Fisher Paykel Solo Nasal Mask User Manual

Solo Nasal Mask
Nasal Pillows Mask
Instructions for Use

Solo Nasal Mask

F &P Solo™ mask
Instructions for Use

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

Contraindications
None.
General warnings & cautions
Any serious incident must be reported to the competent authority and your Fisher & Paykel Healthcare representative.
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 if vomiting occurs.
Warning: Do not use the mask if feeling nauseous or vomiting as this may result in excessive carbon dioxide inhalation 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.
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 indications for use as this may result in a range of harms, some of which are severe.
Caution: Therapy may be compromised if your airway is congested. Use of a different mask may be recommended in this situation. Consult your healthcare provider.
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 cushion 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 F&P Solo 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 (tooth movement and/or misalignment).
• Claustrophobia and/or anxiety.
• Eye dryness, swelling and/or redness.

If you experience any of the above side effects, including any not listed in theseinstructions, discontinue using the F&P Solo mask and consult your physician immediately. Any other serious incidents must be reported to the competent authorityand your Fisher & Paykel Healthcare representative.

Mask parts & features
Refer to the mask diagram on the front panel of these instructions.

(A) Frame
(B) Headgear
(C) Tube
(D) Swivel
(E) Exhaust Holes
(F) Nasal Cushion
(G) Pillows Cushion

Operating instructions

Please refer to the Warnings and Cautions within these instructions. Failure to follow the operating instructions may compromise the performance and safety of the mask. Only use your mask for its Intended Purpose as directed in these instructions.
Conditions of use
The operating pressure range of your mask is 4 to 20 cmHO2.
Warning: Only use the mask within the specified pressure range. Use outside of this range may result in excessive carbon dioxide inhalation 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.
Caution: Replace your mask/components after any of the following occur as failure to do so may compromise the function of the mask.

• After the expiry date printed on the external label on the mask packaging.
• Mask excluding Headgear: 12 months from date of first use of the Frame (A),
  Tube (C), Swivel (D) or Cushion (F or G) Headgear: 6 months from date of first use of the Headgear (B).

Caution: When storing or traveling with your mask ensure it is stored in such a way to avoid bending or twisting as this may compromise the function of the mask.
Before use
Before using your mask the first time: Remove all packaging.
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.
Warning: Inspect the Exhaust Holes (E). Ensure air is flowing through the exhaust and do not use if blocked as this may result in excessive carbon dioxide inhalation.
Caution: Inspect the mask for damage or deterioration. If there is any visible deterioration (cracking, tears, etc.), do not use the mask and seek replacementpart(s) from your healthcare provider as using the mask may result in lacerationsor compromised therapy.
Caution: Inspect the mask for soiling and dust and, if present, follow the cleaninginstructions to remove the soiling or dust as this may result in a range of harms,some of which are severe.

Fitting your mask
Remove all packaging before using the mask.
Refer to the fitting images inside the front cover of these instructions.

1. Anchor the grey strap behind your head and pull forward to stretch the Headgear (B) over your head.
2. Position the Cushion (F or G) under your nose and orange strap on the top of your head.
3. Connect the Swivel (D) to the PAP device breathing tube. Turn on the PAP device.
4. Pull the Cushion (F or G) away from the nose to loosen the Headgear (B).
5. Push the Cushion (F or G) into the nose to tighten Headgear (B).

Useful tips:

• Adjustment tip iii : iv  The Headgear (B) can be adjusted by lengthening and shortening the side straps.
• The Cushion (F or G) should seal and feel comfortable under your nose.
• Your nose should never be inside the Nasal Cushion (F) opening.
• If you are experiencing any leaks try repositioning the Cushion (F or G) under your nose.

Warning: Do not overtighten the mask as this may result in facial deformation.
Caution: Failure to follow fitting instructions or using the incorrect mask size may result in pressure sores or excessive leak causing eye injury.

Disassembling your mask v

1. Unclip the front of the Headgear (B) from the Frame (A) located in front of the Exhaust Holes (E).
2. Pull the Cushion (F or G) from the Frame (A).

