DIRECTION 5854713-100, REVISION 2
VENUE FIT™ SERVICE MANUAL
1-26
Chapter 1 - Introduction
P R E L I M I N A R Y
The Venue Fit 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 Fit 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.
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.
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Compliance
The Venue Fit™ 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 Fit™ User Manual.
NOTE:
For EMC Guidance and Manufacturer’s Declarations, refer to the tables provided in .
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.
WARNING
WARNING
The connection of equipment or transmission networks other than as specified in the
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.
Summary of Contents for Venue Fit
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