Approved Ondal Adaptations; Combination With Products Of Other Manufacturers; Patient Environment - Ondal ACROBAT LCH Operating Instructions Manual

1 Important Information for Safe Use
Approved accessories
Observe the Operating Instructions
for combined products
Abbildung 1:Patient environment, Figure
A.9 from IEC 60601-1:2005
1505093, Edition 2012-05, Version 5
1
1.8

Approved Ondal adaptations

The following Ondal products are approved as accessories to the pendant system:
• Ondal accessories as described in
– 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 Ondal product with the pendant system must be
approved by Ondal Medical Systems GmbH. If applicable, the conformity evaluation
must be renewed.
1.9

Combination with products of other manufacturers

• The pendant system can be combined with the adaptations and end devices (e.g. flat
screen, OR lamp, etc.) of third-party manufacturers. To prevent dangerous overload
which can damage or lead to damage or collapse of the pendant system, the maxi-
mum load bearing capacity specified in
must be adhered to.
• The party placing the appliance into operation is responsible for the validation of the
overall system. A conformity evaluation 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 and in par-
ticular the relevant pages with information on the operation of the end device.
• Power packs intended for the supply of end devices must ensure electrical isolation
and provide 2 protective measures in accordance with EN 60601-1.

1.10 Patient environment

(See "Figure 1")
Medical electrical devices which contain tangible parts and are attached to the spring arm
and positioned within the patient environment must provide two Means of Patient Protec-
tion (MOPP) in accordance with EN 60601-1.
If tangible parts are positioned outside the patient environment, two Means Of Operator
Protection (MOOP) in accordance with EN 60601-1 must be provided.
The dimensions in the figure show minimum extent of the patient environment in a free
surrounding.
66
"Chapter 12, Optional Accessories, on page 107"
"Chapter 11, Technical Data, on page 105"
GB
.