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The operator may operate the device only if an on-site functional test has previously been performed by
Gebrüder Martin or a person authorized by Gebrüder Martin. In addition, a responsible person designated
by the operator must have been instructed in the proper handling, application and operation of the device,
as well as in its permissible combination with other medical devices, objects and accessories. This duly
instructed officer shall subsequently be responsible for familiarizing the operator’s staff with the device as
the need arises.
We recommend documenting all user instructions in a medical device logbook. A copy of the logbook is
available from Gebrüder Martin.
The operational safety of the device must be verified at regular intervals, see section 14.2 “Inspection and
Maintenance”, page 100.
If the device is not functionally reliable and/or safe to operate, it must be marked as such and withdrawn
from service. A technical check is mandatory in any such case.
