NeuroConn DC-Stimulator Manual de usuario

Programmable Direct Current Stimulator

DC-STIMULATOR

User manual

Table of contents

........................................................................................................................ 8

Preface

........................................................................................................................ 10

Safety

................................................................................................................ 11Important Notes

................................................................................................................ 14Safety aspects of transcranial Direct Current Stimulation (tDCS)

................................................................................................................ 15Safe stop mode

........................................................................................................................ 16

Getting Started

................................................................................................................ 16Components

.......................................................................................................... 17DC-STIMULATOR

.......................................................................................................... 20Equipment

.......................................................................................................... 20Consumables

................................................................................................................ 22Type label

................................................................................................................ 23Power supply

................................................................................................................ 25Activating the DC-STIMULATOR

................................................................................................................ 25Mode standby

................................................................................................................ 25Turning off the DC-STIMULATOR

........................................................................................................................ 27

Operating Basics

................................................................................................................ 28External charger

................................................................................................................ 29Electrodes

.......................................................................................................... 30Cleaning and storing

................................................................................................................ 31Impedance control

................................................................................................................ 33Additional hardware

.......................................................................................................... 33Trigger input

................................................................................................................ 34Cleaning the device

................................................................................................................ 35Moving the device

................................................................................................................ 37Storing the device

........................................................................................................................ 38

Software Reference Manual

................................................................................................................ 38Display, button, menu

Table of contents

................................................................................................................ 40PARAMETER

.......................................................................................................... 40tDCS

................................................................................................................ 41STIMULATION

................................................................................................................ 43SYSTEM

.......................................................................................................... 44Trigger input (optional)

.......................................................................................................... 45Impedance limit

.......................................................................................................... 46Load setting

.......................................................................................................... 47Study mode (optional)

....................................................................................................... 49Procedure

.......................................................................................................... 51Language set

.......................................................................................................... 52Signal tone

.......................................................................................................... 52Backlight brightness

................................................................................................................ 53MASTERCODE (optional)

........................................................................................................................ 55

Troubleshooting

........................................................................................................................ 56

Technical Specifications

........................................................................................................................ 58

Electromagnetic compatibility

................................................................................................................ 58Information for ensuring electromagnetic compatibility

................................................................................................................ 59Guidance and manufacturer's declaration - electromagnetic emissions

................................................................................................................ 59Guidance and manufacturer's declaration - electromagnetic immunity

................................................................................................................ 62

Recommended separation distances between portable and mobile RF

communication equipment and the device or system

........................................................................................................................ 64

Service

................................................................................................................ 65Safety inspection

........................................................................................................................ 66

Distributors

........................................................................................................................ 73

Intended use and therapeutic application

........................................................................................................................ 79

Disclaimer

........................................................................................................................ 80

Notes

........................................................................................................................ 81

Manuals Equipment

................................................................................................................ 81Rubber electrodes and sponge pads

Table of contents

................................................................................................................ 82Electrode paste Ten20

Chapter 1 - Preface

Preface1

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.

Chapter 1 - Preface

Note

The following signs bring important information to your attention:

This informs the user that failure to follow these instructions may cause harm to

the user and others or may damage the DC-STIMULATOR or other equipment.

This is a general hint or useful advice for better use of the DC-STIMULATOR.

Chapter 2 - Safety

Safety2

The DC-STIMULATOR has been certified as an active medical device class IIa.

CAUTION FOR UNITED STATES OWNERS AND OPERATORS:

Investigational Device. Federal (or US) law limits this device to

investigational use.

The construction of the DC-STIMULATOR conforms to the regulations set out in the

Medical Device Directive 93/42/EEC (Date of issue 14th June 1993), which was put into

German law. The requirements of the following standard(s) or normative document(s) are

fulfilled:

EN 60601-1:2006 Medical electrical equipment Part 1: General requirements for safety

EN 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for

safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

EN 62304:2006 Medical device software - Software life-cycle process

EN 62366:2008 Medical devices - Application of usability engineering to medical devices

EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and

testing within a risk management process (ISO 10993-1:2009)

EN ISO 14971:2012 Medical devices - Application of risk management to medical devices

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