Electrical Safety; Mains Isolation; X-Ray Protection; Prevention Of Cross-Contamination - GENDEX GX S-700 Manual Del Usuario

Gendex GXS-700
TM

Electrical Safety

The product must be used only in rooms or areas which comply with all laws and regulations
applicable to electrical safety in medical premises, such as CEI standards regarding use of an
additional ground terminal for potential connections.
The GXS-700 sensor conforms to safety standard IEC 60601-1.
Gendex GXS-700 sensor is not suitable to be operated in oxygen rich and/or explosive
environments.
All IT components electrically connected to the GXS-700 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 intentional or
unintentional contact can occur between a Patient and parts of the ME Equipment or
ME System or between a Patient and other persons touching parts of the ME Equipment or
ME System."

Mains Isolation

Disconnection from the supply mains occurs at the input to the computer. The
sensor can also be disconnected from the computer.

X-ray Protection

All X-ray equipment for Dental Intra-ora. Radiography for GXS-700 must conform to IEC
60601-2-65:2012.
The rules of dental radiography still apply to digital X-ray systems. Please continue to use
protection for your patients. As a clinician, clear the immediate area when exposing the sensor.

Prevention of Cross-Contamination

To help prevent cross-contamination between patients, place a new hygienic barrier
on the sensor for each new patient. The hygienic barrier must cover the sensor and
at least 3-4 in. (7-10 cm) of the cable.
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