FISHER PAYKEL EVF1XMLU Evora Full Face Mask User Guide

FISHER PAYKEL EVF1XMLU Evora Full Face Mask User Guide

INTENDED USE/INDICATIONS FOR USE

The F&P Evora™ Full Face mask is intended to be used by adults weighing ≥ 66 lbs (30 kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Evora Full Face mask is intended for single-patient use in the home.

CONTRAINDICATIONS

None.

CLINICAL BENEFITS

Positive airway pressure (PAP) therapy delivered through the Evora Full Face mask, when administered at a pressure prescribed by a certified and practicing physician, can effectively treat respiratory conditions which require effective airway management. This can be achieved by preventing or relieving airway obstruction, when this results in airflow reduction at the upper airway level or reduced gas exchange.

Not receiving or discontinuing PAP therapy contrary to medical advice can result in the development, recurrence, or exacerbation of symptoms associated with the respiratory condition for which treatment has been prescribed. Decisions regarding the modification or cessation of PAP therapy for any given individual should be made with or at the discretion of a qualified healthcare professional.

GENERAL WARNINGS

Any serious incident must be reported to the competent authority and your Fisher & Paykel Healthcare representative.

Warning

• Warning: Do not use the mask without supervision on patients who are unable to remove the mask themselves as this may result in excessive carbon dioxide inhalation or suffocation if vomiting occurs.
• Warning: Do not use the mask if feeling nauseous or vomiting as this may result in excessive carbon dioxide inhalation or suffocation if vomiting occurs.
• Warning: Do not use the mask unless the PAP device is turned on and operating properly as this may result in excessive carbon dioxide inhalation or suffocation.
• Warning: This mask is not suitable for life support ventilation as this may result in death.
• Warning: Do not administer drugs or medications into the device or breathing tube, with the exception of supplemental oxygen, as it may impact the efficacy of the medicine.
• Warning: Do not use the mask outside of the population stated in the intended use as this may result in a range of harms, some of which are severe.
• Caution: Discontinue use and consult your healthcare provider or physician if you are experiencing:
  • Discomfort or irritation near your eyes as this may result in an eye injury.
  • Excessive leaks between the mask seal and your face as this may result in compromised therapy.
  • An adverse reaction after using the mask, including an allergic reaction.

POSSIBLE SIDE EFFECTS

While using the Evora Full Face mask, you may experience:

• Difficulty sleeping
• Facial irritation (pressure sores, skin redness, skin dryness and/or abrasion)
• Oral pain (toothache and/or gum soreness)
• Dental deformation
• Claustrophobia and/or anxiety
• Eye dryness, swelling and/or redness

If you experience any of the above side effects, including others not listed in this guide, discontinue using the Evora Full Face mask and consult your physician immediately.

MASK PARTS AND FEATURES

Refer to the mask diagram (i) on the inside front cover of this guide.

• (A) Seal
• (B) Frame
• (C) Headgear
• (D) Headgear Clips
• (E) Swivel
• (F) Frame Clip
• (G) Tube
• (H) Flap Vents
• (I) Flap
• (J) Exhaust Holes

OPERATING INSTRUCTIONS

Please refer to the Warnings and Cautions within this guide. Failure to follow the operating instructions may compromise the performance and safety of the mask. Only use your mask for its intended use as directed in this guide.

CONDITIONS OF USE

The operating pressure range of your mask is 4 to 30 cmH2O.

Warning: Only use the mask within the specified pressure range. Use outside of this range may result in excessive carbon dioxide inhalation, suffocation or excessive leak which may result in an eye injury.

Warning: Your mask should only be used with approved PAP equipment recommended by your physician or respiratory therapist.
Using the mask with any other medical device could decrease the safety or alter the performance of the mask.

The operating temperature range of your mask is 5 to 40 °C (41 to 104 °F).

Store your mask dry in clean conditions. The storage temperature of your mask is -20 to 50°C (-4 to 122 °F).

