Other Relevant Documents; Warranty And Liability; Obligation Of System Owner And Personnel - Dentsply Sirona Orthophos E Ceph Operating Instructions Manual

1 General data

1.5 Other relevant documents

Maintenance
Exclusion of liability
Certificate of work
8
Other relevant documents
1.5
The X-ray system includes other components, such as PC software,
which are detailed in separate documents. Instructions and warning and
safety information provided in the following documents must be taken
into account:
● SIDEXIS 4 User Manual

Warranty and liability

1.6
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.

Obligation of system owner and personnel

1.7
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. Dentsply Sirona
recommends monthly testing.
Dentsply Sirona
Operating Instructions Orthophos E
67 11 001 D3352
D3352.201.12.01.02 03.2019