StarStim User manual Neuroelectrics
Contents
1. A The use of cables or electrodes other than the ones delivered with the product might produce higher EMC emissions and less EMC immunity Z The device cannot be used beside or piled under other equipment If such usage is needed check the normal configuration Z The device can only be used in healthy skin without wounds NE 5 Starstim STIMULATING AND MONITORING THE BRAIN neuroelectrics 6 Conditions of use StarStim must be used in normal temperature and pressure conditions T range 10 45 C humidity 20 90 atmospheric pressure 700 1000 hPa 7 Contents of the box When you first open the box you will see the following items Neoprene cap Under the foam cover you will find the rest of the kit Neuroelectrics Control Box NECBOX 10 wire cable with the electrode back ends Electrode front ends Battery charger NE headband NE cap USB containing this manual and NIC software installer Neuroelectrics Instrument Control Software Curved syringe with gel mandatory for the PG PGF and optional for the electrodes NE 6 Starstim STIMULATING AND MONITORING THE BRAIN neuroelectrics 8 Technical Specifications EEG functionality Number of Channels 8 Channels Bandwidth O to 125 Hz Sampling rate 500 SPS Resolution 24 bits 0 05 microVolt Measurement Noise lt 1 uV RMS Input impedance 1000 Mohm minimum Allows for Stimulation simultaneously Stimu2. b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m NOTE 1 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NE Starstim STIMULATING AND MONITORING THE BRAIN neuroelectrics The StarStim is intended to be used in a controlled radiated RF environment The user of the StarStim can help to prevent the electromagnetic interferences keeping a minimum distance between the portable RF device transmitter and the StarStim as recommended below according to the maximum output power of the communications device Rated Maximum E Separation distance metres Output Power of Transmitter to 800 MHz to 2 5 GHz watts d 1 2VP d 2 3VP 0 01 0 12 gt O12 0 23 0 1 0 38 i 0 38 0 73 1 1 2 1 2 2 3 10 3 8 38 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the separation distance can be estimated using the equation in the corresponding column where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NE Starstim STIMULATING AND MONITORING THE BRAIN neuroelectrics 19 Change record Issue Date Changes made Author
3. 1 0 14 02 12 First version Guillem Mitj 1 1 19 03 12 Some minor corrections Guillem Mitj 1 2 13 04 12 Update after 60601 non confirmities Guillem Mitja 1 3 26 07 12 Charging LED added Guillem Mitja KES STIMULATING AND MONITORING THE BRAIN NE neuroelectrics Teodor Roviralta 45 08022 Barcelona Spain Tel 34 93 254 03 66 mail www neuroelectrics com www neuroelectrics com
4. 5 cycles for 5 cycles of the StarStim requires continued a oowers on i operation during power main S i PPY 70 U 70 U interruptions it is recommended ee 30 dip in U 80 dip in U that the StarStim image intensifier for 25 cycles for 25 cycles be powered from an uninterruptible IEC 610097411 power supply or a battery lt 5 U lt 5 U gt 95 dip in i gt 95 dip in U for 5 sec U for 5 sec If image distortion occurs it may be necessary to position the Power frequency StarStim image intensifier further 50 60 Hz i from sources of power frequency magnetic field i 3A m 3A m magnetic fields or to install magnetic Z shielding The power frequency IEC 61000 4 8 Z S magnetic field should be measured i l in the intended installation location to ensure that it is sufficiently low Note U is the A C main s voltage prior to application of the test level Starstim STIMULATING AND MONITORING THE BRAIN neuroelectrics The StarStim is suitable for use in the specified electromagnetic environment The customer and or the user of StarStim should ensure that it is used in an electromagnetic environment as described below IEC 60601 1 2 Test Level Compliance Electromagetic Level Environment Guidance Immunity Test 3 Vrms E Portable and mobile RF communications 50 kHz to 3Vrms equipment should be used no closer 80 MHz to any part of the StarStim incl
