React Health Rio Ii Nasal Pillows Interface User Manual (+ PDF)

The RioTM II Nasal Pillows Interface 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 restricts the
sale of this device to sale by or on the order of a physician.

Medical Information

Note: The RioTM II does not contain latex, PVC, or DEHP
materials. If you have ANY reaction to any part of the interface,
discontinue use and consult your sleep therapist.

recommended by your physician or respiratory therapist. It
should not be used unless the flow generator is turned on and
operating properly. The vent holes should never be blocked.

Technical Specifications section for details of the
Pressure-Flow Curve). If the interface pressure during exhalation
is too low, there may not be enough exhaust vent flow to completely
flush the exhaled air delivery hose from the before the next
inhalation begins.

and consult your physician.

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 in the flow generator enclosure. The accumulation of
oxygen in the flow generator enclosure will create a fire hazard.
This warning applies to most types of flow generators.

the image and the 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
settings, patient breathing pattern, interface selection and the
leak rate.

Nasal Pillows Size

You can choose the appropriate nasal pillows from S, M and L
sizes, depending on individual dimensions.

	L1 (inch)	L2 (inch)
S	0.87	0.20
M	0.95	0.20
L	1.09	0.27

Fitting

Thread the two side straps of the headgear through the gaps in
panels separately, then fold back over to secure.
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.
Adjust each end of the side strap evenly until the interface
sits comfortably just under the nose. Reattach the fastening
tabs.
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.
Finally connect the end of the interface tubing into your
device air tubing. Your interface is now fitted and ready to
use.

Notes: Refer to your flow generator manual for details on
setting and operation.

Product information: The RioTM II Nasal Pillows
Interface is a light, flexible, and quiet product designed to
minimize contact with the user’s face, ensuring that they feel
comfortable during therapy. It is intended for adult patients (>
30 kg) prescribed continuous positive airway pressure or Bi-level
therapy and is intended for single patient reuse in the home
environment. The product does not contain latex, PVC, or DEHP
materials. The RioTM II Nasal Pillows Interface comes with
headgear, nasal pillows (available in S, M, L sizes), panel, soft
sleeves, clip, elbow, frame, short tube, and swivel components.
Product usage instructions: 1. Thread the two side
straps of the headgear through the gaps in panels separately, then
fold back over to 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 of the side strap evenly until the interface sits
comfortably just 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. Note: Refer to your flow
generator manual for details on setting and operation. The
appropriate nasal pillows can be chosen from S, M, and L sizes,
depending on individual dimensions. At a fixed flow rate of
supplemental oxygen flow, the inhaled oxygen concentration will
vary, depending on the pressure settings, patient breathing
pattern, interface selection, and the leak rate. If you have ANY
reaction to any part of the interface, discontinue use and consult
your sleep therapist. The vent holes should never be blocked.

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RioTMII Nasal Pillows Interface
User Manual

Disassembly

Reassembly

RioTM II Components

1 Headgear 3 Panel 5 Clip 7 Frame 9 Swivel
Fitting
1

2 Nasal Pillows (available in S, M, L) 4 Soft sleeves 6 Elbow 8 Short tube
2

3
RioTM II Nasal Pillows Interface
Thank you for choosing the RioTM II Nasal Pillows Interface. The RioTM II Nasal Pillows Interface is light, 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 system.
Intended Use
The RioTM II 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 restricts the sale of this device to sale by or on the order of a physician.
Medical Information
Note: The RioTM II does not contain latex, PVC, or DEHP materials. If you have ANY reaction to any part of the interface, discontinue use and consult your sleep therapist.
WARNING and CAUTION · This interface should be used only with flow generators (CPAP or Bi-level)
recommended by your physician or respiratory therapist. It 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 for use with
special interfaces with connectors which have vent holes (vent holes are located in the elbow) or separate exhalation devices that allow a continuous flow of air out of the interface. When the flow generator is on and operating properly, the fresh air from the flow generator will flush the exhaled air out through the attached exhalation port. However, when the flow generator is not operating (e.g. power failure), the fresh air supplied through the interface is insufficient, and exhaled air may be re-inhaled. In this situation, remove the RioTM II immediately.
· The exhaust vent flow is lower at lower interface pressure (see section
“Technical Specifications” section for details of the Pressure-Flow Curve). If the interface pressure during exhalation is too low, there may not be enough exhaust vent flow to completely flush the exhaled air delivery hose from the before the next inhalation begins.
· Discontinue using the interface if you frequently experience nasal irritation,
and consult your physician.
· If 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 in the flow generator enclosure. The accumulation of oxygen in the flow generator enclosure will create a fire hazard. This warning applies to most types of flow generators.
· Please refrain from smoking while oxygen is in use. · The images shown here are indicative only. If there is inconsistency between
the image and the 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 settings, patient breathing pattern, interface selection and the leak rate.

