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Summary of Contents for Soterix Medical 2001
- Page 1 Operator’s Manual No part of this manual may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, microfilming, recording, or otherwise, without written permission from Soterix Medical Inc.
- Page 2 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Version 2 July 2015 Copyright © 2012-2015, Soterix Medical Inc Page ii Investigational device. Federal (or United States) law limits device to investigational use. www.SoterixMedical.com...
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Page 3: Notice
INFORMATIONAL PURPOSES. THE CONTENT AND THE PRODUCT IT DESCRIBES ARE SUBJECT TO CHANGE WITHOUT NOTICE. IN NO EVENT WILL SOTERIX MEDICAL INC., BE LIABLE FOR THE DAMAGES ARISING FROM OR RELATED TO THE USE OF THIS MANUAL OR THE PRODUCT IT DESCRIBES. - Page 4 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual CAUTION As an ultimate user of this apparatus, you have the responsibility to understand its proper function and operational characteristics. This operator’s manual should be thoroughly read and all operators given adequate training before attempting to place this unit in service.
- Page 5 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual This page is left intentionally blank to provide an insertion place of any changes subsequent to the printing of this document. Copyright © 2012-2015, Soterix Medical Inc Page v Investigational device. Federal (or United States) law limits device to investigational use.
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Page 6: Table Of Contents
1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Contents Page Title Page iii. Notice Caution Contents Introduction Intended Use Getting to Know the Product Use of This Manual Health and Safety Precautions and Warnings Regulatory Statements Product Description Items Supplied... -
Page 7: Introduction
Use of this Manual - 6 This chapter introduces you to the basics required to use this manual fully as well as operate the Soterix Medical 1x1 tES line of stimulators. Intended Use: This section gives a description of the process of transcranial Electrical Stimulation and intended use. -
Page 8: Intended Use
While for tPCS, tACS, and tRNS, the main determinants are intensity, duration, and frequency. Soterix Medical tES systems allow precise reproduction of tES doses commonly used in medical literature. Soterix Medical engineers and scientists can work with you to determine the best configuration for your application. - Page 9 Soterix Medical 1x1 tES Low-Intensity Stimulator, which are specifically designed for clinical tES. For example, the unique PRE-STIM TICKLE and RELAX features available on all Soterix Medical 1x1 models are designed to condition the skin prior to stimulation and allow the operator to accommodate subject feedback without stopping stimulation.
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Page 10: Getting To Know The Product
(for instance tPCS, tACS, and tRNS) to be DC offset, shifting it into the positive territory. The Soterix Medical 1x1 line of low-intensity tES stimulators is designed to generate low levels of current between the electrodes placed on the body. - Page 11 , SMARTscan-ES , RELAX, and PRE-STIM TICKLE. By reading this manual and understanding these unique features, operators of the Soterix Medical 1x1 tES can enhance the efficacy and comfort of tES. Copyright © 2012-15, Soterix Medical Inc. Page 5 Investigational device. Federal (or United States) law limits device to investigational use.
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Page 12: Use Of This Manual
Use of This Manual This manual contains details of installation, setup, and operation of the Soterix Medical 1x1 tES unit and its accessories. This manual must be read in its entirety before commencing any stimulation with the Soterix Medical 1x1 tES unit. If the instructions in this manual are not precisely followed, the performance of this product and/or the safety of the user and/or patient may be compromised. - Page 13 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Classifications In accordance with IEC 60601-1 - Internally powered equipment -Type BF equipment. -Continuous operation according to the mode of the operation. -Portable equipment. In accordance with EU Medical Device Directive - Class IIa Copyright ©...
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Page 14: Health And Safety
1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Precautions and Warnings - 9 Regulatory Health and Safety Statements - 12 This chapter dictates required precautions for both you and your patient’s safety. Precautions and Warnings: Read this section for the important list of precautionary measures required to operate this device. -
Page 15: Precautions And Warnings
Operator’s Manual Precautions and Warnings To prevent damage to your Soterix Medical product or injury to yourself or to others, read the following safety precautions in their entirety before using this equipment. Keep these safety instructions where all those who use the product can easily access them. - Page 16 If irritation occurs, consult your clinician. Do not place the Soterix Medical 1x1 tES electrodes or sponges over previously irritated, burnt, or damaged skin. Since sponge current density (injected current / sponge area)
- Page 17 To-date there have been no published studies in pregnant women. The safety of electrical stimulation during pregnancy has not been established. All operators must ensure that Soterix Medical 1x1 tES Low- Intensity Stimulator is applied within local and federal or country guidelines as relevant.