5. 6 A2 1996 A3 1997 A2 ERR 1999 UNE EN 60601 1 2 2008 UNE EN 60601 2 26 2004 3 Regulatory information Manufacturer Neuroelectrics Barcelona SL C Teodor Roviralta 45 08022 Barcelona Spain Telephone 34 93 254 03 70 Brand StarStim Models StarStim 4 Use environment The StarStim system have been designed for the use in a clinical environment hospital or research center neuroelectrics NE 4 Starstim STIMULATING AND MONITORING THE BRAIN 5 Safety Warnings Note for clinical use Brain stimulation must be always used according to medical prescription A Brain Stimulation must be used AFTER the prescription of a stimulation protocol made by the specialized and qualified medical personnel who owns and operates the StarStim Software A Before the brain stimulation is prepared please inform the prescribing clinician or operator of the presence of any pacemakers intracranial electrodes implanted defibrillators cranial pathologies e g holes plaques or any other prosthesis In these cases the use of the device could become unsafe A The results of the measurements must be analysed by a doctor or specialist No self medication should be done based on this results A The device must never be opened or damaged gt The battery can only be replaced by authorized personnel Z Before using please check that the device is undamaged and the packaging has not be
6. ISO 7000 1641 read instructions before use symbol according to UNE EN 980 ISO 7000 2606 do not use device if product or packaging have been damaged symbol according to UNE EN 980 Do not throw StarStim in generic waste symbol WARNING When 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 CE marked device certified by the Notified Body n 0120 of the European Community Starstim STIMULATING AND MONITORING THE BRAIN neuroelectrics 18 EMC information The StarStim is suitable for use in the specified electromagnetic environment The costumer and or user of the StarStim should ensure that is used in an electromagnetic environment as described below es Electromagnetic Emissions Test Compliance Environment Guidance The StarStim uses RF energy only RF Emissions for its internal function Therefore its Group 1 RF emissions are very low and are CISPR 11 not likely to cause any interference in nearby electronic equipment RF Emissions Class B CISPR 11 EREA panenna The StarStim is suitable for use in all Harmonie Emissions f establishments including domestic Class A establishments and those directly IEC 61000 3 2 connected to the public low voltage power supply network that supplies E Suggnandigpec anita asantas buildings used for domestic purposes V
7. SLal S STIMULATING AND MONITORING THE BRAIN User manual v1 3 NE gt Table of Contents 1 Intended use 2 Safety Information 3 Regulatory information 4 Use environment 5 Safety Warnings 6 Conditions of use 7 Contents of the box 8 Technical Specifications 9 NECBOX Device description 10 Assembling and using the kit 11 System Requirements 12 Signal quality check 13 Silver Silver Chloride Ag AgCl electrode instructions 13 1 Precautions for handling electrodes 13 2 Conditioning 13 3 Cleaning 13 4 Sterilization 13 5 Darkening 13 6 Storage 13 7 Malfunction 13 8 Noisy electrodes 13 9 Life expectancy 14 Neoprene cap cleaning and disinfecting instructions 15 NECBOX cleaning instructions 16 Battery operating safety instructions 16 1 Charging the battery 17 Symbols used 18 EMC information 19 Change record oon om oa Ff gt FF W oOo nN O1 O1 O1 pA RAR LR d CO um oa Oo N i Starstim STIMULATING AND MONITORING THE BRAIN neuroelectrics 1 Intended use StarStim is a transcranial current stimulation device and an EEG monitoring device all in one The device is battery operated Brain stimulation can be used only under medical prescription or under the supervision of an appropriate Ethics Committee as regulated in each country of intended use Transcranial Current stimulation tCS is a neurophysiological technique capable of m
8. d ON The charging LED located near the connector shows colour yellow when charging and green when it s fully charged It should be noted that the battery will be over discharged if the device is not used for a long time In order to prevent over discharging the battery should be charged periodically QOver discharging may cause loss of cell performance or damage battery function Expected life cycle gt 500 cycles gt 70 of initial capacity Charging with a higher voltage than specified may cause damage to cell The usual time to charge a battery from the cut off voltage to the maximum capacity is around 2 hours but it depends on every specific battery battery life and memory is a function of time The system can be connected to any Class 2 electrical installation Storage E NECBOX temperature electrical specifications Operating temperature Charging Voltage input nominal 5V DC Voltage input min max 4 25 7 V Power input 5 W Current output 2mA per channel 15V in Frequency U 0250 Hz none Charging 0 C to 45 C 1 year Discharging 20 C to 60 C at 20 C to 35 C Starstim STIMULATING AND MONITORING THE BRAIN neuroelectrics 17 Symbols used Simbol Description IEC 60417 5333 BF type applicable part according to UNE EN 60601 1 2008 ISO 7010 W001 Warning signal according to UNE EN 60601 1 2008 Parts marked with this symbol are not protected against defibrillator
