Welch Allyn CP 50 Directions For Use Manual page 53

Directions for use
The Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph is intended for use in the electromagnetic
environment specified below. The customer or the user of the Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting
electrocardiograph should assure that it is used in such an environment.
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Note1: 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 Welch AllynCP 50™ and CP 50 Plus™ 12-lead
resting electrocardiograph is used exceeds the applicable RF compliance level above, the Welch AllynCP 50™ and CP 50
Plus™ 12-lead resting electrocardiograph should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the Welch AllynCP 50™ and CP 50
Plus™ 12-lead resting electrocardiograph.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Electromagnetic immunity
IEC 60601 test level Compliance level
3 Vrms 3 V
150 kHz to 80 MHz
3 V/m 80 MHz to 2.5 3 V/m
GHz
Guidance and manufacturer's declarations 49
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the Welch AllynCP 50™ and CP 50 Plus™ 12-
lead resting electrocardiograph, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d= (1.17)
d= (1.17) 80 to 800 MHz
d= (2.33) 800 MHz to 2,5 GHz
whereP 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
a
survey , should be less than the compliance
level in each frequency range
may occur in the vicinity of equipment marked
with the following symbol:
b
. Interference