Appendix C: IEC 60601-1-2 Requirements, 2nd Edition, 2001
Veterinary 3 Parameter Advisor
®
Operation Manual
C-3
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
The Advisor
®
Vital Signs Monitor is intended for use in the electromagnetic environment specified below. The
customer or user of the Advisor
®
Vital Signs Monitor should assure that it is used in such an environment.
IMMUNITY TEST
IEC 60601 TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Conducted RF
IEC 61000-4-6, 2003
3 V,
80% AM modulation @ 2
Hz 0.15 MHz to 80 MHz
3 V
Radiated RF
IEC 61000-4-3, 2002
10 V/m,
80 % AM @ 2 Hz
80 MHz – 2500 MHz
10 V/m for all
parameters (Edwards
Lifesciences TruWave,
and Abbott Critical
Care Systems
Transpac® IV invasive
pressure transducers)
Portable and mobile RF
communications equipment
should be used no closer to any
part of the Advisor® Vital Signs
Monitor, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation
distance:
d = 1.2√P
d = 0.35√P 80 MHz to 800 MHz
d = 0.7√P 800 MHz to 2.5 GHz
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:
4
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 animals.
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 Advisor
®
Vital Signs
Monitor is used exceeds the applicable RF compliance level above, the Advisor
®
Vital Signs Monitor should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the Advisor
®
Vital Signs Monitor.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
