Warranty And Liability; Obligation Of System Owner And Personnel - Sirona galileos comfort plus Operating Instructions Manual

1 General information
1.5 Warranty and liability
Maintenance
Exclusion of liability
Certificate of work
8
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
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 must ensure that all inspections and maintenance
events take place.
As manufacturers of medical electrical equipment, we can assume
responsibility for the safety properties of the system only if maintenance
and repair work on the system is performed by ourselves or by agencies
expressly authorized by us, and if components affecting safe operation of
the system are replaced by original spare parts in case of failure.
If the system owner fails to fulfill the obligation to have inspections and
maintenance work performed or ignores error messages, Sirona Dental
Systems GmbH and its authorized dealers cannot assume any liability for
resulting damage.
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.
Sirona Dental Systems GmbH
64 91 208 D3437
D3437.201.09.07.02 12.2015