9. Further Information
⚠️ 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.
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Explanation of Warning:
- 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.
- 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.
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Discontinue use and consult your healthcare provider or physician if the following occurs:
- Discomfort or irritation in or near the eyes.
- Excessive leaks between mask Seal and face.
- Gum, jaw or mouth soreness/ discomfort or an aggravation of an existing dental condition occurs.
- Allergic reaction.
- Mask discomfort or irritation.
- Do not use if vomiting or feeling nauseous.
- Do not block Elbow side vents.
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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.
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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.
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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.
Contraindication
None known.
Disposal
Your mask does not contain any hazardous material and may be disposed of with general waste.