RespShop Simplus Full Face Mask Instruction Manual

Patient Instructions for Use

REF 185047915 REV H 2023-05 © 2023 Fisher & Paykel Healthcare Limited

Fisher & Paykel Healthcare Ltd, 15 Maurice Paykel Place, East Tamaki, Auckland 2013, PO Box 14 348 Panmure, Auckland 1741, New Zealand
Tel: +64 9 574 0100 Email: info@fphcare.co.nz Web: www.fphcare.com

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[I]

[II]

[III]

[IV]

For patent information see,www.fphcare.com/ip

Comfort       Seal        Easy Use

F&P Simplus™ Full Face Mask

Patient Instructions for Use

The F&P Simplus Full Face 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 Simplus Full Face Mask is intended for Single Patient Adult Use in the home and Multiple Patient Adult Use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

Warnings

• Before using the mask, ensure the Silicone Flap is present and undamaged in the Elbow (E) and the Elbow exhaust slots are not occluded. This assembly ensures CO2 re-breathing is kept to a minimum when the CPAP is switched off (e.g. during a power failure).

• 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 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.

• Do not store the mask in direct sunlight.

• This mask is not suitable for life support ventilation.

• This mask must be used under qualified supervision for users whom are unable to remove the mask themselves.

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, when used in accordance with 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 a period of 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.

[I] Mask Parts

A. Silicone Seal      D. Headgear Clips      G. Buckle
B. Mask Frame      E. Elbow
C. Headgear          F. Swivel

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

[II] Fitting Your Mask

Remove all packaging before using your mask.

1. Hold the Frame (B) with one hand and the Headgear (C) in the other. One of the Headgear Clips (D) should be hooked onto the Frame (B).
2. Place the Seal (A) on the face and guide the Headgear (C) over your head.
3. Hook the unattached Headgear Clip (D) onto the Frame (B).
4. Gently tighten the Headgear Straps in the correct order. Position the top strap (1) when first fitted and straps (2) and (3) when adjusting to avoid leak.

CAUTIONS

• Ensure the headgear is not overtightened. The mask, when correctly worn, should be able to be pulled away from the mouth without adjusting the straps or disconnecting the headgear clips.

FITTING TIPS

• Do not over-tighten any of the Headgear Straps.
• Forehead Straps should rest horizontally on the forehead, just above the ears.

[III] Mask Assembly/Disassembly

1. Push the Silicone Seal (A) onto the Mask Frame (B) in the orientation shown until a confirmation click is heard.
2. Slide the Forehead Loops of the Headgear (C) into the slots of the Mask Frame (B). This can be done without undoing the VELCRO® brand tabs.
   VELCRO® is a registered trademark of Velcro Industries B.V.
3. Hook the Headgear Clips (D) onto the Mask Frame (B).
4. Push the Swivel (F) onto the Elbow (E).
5. Attach the assembled mask to the CPAP tube. Ensure that the Swivel (F) is removed from the CPAP tube when disassembling.

[IV] Headgear Assembly/Disassembly

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

1. Loop the Crown Straps of the Headgear (C) through the Buckle (G).
2. Fold the Forehead Straps of the Headgear (C) back on itself.
3. Loop the Bottom Straps of the Headgear (C) through the Headgear Clips (D).

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:
  i. Inspect it for damage. If there is any visible deterioration (cracking, tears, etc) do not use and seek replacement part(s).
  ii. Inspect the exhaust holes on the silicone seal (A). Do not use if blocked.
  iii. Make sure the air path through the mask is clear.
  iv. Do not remove the Elbow (E) from the Mask Frame (B). It is not intended to be detachable.
  v. Do not pull on or attempt to remove the Silicone Flap from the Elbow, or attempt to disassemble the Elbow. It is not intended to be disassembled.

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 (D) from the Mask Frame (B).
2. Slide the Forehead Straps of the Headgear (C) downwards from the top of the Mask Frame (B).
3. Remove the Silicone Seal (A) from the Mask Frame (B).
4. Remove the Swivel (F) from the Elbow (E).

Cleaning Your Mask at Home

After each use:

1. Wash your mask excluding the Headgear Assembly 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.

After 7 days of use:

1. Hand-wash the Headgear Assembly 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

• It is not necessary to remove the Headgear Clips (D) or the Buckle (G) when cleaning the Headgear (C).
• 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.

The above actions may deteriorate or damage the mask and shorten its life. If your F &P Simplus Full Face 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 your healthcare provider.

Technical Specifications

EXHAUST FLOW

The F&P Simplus Full Face Mask has exhaust holes to expel the air that you exhale from the mask. It is important that these exhaust holes are not blocked by any object. This controlled leak ensures all exhaled CO2 is expelled from the mask.

Pressure (cmH2O)|

4

| 5| 7| 9| 11| 13| 15| 17| 19| 21| 23|

25

---|---|---|---|---|---|---|---|---|---|---|---|---
Flow (L/min)|

22

| 25| 29| 33| 37| 40| 43| 46| 49| 52| 54|

57

F &P Simplus Exhaust Flow

RESISTANCE TO FLOW

Pressure drop through mask @ 50 L/min: 0.17 ± 0.1 cmH2O
Pressure drop through mask @ 100 L/min: 0.64 ± 0.1 cmH2O

MASK DEAD SPACE

Small = 251 cc      Medium = 278 cc      Large = 310 cc

INSPIRATORY AND EXPIRATORY RESISTANCE

The inspiratory resistance of the mask (in combination with the Non- Rebreathing Valve) is 0.67 cmH2O
The expiratory resistance of the mask (in combination with the Non-Rebreathing Valve) is 0.12 cmH2O
The opening to atmosphere pressure of the Non-Rebreathing Valve is 0.33 cmH2O
The closing to atmosphere pressure of the Non-Rebreathing Valve is 0.79 cmH2O

SOUND

The Sound Power Level of the mask is 25.8 dBA, with uncertainty 2.5 dBA.
The Sound Pressure Level of the mask is 17.8 dBA, with uncertainty 2.5 dBA.

Multi-Patient Cleaning Instructions

For the US only, multi-patient cleaning instructions apply only to Sleep Lab masks: 400475SL, 400476SL and 400477SL.

Your F&P Simplus Full Face Mask is provided patient-ready. To reuse between patients please follow the guidelines on the following website: www.fphcare.com/disinfection

If you do not have Internet access, please contact your Fisher & Paykel Healthcare representative or see details below.

To ensure traceability, mask components belonging to an individual mask must be reassembled back into the same mask after cleaning.

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

HIGH-LEVEL DISINFECTION PARAMETERS

| Pasteurisation
---|---
All other parts| 10 minutes at 80 °C (176 °F)
C, D, G| Hand-wash the Headgear in soap dissolved in lukewarm water. Dry out of direct sunlight.

• The F&P Simplus Full Face 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 Simplus Full Face Mask and accessories are not made with natural rubber latex. Many people find CPAP or Bi-Level therapy causes dryness of the nose and throat. Heated humidification can substantially reduce these symptoms.

F &P and Simplus are trademarks of Fisher & Paykel Healthcare Limited.

References

• About Us | Fisher & Paykel Healthcare

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