KaVo 1.007.0150, Инструкция по эксплуатации

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Instructions for use INTRA LUX Motor KL 703 LED – 1.007.0150
2 Safety | 2.8 Qualification of personnel
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2.8 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 The device may be used only if the user has completed the appropriate
medical training.
4
Make sure that the user has read and comprehends the national and re-
gional regulations.
2.9 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 After servicing, interventions on and repairs of the device and before re-use,
have the service personnel perform safety checks on the device.
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.
2.10 Property damage
Contaminated and moist compressed air can cause malfunctions and premature
wear.
4 Make sure to supply dry, clean and uncontaminated compressed air in ac-
cordance with DIN EN ISO 7494-2.
Contaminated water can cause malfunctions and premature wear.
4 Make sure that the water quality generally complies with DIN EN ISO
7494-2, permissible pH 7.2 to 7.8.