Safety Information; Intended Use; Contraindications - Philips Respironics 3100 NC Gebrauchsanweisung

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

Therapy Mask 3100 NC and SP are contraindicated for use with medical devices that are
affected by magnets with a field strength of 0.2 mT at 2 inches (5 cm) from the device.
Warning: Indicates the possibility of danger to the user or operator.
Caution: Indicates the possibility of damage to the device.
Warnings
• 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.
• 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 block the exhalation ports.
• 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.
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