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Medtronic autoLog IQ Benutzerhandbuch Seite 52

Autotransfusionssystem
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Size: 7 x 9 in (178 x 229 mm)
Phenomenon
Electrostatic discharge
Radiated RF EM fields
Proximity fields from RF wireless commu-
nications equipment
Rated power frequency magnetic fields
Phenomenon
Electrical fast transients / bursts
Surges
Line-to-line
Surges
Line-to-ground
Conducted disturbances induced by RF
fields
Voltage dips
Voltage interruptions
a
Significant power loss may cause the device to shut off.
Phenomenon
Electrostatic discharge
Electrical fast transients / bursts
Surges
Line-to-ground
Conducted disturbances induced by RF
fields
IEC 60601-1-2 table 9 – test specifications for enclosure port immunity to RF wireless communications equipment
Test frequency
(MHz)
385
450
710
745
780
English
M967226A006 1B Medtronic Confidential
IEC 60601-1-2 table 4 – enclosure port
Basic EMC
standard or
test method
IEC 61000-4-2
IEC 61000-4-3
IEC 61000-4-3
IEC 61000-4-8
IEC 60601-1-2 table 5 – input AC power port (1 of 2)
Basic EMC
standard
IEC 61000-4-4
IEC 61000-4-5
IEC 61000-4-5
IEC 61000-4-6
IEC 61000-4-11
IEC 61000-4-11
IEC 60601-1-2 table 8 – signal input/output parts port
Basic EMC
standard
IEC 61000-4-2
IEC 61000-4-4
IEC 61000-4-5
IEC 61000-4-6
Band
Service
Modulation
(MHz)
Pulse modula-
380 – 390
TETRA 400
GMRS 460,
430 – 470
±5 kHz deviation
FRS 460
Pulse modula-
LTE Band 13,
704 – 787
17
Immunity test levels
Professional healthcare facility environment
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
3 V/m
80 MHz – 2.7 GHz
80% AM at 1 kHz
See IEC 60601-1-2 table 9
30 A/m
50 Hz or 60 Hz
Immunity test levels
Professional healthcare facility environment
±2 kV
100 kHz repetition frequency
±0.5 kV, ±1 kV
±0.5 kV, ±1 kV, ±2 kV
3 V
0.15 MHz – 80 MHz
6 V in ISM bands between 0.15 MHz and 80 MHz
80% AM at 1 kHz
0% U
; 0.5 cycle
T
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0% U
; 1 cycle
T
and
a
70% U
; 25/30 cycles
T
Single phase: at 0°
0% U
; 250/300 cycle
a
T
Immunity test levels
Professional healthcare facility environment
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
±1 kV
100 kHz repetition frequency
±2 kV
3 V
0.15 MHz – 80 MHz
6 V in ISM bands between 0.15 MHz and 80 MHz
80% AM at 1 kHz
Maximum
power
(W)
tion
1.8
18 Hz
FM
2
1 kHz sine
tion
0.2
217 Hz
52
Immunity test
Distance
level
(m)
(V/m)
0.3
27
0.3
28
0.3
9
Composed: 2018-06-08 06:06:55
PSJ - Size-selectable package manual 02-MAY-2018
502431-132

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