Therapy Mask 3100 NC
Therapy Mask 3100 SP
Instructions for Use
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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 patient use in the home and multi-patient use in the hospital/
institutional environment. The mask is to be used on patients >7 years old (>40 lbs) 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 or DEHP.
• An electronic copy of these instructions can be found at: www.philips.com/IFU.
Contraindications
Use of this mask is contraindicated in patients with the following metallic implants: brain
shunts, aneurysm clips, splinters in the eyes, and certain neurostimulators used in and around
the head and neck.
Warning: Indicates the possibility of danger to the user or operator.
Caution: Indicates the possibility of damage to the device.
Warnings
• Magnets are used in the mask. The magnetic field strength is 400 mT. Ensure the
mask is kept at least 2 inches (5 cm) away from any active medical implant or medical
device that can be impacted by the magnetic field (e.g., pacemaker, defibrillators,
neurostimulators, cochlear implants, hearing aids) to avoid possible effects from
localized magnetic fields.
• This mask is not intended for patients who are dependent on mechanical ventilation
for their life support.
• 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 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: unusual chest discomfort, shortness of breath, severe headache, eye
pain or eye infections.
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