7200791 Service Manual for the HELION
®
XENION
®
Surgical Lighting System GB
43
14 Functional Check, Hand-Over and Customer Instruction
Hand-over to the customer
Check the earth connections
Acceptance protocol
according to the current standards
Demonstration on hand-over
Inspection intervals
By authorised staff only
14.1
14.1
14.1
14.1
14.1 Important Information
Important Information
Important Information
Important Information
Important Information
WARNING - Malfunction:
Before the initial operation of the light system the elec-
trical supply has to be checked and approved by quali-
fied staff.
• A functional check has to be performed after servicing has
been completed.
• Check that the earth connections comply with the current stand-
ards in your country.
• The lighting system must not be handed over to the customer
until it has been tested. The hand-over must be documented
in writing in accordance with the acceptance protocol in this
service manual and verified by the customer.
• The hand-over must comply with the standards DIN EN 60601-
2-41 “Particular requirements for the safety of surgical lumi-
naires and luminaires for diagnosis“ and VDE 0751-1 “Re-
peat tests/inspections of medical electrical devices or systems”
and be documented in writing in accordance with the accept-
ance protocol and verified by the customer.
• The equipment must be demonstrated to the customer on hand-
over.
14.2
14.2
14.2
14.2
14.2 Inspection intervals and authorised staff
Inspection intervals and authorised staff
Inspection intervals and authorised staff
Inspection intervals and authorised staff
Inspection intervals and authorised staff
During and/or after all work on a surgical lamp and/or lamp com-
bination, such as initial installation, repairs or maintenance, but
at least every 12 months, a safety check is to be carried out by an
authorised person! In addition, in the case of initial installation,
the monitoring activities listed in this appendix must be carried out
comprehensively and conscientiously, and recorded!
Following subsequent maintenance or repairs and/or every 12
months, these monitoring activities, in the form of safety checks or
intensive maintenance, should be repeated and confirmed.
In the case of initial installation, the safety checks or monitoring
activities must only be carried out by persons who, due to their
training, knowledge and practical experience, are able to carry
out such checks properly and are not under any other obligations
as regards these monitoring activities!
This knowledge, capabilities and requirements are only met by
staff of the TRUMPF Medizin Systeme GmbH Technical Customer
Service or specially trained persons authorised by them!
