Standards and IEC Classifications
9-10
Force FX Electrosurgical Generator C User’s Guide
Type CF Equipment (IEC 60601-1)/Defibrillator Proof
Liquid Spillage (IEC 60601-2-2 Clause 44.3)
The Force FX-C generator enclosure is constructed so that liquid spillage in normal use
des not wet electrical insulation or other components which when wetted are likely to
adversely affect the safety of the equipment.
Electromagnetic Interference
When placed on or beneath an activated Covidien electrosurgical generator, the Force
FX-C generator operates without interference. The generator minimizes electromagnetic
interference to video equipment used in the operating room.
Electromagnetic Compatibility (IEC 60601-1-2 and
IEC 60601-2-2)
The Force FX-C generator complies with the appropriate IEC 60601-1-2 and 60601-2-2
specifications regarding electromagnetic compatibility.
Applied Parts E2515, E2516, E2003, E4053-CT, E7507, E7506, E6008B, and E6009 were
tested with the unit and the combination was found to be in compliance with IEC 60601-
2-2 (Third Edition). Safety of use of other accessories, not identified in these instructions,
has not been determined by Underwriters Laboratories, Inc.
Voltage Transients (Emergency Generator Mains Transfer)
The Force FX-C generator operates in a safe manner when the transfer is made
between line AC and an emergency generator voltage source.
The Force FX-C generator provides a high degree of protection against electric shock,
particularly regarding allowable leakage currents. It is type CF isolated (floating)
output and may be used for procedures involving the heart.
The Force FX-C generator patient return electrode terminal is protected from
defibrillator discharge according to ANSI/AAMI HF18 and IEC 60601-2-2.
Notice
The Force FX-C generator requires special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in the Force
FX Electrosurgical
Generator C Service Manual
.
Portable and mobile RF communications equipment can affect the Force FX-C generator. Refer to
the EMC information provided in the Force
FX Electrosurgical Generator C Service Manual
.
Summary of Contents for Force FX-C
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