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Appendix A Specifications
Comply with 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 (IEC 60601-2-37), Medical Electrical Equipment Part 2-37: Particular
Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical
Diagnostic and Monitoring Equipment
EN 60601-1-2 (IEC 60601-1-2), Medical electrical equipment- Part 1-2: General
requirements for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests
Classications Type of protection against
electrical shock
Class I
Degree of protection
against electrical shock
Type-BF applied part
Installation Type Mobile equipment
Degrees of protection against
harmful liquid
System is IPX0
Probe (from the acoustic window to the junction line) is
IPX7
Foot switch is IPX4
According to the 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.
Environmental
Requirement
Operations Storage and Transportation
Ambient Temperature 10°C~40°C -20°C~+55°C
Relative Humidity
30%~75%
(no condensation)
20%~90%
(no condensation)
Atmospheric Pressure 700hPa~1060hPa 700hPa~1060hPa
Power Supply 100-240V~, 2.7-1.1A, 50/60Hz
Fuse Type: 50CT
Breaking capacity: 1500 amperes at 250V AC
Blowing time rating: 30 minutes (Max.)
Current rating: 3.15A
Applied Parts Probes, ECG electrodes
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