Warranty And Liability; Obligation Of System Owner And Personnel - Sirona Orthophos XG 5 Operating Instructions Manual

Sirona Dental Systems GmbH
Operating Instructions ORTHOPHOS XG 5 / Ceph
Maintenance
Exclusion of liability
Certificate of work
60 04 811 D3352
D3352.201.04.25.23 12.2017
1.5

Warranty and liability

In the interest of the safety and health of patients, users and other
persons, inspection and preventive maintenance must be performed at
scheduled intervals to ensure the operational reliability and functional
safety of your product (IEC 60601-1 / DIN EN 60601-1 etc.).
The system owner is responsible for making sure that all scheduled
inspections and preventive maintenance activities are performed.
As manufacturers of medical electrical equipment we can assume
responsibility for the safety-related features of the equipment only if
maintenance and repair are carried out only by ourselves or agencies
expressly authorized by us, and if components affecting safe operation of
the system are replaced with original spare parts upon failure.
In the event that the system owner fails to fulfill the obligation to perform
scheduled inspections and preventive maintenance activities or ignores
error messages, Sirona Dental Systems GmbH and its authorized dealers
cannot assume any liability for damages.
We suggest that you request a certificate, showing the nature and extent
of the work performed, from those who carry out such work, and specify
that the certificate show any changes in rated parameters or working
ranges, as well as the date, the name of the firm and a signature.
1.6

Obligation of system owner and personnel

These operating instructions presuppose that you are familiar with the
use of Sidexis software.
Prior to the exposure, please ask women of a childbearing age as to
whether they are pregnant or not. If the patient is pregnant, a risk/benefit
analysis must be performed.
According to the X-ray Ordinance of Germany, owners of X-ray
equipment must perform constancy tests at regular intervals in order to
ensure the safety of operating staff and patients. Sirona recommends
monthly testing.
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