Skytrofa Auto-Injector, Instructions For Use Manual

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Product Informa
tion
59 58
Electromagnetic
Compatibility (EMC)
Compliance Levels
Basic EMC
Standard
EMC - RF Field radiated
emission in 10 m (maximum):
a) 30 MHz to 230 MHz:
≤ 30 dB (µV/m) quasi-peak.
b) 230 MHz to 1 GHz:
≤ 37 dB (µV/m) quasi-peak.
c) Internal source <108 MHz
IEC / EN 60601-1-2,
4-th Edition
CISPR 11 / EN 55011
EMC - RF Field radiated
immunity - Electrical field:
a) 10 V/m 80-2700 MHz.
1 kHz 80% AM
IEC / EN 60601-1-2,
4-th Edition
IEC 61000-4-3
EMC - Power Frequency
Magnetic field, Immunity:
a) 30 A/m
IEC / EN 60601-1-2,
4-th Edition
IEC 61000-4-3
EMC - Fast transients and
bursts:
a) Fast transients and bursts
±2 kV ac mains
b) Surge ±1 kV Line-to-Line ac
mains
c) Conducted immunity
disturbance by RF fields
3 Vrms
150 kHz to 80 MHz
(6 Vrms in ISM and amateur
radio bands)
d) Conducted emission
150 kHz-30 MHz
120 V @ 60 Hz
IEC / EN 60601-1-2,
4-th Edition
IEC 61000-4-4
IEC 61000-4-5
IEC 61000-4-6
IEC 61000-4-11
EMC Compliance Levels
EMC - Voltage dips and
interruptions:
a) <5% UT for 5 sec
b) <5% UT for 0.5 cycles
c) 70% UT for 25 cycles
d) 40% UT for 5 cycles
IEC / EN 60601-1-2,
4-th Edition
IEC 61000-4-11
EMC - RF Field Immunity to
Proximity fields from Wireless
communication equipment,
Immunity at 0.3 m separation:
a) 27 V/m @ 380-390 MHz
b) 28 V/m @ 430-470 MHz
c) 9 V/m @ 704-787 MHz
d) 28 V/m @ 800-960 MHz
e) 28 V/m @ 1700-1990 MHz
f) 28 V/m @ 2400-2570 MHz
g) 9 V/m @ 5100-5800 MHz
IEC / EN 60601-1-2,
4-th Edition
IEC 61000-4-39
ESD immunity:
a) ± 8 kV contact
b) ± 2, 4, 8 and 15 kV air
IEC / EN 60601-1-2,
4-th Edition
IEC 61000-4-2