Angel
®
cPRP System
Operator’s Manual
7-3
Technical Data
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic
environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
+/-6kV contact
+/-8kV air
A
Floors should be wood,
concrete or ceramic
tile. If floors are
covered with synthetic
material, the relative
humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
+/-2kV for power
supply lines
+/-1kV for input /
output lines
A
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC 61000-4-5
+/-1kV differential
mode
+/-2kV common
mode
A
Mains power quality
should be that of a
typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines IEC
61000-4-11
<5% U
T
(>95% dip in U
T
)
for 0.5 cycle
40% U
T
(60% dip in U
T
)
For 5 cycles
70% U
T
(30% dip in U
T
)
For 25 cycles
<5% U
T
(>95% dip in U
T
)
For 5 sec
A
B
A
B
Mains power quality
should be that of a
typical commercial or
hospital environment. If
the user of the Angel
®
Concentrated Platelet
Rich Plasma (cPRP)
System requires
continued operation
during power mains
interruptions, it is
recommended that the
Angel
®
Concentrated
Platelet Rich Plasma
(cPRP) System be
powered from an
uninterruptible power
supply or a battery.
Power frequency
(50 / 60 Hz)
magnetic field IEC
61000-4-8
3 A/m
A
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
Guidance and manufacturer’s declaration – electromagnetic immunity
The Angel
®
Concentrated Platelet Rich Plasma (cPRP) System is intended for
use in the electromagnetic environment specified below. The customer or the
user of the Angel
®
Concentrated Platelet Rich Plasma (cPRP) System should
assure that it is used in such an environment.
Note: U
T
is the a.c. mains voltage prior to application of the test level.