Chapter 2 - Safety And Disposal Procedures; Electrical Safety - GENDEX GXS-700 Manuel D'utilisateur

Chapter
2
The device must be installed and used in accordance with the safety regulations and
instructions for use supplied in this User Manual, for the purposes and applications for which
it is intended.
Modifications and/or additions to the GXS-700 must be made exclusively by Gendex personnel
or by parties expressly authorized for the purpose by Gendex. Any modifications or additions
must always comply with standards and generally recognized rules of good workmanship.

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."
Always check sensor prior to use.
WARNING
Do not continue to use the GXS-700 if there is visible damage to the sensor
housing and/or cable.
032-0279-EN Rev 1
Safety and Disposal
Procedures
2-1