Maico ERO-SCAN Operation Manual page 13

WARNING
In Case of Emergency
WARNING
WARNING
1
8106556 Rev. 11
Operation Manual ERO•SCAN
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 USB cable at any time.
Do not use the device if the mains cable and/or the plug is
damaged.
To transfer data to a PC, establishing a PC-connection via USB
is required.
To learn how to safely establish a connection with a power
supplied PC or laptop (medical device/non-medical device) or
to a battery-driven laptop see:
Section 4.5
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. If the
device is connected to a PC (IT equipment forming a system)
ensure not to touch the patient while operating the PC. Do not
touch the patient and the printer at the same time.
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.
The consequence of not following this warning could be a
too high leakage current to the patient.
Do not touch the contacts on the bottom of the device and
the patient at the same time. When connected to computer
equipment do not simultaneously touch the computer
equipment and the patient at the same time. The consequence
could be a too high leakage current to the patient.
11
Establishing a PC-Connection
®
13//08/2020