Spectros Medical Devices Inc.
Page 40 of 44
Rev B
T-STAT 2.0 User Manual
Table 3
Guidance and manufacturer’s declaration –
electromagnetic immunity
The T-Stat® 2.0 is intended for use in the electromagnetic environment specified below. The customer or the user of the T-
Stat®2.0 should assure that it is used in such an environment.
IMMUNITY test
IEC 60601 test level
Compliance level
Electromagnetic environment
–
guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the T-Stat®2.0,
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3V
Recommended separation distance
D=1.2xP
.5
D=1.2xP
.5
80 MHz to 800 MHz
D=2.3P
.5
800 MHz to 2,5 GHz
Radiated RF IEC
61000-4-3
3 V/m
80 MHz to 2,5 GHz
3V/m
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 metres (m).
Field strengths from fixed RF transmitters, as deter-mined
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 the is used exceeds the applicable RF compliance level above, the T- Stat®
2.0 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the T-Stat® 2.0.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.