27
Statement
The product is designed compatible with the high-frequency surgical equipment, i.e. it is allowed to keep
working or standby near the high-frequency surgical equipment.
In case of interrupted AC input voltage, the product will shut down, and once the power supply is restored, it
can be manually restored by the operator. The degradation in such case is acceptable because it will neither
cause unacceptable risks nor impair basic safety or essential performance.
The degradation due to electrostatic discharge or electrical fast transient/burst is acceptable because it will
neither cause unacceptable risks nor impair basic safety or essential performance.
The vertical-line flashing on the screen can automatically restore to the previous state.
EMI compliance
Table 1. Emission
Phenomenon
Compliance
Electromagnetic Environment
Radio frequency
emission
CISPR 11
Group 1, Class A
Professional medical environment
Harmonic distortion
IEC 61000-
3
-2
Class A
Professional medical environment
Voltage fluctuation
and Flicker
IEC 61000-
3
-
3
Compliance
Professional medical environment
Caution:
The emission characteristics of the product make it suitable for use in industrial areas and hospitals
(CISPR 11 Class A). If being used in the residential environment (CISPR 11 Class B required usually),
the product may not provide adequate protection for radio frequency communication services. The
user may be required to take mitigation measures, for example, relocating or redirecting the
product.
EMS compliance
Table 2. Enclosure Port
Phenomenon
Basic EMC standards
Immunity test level
Professional medical environment
Electrostatic discharge
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
Radiated,
radio-frequency,
electromagnetic field
IEC 61000-4-
3
3 V/m
80 MHz–2.7 GHz
80% AM at 1 kHz
Fields near the
radio-frequency
wireless
communication
devices
IEC 61000-4-
3
Refer to Table 3