Bioness VEC-1000, Clinicians Manual

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Chapter 15 - Electromagnetic Compatibility (EMC) Information
Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
The Vector Elite System is intended for use in the electromagnetic environment specified below. The
customer or the user of the Vector Elite System 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
3 Vrms
150 kHz to
80 MHz
6 Vrms
ISM and
Amateur
Radio Bands
3 Vrms
150 kHz to
80 MHz
6 Vrms
ISM and
Amateur
Radio Bands
Recommended separation distance:
d = 1.2√P
Radiated RF
IEC 61000-
4-3
10 V/m
80 MHz to
2.7 GHz
Proximity
Fields per
60601-1-2 4th
edition
[E
1
] = 10 V/m
in 26 MHz to
2.7 GHz
Proximity
Fields per
60601-1-2
4th edition
Recommended separation distance:
d = 0.4√P, 80–800 MHz range
d = 0.7√P, 800-2700 MHz range
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.
NOTE 3: 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).
NOTE 4: 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
NOTE 5: Interference may occur in the vicinity of equipment marked with the following symbol:
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 Vector Elite system is used
exceeds the applicable RF compliance level above, the Vector Elite system should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as re-orienting or relocating the Vector Elite system.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.