Anatomic SITT Zitzi Starfish Pro, Руководство пользователя

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14 User manual Zitzi Starfish Pro www.anatomicsitt.com | +46 11 16 18 00
Recommendations
Every time the product is changed in some way, an assessment has to be made to
determine if it is an adaptation or a customization.
An adaptation is any change made in comprehension of the CE mark. All other
changes are customizations. Adaptations must only be made by a person deemed
to be qualified for the task and should always be made in a professional manner.
Allowed adaptations within the framework of CE marking
The footrest profile may be shortened to fit the user better.
The length of the armrest profile may be shortened to better fit the user.
The length of the backrest profile may be shortened. The profile must never be
shorter than all brackets for the back plate can be mounted on.
The urine protection can be cut to the desired length.
Risk analysis
Note that a risk assessment always should be done for an adaptation as well as for
a customization of a medical aid. The product must never become dangerous to
use after adaptation.
Marking
The product should be notified that it is adapted to a specific user so that it can not
be mistaken for a standard product.
Adaption and customization