BMC iVolve F1A User manual

English
iVolve F1A Full Face Mask
User Manual
0123

iVolve F1A Full Face Mask User Manual V2.0
English
Table of Contents
iVolve F1A Full Face Mask............................................................1
Intended Use.................................................................................1
Before Using the Mask..................................................................2
Components of the iVolve F1A 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.......................................................................................12
Limited Warranty.........................................................................13

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iVolve F1A Full Face Mask
Thank you for choosing BMC’s iVolve F1A Full Face Mask
(BMC-FM1A). 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 iVolve F1A 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 iVolve F1A 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
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

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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 iVolve F1A 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 iVolve F1A Full Face Mask
Components of the iVolve F1A Full Face Mask

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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
1
2
3
Attach the upper
headgear straps by
threading them through
the upper hooks of the
headgear frame, and
fold the lower headgear
straps as shown in the
picture.
Pull the upper straps
over your head and
hold the mask against
your face.
Bring the lower straps
below your ears, and loop
them into the lower hooks
on the headgear frame.
4
5
6
Adjust the upper
headgear straps evenly
until they are
comfortable.
Adjust the lower
headgear straps evenly
until they are
comfortable.
Connect the air tubing to
the swivel. Then turn on
the device and adjust the
mask to the right position
without air leakage.

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Disassembling the Mask
1
2
3
Detach the air tubing.
Detach the headgear
straps by unthreading the
upper and lower straps
from the hooks of the
headgear frame.
Remove the elbow
assembly from the
cushion frame, and then
pulling away the
headgear frame.
4
Remove the thin pad
and cushion from the
cushion frame, and
detach the cushion from
the thin pad.

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Cleaning the Mask at Home
Notes:
The mask and headgear can only be cleaned through hand
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
To optimize the mask seal, facial oils should be removed from the
cushion before use.
Handwash the mask by gently rubbing in warm (30°C) water using
mild soap or diluted dishwashing detergent.
If the pick-off port cover requires cleaning, use a soft bristle brush.
Rinse all components well with drinking quality water and allow
them to air dry out of direct sunlight.
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.

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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
Fit the cushion into the
thin pad to form a
cushion assembly.
Lock the cushion
assembly securely into
the cushion frame.
Gently push the headgear
frame onto the cushion
frame.
4
5
Insert the elbow
assembly to the
cushion frame.
Attach the headgear
straps to the frame as
shown above.

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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.
Thin pad is misplaced on
the cushion frame.
Check insertion of the thin
pad and reinsert correctly
according to the instructions
in “Reassembling the Mask”
section.
Mask’s thin pad is
misaligned or creased
on the face.
Make sure the thin pad is
properly aligned according to
the instructions in
“Reassembling the Mask”
section. Make sure the thin
pad has no creases. Check
the cushion and thin pad,
and reposition the mask over
your face.
Mask’s cushion and thin
pad may be dirty.
Clean the cushion and thin
pad according to instructions
in “Cleaning the Mask at
Home”section.
Mask is too noisy.
Mask is assembled
incorrectly.
Reassemble the mask.
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
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 246 ml.
Therapy Pressure
4 to 30 cmH2O
Resistance
Drop in Pressure measured (average for 3 sizes)
at 50 L/min: 0.1 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 0.6 cmH2O per L/S.
The expiratory resistance of the mask (in combination
with the Non-Rebreathing Valve) is 1.7 cmH2O per L/S.
The Non-Rebreathing
Valve
open-to-atmosphere
pressure
0.9 cmH2O
The Non-Rebreathing
Valve
closed-to-atmosphere
pressure
1.0 cmH2O
Sound
DECLARED DUAL-NUMBER NOISE EMISSION
VALUES in accordance with ISO 4871. The A-weighted
sound power level of the mask is 30 dBA, with uncertainty
3 dBA. The A-weighted sound pressure level of the mask
at a distance of 1 m is 22 dBA, with uncertainty 3 dBA.
Flow Rate（L/min）
Mask Pressure (cmH2O)
Mask

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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 iVolve F1A mask does not contain any hazardous substances
and may be disposed of with your normal household refuse.
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
Not made with natural rubber latex
Temperature limitation
Humidity limitation

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Limited Warranty
It is warranted that the iVolve F1A Full Face Mask, including its
components, frame, cushion, headgear 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.
The expected service life of iVolve F1A 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: October 17, 2016