Auxiliary Devices Safety - GE Voluson i BT06 Service Manual

GE
D KTI106052, R
IRECTION
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Auxiliary Devices Safety

Power Supplies for additional equipment MUST comply with IEC 60601-1.
WARNING WARNING
!! WARNING:
WARNING WARNING DO NOT attempt to use different peripherals and accessories (brand and model;
connected via the PCMCIA or USB ports) other than approved and provided by
!! WARNING:
GE!
The ultrasound system is an extremely sensitive and complex medical system.
Any unauthorized peripherals may cause system failure or damage!
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.
WARNING WARNING For Ethernet connection, a separation device has to be used.
!! WARNING:
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.
* IEC xxx stands for standards such as:
• IEC 60601 for medical devices
• IEC 60950 for information technology equipment etc.
Internally powered, applied parts type BF according to IEC60601-1 including national deviations
NOTICE
Information for service personnel:
For safety test without AC-mains connection (battery operated): apply Class II limits for electrical safety
test of Voluson i/e (e.g. NC (normal condition) 100µA touch-current acc. IEC60601-1)
For safety test with AC-mains connection (by AC/DC adapter or Voluson Station/Cart): apply Class I
limits for electrical safety test of Voluson i/e (e.g. NC (normal condition) 500µA earth-leakage-current,
100µA enclosure leakage current, 100µA touch-current; SFC (single fault condition, like open PE or
open L/N) 1000µA earth-leakage-current, 500µA enclosure leakage current, 500µA touch-current; acc.
IEC60601-1); Do not perform ground continuity test on accessible conducting parts of the Voluson i/e.
These parts are either isolated (floating) or connected to functional earth but not protective earth, i.e.
the connection is not designed to withstand 25A ground continuity test and can damage the Voluson i/e.
Always observe national applicable regulations which might require different limits
The system integrator (any person connecting the medical device to other devices) is responsible
NOTICE
that the connections are safe.
!! NOTICE:
If in doubt, consult the technical service department or your local representative.
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
!! CAUTION:
international standards. All equipment must comply with UL, CSA and IEC requirements.
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Section 1-3 - Safety Considerations
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