Mindray Zonare ZS3, Service Manual

Page: 32 / 295

ZS3 Service Manual Page 32 of 295
22. P9-3ic

Penetration Depth: 18 CM

Number of Elements: 64

Field of View: 80 degrees

Ultrasound Bandwidth: 9-3 MHz
Standards and Compliance
The ZS3 system has been designed, manufactured, tested, and certified to comply with
the following internationally recognized standards.
IEC 60601-1: 2012: Medical electrical equipment part 1: General requirements for basic
safety and essential performance.
IEC 60601-1-2: 2014: Medical electrical equipment part 1-2: General requirements for
basic safety and essential performance. Collateral standard: Electromagnetic
disturbances - Requirements and tests.
IEC 60601-2-37: 2007: Medical electrical equipment part 2-37: Particular requirements
for the basic safety and essential performance of ultrasonic medical diagnostic and
monitoring equipment.
IEC 60601-1-2: 2014 Certification
Specification Compliance
CISPR 11
– RF emissions
Group 1, Class A
The ZS3 system is suitable for use in all establishments
other than domestic and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes.
IEC 61000-3-2 harmonic emissions Class A
IEC 61000-3-3 voltage
fluctuations/flicker emissions Complies
IEC 61000-4-2 electrostatic discharge
(ESD)
Compliance level:
±6 kV contact
±8 kV air
Electromagnetic environment guidance :
Floors should be wood, concrete, or ceramic tile. If floors
are covered with a synthetic material, the relative humidity
should be at least 30%.
IEC 61000-4-3 Radiated Field Immunity
Compliance level:
80MHz - 2.5GHz
3V/m, 80%@2Hz
IEC 61000-4-4 electrical fast transients
(EFT)
Compliance level:
±2 kV for AC Mains
±1 kV for I/O lines
Electromagnetic environment guidance :
Main power quality should be that of a typical commercial or
hospital environment.