BMC iVolve BMC-FM User manual

English
iVolve Full Face Mask
User Manual
0123

iVolve Full Face Mask User Manual V1.3
English
Table of Contents
iVolve Full Face Mask ...................................................................1
Intended Use.................................................................................1
Before Using the Mask..................................................................2
Parts of the iVolve Full Face Mask................................................4
Getting the Right Cushion Size.....................................................5
Fitting the Mask.............................................................................6
Adjusting the Forehead Pad..........................................................8
Disassembling the Mask ...............................................................9
Cleaning the Mask at Home........................................................10
Disinfecting the Mask between Patients .....................................11
Reassembling the Mask..............................................................11
Troubleshooting...........................................................................13
Technical Specifications ..............................................................14
Storage........................................................................................15
Disposal.......................................................................................15
Symbols.......................................................................................15
Limited Warranty.........................................................................16

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iVolve Full Face Mask
Thank you for choosing BMC’s iVolve Full Face Mask (BMC-FM).
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 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 Full Face Mask is:
•to be used by adult patients (> 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: 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 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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Parts of the iVolve Full Face Mask
Parts of the iVolve 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 for comfortable
therapy.
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
Hold the mask over
your face to find
whether the angle of
the forehead frame is
appropriate to you. Go
to Step 4 if your answer
is “Yes.”
Adjust the forehead pad
by pressing or pulling
out the bulges on the
forehead pad to an
appropriate level. Go to
Step 4 if it is OK.
Refer to “Adjusting the
Forehead Pad” section to
adjust the forehead pad.
Repeat previous steps.
Three levels marked as
“1,” “2,” “3” are available.
4
5 6
Attach the headgear
straps by threading
them through the gaps
of the forehead frame
and clips.
Hold the mask over
your face and pull the
headgear straps over
your head.
Place the lower straps
below your ears, and
connect the clips to the
main frame.
a b

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7
8
9
Adjust the headgear
straps in the same way
until they are
comfortable and firm,
and reattach the iVolve
Full Face Mask.
Connect the main air
tubing to the swivel
directly or through the
optional vice-swivel for
the convenience of
detachment. Then
connect the free end of
the air tubing to your
flow generator and turn
the flow generator on.
Adjust the main frame until
the mask is evenly
positioned on your face. It
should be comfortable,
with an effective seal.
Adjust the headgear straps
if necessary.

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Adjusting the Forehead Pad
1 2
As the figure shows, the main frame has 3
positions for fitting different people’s faces. Position
“2” is the default position. You can do as described
in Step 1 of “Fitting the Mask” section to find if the
default position is appropriate to you.
Adjust the forehead pad by
pressing or pulling out the
bulges on the forehead
pad to an appropriate
level. Go to Step 4 of
“Fitting the Mask” section,
if it is OK.
3 4 5
Pull out the elbow and
forehead frame to
make sure the main
frame can be separated
from cushion frame.
Separate the main
frame and revolve the
main frame to another
position.
Insert the forehead frame
to the set position, and
insert the elbow to
assemble the mask.
Repeat steps 2 ～5 of
this section until the mask
fits best.
“2”
“1”
“3”
a b
3 2 1

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Disassembling the Mask
1 2 3
Detach the air tubing or
the optional vice-swivel.
Unclip the clips and
unthread the upper
headgear straps. It is not
necessary to remove the
clips from the headgear.
Pull the forehead frame
out of the main frame.
4
5
6
Remove the forehead
pad from the forehead
frame.
Remove the elbow
assembly from the mask
frame. The main frame
will be apart.
Remove the thin pad and
cushion from the cushion
frame.

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Cleaning the Mask at Home
Notes:
The mask and headgear can only be cleaned through hand
washing.
The headgear may be washed without removing the clips.
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. Do not soak the mask.
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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Disinfecting the Mask between Patients
The iVolve mask should be disinfected when used between
patients. Detailed disinfection instructions are available in the
Disinfection Instructions, and must be consulted before
multi-patient use.
Reassembling the Mask
1
2
3
Align the cushion with
the thin pad. Cover the cushion with the thin pad. Make sure
that the directions of thin
pad and cushion are
aligned.
Gently push the main
frame onto the cushion
frame. Make sure the set
position is comfortable
and convenient for you
and the mask is firmly
sealed.
4
5
6
Attach the elbow
assembly to the mask
assembly. To do this,
push the elbow into the
seal ring until it clicks
into place.
Insert the forehead pad
into the forehead frame
to the desirable position.
Insert the forehead frame
into the selected position
of the main frame.

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7
8
A
ttach the headgear
straps by threading
them through the gaps
of the forehead frame
and clips.
Connect the main air
tubing to the swivel
directly or through the
optional vice-
swivel for
the convenience of
detachment.

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Troubleshooting
Problem Possible reason Possible solution
Mask won’t seal
properly or is
uncomfortable.
Mask may have been
fitted incorrectly or is
incorrectly adjusted.
Carefully follow instructions
in “Fitting the Mask” section.
Make sure the headgear is
not over-tightened. Adjust
the main frame to find a
suitable position.
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. Undo
clips, 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 1.2 cmH2O per L/S.
The expiratory resistance of the mask (in combination with the
Non-Rebreathing Valve) is 1.4 cmH2O per L/S.
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.
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
Flow Rate（L/min）
Mask Pressure (cmH2O)

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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 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
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 the iVolve Full Face Mask, including its
components, frame, cushion, 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 (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
Tel
:
0049-40-2513175
Fax
:
0049-40-255726
Issue date: July 1, 2015