Vante 3120 Instruction Manual - page 19
Vante
™
Model 3120
11
4. Radio Frequency System Safety Considerations
4.1 Introduction
4.1.1 Vante™ manufactures a variety of instruments which incorporate the use of
radio frequency (RF) for sealing, welding, or forming thermoplastics. Typical
uses include biopharmaceutical tube sealing, thermoplastic welding and
thermoplastic forming processes. When in operation, these RF instruments emit
radio frequency energy to people, other instruments, and equipment located in
close proximity. Current Vante™ RF instruments operate at a frequency
authorized by the Federal Communications Commission (FCC) and the
International Telecommunications Union (ITU) for industrial, scientific, and
medical (ISM) use. The following is an advisory regarding RF instrument use
and associated safety considerations.
4.2 RF Effects On Human Tissue
4.2.1 Vante™ RF instruments are in compliance with (IEEE) C95.1-1991,
standards for safe exposure levels to RF energy. However, misuse or direct
contact between tissue and RF electrode(s) can result in severe RF burns.
4.3 RF Effects On Pacemakers
4.3.1 There is no evidence that Vante™ RF instruments interfere with the
function of modern cardiac pacemakers. However, as a precaution, Vante™
recommends that RF sealers not be operated in a continuous, rhythmic duty cycle
within an eight-foot radius of an individual wearing a pacemaker.
4.4 Electrical Safety
4.4.1 Vante™ RF devices meet or exceed appropriate electrical safety standards,
and pose no electrical shock hazard when used with properly fused and grounded
outlets.
4.5 RF Effects On Electronic Equipment
4.5.1 Vante™ instruments produce RF power, and during operation emit some
RF energy from the electrodes. While most modern electronic equipment and
instruments provide shielding from RF energy, improperly shielded electronic
devices operating in close proximity to an RF instrument may be affected. If
interference is suspected, appropriate electronic shielding, moving equipment
further away from the RF instrument, or operating from a different electrical
circuit may be necessary.