Medtronic GUARDIAN LINK 3 Manual Del Usuario página 39

Guidance and manufacturer's declaration
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
Emissions Test
RF emissions CISPR 11
CISPR 11 Group 1, Class B
Harmonic emis‐ Not applicable
sions
IEC 61000-3-2
Voltage fluctua‐ Not applicable
tions/flicker emis‐
sions
IEC 61000-3-3
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
Immunity Test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Conducted disturbances
induced by RF fields
Electrical fast transi‐
ent/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Note: U
is the a.c. mains voltage prior to application of the test level.
T
Voltage dips, short inter‐
ruptions, and voltage
variations on power sup‐
ply lines
Compliance
The transmitter uses RF energy only for system communi‐
cations. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equip‐
ment.
Note: The preceding statement is required by IEC
60601-1-2 for Group 1, Class B devices. Since the transmitter
is battery powered, its emissions will not be affected by the
establishment power supply and there is no evidence of any
issues associated with the use of the system in domestic
establishments.
IEC 60601-1-2:2014
Test Level
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air
3 V
RMS
150 kHz to 80 MHz
6 V
RMS
ISM bands between
150 kHz to 80 MHz
±2 kV
100 kHz repetition fre‐
quency
Line to Line: ±0.5 kV,
±1 kV
Line to Ground: ±0.5 kV,
±1 kV, ±2 kV
0% U ; 0.5 cycles (at 0°,
T
45°, 90°, 135°, 180°, 225°,
270°, and 315°)
0% U ; 1 cycle (at 0°)
T
Electromagnetic Environment - Guidance
Max foreseeable use
condition per IEC
60601-1-2:2014
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air
Not applicable
Not applicable
Not applicable
Not applicable
39
Electromagnetic Envi‐
ronment Guidance
For use in a typical
domestic, commercial,
or hospital environment.
Requirement does not
apply to this battery
powered device.
Requirement does not
apply to this battery
powered device.
Requirement does not
apply to this battery
powered device.
Requirement does not
apply to this battery
powered device.