Newronika HDCstim User manual

tDCS - Portable & Programmable
Direct Current Stimulator
User’s manual
Version V16E –June 2020

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HDCstim®is manufactured by
Newronika S.p.A.
Via Dante 4
20121 Milano - Italia
(operative labs: Via T. Tasso 1 - 20093 Cologno Monzese (MI) –Italy)
This manual is drawn up by Newronika S.p.A. and the reproduction,
also partial, cannot be performed without the permission of
Newronika S.p.A.
For every further information it is possible to send an e-mail to
[e-mail]
HDCstim®is a part of HDCkit and it is an active medical device of
class IIa (European Notified Body 0068 - MTIC InterCert –Registered Office: Via
Leopardi, 14 –20123 MILANO (MI) ITALY / Operative Lab: Via Moscova, 11 - 20017 RHO
(MI) ITALY).
HDCstim is CE marked:

© 2020. Newronika S.p.A. Tutti i diritti riservati. All rights reserved. 3
INDEX
INDEX.............................................................................................................................................3
INTENDED USE.............................................................................................................................4
WARNINGS....................................................................................................................................5
LEGEND: used symbols according to EN ISO 15223-1:2016 .........................................................5
APPLIED DIRECTIVES AND STANDARDS ...................................................................................7
WHAT YOU WILL FIND IN THE PACKAGING ...............................................................................7
SAFETY WARNINGS .....................................................................................................................8
CONDITIONS OF USE...................................................................................................................9
GLOSSARY....................................................................................................................................9
HDCstim®DESCRIPTION.............................................................................................................10
LABELING DESCRIPTION...........................................................................................................11
HDCstim®FUNCTIONING............................................................................................................11
BATTERY INSERTION .............................................................................................................11
FIRST USE ...............................................................................................................................12
HDCstim®PROGRAMMING......................................................................................................12
HOW TO MAKE A STIMULATION ............................................................................................12
THE PROGRAMMED TREATMENT.........................................................................................13
CONNECTION TO ELECTRODES HDCel................................................................................14
USE FOR A PROGRAMMED STIMULATION...........................................................................14
STIMULATION FAILURE..........................................................................................................15
HOW TO ABORT A PROGRAMMED STIMULATION...............................................................16
STIMULATION IMPEDANCE MONITORING ............................................................................17
BATTERY REPLACEMENT......................................................................................................17
HDCstim®MAINTENANCE...........................................................................................................18
ENVIRONMENTAL CONDITIONS OF TRANSPORT, STORAGE AND USE OF HDCstim®.........18
CUSTOMER SERVICE/WARRANTIES ........................................................................................19
DISPOSAL....................................................................................................................................19
HDCstim Electromagnetic Compliance .........................................................................................20
TECHNICAL SPECIFICATIONS...................................................................................................22

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INTENDED USE
HDCstim®is part of the HDCkit system for the delivery of direct current stimulation-controlled
treatments. HDCstim® is a battery supplied, programmable system for direct current (DC)
stimulation.
HDCstim®can be used only under medical prescription.
Transcranial DC stimulation is a neurophysiological technique able to modulate the
excitability of the biological tissue of the central and peripheral nervous system, through the
delivery, for a finite time length, of an electrical field. It has been demonstrated in recent
years that the technique is safe and beneficial. However, its application must be controlled
by specialized medical personnel able to guarantee correct stimulation parameters.
HDCstim®must be always used according to applications already described in the
literature. In any other case, the local Ethics Committee or analogous Body must be
required.
HDCstim®is specifically designed to be used only under medical prescription. HDCstim®
can be used only if programmed by specialized medical personnel through the HDCprog
device. Otherwise, HDCstim®cannot and should not be used. The first programming of the
device has to be performed by doctor in hospital using HDCprog or ISOcable. HDCstim®
can be used at home and the doctor can monitor the treatment at home and eventually
renew the cycle of treatment at home using ISOcable system. In this way daily tDCS
treatments can be performed at home and programming with ISOcable reduces travel
expenses between home and hospital for the treatment renew. Remote control of HDCstim®
using PC at home is available starting from HDCstim®firmware version 6.0.
Because the treatment can be performed only following the prescription made by specialized
personnel, the DC stimulation delivered by HDCstim®can be considered safe.
It is contraindicated to use the HDCkit system for tDCS treatment in pregnant women,
children below 18 years, patients with pacemakers, intracranial electrodes, implanted
defibrillators, or any other prosthesis.
Read carefully the User’s manual before using HDCstim®.
HDCstim®is intended to be used in home environment, by the patient and/or caregivers
(intended as lay operators).

© 2020. Newronika S.p.A. Tutti i diritti riservati. All rights reserved. 5
WARNINGS
In the manual, this symbol indicates a warning point.
Not following the instructions by this symbol could cause the HDCstim®to malfunction,
cause damage to the unit or create a potential danger in the administration of the treatment.
LEGEND: used symbols according to EN ISO 15223-1:2016
Caution. It indicates the need for the user to consult the
instructions for use for important cautionary information such as
warnings and precautions that cannot, for a variety of reasons, be
presented on the medical device itself.
Mandatory to follow instructions for use.
Refer to instruction manual/booklet
Type BF applied part.
Catalogue number.
It indicates the manufacturer’s catalogue number so that the
medical device can be identified.
Serial number.
It indicates the manufacturer’s serial number so that a specific
medical device can be identified.
Manufacturer.
It indicates the medical device manufacturer.
.
Date of manufacture.
It indicates the date when the medical device was manufactured.
Product packaging can be recycled
Fragile, handle with care.
It indicates a medical device that can be broken or damaged if not
handled carefully.