DreamWisp
Nasal Mask with Over the Nose Cushion
Instructions for use - e
1 Safety Information
Intended Use
This nasal mask is intended to provide an interface for application of Continuous Positive Airway
Pressure (CPAP) or bi-level therapy to patients. The mask is intended for single patient use in the
home or multi-patient use in the hospital/institutional environment. The mask is to be used on
patients (>66 lbs/30kg) 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.
Warnings
A Warning indicates the possibility of injury to the user or operator
•
This mask is not for use on patients dependent on mechanical ventilation for their life
support.
•
Do not block or seal off the exhalation ports.
•
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.
•
Discontinue use and consult your healthcare professional if any of the following
symptoms occur: unusual chest discomfort, shortness of breath, severe headache,
eye pain or eye infections.
•
Discontinue use and contact your healthcare professional if any of the following
symptoms occur: skin redness, irritation, discomfort, blurred vision, or drying of the
eyes.
•
Discontinue use and consult your healthcare professional if any of the following
symptoms occur: tooth, gum, or jaw soreness. Use of a mask may aggravate an
existing dental condition.
•
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.
•
The headgear clips contain magnets. Contact your healthcare professional before
you use this mask.
•
Some medical devices may be affected by magnetic fields. The magnetic clips in
this mask should be kept at least 2 in. (50 mm) away from any active medical device
with special attention to implanted devices such as pacemakers, defibrillators and
cochlear implants.
•
Do not use in or near magnetic resonance imaging (MRI) equipment.
•
Keep unassembled magnetic headgear clips out of reach of children. In case of
accidental swallowing, seek medical assistance immediately.
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