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16
Initial and Repeated Commissioning and Handover
Initial commissioning
1568911, Edition 2019-04, Version 0
1. The pendant system must be properly installed. Instructions for installation are in-
cluded 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 and 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 Navigator M6 is 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
initial commissioning and documented by signing a test report in accordance with
Appendix G DIN EN 62353.
The following points must be observed during handover to the operator:
1. The pendant system and 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 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.
80
EN
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