5
Note.
The following degradation associated with essential performance are not allowed during testing: com-
ponent failure, changes in programmable parameters, resets to factory defaults, changes in operating modes,
false alarms, cessation or interruption of any intended operation, even if accompanied by an alarm, initiation
of any unintended operation, including unintended or uncontrolled motion, even if accompanied by an alarm,
error of a displayed numerical value sufficiently large to affect diagnosis or treatment, noise on a signal in
which the noise is indistinguishable from physiologically-produced signals or the noise interferes with interpre-
tation of physiologically-produced signals.
Radiated RF
IEC 61000-4-3
3V/m
80 Mhz to
2.7 GHz
3V/m
Where P is the maximum 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 electromagnetic site
survey,
1
should be less than the compli-
ance level in each frequency range.
2
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Note 1.
At 80 Mhz and at 800 MHz, the higher frequency range applies.
Note 2.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorp-
tion and reflection from structures, objects, and people.
Note 3.
The frequency range between 100-150 kHz is associated with interference from low frequency RFID
equipment.
Note 4.
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz tested are
6.765 MHz to 6.975 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to
40.70 MHz.
Note 5.
Tested for immunity to RF interference from transmitters operating at 125 kHz, 134.2 kHz and in
the frequency ranges between 3.155 MHz to 3.4 MHz and between 7.4 MHz to 8.8 MHz.
1. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcasts 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 mea-
sured field strength in the location in which the console is used exceeds the applicable RF compliance level above, the con-
sole should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the console.
2. Unless otherwise noted, over the frequency ranges 150 kHz to 80 Mhz, field strength should be less than 10 V/m.
The Thermogard XP console is intended for use in an electromagnetic environment in which radiated RF dis-
turbances are controlled. You can help prevent electromagnetic interference by maintaining a minimum dis-
tance between portable and mobile RF communications equipment (transmitters) and the console as
recommended below, according to the maximum output power of the communications equipment.
Table 1.3. Recommended separation distances between portable and mobile RF communications
equipment and the console.
Immunity Test
IEC 60601 Test
Level
Compliance Level
Electromagnetic environment
guidance
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