Service And Repair - KaVo SURGmatic S11 L Instructions For Use Manual

Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005
2 Safety | 2.6 Service and repair

2.6 Service and repair

Repairs, servicing and safety checks may only be performed by trained service
personnel. The following persons are authorized to do this:
▪ Service technicians of KaVo branches after the appropriate product training
▪ Service technicians of KaVo authorized dealers after the appropriate product
training
Comply with the following items during all servicing work:
4 Have the service and testing tasks carried out in accordance with the Medi-
cal Device Operation Ordinance.
4 Following expiration of the warranty, have the tool holding system checked
once a year.
4 Have the medical device evaluated by a professional shop with regard to its
cleaning, servicing and functional needs according to an in-house service in-
terval. Define the service interval depending on the frequency of use.
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 peo-
ple. This may result in aspiration, swallowing of parts and possibly even a risk
of suffocation.
4 Only use spare parts that comply with the specification for repair; original
KaVo spare parts comply with the specification.
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 reason-
able suspicion that the safety and health of patients or users may be jeopar-
dized, is prohibited by the German medical device law §4, section 1 no. 1 and
requires a separate conformity check.
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