Miltenyi Biotec CliniMACS Formulation Unit User Manual page 44

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Based on technical limitations of the internal power supply voltage,
interruptions on power supply input lines for longer than 10 ms may lead to
cessation of the process (power failure). The process cannot be resumed after a
power failure. It is recommended that the CliniMACS Prodigy is powered from
an uninterruptible power supply or a battery that starts within 10 ms.
Guidance and manufacturer's declaration – Electromagnetic immunity
The CliniMACS Formulation Unit is intended for use in the electromagnetic
environment specified below. The customer or the user of the instrument should
assure that it is used in such an environment.
Immunity test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast
transients (Bursts)
IEC 61000-4-4
Surges
IEC 61000-4-5
Voltage dips,
interruptions, and
variations
IEC 61000-4-11
Rated power frequency
magnetic field
IEC 61000-4-8
Conducted
disturbances induced
by RF fields
IEC 61000-4-6
Radiated RF EM fields
IEC 61000-4-3
Proximity fields from
RF wireless
communication
equipment
IEC 61000-4-3
Table A.2: Guidance and manufacturer's declaration – Electromagnetic immunity
IEC 60601-1-2 Test level
±8 kV contact discharge
±2 kV, ±4 kV, ±8 kV, ±15 kV
air discharge
±2 kV 100 kHz repetition
frequency
Power supply lines
±1 kV 100 kHz repetition
frequency
Input/output lines
±0.5 kV, ±1 kV line to line
±0.5 kV, ±1 kV, ±2 kV line
to ground
during 0.5 cycle
0% U
T
@ 0°, 45°, 90°, 135°, 180°,
225°, 270°, 315°
0% U during 1 cycle and
T
70% U during 25/30 cycles
T
(single phase) @ 0°
0% U during 250/300 cycle
T
30 A/m 50 Hz or 60 Hz
3 V (0.15 MHz to 80 MHz)
6 V in ISM bands between
0.15 MHz and 80 MHz 80%
AM @ 1 kHz
3 V/m (80 MHz–2.7 GHz)
80% AM @ 1 kHz
See table below:
Specifications for immunity
to RF wireless
communication equipment
Compliance level
±8 kV contact discharge
±2 kV, ±4 kV, ±8 kV, ±15 kV
air discharge
±2 kV 100 kHz repetition
frequency
Power supply lines
±1 kV 100 kHz repetition
frequency
Input/output lines
±0.5 kV, ±1 kV line to line
±0.5 kV, ±1 kV, ±2 kV line
to ground
0% U during 0.5 cycle
T
@ 0°, 45°, 90°, 135°, 180°,
225°, 270°, 315°
0% U during 1 cycle and
T
70% U during 25/30 cycles
T
(single phase) @ 0°
0% U during 250/300
T
cycle°
30 A/m 50 Hz or 60 Hz
3 V (0.15 MHz to 80 MHz)
6 V in ISM bands between
0.15 MHz and 80 MHz 80%
AM @ 1 kHz
3 V/m (80 MHz–2.7 GHz)
80% AM @ 1 kHz
See table below:
Specifications for immunity
to RF wireless
communication equipment