GE H48681XB, Service Manual

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IEC XXX compliant devices (protection class I) may be connected with an additional safety
measure.
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IEC 60601 compliant devices may be connected as such.
For all situations 1 and 2, the additional device shall be installed outside the typical patient environment.
Possible additional safety measures are additional protective earth connection between the 2 devices, or a
safety isolation mains transformer for the other device.
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 air
clearance and creepage distance of the isolation device in agreement with IEC60601 incl. national
deviations. 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 Voluson E-Series ultrasound system.
* IEC xxx stands for standards such as:
•
IEC60601 for medical devices
•
IEC60950 for information technology equipment etc.
Note The system integrator (any person connecting the medical device to other devices) is responsible that
connections are safe. If in doubt, consult the technical service department or your local representative.
Caution
The leakage current of the entire system including any / all auxiliary equipment must not exceed the limit
values as per EN60601-1-1 (IEC60601-1-1) respectively other valid national or international standards. All
equipment must comply with UL, CSA, IEC or other relevant requirements.
Caution
Please observe that some printers may not be medical devices! If Bluetooth-, Line- or Laser Printers are no
medical devices, they have to be located outside of the typical patient environment. Examples for typical
patient environments can be found in standard IEC 60601 (see illustrations below).
Caution
Auxiliary equipment must only be connected with the special main outlet provided for the electrical safety of
the system.
Caution
Auxiliary equipment with direct main connection requires galvanic separation of the signal and/or control
leads.
Note Always observe the instructions given in the manual of the peripheral/auxiliary device.
For hardware installation procedures see: Chapter 3 – Setup Instructions
Warning
After each installation, the leakage currents have to be measured according to IEC 60601-1, UL 60601-1,
IEC 62353 or other relevant standard.
Note
All peripherals mounted on the Voluson E-Series system chassis must be firmly secured in position.
Introduction
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Voluson E-Series Service Manual
KTD106657 Revision 2