Newronika HDCstim User manual

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

2
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.

6
Keep dry.
It indicates a medical device that needs to be protected from
moisture.
Temperature limit.
It indicates the temperature limits to which the medical device can
be safely exposed.
Humidity limitation.
It indicates the range of humidity to which the medical device can
be safely exposed.
Atmospheric pressure limitation.
It indicates the range of atmospheric pressure to which the
medical device can be safely exposed.
Recycle: Electronic Equipment.
Do not dispose of this product in the unsorted municipal stream.
Dispose of this product according to local regulations. For
instruction on proper disposal of product contact Newronika.
Two AA alkaline batteries (not rechargeable LR6)
IP20
Degree of ingress Protection Provided by enclosure.
Protected against solid foreign objects of 12.5mm and greater and
not protected against the effect of the water.
IP03
Degree of ingress Protection Provided by HDCstim Bag.
Not protected against solid foreign objects and protected and
against the effect of water sprayed at an angle up to 60° on either
side of the vertical.
European Conformity, this symbol is applied in accordance with
the relevant provisions of Directive 93/42/EEC on active
implantable medical devices. With it, Newronika declares that this
medical device is in compliance with the essential requirements
and other relevant provisions of this Directive.
0068

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APPLIED DIRECTIVES AND STANDARDS
HDCstim®is a class IIa device according to the classification in the Council Directive
93/42/EEC for medical is compliant with to the following Standards and Directives:
Standard
Title
EN 60601-
1:2006/A1:2013
Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
EN 60601-1-2:2015
Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests
EN 60601-1-11:2010
Medical electrical equipment - Part 1-11: General requirements for
basic safety and essential performance - Collateral standard:
Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
EN 62304:2006
Medical device software - Software life-cycle processes
IEC 62366:2008
Medical devices - Application of usability engineering to medical
devices
EN ISO 13485:2006
Medical devices - Quality management systems - Requirements
for regulatory purposes
EN ISO 14971:2012
Medical devices - Application of risk management to medical
devices
EN ISO 15223-
1:2016
Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1: General
requirements
WHAT YOU WILL FIND IN THE PACKAGING
HDCstim® is given in a packaging containing:
•N.1 HDCstim® stimulator.
•N.1 electrode cable.
•N.1 carrying case for stimulator (HDCstim Bag).
•N.2 batteries 1.5V type AA.
•N.1 user’s manual.
•N.1 declaration of conformity.
•N.1 warranty.
•N.1 CE certificate.

8
SAFETY WARNINGS
HDCstim® shall be used for applications described in the literature. For any other
case, it is mandatory to have the approval of the Ethical Committees.
There are no studies in the literature describing the effects of direct current treatments
on pregnant women, or children below 18 years. Do not use in these patients.
Do not use HDCstim® if pacemakers, intracranial electrodes, defibrillators, or any other
prosthesis are implanted in the patient.
HDCstim® must be used AFTER the prescription of a stimulation schedule made by the
specialized and qualified medical personnel who owns and operates the HDCprog
accessory and a valid PIN for authentication procedures.
The remote control of HDCstim® using ISOcable at home can be performed only AFTER
the prescription in hospital of the first cycle of treatment (initialization of HDCstim®) by
specialized personnel who owns ISOcable and operates with a valid PIN (personal
identification number) for authentication procedures.
During HDCstim® programming, inform the healthcare specialist in case you have
pacemakers, intracranial electrodes, defibrillators, or any other prosthesis.
HDCstim®must be used only with HDCel electrodes and strictly following the directions
in HDCel manual.
HDCstim®must never be opened or damaged. Only access to the battery
compartment is allowed.
HDCstim®must not be used with rechargeable batteries.
Before using, please check that the device is undamaged.
In the case of malfunction, immediately contact the manufacturer or the distributor.
HDCstim®is not protected against excessive moisture or immersion in liquid. Keep the
device far away from liquids. In the case of HDCstim®becoming wet or damp, do not use
the device, remove its batteries and immediately contact the manufacturer or the
distributor.
Do not touch HDCel while stimulation is ON.
You must use HDCstim®only with the cable included in the kit. The cable shall not be
used for other applications from those described in this manual.
The device shall be used according to the education performed by physician during the
delivery of the device. Do not use the device differently.
When HDCstim® is turned on, the device will remain on until the user moves the ON/OFF
level in the off position.
At home keep always HDCstim®and its accessories away from children in order to avoid
the risk of suffocation and strangulation.
Before connecting HDCstim®to your PC please read carefully the user manual of
ISOcable.
While being stimulated, do not use any electronic device such as communication or
entertainment devices (i.e. GSM/UMTS cellular phones or cordless phones, MP3 players
with headset).

