KaVo CONNECTbase, Инструкция по эксплуатации

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Instructions for use KaVo CONNECTbase
2 Safety | 2.4 Accessories and combination with other equipment
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2.4 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
Do not make any modifications to the device unless these have been ap-
proved by the manufacturer of the product.
The use of non-approved accessories as well as non-approved modifications
made to the medical device cause the conformity of the medical device accord-
ing to MDR 2017/745 to be voided. Anybody using non-approved accessories or
making non-approved modifications is deemed, according to MDR 2017/745, to
be the sole liable manufacturer of the medical device and to assume full re-
sponsibility. The new manufacturer is obliged to provide a new declaration of
conformity for the new medical device.
2.5 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.
The operator is responsible for making sure that the product is not used by un-
authorised persons.
2.6 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.
Improper maintenance and care may lead to premature wear and malfunction.
4
Service regularly with suitable agents.
The operator may only carry out repair work if the device is switched off and no
patient is being treated.
2.7 Internet security (Cybersecurity)
Unauthorised access by malware can lead to data loss are unauthorised disclos-
ure of sensitive data.
4
Always use a current virus scanner with firewall.
Hard disk defects can lead to data loss.
4
Generate backup copies regularly.
4 Keep backup copies in a safe location.