RespShop F and P Zest Q Nasal Mask Instruction Manual

185047073 REV A 2011-10 © 2011 Fisher & Paykel Healthcare Limited

Nasal Mask

Patient Instructions for Use

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Manufacturer
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
Fax: +64 9 574 0158
Email: info@fphcare.co.nz
Web: www.fphcare.com

Australia
Fisher & Paykel Healthcare Pty Limited
36–40 New Street, PO Box 167
Ringwood, Melbourne
Victoria 3134, Australia

Tel: +61 3 9879 5022
Fax: +61 3 9879 5232

Austria
Tel: 0800 29 31 23
Fax: 0800 29 31 22

Benelux
Tel: +31 40 216 3555
Fax: +31 40 216 3554

China
Tel: +86 20 3205 3486
Fax: +86 20 3205 2132

France
Tel: +33 1 6446 5201
Fax: +33 1 6446 5221

Germany
Tel: +49 7181 98599 0
Fax: +49 7181 98599 66

India
Tel: +91 80 4284 4000
Fax: +91 80 4123 6044

Irish Republic
Tel: 1800 409 011

Italy
Tel: +39 06 7839 2939
Fax: +39 06 7814 7709

Japan
Tel: +81 3 3661 7205
Fax: +81 3 3661 7206

Northern Ireland
Tel: 0800 132 189

Spain
Tel: +34 902 013 346
Fax: +34 902 013 379

Sweden
Tel: +46 8 564 76 680
Fax: +46 8 36 63 10

Switzerland
Tel: 0800 83 47 63
Fax: 0800 83 47 54

Taiwan
Tel: +886 2 8751 1739
Fax: +886 2 8751 5625

Turkey
Tel: +90 312 354 34 12
Fax: +90 312 354 31 01

UK
Fisher & Paykel Healthcare Ltd
Unit 16, Cordwallis Park
Clivemont Road, Maidenhead
Berkshire SL6 7BU, UK

Tel: +44 1628 626 136
Fax: +44 1628 626 146

USA/CANADA
Tel: +1 800 446 3908
or +1 949 453 4000
Fax: +1 949 453 4001

F&P Zest™ Q Nasal Mask

Patient Instructions for Use

The F&P Zest Q Petite Nasal Mask is intended to be used by individuals greater than 66 lbs (30 kg) who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Zest Q Petite Nasal Mask is intended for Single Patient Use in the home and Multiple Patient Use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

The F&P Zest Q Nasal Mask and F&P Zest Q Plus Nasal Mask are intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Zest Q Nasal Mask and F&P Zest Q Plus Nasal Mask are 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.

Assembling Your Mask

Your F&P Zest Q Nasal Mask is fully assembled and ready to use. However, when you need to clean your mask follow these instructions for reassembly:

1. Place the Foam Cushion (D) into the Silicone Seal (C) in the orientation shown in the diagram.
2. Starting with the slot at the apex of the Silicone Seal, assemble onto Mask Base (A). Push firmly together.
3. Lay the Stretchgear™ Headgear (H) flat, with the label side down. Position the assembled mask over the Headgear and attach the four straps into the corresponding slots in the Forehead Rest (F) and the Glider™ Strap (E). This can be done without undoing the VELCRO® brand tabs*, by sliding the Headgear into the slots.

• VELCRO® is a registered trade mark of Velcro Industries B.V. 4. To assemble the Diffuser System, place the Diffuser (J) in Cover (I) , then attach to the Elbow (B). Attach Elbow (B) to Mask Base (A).

  1. Diffuser System (I and J)

Fitting Your Mask

1. Remove the plastic cover from the Silicone Seal.
2. Holding your mask in one hand, spread the Stretchgear™ Headgear (H) with your free hand, just enough to fit comfortably over your head.
3. Lightly hold the mask against your face, covering the nose, then slowly pull the Headgear over your head.
4. Attach the Headgear to the Glider™ Strap (E).
5. Pull the lower straps as low as possible down the back of your neck. Gently tighten straps to remove slack. Connect to CPAP/Bi-Level machine set at prescribed pressure.

• If necessary, tighten the lower straps to eliminate any leaks (avoid over-tightening the straps).
• When you need to remove your mask, unhook the Stretchgear™ Headgear from the Glider™ Strap.

FITTING TIPS

• Forehead pads should rest gently on the forehead without top straps being pulled too tightly.
• If there are any leaks after gently tightening the top and lower straps, pull the mask slightly out from the face while straps are still attached. This will allow the Silicone Seal to inflate with air. Put the mask back onto the face.

Cleaning Your Mask

To ensure continuing safety and comfort for your F&P Zest Q Nasal Mask:

• Before first use:
  Hand-wash the Stretchgear™ Headgear (H) in pure soap dissolved in lukewarm water. Do not soak for longer than 10 minutes, then rinse in fresh water and allow to dry out of direct sunlight.

• Before each use:
  Inspect the mask for deterioration. Do not use if damaged.

• After each use:
  1. Disassemble the Silicone Seal (C) , Foam Cushion (D) , Elbow (B) and the Headgear (H) from the Mask Base (A).
  2. Wash the Silicone Seal and Mask Base in pure soap dissolved in lukewarm water. Do not soak for longer than 10 minutes.
  3. Rinse thoroughly with fresh water, ensuring that all soap residue is removed.
  4. Wipe the Foam Cushion with a damp cloth. (Do not immerse the Foam Cushion in water.)
  5. Leave all parts to dry out of direct sun light before reassembling.
  6. The Diffuser (J ) should not be washed or rinsed. Simply replace it with a new Diffuser (J ) 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 Zest Q Nasal Mask may be used with, or without, the Diffuser System ( I and J ).

