Gamma CADIAX 4 A, Operating Instructions Manual

Page: 14 / 80

CADIAX compact
14
1.2.2 Special information about medical electrical devices
1.2.2.1 Setting up the CADIAX device
If the computer connected with the
CADIAX device is in the proximity of the
patient, it must have been tested in com-
pliance with standard EN 60601-1.
The patient proximity (definition according
to standard EN 60601-1) is the area
within which the patient could, intention-
ally or unintentionally, come into contact
with:
·
either any parts of the medical elec-
trical device/system, or
·
with someone using or touching a part
of the device/system.
Definition of patient proximity, according to standard EN
60601-1
If the computer connected with the CADIAX device is not built according to standard EN 60601-1, it
must be set up outside the proximity of the patient.
If such a computer is set up inside the patient's proximity, it and all devices connected to it (e.g. mon-
itor) have to be isolated according to EN 60601-1. Power sources have to be connected through a med-
ical isolation transformer and tethered network connections through a medical network isolator.