27/04/04 © Söring Users manual RF-units
1
not valid for MBC600
-6-
2. Important notes regarding the operation of RF Surgery units
During operation of RF surgery equipment disturbances of other electronic devices
may occur due to generated interfering signals.
2.1. Operating of RF Surgery Equipment
The user is only allowed to operate such RF Surgery Equipment after the manufacturer or the
distributor has:
1. Checked the equipment for faultless function at the location of operation and
2. Introduced the person responsible to the operation of equipment according to the instruction
manual.
2.2. User instructions
RF Surgery equipment is only to be operated by persons, who have been introduced to the
correct use of the equipment according to the instruction manual. Only people with sufficient
knowledge of how to handle the equipment and practical experience are allowed to instruct
others.
If such instruments are combined with additional equipment, the instruction of the operating
personnel must be extended to the combination and its special functions.
2.3. Prescribed safety checks
The user of the RF Surgery unit must carry out the prescribed safety checks within the period
stipulated and to the extent required. The extent and the periods for safety checks for RF
equipment must be performed according to manufacturer's recommendations regarding extent
and periods of inspections during servicing.
Safety checks of the technical protocols must be assigned only to those who have the
appropriate education, the knowledge, and the experience gained during their practical work
enabling them to carry out those checks accordingly. The safety check should be performed in
a distraction free environment. If failures are found during safety checks, which may endanger
patients, staff or third parties, the technician must immediately inform the authority responsible
for the use of the instrumentation.
2.4. Medical Product Log Book
The supervising operator of RF Surgery units must keep a medical product log book. Other
documentation is equivalent to the medical product log book, as long as it fulfills the
requirements of the medical product log book to the same extent and is available for the user
at any time.
The following entries are to be made in the medical product log book
1. Date and time of the function test before operating the equipment for the first time.
2. Date and time of instruction, as well as the names of the instructed persons.
3. Date and time of performing required safety checks and maintenance as well as the name of
the person or the company performing these checks.
4. Date, time, kind, and consequences of failures and of re-occurring similar operation
mistakes.
A copy of the CE certificate must be kept with the medical product log book.
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