9. e electrodes need some time to achieve electrochemical equilibrium with the skin and electrolytes in the human body 13 3 Cleaning Silver silver chloride Ag AgCl electrodes behave like sponges they absorb water and electrode gel The deeper the water gel has penetrated the electrode the longer it will take afterwards for the water to evaporate As long as your electrodes are wet corrosion will take place This corrosion process will in the long run make your electrodes noisier That s why its important to clean the electrodes immediately after use and then let them dry Use warm tap water to rinse the gel from the electrodes make sure to keep the connector dry Warm water up to 50 degrees Celsius will dissolve the gel more quickly Use a soft brush for removing gel residues from the electrodes only if absolutely necessary Softly dry the electrodes with a paper towel or let them hang to dry Only use soap if water does not seem to clean the electrodes properly Never use solvents e g acetone acids or alkaline Do not let the electrodes dry without being cleaned first When the electrodes dry while covered with gel salt minerals the cleaning process will be more difficult 13 4 Sterilization When sterilization is required only gas or liquid agents should be employed Disinfectants containing mercury phenols bromine iodine zinc tin and organo metallic compounds should be avoided The electrodes and cable insulation will n
10. en affected by transport or storage A ln the case of malfunction immediately contact the manufacturer or the distributor A The device is not protected against excessive moisture or immersion in liquid In the case of the device becoming wet or damp do not use it and immediately contact the manufacturer Z Do not touch the device during stimulation or while EEG monitoring is on neuroelectrics A Always unplug the USB power supply from the device prior to connecting electrodes to the subject The device will not work when charging the battery Z Never use the device or install the electrodes on the head of the patient while connected to the power network A The device must be used only with Ag AgCl electrodes for EEG recommended by the manufacturer Z The electrodes for stimulation can be Ag AgCl or carbon rubber electrodes with sponges soaked with saline solution They must be bigger than 3 mm to avoid high density currents A The device is not protected against other high frequency devices To avoid risks place the CMR DRL as far as possible from the s and return electrode of the high frequency device A The device is wireless and might be affected by other RF devices Z The device needs special EMC precautions It needs to be used according to user manual information regarding EMC A The EMC emissions and immunity has been tested using the 10 wire or 12 wire 34 cm cables provided with the system
11. f the pellets will change from grey brown silver chloride to silver due to the loss of the chloride The AgCI slowly dissolves in gel and water during the cleaning Eventually this leaves only silver behind The resulting pure silver electrode has much higher drift and noise characteristics than the original Ag AgCl electrode At this point replacement is recommended 14 Neoprene cap cleaning and disinfecting instructions After each use the neoprene cap or the neoprene band should be cleaned and disinfected Use warm tap water to rinse the gel and some ivory soap to clean the cap Dry the cap consciously using paper towel Spray the cap with disinfectant and let sit for 10 minutes Rinse cap thoroughly Hang up the cap to dry 15 NECBOX cleaning instructions After each use the NECBOX should be cleaned using a dry paper towel NE Starstim STIMULATING AND MONITORING THE BRAIN neuroelectrics 16 Battery operating safety instructions 16 1 Charging the battery The battery can only be charged when the power ON switch is at the OFF position To charge the battery the following specifications have to be meet 5V nominal output 4 25 7 V 1 A current output Battery charger complies according Stardard IEC EN 60601 1 The battery charger has to be connected to the microUSB connector located at the rear part of the NECBOX The battery state of charge is measured by the software while the device is powere
