BMC REACTHEALTH Siesta User manual

Siesta Nasal Mask
User Manual
Components of the Mask
Components of the Siesta Nasal Mask
Siesta Nasal Mask
Thank you for choosing REACT HEALTH’s Siesta Nasal Mask.
The Siesta Nasal 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 Siesta Nasal Mask channels airflow non-invasively to the patient
from a positive airway pressure device such as a continuous positive
airway pressure (CPAP) or bi-level system.
The Siesta Nasal 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 by or
on the order of a physician.
Before Using the Mask
WARNINGS
•The vent holes must be kept clear.
•This mask should only be used with CPAP or bi-level devices
recommended by a physician or respiratory therapist.
•The mask should not be used unless the device is turned on. Once
the mask is fitted, ensure the device is blowing air.
Explanation: CPAP and bi-level devices are intended to be used
with special masks (or connectors) which have vent holes to allow
continuous flow of air out of the mask. When the device is turned on
and functioning properly, new air from the device flushes the
exhaled air out through the mask vent holes. However, when the
device is not operating, insufficient fresh air will be provided through
the mask, and the exhaled air may be rebreathed. Rebreathing of
exhaled air for longer than several minutes can, in some
circumstances, lead to suffocation. This applies to most models of
CPAP or bi-level devices.
•This mask is made with silicone parts. Please do not use if the
patient is allergic or sensitive to silicone.
•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 CPAP or bi-level device is
not in operation, so that unused oxygen does not accumulate in the
device enclosure and create a fire hazard.
•Oxygen supports combustion. Oxygen must not be used while
smoking or in the presence of an open flame. Only use oxygen in
well ventilated rooms.
•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 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, and
optimum therapy may not be achieved. Leak or variation in the rate
of leak, may affect the function of the CPAP or bi-level device.
•Stop using the Siesta Nasal Mask and consult your physician or
sleep therapist, if you have ANY adverse reaction to the use of the
mask.
•Refer to your CPAP or bi-level device manual for details on settings
and operational information.
•Remove all packaging before using the mask.
•Images shown here are indicative only. If there is inconsistency
between the image and actual product, the actual product shall
govern.
Fitting the Mask
1
2
3
Attach the headgear
straps by threading them
through the slots in
forehead frame and clips.
Hold the mask over your
nose and pull the
headgear over your head.
Bringing the lower
headgear straps below
your ears, connect the
clips to the Frame
assembly.
4
5
6
Adjust the upper headgear
straps evenly until they are
comfortable and secure,
and reattach the mask.
Adjust the lower headgear
straps evenly until they are
comfortable and secure,
and reattach the mask.
Mask is worn as shown.
Disassembling the Mask
1
2
3
Undo and remove the
upper headgear straps out
of the slots in the Frame.
Remove the Cushion
assembly from the Frame
assembly.
Remove the Short
tube from the Frame
assembly.
Cleaning the Mask
Notes:
•The mask and headgear can only be cleaned by washing by hand.
•The headgear may be washed without removing the clips.
•When washing the mask, the Elbow and the Frame cannot be
disassembled from the Frame assembly.
CAUTIONS
•Always follow cleaning instructions and 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, otherwise may damage the mask.
•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.
Headgear
Cushion assembly
Clips
Short tube
Swivel
Frame assembly
Soft sleeves
Elbow
Connector
Frame

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 water (approx. 86°F / 30°C)
using mild, unscented liquid dish detergent 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 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 Short tube onto
the Frame assembly and
confirm that the Swivel is
securely attached.
Install the Cushion
assembly onto the
Frame assembly and
confirm that the
Cushion assembly is
securely attached.
Install the upper-half of
the headgear onto the
upper slot of the Frame
assembly.
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.
Mask size is wrong.
Consult your clinician.
Mask is not tightened
correctly.
Tighten both upper and lower
headgear straps.
Cushion is misaligned or
creased on face.
Ensure cushion is properly
aligned according to the
instructions in “Reassembling
the Mask”. Make sure
cushion has no creases in it.
Mask cushion may be
dirty.
Clean cushion according to
instructions in “Cleaning the
Mask”.
Mask is too noisy.
Mask is assembled
incorrectly.
Reassemble mask.
Vents are blocked or
partially blocked.
Clean the vents according to
instructions in “Cleaning the
Mask”.
Technical Specifications
Pressure–Flow
Curve
Pressure (cmH2O)
4
9
15
20
25
Flow Rate (L/min)
19
30
39
46
52
Dead Space
Information
Dead space is the empty volume of the mask up to the
elbow. The dead space of the mask varies with cushion size
but is less than 105 mL.
Therapy
Pressure
4 to 25 cmH2O
Resistance
Drop in Pressure measured (average for 3 sizes)
at 50 L/min: 0.2 cmH2O
at 100 L/min: 0.8 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 Siesta Nasal 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 Siesta Nasal 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
V1.2
391100 Issue date: December 9, 2022