Arthrex Angel, Operator'S Manual

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Technical Data
Angel ® cPRP System Operator’s Manual
7-3
Guidance and manufacturer’s declaration – electromagnetic immunity
The Angel System is intended for use in a professional healthcare facility environment, details
for the electromagnetic environment are specified below. The operator of the Angel System
should assure that it is used in this environment. If the Angel System is used within these
prescribed environments, the system will continue to process whole blood or a mixture of
whole blood and bone marrow without manufacturer service.
The
The EMC compliance levels in the table below represent the lowest levels of compliance for
the Angel System .
Immunity test
Compliance Level
IEC 60601-1-2
Electromagnetic
environment - guidance
(2007) (2014)
Electrostatic
discharge
(ESD)
IEC 61000-4-2
+/-6kV contact
+/-8kV air
+/-8kV contact
+/-15kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Radiated RF
IEC 61000-4-3
3 V/m
80MHz - 2.5GHz
1
3V/m
80 MHz - 2.7
GHz
80% 1 kHz AM
No additional RF
shielding environment
requirements necessary.
Electrical fast
transient/
burst
IEC 61000-4-4
+/-2kV for power
supply lines
+/-1kV for input/
output lines
+/-2kV
100kHz repetition
frequency
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC 61000-4-5
+/-1kV differential
mode
+/-2kV common
mode
+/-1kV differential
mode
+/-2kV common
mode
Mains power quality
should be that of a
typical commercial or
hospital environment.
Conducted RF
IEC 61000-4-6
3 Vrms 150kHz to
80MHz 1
3Vrms
6Vrms for ISM
bands
0.15 to 80 MHz
80% 1 kHz AM
No additional RF
shielding environment
requirements necessary.