Safety Precautions
LOGIQ E9
–
User Guide
4-25
Direction 5454884-100 English
Rev. 1
Peripherals used in the patient environment (continued)
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 IEC60601-1-1. Everyone who connects additional
equipment to the signal input part or signal output part of the
LOGIQ E9 system configures a medical system, and is therefore
responsible to ensure that the system complies with the
requirements of the valid version of IEC60601-1-1. If in doubt,
consult the technical service department or your local GE
Healthcare representative.
General precautions for installing an alternate on-board device
would include:
1. The added device must have appropriate safety standard
conformance and CE Marking.
2. The total power consumption of the added devices, which
connect to the LOGIQ E9 and are used simultaneously,
must be less than or equal to the rated supply of the LOGIQ
E9.
3. There must be adequate heat dissipation and ventilation to
prevent overheating of the device.
4. There must be adequate mechanical mounting of the device
and stability of the combination.
5. Risk and leakage current of the combination must comply
with IEC/EN 60601-1-1.
6. Electromagnetic emissions and immunity of the combination
must conform to IEC/EN 60601-1-2.
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