BMC iVolve N2 User manual

English
iVolve N2 Nasal Mask
User Manual
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iVolve N2 Nasal Mask User Manual V2.0
English
Table of Contents
iVolve N2 Nasal Mask ......................................................................1
Intended Use....................................................................................1
Before Using the Mask.....................................................................2
Parts of the Mask .............................................................................3
Fitting the Mask................................................................................4
Disassembling the Mask ..................................................................5
Getting the Right Cushion Size........................................................5
Cleaning the Mask in the Home.......................................................6
Reprocessing the Mask between Patients.......................................7
Reassembling the Mask...................................................................8
Troubleshooting................................................................................9
Technical Specifications .................................................................10
Storage...........................................................................................11
Disposal..........................................................................................11
Symbols..........................................................................................11
Limited Warranty............................................................................12

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English
iVolve N2 Nasal Mask
Thank you for choosing BMC’s iVolve N2 Nasal Mask (BMC-NM2).
The Nasal 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 guide provides you with the
information you need for the correct use of your mask.
Intended Use
The iVolve N2 channels airflow noninvasively to a patient from a
positive airway pressure device such as a continuous positive
airway pressure (CPAP) or Bi-level system.
The iVolve N2 is:
•To be used by adult patients (> 30 kg) for whom positive airway
pressure 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.
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
clinician to check if they are compatible with the flow generator.
If used outside specification or if 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 flow generator function.
Stop using the iVolve N2 if you have ANY adverse reaction to
the use of the mask, and consult your physician or sleep
therapist.
Refer to your flow generator manual for details on settings and
operational information.

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Parts of the Mask
Construction of the iVolve N2 Nasal Mask

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Fitting the Mask
1
2
3
Attach the headgear
straps by threading
them through the
gaps of forehead
frame and clips.
Hold the mask over
your nose and pull
the headgear over
your head.
Bringing the lower
straps below your
ears, connect the
clips to the main
frame.
4
5
6
Adjust the headgear
straps evenly until
they are comfortable
and firm, and reattach
the mask.
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.
Connect the main air
tubing to the swivel
directly. Then connect
the free end of the air
tubing to your flow
generator and turn
the flow generator on.

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Disassembling the Mask
1
2
3
Detach the air tubing.
Unclip the clips and
unthread the upper
headgear straps. It is
not necessary to
remove the clips from
the headgear.
Remove the forehead
pads from the
forehead frame.
Remove the cushion
assembly from the
mask frame.
Getting the Right Cushion Size
The following drawings are the different features of face. The
length of the nose is “N1”, and the width of the nose is “N2”.
There are masks in three different sizes provided for
comfortable therapy. “S”, “M”and “L”represent Small, middle
and large, respectively.
The mask cushion is designed shaping with men’s nose, when
the dimensions of patient’s nose are equal with the mask, the
mask will fit the nose at the most fit place. Otherwise, he should
choose another size.
Choose the smallest size mask cushion that is wide enough to
extend beyond the nostrils but does not obstruct breathing.

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Dimensions of Face and the Mask
Cleaning the Mask in the Home
Notes:
The mask and headgear can only be cleaned by handwashing.
The headgear may be washed without removing the clips.
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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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.
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.

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Reassembling the Mask
1
2
3
Insert the cushion
onto the mask frame.
Ensure that the bulge
on the main frame
embeds into the
notch on the cushion.
Insert the forehead
pad into the main
frame to the
desirable position.
Attach the headgear
straps by threading
them through the gaps
of forehead frame and
clips.

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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”. Check
headgear is not
over-tightened. Revolve the
main frame to find a
suitable position.
Mask is wrong size.
Talk to your clinician.
Thin pad is misplaced
on cushion frame.
Check insertion of thin pad
and reinsert correctly
according to the
instructions in
“Reassembling the Mask”.
Mask thin pad is
misaligned or creased
on face.
Ensure thin pad is properly
aligned according to the
instructions in
“Reassembling the Mask”.
Make sure the thin pad has
no creases in it: undo clips,
check cushion and thin pad
and reposition the mask
over your nose.
Mask cushion and thin
pad may be dirty.
Clean cushion and thin pad
according to instructions in
“Cleaning the Mask in the
Home”.
Mask is too
noisy.
Mask is assembled
incorrectly.
Reassemble mask.
Vents are blocked or
partially blocked.
Clean vents according to
instructions in “Cleaning the
Mask in the Home”.

