Ambu aBox 2 Mode D'emploi page 43

warranty (pursuant to the cleaning and disinfection procedures in chapter 14). Ambu is
entitled to reject a displaying unit which has not been duly decontaminated, in which case
this limited warranty shall not apply.
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 IEC 60601-1-2
test level
Electrostatic +/- 8 kV contact
discharge +/- 2, 4, 8, 15 kV air
(ESD)
IEC 61000-4-2
Electrical fast +/- 2 kV for power
transient / supply lines
burst +/- 1 kV for input /
IEC 61000-4-4 output lines
Surge +/- 1 kV line(s)
IEC 61000-4-5 to line(s)
+/- 2 kV line(s)
to earth
Compliance Electromagnetic Environment Guidance
Group 1 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.
Class A The system is suitable for use in all establishments
other than domestic, and may be used in
Complies
domestic establishments and those directly
connected to the public low-voltage power
supply network that supplies buildings used for
Complies
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
+/- 1 kV line(s)
to line(s)
+/- 2 kV line(s)
to earth
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.
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