F&P Solo Manual

General warnings & cautions

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

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.

Do not use the mask if feeling nauseous or vomiting as this may result in excessive carbon dioxide inhalation if vomiting occurs.

Do not use the mask unless the PAP device is turned on and operating properly as this may result in excessive carbon dioxide inhalation.

This mask is not suitable for life support ventilation as this may result in death.

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.

Do not use the mask outside of the intended purpose as this may result in a range of harms, some of which are severe.

Therapy may be compromised if your airway is congested. Use of a different mask may be recommended in this situation. Consult your healthcare provider.

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.

myMask App

*Not available in all countries

Intended purpose

The F&P Solo mask is intended to be used as a patient interface in a non-invasive positive airway pressure (PAP) therapy system to deliver pressurized air from the breathing tube to the patient's upper airway. The patients are intended to be adults weighing ≥66 lbs (30 kg). The mask is intended to be used for single patient re-use in the home for the treatment of a respiratory condition and in a hospital or other clinical setting to investigate the optimal pressure required for the treatment of a respiratory condition.

Contraindications

None.

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 these instructions, discontinue using the F&P Solo mask and consult your physician immediately. Any other serious incidents must be reported to the competent authority and your Fisher & Paykel Healthcare representative.

Product parts & features

See Fig.

1. Frame
2. Headgear
3. Tube
4. Swivel
5. Exhaust Holes
6. Nasal Cushion
7. 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 cmH₂O.

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.

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).

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

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).

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:

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.

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.

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.

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 product

Remove all packaging before using the mask.
Refer to the fitting images .

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 : 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.

Do not overtighten the mask as this may result in facial deformation.

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

Disassembling your product

See image

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).

Do not attempt to remove the swivel as this may compromise the function of the mask.

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

Assembling your product

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 product 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.

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.

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.

Failure to follow the cleaning instructions may compromise the function of the mask.

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

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

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.

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

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.

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

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.

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.

Product materials

The F&P Solo mask and accessories are pyrogen free and not made with natural rubber latex or DEHP.

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.

Replacement parts

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

*Not available in all countries.

Symbol definitions

Date of manufacture	Manufacturer	Catalogue number	Batch code	Medical device	Authorized European Representative
Storage temperature limitation	Caution/Warning	Humidity limitation	Use by date	Rx only Prescription only	Unique device indicator
S Small cushion size	M Medium cushion size	L Large cushion size	W Wide cushion size	Importer	Distributor

Documents / Resources

References

• App Store - Apple
• Google Play

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Here you can download full pdf version of manual, it may contain additional safety instructions, warranty information, FCC rules, etc.

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