EDAN iSE Series Service Manual page 14

iSE Series Electrocardiograph Service Manual
28. Connecting any accessory (such as external printer) or other device (such as the
computer) to this electrocardiograph 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 provided by
medical electrical equipment complying with IEC/EN 60601-1, and
b) Outside the patient environment, the level of safety appropriate for non-medical
electrical equipment complying with other IEC or ISO safety standards.
29. All the accessories connected to system must be installed outside the patient vicinity,
if they do not meet the requirement of IEC/EN 60601-1.
30. If multiple instruments are connected to a patient, the sum of the leakage currents
may exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard.
Consult your service personnel.
31. The electrocardiograph shall not be serviced or maintained while in use with a
patient.
32. The appliance coupler or mains plug is used as isolation means from supply mains.
Position the electrocardiograph in a location where the operator can easily access
the disconnection device.
33. The medical electrical equipment needs to be installed and put into service according
to Appendix 2 EMC information in the User Manual.
34. The equipment should not be used adjacent to or stacked with other equipment, refer
to the recommended separation distances provided in Appendix 2 EMC Information
in the User Manual.
35. Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to the recommended separation distances provided in Appendix 2
EMC Information in the User Manual.
36. Assembly of the electrocardiograph and modifications during actual service life shall
be evaluated based on the requirements of IEC60601-1.
WARNING
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Safety Guidance