power failure.
• The mask should not be warn by patients who are unable to
remove the mask or are prone to vomiting. Wearing the mask
under these conditions creates the risk of suffocation.
• This CPAP mask should be used only with CPAP systems
recommended by your physician or respiratory therapist.
• If oxygen is used with the CPAP system, the oxygen flow must
be turned off when the CPAP machine is not operating.
Explanation of the warning:
When the CPAP device is not in operation and the oxygen flow
is left on, oxygen delivered into the ventilator tubing may
accumulate within the CPAP machine enclosure. Oxygen
accumulated in the CPAP machine enclosure will create a risk of
fire. This warning applies to most types of CPAP systems.

Safety
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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.
Risk of injury from mask slipping!
If the mask slips or falls off, therapy is ineffective.
Monitor patients with restricted ability to 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-party items are used, functional failures and restricted
fitness for use may result. Biocompatibility requirements may
also not be met. Please note that in these cases, any claim under
warranty and liability will be void if neither the accessories nor
genuine replacement parts recommended in the instructions for
use are used.
• The mask parts filled with gel are sensitive components. Handle
them with care to prevent deformations and damage.

Product description
10 EN EasyFit®SilkGel Full Face Mask
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• 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.
3 Product description
3.1 Overview
1
2
3
4
5
6
7
9
10
11
12
13
8

Product description
EasyFit®SilkGel Full Face Mask EN 11
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No. Designation Description
1
Headgear for
EasyFit®SilkGel
Full Face Mask
The headgear is used to secure the mask on the head.
2Forehead cushion
The forehead cushion acts as a pillow between the
forehead support and the head. It ensures that the
forehead support lies softly against the head and that
little pressure is applied.
3Fine adjustment
component
Fine adjustment component enables you to modify
the distance between the forehead cushion and the
forehead.
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 measurement tube or oxygen supply can
be connected. Close the ports if they are not being
used.
6Retaining ring The retaining ring keeps the elbow in position.
7Elbow The elbow with ball joint can be rotated up to 360°.
8Anti-asphyxia
valve
The anti-asphyxia valve has an opening to the
atmosphere through which you can inhale ambient
air if the therapy device fails.
9Rotating sleeve
The rotating sleeve connects the mask tube to the
elbow so that it can be rotated. The mask tube can be
disconnected from the elbow at the rotating sleeve
for cleaning.
10 Mask frame Basic frame of the mask.
11 Headgear clips The headgear clips connect the mask to the headgear

Product description
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3.2 Compatible devices
• You can use the mask with all therapy devices which are for the
non-life-support treatment of patients with sleep apnea or
respiratory insufficiency.
• With many combinations of device, the actual pressure in the
mask will not correspond to the prescribed therapy pressure,
even if the therapy device is displaying the correct pressure.
Have the device combination adjusted by a 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 soon as you remove the
mask or it slips out of position.
12 Mask cushion
The mask cushion acts as a pillow between the mask
frame and the face. It ensures that the mask frame
lies softly against the face and that little pressure is
applied.
13 Tube anchoring
strap
The tube anchoring strap is used to fix the device tube
to the side or the top of the headgear if you want to
keep the device tube in over-head position.
No. Designation Description

Product description
EasyFit®SilkGel Full Face Mask EN 13
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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. Never close the gap. This will
ensure that no CO2builds up in the mask.
6
10

Product description
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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. If the therapy device fails, the opening is free
so that ambient air flows into the mask.
8

Product description
EasyFit®SilkGel Full Face Mask EN 15
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3.5 Ports for pressure measurement
The mask has two ports 5which 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.
5
cap

Operation
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4Operation
4.1 Apply mask
1. Unfasten the bottom headgear clip on the mask.
2. Pull headgear 1over your head and place the mask on the face.
3. Attach headgear clip 11 to the mask.
1
11

Operation
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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.
3. Remove mask from your head.
13
11

Operation
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4.3 Adjust mask
1. Keep the top tabs of coarse adjustment component 4
depressed.
2. Push fine adjustment component 3into one of the three
engaged positions.
3. If you need to adapt the height of forehead cushion 1: rotate
fine adjustment component 3through 180°.
4
3

Operation
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4. Keep the bottom tabs of coarse adjustment component 4
depressed.
5. Push coarse adjustment component 4into 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. Adjust headgear 1with the aid of the hook-and-loop tabs so
that the mask seals on the face but is not too tight.
4
1

Operation
20 EN EasyFit®SilkGel Full Face Mask
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4.4 Disassemble mask
1. Unfasten the headgear clip 11 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 the ends of
the headgear with both hands and pushing the tab back
down firmly.
11
cap
5