Medtronic GUARDIAN 4 Bedienungsanleitung Seite 39

Guidance and Manufacturer's Declaration - Electromagnetic Immunity
Immunity Test IEC 60601-1-2:2014 Test
Electrostatic dis‐ ±8 kV contact
charge (ESD) ±2 kV, ±4 kV, ±8 kV,
IEC 61000-4-2 ±15 kV air
Conducted distur‐ 3 V
bances induced 150 kHz to 80 MHz
by RF fields 6 V
ISM bands between
150 kHz to 80 MHz
Electrical fast tran‐ ±2 kV 100 kHz repetition fre‐
sient/burst quency
IEC 61000-4-4
Surge Line to Line: ±0.5 kV, ±1 kV
IEC 61000-4-5 Line to Ground: ±0.5 kV,
±1 kV, ±2 kV
Note: U
is the a.c. mains voltage prior to application of the test level.
T
Voltage dips, short 0% U
interruptions, and 90°, 135°, 180°, 225°, 270°,
voltage variations and 315°)
on power supply 0% U
lines 70% for 25/30 cycles (at 0°)
IEC 61000-4-11 0% for 250/300 cycles
Power frequency 30 A/m
(50/60 Hz) mag‐
netic field
IEC 61000-4-8
Proximity fields IEC 60601-1-2:2014,
from RF wireless Table 9
communications
equipment
IEC 61000-4-3
Note: U
is the a.c. mains voltage prior to application of the test level.
T
Radiated RF 10 V/m
IEC 61000-4-3 80 MHz to 2.7 GHz
Level
RMS
RMS
; 0.5 cycles (at 0°, 45°,
T
; 1 cycle (at 0°)
T
Max foreseeable
use condition
per IEC
60601-1-2:2014
±8 kV contact For use in a typical domestic,
±2 kV, ±4 kV, ±8 kV, commercial, or hospital envi‐
±15 kV air ronment.
Not applicable Requirement does not apply
to this battery powered
device.
Not applicable Requirement does not apply
to this battery powered
device.
Not applicable Requirement does not apply
to this battery powered
device.
Not applicable Requirement does not apply
to this battery powered
device.
30 A/m For use in a typical domestic,
commercial, or hospital envi‐
ronment.
IEC For use in a typical domestic,
60601-1-2:2014, commercial, or hospital envi‐
Table 9 ronment.
10 V/m
Portable and mobile RF com‐
80 MHz to 6 GHz
munications equipment
39
Electromagnetic Environ‐
ment Guidance