BMC REACTHEALTH NUMA User manual

NUMA Full Face Mask
User Manual
Components of the NUMA Full Face Mask
Components of the NUMA Full Face Mask
NUMA Full Face Mask
Thank you for choosing BMC’s NUMA Full Face Mask. The mask 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.
The Mask is Not made with natural rubber latex.
Intended Use
The NUMA 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 NUMA 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 reuse.
CAUTION: In the US, Federal law restricts the sale of this device to sale by or on
the order of a physician.
Before Using the Mask
WARNINGS
•The vent holes must be kept clear.
•Explanation of Warning: CPAP systems are intended for use with special
masks with connectors which have vent holes that allow a continuous flow of
air out of the mask. When the CPAP machine is on and operating properly, the
fresh air from the CPAP machine flushes the exhaled air out through the
attached mask exhalation port. However, when the CPAP machine is not
operating, the fresh air supplied through the mask is insufficient, and exhaled
air will be re-inhaled. Rebreathing of exhaled air for more than several minutes
may, 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 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,
unresponsive, or unable to remove the mask.
•Follow all precautions when using supplemental oxygen.
•Oxygen flow must be turned off when the PAP Device is in operation, so that
unused oxygen does not accumulate in the PAP Device enclosure and create
a fire hazard.
•At a fixed flow rate of supplemental oxygen, 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 it is compatible with the PAP Device. If it is used beyond technical
specifications or used with incompatible devices, the seal and comfort of the
mask may not be effective, and optimum therapy may not be achieved. Leak or
variation in the rate of leak, may affect the function of the PAP device.
•Stop using the NUMA 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 PAP Device manual for details on settings and operational
information.
•Images shown here are indicative only. If there is inconsistency between the
image and actual product, the actual product shall govern.
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
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 holes of the
mask and secure them.
Fold the lower straps to
make loops and fasten.
Place the mask on the face
and extend the upper part
of the headgear to the back
of the head. Please confirm
that the name on the back
of the headgear faces
outward when the headgear
is worn.
Pull the lower straps
forward beneath the ears
and insert them into the
fixed hooks on the lower
part of the mask frame.
4
5
6
Stretch the upper straps of
the headgear as shown in
the figure to secure the
mask.
Repeat the process for the
lower headgear as shown in
the figure to secure the
mask.
Power on the device and
start ventilation. Connect
the respiratory hose to the
swivel of the mask. Adjust
the mask to ensure a tight
seal.
Disassembling the Mask
Notes:
1. The elbow assembly cannot be disassembled from the frame assembly.
2. The elbow assembly cannot be disassembled.
3. The valve cannot be disassembled. Or it may cause damage, and its
installation would be difficult.
1
2
3
Remove the upper straps of
the headgear out of the holes
in the mask frame.
Remove the cushion from
the installation groove in
the mask frame.
Remove the forehead pad
from the installation groove
in the mask frame.
Frame assembly
Headgear
Valve
Elbow
Forehead pad
Cushion
Swivel
Elbow assembly
H
H (inch)
Size
3.15 ≤H ≤3.54
S
3.54 < H ≤3.94
M
3.94 < H ≤4.53
L

Cleaning the Mask
Notes:
•The mask and headgear can only be cleaned by hand washing.
•The elbow, the swivel and the valve cannot be disassembled 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 disassemblyinstructions.
•Thoroughly clean the separated mask components (excluding headgear) by
gently rubbing in warm (approx. 86°F / 30°C) water using mild unscented liquid
dish detergent (e.g., Alconox diluted at 1%) for up to 10 minutes.
•Use a soft bristle brush to clean the vent.
•Rinse all components well with drinking quality water and allow them to air dry
out of direct sunlight.
•When all components are dry, reassemble the mask according to the
reassembly instructions.
Weekly
Hand wash the headgear and all components in warm (approx. 86°F / 30°C), mild
unscented liquid dish detergent (e.g., Alconox diluted at 1%) for up to 10 minutes.
Rinse the components well with drinking quality water and allow them to air dry out
of direct sunlight before reassembling.
Reassembling the Mask
1
2
3
Install the forehead pad
into the upper-half
installation groove of the
mask frame.
Install the cushion into the
lower-half installation groove of
the mask frame and ensure the
cushion fits well into the groove.
Install the upper-half
headgear onto the upper-half
installation holes of the mask
frame.
Technical Specifications
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.
Technical Specifications
Pressure–Flow Curve
Pressure (cmH2O)
3
12
22
31
40
Flow Rate (L/min)
18
40
56
67
78
Dead Space
Information
Dead space is the empty volume of the mask up to the swivel.
The dead space of the mask varies with cushion size 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-atmosphere
pressure
1.0 cmH2O
The Non-Rebreathing
Valve
closed-to-atmosphere
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 an uncertainty of 3 dBA. The A-weighted
sound pressure level of the mask at a distance of 1 m is 20 dBA,
with an uncertainty of 3 dBA.
Environmental
Conditions
Operating temperature: +5°C ~ +40°C (41°F ~ 104°F)
Operating humidity: 10% ~ 93% relative humidity non-condensing
Storage and transport temperature: -20°C ~ +55°C (-4°F ~ 131°F)
Storage and transport humidity:
10% ~ 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.
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.
Batch code
Catalogue number
Temperature limit
Humidity limitation
Manufacturer
Authorized Representative in the European Community
Limited Warranty
The expected service life of NUMA Full Face Mask is one year.
For any questions or comments concerning this product, please contact:
Manufactured for:
REACT HEALTH
5101 Fruitville Rd., Suite 200
Sarasota, FL 34232
T: [phone]
For additional information, please visit our Patient Resources Page at:
www.reacthealth.com
Manufacturer:
BMC Medical Co., Ltd.
Room 901, Building 1, No.28 Pingguoyuan Road, Shijingshan, Beijing 100041, CHINA
URL: en.bmc-medical.com
E-mail: [e-mail]
Tel: [phone]
Fax: [phone] Ext. 810
Contract Manufacturer:
BMC (Tianjin) Medical Co., Ltd.
2/F North Area and 3/F, Building No.4, No.1 Xinxing Road, Wuqing District,
(301700) Tianjin, PEOPLE'S REPUBLIC OF CHINA
Tel: [phone]
BMC (Dongguan) Medical Co., Ltd.
3/F and 4/F, Building 3, No. 770 Xiecao Road, Xiegang Town, 523000 Dongguan,
Guangdong, PEOPLE'S REPUBLIC OF CHINA
V1.3
390824 Issue date: December 9, 2022
Flow Rate (L/min)
Mask Pressure (cmH2O)