Mercado Medic REAL 8000 PLUS, Инструкция по эксплуатации

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5.14. Individual adaptation
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.
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 details such as seats, back
supports and armrests are adaptable, but
the user must make sure not to exceed
the existing outer permitted adjustment
of the device.
• The patient’s centre of gravity must be
maintained over the lifting mechanism.
• 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.
For devices specially adapted by healthcare
services, outside Mercado Medic’s directive,
device liability passes to the healthcare
services until the device has been restored
to original condition or removed from the
market. Mercado Medic will then re-assume
device liability in accordance with the CE
marking Regulation on Medical Devices (EU)
2017/745, MDR.
For questions regarding customisation,
please contact the device Manager at
Mercado Medic using the contact details of
the head office under Section 1.1. Contact
details.
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Instructions for use for REAL 8000 PLUS Ophthalmology medical clinic chairs Configurations and settings
21-08997-EN-00