76
1505093, Edition 2012-05, Version 5
GB
4 Initial and Repeated Commissioning
Initial commissioning 1. The pendant system must be installed. Installation instructions are included in the
scope of delivery of the product.
2. For commissioning following installation, proper initial commissioning must be car-
ried out for the entire pendant system.
Functional test Prior to using the pendant system on a patient for the first time, a functional test at the
place of installation must be carried out by the operator or a person authorised by the op-
erator; the persons authorised by the operator must have been duly instructed by the op-
erator.
To use the pendant system for medical operation, these Operating Instructions only apply
if:
1. The functional reliability of the pendant system has been ensured.
2. The maximum permissible loading capacity (payload) has been safely determined
and is indicated on a label attached to the spring arm or adaptation.
3. Proper functioning has been approved by the operator during initial commissioning
and documented by signing a declaration of acceptance.
The following points must be observed during handover to the operator:
1. The pendant system must be subjected to extensive tests before being handed over
to the operator.
2. Handover must be documented in writing including confirmation by the operator.
3. On handover, the operator must be instructed in the functioning and effect of the
maximum loading capacity (payload).
4. In addition, the operator must be instructed in the functioning, operation, cleaning
and disinfection of the pendant system during the handover procedure.
5. Permitted adjustments in accordance with the Operating Instructions included in the
scope of delivery must be explained to the operator on handover.
6. On completion of the instruction, an instruction certificate must be created and
signed in order to document that the operator/user has understood the special oper-
ator control actions required for normal use.
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