© 2020. Newronika S.p.A. Tutti i diritti riservati. All rights reserved. 9
During stimulation, keep all electronic and communication devices (such as GSM/UMTS
cellular phones or cordless phones) a minimum distance of 30cm away from the
HDCstim®and the person being stimulated
During the use of HDCstim® there might be interference with other instrumentation.
Keep always the stimulator inside the black carrying case: do not use the device without
the carrying case.
Do not use HDCstim® and its accessories (including electrodes) if they are damaged,
degraded or loosened because the stimulation might be ineffective.
CONDITIONS OF USE
HDCstim must be used in normal temperature and pressure conditions (Temperature range:
from +5°C to +40°C; Relative humidity range: from 15% to 90%; Atmospheric pressure
range: from 700hPa to 1060hPa).
GLOSSARY
•TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS): neurophysiological
technique consisting in the application of weak direct currents on the skin.
•ANODAL STIMULATION: stimulation in which the active electrode (on the head) is
the positive stimulation pole (red connector).
•CATHODAL STIMULATION: stimulation in which the active electrode (on the head)
is the negative stimulation pole (black connector).
•MONOCHANNEL STIMULATION: stimulation in which there is one active electrode
and one reference.
•BICHANNEL STIMULATION: stimulation inwhich there are two active electrodes and
one reference.
•MINIMUM INTERVAL BETWEEN TWO CONSECUTIVE STIMULATIONS: minimum
time that must elapse before the system is allowed to start another stimulation after
finishing the current stimulation.
•tDCS TREATMENT: a tDCS treatment consists of a cycle of N stimulations that takes
10-40 minutes and has to be performed daily or 2-3 times a week according to the
prescription by the doctor. Time interval between two consecutive stimulation is set
during the programmation of the stimulator. If you turn on HDCstim® before this time
interval on the display you can see the following code:
Where DXX is the number of days and HXX is the hours it is necessary to wait before
to the next stimulation.
DXXHXX Time to next stimulation

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HDCstim®DESCRIPTION
1. LCD screen: indicates the number of programmed stimulations and the time that must
elapse (days/hours) before starting a new stimulation. When the stimulation is ON, it
indicates the time countdown (minutes/seconds) until the end of the stimulation and
the number of failures occurred during the current stimulation.
2. BLUE LED: stimulation ON.
3. GREEN LED: HDCstim®ON.
4. ON switch.
5. Connection to HDCprog or ISOcable.
6. Stimulation ON button.
7. Connection to HDCel.
8. Technical specifications label.
9. Battery compartment.
10.Batteries.
11.Connection cable for electrodes.

© 2020. Newronika S.p.A. Tutti i diritti riservati. All rights reserved. 11
LABELING DESCRIPTION
Accessories
Description
Labeling
HDCstim®
Device for providing
controlled and
programmed
treatments for
transcranical direct
current stimulation
Device Label
External device label
HDCstim®FUNCTIONING
Batteries are supplied with the HDCstim®(2 type AA, 1.5V) and they are already installed in
the unit
Inside the device is contained a secondary battery preventing from losing treatment settings
during primary battery replacement.
BATTERY INSERTION
Open cover 9 and insert batteries as in the picture.
Close cover 9.
-
+-
+

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FIRST USE
Put the switch 4 in the ON position. The green led (3) and the LCD (1) are now ON. Because
the stimulator is not yet programmed, the LCD (1) will show P00 on the bottom part and the
battery charge indicator in the upper part.
Because no treatments were programmed, HDCstim®cannot delivery any stimulation.
HDCstim®PROGRAMMING
Prior to use, HDCstim®must be programmed by specialized personnel.
Once programmed, the HDCstim®will be given back to the subject or patient. The first
stimulation cannot be started before the interval of time set by the specialized personnel is
fully elapsed after the programmation.
Please follow carefully any instructions given to you by the specialized medical
personnel before use.
HOW TO MAKE A STIMULATION
How to make a stimulation is summarized in the following points.
Read carefully before using HDCstim®.
1. Put the stimulator inside the carrying case and place it in the middle of a table in
order to avoid accidental falls of the device during the treatment. The patient must
seat down and do not move during the stimulation.
2. Place electrode on the scalp and connect cables according to the tDCS prescription.
3. Connect the red cable to the Ch1 input of cable 11 and the black cable to the central
input of cable 11. Insert the jack of cable 11 into the connector 7 of HDCstim®.
4. Switch HDCstim®ON (switch 4).
P00
Batterychargelevel indicator
Number of programmed stimulation available

