EDAN SE-601B - Page 11

SE-601 Series Electrocardiograph Service Manual Safety Guidance
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WARNING
20. SHOCK HAZARD - Don’t connect electrical equipment, which has not been supplied
as a part of the system, to the multiple portable socket-outlet supplying the system.
21. Do not connect any equipment or accessories that are not approved by the
manufacturer or that are not IEC/EN 60601-1-1 approved to the electrocardiograph.
The operation or use of non-approved equipment or accessories with the
electrocardiograph is not tested or supported, and electrocardiograph operation and
safety are not guaranteed.
22. Any non-medical equipment (such as the external printer) is not allowed to be used
within the patient vicinity (1.5m/6ft.).
23. Do not exceed the maximum permitted load when using the multiple portable
socket-outlet(s) to supply the system.
24. Multiple portable socket-outlets shall not be placed on the floor.
25. Do not use the additional multiple portable socket-outlet or extension cord in the
medical electrical system, unless it’s specified as part of the system by manufacturer.
And the multiple portable socket-outlets provided with the system shall only be used
for supplying power to equipment which is intended to form part of the system.
26. Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing
equipment and IEC/EN 60601-1 for medical equipment). Furthermore all
configurations shall comply with the valid version of the standard IEC/EN 60601-1-1.
Therefore anybody, who connects additional equipment to the signal input or output
connector to configure a medical system, must make sure that it complies with the
requirements of the valid version of the system standard IEC/EN 60601-1-1. If in
doubt, consult our technical service department or your local distributor.
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