Ambu VivaSight 2 DLT 35 Fr Mode D'emploi page 12

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 manual.
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
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
12
Compliance
Group 1
Class A
Not applicable
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
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 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-orientation the equipment.
Compliance
Level
+/- 8 kV contact
+/- 2, 4, 8,
15 kV air
+/- 2 kV power
supply lines
N/A
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.