Summary of Contents for Newronika HDCstim
- Page 1 tDCS - Portable & Programmable Direct Current Stimulator User’s manual Version V16E – June 2020...
- Page 2 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.
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Page 3: Table Of Contents
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 © 2020. Newronika S.p.A. Tutti i diritti riservati. All rights reserved. -
Page 4: Intended Use
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. -
Page 5: Warnings
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. - Page 6 IP20 Protected against solid foreign objects of 12.5mm and greater and not protected against the effect of the water. Degree of ingress Protection Provided by HDCstim Bag. Not protected against solid foreign objects and protected and IP03 against the effect of water sprayed at an angle up to 60° on either side of the vertical.
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Page 7: Applied Directives And Standards
• 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. © 2020. Newronika S.p.A. Tutti i diritti riservati. All rights reserved. -
Page 8: Safety Warnings
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. -
Page 9: Conditions Of Use
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). -
Page 10: Hdcstim Description
(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 4. ON switch. 5. Connection to HDCprog or ISOcable. 6. Stimulation ON button. -
Page 11: Labeling Description
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. © 2020. Newronika S.p.A. Tutti i diritti riservati. All rights reserved. -
Page 12: First Use
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... -
Page 13: The Programmed Treatment
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. © 2020. Newronika S.p.A. Tutti i diritti riservati. All rights reserved. -
Page 14: Connection To Electrodes Hdcel
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. -
Page 15: Stimulation Failure
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. -
Page 16: How To Abort A Programmed Stimulation
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... -
Page 17: Stimulation Impedance Monitoring
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 ®... -
Page 18: Hdcstim Maintenance
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 ®... -
Page 19: Customer Service/Warranties
DISPOSAL In order to receive disposal instructions please contact the manufacturer at support@newronika.com ® Do not throw HDCstim in generic waste. Discharged batteries must be disposed appropriately. © 2020. Newronika S.p.A. Tutti i diritti riservati. All rights reserved. -
Page 20: Hdcstim Electromagnetic Compliance
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: •... - Page 21 TABLE 2. Manufacturer Declaration – Electromagnetic immunity The HDcstim is intended for use in the electromagnetic environment specified below. The customer or the user of the HDCstim should assure that it is used in such an environment. Test for Test level IEC 60601-1-...
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Page 22: Technical Specifications
® 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. Sterilization Not sterile Latex-Free Product Phthalate-free Product Disposable or reusable... - Page 23 Atmospheric pressure range: from 700hPa to 1060hPa *measured during standard test with 100% battery charge. ** the method for mean impedance estimation is described in the HDCprog manual. © 2020. Newronika S.p.A. Tutti i diritti riservati. All rights reserved.
- Page 24 Newronika S.p.A. Via Dante 4 20121 Milano - Italy (operative labs: Via T. Tasso 1 - 20093 Cologno Monzese (MI) – Italy) Tel: (+39) 02 84109381 www.newronika.com www.hdcstim.com...
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