Auxiliary Devices Safety - GE LOGIQ S8 Service Manual

GE H
EALTHCARE
D 5394227, 12
IRECTION
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Auxiliary Devices Safety

Power Supplies for additional equipment MUST comply with IEC 60601-1.
WARNING WARNING
DO NOT attempt to use different peripherals and accessories (brand and model;
WARNING WARNING
connected via USB ports) other than approved and provided by GE Healthcare!
The ultrasound system is an extremely sensitive and complex medical system.
Any unauthorized peripherals may cause system failure or damage!
After each installation, the leakage currents have to be measured according to
WARNING WARNING
IEC 60601-1 respectively UL 60601-1.
The LOGIQ S8 may be used with an isolation transformer to provide the required separation from mains
for both, the system and the auxiliary devices.
One AUX main outlet is located at the primary power supply. It is used for connecting the two-fold splitter
whose outlets are led to the shelves intend for auxiliary devices (e.g., printers) and the AUX main outlet
that is accessible on the back of the control console.
The IEC 60601-1-1 standard provides a guideline for safely interconnecting medical devices in systems.
"Equipment connected to the analog or digital interface must comply with the respective IEC/UL
standards (e.g. IEC 60950 / UL 60950 for data processing equipment and IEC 60601-1 / UL 60601-1
for medical equipment).
Everybody who connects additional equipment to the signal input portion or signal output portion
configures a medical system, and is therefore responsible that the system complies with the
requirements of the system standard IEC 60601-1-1.
Special care has to be taken, if the device is connected to computer network (e.g., Ethernet), because
other devices could be connected without any control. There could be a potential difference between
the protective earth and any line of the computer network including the shield.
In this case the only way to operate the system safely is to use an isolated signal link with minimum
4mm creepage distance, 2.5mm air clearance of the isolation device. For computer networks there are
media converters available which convert the electrical to optical signals. Please consider that this
converter has to comply with IEC xxx standards* and is battery operated or connected to the isolation
mains output of the LOGIQ S8.
* IEC xxx stands for standards such as:
• IEC 60601 for medical devices
• IEC 60950 for information technology equipment etc.
The leakage current of the entire system including any / all auxiliary equipment must not exceed
CAUTION
the limit values as per EN 60601-1-1:1990 (IEC 60601-1-1) respectively other valid national or
international standards. All equipment must comply with UL, CSA and IEC requirements.
1 - 20 Section 1-4 - Safety Considerations
LOGIQ S8/LOGIQ E8 S M
ERVICE ANUAL