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5. Radio Frequency System Safety Considerations
5.1 General Information
Vante
manufactures a variety of instruments which incorporate the use of radio
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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
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.
5.2 RF Effects On Human Tissue
Misuse or direct contact between tissue and RF electrode(s) can result in severe RF burns.
5.3 RF Effects On Pacemakers
There is no evidence that Vante
cardiac pacemakers.
5.4 Electrical Safety
Vante
RF devices meet or exceed appropriate electrical safety standards and pose no
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electrical shock hazard when used with properly fused and grounded outlets.
5.5 RF Effects On Electronic Equipment
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.
RF instruments interfere with the function of modern
®
Vante
Model 4105
®
RF
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