Philips Respironics AF811 Gebrauchsanweisung

Instructions for Use
AF811 SE Gel Full Face Mask
Intended Use
The AF811 SE Gel Full Face Mask is intended to provide a patient interface for application
of noninvasive ventilation. The mask is to be used as an accessory to ventilators which
have adequate alarms and safety systems for ventilation failure and which are intended
to administer CPAP or positive pressure ventilation for treatment of respiratory failure,
respiratory insufficiency or obstructive sleep apnea. The mask is for single use in the
hospital/institutional environment only. The mask is to be used on patients (>66lbs/30kg)
who are appropriate candidates for noninvasive ventilation.
Note: An exhalation port is not built into the AF811 SE Gel Full Face Mask. A separate
exhalation device must be used with this mask.
Note: This mask does not contain natural rubber latex or DEHP.
Caution: U. S. federal law restricts this device to sale by or on the order of a physician.
Symbols
Warning or
Caution
Does not contain
natural rubber latex
Warnings:
• This mask is not suitable for providing life support ventilation.
• A separate exhalation device must be used with this mask.
• This mask is designed for use with CPAP or bi-level systems recommended by your health
care professional or respiratory therapist. Do not wear this mask unless the CPAP or bi-level
system is turned on and operating properly. Do not block or try to seal the exhalation port.
Explanation of the Warning: CPAP systems are intended to be used with special masks with
connectors which have vent holes to allow continuous flow of air out of the mask. When
the CPAP machine is turned on and functioning properly, new air from the CPAP machine
flushes the exhaled air out through the attached mask exhalation port. However, when the
CPAP machine is not operating, enough fresh air will not be provided through the mask,
and exhaled air may be rebreathed. This warning applies to most models of CPAP systems.
• If oxygen is used with the device, the oxygen flow must be turned off when the device is
not operating. Explanation of the Warning: When the device is not in operation, and the
oxygen flow is left on, oxygen delivered into the ventilator tubing may accumulate within
the device enclosure. Oxygen accumulated in the device enclosure will create a risk of fire.
• Oxygen supports combustion. Oxygen should not be used while smoking or in the
presence of an open flame.
• At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will
vary, depending on the pressure settings, patient breathing pattern, mask selection, and
the leak rate. This warning applies to most types of CPAP and bi-level machines.
• Some users may experience skin redness, irritation, or discomfort. If this happens,
discontinue use and contact your healthcare professional.
• The patient's physician should be contacted if the patient
experiences the following symptoms while using the masks
Consult instructions
Note
for use
Do Not
Reuse
E N G L I S H
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