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1. Declaration of Conformity
We declare that our medical devices as well as our accessories for medical devices are in conformity with the
requirements of the Medical Devices Directive 93/42/EEC. Therefore, the FIOR & GENTZ products bear the CE marking.
2. Warranty
The warranty only applies if the product is used under the described conditions and for the intended purpose. The
warranty expires if the product is used differently, if it is combined with other system components or materials or
if it is mounted according to a different production technique than the one recommended by the FIOR & GENTZ
Orthosis Configurator. A combination with products from other manufacturers requires a written consent by the
seller. The warranty and guarantee expire if the product is mounted several times. For further information, we
refer to our General Terms and Conditions of Business Transactions, Sales, Delivery and Payment.
3. Safety Information
This manual is addressed to orthotists. That is why the content basically confines to features of the product. It
does not contain any notes about dangers which are obvious to orthotists. Please note that the product is not
supposed to be combined with other components or materials than with those recommended by the FIOR & GENTZ
Orthosis Configurator.
To achieve maximum safety, please show the patient and/or the care team how to use and maintain the product
correctly. Enclosed to this manual you will find a patient information which has to be given to the patient and/
or the care team.
For information reasons and for the safety of your patient, please note all information provided in this manual
including notes, tables and illustrations. In particular, note the safety instructions indicated by DANGER, WARNING,
CAUTION and NOTICE that are listed and explained in the following paragraph. Ignoring this information may
lead to patient injuries and property damage.
All serious incidents connected to the product shall be reported to the manufacturer or the responsible
authorities.
4. Safety Instructions
4.1 Classification of the Safety Instructions
Important information about a possible dangerous situation which,
DANGER
if not avoided, leads to death or irreversible injuries.
Important information about a possible dangerous situation which,
if not avoided, leads to reversible injuries that need medical treatment.
WARNING
Important information about a possible dangerous situation which,
if not avoided, leads to light injuries that do not need medical treatment.
CAUTION
Important information about a possible situation which,
if not avoided, leads to damage of the product.
NOTICE
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