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Appendix A Specifications
Complied Standards
EN 60601-1 (IEC 60601-1), Medical electrical equipment Part 1:
General
requirements for basic safety and essential performance, Class I,
BF, continuous
operation
EN 60601-2-37:2008 (IEC 60601-2-37:2007), Medical Electrical Equipment
Part2-37: Particular Requirements for the Basic Safety and Essential
Performance of
Ultrasonic Medical Diagnostic and Monitoring Equipment
EN 60601-1-2:2007 (IEC 60601-1-2: 2007), Class A
Type of protection
against electric shock
Class I Equipment
Degree of protection
against electric shock
Type-BF applied part
Operation mode
Continuous working
Installation and
operation type
Mobile Equipment
Degrees of protection
against harmful liquid
System is IPX0
Probe (from the acoustic window to the
junction line) is IPX7
Footswitch is IPX4
Safety Types
Degree of safety of
application
The equipment is not suitable for use in the
presence of a flammable anesthetic mixture with
air, oxygen or nitrous
oxide.
Operations
Storage and Transportation
Relative Humidity
25% to 80%, non-
condensing
25% to 93%, non-condensing
Ambient Temperature
5°C to +40°C
-20°C to +55°C
Atmospheric Pressure
700hPa to 1060hPa
700hPa to 1060hPa
Environmental
Requirement
Max. Altitude
3000m
3000m