Caution: Do not store your mask in direct sunlight as this may compromise the function of the mask.

The expiry date is printed on the label of the plastic bag. Do not use your mask after its expiry date.

For single-patient use in the home, replace the mask no later than 12 months after the date of first use.

BEFORE EACH USE

Before using your mask the first time:

• Remove all packaging (plastic bag and cardboard insert).

Before using your mask each time:

• Warning: Make sure the air path through the mask is free from blockages that may prevent or restrict airflow as this may result in excessive carbon dioxide inhalation or suffocation. The air path includes Swivel (E), Tube (G), Frame (B) and Seal (A).

• Warning: Inspect the Exhaust Holes (J). Ensure air is flowing through the exhaust and do not use if blocked as this may result in excessive carbon dioxide inhalation or suffocation.

• Warning: Inspect the Flap (I) to ensure it is moving freely. If it is not, this may result in excessive carbon dioxide inhalation or suffocation.

• Warning: Inspect the Flap Vents (H) to ensure they are not blocked.
  If they are blocked this may result in excessive carbon dioxide inhalation or suffocation.

• Caution: Inspect the mask for damage or deterioration. If there is any visible deterioration (cracking, tears, etc.), do not use the mask and seek replacement part(s) from your healthcare provider as using the mask may result in lacerations or compromised therapy.

• Caution: Inspect the mask for soiling and dust and, if present, follow the cleaning instructions to remove the soiling or dust as this may result in a range of harms, some of which are severe.

FITTING YOUR MASK

1. Ensure that both Headgear Clips (D) are unhooked from the Frame (B).

2. Place the Seal (A) onto your face and guide the Headgear (C) over your head.

3. Hook both Headgear Clips (D) onto the Frame (B).

4. Gently tighten the Headgear (C) straps, starting with the blue upper straps, followed by loosely fitting the lower straps.

5. Connect the Tube (G) with the Swivel (E) to the PAP tube. Turn on the PAP device. Repeat step 4 until the mask seals and the Seal (A) feels comfortable on your face. If you are experiencing mask leaks, you may need to lift the Seal (A) off your face and reposition it. If the Headgear (C) touches the ear, adjust the straps on the top of your head.

Note: If you are unable to adjust the lower headgear straps because they are too short, please contact your healthcare provider to order the following headgear: 400EVF122 – Evora Full Headgear Spare Extra Large.

Warning: Do not over tighten the mask as this may result in facial deformation or suffocation if aspiration of liquid, such as vomit, occurs.

Caution: Failure to follow fitting instructions or using the incorrect mask size may result in pressure sores or excessive leak causing eye injury

TAKING OFF YOUR MASK

Unhook both Headgear Clips (D) from Frame (B). Move the Mask away from your face. The straps of the Headgear (C) do not need to be loosened.

DISASSEMBLING YOUR MASK

1. Unhook both Headgear Clips (D) from the Frame (B).
2. Pull the Frame Clip (F) from the Frame (B), but leave it attached to the Headgear (C).
3. Pull the Seal (A) from the Frame (B).
4. Pull the Tube (G) from the Frame (B).
5. Pull the Swivel (E) from the Tube (G).

Useful Tip:
Check the Swivel (E) is not stuck in the PAP tube.

ASSEMBLING YOUR MASK

1. Push the Seal (A) firmly into place on the Frame (B) to click into place.

2. Push the Tube (G) onto the Frame (B) to click into place.

3. Push the Swivel (E) onto the Tube (G) to click into place.
   

4. Connect the Frame Clip (F) to the Frame (B) to click into place.
   

5. Hook the Headgear Clips (D) onto the Frame (B) to click into place.
   

CLEANING YOUR MASK AT HOME

After each use: Wash the Seal (A). Wash the Frame (B) with the Tube (G) connected.

