¡
The device owner must have periodic safety inspections performed.
¡
Safety inspections may be performed only by BERCHTOLD employees
or authorized, knowledgeable professionals who have obtained writ-
ten permission from BERCHTOLD.
¡
If defects are found that pose a risk to patients, employees or third
parties, the device owner must immediately notify the responsible au-
thorities.
¡
The protocol prepared by the authorized, knowledgeable professio-
nal concerning the employed measurement procedures and results
and other evaluations must be retained until the next inspection.
NOTICE
No liability for non-compliance with time intervals!
1. The manufacturer assumes no liability for material dam-
age or personal injury if safety inspections are not or-
dered and carried out by the due date.
¡
Functional failures and problems with the device that have resulted in
personal injury must be immediately reported to the responsible au-
thorities and the manufacturer.
¡
The safety evaluation must include the following information:
¡
What was the cause of the event?
¡
Was the device in proper condition?
¡
Was the risk eliminated after the defect was corrected?
¡
Was new knowledge obtained that requires other or additional pre-
cautions be taken?
¡
The device owner should maintain a maintenance record with the
following information:
¡
Designation and specifications that identify the device
¡
Testing, PMs and corrective maintenance actions from initial startup
throughout the life of the device.
Safety inspections
Accident and damage
reports
Maintenance Record
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
Safety
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