neuroConn DC-Stimulator, User Manual, Page: 8 / 85

Chapter 1 - Preface
8
Preface 1
Thank you for buying a product of neuroConn GmbH.
The DC- STIMULATOR allows you to perform a transcranial direct current stimulation
(tDCS) as part of a non-invasive Interventional Neurophysiology. Weak electrical currents
(max 2 mA) at a duration of 15..30 minutes are applied at different positions on the head.
The electrical charge and current density applied during tDCS are far below the threshold for
releasing a stimulus and take modular effect to existing neuronal elements.
Depending on duration, used current, current density and frequency the stimulation is
effective on inhibiting or activating cortical activity.
If established treatments fail a supporting therapeutic effect on depression and neuropathic
pain in the lower limbs is probable and during rehabilitation of speech and motor skills after
stroke and on auditory hallucinations in schizophrenia possible.
Users of the DC- STIMULATOR are physicians and psychologists with knowledge about the
effects of non-invasive brain stimulation and experience in brain stimulation.
The essential performance of the DC- STIMULATOR during cranial electrotherapy is to
ensure that:
•
a maximum output current of 2 mA will not be exceeded (max. tolerance 5 %)
•
a predefined stimulation time will not be exceeded (max. tolerance (1%)
This manual shows you how to operate the DC- STIMULATOR .
The devices of the neuroConn GmbH are delivered with user manuals in English or German
language (Germany, Austria and Switzerland) depending on the destination country.
The manual contains all the information required by Directive 93/42/EEC Annex I Section 13.
Also the standards EN1041:2008 (Providing of information by the manufacturer of medical
devices) and EN980:2008 (Symbols for the labeling of medical products) as well as
EN60601:2006 (Medical electrical equipment; part 1: general requirements for safety)
including the essential performance characteristics: table D.1 – Common symbols & table
D.2 safety marks are applied.