16060-101 Rev. M
43
Guidance Tables
(
continued)
Table 204
– Guidance and Manufacturer’s Declaration
Electromagnetic Immunity
Medical Electrical Equipment and Medical Electrical Systems that are NOT Life-supporting
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Reichert 7CR is intended for use in the electromagnetic environment specified below. The
customer or user of the Reichert 7CR should ensure that it is used in such an environment.
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment
- Guidance
Conducted distur-
bances induced
by RF fields
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
6 Vrms
in ISM bands between
150 kHz and 80 MHz
80% AM at 1 KHz
(V1) = 3 Vrms
150 kHz to 80 MHz
(V1) = 6 Vrms in ISM
bands between 150
kHz and 80 MHz
80% AM at 1 KHz
Portable and mobile RF communications equip-
ment should be no closer to any part of the
Reichert 7CR, including cables, than the recom-
mended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended Separation Distance:
d=(3.5/V1)(√P)
d=(3.5/E1)(√P)
80 to 800 MHz
d=(7/E1)(√P)
800 MHz to 2.7 GHz
Where P is the max output power rating of the
transmitter in watts (W) according to the trans
-
mitter manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from fixed transmitters, as deter
-
mined by an electromagnetic site survey, should
be less than the compliance levels in each
frequency range.
Interference may occur in the vicinity of equip-
ment marked with the following symbol.
Radiated RF
Electromagnetic
Fields
IEC 61000-4-3
3 V/m
80 MHz to 2.7 GHz
80% AM at 1kHz
(E1) = 3 V/m
80 MHz to 2.7 GHz
80% AM at 1kHz
10 V/m
80 MHz to 2.7 GHz
80% AM at 1kHz
(E1) = 10 V/m
80 MHz to 2.7 GHz
80% AM at 1kHz
Note 1:
At 80 MHz and 800 MHz, the separation distance for 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.
* 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. The measured field strength in the location in which the ME Equipment or ME System
should be observed to verify normal operation. If abnormal performance is observed, additional measures many be
necessary, such as re-orienting or relocating the ME Equipment or ME System.
* Over the frequency range 150 kHz to 80 MHz, field strengths should be less then [V1] V/m.
* The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz;
13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands
between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3
MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz
to 24,99 MHz, 28,0 MHz, to 29,7 MHz and 50,0 MHz to 54,0 MHz.
