Qualification Of Personnel; Service And Repair; Internet Security (Cybersecurity) - KaVo ESTETICA E30 Instructions For Use Manual

Instructions for use ESTETICA E30
2 Safety | 2.8 Qualification of personnel
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.

2.8 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 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.

2.9 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.
Improper maintenance and care may lead to premature wear and malfunction.
4 Service regularly with suitable agents.
Residual liquids of any type can cause stains on or damage to cushions and
parts of the housing.
4 Remove any residual liquids without delay.
The operator may only carry out repair work if the device is switched off and no
patient is being treated.

2.10 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.
The user is responsible for backing up data.
For security reasons, the database and all document files should be backed up
regularly. A data backup schedule should be prepared.
KaVo recommends daily backup.
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