Compliance - GE Venue Go Service Manual

P R E L I M I N A R Y
D 5813707-100, R
IRECTION
A Wireless LAN device is built into the Venue Go, and is not user-accessible ('Connectivity' on page 8-
29). Conforms to IEEE 802.11ac/a/b/g/n WiFi with Bluetooth 4.0 Standard. The Wireless LAN device is
an option on the system and can only be activated by installation of a special unique option key license
supplied separately by GE.
The Venue Go may also be used safely while connected to devices other than those recommended
above if the devices and their specifications, installation, and interconnection with the system conform
to the requirements of IEC/EN 60601-1.
Accessory equipment connected to the analog and digital interfaces must be certified according to the
respective IEC standards (i.e., IEC60950 for data processing equipment and IEC60601-1 for medical
equipment). Furthermore, all complete configurations shall comply with the valid version of the system
standard IEC60601-1. Anyone connecting additional equipment to the signal input part or signal output
part of the Venue Go system is in fact configuring a medical system, and is therefore responsible to
ensure that the system complies with the requirement of the valid version of IEC60601-1. If in doubt,
consult the technical service department or your local GE representative.
The connection of equipment or transmission networks other than as specified in the
WARNING WARNING
user instructions can result in an electric shock hazard or equipment malfunction.
Substitute or alternate equipment and connections requires verification of
compatibility and conformity to IEC/EN 60601-1 by the installer.
Equipment modifications and possible resulting malfunctions and electromagnetic
interference are the responsibility of the owner.
General precautions for installing an alternate off-board, remote device or a network would include:
1.) The added device(s) must have appropriate safety standard conformance and CE Marking.
2.) There must be adequate heat dissipation and ventilation to prevent overheating of the device.
3.) The added device(s) must be used for their intended purpose having a compatible interface.
4.) Risk and leakage current of the combination must comply with IEC/EN 60601-1.
5.) Electromagnetic emissions and immunity of the combination must conform to IEC/EN 60601-1-2.
1-9-3

Compliance

The Venue Go™ ultrasound scanner conforms to all applicable conducted and radiated emission limits
and to immunity from electrostatic discharge, radiated and conducted RF fields, magnetic fields and
power line transient requirements.
NOTE: For applicable standards refer to the Safety Chapter in the Venue Go™ User Manual.
NOTE: For EMC Guidance and Manufacturer's Declarations, refer to the tables provided in
Discharge (ESD) Prevention
NOTE: For CE Compliance, it is critical that all covers, screws, shielding, gaskets, mesh and clamps are in good
condition and installed tightly without skew or stress. Proper installation following all comments noted
in this service manual is required in order to achieve full EMC performance.
2
EVISION
on page 1 - 30.
Chapter 1 - Introduction
V G ™ S M
ENUE O ERVICE ANUAL
Electrostatic
1-29