BIOTRONIK CRM Reocor D Manuel Technique page 92

93
Checking the Test level
resistance to according to
interference IEC 60601
COMMENT: These guidelines do not necessarily apply in all situations. The spread of
electromagnetic waves is influenced by absorption and reflection from buildings,
objects, and humans.
a) The ISM bands (for industrial, scientific and medical applications) between 150 kHz
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.
b) The compliance level in the ISM frequency bands between 150 kHz and 80 MHz and
in the frequency range 80 MHz to 2.5 GHz is designed to reduce the likelihood that
mobile communication devices cause interference if they are unintentionally
brought into the patient area. For this reason a greater safety distance is recom-
mended in these frequency ranges (factor 1.2 instead of 0.35).
c) The field strengths of stationary transmitters, such as base stations for cellular
phones and land mobile radios, amateur radio stations and radio and TV broadcasts
cannot be predicted with accuracy. To assess the electromagnetic environment by
fixed HF transmitters, a study of the location should be considered. If the measured
field strength exceeds the HF compliance level at the location where the device is
used, the device must be observed to ensure correct functioning. Additional mea-
sures may be necessary, such as re-orienting or relocating the external pacemaker.
d) In the frequency range of 150 kHz to 80 MHz the field strengths should be less than
10 V/m.

Conformity According to IEC 60601-1-2
Compliance
level
Guidelines for the
electromagnetic environment
P is the maximum rated power
of the transmitter in watts [W]
according to the information
from the transmitter manu-
facturer and d is the recom-
mended safe distance in
b)
meters [m] .
The field strength of stationary
transmitting devices must be
c)
measured on site and must be
lower than the compliance
level at all frequencies
Interference can occur in
devices that have the following
warning sign.
d)
.