Airway Morf User Instructions

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Intended Use
The Morf Nasal Mask is intended to be used by individuals who
have been diagnosed by a Physician as requiring CPAP or Bi-Level
ventilator treatment. The Morf Nasal Mask is intended for single
patient adult(>66lb/30kg) use in the home, hospital or other
clinical setting.
Operating Instructions
The operating pressure range of the mask is 4-20cm H20.
The transport and storage temperature range of the mask is -20 to
50°C (40 – 122°F).
The operating temperature of the mask is 5-40°C (40 – 104°F).
Before each use:
- Make sure the air path through the mask is clear
- Inspect the vent holes. Do not use if blocked
- Inspect the mask for damage. Do not use if there are any visible
deterioration (tears, cracks etc), and seek replacement part(s).
Note: Failure to follow the operating instructions may compromise
the performance and safety of the mask.
Warnings
US Federal Law restricts this device to sale by, or on order of, a
physician.
This mask should only be used with CPAP/Bi-Level equipment
recommended by your physician or respiratory therapist. A mask
should not be used unless the CPAP/Bi-Level device is turned on
and operating properly. The vent holes of the mask should never be
blocked.
Explanation of warning: CPAP and Bi-Level machines are intended
to be used with special masks which have exhalation ports to allow
continuous flow of air out of the mask. When the CPAP/Bi-Level
machine is turned on and functioning properly, new air from the
CPAP/Bi-Level machine flushes the exhaled air out through the
exhalation ports. However, when the CPAP/Bi-Level machine is not
operating, enough fresh air will not be provided through the mask,
and exhaled air may be re-breathed. Re-breathing of exhaled air for
longer than several minutes can in some circumstances lead to
su ocation.
If oxygen is used with CPAP/Bi-Level machine, the oxygen flow
must turned o when the CPAP/Bi-Level machine is not operating.
Explanation of warning: When the CPAP/Bi-Level device is not in
operation, and the oxygen flow is left on, oxygen delivered into the
ventilator tubing may accumulate within the CPAP/Bi-Level
machine enclosure. Oxygen accumulated in the CPAP/Bi-Level
machine enclosure will create a risk of fire.
Do not use Polyvinyl Chloride (PVC) pressure and/or oxygen tubing.
Use silicone tubing instead.
Explanation of warning: Flexible PVC contains elements that can be
detrimental to the materials of the mask, and may lead to cracking
or breakage of mask components.
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Discontinue use if reaction occurs to any part of the mask and
consult physician.
•
Discontinue use if experiencing discomfort and consult physician.
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Mask is single patient use.
•
Discontinue use of mask if damaged or cracked and seek
replacement.
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Do not use mask if vomiting or feeling nauseous.
•
Do not use mask if patient is unable to remove mask by
themselves.
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Use on adults only (>66lb/30kg).
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Shake loose hot water o seal before placing on face for fitting.
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Do not to misuse mask.
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Only use the mask with approved CPAP or Bi-Level machine that
complies with ISO 17510-1 or ISO 14971.
•
Use a humidifier if experiencing nasal congestion or dry airway.
•
Do not store or transport the mask in temperatures outside of -20
to 50°C.
•
Electrically conductive breathing tubes should not be used (does
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not apply to approved heated breathing tubes).
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Combinations with other medical products can alter the
performance of the product, e.g. combinations with: humidifier for
medical use, nebulizer, heat and moisture exchanger (HME),
filters, CPAP, Bi-level positive airway pressure device,
self-adjusting sleep apnea breathing therapy device, or additional
oxygen supply.
User Instructions
Airway Management Contacts
Manufacturer
4300 Alpha Rd, Suite 115
Farmers Branch, TX 75244
Tel: (866) 264-7667
Fax: (214) 691-3151
Website: www.tapintosleep.com
80024 REV A
Patents: www.tapintosleep.com/patents