Vante SEBRA 2605, Operation Manual

Page: 29 / 32

7-2
7-1
P/N VT-108732-US, Manual revision: C
Radio Frequency System Safety Considerations
G
ENERAL
I
NFORMATION
Vante manufactures a variety of instruments that incorporate the use of radio
frequency (RF) for sealing, welding, or forming thermoplastics. Typical uses
include the sealing of blood bag and apheresis tubing, and plastic welding or
forming manufacturing 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 Interna-
tional Telecommunications Union (ITU) for industrial, scientific, and medical
(ISM) use. The following is an advisory regarding RF instrument use and
associated safety considerations.
RF Effects On
Human Tissue
Misuse or direct contact between tissue and RF electrode(s) can result in severe
RF burns.
RF Effects On
Pacemakers
There is no evidence that Vante RF instruments interfere with the function of
modern cardiac pacemakers.
Electrical Safety
Vante RF devices meet or exceed appropriate electrical safety standards, and pose
no electrical shock hazard when used with properly fused and grounded outlets.
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 Effects In
Potentially
Explosive
Atmospheres
Do not operate Vante RF instruments in any area with a potentially explosive
atmosphere. It is possible for the RF electrodes to arc, initiating an explosion
or fire.
Warning: Vante recommends strict adherence to the procedures specified
in the instrument Operation Manual. Misuse or modification of an instrument
may result in unsafe or hazardous situations.
Chapter 7