Operation Manual easyTone
8529689 Rev. 2
9
10/05/2022
Data transfer to the PC can be done via WiFi or USB connection.
To learn how to safely establish a PC connection with a power
supplied PC or laptop via USB connection (medical device/non-
medical device) or to a battery-driven laptop see:
Section 4.3
This equipment is intended to be connected to other equipment
thus forming a Medical Electrical System. External equipment
intended for connection to signal input, signal output or other
connectors shall comply with the relevant product standard e.g.
IEC 60950-1 for IT equipment and the IEC 60601-series for
medical electrical equipment. In addition, all such combinations
– Medical Electrical Systems – shall comply with the safety
requirements stated the general standard IEC 60601-1, edition
3, clause 16. Any equipment not complying with the leakage
current requirements in IEC 60601-1 shall be kept outside the
patient environment i.e. at least 1.5 m from the patient support
or shall be supplied via a separation transformer to reduce the
leakage currents. Any person who connects external
equipment to signal input, signal output or other connectors has
formed a Medical Electrical System and is therefore
responsible for the system to comply with the requirements. If
in doubt, contact qualified medical technician or your local
representative.
A Separation Device (isolation device) is needed to isolate
the equipment located outside the patient environment from
the equipment located inside the patient environment. In
particular such a Separation Device is required when a
network connection is made. The requirement for the
Separation Device is defined in IEC 60601-1 clause 16.
If the device is connected to a PC (IT equipment forming a
system) assembly and modifications shall be evaluated by
qualified medical technician according to safety regulations
in IEC 60601-series.
Do not touch the contacts of the device/tablet and the
patient at the same time.
If the tablet is connected to a PC (IT equipment forming a
system) do not touch the patient and the IT equipment at
the same time.
The consequence of not following this warning could be a
too high leakage current to the patient.
WARNING
WARNING
WARNING
WARNING
WARNING
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