After 7 days use: Wash the Swivel (E) and the complete Headgear (C). Wash the Tube (G) disconnected from the Frame (B). It is not necessary to remove the Frame Clip (F) and the Headgear Clips (D) from the Headgear (C).

1. Disassemble for cleaning as described in the ‘Disassembling your mask’ section above.
2. Hand-wash the mask parts in soap dissolved in lukewarm water. Do not soak for more than 10 minutes.
3. Rinse thoroughly in fresh water. Ensure that all soap residue has been removed.
4. Inspect all parts to ensure they are visually clean. If necessary, repeat the cleaning steps until all parts are visually clean.
5. Leave all parts to dry out of direct sunlight before reassembling.

Warning: Do not share your mask with another person when using it at home as it may result in the transfer of biological agents such as viruses or bacteria.

Caution: Only clean the mask with cleaning products specified in the cleaning instructions of this guide, as any other products may result in an adverse reaction if cleaning residue is left behind.

Caution: Do not clean the mask with products containing alcohol, antibacterial agents, antiseptic, bleach, chlorine or moisturizer as these may compromise the function of the mask.

Caution: Do not clean the mask in a dishwasher as this may compromise the function of the mask.

Caution: Failure to fully disassemble the mask may compromise the effectiveness of cleaning and may result in a range of harms, some of which are severe.

ADVANCED DISASSEMBLY

To disassemble Headgear Clips (D) and Frame Clip (F) from the Headgear (C):

1. Lie the flexed tabs flat against the Headgear strap and glide them through the Headgear Clip (D) and Frame Clip (F) openings.
2. Unhook the Headgear Clips (D) and remove the Frame Clip (F) from Frame (B).

ADVANCED ASSEMBLY

To assemble Headgear Clips (D) and Frame Clip (F) to Headgear (C):

1. Hook the Headgear Clips (D) back onto the Frame (B). Connect the Frame Clip (F) to the Frame (B) to click in place.
2. Thread the bottom straps of the Headgear (C) through the Headgear Clip (D) openings.
3. Thread the blue top straps of the Headgear (C) through the Frame Clip (F) openings.

SYMBOL DEFINITIONS

| Catalogue number| | CE Marking
---|---|---|---
| Manufacturer| | Prescription only
| Authorized European Representative| | Extra Small seal size
| Batch code| | Small to Medium seal size
| Storage temperature limitation| | Large seal size
| Date of manufacture| | Standard headgear size
| Consult instructions for use| | Extra Large headgear size
| Caution/Warning| | Medical device
| Single patient multiple use| | Use by date
| Humidity limitation| | Unique device indicator

OXYGEN/PRESSURE PORT CONNECTOR

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

Warning: Mask use with supplemental oxygen will create a risk of fire. Do not smoke, or be in the vicinity of someone smoking, or any other ignition source while using supplemental oxygen with your mask. This may result in ignition of the oxygen, leading to serious burns or death.

USE WITH OTHER PAP DEVICES

Warning: When using the Evora Full Face mask with other 22 mm connector (ISO-5356-1) compatible PAP devices (including an F&P Oxygen/Pressure Port Connector REF 900HC452): Refer to the user instructions for that device as there may be additional warnings and cautions that if not followed may result in a range of harms, some of which are severe.

TECHNICAL SPECIFICATIONS

EXHAUST FLOW INFORMATION

Pressure (cmH2O) 4 6 8 10 12 14 16 18 20 22 24 26 28 30
Flow (L/min) 21 25 28 32 35 38 41 44 46 49 51 54 56 58

Due to manufacturing variations, the exhaust flow rates may vary from the nominal values shown above.

RESISTANCE TO FLOW
Pressure drop through the mask at 50 L/min: 0.9±0.3 cmH2O.
Pressure drop through the mask at 100 L/min: 2.2±0.3 cmH2O.

