EDAN iSe Series User Manual page 23

iSE Series Electrocardiograph User Manual
9. The disposable electrodes can only be used for one time.
10. Do not touch the patient, bed, table or the equipment while using the ECG
together with a defibrillator.
11. Do not touch accessible parts of electrical equipment and the patient
simultaneously.
12. 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.
13. Pay close attention to the examination to avoid missing important ECG
waveforms.
14. Do not connect any equipment or accessories that are not approved by the
manufacturer or that are not IEC/EN 60601-1 approved to the system. The
operation or use of non-approved equipment or accessories with the system is
not tested or supported, and system operation and safety are not guaranteed.
15. The use of patient cable and other accessories not supplied by the
manufacturer may result in increased emissions or decreased immunity of the
equipment.
16. Any non-medical equipment (such as the external printer) is not allowed to be
used within the patient vicinity (1.5m/6ft.).
17.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 configuration shall comply with the valid version of the
standard IEC/EN 60601-1. 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. If in doubt, consult our
technical service department or your local distributor.
18.Connecting any accessory (such as external printer) or other device (such as
the computer) to this system makes a medical system. In that case, additional
safety measures should be taken during installation of the system, and the
system shall provide:
a) Within the patient environment, a level of safety comparable to that
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Introduction