BMC Fealite User manual

English
Fealite Nasal Pillows System
User Manual
0123

Fealite Nasal Pillows System User Manual V1.8
English
Table of Contents
Fealite Nasal Pillows System·························································1
Intended Use··················································································1
Medical Information········································································1
Parts of the Fealite·········································································3
Fitting the Fealite············································································5
Using Tube Retainer (Optional)······················································7
Removing the Fealite ·····································································7
Disassembling for Cleaning ···························································8
Cleaning the Fealite in the Home···················································9
Reassembling the Fealite·····························································10
Disposal························································································ 11
Technical Specifications······························································· 11
Symbols························································································12
Limited Warranty··········································································13

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FealiteNasal Pillows System
Thank you for choosing BMC’s Fealite Nasal Pillows System.
The nasal pillows system is light, flexible and quiet. It is designed to
minimize contact with your face, thus ensuring that you feel
comfortable during therapy. This user guide provides you with the
information you need for the correct use of your system.
Intended Use
The Fealite is intended for single patient reuse by adult patients
(> 30 kg) prescribed continuous positive airway pressure or
Bi-level therapy for use in home, hospitals or clinics.
CAUTION: Federal law restricts the sale of this device to sale by or
on the order of a physician.
Medical Information
Note: The Fealite does not contain latex, PVC, or DEHP materials.
If you have ANY reaction to any part of the system, discontinue use
and consult your sleep therapist.
WARNING and CAUTION
This system should be used only with flow generators (CPAP
or Bi-level) recommended by your physician or respiratory
therapist. It should not be used unless the flow generator is
turned on and operating properly. The vent holes should never
be blocked.
Explanation of the Warning:Flow generators are intended to

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be used with special interfaces with connectors which have
vent holes (vent holes are located on the elbow) or separate
exhalation devices to allow continuous flow of air out of the
interface. When the flow generator is turned on and functioning
properly, new air from the flow generator will flush the exhaled
air out through the attached exhalation port. However, when
the flow generator is not operating (eg, power failure), not
enough fresh air will be provided through the system, and
exhaled air may be re-breathed. In this situation, remove the
Fealite immediately.
The exhaust vent flow is lower at lower system pressure (see
section “Technical Specifications” for Pressure-Flow Curve
details). If the system pressure during expiration is too low,
there may not be enough exhaust vent flow to completely flush
the air delivery hose of exhaled air before the start of the next
inspiration.
Discontinue using the Fealite if you frequently experience nasal
irritation, and consult your physician.
If oxygen is used with the flow generator, the oxygen flow must
be turned off when the flow generator is not operating.
Explanation of the Warning: When the flow generator is not in
operation, and the oxygen flow is left on, oxygen delivered into
the ventilator tubing may accumulate within the flow generator
enclosure. Oxygen accumulated in the flow generator
enclosure will create a risk of fire. This warning applies to most
types of flow generators.
Please refrain from smoking while oxygen is in use.
Note: At a fixed flow rate of supplemental oxygen flow, the inhaled
oxygen concentration will vary, depending on the pressure settings,
patient breathing pattern, interface selection and the leak rate.

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Parts of the Fealite

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Figure 1 Construction of the Fealite
Tube Retainer
Strap
Swivel
Short Tube
Clip
Frame
Left Panel
Nasal Pillows
Elbow
Clamp
Soft Sleeve
(Optional parts)
Right Panel

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Fitting the Fealite
1
2
3
Thread the two straps
through the gaps in
panels separately,
then fold back over to
secure.
Put the headgear on
your head and Insert
the nasal pillows into
your nostrils. Make
sure the top strap
passes over the top of
your head.
Gently tighten the top
strap (overtighting
may cause excess
pressure on your
nose).
4
5
6
Adjust each end of
the back strap
(overtighting may
cause excess
pressure on upper
lips).
Alternate the
adjustment of
headgear straps until
they rest comfortably
and rotate nasal
pillows assembly to
adjust nasal pillows
angle to ensure them
sit comfortably inside
your nostrils.
Connect one end of
the main air tubing to
your flow generator
and the other end to
the swivel. Turn your
flow generator on.

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Take time to adjust
the headgear straps,
angle of the pillow
assembly and position
of the short tube
assembly to achieve a
secure and
comfortable fit.
Note: Refer to your flow generator manual for details on setting
and operational information.
If you feel air leak, readjust the angle of the nasal pillows to get a
better seal. If you are unable to resolve any leaks, you may need
an alternative nasal pillows size.

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Using Tube Retainer (Optional)
Wrap tube retainer
over the short tube.
Make sure smooth
surface sits outside.
Thread one end of the
tube retainer into the
gap of the other end.
Attach both ends of
the tube retainer onto
the top strap.
Removing the Fealite
To remove the Fealite, pull the nasal pillows assembly away from
your nose and lift the headgear off your head. You do not need to
loosen the headgear straps.

