In case of emergency, disconnect the device from power supply.
Position the device in such a way that it can be easily
disconnected from the power plug at any time.
Do not use the device if the power supply unit and/or the
plug is damaged.
To transfer data to a PC, establishing a PC-connection via
USB is required. See section 4.2.4 on how to safely establish
a connection with a power supplied PC or laptop (medical
device/non-medical device) or to a battery-driven laptop.
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 and the patient at the
same time.
If the device 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.
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