RespShop F and P Pilairo Q Nasal Pillow Mask Instruction Manual

RespShop F and P Pilairo Q Nasal Pillow Mask

Patient Instructions for Use

The F&P Pilairo Q Nasal Pillows Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Pilairo Q Nasal Pillows Mask is intended for single-patient adult use in the home and multiple-patient adult use in the hospital or other clinical settings where proper disinfection of the device can occur between patient uses.

Warnings

• Only use Pilairo Q Diffuser spare parts.
• Ensure only one fabric Diffuser (H) is used in the Diffuser System (H and I).
• This mask should only be used with approved CPAP or Bi-Level equipment recommended by your physician or respiratory therapist. A mask should not be used unless the CPAP or Bi-Level machine is turned on and operating properly. The exhaust holes associated with the mask should never be blocked.
• Explanation of Warning: CPAP and Bi-Level machines are intended to be used with special masks, which have exhaust holes to allow continuous flow of air out of the mask. When the CPAP or Bi-Level machine is turned on and functioning properly, new air from the CPAP or Bi-Level machine flushes the exhaled air out through the mask’s exhaust holes. However, when the CPAP or Bi-Level machine is not operating, not enough fresh air will be provided through the mask, and exhaled air may be re-breathed. Re-breathing of exhaled air for longer than several minutes can lead to suffocation in some circumstances.
• At low CPAP or Bi-Level pressures, the flow through the exhaust holes may be inadequate to clear all exhaled gas from the tubing. Some re-breathing may occur.
• Do not block the exhaust holes. Before use, always ensure that the gas is flowing out the exhaust holes.
• Do not use the mask if vomiting or feeling nauseous.
• Discontinue use if discomfort or irritation occurs, and consult your healthcare provider.
• Discontinue using the mask if there is an allergic reaction to any part of the mask. Consult your physician if this occurs.
• If oxygen is used with a CPAP or Bi-Level machine, the oxygen flow must be turned off when the CPAP or Bi-Level machine is not operating. Oxygen accumulated in the CPAP or Bi-Level machine enclosure will create a risk of fire.
• Keep ignition sources (e.g. smoking) away from anyone using oxygen with this mask.
• California residents please be advised of the following, according to Proposition 65: This product contains chemicals known to the State of California to cause cancer, birth defects and other reproductive harm. For more information, please visit www.fphcare.com/prop65.

CAUTIONS

• Use the mask only for its intended use as directed in this booklet.
• US Federal Law restricts this device to sale by, or on order of, a physician.

Warranty Statement

Fisher & Paykel Healthcare warrants that the mask (excluding foams and material diffusers), when used per its instructions for use, shall be free from defects in workmanship and materials and will perform in accordance with Fisher & Paykel Healthcare’s official published product specifications for 90 days from the date of purchase by the end user. This warranty is subject to the limitations and exceptions set out in detail in www.fphcare.com/osa/mask- solution/mask-warranty.html

DISPOSAL
The device does not contain any hazardous substances and may be disposed of with general waste.

Mask Parts

• A. Silicone Seal
• B. Mask Frame
• C. Elbow
• D. Stabilizers
• E. FlexiTube
• F. Male Swivel
• G. Female Swivel
• H. Diffuser
• I. Diffuser Cover
• J. Stretchwise Headgear
• K. Headgear Hooks
• L. Adjustable Headgear
• M. Headgear Clips
• N. Buckle

NOTE: The Elbow (C) is permanently attached to the Frame (B). It is not intended to be removed.

Fitting Your Mask with Stretchwise Headgear (J)

Remove all packaging before using your mask.

1. Hold the Silicone Seal (A) away from your nose, use your fingers to carefully spread open the soft side wings of the Silicone Seal (A) and then guide the two openings into your nostrils.
2. Hold the Mask Frame (B) and Elbow (C) area with one hand and stretch the Stretchwise Headgear (J) over your head with the other hand.
3. The two openings on the Silicone Seal (A) should fit securely into your nose.

FITTING TIP
If there are any leaks after fitting the mask, pull the Silicone Seal (A) away from the face while the Headgear (J) is still attached. This will allow the Silicone Seal (A) to inflate with air. Place the mask back so that the two openings on the Silicone Seal (A) fit securely into your nose.

