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Safety information
2.4
About requirements for connections to external devices
Operator's Manual V1.1 • EasyOne Air • EasyOne Connect
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch
EasyOne Connect is installed on a PC or laptop, to which EasyOne Air is
connected via the cradle or wirelessly.
The PC or laptop is not part of the equipment supplied by the manufacturer
and is considered a requisite accessory that is necessary to use EasyOne Air
with the PC software EasyOne Connect.
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
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