BMC 3B Rio II User manual

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Reassembly
RiorM ll Nasal Pillows lnterface
Thank you for choosing the RiorM ll Nasal Pillows lnterface-
The RiorM ll Nasal Pillows Interface is light, flexible and quiet. lt 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 system.
lntended Use
The RiorM ll is intended for adult patients (> 30 kg) prescribed continuous positive
airway pressure or Bi-level therapy, and it is intend for single patient reuse in the
home environment.
CAUTION: Federal law restricls /he sa/e of this device to sale by or on the order of
a physician.
Medical lnformation
Note: The RlorM // does not contain latex, PVC, or DEHP materials. lf you have
ANY reaction to any paft of the inteiace, discontinue use and consult your sleep
therapist.
zt\ wnmtNc and cAUTtoN
. This interface should be used only with flow generators (CPAP or Bi-level)
recommended by your physician or respiratory therapist. lt should not be used
unless the flow generator is turned on and operating properly. The vent holes
should never be blocked.
. Explanation of the Warning: Flow generators are intended to be used with
special interfaces with connectors which have vent holes (vent holes are
located on the elbow) or separate exhalation devices to allow continuous flow
of air out of the interface. When the flow generator is turned on and functioning
properly, new air from the flow generator wili flush the exhaled air out through
the attached exhalation port. However, when the flow generator is not
operating (ie, power failure), not enough fresh air will be provided through the
interface, and exhaled air may be re-breathed. ln this situation, remove the
RiorM ll immediately.
. The exhaust vent flow is lower at lower interface pressure (see section
"Technical Specifications" for Pressure-Flow Curve details). lf the interface
pressure during expiration is too low, there may not be enough exhaust vent
flow to completely flush the air delivery hose of exhaled air before the start of
the next inspiration.
. Discontinue using the interface if you frequently experience nasal irritation,
and consult your physician.
. lf oxygen is used with the flow generator, the oxygen flow must be turned off
when the flow generator is not operating. Explanation of the Warning: When
the flow generator is not in operation, and the oxygen flow is left on, oxygen
delivered into the ventilator tubing may accumulate within the flow generator
enclosure. Oxygen accumulated in the flow generator enclosure will create a
risk of fire. This warning applies to most types of flow generators.
. Please refrain from smoking while oxygen is in use.
. lmages shown here are indicative only. lf there is inconsistency between the
image and actual product, the actual product shall govern.
Note: At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen
concentration will vary, depending on the pressure seftings, patient breathing
pattern, interface selection and the leak rate.
2
RiorM Momponents 3
2
3
1 Headgear
Panel
Clip
Frame
Swivel
Fitting
Soft sleeves
Elbow
Short tube
4
6
8
7
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User Manual I

Nasal Pillows Size
You can choose the appropriate nasal pillows from "S", "M" and "L" sizes
depending on individual dimensions.
Size Ll (mm) L2 (mm)
S 22.1 5.1
IV 24.2
L27.6 6.8
Fitting
1. Thread the two side straps of the headgear through the gaps in panels
separately, then fold back over lo secure.
2. Put the headgear over your head by holding the back strap and stretching it around
the back of your head. The top strap should sit comfortably on top of your head.
3. Adjust each end ofthe side strap evenly until the interface sits comfortablyjust
under the nose. Reattach the fastening tabs.
4. Move the interface away from your face then place it back to get a comfortable
fit. Ensure the nasal pillows fit securely into your nostrils with both pillows
positioned upright.
5. Finally connect the end of the interface tubing into your device air tubing. Your
interface is now fitted and ready to use.
,Votes.' Refer fo your flow generator manual for details on setting and operational
information.
Three nasal pillows slzes (5, M, L) are available, hold the pillows on your nostils
ensuring that the Pillows size (ie, M) correctly fits for you.
lf you feel air leak, readjust the angle of the nasal pillows to get a better seal. lf you
are unable to resolve any leaks, you may need an alternative nasal pillows size.
Removal
To remove the interface, pull the nasal pillows assembly awayfrom your nose and
lift the headgear off your head. You do not need to loosen the headgear straps.
Disassembly
1. Holding the short tube on the interface, squeeze and pull the nasal pillows
away from the clip in the interface frame.
2. Remove the headgear from the interface.
IVotes.'
. The shoti tube assembly cannot be taken apaft.
. Do not pull on the shotl tube or the flow generator tubing as they may get
damaged.
