g.tec medical engineering GmbH
g.USBamp, USB Biosignal Amplifier: Instruction for use
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V2.16.09
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Important Notes
Attention
conductible parts of all electrodes must
not
have contact to earth or other conductible parts
the device is
not
protected against the effect of cardiac defibrillator discharge
the device must
not
be used in humans with pace-makers or electrical stimulators
the potential equalization conductor should be connected to a potential equalization conductor
of the room where g.USBamp is used
it is not allowed to use other power supply units than the original medical technical power
supply which is delivered with g.USBamp
pay attention to the precautions regarding electromagnetic compatibility (see Chapter
Electromagnetic compatibility)
the operator has to be familiar with the operation of g.USBamp and must operate the device
according to the instruction for use manual.
pay attention to avoid electrostatic discharge impulses when connecting electrode to the
safety sockets of the device (see Chapter Save operation of g.USBamp)
every time before using g.USBamp check the device and its accessories for possible
damages of connectors, sockets and cables. Cables, connectors, accessories, or other parts
of the equipment must be replaced immediately when damaged or not working correctly.
Warning and safety notice
If g.USBamp is connected to other devices (except the power supply supplied with g.USBamp) like a
PC the following leakage currents have to be checked.
Ground leakage current
Enclosure leakage current
Patient leakage current
The leakage currents must be checked if several g.USBamps are interconnected according to IEC
60601-2-49. The interconnection of several g.USBamp or the connection to other devices can
decrease the degree of protection from cardiac float (CF) to body float (BF).
Accessory equipment connected to the analog and digital interfaces must be certified according to the
respective IEC standards (e.g. IEC 60950 for data processing equipment and IEC 60601-1 for medical
equipment). Furthermore all configurations shall comply with the system standard IEC 60601-1-1.
Everybody who connects additional equipment to the signal input part or signal output part configures
a medical system, and is therefore responsible that the system complies with the requirements of the
system standard IEC 60601-1-1. If in doubt, consult the technical service department or your local
representative.
