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Appendix 1: Electromagnetic Compatibility
Like other electrical medical equipment the aScope 3 system requires special precautions to ensure electromagnetic compatibility with other electrical
medical devices. To ensure electromagnetic compatibility (EMC) the aScope 3 system must be installed and operated according to the EMC information
provided in this manual.
The aScope 3 system has been designed and tested to comply with IEC 60601-1-2 requirements for EMC with other devices.
WARNING
Electronic equipment may affect the normal function of the aScope 3 system.
WARNING
The aScope 3 system consists of the parts described in section 2. They may only be replaced by Ambu authorised parts. Failure to comply with this may
reduce safety and efficiency.
WARNING
If the aScope 3 system is used adjacent to or stacked with other equipment, observe and verify normal operation of the aScope 3 system prior to using it.
Consult the tables below for guidance in placing the aScope 3 system.
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
The aScope 3 system is intended for use in the electromagnetic environment specified below. The customer or the user of aScope 3 system shall ensure
that it is used in such environment
Emissions Test
Compliance
Result
Electromagnetic Environment - Guidance
RF emissions
CISPR 11
EN 55011
Group 1, Class B
Pass
The aScope 3 system is suitable for use in all
establishments, including domestic establishments
and those directly connected to the public low-
voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions
IEC/EN 61000-3-2
N/A
N/A
Voltage Fluctuations/Flicker emissions
IEC/EN 61000-3-3
Complies
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The aScope 3 system is intended for use in the electromagnetic environment specified below. The customer or the user of the aScope 3 system shall
ensure that it is used in such an environment.
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment Guidance
Electrostatic Discharge (ESD)
IEC/EN 61000-4-2
+/-6kV contact
+/-8kV air
2; 4; 6kV contact
2; 4; 8kV air
If floors are covered with synthetic material the
relative humidity shall be at least 30%
Electrical Fast Transient/Burst – EFT
IEC/EN 61000-4-4
AC Power port: +/-2kV
Signal cable greater than
3 /- 1kV
+/- 2kV Power line
No signal cable greater than
3 metres.
Mains power quality shall be that of a typical
commercial or hospital environment
Surge Immunity Test
IEC/EN 61000-4-5
+/- 1kV differential mode
+/- 2kV common mode
Open circuit Voltage: 1.2/50µs
Short circuit current: 8/20µs
AC power Port line to line: 1kV
Line to earth (ground) 2kV
Mains power quality shall be that of a typical
commercial or hospital environment
Voltage Dips, short interruptions and
voltage variations on power supply
input lines
IEC/EN 61000-4-11
<5% Ut (95% dip in Ut)
for 0.5 cycle
40% Ut (60% dip in Ut)
for 5 cycles
70% Ut (30% dip in Ut)
for 25 cycles
<5% Ut (95% dip in Ut)
for 5 sec.
100% reduction 0.5 period
40% reduction for 5 periods
30% reduction for 25 periods
100% reduction for 5 sec.
Mains power quality shall be that of a typical
commercial or hospital environment
If the use of aScope 3 system requires continued
operation during power mains interruptions the
aScope 3 system can be powered by the built in
rechargeable battery.
Power frequency (50/60Hz)
magnetic field
IEC/EN 61000-4-8
3 A/m
3 A/m
