Medical Information; Indications For Use; Contraindications; Warnings - ResMed S8 Elite System Clinician Manual

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338210r3 Eng.book Page 7 Monday, July 11, 2005 1:28 PM
M
I
EDICAL
NFORMATION
I
NDICATIONS FOR
The
CPAP system is indicated for the treatment of obstructive sleep apnea
S8 E
LITE
(OSA) in adult patients.
The
CPAP system is intended for home and hospital use.
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CAUTION
!
In the US, Federal law restricts this device to sale by or on the order of a physician.
C
ONTRAINDICATIONS
The
is not a life support device and may stop operating with power failure or
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certain fault conditions. It should not be used by patients who are dependent on
continuous therapy.
Positive airway pressure therapy may be contraindicated in some patients with the
following pre-existing conditions:
severe bullous lung disease
pneumothorax
pathologically low blood pressure
dehydration
cerebrospinal fluid leak, recent cranial surgery, or trauma.
W
ARNINGS
The entire manual should be read before using the
Advice contained in this manual should not supersede instructions given by the
prescribing physician.
A patient should not connect a device to the data communication port unless
instructed to do so by their health care provider or physician. Only ResMed
products are designed to be connected to the data communication port.
Connecting other devices could result in injury, or damage to the
The
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ResMed, or by a physician or respiratory therapist. A mask should not be used
unless the
S8 E
holes associated with the mask should never be blocked.
Explanation: The
*
connectors
) which have vent holes to allow continuous flow of air out of the
mask.
When the device is turned on and functioning properly, new air from the device
flushes the exhaled air out through the mask vent holes. However, when the
device is not operating, insufficient fresh air will be provided through the mask, and
*
Ports may be incorporated in the mask or in connectors that are near the mask.
U
SE
should only be used with masks (and connectors
device is turned on and operating properly. The vent hole or
LITE
is intended to be used with special masks (or
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.
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device.
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*
) recommended by
M
I
EDICAL
NFORMATION
7

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