64 09 713 D3610
D3610
.
201.01.08
.
02 09.2016
11
Sirona Dental Systems GmbH
2 Safety instructions
Operating Instructions and Installation XIOS XG USB module and sensors
2.6 Trouble-free operation
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2.6
Trouble-free operation
Use of this unit is permissible only if it works properly without
malfunctions. If trouble-free operation cannot be ensured, the unit must
be taken out of service, checked by authorized technicians for
malfunctions and, if necessary, repaired or replaced.
2.7
Maintenance
Reference to Regular Inspections, USB Module
In the interest of the safety and health of patients, users and other
persons, inspections 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.), see "Regular Inspections" [ → 64].
The owner is responsible for making sure that all inspections are
performed.
In the event that the system owner fails to fulfill the obligation to perform
scheduled inspection activities or ignores error messages, Sirona Dental
Systems GmbH and its authorized dealers cannot assume any liability for
damages.
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.
We suggest that you request a certificate showing the nature and extent
of the work performed from those who carry out such work; it must contain
any changes in rated parameters or working ranges (if applicable), as well
as the date, the name of the company and a signature.
2.8
Changes and extensions to the device
Modifications to this system which might affect the safety of the system
owner, patients or other persons are prohibited by law!
For reasons of product safety, this product may be operated only with
original Sirona accessories or third-party accessories expressly approved
by Sirona. The user is responsible for any damage resulting from the use
of non-approved accessories.
If devices that are not approved by Sirona are connected, they must
comply with the applicable standards, e.g.:
● IEC 60950-1 or IEC 62368-1 for IT equipment (e.g. PC) and
● IEC 60601-1 for medical devices.
In case of doubt, contact the manufacturer of the system components.
2.9
Combination with other units
Permissible combinations are specified in the Declaration of Conformity
by the system integrator.