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Visual-ICE
™
MRI Cryoablation System
11-3
11.8.2 Electromagnetic Compatibility and Immunity (EMC and EMI)
The Visual-ICE MRI Cryoablation System needs special precautions regarding electromagnetic
compatibility (EMC) and needs to be installed and placed into service according to the EMC
information provided below.
The Visual-ICE MRI Cryoablation System has been tested in the operating room environment for
electromagnetic compatibility (EMC) and electromagnetic interference (EMI) compliance. The Visual-
ICE MRI Cryoablation System has been tested to be in compliance with IEC 60601-1-2 and EN
55011.
Portable and mobile radiofrequency (RF) communications equipment can affect the Visual-ICE MRI
Cryoablation System, causing it to operate improperly.
Table 11-1. Cable Lengths
Cable Length
Power Cable 4.6 m (15 ft)
Ethernet Cable 3 m (10 ft)
External Video Cable
(ELC303167)
5 m (16 ft)
Gas Tubing
(connected to needles)
2.5 m (8 ft)
Gas Supply Lines
(connected to argon and
helium gas cylinders)
Available lengths:
5 m (16 ft), 8 m (26 ft)
Junction Box Harnesses
Available lengths:
5 m (16 ft), 10 m (33 ft),
15 m (49 ft)
NOTE: The Gas Supply Lines and Junction Box Harnesses are available in more than one length to
accommodate procedure room variations.
WARNING. Use of cables other than those specified, with the exception of those sold by
Galil Medical for use as replacement parts for internal components, may result in increased
emissions or decreased immunity of the Visual-ICE MRI Cryoablation System.
WARNING. The Visual-ICE MRI Cryoablation System should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use is necessary, the Visual-ICE MRI System
should be observed to verify normal operation.
WARNING. Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the Visual-ICE MRI Cryoablation System, including cables specified for use with the system.
Otherwise, degradation of the performance of this equipment could result.