neuroConn DC-Stimulator, User Manual

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Chapter 2 - Safety
11
Important Notes
Stimulation currents of greater than 2,000 µ A or stimulation durations of
longer than 20 min are for research purposes only. The manufacturer
assumes no liability for any injury in these cases.
DC currents can harm body tissue. Ensure that limitations for current density are
adhered to. The German authority ”Bundesinstitut für Arzneimittel und
Medizinprodukte (BfArM)“ recommends a current density limit of 0.1 mA/cm
² . The
manufacturer assumes no responsibility for any injury caused by a too high
current density.
Modifications and repair of the DC- STIMULATOR must be carried out only by the
manufacturer or a company authorized by the manufacturer.
The DC- STIMULATOR must never be opened. The manufacturer assumes no
responsibility for any damage caused by such a practice. If any technical
problems are experienced, always inform the dealer or manufacturer.
Medical electrical devices such as the DC- STIMULATOR are subject to
particular precautions regarding EMC and must be installed and operated
according to established practice.
Portable and mobile HF communication equipment can influence electrical
devices such as the DC-
STIMULATOR .
The DC- STIMULATOR is not protected against liquid spills (IEC 60529: IP20).
The operator should avoid handling liquids when using the device as there is a
risk of electric shock. Should liquid spill onto the device, please unplug the device
and inform the dealer or manufacturer immediately.
The device must not get in contact with liquid spills because liquid spills can
damage the device and can be a risk for the patient, the operator or third persons.