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.
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.
The device is not intended for operation in areas with an
explosion hazard. Do NOT use the device in a highly
oxygen-enriched environment, such as a hyperbaric
chamber, oxygen tent, etc. If the device is not used switch it
off and disconnect it from the power supply.
Never short-circuit the terminals.
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