User's Manual

Clarius Ultrasound Scanner - HD3 Scanners Safety Topics
revision 1 59
To reduce ESD:
• Use anti-static spray on carpets, linoleum, and mats. Or use a ground wire connection
between the system and the patient table or bed.
Electromagnetic Emissions
Ensure that the Clarius Ultrasound Scanner is used only in those operating environments
indicated in the following table. Operating the system in an environment that does not meet
these conditions may degrade system performance.
Electromagnetic Immunity
DECLARATION OF ELECTROMAGNETIC EMISSIONS
Emissions Test Compliance Electromagnetic Environment
RF emissions, CISPR 11 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.
RF emissions, CISPR 11 Class B The system is suitable for use in all establishments,
except domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes
Harmonic emissions, IEC 61000-3-2 Class A
Voltage fluctuations/flicker emissions, IEC
61000-3-3
Complies
Immunity Test IEC 60601-1-2 Test Level Compliance Level
ESD
EN/IEC 61000-4-2
+/-2kV, +/-4kV, +/-8kV Contact
+/-2kV, +/-4kV, +/-8kV, +/-15kV Air
+/-2kV, +/-4kV, +/-8kV contact
+/-2kV, +/-4kV, +/-8kV, +/-15kV Air
Radiated, radio frequency electromagnetic
field immunity (1 kHz 80% AM for ETSI 301
489-1 and -17, 2 Hz modulation for IEC
60601-1-2)*
EN/IEC 61000-4-3
3 V/M
2 Hz modulation
80% AM at 1 kHz modulation
3 V/M
2 Hz modulation
80% AM at 1 kHz modulation
Electrical fast transient
IEC 61000-4-4
+/-0.5kV, +/-1.0kV, +/-2.0kV +/-0.5kV, +/-1.0kV, +/-2.0kV
Immunity to surge
IEC 61000-4-5
0.5kV, 1.0kV differential mode 0.5kV, 1.0kV differential mode
Conducted radio frequency electromagnetic
immunity test
IEC 61000-4-6
3 V RMS outside the ISM band, 6 V RMS
in the ISM band, 80% AM at 1 kHz
3 V RMS outside the ISM band, 6 V RMS
in the ISM band, 80% AM at 1 kHz