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Instructions for use MULTIflex LED coupling 460 LED - 1.007.3201
2 Safety | 2.5 Accessories and combination with other equipment
To ensure optimum function and to prevent property damage, please comply
with the following instructions:
4 Service the medical device regularly with care products and systems as de-
scribed in the instructions for use.
4 The device should be reprocessed and stored in a dry location, according to
instructions, if it is not to be used for an extended period of time.
2.5 Accessories and combination with other equipment
Use of non-authorised accessories or non-authorised modifications of the device
could lead to injury.
4 Only use accessories that have been approved for combination with the
product by the manufacturer.
4 Only use accessories that are equipped with standardised interfaces.
4 Do not make any modifications to the product.
2.6 Qualification of personnel
Application of the product by users without the appropriate medical training
could injure patients, users or third parties.
4 Make sure that the user has read and fully comprehends the instructions for
use.
4 Make sure that the user has read and comprehends the national and re-
gional regulations.
4 The device may be used only if the user has completed the appropriate
medical training.
2.7 Service and repair
Repairs, servicing and safety checks may only be performed by trained service
personnel. The following persons are authorised to do this:
▪ Service technicians of KaVo branches after the appropriate product training
▪ Service technicians of KaVo authorised dealers after the appropriate product
training
Observe all the following items during servicing work:
4 Have the service and testing tasks carried out according to the Medical
Device Operator Ordinance.
4 KaVo recommends specifying in-house service intervals where the medical
device is brought to a professional shop for cleaning, servicing and a func-
tion check. 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
people. 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 of a modified product in the market, in which the reasonable
suspicion exists to endanger the safety and health of patients or users, is pro-
hibited by Medical Device Law §4, Abs.1 No. 1 and therefore requires its own
conformity check.
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