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User manual Zitzi Active
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Guidelines and recommendations
Every time the Zitzi Active is altered 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.
The CE mark means that the product fulfils all of the essential European safety
requirements.
Note that a risk assessment always should be done for an adaptation as well as for
a customizing of a medical aid. The product must never become dangerous to use
after adaptation.
The product should be provided with a note that it is adapted to a specific user,
so that it cannot be mistaken for a standard model product.
Adaptions on Zitzi Active
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.
Cut footrest profiles
The footrest profile may be shortened to fit the user better.
Cut backrest profile
The backrest profile may be shortened to fit the user better. The profile must never
be shorter than allowing all the backrest brackets to be mounted on it.
Adaptation and customization