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Disassembling for Cleaning
Disconnect the flow
generator tubing. Hold
the swivel and pull it
away from the flow
generator tubing.
Detach the short tube
assembly. To do this,
hold the elbow and
pull it away from the
frame.
Remove clip from
frame.
Disassemble the
nasal pillows
assembly. To do this,
detach the clip and
peel the nasal pillows
off the frame.
Note: The short tube assembly cannot be taken apart.
CAUTION
Do not pull on the short tube or the flow generator tubing as
they may get damaged.
To disassemble the Fealite for daily cleaning, follow steps 1-3.
To disassemble the Fealite for weekly cleaning, follow steps 1-5.

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Cleaning the Fealite in the Home
Notes:
Wash your hands before cleaning the mask.
Wash the headgear before first time use, as the dye may run. It
is important to always handwash the headgear.
Daily
Handwash the nasal pillows assembly, short tube assembly and
cap in warm (approx. 30°C), soapy water for one minute. Use pure
soap. Rinse the components well with drinking quality water and
allow to air dry out of direct sunlight and heat.
Note: Ensure that the vent holes are not blocked. Use a soft
bristle brush to clean the vent.
Weekly
Handwash the headgear and all components in warm, (approx.
30°C) and soapy water. Use pure soap. Rinse the components well
and allow them to air dry out of direct sunlight.
CAUTION
Do not use solutions containing bleach, chlorine, alcohol,
aromatics, moisturizers, antibacterial agents, or scented oils to
clean any part of the system or air tubing. These solutions may
cause damage and reduce the life of the product.
Exposing any part of the system or tubing to direct sunlight or
heat may cause deterioration.
If any visible deterioration of a component is apparent (cracking,
crazing, tears etc.), the component should be discarded and
replaced.

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Reassembling the Fealite
1
2
3
Wrap the nasal
pillows around the
frame in the correct
position. Make sure
the nasal pillows are
pointing upwards.
Insert the nasal
pillows edges into the
groove of the frame.
Make sure assemble
it in the right side, or it
cannot be attached
tightly to the frame.
Hold the clip and align
the circle in its middle
with the one on the
frame. Gently push the
clip onto the frame to
secure the nasal
pillows in place.
4
5
6
Attach the short tube
assembly to the
nasal pillows
assembly. To do
this, push the elbow
into the seal ring
until it clicks into
place.
Thread both ends of
two straps through the
gaps in the panels.
Make sure rough
surface of straps sits
outside.
S
lip the headgear on
your head and adjust
the position.

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Disposal
The Fealite Nasal Pillows System does not contain any hazardous
substances and may be disposed of with your normal household
refuse.
Technical Specifications
Pressure
Flow Curve
Dead Space
Information Dead space is the empty volume of the nasal pillows
and short tube assembly up to the swivel.
The dead
space of the Fealite for all nasal pillows sizes is 96 mL.
Therapy
Pressure
4 to 20 hPa.
Resistance Drop in pressure measured (average for three nasal
pillows sizes) at 50 L/min: 1.0 hPa at 100 L/min: 3.1 hPa.
Sound DECLARED DUAL-
NUMBER NOISE EMISSION
VALUES in
accordance with ISO 4871. The
A-weighted sound power level of the mask is 26 dBA,
with uncertainty 3 dBA. The A-
weighted sound
pressure level of the mask at a distance of 1m is 18
dBA, with uncertainty 3 dBA.
Environmental
Conditions Operating temperature: +5°C to +40°C
Operating humidity: 0% ~
93% relative humidity
non-condensing.
Storage and transport: -20°C to +55°C
Storage and transport humidity: 0% ~
93% relative
humidity non-condensing.

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Symbols
System and Packaging
Caution, consult accompanying documents
Lot number
Does not contain latex
Temperature limitation
Humidity limitation
User Guide
Indicates a Warning or Caution and alerts you to a possible
injury or explains special measures for the safe and effective
use of the device.

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Limited Warranty
It is warranted that Fealite Nasal Pillows System, including its
components, frame, nasal pillows, headgear, tubing and other
accessories shall be free from defects in material and workmanship
for a period of ninety (90) days from the date of purchase by the
initial consumer.
To exercise the rights under this warranty, contact the local
authorized dealers.
MANUFACTURER:
BMC MEDICAL CO., LTD.
Room 110 Tower A Fengyu Building, No. 115 Fucheng Road,
Haidian, 100036 Beijing, PEOPLE’S REPUBLIC OF CHINA
Tel:
[phone]
Fax:
[phone] Ext. 810
EU AUTHORISED REPRESENTATIVE:
Shanghai International Holding Corp. GmbH
Eiffestrasse 80, 20537 Hamburg, Germany
Tel:
0049-40-2513175
Fax:
0049-40-255726
Issue date: August 19, 2015