User's Manual

Min I(Smart) User Manual
14
Guidance and manufacturer´s declaration – electromagnetic immunity –
for EQUIPMENT and SYSTEM
Guidance and manufacturer´s declaration – electromagnetic immunity
The Mini I(Smart I) Electric Oral Anesthesia Injector is intended for use in the electromagnetic environment specified
below. The customer or the user of the Mini I(Smart I) Electric Oral Anesthesia Injector 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
Radiated RF
IEC
61000-4-3
3 Vrms
150 kHz to 80 MHz
6 V in ISM and
amateur radio bands
between 0,15 MHz and
80 MHz
10 V/m
80 MHz to 2.7 GHz
385MHz-5785MHz
Test specifications for
ENCLOSURE PORT
IMMUNITY to RF
wireless
communication
equipment (Refer to
table 9 of IEC
60601-1-2:2014)
N/A
10 V/m
80 MHz to 2.7 GHz
385MHz-5785MHz
Test specifications for
ENCLOSURE PORT
IMMUNITY to RF
wireless
communication
equipment (Refer to
table 9 of IEC
60601-1-2:2014)
Portable and mobile RF communications equipment
should be used no closer to any part of the Mini I(Smart I)
Electric Oral Anesthesia Injector, including cables, than
the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
P
V
d ]
5.3
[
1

P
V
d ]
12
[
2

P
E
d ]
5.3
[
1

80 MHz to 800 MHz
P
E
d ]
7
[
1

800 MHz to 2.7 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).
b
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: