Instructions for Use Fabius MRI SW 3.n 9
For Your Safety and that of Your Patients
Patient safety
The design of the medical device, the accompany-
ing literature, and the labeling on the medical
device take into consideration that the purchase
and use of the medical device are restricted to
trained professionals, and that certain inherent
characteristics of the medical device are known to
the trained operator. Instructions, warnings, and
caution statements are limited, therefore, largely to
the specifics of the Dräger design.
This publication excludes references to various
hazards which are obvious to a medical profes-
sional and operator of this medical device, to the
consequences of medical device misuse, and to
potentially adverse effects in patients with abnor-
mal conditions. Medical device modification or mis-
use can be dangerous.
Patient monitoring
The operators of the medical device must recog-
nize their responsibility for choosing appropriate
safety monitoring that supplies adequate informa-
tion on medical device performance and patient
condition.
Patient safety may be achieved through a wide
variety of different 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.
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