© 2020. Newronika S.p.A. Tutti i diritti riservati. All rights reserved. 13
5. The number of stimulations still available will be displayed on the (which will be
different to P00 on the LCD screen)
6. Verify the time interval before next stimulation (button 6, should not be dXXHXX
where x is a number different from 0).
7. Press button 6 for 7 seconds (until the line 0000000 appears on the LCD 1).
8. Release button 6 and the blue LED (2) will then flash. ‘EL’ will appear on the LCD
until the current of stimulation reaches 100% of the prescribed intensity and the
impedance check finishes.
9. During the stimulation the blue LED (2) is off while the green LED (3) will remain on.
The LCD will show a countdown to the end of the stimulation.
10.At the end of the stimulation, the countdown on the LCD screen will display 00:00F00.
11.Switch HDCstim®OFF (switch 4)
THE PROGRAMMED TREATMENT
The treatment is prescribed according to a user’s needs by specialized personnel. Each
treatment consists of a number of programmed stimulations that should be administered,
with a minimum time interval elapsing between two consecutive stimulations.
When HDCstim®is switched ON without stimulating, the LCD (1) shows PXX, representing
the number of stimulations to be done until the end of the treatment prescribed (for instance,
if the prescription was of 5 stimulations, before the first stimulation starts P05 will be shown,
whereas, if 2 stimulations have been already done P03 will be shown). In addition, the
battery charge level indicator is displayed at the top right corner of the screen.
By briefly pressing button 6, the time to next stimulation is shown in the form dXXHXX.
For instance, if one stimulation every 2 days was prescribed, and the last stimulation ended
on Monday at 12am, the display will show d01H02 if the time is currently 10am on the
following Tuesday. Therefore, before the next stimulation, the user should wait 1 day and 2
hours (until Wednesday at 12am).
Stimulation cannot be administered before the time indicated is fully elapsed.
PXX
Batterychargelevel indicator
Number of programmed stimulation available
DXXHXX Time to next stimulation

14
Only in case of use in presence of specialized personnel (inside hospital), the stimulator
HDCstim®can be programmed in “Free” mode (*only available in firmware version 5 and
later) that allows infinite number of stimulations (N) and without time constraints (interval).
In this case the LCD shows:
Where:
x.x is the current intensity (mA); yy is the stimulation duration (minutes)
n is the number of channel (1= monochannel, 2 = bichannel).
CONNECTION TO ELECTRODES HDCel
Use HDCel to administer the treatment.
Read carefully the instructions on HDCel user’s manual before making the
connection.
When HDCstim®is OFF, place the electrodes as described in HDCel user’s manual and
connect cable 11 to connector 7. Then, connect the electrodes: the cathode must be
connected to the black socket and the anodes to the red sockets.
If the stimulation prescribed is monopolar, connect only one anode to one red socket. If the
stimulation is bipolar, connect both red cables.
After the connection, switch HDCstim®ON (switch 4). The green LED (3) and the LCD (1)
will be ON. The LCD (1) will show the number of stimulations still available.
USE FOR A PROGRAMMED STIMULATION
After electrode connection, if the time interval between two consecutive stimulations is fully
elapsed, the simulator can be used.
HDCstim®can deliver the stimulation if and only if the minimum time interval
between two consecutive stimulations is fully elapsed.

