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AF541 EE Leak 1 Oro-Nasal Mask
Instructions for Use -
e
Safety information
Intended Use
This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients.
The mask is for single use in the hospital/institutional environment only. The mask is to be used on
patients (>40lbs/20kg) for whom CPAP or bi-level therapy has been prescribed.
Caution:
U.S. Federal law restricts this device to sale by or on the order of a physician.
Note:
This mask is not made with natural rubber latex , BPA or DEHP.
Contraindications
This mask is not for use on patients with the following conditions: recent eye surgery or dry eyes,
hiatal hernia, excessive reflux, impaired cough reflex, and impaired cardiac sphincter function.
This mask should also not be used on patients who need life support ventilation, who are taking a
prescription drug that may cause vomiting, or on patients that are uncooperative, unresponsive, or
unable to remove the mask by themselves.
Warnings
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This mask requires a separate exhalation device.
•
Use of this mask while the system is not on and operating may cause rebreathing of exhaled air.
Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to
suffocation.
•
Monitor or intervene if the patient experiences skin redness, irritation, discomfort, blurred vision, or
drying of the eyes.
•
Monitor or intervene if any of the following symptoms occur: Unusual chest discomfort, shortness of
breath, stomach distension, belching, severe headache, eye pain or eye infections.
•
Monitor or intervene if any of the following symptoms occur: tooth, gum, or jaw soreness. Use of a
mask may aggravate a patient’s existing dental conditions.
•
This mask is for single use only and is not intended to be disinfected or cleaned after patient use.
Dispose of the mask after patient use.
•
This mask is not designed for multi-patient use. Respironics cannot guarantee the performance
specifications once this mask has been disinfected.
•
A minimum of 3cm H₂O (hPa) must be maintained when using this mask.
•
Attaching an exhalation device requires therapy pressure level adjustment to compensate for
increased leak.
•
Do not overtighten the headgear straps. Watch for signs of overtightening, such as excessive
redness, sores or bulging skin around the edges of the mask. Loosen the headgear straps to alleviate
symptoms.
•
Do not block the anti-asphyxia valve.
