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13
Technical Data
Approved adaptions
Read the Operating Instructions
for combined medical products
1568913, Edition 2019-06, Version 0
The following Nuvo products are approved as adaptions to the pendant system:
•
Chapter 15, "Approved Nuvo Products", on page 54,
•
Chapter 16, "Optional Accessories", on page 54,
•
Chapter 17, "Possible Combination with Third-Party Products", on page 54:
–
The components are adapted to each other and safe to operate. Any other type of
installation, and in particular the use of components from third-party manufacturers,
is strictly prohibited because these components can be potential sources of danger.
–
The combination of any other Nuvo product with the pendant system must be
approved by Nuvo Surgical. If applicable, the conformity
assessment must be repeated.
•
The pendant system can be equipped with adaptions and end devices from third-party
manufacturers. To prevent dangerous overload, which can damage or lead to a col-
lapse of the pendant system, the maximum load bearing capacity specified in Chapter
, "", on page 45 must be adhered to:
–
The party placing the appliance into operation is responsible for the validation of the
overall system. A conformity assessment procedure shall be executed if required
and a declaration in accordance with Article 12 of 93/42/EEC (Medical Device Direc-
tive, MDD) shall be provided.
–
Read the Operating Instructions provided by the third-party manufacturer and in
particular the relevant pages with information on the operation of the end device.
48
en
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