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Summary of Contents for Neuroelectrics Starstim 8
- Page 1 Neuroelectrics User Manual Starstim 8 / Starstim tcs CAUTION: INVESTIGATIONAL DEVICE Limited by United States law to investigational use.
- Page 2 Avinguda Tibidabo, 47 bis 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© by Neuroelectrics®. All rights reserved.
- Page 3 Telephone: + 34 93 254 03 70 Starstim 8 Starstim tcs The manufacturer should be contacted: - for assistance, if needed, in setting up, using or maintaining the Starstim 8 system; - to report unexpected operation of events that result from the usage of the device.
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Page 4: About The Starstim User Manual
Starstim User Manual does not discard the need of reading the Electrode and NIC parts. The Neuroelectrics User Manual includes three parts: The PDF version of all parts of the Neuroelectrics User Part I: Starstim User Manual Manual can be found under the Documentation section of... -
Page 5: Change Of Record
First version Neuroelectrics User Manual divided in three parts: 2016.02.18 (1) Enobio / Starstim, (2) Electrode and (3) NIC. 2016.05.10 Starstim tCS info added to Starstim 8 manual 2017.07.25 Product contents update (Starstim tCS info removed). 2017.08.23 Regulatory info update Starstim BT and Wi-Fi unified and Starstim tCS info added to 2018.05.07... -
Page 6: Table Of Contents
IV.2 Technical Specifications........17 Use of Starstim ............7 IV.3 Contents of the Starstim package ......19 I.1 Transcranial Current Stimulation (tCS) ......8 IV.4 Necbox: Neuroelectrics Control Box .....25 I.2 Intended Use .............9 IV.5 Assembling the Necbox ........27 I.3 Conditions of Use ............ 10 IV.6 Necbox battery ............27... -
Page 7: Use Of Starstim
I. Use of Starstim Starstim 8 is a transcranial current stimulation (tCS) and an electroencephalogram (EEG) monitoring device, all in one. Starstim 8 is a modern neurostimulator: It is a wireless operating system AgCl electrode that can be used for EEG or tCS... -
Page 8: Transcranial Current Stimulation (Tcs)
Transcranial Current Stimulation (tCS) Transcranial current stimulation (tCS) use. involving synapticl modification. is a neurophysiological technique The tCS technique is classified capable of modulating the excitability into three types according to the Transcranial Alternating Current of the neuronal tissue of the central waveform of the stimulation current Stimulation (tACS) and peripheral nervous system... -
Page 9: Intended Use
Commitee or analogous Body must be to control the placebo effect. required for the experimental use of this device. Starstim 8 and Starstim tcs can only be used with electrodes and cables commercialized by Neuroelectrics. Read the Neuroelectrics User Manual... -
Page 10: Conditions Of Use
Conditions of Use Starstim must be used with normal temperature, humidity, and pressure conditions: Temperature Range: +5 to 40 °C Humidity: 15 - 93 % Atmospheric Pressure: 700 - 1.000 hPa The device must be stored inside the box between uses, in the following environmental conditions: Temperature Range: -25 to +65 °C Humidity: 15 - 93 %... -
Page 11: Quality And Regulatory Information
II. Quality and Regulatory Information... -
Page 12: Ii.1 Quality Management System
Audience only Neuroelectrics is an ISO 13485 Europe CAUTION: and ISO 9001 certified company. In Europe, Starstim 8 is intended for US Federal Law classifies Thus, our medical devices are research use only. Neuroelectrics® Starstim 8 as an designed and manufactured following Investigational Device. -
Page 13: Safety Information
III. Safety Information Starstim 8 conforms to the following standards: Medical device software life-cycle Electrical Safety EN 62304:2006 + Corr.:2009 + AC:2010 EN 60601:2006 + Err.:2008 + Corr:2010 + AC:2013 + A11:2011+ A12:2014 Biological evaluation EN 60601-1-6:2010 EN ISO 10993-1:2009 + AC:2010... -
Page 14: Iii.1 Safety Warnings
III.1 Safety Warnings Note for clinical use: Brain opened or damaged. be used with Ag/AgCl electrodes stimulation must be always used recommended by the manufacturer. The battery can only be replaced according to medical prescription. by authorized personnel. For stimulation, Ag/AgCl electrodes Brain stimulation must be used AFTER or carbon rubber electrodes The device is not protected... - Page 15 Neuroelectrics to The cap is intended to be on the the device to the PC. So, even if there’s patient for less than 24 hours.
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Page 16: The Starstim System
Lastly, it describes the session, with or without simultaneous EEG monitoring Neuroelectrics Control Box (Necbox) which is the core and the control unit of Starstim. -
Page 17: Iv.2 Technical Specifications
IV.1 IV.2 Features Technical Specifications Wireless, wearable EEG functionality * Maximum current per and easy-to-set concept channel: ± 2 mA Number of channels: Flexible electrode placement (up to) 8 channels Current resolution: 1 µA based on the 10-10 system Sampling rate: 500 SPS Current accuracy: 1% Conduct mobile studies away Bandwidth: 0 to 125... - Page 18 Scientific (ISM) band. The Nexbox from 2.412 to 2472 MHz connects through the wireless link Communication: Transmitting power: Max. +16dBm to the Neuroelectrics Instrument NE001: Bluetooth® 3.0 and 2.1 Qualifications: CE, FCC, IC, Controller (NIC) software running on a NE001WF: Wi-Fi IEEE 802.11 b/g/n Japan and South-Korea computer.
