Safety information
Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch
16
2.4
About requirements for connections to external devices
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
μ
A
• with interruption of the (not permanently connected) protective earth
conductor: 500
μ
A
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