Nasal Pillows Size
You can choose the appropriate nasal pillows from “S”, “M” and “L” sizes, depending on individual dimensions.

Size L1 (inch) L2 (inch)

0.87

0.20

0.95

0.20

1.09

0.27

Fitting
1. Thread the two side straps of the headgear through the gaps in panels separately, then fold back over to 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 of the side strap evenly until the interface sits comfortably just 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.
Notes: Refer to your flow generator manual for details on setting and operation.
Three nasal pillows sizes (S, M, L) are available. Place the pillows over your nostrils to ensure that the Pillows size (e.g., M) correctly fits for you.
If you feel an air leak, readjust the angle of the nasal pillows to get a better seal. If you cannot resolve any leaks, you may need an alternative nasal pillows size.
Removal
To remove the interface, pull the nasal pillows assembly away from 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 on the interface frame.
2. Remove the headgear from the interface.
Notes: The short tube assembly cannot be taken apart.
Do not pull on the short 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 RioTM II in the Home
Notes: Wash your hands before cleaning the interface.
Wash the headgear before first time use. The wrist belt may fade slightly that is normal. It is important to always hand wash the headgear.
Daily / After Each Use
· Disassemble the interface components according to the disassembly instructions. · Thoroughly clean the separated interface components (excluding headgear) by
gently rubbing in warm water (approx. 86°F / 30°C) using mild, unscented liquid dish detergent for 10 min.
· Use a soft bristle brush to clean the vent. · Rinse all components except the Left and Right Panel well with drinking quality
water and allow them to air dry out of direct sunlight.
· When all components are dry, reassemble the interface according to the
reassembly instructions.
Weekly Hand wash the headgear and all components in warm water (approx. 86°F / 30°C), mild, unscented liquid dish detergent for up to 10 minutes. Rinse the components well and allow them to air dry out of direct sunlight.
CAUTIONS · Always follow cleaning instructions and do not use solutions containing bleach,
chlorine, 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.
· If any visible deterioration of a component is apparent (cracking, crazing, tears,
etc.), the component should be discarded and replaced.
Additional Information
Note: For additional instruction, please visit our website at www.reacthealth.com. An instructional video is available for viewing under the RioTM II tab.
Storage
Ensure that the interface is thoroughly clean before storing it for any length of time. Store the interface in a dry place out of direct sunlight.
Note: The RioTM II Nasal Pillows Interface is not made with natural rubber latex.

Disposal
The RioTM II Nasal Pillows Interface does not contain any hazardous substances and may be disposed of with your normal household refuse.
Technical Specifications

Flow Rate (L/min)

Pressure Flow Curve

Dead Space Information Therapy Pressure Resistance
Sound
Environmental Conditions

Interface Pressure (cmH2O)

Pressure (cmH2O)

12 16 20

Flow Rate (L/min) 20 29 38 45 50

Dead space is the empty volume of the nasal pillows and short tube assembly up to the swivel. The dead space of the interface for Large Pillows is 92 ml.
4 to 20 cmH2O.
Drop in pressure measured (average for three nasal pillows sizes) at 50 L/min: 0.5 cmH2O at 100 L/min: 1.6 cmH2O DECLARED DUAL-NUMBER NOISE EMISSION VALUES in accordance with ISO 4871. The A-weighted sound power level of the interface is 26 dBA, with an uncertainty of 3 dBA. The A-weighted sound pressure level of the interface at a distance of 1 m is 18 dBA, with an uncertainty of 3 dBA. 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.

Symbols
Interface 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 RioTM II Nasal Pillows Interface 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: (863) 226-6285 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: [email protected] Tel: +86-10-51663880 Fax: +86-10-51663880 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: +86-22-82939881 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

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Issue date: December 9, 2022