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WARNINGS
• 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.
• Your mask should only be used with approved CPAP or Bi-Level equipment recommended by your
physician or respiratory therapist. Your mask should not be used unless the CPAP or Bi-Level machine
is turned on and operating properly. To avoid having an adverse effect on the safety and quality of the
therapy, the exhaust holes on 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.
i. Device switched on (with mask connected): 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.
ii. Device switched off (with mask connected): When the CPAP or Bi-Level machine is turned off,
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 of exhaled air may occur.
• Discontinue use and consult your healthcare provider or physician if the following occurs:
i. Discomfort or irritation in or near the eyes.
ii. Excessive leaks between mask Seal and face.
iii. Gum, jaw or mouth soreness/ discomfort or an aggravation of an existing dental condition occurs.
iv. Allergic reaction.
v. Mask discomfort or irritation.
• Do not use if vomiting or feeling nauseous.
• Do not block Elbow side vents.
• Mask use with oxygen: With your 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 your CPAP or Bi-Level machine
enclosure will create a risk of fire. You should not smoke or be in the vicinity of someone smoking while
using oxygen with your mask.
• As part of good hygiene, always follow cleaning instructions and use mild soap. Some cleaning
products may damage the mask, its parts and their function, or leave harmful residual vapours that
could be inhaled if not rinsed thoroughly.
• California residents please be advised of the following, pursuant to Proposition 65: This product
contains chemicals known to the State of California to cause cancer, birth defects and other
reproductive harm. For more information, please visit: www.fphcare.com/prop65
CAUTIONS
• Use your mask for its intended use as directed in this guide.
• If any visible deterioration of a system component is apparent (cracking, discolouration, tears etc), the
component should be discarded and replaced.
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/
CONTRAINDICATION
None known.
DISPOSAL
Your mask does not contain any hazardous material and may be disposed of with general waste.
PATENT INFORMATION
For patent information, see www.fphcare.com/ip
ENGLISH 7
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