Conformance To Standards; Safety Considerations - KaVo DEXIS Titanium Benutzerhandbuch

2.6.1 Conformance to Standards

All X-ray equipment for Dental Intra-oral Radiography used with DEXIS Tita-
nium must conform to IEC 60601-2-65.
The DEXIS Titanium sensor conforms to safety standard IEC 60601-1.
All IT components electrically connected to the DEXIS Titanium sensor
must conform to IEC 60950-1.
Normally, the IT components are placed OUTSIDE the patient environment.
IT components placed INSIDE the patient environment, due to customer
site requirements, must also conform to IEC 60601-1.
IEC 60601-1 defines the "Patient environment" as "any volume in which in-
tentional or unintentional contact can occur between a Patient and parts of
the Medical Equipment (ME) or ME System or between a Patient and other
persons touching parts of the ME Equipment or ME System."
CAUTION
US Federal law restricts this device to sale by or on the order of a
dentist or other licensed practitioner.

2.6.2 Safety Considerations

All external surfaces of the sensor, sensor cable, sensor holders and the
sensor sheaths are considered to be applied parts and are safe for normal
or accidental patient contact during use.
The DEXIS Titanium sensor has no serviceable parts. Do not open the de-
vice to service it. All aspects of the sensor that are meant to be attended to
by the operator are accessible without opening the internal components of
the device. If there is a service problem, contact a qualified dealer service
representative or DEXIS Technical Support.
English
Install ation, Care, an d Mai nte nance
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