Welch Allyn CP 200 12-Lead Resting Electrocardiograph - User Manual User Manual

Page 103

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Directions for Use

Appendix B EMC Guidance and Manufacturer’s Declarations

99

Table 7. Electromagnetic Immunity

The CP 200 electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or user of the CP 200
electrocardiograph 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 CP 200 electrocardiograph, including cables, than the
recommended separation distance calculated from the equation applicable
to the frequency of the transmitter.

Recommended separation distance

Conducted RF
IEC 61000-4-6

3 Vrms
150 kHz to 80 MHz

3 Vrms

d = (1.17)

Radiated RF
IEC 61000-4-3

3 V/m
80 MHz to 2.5 GHz

3 V/m

d = (1.17)

80 MHz to 800 MHz

d = (2.33)

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 metres (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 the CP 200
electrocardiograph is used exceeds the applicable RF compliance level above, the electrocardiograph should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
electrocardiograph.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

P

P

P

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