4. CE-conformity John GmbH, as manufacturer, declares under its sole responsibility that the JOSI-Wismi is a medical device in compliance with the applicable requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council.
This chapter on transport in vehicles does not refer to the transport of JOSI-Wismi users in public transport. John GmbH does not impose any additional requirements on the product for the transport of JOSI-Wismi users on public transport. However, be sure to always observe the respective requirements and authorisations of the individual transport companies and their individual vehicles.
The combination of the JOSI-Wismi with the Decon E-Drive has been approved for vehicle transport by both manufacturers John GmbH and Decon AB. This model variant of the JOSI-Wismi in size L was successfully crash-tested in accordance with ISO 7176-19 and is the heaviest authorised model variant.
For the operating instructions and guarantee conditions, please observe the enclosed manual for the Decon E-Drive! It is recommended to have the installation carried out by the manufacturer (John GmbH). The installation must be carried out by a specialist. 21. Care and maintenance 21.1 Technical inspection...
The guarantee conditions of the Decon electric drive (if mounted) can be found in the product manual. 26. Reporting serious incidents All serious incidents occurring in connection with the products must be reported to the manufacturer (John GmbH) and the competent authority. „Serious incident“ means any incident that directly or indirectly led, might have led or might lead to any of the following: the death of a patient, user or other person;...
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