UNLOCKING POTENTIAL | TERUMOBCT.COM Page 7 of 15 Version 1.0 Rev 02/2021
©2021 Terumo BCT, Inc.
of the test level.
Table 3: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
T-SEAL III is intended for use in the electromagnetic environment specified below. The customer or
the user of T-SEAL III should assure that it is used in such an environment.
Electromagnetic Environment —
Guidance
Portable and mobile RF communications equipment should be used no closer to any part of
T-SEAL III including cables than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance:
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
150 kHz to 80 MHz
10 V/m
80 MHz to 2.5 GHz
10 V/m
communications equipment should
be used no closer to any part of the
sealer, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Where P is
the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,
a
should
be less than the compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which T-SEAL III is used exceeds the applicable RF compliance level above, it
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating T-SEAL III.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.