DeVilbiss EasyFit Nasal Mask Silicone, EasyFit Nasal Mask Gel Instructions For Use Manual
EasyFit™ Nasal Mask
EasyFit Nasal Mask, Silicone
EasyFit Nasal Mask, Gel
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
Overview
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EasyFit Nasal Mask, Silicone
EasyFit Nasal Mask, Gel
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Note: The complete user information consists of this leaflet and the instructions for use.
DV67105 - 09.09
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Operation
DV67105 - 09.09
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1 Device Description
Legend
(Description of individual parts: see
enclosed leaflet)
1 Headgear
2 Forehead cushion
3 Fine adjustment component
4 Coarse adjustment component
5 Forehead support
6 Ports for pressure measurement
7 Oxygen port cap
8 Rotating sleeve
9 Elbow
10 Retaining ring
11 Mask frame
12 Mask cushion
13 Headgear clip
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
(> 66 pounds or 30 kg). The nasal mask is
offered in two versions:
EasyFit Nasal Mask, Silicone
EasyFit Nasal Mask, Gel
Before use by the patient
Patients must be instructed in the use of the
mask by qualified personnel before therapy
begins.
2 Safety instructions
Warnings and cautions
For your safety, please observe the following
points:
Warning
• Please read these instructions for use very
carefully. They are a part of the product
and should be available at all times.
• This mask should be used only with CPAP
or bi-level systems recommended by your
physician or respiratory therapist.
• If oxygen is used with the CPAP or bi-level
system, the oxygen flow must be turned off
when the CPAP or bi-level machine is not
operating.
Explanation of the warning: When the
CPAP or bi-level device is not in
operation, and the oxygen flow is left on,
oxygen delivered into the CPAP tubing
may accumulate within the CPAP or bilevel machine enclosure. Oxygen
accumulated in the CPAP or bi-level
machine enclosure will create a risk of
fire. This warning applies to most types of
CPAP or bi-level systems.
• The mask is designed for therapy pressure
between 4 and 30 cm H
2
O. The nasal
mask must not be used at higher or lower
therapy pressures.
• Patients with limited spontaneous
respiration must be monitored at all times.
The appropriate negative pressure/leak
alarm on the ventilation device must be
activated.
• Patients with obstructive and restrictive lung
diseases should be examined on an individual basis during use of the mask, for example with regard to re-inhalation of CO
2
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• The mask is equipped with an integral
exhalation valve. Do not connect any
additional exhalation valves as desired
therapy pressure may not be reached.
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• Do not put the nasal mask over your face
for a prolonged period unless the therapy
device is connected to the mask and
switched on. The flow of air from the
therapy device serves among other things
to remove the exhaled air from the mask
and hose. If the therapy device is not
switched on, there is a risk of re-inhalation
when you breathe through your nose. In
some circumstances this may lead to
suffocation.
• Do not close the openings in this mask
except in situations described in these
instructions for use. Otherwise there is a risk
of re-inhaling CO
2
and suffocation.
• The connection to the device’s hose system
must be airtight and should not be allowed
to loosen due to therapy pressure.
• Do not use a breathing hose that is
electrically conductive.
• Clean the mask as described under Section 4
“Cleaning Instructions.” 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.
Caution
• At low CPAP pressures the flow through the
exhalation slots may be inadequate to
clear all exhaled gas from the tubing.
Some re-inhalation may occur.
• If supplemental oxygen is used, the inhaled
oxygen concentration will vary, depending
on the pressure settings, patient breathing
pattern, mask selection and the leak rate.
• Malfunctions and a lack of biocompatibility
may result if third-party articles are used.
Bear in mind that in these cases any
warranty entitlement and liability shall lapse
if the accessories recommended in the
instructions for use or original spare parts
are not utilized.
Side effects
The following side effects may occur during
short-term or long-term use: nasal congestion,
dry nose, dry mouth in the morning, sinus
pressure, irritation of the conjunctiva as well as
irritating noises during exhalation.
Wearing the mask can also lead to tenderness
of the face or reddening of the skin.
3Operation
Fig. C-G: see enclosed leaflet.
3.1 Adjust forehead support (Fig. C)
Fine adjustment
Squeeze the upper side tabs of the coarse
adjustment component inwards. Place the fine
adjustment component in one of the stop
positions shown.
The height of the forehead cushion can be
adjusted (approx. 1 cm). To do this, turn the
fine adjustment component through 180° and
position it as described above.
Coarse adjustment
Squeeze the lower side tabs of the coarse
adjustment component inwards. Place it in one
of the slots in the mask frame.
3.2 Putting on the mask (Fig. B)
1. Unhook one of the lower headgear clips
on the mask.
2. Guide the headgear over your head and
hook the headgear clip back onto the
mask.
3. Adjust the upper and lower straps of the
headgear so that the mask sits firmly, but
not too tightly, on your face.
The headgear provides the following
options for you to do this (see also
"Overview" on the attached leaflet):
– coarse adjustments: slot "
a" or "b" of the
headgear.
– fine adjustments: four hook-and-loop
straps.
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