Neuroelectrics Starstim 8 Скачать руководство пользователя страница 1

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Neuroelectrics User Manual

Starstim 8 / Starstim tES / Starstim-Home tES

CAUTION: INVESTIGATIONAL DEVICE

Limited by United States law to investigational use.

Содержание Starstim 8

Страница 1: ...Neuroelectrics User Manual Starstim 8 Starstim tES Starstim Home tES CAUTION INVESTIGATIONAL DEVICE Limited by United States law to investigational use...

Страница 2: ...08035 Barcelona Spain Tel 34 93 254 03 66 Fax 34 93 212 64 45 US Office 210 Broadway Suite 201 Cambridge MA 02139 USA Tel 1 617 682 0770 Email info neuroelectrics com www neuroelectrics com Copyright...

Страница 3: ...stim 8 system to report unexpected operation of events that result from the usage of the device Manufacturer Neuroelectrics Barcelona SLU Avinguda Tibidabo 47 bis 08035 Barcelona Spain Telephone 34 93...

Страница 4: ...trode User Manual u u Part III NIC User Manual Before you first use the Starstim system you should read the three parts of the Neuroelectrics User Manual The Starstim User Manual does not discard the...

Страница 5: ...im 2 Electrode and 3 NIC 2 1 2016 05 10 Starstim tCS info added to Starstim 8 manual 2 2 2017 07 25 Product contents update Starstim tCS info removed 2 3 2017 08 23 Regulatory info update 2 4 2018 05...

Страница 6: ...Geltrodes replace Geltrodes Added Testboard section Updated Regulatory Information 2 7 2019 12 03 Extension of product labelling description Naming consistency update Starstim New Image Starstim tCS...

Страница 7: ...13 II 2 Medical Device Regulations 13 II 3 For US Audience only 13 III Safety Information 14 III 1 Safety Warnings 15 IV The Starstim System 17 IV 1 Features 18 IV 2 Technical Specifications 19 IV 3...

Страница 8: ...is possible before during and after stimulation u u Multiple independent stimulation channels improve the spatial distribution of the electric field u u Variety of waveforms for stimulation current tD...

Страница 9: ...tDCS tACS and tRNS Additionally the Sham mode can be used for controlled experiments Transcranial Direct Current Stimulation tDCS tDCS is the most popular tES technique and it is described by stimulat...

Страница 10: ...er or in case of tES Home remotely at study subject s home They must be always used according to the brain stimulation applications described in the literature In any other case the supervision of a l...

Страница 11: ...3 u u Atmospheric Pressure 700 1 000 hPa The device must be stored inside the box between uses in the following environmental conditions u u Temperature Range 25 to 65 C u u Humidity 15 93 This equipm...

Страница 12: ...12 II Quality and Regulatory Information...

Страница 13: ...arstim tES and Starstim Home tES are intended for research use only Canada In Canada Starstim 8 and Starstim tES is approved as a medical device and conform with the Canadian Medical Device Regulation...

Страница 14: ...62304 2006 Corr 2009 AC 2010 Biological evaluation u u EN ISO 10993 1 2009 AC 2010 Usability u u EN 62366 1 2015 AC 2015 Others u u EN ISO 980 2008 u u EN ISO 15223 1 2016 u u EN 1041 2008 A1 2013 u...

Страница 15: ...touch the device during stimulation or while EEG monitoring is on W W Never use the device or install the electrodes on the head of the patient while connected to the power network W W Do not switch t...

Страница 16: ...ill interference with a higher Signal Quality Index W W The modification of the device is not allowed W W If the device has not been used during a long period of time the user should check visually th...

Страница 17: ...oduct name a picture and a short description of its function Lastly it describes the Neuroelectrics Control Box Necbox which is the core and the control unit of Starstim For further information regard...

Страница 18: ...led u u Resolution 24 bits 0 05 V u u Measurement noise 1 V RMS u u Common mode rejection ratio 115 dB u u Input impedance 1 G Stimulation functionality u u Number of channels up to 8 channels u u Sam...

Страница 19: ...is a wireless device operating at the 2 4GHz Industrial Medical and Scientific ISM band The Nexbox connects through the wireless link to the Neuroelectrics Instrument Controller NIC software running o...

Страница 20: ...Power Supply Plug 1 NE014 Curved Syringe 1 NE015 USB Stick with Manuals NIC 1 NE016a Electrode Gel 250cl 1 NE017 NE017 H 10 Electrode Cable color coded 1 NE019 M NE019 M Home Neoprene Headcap M 54 cm...

Страница 21: ...es EEG NG Geltrode NE032 Stimulation tES Sponstim 25 NE026a Sponstim 8 NE026b EEG tES NG Pistim NE029 Reference Sticktrode NE025 Earclip NE027 Regarding the electrodes you must use them according to t...

Страница 22: ...ox battery u u The type of the power supply plug EU US UK included in the kit depends on the country of the customer NE055 NE055W NE013a NE013b NE013c Curved Syringe u u The curved syringe is used to...

Страница 23: ...xterior face of the sponge that contacts with the scalp NE033 10 Electrode Cable u u The 10 electrode cable has 10 electrode medical sockets compatible with the electrodes commercialized by Neuroelect...

Страница 24: ...ard using either the testboard cable or the 10 electrode cable When the device is connected to the testboard it responds as a properly placed system on the subject s scalp with a very similar electric...

Страница 25: ...ea u u MRI kit Filter Harness and MRI compatible electrodes Take your hybrid EEG tCS system to the MRI room These items are available upon request Please contact our sales team if you want your Starst...

Страница 26: ...g and its dimensions are 87 mm x 61 mm x 24 8 mm The following diagrams describe the details of the Necbox IV 4 Necbox Neuroelectrics Control Box 1 Charging LED Yellow when charging green when charged...

Страница 27: ...6 Velcro To attach the Necbox to the neoprene cap 7 Technical Specifications labels Serial Number SN with the EYYYYMMDD format where YYYY MM and DD are the manufacturing year month and day respectivel...

Страница 28: ...u The battery should not be over discharged when the device is not used for a long time It should be periodically charged instead u u Overdischarging may cause loss of cell performance and or damage t...

Страница 29: ...after each use Neoprene Headcap The Neoprene Headcap should be cleaned and disinfected as it follows u u Rinse the gel with warm tap water and ivory soap u u Dry the cap conscientiously using paper t...

Страница 30: ...board cable from the cable slot of the Necbox to the head shaped section of the testboard IV 8 Testboard Impedance toubleshooting Testboard allows to check the correct setup of the system when having...

Страница 31: ...hen you want throw away the device NEVER throw it in the trash but go to the RECYCLABLE POINT or the nearest waste collection for further treatment thus contributing to environmental care ISO 60417 51...

Страница 32: ...annot communicate with the device Check that the device is switched on that the device has battery that the computer Wi Fi USB communication is working properly and the device is close to the computer...

Страница 33: ...33...

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