• Every 7 days:
  Hand-wash the Stretchgear™ Headgear (H) in pure soap dissolved in lukewarm water. Do not soak for longer than 10 minutes, then rinse in fresh water and allow to dry out of direct sunlight.

CAUTIONS

• Do not soak the mask for longer than 10 minutes.
• Do not wash the mask in the dishwasher.
• Do not clean the mask with products containing alcohol, anti-bacterial agents, antiseptic, bleach, chlorine or moisturizer.
• 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 Zest Q Nasal Mask weakens or cracks, discontinue use and seek replacement immediately.

Operating Instructions

• The operating pressure range of the mask is 4-25 cmH2O.
• The operating temperature range of the mask is 5-40 °C (40-104 °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) Ensure Elbow (B) has vent holes and do not use if blocked.
  iii) 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.

Warnings

• Only use F&P Zest Q Diffuser spare parts.

• Ensure only one fabric Diffuser (J) is used in the Diffuser System (I and J).

• This mask should be used only with 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.
  Explanation of Warning: CPAP and Bi-Level machines are intended to be used with special masks which have exhalation ports to allow continuous flow of air out of the mask. When the CPAP/Bi-Level machine is turned on and functioning properly, new air from the CPAP/Bi-Level machine flushes the exhaled air out through the mask exhalation ports. However, when the CPAP/Bi- Level machine is not operating, enough fresh air will not be provided through the mask, and exhaled air may be re-breathed. Re-breathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation.

• At low CPAP/Bi-Level pressures the flow through the exhalation ports may be inadequate to clear all exhaled gas from the tubing. Some re-breathing may occur.

• Do not block the gas exhaust ports. Before use, always ensure that gas is flowing out the exhaust ports.

• 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.

• Use with Stroke Patients: One study has shown poor compliance with CPAP therapy in stroke patients. Careful evaluation of the patient’s capabilities for CPAP therapy should be exercised.

• If re-using the F&P Zest Q Nasal Mask between patients, refer to the Multi-Patient Cleaning Instructions for the F&P Zest Q Nasal Mask.

• If oxygen is used with CPAP/Bi-Level machine, the oxygen flow must be turned off when the CPAP/Bi-Level machine is not operating. Oxygen accumulated in the CPAP/Bi-Level machine enclosure will create a risk of fire.

• Keep ignition sources (e.g. smoking) away from anyone using oxygen with this mask

CAUTIONS

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

For additional information contact your local homecare provider

Warranty and Disposal

WARRANTY STATEMENT
Fisher & Paykel Healthcare warrants that the mask (excluding foams and material diffusers), 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 http://www.fphcare.com/osa/productWarranty.asp

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

Oxygen/Pressure Port Connector

If pressure readings and/or additional oxygen are required, an Oxygen/Pressure Port connector is available (REF 900HC452).
www.fphcare.com/en/osa/mask-resources.html

Technical Specifications

EXHAUST FLOW
Nasal masks for CPAP and Bi-Level have exhaust flow holes to expel the air that you exhale from the mask. The F&P Zest Q Nasal Mask has a unique Diffuser system that is designed to diffuse the 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 (I and J).

Pressure (cmH2O)| Flow with Diffuser System (I and J) (L/min)| Flow without Diffuser System (L/min)
---|---|---
4| 20| 21
5| 23| 24
7| 27| 28
9| 31| 33
11| 35| 36
13| 38| 40
15| 41| 43
17| 44| 46
19| 47| 49
21| 50| 52
23| 52| 54
25| 54| 56

F &P Zest™ Exhaust Flow

a: Exhaust Flow (L/min)
b: Pressure (cmH2O)
c: without Diffuser System
d: with Diffuser System (I and J)

RESISTANCE TO FLOW
Pressure drop through mask with Diffuser System (I and J) @ 50 L/min 0.3 ± 0.1 cmH2O
Pressure drop through mask with Diffuser System (I and J) @ 100 L/min 1.1 ± 0.1 cmH2O
Pressure drop through mask without Diffuser System @ 50 L/min 0.3 ± 0.1 cmH2O
Pressure drop through mask without Diffuser System @ 100 L/min 1.1 ± 0.1 cmH2O

MASK DEAD SPACE
F&P Zest Q Petite = 40 cc       F&P Zest Q = 60 cc       F&P Zest Q Plus = 90 cc

SOUND
The Sound Power Level of the mask with Diffuser System (I and J) is 23 dBA, with uncertainty 2.5 dBA.
The Sound Pressure Level of the mask with Diffuser System (I and J) is 15 dBA, with uncertainty 2.5 dBA.
The Sound Power Level of the mask without Diffuser System is 28 dBA, with uncertainty 2.5 dBA.
The Sound Pressure Level of the mask without Diffuser System is 20 dBA, with uncertainty 2.5 dBA.

Multi-Patient Cleaning Instructions

Your F&P Zest Q Nasal Mask is provided patient-ready. To reuse between patients please 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.

The F &P Zest Q Nasal Mask and accessories are Latex free.
Many people find CPAP/Bi-Level therapy causes dryness of the nose and throat.
Heated humidification can substantially reduce these symptoms.

Comfort       Seal        Easy Use

This product is covered by or for use under one or more of the following patents or patent applications in the corresponding countries listed below.

USA: US6615834, US6789541, US6701926, US6951218, US7017576, US7308895
Australia: AU784321, AU785331, AU2002302002, AU2003281188, AU2004294873, AU2005228827, AU2009202852

Europe: EP1163924 (GB, IT, ES), EP1905475, EP1306098, EP1289590, EP1521613, EP1720593, EP1737524, EP2145645

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