Anatomic SITT Zitzi Guppy G2, User Manual

Page: 37 / 40

37 User manual Zitzi Guppy G2 www.anatomicsitt.com | +46 11 16 18 00
Adaptation and customization
NOTE!
The CE marking expires on customized products.
Guidelines and recommendations
Every time the Zitzi Guppy 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.
Allowed adaptations of the Guppy
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.
Holes in the seat plate
Holes in the seat plate may be added for assembly. However, the following criteria
must be followed:
•
No more than 4 holes
•
Holes no larger than 6.5 mm
•
Holes must not be less than 15 mm from existing holes and grooves
•
Holes must not be less than 15 mm from the edge of the plate
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.