12. ft Before the EEG establishes a good redox reaction on each electrode the signal recorded might have a large DC drift This DC drift could affect the results recorded and should be avoided In the figure a signal with a significant amount of drift is compared to a normal signal Normal signal Signal with high drift Time Sec Time Sec Contact impedance Before any stimulation the software checks the contact impedance of each electrode If the impedance is higher than the normal values the stimulation protocol can t be started If an electrode has a very high contact impedance or shows high noise at the signal it should be changed because it has reach the end of its life Noisy electrodes If the signal shows too high drift or noise the electrodes might be at the end of their lives The figure shows a signal with a considerable noise ooo Time Sec gt 13 Starstim STIMULATING AND MONITORING THE BRAIN neuroelectrics 13 Silver Silver Chloride Ag AgCl electrode instructions 13 1 Precautions for handling electrodes Electrodes should not come into direct contact with metals as this may cause corrosion Avoid touching or contaminating the bare electrode surface as dirt can increase calibration times Use of corrosive chemicals will damage the electrodes 13 2 Conditioning To minimize DC offset and drift place the electrodes in the working position 5 minutes before starting the measurement Th
13. lation functionality gt Number of channels 8 channels Types of Stimulation tDCS tACS tRNS sham Current maximum of plus minus 2mA per electrode Current accuracy lt 10 lt 1 after calibration Current precision lt 1 uA Configurable Ramp up and Ramp down time Current configurable independently for each channel x Voltage up to 15 V 80 V of stimulation potential Variance of tRNS stimulation lt 640 uA Other Technical Specifications Communication Bluetooth 2 1 Output EDF ASCII data files or tcp ip raw data streaming 3 axes accelerometer microSD card for off line storage Operating time 8 hours for EEG only Dimensions 60 x 85 x 20 mm Weight 65 g Compatible with Windows 7 Windows Vista Windows XP MAC OS X NE 7 Starstim 9 NECBOX Device description E Description tall Ne oeer rcelona Te tee RO A T 08022 Bar celon a Spain starstim HAX N ES N 3 4 2 a lee z Ic 250 1720 put 2mA iV fre q O siaran 10 Assembling and using the kit 1 Install front ends in the neoprene cap or the neoprene band in the desired positions use software instructions if you want to use a preset montage 2 Dut The cap or the band on the subject s head with the electrode front ends installed 3 Place the NECBOX at the rear of the cap attached by means of the Velcro 4 Connect the device cable to the NECBOX ES WS Pos Stars
14. odulating the excitability of the neuronal tissue of the central and peripheral nervous system through the application for a finite time length of an electrical field This electric field is generated by the application of weak electrical currents through the scalp and into the brain It has been demonstrated in recent years that the technique is safe and beneficial if used within the known bounds of intensity density and duration However its application must be controlled by specialized medical personnel able to guarantee the application of correct stimulation parameters StarStim must be always used according to applications already described in the literature In any other case the supervision of a local Ethics Commitee or analogous Body must be required for the experimental use of this device StarStim is specifically designed to be used only under medical prescription Because the treatment can be performed only following the prescription made by specialized personnel the current stimulation delivered by StarStim can be considered safe Read the User Manual carefully before using StarStim NE 3 Starstim STIMULATING AND MONITORING THE BRAIN 2 Safety Information StarStim is a class lla device according to the classification in the Council Directive 93 42 CEE for medical devices It conforms to the following Standards and Directives gt Directive 93 42 CEE for medical devices UNE EN 60601 1 1993 A1 199
