KERR ENDODONTICS Elements 8:1 Instructions For Use Manual page 26

2 Safety
As a result of the use of NON-KaVo original spare parts during
the repair, parts such as covers may become undone and injure
the patient, user or other people. This may result in aspiration,
swallowing of parts and possibly even a risk of suffocation.
▶ Only use spare parts that comply with the specification for
repair; original KaVo spare parts comply with the specifica-
tion.
Note
If a repair is done with NON-KaVo original spare parts, this may
constitute a product modification that leads to the loss of CE
conformity. In the event of damage, the responsibility is with the
service company or the operator.
The introduction into the market of a modified product, where
there is reasonable suspicion that the safety and health of pa-
tients or users may be jeopardised, is prohibited by the German
medical device law §4, section 1 no. 1 and requires a separate
conformity check.
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