Caution: Do not attempt to remove the swivel as this may compromise the function of the mask.
Caution: Do not attempt to remove the tube from the frame as this may compromise the function of the mask.

Assembling your mask

1. Push the Cushion (F or G) on to the Frame (A).
2. Push the Headgear (B) down on to the Frame (A) in front of the Exhaust Holes (E).

Cleaning your mask at home
Mask excluding Headgear: After each use, wash the Frame (A), Tube (C), Swivel (D) and Cushion (F or G).
Headgear: After 7 days use, wash the Headgear (B) thoroughly to minimize any dirt and oil build up to maintain longevity and function.

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. Do not extend headgear while wet.
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 guidelines of these instructions, as any other products may result in an adverse reaction if cleaning residue is left behind.
Caution: Failure to follow the cleaning instructions may compromise the function of the mask.
Caution: Do not clean the mask with products containing alcohol, 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.

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 F&P Solo 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 Instructions for Use 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
The F&P Solo 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 exhaled CO2 is expelled from the mask.

Resistance to flow
Pressure drop through the nasal mask at 50 L/min: 0.8 ± 0.5 cmH₂O.
Pressure drop through the nasal mask at 100 L/min: 2.9 ± 1.0 cmH₂O.
Pressure drop through the pillows mask at 50 L/min: 1.6 ± 1.1 cmH₂O.
Pressure drop through the pillows mask at 100 L/min: 6.0 ± 3.1 cmH₂O.

Mask dead space

Nasal:| Small = 29.6 cm³
Wide = 36.9 cm³| Medium = 26.8 cm³| Large = 31.1 cm³
---|---|---|---
Pillows:| Small = 25.8 cm³| Medium = 27.7 cm³| Large = 30.5 cm³

Sound
The sound power level of the mask is 31.5 dBA, with uncertainty ± 2.5 dBA.
The sound pressure level of the mask is 23.6 dBA, with uncertainty ± 2.5 dBA.

Mask materials
The F&P Solo mask and accessories are pyrogen free and 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 F&P Solo mask, as this may cause an adverse reaction.

Carbon Reinforced Nylon
Tube| Polycarbonate (PC)/Polyurethane
Swivel| Nylon

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 F&P Solo mask does not contain any hazardous materials and may be disposed of with general waste.
Intellectual property information
F&P, F&P Solo, and myMask are trademarks of Fisher & Paykel Healthcare Limited.
For patent information, see www.fphcare.com/ip

Symbol definitions

| | | | |
---|---|---|---|---|---
Single patientmultiple use| Date of manufacture| Recycling symbol| Manufacturer| Catalogue number| Batch code
| | | | |
Authorized European Representative| Storage temperature limitation| Caution/ Warning| Humidity limitation| Medical device| Use by date
| | | | S| M
Prescription only| Unique device indicator| Consult instructions for use| Follow instructions for use| Small cushionsize| Medium cushion size
L| ****| | | |
Large cushionsize| Wide cushion size| Importer| Distributor| Authorised representative for
Switzerland| UK Responsible Person

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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
Australia (AU) (Sponsor) Fisher  &  Paykel Healthcare Pty Ltd, 19-31 King Street, Nunawading, Melbourne, Victoria 3131. Tel:  +61  3  9871  4900
Fisher  &  Paykel do Brasil, Rua Sampaio Viana, 277 cj 21, Paraíso, 04004-000, São Paulo  –  SP, Brazil Tel:  +55  11  2548  7002
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Fisher & Paykel Healthcare GmbH, Säntisstrasse 2, 9501 Wil / SG, Switzerland Tel: 0800 83 47 63
Fisher & Paykel Healthcare Ltd, Unit 16, Cordwallis Park, Clivemont Road, Maidenhead, Berkshire SL6 7BU, UK Tel: 0800 132 189  USA (US)/Canada (CA) Tel: 1800 446 3908 or +1 949 453 4000

REF 621682 REV B 2023-06
© 2023 Fisher & Paykel Healthcare Limited

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