42
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
IEC 60601-1-2 Test level
Compliance level
Electrostatic discharge
(ESD)
IEC 61000-4-2
±8 kV contact discharge
±2 kV, ±4 kV, ±8 kV, ±15 kV
air discharge
±8 kV contact discharge
±2 kV, ±4 kV, ±8 kV, ±15 kV
air discharge
Electrical fast
transients (Bursts)
IEC 61000-4-4
±2 kV 100 kHz repetition
frequency
Power supply lines
±1 kV 100 kHz repetition
frequency
Input/output lines
±2 kV 100 kHz repetition
frequency
Power supply lines
±1 kV 100 kHz repetition
frequency
Input/output lines
Surges
IEC 61000-4-5
±0.5 kV, ±1 kV line to line
±0.5 kV, ±1 kV, ±2 kV line
to ground
±0.5 kV, ±1 kV line to line
±0.5 kV, ±1 kV, ±2 kV line
to ground
Voltage dips,
interruptions, and
variations
IEC 61000-4-11
0%
U
T
during 0.5 cycle
@ 0°, 45°, 90°, 135°, 180°,
225°, 270°, 315°
0%
U
T
during 1 cycle and
70%
U
T
during 25/30 cycles
(single phase) @ 0°
0%
U
T
during 250/300 cycle
0%
U
T
during 0.5 cycle
@ 0°, 45°, 90°, 135°, 180°,
225°, 270°, 315°
0%
U
T
during 1 cycle and
70%
U
T
during 25/30 cycles
(single phase) @ 0°
0%
U
T
during 250/300
cycle°
Rated power frequency
magnetic field
IEC 61000-4-8
30 A/m 50 Hz or 60 Hz
30 A/m 50 Hz or 60 Hz
Conducted
disturbances induced
by RF fields
IEC 61000-4-6
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 (0.15 MHz to 80 MHz)
6 V in ISM bands between
0.15 MHz and 80 MHz 80%
AM @ 1 kHz
Radiated RF EM fields
IEC 61000-4-3
3 V/m (80 MHz–2.7 GHz)
80% AM @ 1 kHz
3 V/m (80 MHz–2.7 GHz)
80% AM @ 1 kHz
Proximity fields from
RF wireless
communication
equipment
IEC 61000-4-3
See table below:
Specifications for immunity
to RF wireless
communication equipment
See table below:
Specifications for immunity
to RF wireless
communication equipment
Table A.2: Guidance and manufacturer’s declaration – Electromagnetic immunity
