Zitzi DELFI PRO, Руководство пользователя

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User manual
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Zitzi Delfi Pro
Guidelines and recommendations
Risk assessment
Every time the Zitzi Delfi Pro 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 customization of a medical aid. The product must never become dangerous
to use after adaptation.
The product should be fitted with a note that it is adapted to a specific user,
so that it cannot be mistaken for a standard model product.
Adaptation and customization
Note!
The CE-mark is no longer valid if the product is customized.