Chapter 12: Specifications
Fresenius Medical Care
AquaA
IFU-EN-US 06B-2021
165
Electromagnetic immunity
Guidance and manufacturer's declaration – electromagnetic immunity
The
AquaA
device is intended for use in the electromagnetic environment specified below. The customer or the
user of the
AquaA
device should assure that it is used in such an environment.
Immunity test
IEC 60601-1-2 test
level
Compliance level
Electromagnetic environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
and ±15 kV air
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
and ±15 kV air
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
±2 kV for power
supply lines
±2 kV for power
supply lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±0.5 kV and ±1 kV
normal mode
voltage
±0.5 kV, ±1 kV and
±2 kV common
mode voltage,
line(s) to earth
±0.5 kV and ±1 kV
normal mode
voltage
±0.5 kV, ±1 kV and
±2 kV common
mode voltage,
line(s) to earth
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
0 % U
T
for 0.5 cycle
(at 0, 45, 90, 135,
180, 225, 270 and
315 degrees)
0 % U
T
for 1 cycle
70 % U
T
for
25 cycles at 50 Hz
or 30 cycles at
60 Hz
0 % U
T
for
250 cycles at 50 Hz
or 300 cycles at
60 Hz
0 % U
T
for 0.5 cycle
(at 0, 45, 90, 135,
180, 225, 270 and
315 degrees)
0 % U
T
for 1 cycle
70 % U
T
for
25 cycles at 50 Hz
or 30 cycles at
60 Hz
0 % U
T
for
250 cycles at 50 Hz
or 300 cycles at
60 Hz
In the event of a short power supply
interruption, the
AquaA
device will turn
off.
Mains power quality should be that of a
typical commercial or hospital
environment.
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or hospital
environment.
Note:
U
T
is the a.c. mains voltage prior to application of the test level.
Содержание AquaA
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Страница 10: ...10 Fresenius Medical Care AquaA IFU EN US 06B 2021 ...
Страница 32: ...Chapter 2 Important information 32 Fresenius Medical Care AquaA IFU EN US 06B 2021 ...
Страница 108: ...Chapter 4 Operation 108 Fresenius Medical Care AquaA IFU EN US 06B 2021 ...
Страница 138: ...Chapter 6 Cleaning disinfection preservation 138 Fresenius Medical Care AquaA IFU EN US 06B 2021 ...
Страница 152: ...Chapter 9 Installation 152 Fresenius Medical Care AquaA IFU EN US 06B 2021 ...
Страница 156: ...Chapter 11 Technical Safety Checks and maintenance 156 Fresenius Medical Care AquaA IFU EN US 06B 2021 ...
Страница 186: ...Chapter 13 Definitions 186 Fresenius Medical Care AquaA IFU EN US 06B 2021 ...
Страница 217: ...Chapter 14 Options Fresenius Medical Care AquaA IFU EN US 06B 2021 217 ...
Страница 218: ...Chapter 14 Options 218 Fresenius Medical Care AquaA IFU EN US 06B 2021 ...
Страница 228: ...Chapter 15 Appendix 228 Fresenius Medical Care AquaA IFU EN US 06B 2021 Participant Name Date signature ...