Instructions for use HealOzone 2130 C
2 Safety
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2.2 Intended purpose
Table 3
Immunity tests
IEC 60601 test level
Conformance level
Electromagnetic environment - gui‐
delines
Conducted HF distur‐
bances according to
IEC 61000-4-6
3 V
eff
150 kHz to 80
MHz outside of ISM
bands
a
10 V
eff
Portable and mobile radio devices
should not be used closer to the
HealOzone 2130 C including the
electrical lines than the recom‐
menced safe distance calculated
using the equation for the transmis‐
sion frequency.
Recommended safe distance:
d=0.35
P
d=0.35
P
for 80 MHz to 800 MHz
d=0.70
P
for 800 MHz to 2.5 GHz
with P as the maximum rated power
of the transmitter in Watts (W) ac‐
cording to the transmitter manufac‐
turer, and d as the recommended
safe distance in meters (m).
b
The field strength of stationary ra‐
dio transmitters should be less than
the conformance level at all fre‐
quencies in an on-site check
a
.
d
Disturbances are possible close to
devices that have the following
symbol .
NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not be applicable in every case. The spread of
electromagnetic waves is absorbed and reflected by buildings, objects and people.
a
The ISM frequency bands (for industrial, scientific and medical applications) bet‐
ween 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 conformance levels in the ISM frequency bands between 150 kHz and 80 MHz
and the frequency range of 80 MHz and 2.5 GHz are intended to reduce the pro‐
bability that mobile and portable communications equipment will produce distur‐
bances when they are unintentionally brought near the patient. For this reason, the
additional factor of 10/3 is used when calculating the recommended safe distances
within these frequency ranges.
c
The field strength of stationary transmitters such as base stations of mobile tele‐
phones and land mobile radio devices, amateur radio stations, AM and FM, radio
and television broadcasters cannot be theoretically predetermined. To determine
the electromagnetic environment of stationary transmitters, a study of the location
should be considered. When the measured field strength at the site where the Hea‐
lOzone 2130 C is used exceeds the above conformance level, the HealOzone 2130
C should be monitored to demonstrate proper function. When unusual performance
features are observed, additional measures may be necessary such as realigning
or moving the HealOzone 2130 C.
d
Within the frequency range of 150 kHz to 80 MHz, the field strength should be less
than 3V
eff
V/m.
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