Appendix 1. Electromagnetic Compatibility - Ambu aView 2 Advance Instrucciones De Uso

Appendix 1. Electromagnetic compatibility

Like other electrical medical equipment, the system requires special precautions to ensure
electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic
compatibility (EMC) the system must be installed and operated according to the EMC
information provided in this Instructions for Use. The system has been designed and tested to
comply with IEC 60601-1-2 requirements for EMC with other devices.
Guidance and manufacturer's declaration – Electromagnetic emission
The system is intended for use in the electromagnetic environment specified below.
The customer or the user of the system should assure that it is used in such an environment.
Emissions Test
RF emission CISPR 11
RF emission CISPR 11
Harmonic emission
IEC/EN 61000-3-2
Voltage fluctuations/
flicker emissions
IEC/EN 61000-3-3
Note 1: The emissions Characteristics of this equipment makes it suitable for use in industrial areas and
hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally
required) this equipment might not offer adequate protection to the radio-frequency communication service.
The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
Guidance and manufacturer's declaration – Electromagnetic immunity
The system is intended for use in the electromagnetic environment specified below.
The customer or the user of the system should assure that it is used in such an environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient / burst
IEC 61000-4-4
Surge
IEC 61000- 4-5
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
40
Compliance
Group 1
Class A
Complies
Complies
IEC 60601-1-2
test level
+/- 8 kV contact
+/- 2, 4, 8, 15 kV air
+/- 2 kV for power
supply lines
+/- 1 kV for input /
output lines
+/- 1 kV line(s)
to line(s)
+/- 2 kV line(s)
to earth
30 A/m
Electromagnetic environment guidance
The system uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
The system is suitable for use in all
establishments other than domestic, and may be
used in domestic establishments and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes, provided the
following NOTE 1 is heeded.
Compliance level
+/- 8 kV contact
+/- 2, 4, 8, 15 kV air
+/- 2 kV power
supply lines N/A
30 A/m
Electromagnetic
environment guidance
If floors are covered with
synthetic material the
relative humidity shall
be least 30 %.
Mains power quality shall
be that of a typical
commercial or hospital
environment.
Mains power quality
shall be that of a typical
commercial or hospital
environment.
Power frequency
magnetic fields should be
at levels characteristic of a
typical location in a
typical commercial or
hospital environment.