S2/S2BW
Digital Color Doppler Ultrasound System
2.8 Electrical Safety
Only trained health professionals should operate this system. This equipment complies with the following
standards:
• The equipment conforms with the following regulations for electrical safety,
–
IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and
essential performance, Class I, BF, continuous operation
–
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
• The equipment conforms with the following EMC/EMI standards: IEC60601-1-2, Class A (CE)
• Degrees of protection against harmful liquid:
For the main
system:
IPX0
For the transducer:
IPX7, from the acoustic window to the junction line (
Fig-
ure 13.1);
and IPX1 for other parts that may contact with the pa-
tient, excluding the transducer connector.
For maximum safety, adhere to these guidelines:
• Proper grounding of the system is critical to avoid electrical shock. For protection, ground the
system with a three-conductor cable, and plug the system into a hospital-grade receptacle
or outlet.
• Do not remove or entangle the grounding wire.
• Do not remove the protective covers of the system. These covers protect users from hazardous
voltages. Only authorized service technicians can make replacements of the parts inside the
system.
• Never use this system while inflammable gas is present!
• Devices must be powered from a receptacle marked “hospital grade” before being con-
nected to the system directly. In case “hospital grade” receptacles are not available, use
isolation transformers instead.
Use of foot switch:
The foot switch paddle must not be used in the operating room.
Take the following precautions when an optional printer is connected to your ultrasound system:
1. When the ultrasound system and the optional printer are connected to the mains outlets, the
outlets must have the protective grounding conductor.
2. The accessories provided with the ultrasound system are safe to operate in patient environ-
ment. Other accessories or devices not listed in the supported accessories’ list (Contact the
manufacturer for the updated and complete list of accessories.) must not be used.
3. Installation of the system must be performed by the service engineer authorized by SonoScape.
P/N: 4710.00149A01
2-9