WARNING
Do not release the mask until securely positioned on your face.

Fitting Your Mask with Adjustable Headgear (L)

Remove all packaging before using your mask.

1. Hold the Silicone Seal (A) away from your nose, use your fingers to carefully spread open the soft side wings of the Silicone Seal (A), and then guide the two openings into your nostrils.
2. Hold the Mask Frame (B) with one hand and position the Adjustable Headgear (L) by pulling the bottom strap down over the head until secure. Ensure the Buckle (N) is positioned at the top.
3. Adjust the crown strap so that the crown straps are directly above each ear. Then adjust the side straps so that the headgear sits just above each ear.

FITTING TIP
Your F&P Pilairo Q works best when the mask is not fastened too tight. The Silicone Seal (A) inflates with CPAP to provide a comfortable seal.

Mask Assembly/Disassembly

NOTE: Be gentle when handling the Silicone Seal (A).

1. Insert the top edge of the Silicone Seal (A) into the top of the channel in the Mask Frame (B). Take care to insert the key into the slot in the channel.

2. Pull the bottom edge of the Silicone Seal (A) over the edge of the bottom of the channel in the Mask Frame (B). Ensure that there are no gaps around the edge.
   3A Stretchwise Headgear (J):
   Fasten the Headgear Clips (M) onto each of the posts located at the ends of the Mask Base.
   3B Adjustable Headgear (L):
   Connect the Adjustable Headgear (L) using the Headgear Hooks (K) onto each of the posts located at the ends of the Mask Frame (B). Ensure the Buckle (N) is positioned at the top.

3. Attach the assembled mask to the CPAP tube. Ensure that the Female Swivel (G) is removed from the CPAP tube when disassembling.

4. To assemble the Diffuser System, place the Diffuser (H) in Diffuser Cover (I), then attach it to the Elbow (C).

Adjustable Headgear (L) Assembly/Disassembly

Lay the Adjustable Headgear (L) flat, with label side facing up.

1. Loop the Crown Straps of the Adjustable Headgear (L) through the Buckle (N).
2. Fold the side straps of the Adjustable Headgear (L) back on itself.
3. Loop the side straps of the Adjustable Headgear (L) through the Headgear Hooks (K).

Operating Instructions

• The operating pressure range of the mask is 4 to 25 cmH2O.
• The operating temperature range of the mask is 5 to 40 °C (40 to 104 °F).
• Before using the mask each time:

1. Inspect it for damage. If there is any visible deterioration (cracking, tears, etc) do not use and seek replacement part(s).
2. Inspect the exhaust holes on the Elbow (C). Do not use if blocked.
3. Make sure the air path through the mask is clear.

NOTE: Failure to follow the operating instructions above may compromise the performance and safety of the mask.

Disassembly for Cleaning

1. Unhook the Headgear Clips (M) OR Headgear Hooks (K) from the Mask Frame (B).
2. Remove the Silicone Seal (A) from the Mask Frame (B).
3. Remove the Female Swivel (G) from the Male Swivel (F).

Cleaning Your Mask at Home

After each use:

1. Wash your mask excluding the Headgear Assembly (J and/or L) in soap dissolved in lukewarm water. Do not soak for more than 10 minutes.
2. Rinse thoroughly with fresh water, ensuring that all soap residues are removed.
3. Leave all parts to dry out of direct sunlight before reassembling.
4. The Diffuser (H) should not be washed or rinsed. Simply replace it with a new Diffuser (H) if it becomes noisy or deteriorates. It should last two to three months. Small dots may appear on the Diffuser – these do not affect its performance. The F&P Pilairo Q Nasal Pillows Mask may be used with, or without, the Diffuser System (H and I).

Note: If it is used without the Diffuser System (H and I) noise may be greater. Please see the Sound section for more details.

After 7 days of use:

1. Hand-wash the Headgear Assembly (J and/or L) in soap dissolved in lukewarm water. Do not soak for more than 10 minutes.
2. Rinse thoroughly with fresh water, ensuring that all soap residues are removed.
3. Leave all parts to dry out of direct sunlight before reassembling.

