About Requirements For Connections To External Devices - NDD EasyOne Pro Operator's Manual

Safety information
2.4

About requirements for connections to external devices

Operator's Manual V5.0 • EasyOne Pro/LAB Rev. 05
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch
In your capacity as the operator of the medical electrical device you are
obliged to ensure that the specific, applicable safety requirements for the
operation of a medical-electrical device are complied with.
The following conditions must be met:
• All equipment operated in the patient environment must meet the
requirements of IEC 60601-1.
• All equipment set up outside the patient environment must meet the
requirements of the applicable IEC or ISO safety standards (e.g.
IEC 60950-1).
 Patient environment
If devices that do not fulfill the requirements of IEC standard 60601-1 are
operated in the patient environment, it must be ensured that the maximum
allowed touch currents will not be exceeded.
The following limits are applicable:
• normal condition: 100 μA
• with interruption of the (not permanently connected) protective earth
conductor: 500 μA
Appropriate measures must be taken if these limits are exceeded.
Suggestions:
• additional protective earth connection of the PC or
• isolating transformer for the PC or
• isolating transformer with built-in power outlet strip for the PC and the
devices connected to it
EN 60601-1:2006 specifies the requirements for power outlet strips.
Bear in mind that the touch currents may vary with the system configuration.
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