BMC F2 User manual

English
F2 Full Face Mask
User Manual
0123

F2 Full Face Mask User Manual V2.1
English
Table of Contents
F2 Full Face Mask.......................................................................... 1
Intended Use.................................................................................. 1
Before Using the Mask.................................................................... 2
Components of the F2 Full Face Mask............................................ 4
Getting the Right Cushion Size ....................................................... 5
Fitting the Mask .............................................................................. 6
Disassembling the Mask................................................................. 7
Cleaning the Mask at Home............................................................ 8
Reprocessing the Mask between Patients....................................... 9
Reassembling the Mask.................................................................. 9
Troubleshooting............................................................................ 10
Technical Specifications.................................................................11
Storage......................................................................................... 12
Disposal ....................................................................................... 12
Symbols ....................................................................................... 13
Limited Warranty........................................................................... 14

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F2 Full Face Mask
Thank you for choosing BMC’s F2 Full Face Mask (BMC-FM2). The
mask is comfortable, flexible and quiet. It is designed to minimize
contact with your face, thus ensuring that you feel comfortable during
therapy. This user manual provides you with the information you
need for the correct use of your mask.
Intended Use
The F2 Full Face Mask channels airflow non-invasively to a patient
from a positive airway pressure device such as a continuous positive
airway pressure (CPAP) or bi-level system.
The F2 Full Face Mask is:
•to be used by adult patients (> 66 lb / 30 kg) for whom positive
airway pressure therapy has been prescribed.
•intended for single-patient re-use in the home environment and
multi-patient re-use in the hospital / institutional environment.
CAUTION: In the US, Federal law restricts the sale of this device to
sale by or on the order of a physician.

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Before Using the Mask
WARNINGS
The vent holes must be kept clear.
Explanation of Warning: CPAP systems are intended to be
used with special masks with connectors which have vent holes
to allow continuous flow of air out of the mask. When the CPAP
machine is turned on and functioning properly, new air from the
CPAP machine flushes the exhaled air out through the attached
mask exhalation port. However, when the CPAP machine is not
operating, enough fresh air will not be provided through the
mask, and exhaled air will be rebreathed. Rebreathing of
exhaled air for longer than several minutes can, in some
circumstances, lead to suffocation. This warning applies to
most models of CPAP systems.
At low CPAP pressures the flow through the exhaled port may
be inadequate to clear all exhaled gas from the tube. Some
rebreathing may occur.
To minimize the risk of vomiting during sleep, the patient should
avoid eating or drinking for three hours before using the mask.
This mask is not recommended if the patient is taking a
prescription drug that may cause vomiting.
Do not use the mask without the Non-Rebreathing Valve in
place.
This mask should not be used on patients who are
uncooperative, obtunded, unresponsive, or unable to remove
the mask.
Follow all precautions when using supplemental oxygen.
Oxygen flow must be turned off when the flow generator is not
operating, so that unused oxygen does not accumulate within
the flow generator enclosure and create a risk of fire.
At a fixed flow rate of supplemental oxygen flow, the inhaled

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oxygen concentration varies, depending on the pressure
settings, patient breathing pattern, mask, point of application
and leak rate.
The technical specifications of the mask are provided for your
clinician to check if it is compatible with the flow generator. If it
is used beyond technical specifications or used with
incompatible devices, the seal and comfort of the mask may not
be effective, optimum therapy may not be achieved, and leak,
or variation in the rate of leak, may affect the function of the
flow generator.
Stop using the F2 Full Face Mask and consult your physician or
sleep therapist, if you have ANY adverse reaction to the use of
the mask.
Refer to your flow generator manual for details on settings and
operational information.

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Components of the F2 Full Face Mask
Components of the F2 Full Face Mask
Cushion
Forehead pad
Frame assembly
Headgear
Elbow assembly
Elbow
Valve
Swivel

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Getting the Right Cushion Size
The following drawing describes the different features of face
and the length of the face (H) you need to measure.
The masks are available in three different sizes.
Choose the appropriate size according to the table below.
Getting the Right Cushion Size
H
H (mm)
Size
80 ≤H ≤90
S
90 < H ≤100
M
100 < H ≤115
L

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Fitting the Mask
Use a standard conical connector if pressure readings and / or
supplemental oxygen are required.
1
2
3
Pass the upper straps
of the headgear
through the installation
hole of the mask as
shown in the figure
and secure it, repeat
the process with the
lower straps.
Place the mask on the
face and extend the
headgear to the back
of the head / Please
confirm that the label
on the back of the
headgear faces
outward when the
headgear is worn.
Bring the lower-half
straps beneath the
ear and encircle the
face and then insert it
into the fixed hook on
the lower-half part of
the mask frame.
4
5
6
Extend the upper-half
straps of the headgear
as shown in the above
figure until the mask is
fixed properly.
Repeat the process for
the lower-half
headgear as shown in
the above figure until
the mask is fixed
properly.
Open the device for
the air supply. Attach
the respiratory hose
with the connector on
the base of the mask.
Adjust the position of
the mask to confirm a
tight seal.

