Dräger 8413417 Instrucciones De Uso página 23

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to potentially adverse effects in patients with
abnormal conditions. Medical device modification
or misuse can be dangerous.
Patient monitoring
The operators of the medical device are
responsible for choosing appropriate safety
monitoring that supplies adequate information on
medical device performance and patient condition.
Patient safety may be achieved through a wide
variety of means ranging from electronic
surveillance of medical device performance and
patient condition, to simple, direct observation of
clinical signs.
The responsibility for the selection of the best level
of patient monitoring lies solely with the medical
device operator.
Functional Safety
The medical air compressor has no essential
performance features according to IEC 60601-1,
whose absence or reduction presents an
unreasonable risk.
General WARNINGS and CAUTIONS
The following WARNINGS and CAUTIONS apply to
general operation of the device.WARNINGS and
CAUTIONS specific to subsystems or particular
features appear with those topics in later sections
of these Instructions for Use or in the Instructions
for Use of any product being used with this device.
WARNING
Do not use the medical device during
magnetic resonance imaging (MRI, NMR,
NMI)! This may impair correct functioning of
the medical device and endanger the patient.
WARNING
Do not use the medical device in hyperbaric
chambers! This may impair correct
functioning of the medical device and
endanger the patient.
Instructions for Use Air Compressor
WARNING
Fire hazard!
Do not use the medical device in conjunction
with flammable gases or flammable solutions
that can mix with air, oxygen or nitrous oxide,
or other sources of ignition since the medical
device could ignite. Do not allow the medical
device to come into contact with sources of
ignition.
Note on EMC/ESD risk for the device function
General information on electromagnetic
compatibility (EMC) pursuant to international EMC
standard IEC 60601-1-2:
Electromedical devices are subject to special
precautionary measures concerning
electromagnetic compatibility (EMC) and must be
installed and put into operation in accordance with
the EMC information provided on page 33.
Portable and mobile RF communications
equipment can affect medical electrical equipment.
Keeping the Instructions for Use
CAUTION
The Instructions for Use must be kept in an
accessible location for users.
Only for US:
WARNING
To maintain grounding integrity, connect only
to a "hospital grade" receptacle. Always
disconnect supply before servicing.
English / US English
23

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