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Page 20: Iv.3 Contents Of The Starstim Package
IV.3 Contents of the Starstim 8 package The Neuroelectrics® Starstim 8 package contains all the the box, please confirm you have all the items listed below components required to perform an EEG monitoring or as well as the right quantity of each electrode model. - Page 21 Neuroeletrics Electrodes Stimulation (tCS) EEG & tCS Reference In this page we present the electrodes included in the package, but you must read the Electrode User Manual to learn how to use, to assemble and to Geltrode Sponstim 25 Pistim Sticktrode clean the electrodes.
- Page 22 Starstim Necbox NE012 / NE012WF The StarStim Neuroelectrics Control Box (Necbox) is the core of the Starstim system. The necbox is battery operated and it is wirelessly paired with the computer using the Nic software. The necbox battery should never be charged when the device is being used.
- Page 23 10 Electrode Cable NE017 The 10 electrode cable has 10 electrode medical sockets compatible with the electrodes commercialized by Neuroelectrics. It contains 8 channels for EEG monitoring or for stimulation, and two reference channels labelled with CMS & DRL. Neoprene Headcap M (54 cm)
- Page 24 This cable is not needed if you choose to connect the necbox and the testboard head using the electrode cable. USB Charging Cable (only included in Starstim 8 system) NE043 The USB charging cable is an alternative to the USB power adapter & power supply plug.
- Page 25 Item Name / Description Code USB Cable & Isolator NE164/ NE172 The USB Cable & Isolator can be used to transmit EEG and Stimulation data between the device and the computer. As we have aleady seen in the validation. This should always be used with the extendor cable.
- Page 26 IV.5 Necbox: Neuroelectrics Control Box The Necbox is the core and the control unit of Starstim. The Necbox is a battery operated device. It weighs 85 g and its dimensions are 87 mm x615 mm x 24.8 mm. The following...
- Page 27 NEUROELECTRICS BARCELONA AV. Tibidabo 47 bis 08035 Barcelona Spain MAC: Input: 5 W, 4.8 - 5.5V IP21 Pin connector slots MicroSD card slot Velcro Technical Specifications labels 10-pin slot to connect with Slot for microSD card (Card To attach the Necbox to the the electrode cable.
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Page 28: Iv.5 Assembling The Necbox
IV.6 IV.7 Assembling the Necbox Necbox battery The battery can only be charged Overdischarging may cause when the power switch is at the OFF loss of cell performance and/ position. The battery charger connects or damage to battery function. to the Necbox through the microUSB Expected life cycle: / micro HDMI connector located at the After 500 >... -
Page 29: Iv.7 Cleaning Instructions
IV.8 Cleaning Instructions Electrical specifications for charging: Necbox & Electrode Cable Electrodes Voltage nominal input: 5 VDC The Starstim Necbox should be The cleaning instructions for the Voltage input min/max: cleaned using a dry paper towel after electrodes can be found in the 4.8 VDC - 5.5 VDC each use. -
Page 30: Symbols Used
V. Symbols Used Symbol Description Symbol Description ISO 7010-W001 Warning signal according to UNE-EN 60601-1=2008 ISO 7000-0632 Transport and storage Parts marked with this symbol are not protected against defibrillator. temperature conditions IEC 60417-5008 Switch OFF according to ISO 7000-2620 Transport and storage EN 60601-1:2006 humidity conditions IEC 60417-5007 Switch ON according to... -
Page 31: Error Messages
VI. Error Messages The following messages might appear during normal operation: Error message Cause Actions Connection lost The computer cannot communicate Check that the device is switched on, that with the device. the device has battery, that the computer Bluetoot h/ Wi-Fi / USB communication is working properly, and the device is close to the computer. -
Page 32: Electromagnetic Compatibility (Emc) Information
VII. Electromagnetic Compatibility (EMC) Information... - Page 33 For Professional Use The Starstim is suitable for use in the specified electromagnetic environment. The customer and/or user of the Starstim should ensure that is used in an electromagnetic environment as described below: Emissions Electromagnetic Test Compliance Environment Guidance RF Emissions Group 1 The Starstim uses RF energy only for its internal function.
- Page 34 The Starstim image intensifier is suitable for use in the specified electromagnetic environment. The customer and/or the user of Starstim image intensifier should ensure that it is used in an electromagnetic environment as described below: Immunity IEC 60601-1-2 Compliance Test Test Level Level Electrostatic discharge (ESD)
- Page 35 The Starstim is suitable for use in a professional healthcare facility environment except near HF surgical equipment and the RF shielded room for magnetic resonance imaging. The essential performance of the Starstim is the measure of the EEG and the transcranial stimulation. In case of EM disturbances, the operator can experience lost of communication between the Starstim and the PC.
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