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Disassembling the Mask
Notes:
1. The elbow assembly cannot be dissembled from the frame
assembly.
2. The elbow assembly cannot be disintegrated.
3. The valve cannot be dissembled, or damage may be incurred
and the re-installation will become more difficult.
1
2
3
Undo and remove the
upper-half headgear
straps out of the hole
on the mask frame.
Remove the cushion
from the installation
groove on the mask
frame.
Remove the forehead
pad from the installation
groove on the mask
frame.

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Cleaning the Mask at Home
Notes:
The mask and headgear can only be cleaned through hand
washing.
The elbow, the swivel and the valve cannot be dissembled for
washing.
CAUTIONS
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.
Daily / After Each Use
Disassemble the mask components according to the
disassembly instructions.
Thoroughly clean the separated mask components (excluding
headgear), by gently rubbing in warm (approx. 30°C) water
using mild soap.
Use a soft bristle brush to clean the vent.
Rinse all components well with drinking quality water and allow
to air dry out of direct sunlight.
When all components are dry, reassemble according to th e
reassembly ins t ruc t ions.

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Weekly
Hand wash 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.
Reprocessing the Mask between Patients
This mask should be reprocessed when used between patients.
Cleaning and disinfection instructions are available from the BMC
website, www.bmc-medical.com. If you do not have internet access,
please contact your BMC representative.
Reassembling the Mask
1
2
3
Install the forehead
padonto the
upper-half installation
groove of the mask
frame.
Install the cushion
onto the lower-half
installation groove of
the mask frame and
confirm the proper
engagement
between the silicone
gel pad and the
installation groove.
Install the upper-half
headgear onto the
upper-half installation
hole of the mask frame.

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Troubleshooting
Problem
Possible Reason
Possible Solution
Mask won’t seal
properly or is
uncomfortable.
Mask may have been
fitted incorrectly.
Carefully follow
instructions in “Fitting the
Mask”section. Make sure
the headgear is not
over-tightened.
Mask size is wrong.
Consult your clinician.
Mask leaks around
the face.
The cushion is
misplaced on the
cushion frame.
Check insertion of the
cushion and reinsert
correctly according to the
instructions in
“Reassembling the Mask”
section.
Mask is too noisy.
Mask size is wrong.
Consult your clinician.
Vents are blocked or
partially blocked.
Clean the vents according
to the instructions in
“Cleaning the Mask at
Home” section.

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Technical Specifications
Pressure–Flow
Curve
Pressure
(cmH2O)
3
4
8
10
12
16
20
25
30
35
40
Flow Rate
(L/min)
18
22
32
36
40
47
53
60
65
71
78
Dead Space
Information
Dead space is the empty volume of the mask up to the
swivel.
The dead space of the mask varies according to cushion
sizes but is less than 218 mL.
Therapy
Pressure
3 to 40 cmH2O
Resistance
Drop in Pressure measured (average for 3 sizes)
at 50 L/min: 0.15 cmH2O
at 100 L/min: 0.5 cmH2O
Inspiratory and
Expiratory
Resistance
The inspiratory resistance of the mask (in combination
with the Non-Rebreathing Valve) is 1.8 cmH2O at 50
L/min.
The expiratory resistance of the mask (in combination with
the Non-Rebreathing Valve) is 2.0 cmH2O at 50 L/min.
The
Non-Rebreathing
Valve
open-to-atmosp
here pressure
1.0 cmH2O
Flow Rate (L/min)
Mask Pressure (cmH2O)
Mask

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The
Non-Rebreathing
Valve
closed-to-atmosp
here pressure
1.2 cmH2O
Sound
DECLARED DUAL-NUMBER NOISE EMISSION VALUES
in accordance with ISO 4871. The A-weighted sound
power level of the mask is 28 dBA, with uncertainty 3 dBA.
The A-weighted sound pressure level of the mask at a
distance of 1 m is 20 dBA, with uncertainty 3 dBA.
Environmental
Conditions
Operating temperature: +5°C to +40°C (41°F to 104°F)
Operating humidity: 0% ～93% relative humidity
non-condensing
Storage and transport: -20°C to +55°C (-4°F to 131°F)
Storage and transport humidity: 0% ～93% relative
humidity non-condensing
Storage
Ensure that the mask is thoroughly clean and dry before storing it for
any length of time. Store the mask in a dry place out of direct
sunlight.
Disposal
The mask does not contain any hazardous substances and may be
disposed of with your normal household refuse.

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Symbols
System and Packaging
Caution, consult accompanying documents.
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.
Lot number
Catalog number
Not made with natural rubber latex
Temperature limitation
Humidity limitation
Manufacturer
Authorized Representative in the European
Community

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Limited Warranty
It is warranted that the F2 Full Face Mask, including Frame assembly,
Cushion, Forehead pad, Headgear 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.
The expected service life of F2 Full Face Mask is one year.
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 (Europe)
Eiffestraβe 80, 20537 Hamburg, Germany
Tel
:
0049-40-2513175
Fax
:
0049-40-255726
Issue date: March 15, 2017