© 2020. Newronika S.p.A. Tutti i diritti riservati. All rights reserved. 15
To verify the residual time, press button 6 and verify that DXXHXX is written, where X is a
number. Time is described as dXX = days and HXX = hours. The system does not consider
minutes and rounds down the time to the last hour. Hence, if the last stimulation was
delivered at 2:50pm, and there is set a 2-hours minimum interval, it will be possible to deliver
the next stimulation at 4:01 pm. When the minimum interval is fully elapsed, the display will
show d00:H00.
If the time interval is elapsed, press down button 6, without touching HDCel. While pressing
down the button, the LCD (1) screen will show a sequence of ‘0’s.
When the sequence of 0 reaches the end of the screen (7 zeros), release button 6.
The LCD will then display a countdown of the time remaining before stimulation ends,
followed by the letter F and two numbers.
The Letter FXX (failure) is the number of failures occurred during the current stimulation
(see next section).
During stimulation, the blue LED (2) will flash each second.
At the end of the stimulation, the blue LED (2) will go OFF. The LCD will display PXX,
representing the number of stimulations still available. Turn the HDCstim® OFF by using
switch 4, and disconnect the cable from the HDCel (11). Disconnect the HDCel as described
in HDCel user’s manual.
STIMULATION FAILURE
In case of accidental electrode disconnection, or of dry electrodes (see HDCel user’s
manual), it is possible that the stimulation will be automatically stopped, because the
treatment is no longer compliant with the prescription.
In this case, the blue LED (2) will remain on and the following code will appear on the LCD.
D00H00
00000
XX:XXFXX

16
By pressing button 6, the LCD will display an error message and error code. For example,
if code 2929 appears, the cause of the stimulation’s failure is the excessive impedance
detected.
The user should then switch the HDCstim®OFF and verify that:
1. The Electrode’s contact with the skin is adequate;
2. The connector (7) is connected correctly;
3. Electrodes are sufficiently wet.
If the problem is one of the above, apply the HDCel again after having wet the electrodes
with the physiological solution (as described in the HDCel user’s manual). Then, connect to
the HDCel to the HDCstim®once more, following the instructions above.
Now it is possible to restart the treatment:
•Switch HDCstim®ON.
•Press down button 6.
•A countdown to the end of the stimulation will be displayed on the LCD (1) followed
by the letter F and the number of failure occurred (if it is the first one, it will be F01; if,
during the same stimulation, another failure has previously occurred, it will be F02).
•End the stimulation.
It is recommended to restart a failed stimulation as soon as possible, to guarantee
an optimal administration of the treatment.
The number of failures per stimulation is stored on the HDCstim®archive, where it can be
checked at the end of the treatment by the specialized personnel who made the prescription.
HOW TO ABORT A PROGRAMMED STIMULATION
In the case of stimulation failure seconds from the end of the stimulation, or if for any other
reason, you want to end the stimulation session, it is possible to do so by:
•Switching the HDCstim®to OFF
•And then holding down button 6 and switching the HDCstim®to ON (switch 4).
The LCD (1) will display an updated number of stimulations still available as well as the
current stimulation was done. The number of aborted stimulation is stored in the HDCstim®
archive and it will be checked at the end of the treatment by the specialized personnel who
made the prescription.
EL_OFF

© 2020. Newronika S.p.A. Tutti i diritti riservati. All rights reserved. 17
STIMULATION IMPEDANCE MONITORING
To check the electric impedance between electrodes, hold down for 1 second the stimulation
button (6) during treatment.
The stimulation impedance is indicated in Kohm and it is updated every second.
The first value (on the left) is the impedance measured on channel 1’s stimulation and the
second (on the right) is the impedance measured on channel 2’s.
BATTERY REPLACEMENT
The LCD (1) shows the charge level of the batteries.
The batteries are fully charged when all the squares are full. When the indicator shows a
low level (one to two squares), it is recommended to replace the batteries.
The device cannot be used when the battery level is low (no full squares). The internal test
circuit will automatically interrupt the stimulation in the case of a discrepancy between the
administered and set treatment, due to discharged batteries.
Two type AA batteries (1.5V) must be used. Do not use rechargeable batteries.
To change the battery follows these steps:
-Switch OFF the stimulator;
-Open the battery case (9) on the back of HDCstim®
-Change the batteries
-Close the battery case (9)
WARNING: If batteries are changed when the HDCstim®is ON then all the treatment
memory will be lost.
After 2 minutes of no interaction with the device, the HDCstim®automatically switches
OFF. If this occurs, manually switch OFF the HDCstim®, wait for 2 seconds, and switch
the HDCstim®on again. The device will then be ready.
PXX
Batterychargelevel indicator
Number of programmed stimulation available
U00 U00