INSPIRATORY AND EXPIRATORY RESISTANCE
Inspiratory resistance of the mask (in combination with the Non-Rebreathing Valve) is 4.3±1.0 cmH2O.
Expiratory resistance of the mask (in combination with the Non-Rebreathing Valve) is 3.8±1.0 cmH2O.
The opening to atmosphere pressure of the Non-Rebreathing Valve is 0.7±0.3 cmH2O.
The closing to atmosphere pressure of the Non-Rebreathing Valve is 2.2±0.3 cmH2O.

MASK DEAD SPACE
Extra Small = 165.2 cm³ Small-Medium = 162.6 cm³ Large = 164.1 cm³

SOUND
The sound power level of the mask is 28.2 dBA, with uncertainty 2.5 dBA.
The sound pressure level of the mask is 20.2 dBA, with uncertainty 2.5 dBA.

MASK MATERIALS

The Evora Full Face mask and accessories are not made with natural rubber latex or DEHP.

Caution: If you are allergic or intolerant to any of the following materials, consult your physician before using the Evora Full Face mask, as this may cause an adverse reaction.

REPLACEMENT PARTS

The following parts are available for replacement. Please contact your healthcare provider.

Not available in all countries.

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 www.fphcare.com/sleep-apnea/masks/warranty- mask/

DISPOSAL

The Evora Full Face mask does not contain any hazardous materials and may be disposed of with general waste.

PATENT INFORMATION

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

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 Importer/ Distributor

Australia (Sponsor) Fisher & Paykel Healthcare
Pty Ltd, 19-31 King Street, Nunawading,

Melbourne, Victoria 3131. Tel: +61 3 9871 4900
Fax: +61 3 9871 4998

Austria Tel: 0800 29 31 23 Fax: 0800 29 31 22 Benelux
Tel: +31 40 216 3555 Fax: +31 40 216 3554

Brazil Fisher & Paykel do Brasil, Rua Sampaio
Viana, 277 cj 21, Paraíso, 04004-000, São Paulo – SP, Brazil Tel: +55 11 2548 7002

China
: +86 20 32053486
: +86 20 32052132

Denmark
Tel: +45 70 26 37 70 Fax: +46 83 66 310

Finland
Tel: +358 9 251 66 123
Fax: +46 83 66 310

France
Fisher & Paykel Healthcare SAS, 10 Av. du Québec, Bât
F5, BP 512, Villebon-sur-Yvette, 91946 Courtaboeuf Cedex,

France
Tel: +33 1 6446 5201
Fax: +33 1 6446 5221
Email: c.s@fphcare.fr

Germany
Fisher & Paykel Healthcare
GmbH, Deutschland, Österreich, Schweiz, Wiesenstrasse 49, D 73614 Schorndorf, Germany Tel: +49 7181 98599 0 Fax: +49 7181 98599 66

Hong Kong
Tel: +852 2116 0032
Fax: +852 2116 0085

India
Tel: +91 80 2309 6400

Ireland
Tel: 1800 409 011
Fax: +44 1628 626 146

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

Japan
Tel: +81 3 5117 7110
Fax: +81 3 5117 7115

Korea
Tel: +82 2 6205 6900
Fax: +82 2 6309 6901

Mexico
Tel: + 52 55 9130 1626

Norway
Tel: +47 21 60 13 53
Fax: +47 22 99 60 10

Poland
Tel: 00800 49 119 77
Fax: 00800 49 119 78

Russia
Tel. and Fax: +7 495 782 21 50

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
İthalatçı Firma: Fisher Paykel Sağlık Ürünleri Ticaret Limited Şirketi, İletişim Bilgileri: Ostim
Mahallesi 1249. Cadde No:6, Yenimahalle, Ankara, Türkiye 06374, 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: 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

• Home | Fisher & Paykel Healthcare
• About Us | Fisher & Paykel Healthcare
• Mask Warranty | Fisher & Paykel Healthcare | Fisher & Paykel Healthcare

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