Product Manual

SE-1200 Series Electrocardiograph User Manual Safety Guidance
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WARNING
26. Multiple portable socket-outlets shall not be placed on the floor.
27. 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.
28. 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.
29. Parts and accessories used must meet the requirements of the applicable IEC/EN
601 series safety standards, and/or the system configuration must meet the
requirements of the IEC/EN 60601-1-1 medical electrical systems standard.
30. 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.
31. 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.
32. The potential equalization bar can be connected to that of other equipment when
necessary. Make sure that all these devices are connected to the potential
equalization terminal.