18
HDCstim®MAINTENANCE
The HDCstim®must be kept far away from liquids and heat sources. It must not be used if
the unit appears damaged.
To clean the HDCstim®, use a damp cloth. For the display, use one of the cleaners available
on market.
At the end of each stimulation, before to put the device into its packaging, please clean and
dry the stimulator, the cable and the carrying case.
WARNING: never spray liquid cleaners directly on the HDCstim®. This will invalidate
your warranty
HDCstim®does not need to be disinfected or sterilized.
HDCstim®packaging guarantees a safe, reliable transport.
HDCstim®is an electronic device so it does not have an expiration date if the environmental
conditions for transport, storage and use are respected.
HDCstim®can be used for a maximum of twenty (20) years, if stored according to the
instructions for use and if cleaned as described in the instructions of use. At the end of the
service life, it is required to return the device to the manufacturer for performance control
and safety verification.
WARNING: do not expose the HDCstim®to low or high temperatures or to thermic
shocks. This will invalidate your warranty
ENVIRONMENTAL CONDITIONS OF TRANSPORT, STORAGE AND USE
OF HDCstim®
The environmental conditions of transport and storage of HDCstim®depend on its
components. The permissible temperature range during storage and transport is between -
20°C and +45°C, humidity range between 15% to 90%, and pressure range between 700
and 1060hPa. During the transport and storage, the device must be always kept inside its
packaging.
HDCstim®must be used in the following environmental conditions: temperature range is
+5°C - +40° C, humidity range is 15%-90% RH and pressure range is 700-1060hPa.
Keep always the stimulator inside the carrying case.
After each use the device has to be keep inside its packaging.

© 2020. Newronika S.p.A. Tutti i diritti riservati. All rights reserved. 19
The HDCstim®must be always kept far away from heat sources (radiators, gas, light,
heater…), liquids source (tap, sink, tank) or vapour source (electric iron, kettle or nebulizer)
and from lint, dust and light (including sunlight) because there might be a damage of the
device resulting in loss of stimulation.
CUSTOMER SERVICE/WARRANTIES
For any question and clarifications or in case of malfunction or defect of the product or to
report unexpected operation or events please contact immediately the distributor or the
manufacturer:
Informative support: [email protected]om
Technical support: [email protected]
All the products are guarantee for 2 years by the manufacturer. Inside the packaging
you can find the guarantee form where you can find contacts and address of the
manufacturer.
DISPOSAL
In order to receive disposal instructions please contact the manufacturer at
[email protected]
Do not throw HDCstim®in generic waste.
Discharged batteries must be disposed appropriately.

20
HDCstim®Electromagnetic Compliance
HDCstim®shall be able to stimulate the target area based on the stimulation parameters set
by HDCprog.
HDCstim devices manufactured by Newronika conform to IEC60601-1-2:2014 Standard for
both immunity and emissions. HDCstim is intended to be used in home healthcare
environment and in hospital environment by patients under a specific medical prescription.
Nevertheless, special precautions need to be observed:
•The use of accessories and cables other than those specified by Newronika, with the
exception of cables sold by Newronika as replacement parts for internal components,
may result in increased emission or decreased immunity of the device.
•The medical devices should not be used adjacent to or stacked with other equipment.
In case adjacent or stacked use is necessary, the medical device should be observed
to verify normal operation in the configuration in which it will be used.
•Refer to further guidance below regarding the EMC environment in which the device
should be used.
TABLE 1. Manufacturer Declaration –Electromagnetic emissions HDCstim
Test for emissions
Compliance
Guidelines for electromagnetic environment
CISPR 11: RF emission
Group 1
HDCstim does not use RF energy for its internal
functions and for managing system interfaces. RF
emissions are extremely reduced and are not
likely to cause any interference in nearby
electronic equipment.
CISPR 11: RF emission
Class B
HDCstim is suitable for use in all establishments,
including domestic establishments and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes. Harmonic emissions test and
voltage fluctuations / flicker emissions test are not
applicable because the HDCstim is classified as
an internally powered me equipment.
IEC 61000-3-2: Harmonic
emissions
Not Applicable
IEC 61000-3-3: Voltage
fluctuations/ flicker emissions
Not Applicable