86
EN
18 Technical Data
1568911, Edition 2019-04, Version 0
Approved adaptions
The following Nuvo products are approved as adaptions to the pendant system:
•
Chapter 20, “Approved Nuvo Products”, on page 92,
•
Chapter 21, “Optional Accessories”, on page 92,
•
Chapter 22, “Possible Combination with Third-Party Products”, on page 92:
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The components have been adapted to each other and are 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.
Read the Installation Instructions
for combined medical products
•
The pendant system can be equipped with adaptions and end devices of third-party
manufacturers. To prevent dangerous overload, which can damage or lead to a col
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lapse of the pendant system, the maximum load bearing capacity specified in Chapter
18, “Technical Data”, on page 84 must be adhered to:
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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 par
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ticular the relevant pages with information on the operation of the end device.
