Mercado Medic REAL 9200 TWIN Manuel D'utilisation page 73

Instructions for use for medical bariatric work chairs
5.12. Individual customisation
The device must not be equipped with any
accessories or components other than those
approved by Mercado Medic. To maintain the
CE marking, no individual modifications or
changes may be carried out without Mercado
Medic's approval. Modifications may be
made only by personnel who have completed
Mercado Medic's training for servicing and
reconditioning.
Mercado Medic's devices are modular
and can be customised with various
accessories. The components available,
as well as how and for what they are
used, can be found in the document
'Accessories for REAL 9200 TWIN' in the
www.mercado.se/en/mercado-document.
All accessories must be mounted and fixed
so that they maintain their setting and that
there is no possibility for small parts to come
loose. All cables must be secured with cable
ties to the device's structure to minimise the
risk of strangulation.
In addition to its own range, Mercado Medic
has combination agreements with several
companies. A list of the current companies
and components can be found under
the Combination Agreements section of
www.mercado.se/en/mercado-document.
These items may be assembled while
maintaining the CE marking.
If an item that is not on the list of applicable
combination agreements is fitted, the
responsible organisation must carry
out a risk analysis and take over device
responsibility from Mercado Medic regarding
the specific device. If a third-party item
is frequently used on the device, you can
contact Mercado Medic with a request for
a combination agreement between the
supplier of the item in question and Mercado
Medic. The item to be evaluated is sent to
Mercado Medic, which evaluates whether
combination agreements are up to date.
After that, a risk analysis is carried out on
the combination as desired. When a risk
analysis is carried out, the customer receives
a written statement and a new combination
agreement is drawn up. The combination
agreement is presented on the website
www.mercado.se/en/mercado-document.
If the following guidelines are met when
individually adapting authorised personnel
of an organisation other than Mercado
Medic, then Mercado Medic retains device
responsibility for the device.
• Padded components such as seats,
backrests, armrests and neck supports
can be adapted as long as they do not
exceed the existing external dimensions
of the device.
• The user's centre of gravity must be
maintained over the lifting mechanisms.
• Padded parts must be able to withstand
the applicable flammability requirements
and other environmental requirements.
If a third-party seat cushion is used, the
device must be fitted with a seat mat in
anti-slip material of an equivalent size in
order to ensure the safety of the device.
• Surfaces that are loaded with significant
vertical forces must not fall outside the
area (base) that is formed by the centre
points of the castors.
devices that have undergone changes
outside of the above guidelines must be
verified by Mercado Medic in order for
Mercado Medic to continue to retain device
liability.
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Configurations and settings
21-08861-EN-04