CAUTIONS

• Do not remove the Elbow (C) from the Mask Frame (B). It is not intended to be detachable.
• Do not remove the FlexiTube (E) from the Elbow (C) or Male Swivel (F). It is not intended to be detachable.
• Do not clean the mask with products containing alcohol, anti-bacterial agents, antiseptic, bleach, chlorine or moisturizer.
• Do not soak the mask for longer than 10 minutes.
• Do not clean the mask in a dishwasher.
• Do not store the mask in direct sunlight.

The above actions may deteriorate or damage the mask and shorten its life. If your F&P Pilairo Q Nasal Pillows Mask weakens or cracks, discontinue use and seek replacement immediately.

Oxygen/Pressure Port Connector
If pressure readings and/or additional oxygen are required, an Oxygen/Pressure Port Connector is available (REF 900HC452). Please contact the healthcare provider

Technical Specifications

EXHAUST FLOW
The F&P Pilairo Q Nasal Pillows Mask has a unique Diffuser System that is designed to diffuse air that is expelled from the mask. This reduces the draft. The diffuser does not significantly change the amount of air flowing from the mask, therefore the mask can be used with or without the Diffuser System (H and I).

RESISTANCE TO FLOW
Pressure drop through mask with Diffuser System (H and I) @ 50 L/min: 1.17 ± 0.1 cmH2O Pressure drop through mask with Diffuser System (H and I) @ 100 L/min: 5.26 ± 0.1 cmH2O Pressure drop through mask without Diffuser System @ 50 L/min: 1.10 ± 0.1 cmH2O Pressure drop through mask without Diffuser System @ 100 L/min: 4.97 ± 0.1 cmH2O

MASK DEAD SPACE
34 cc

SOUND
The Sound Power Level of the mask is 31.6 dBA, with an uncertainty of 2.5 dBA. The Sound Pressure Level of the mask is 23.6 dBA, with an uncertainty of 2.5 dBA.

Multi-Patient Reprocessing

For the USA only, model 400421 is single patient use only, therefore multi- patient cleaning instructions do not apply. Your F&P Pilairo Q Nasal Pillow Mask is provided patient-ready. To reuse between patients please follow the instructions below or follow the guidelines on the following website: www.fphcare.com/en/osa/mask-resources.html If you do not have Internet access, please contact your Fisher & Paykel Healthcare representative.

HIGH-LEVEL THERMAL/CHEMICAL DISINFECTION PARAMETERS

Failure to properly clean this device may result in inadequate disinfection.

water. Dry out of direct sunlight.
H| Single-patient use, replace between patients.

• The F&P Pilairo Q Nasal Pillows Mask has been validated to withstand 20 cycles of the above parameters.
• Do not use if damaged.
• Disclaimer: It is the user’s responsibility to qualify any deviations from the recommended method of reprocessing.
• Contact your local Homecare Provider for additional information.

The F&P Pilairo Q Nasal pillow mask and accessories are not made with natural rubber latex.

PATENTS
One or more products in this manual are covered by or for use under one or more of the following patents in the corresponding countries listed below.

Australia: AU2010246985
Europe: GB2482092, GB2494493, GB2506304, GB2509641 One or more products in this manual are also covered by or for use under one or more pending patent applications. For patent information, see www.fphcare.com/ip

DESIGN
One or more products in this manual are covered by one or more of the following design registrations or design patents in the corresponding countries listed below.

• Australia: AU341828
• European Community Regd. Des. Nos.: 002005165-001, 002005165-002, 002005165-003, 002005165-004, 002005165-005, 002005165-006, 002005165-007
• USA: D691,257, D740,409, D692,554
• UK
  • Fisher & Paykel Healthcare Ltd,
  • Unit 16, Cordwallis Park,
  • Clivemont Road, Maidenhead,
  • Berkshire SL6 7BU, UK
  • Tel: 0800 132 189
  • Fax: +44 1628 626 146
• USA/Canada
  • Tel: 1800 446 3908 or +1 949 453 4000
    Fax: +1 949 453 4001

References

• About Us | Fisher & Paykel Healthcare

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