27/04/04 ©
Söring
Users manual RF-units
1
not valid for MBC600
-7-
2.5.How to keep the instruction manual and the medical product log book
Instruction manuals and equipment books for RF surgery equipment must be kept, so that they
are always accessible to persons commissioned to use the equipment.
The responsible authority may ask to look at these books at any time.
2.6. Accident and damage report
Function failures or breakdowns of medical equipment causing bodily injury must be reported
immediately to the authority responsible.
The hospital must report the incident to the FDA and include all of the pertinent information as
required by that agency. Suggested information to be gathered by the hospital includes the
following:
1. What caused this event?
2. Was the equipment in proper operating condition
3. If repaired, does danger no longer exist.
4. Has new knowledge been gained which will make other or additional safety provisions
necessary?
2.7 Modifications and repairs
Modifications and repairs must not reduce the safety of the equipment and accessories for the
patient, user, or the environment. Therefore, modifications and repairs to this equipment must
only be carried out by the manufacturer or by persons explicitly authorized by Söring. If non-
authorized persons perform unqualified modifications and repairs to the equipment or
accessories, the manufacturer will not accept liability. Furthermore in this case the warranty
expires.