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Technical Specifications
Pressure–Flow
Curve
0
20
40
60
80
4 8 12 16 20 25 30
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 135 mL.
Therapy
Pressure
4 to 30 hPa.
Resistance
Drop in Pressure measured (average for 3
sizes)
at 50 L/min: 0.2 hPa
at 100 L/min:0.5 hPa
Sound
DECLARED DUAL-NUMBER NOISE
EMISSION VALUES in accordance with ISO
4871. The A-weighted sound power level of
the mask is 32 dBA, with uncertainty 3 dBA.
The A-weighted sound pressure level of the
mask at a distance of 1m is 24 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 (hPa)

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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 N2 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 iVolve N2 Nasal 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.
The expected service life of iVolve N2 Nasal 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
Eiffestraβe 80, 20537 Hamburg, Germany
Tel:
0049-40-2513175
Fax:
0049-40-255726
Issue date: September 18, 2016

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iVolve N2 Nazal Maskesi
Kullanım Kılavuzu
0123

iVolve N2 Nazal Maskesi Kullanım Kılavuzu V2.0
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İçindekiler
iVolve N2 Nazal Maskesi..................................................................1
Kullanım Amacı ................................................................................1
Maskesini Kullanmadan Ö nce..........................................................2
Maske Parçaları ...............................................................................3
Maskenin takılması...........................................................................4
Maskenin sökülmesi.........................................................................5
Uygun Boyutulu Minder seçin ..........................................................6
Ġçmekanda maske temizlenmesi......................................................7
Maskenin hastalar arasında yeniden iĢlem görmesi ........................8
Maskenin tekrar takılması ................................................................8
Sorun Giderme.................................................................................9
Teknik Ö zellikler .............................................................................10
Depolama.......................................................................................11
Bertaraf edilmesi ............................................................................11
Semboller.......................................................................................11
Sınırlı Garanti .................................................................................12

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iVolve N2 Nazal Maskesi
BMC'nin iVolve N2 Nazal Maskesini (BMC-NM2) seçtiğiniz için
teĢekkür ederiz.
Nazal Maskesi, rahat, esnek ve sessizdir. Ciltinizle temasını en aza
indirerek tasarlanmıĢtır, bu nedenle tedavi sırasında size rahat
verecektir. Bu kullanım kılavuzu maskenin doğru kullanımı için
gereken bilgileri size sunmaktadır.
Kullanım Amacı
iVolve N2, Sürekli pozitif havayolu basıncı (CPAP) veya Bi-level
sistemi gibi pozitif hava yolu basıncı cihazdan bir hastaya hava
akımını noninvazif olarak yollıyor.
iVolve N2 ise:
●Pozitif havayolu basıncı reçete edilmiĢ yetiĢkin hastalarda
(> 30 kg) kullanılmak üzere.
●Ev ortamında tek hastada yeniden kullanım ve hastane /
kurumsal ortamında çok hastada yeniden kullanım için
tasarlanmıĢtır.
DİKKAT: Federal yasa, bu cihazın bir doktor tarafından satın
alınması veya sipariş verilmesi sınırlandırmaktadır.

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Maskesini Kullanmadan Ö nce
UYARILAR
Havalandırma delikleri açık tutulmalıdır.
Tamamlayıcı oksijen kullanırken tüm uyarılara uyun.
AkıĢ jeneratör çalıĢmazken, oksijen akıĢı kapalı olmalıdır,
böylece kullanılmayan oksijen akıĢı jeneratör muhafaza içinde
birikir ve yangın riski yaratmaz.
Tamamlayıcı oksijen akıĢı sabit bir akıĢ hızında, inhale oksijen
konsantrasyonu basınç ayarları, hasta solunum Ģekli, maske,
uygulama noktası ve kaçak oranınına bağlı olarak değiĢir.
Maskenin teknik özellikleri ise onların akım jeneratör ile uyumlu
olup olmadığını kontrol etmek için Klinisyene sunulmaktadır.
Belirtimi dıĢında veya uyumsuz cihazlarla birlikte
kullanıldığında, maskenin mühürü ve konforü etkili olmayabilir,
optimum tedavi elde edilemez, ve sızıntı, veya sızıntının
oranındaki değiĢimi akıĢ jeneratör fonksiyonunu etkileyebilir.
Maske kullanımı sürecinde her türlü bir olumsuz reaksiyon
yaĢarsanız, iVolve N2 kullanmayı durdurun ve doktorunuza
veya uyku terapista danıĢın.
Ayarlar ve operasyonel bilgileri ile ilgili ayrıntılar için akıĢ
jeneratör kılavuzuna baĢvurun.

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Maske Parçaları
iVolve N2 Nazal Maske yapısı