Ameda Pearl Instrucciones De Uso página 27

TABLE 3
Guidance and declaration of manufacturer-electromagnetic immunity
(For home healthcare environment)
The device is intended for use in the electromagnetic environment specified below. The customer or the user
of the device should assure that it is used in such an environment
IMMUNITY test IEC 60601 test level
Conducted RF 3V for 0.15 - 80MHz;
IEC 61000-4-6 6V in ISM and amateur
radio bands between
0.15 - 80MHz
80% AM at 1kHz
Radiated RF 10V/m, 80MHz -
IEC 61000-4-3 2.7GHz, 80% AM to
1kHz
Proximity According to Table 9 of
fields from IEC 60601-1-2:2020
RF wireless
communications
equipment IEC
61000-4-3
Proximity According to Table 11
magnetic fields of IEC 60601-1-2:2020
IEC 61000-4-39
TABLE 4
IEC 60601-1-2:2020 Table 11 - Test specifications for ENCLOSURE PORT IMMUNITY to proximity magnetic fields
Test frequency
30 kHz
134,2 kHz
13,56 MHz
a) This test is applicable only to ME EQUIPMENT and ME SYSTEMS intended for use in the HOME
HEALTHCARE ENVIRONMENT.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) r.m.s., before modulation is applied.
a)
Compliance level
3V for 0.15 - 80MHz;
6V in ISM and amateur
radio bands between
0.15 - 80MHz
80% AM at 1kHz
10V/m, 80MHz -
2.7GHz, 80% AM to
1kHz
According to Table 9 of
IEC 60601-1-2:2020
According to Table 11
of IEC 60601-1-2:2020
Modulation
CW
Pulse modulation b)
2,1 kHz
Pulse modulation b)
50 kHz
Electromagnetic environment -
guidance
Portable RF communications
equipment (including peripherals
such as antenna cables and external
antennas) should be used no closer
than 30 cm (12 inches) to any part
of the Ameda Pearl, including cables
specified by the manufacturer.
Otherwise, degradation of the
performance of this equipment
could result.
Interference may occur in the vicinity
of equipment marked with the
following symbol:
Immunity Test Level (A/m)
8
65
7,5
c)
c)
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