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energy level is controlled below a low level at which bioeffects are not generated while diagnostic
information is being accumulated. The total energy is controlled by output intensity and total radiation time.
The output intensity necessary for examinations differs depending on the patient and clinical case.
Not all examinations can be performed with an extremely low level of acoustic energy.Controlling the
acoustic level at an extremely low level leads to low-quality images or insufficient Doppler signals, adversely
affecting the reliability of the diagnosis. However,increasing the acoustic power more than necessary
does always contribute to an increase in quality of information required for diagnosis, rather increasing the
risk of generating bioeffects.
The operator must take responsibility for the safety of patients.
1.3 Electromagnetic Compatibilities
Electromagnetic compatibilities are the abilities of the system or equipment to operate
normally in the electromagnetic environment and not to radiate any electromagnetic interruptions to any
other objects which are in the same environment.
This system is designed in accordance with the current EMC requirement. And the
ultrasound image will degrade instantly if the system is used in the electromagnetic field
environment. If the degradation of the image is found, it is recommended to inspect the
operation environment to confirm the radiation source.
1.3.1 Electromagnetic Radiation
This system is applicable for the following environment. You should use this system
under the suggested environment.
Emission Test
Compliance
Electromagnetic Environment and Guidance
RF emission
CISPR 11
Group 1
ClassA
Harmonic
emission IEC
61000-3-2
Class A
Voltage fluctuations/
flicker emissions IEC
61000-3-3
Complies
The equipment use RF energy only for its internal function.
Therefore, its RF emission is very low and not likely to cause
any interference to nearby electronic equipment.
1.3.2 Electromagnetic Immunity
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic
Environment and
Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6kV Contact
±8kV Air
±
6±6kV Contact
±8kV Air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.