15. oltage fluctuations flicker emissions Complies IEC 61000 3 3 NEw Starstim STIMULATING AND MONITORING THE BRAIN neuroelectrics 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 IEC 60601 1 2 Compliance Electromagetic Immunity Test Test Level Level Environment Guidance Electrostatic E Floors should be wood concrete discharge ESD Oey comer Sky cantan or ceramic tile If floors are covered with synthetic material the relative EC61000 42 ala d humidity should be at least 30 2 kV for power Electrical fast supply lines transient burst 2 kV for power supply lines Main power quality should be that of a typical commercial and or hospital environment kV for input IEC 61000 4 4 N A output lines Tk differential Z 4 kVdifferential T ap Surge i mode DT Main power quality should be that of a typical commercial IEC 61000 4 5 2 kV common N A and or hospital environment mode i i lt 5 U i lt 5 U gt 95 dip in U i gt 95 dip in U for 0 5 cycle i for 0 5 cycle Voltage Main power quality should be that ding shed 40 U 40 U of a typical commercial and or ne bio 60 dip in U 60 dip in U hospital environment If the user d venations for
16. ot withstand steam sterilization 13 5 Darkening Silver chloride is light sensitive Exposure to light will darken the electrode surface This will not impair the electrode performance since the largest interstitial Ag AgCl matrix is not reached by light 13 6 Storage Electrodes should be handled with care They must not be stored in contact with metals especially such active metals as iron or aluminium Also substances that could affect the electrochemical characteristics should be avoided Bare electrodes should be stored in a clean dry and dark container plastic or glass NE 4 Starstim STIMULATING AND MONITORING THE BRAIN neuroelectrics 13 7 Malfunction If an electrode is not operating as specified and you experience noise then please follow the directions below concerning noisy electrodes 13 8 Noisy electrodes A continuously noisy electrode generally means that it has reached its end of life You can extend the life a little bit by using a grain 600 or higher waterproof abrasive paper to polish the electrode tip Use very soft circular movements preferably no more than 2 3 times on the same area removing an even very thin layer across the entire surface 13 9 Life expectancy Ag AgCl sintered electrodes have a limited life span This is caused by several processes such as corrosion the dissolving of the chloride in the pellets and the wearing of the pellet during the cleaning process Eventually the colour o
17. tin IN OTTANIC ONIN NAN J N JLATING Al NG THE RRATN WW TIL DFA IL 1 5 Insert gel if using wet gel electrodes until it reaches the scalp of the subject 6 Prepare the connections cable provided The cable consists of eight EEG electrodes numbered 1 to 8 and two reference electrodes labelled DRL and CMS that act as drive circuit and common mode sensing WE NY YW 9 5 VE pu a pu A A Nooo o o R 1 4 C Ty 0 a 0 N C gt 1 U Starstim 8 Place the stick on electrodes at the mastoid Attach the DRL and CMS back ends to the stick on electrode front ends Place the DRL and CMS electrodes as close as possible to each other L 9 Start the NIC software NIC 1 0 starstim Temporal Window 5_ seconds Ci Scalo Record EME TD Time Seconds mern B TRS a 9 0 HS DELTA THETA CIC EEE 15 Hz BEIA GAMMA DEFAL E dE 10 Refer to the software user manual for the usage of the NIC software gt 11 Starstim STIMULATING AND MONITORING THE BRAIN neuroelectrics 11 System Requirements Windows XP Vista 32 64 bits or MAC OS X Intel gt Snow Leopard 1GB RAM or more Bluetooth adapter or USB 2 0 port CPU Pentium D or better NE Starstim 12 Signal quality check Before any recording the quality of the signal should be checked to ensure the correct measurements Signal dri
18. uding i cables than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter Conducted RF IEC 61000 4 6 Recommended Separation Distance d 1 2VP d 1 2VP 80 MHz to 800 MHz d 2 3VP 800MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the i transmitter manufacturer and d Radiated RF E T 2 3 V m is the recommended separation 80 MHz to 80 MHz to distance in metres m S T S 1 GHz ga f Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength outside the shielded location in which the StarStim is used exceeds the applicable RF compliance level above the StarStim should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the StarStim
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