EDAN SE-1201 User Manual page 10

Electrocardiograph
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SE-1201 Electrocardiograph User Manual
17. The use of equipment that applies high frequency voltages to the patient (including
electrosurgical equipment and some respiration transducers) is not supported and
may produce undesired results. Disconnect the patient data cable from the
electrocardiograph, or detach the leads from the patient prior to performing any
procedure that uses high frequency surgical equipment.
18. If the wireless AP technology is used, in order to maintain compliance with the FCC
RF exposure guidelines, the wireless AP should be installed and operated with a
minimum distance of 20cm between the radiator and the human body. There should
be no shield in or around the room where the wireless AP is used.
19. Fix attention on the examination to avoid missing important ECG waves.
20. SHOCK HAZARD - Don't connect non-medical electrical equipment, which has been
supplied as a part of the system, directly to the wall outlet when the non-medical
equipment is intended to be supplied by a multiple portable socket-outlet with an
isolation transformer.
21. 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.
22. 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.
23. Any non-medical equipment (such as the external printer) is not allowed to be used
within the patient vicinity (1.5m/6ft.).
24. Do not exceed the maximum permitted load when using the multiple portable
socket-outlet(s) to supply the system.
25. Multiple portable socket-outlets shall not be placed on the floor.
26. 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.
27. 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.
WARNING
- 3 -
Safety Guidance

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