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1
Important Information for Safe Use
Read the Operating Instructions
for combined medical products
Figure 4: Patient environment,
illustration A.9 from IEC 60601
1568913, Edition 2019-06, Version 0
1.8
Approved Nuvo products
The following Nuvo products are approved for use on the pendant system:
•
Nuvo products in accordance with Chapter 15, "Approved Nuvo 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. If applicable, the conformity assessment must be repeated.
1.9
Combination with products of other manufacturers
•
The pendant system is combined with the CEMOR monitor carrier system or the Nav-
igator M6. To prevent dangerous overload, which can lead to a failure or collapse 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
Directive, MDD) shall be provided.
–
Read the Operating Instructions provided by the third-party manufacturer to obtain
the information required for the operation of the end device (e.g. flat screen, medical
device, etc.).
•
Power packs intended for the supply of end devices must ensure electrical isolation
and provide two protective measures in accordance with IEC 60601-1.
1.10 Patient environment
(See Figure 4)
•
If medical electrical appliances with tangible parts are attached to the pendant system
and if these are positioned within the patient environment, they must provide two
patient protection measures (MOPP) in accordance with IEC 60601-1.
•
If tangible parts are positioned outside the patient environment, two Means Of
Operator Protection (MOOP) in accordance with IEC 60601-1 must be provided.
•
The dimensions in the Figure illustrate the minimum extension of the patient
environment in an unrestricted area.
14
en
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