Reassembly
1. Attach the nasal pillows to the clip in the interface frame. Make sure the Nasal
pillows triangular opening and the frame platform opening is to point down.
2. The Nasal pillows is in the correct position. Make sure the frame and Nasal
pillows will fit tightly together without any gaps.
3. Thread the two side straps of the headgear through the gaps in panels
separately, then fold back over to secure.
Cleaning the RiorM ll in the Home
,Votes.'
. Wash your hands before cleaning the inteiace.
. Wash the headgear before first time use, as fhe dye may run. lt is important to
always hand wash the headgear.
Daily / After Each Use
. Disassemble the interface components according to the disassembly instructions.
o Thoroughly clean the separated interface components (excluding headgear),
by gently rubbing in warm (approx. 30'C) water using mild liquid detergent for
10 min.
. Use a soft bristle brush to clean the vent.
o Rinse all components except the Left and Right Panel well with drinking
quality water and allow to air dry out of direct sunlight.
. When all components are dry, reassemble according to the reassembly
inslructions.
Weekly
Hand wash the headgear and all components in warm, (approx. 30"C) water and
mild liquid detergent (e.9., Alconox diluted at '1%) for up to '10 minutes. Rinse the
components well and allow them to air dry out of direct sunlight.
GAUTIONS
Always follow cleaning instructions and do not use solutions containing bleach,
chlonne, alcohol, aromatics, moisturizers, antibacterial agents, or scented oils to
clean any component of the interface or air tubing, they may damage the interface.
Exposing any component of the interface or tubing to direct sunlight or heat
may cause deterioration.
lf any visible deterioration of a component is apparent (cracking, crazing, tears
etc), the component should be discarded and replaced.
Additional Information
,Vote.'
For additional instruction, please visit our website at www.3Bproducts.com. An
instructional video is available for viewing under the RiorM ll tab.
Storage
Ensure that the interface is thoroughly clean and before storing it for any length of
time. Store the interface in a dry place out of direct sunlight.
Note:
The RiorM ll Nasal Pillows lnteface is not made with natural rubber latex.
Disposal
The RiorM ll Nasal Pillows lnterface does not contain any hazardous substances
and may be disposed of with your normal house hold refuse.
Technical Specifications
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Pressure Flow
Curve
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lnterface Pressure (cmHrO)
Pressure (cmHrO) 4 8 12 16 20
Flow Rate (Umin) 20 29 38 45 50
Dead Space
lnformation Dead space is the empty volume of the nasal pillows and short
tube assembly up to the swivel. The dead space ofthe interface
for Large Pillows is 92 ml.
Therapy Pressure 4 to 20 cmHro.
Resistance Drop in pressure measured (average for three nasal pillows sizes) at 50 Umin: 0.5 cmHro
at 100 L/min: 1.6 cmHrO
DECLARED DUAL-NUI\,4BER NOISE EMISSION VALUES iN
accordance with ISO 4871. The A-weighted sound power level
of the interface is 26 dBA, with uncertainty 3 dBA. The
A-weighted sound pressure level of the interface at a distance of
1 m is 18 dBA, with uncertainty 3 dBA.
Environmental
Conditions
Operating temperature: +5"C to +40"C (41"F to 104'F)
Operating humidity: 10% - 93% relative humidity non-condensing.
Storage and transport: -20'C to r55'C C4'F to 131'F)
Storage and transport humidity: 10% - 93% relative humidity
non-condensing.
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Symbols
lnterface and Packaging
Caution, consult accompanying documents.
lndicates a Warning or Caution and alerts you to a possible i
explains special measures for the safe and effective use of the injury or device.
A
tor Lot number
Catalog number
Temperature limitation
Humidity limitation
Manufacturer
Authorized Representative in the European Community
Limited Warranty
It is warranted that RiorM ll Nasal Pillows lnterface, including its components,
frame, nasal pillows, 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 your local authorized dealers.
The expected service life of RiorM ll Nasal Pillows lnterface is one year.
For any questions or comments concerning this product or the warranty, please
contact:
Contract Manufacturer:
BMC (Tianjin) Medical Co., Ltd.
2 / F North Area and 3 / F, Building No.4, No.'1 Xinxing Road, Wuqing District,
(30'l 700) Tianjin, P.R.China.
Tel: [phone]
38 Medical,lnc.
203 Avenue A NW, Suite 300
Winter Haven, FL 33881
Email : [email protected]
www.3Bproducts.com
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390891 lssue date: July 13, 2020
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