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Initial and Repeated Commissioning and Handover
Initial commissioning
1568913, Edition 2019-06, Version 0
1. The pendant system must be installed. Instructions for installation are included in the
scope of delivery of the product.
2. For commissioning following installation, proper initial commissioning must be
carried out for the entire pendant system.
Functional test
Prior to using the pendant system and the CEMOR or the Navigator M6 on a patient for the
first time, a functional test must take place at the installation site. This functional test must
be carried out by the operator or a person authorised by the operator, and the
persons authorised by the operator must be duly instructed.
This requirement is considered fulfilled if:
1. the functional reliability of the pendant system and the CEMOR or the Navigator M6
has been ensured,
2. the maximum permissible loading capacity (payload) has been
safely determined and is indicated on a label attached to the Navigator M6,
3. the proper functioning of the appliance has been approved by the operator during in-
itial commissioning and documented by signing a declaration of acceptance.
The following points must be observed during handover to the operator:
1. The pendant system and the CEMOR or the Navigator M6 must not be handed over
to the operator until they have been tested.
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 and the CEMOR or the Navigator M6
during the handover procedure.
5. Furthermore, on handover, the operator must be instructed in the adjustments per-
mitted according to the Operating Instructions included in the scope of delivery.
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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en
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