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Page 18: Regulatory Statements
1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual The Soterix Medical 1x1 Low-Intensity Stimulator should not be used in combination with any other implanted or external electrical stimulation device. Regulatory Statements Transcranial Electrical Stimulation (tES) is an investigational technique. It is limited by Federal law to investigational use under appropriate Institutional Review Board guidelines. -
Page 19: Product Description
1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Items Supplied - 14 Product Description Front Panel - 15 Back Panel - 16 Control Keys - 17 This chapter is comprised of the following sections: Items Supplied: This section gives a checklist of the items that are... -
Page 20: Items Supplied
1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Items Supplied 1 Soterix Medical 1x1 Low-Intensity Transcranial Electrical Stimulator 5 pairs Soterix Medical EASYpad sponges with 2 carbon-rubber electrode insets. EASYpad sponges are rated for one-time use only. 1 Red anode cable 1 Black cathode cable Elastic fasteners (one long, one short) with 2 plastic joints. -
Page 21: Front Panel
1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Front Panel Copyright © 2012-15, Soterix Medical Inc. Page 15 Investigational device. Federal (or United States) law limits device to investigational use. www.SoterixMedical.com... -
Page 22: Back Panel
1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Back Panel Copyright © 2012-15, Soterix Medical Inc. Page 16 Investigational device. Federal (or United States) law limits device to investigational use. www.SoterixMedical.com... -
Page 23: Control Keys
1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Control Keys A display, which indicates the amount of time remaining in the stimulation. A display, which indicates the frequency of waveform. A display which indicates how ―good‖ the contact quality of the leads are. - Page 24 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Allows setting waveform polarity (unipolar, bipolar) prior to the start of stimulation. Stops the stimulation. Adjusts the intensity of the waveform (1, 1.5, 1.75, or 2 mA) prior to the start of stimulation.
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Page 25: Device Operation
1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Inserting and Replacing the Batteries - 20 Description of Special Features - 22 Device Operation Pre-Stimulation Setup - 25 Stimulation Procedure - 30 This chapter outlines the steps needed to operate your Soterix Medical 1x1 tES Low-Intensity... -
Page 26: Inserting And Replacing The Batteries
1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Inserting and Replacing the Batteries The 1x1 tES Low-Intensity Stimulator operates on two 9V alkaline batteries. Duracell is recommended for use. To insert the batteries, flip the device to its back and remove the battery cover. - Page 27 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Note: Batteries should be removed from the 1x1 tES Low- Intensity Stimulator if it is not likely to be used for an extended period of time. Please observe the proper direction of the battery’s polarity...
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Page 28: Description Of Special Features
1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Description of Special Features TRUE CURRENT : The TRUE CURRENT display is active whenever the device is on. For tDCS, TRUE CURRENT always indicates the actual value of current (in mA) being supplied by the device to the electrodes – regardless of device settings. - Page 29 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Stimulation ABORT: At any point during stimulation, the operator may terminate the stimulation by pressing the ABORT button. The operator is responsible for determining when aborting the stimulation is appropriate. It is recommended to hit ABORT if TRUE CURRENT deviates from expected output current and/or TIME REMAINING deviates from expected duration setting.
- Page 30 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual current. The PRE-STIM waveform is determined by the waveform selected by the WAVEFORM SELECTOR switch. During PRE-STIM TICKLE, the TIME REMAINING display will indicate ―Pr‖. The TRUE CURRENT display will indicate the current being delivered for all waveform options available (tDCS, tPCS, tACS) aside of tRNS, where current intensity values are randomly generated.
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Page 31: Pre-Stimulation Setup
1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Pre-Stimulation Setup 1) Turn the POWER switch ON. The TRUE CURRENT display will illuminate and indicate 00.00 mA. The SMARTscan display will illuminate indicating a low quality. The FREQUENCY display will either indicate 000.0 Hz or 050.0 Hz... - Page 32 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual 4) Clean the surface of the skin to remove any signs of lotion, dirt, etc. and allow it to dry. Inspect the rubber insets and sponges for wear. If there is any evidence of deterioration, throw out the dirty components and use a new electrode.
- Page 33 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Electrode sponges should remain moist across the entire surface for the duration of stimulation. If the sponges are dry, do not start stimulation. If any irritation or discomfort occurs, discontinue use and consult a clinician...
- Page 34 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Intensity Ramp down Ramp up Duration (~30 seconds) (~30 seconds) Figure 1: Active tDCS waveform Figure 2: Active tPCS waveform (left). Active tACS waveform (middle). Active tRNS waveform (right). All waveforms depicted are bipolar.
- Page 35 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual 11) Select either SHAM ON or OFF using the switch. (SHAM ON waveform shown below for tDCS) Ramp up Ramp down Duration (~30 seconds) (~30 seconds) Intensity Figure 4: Sham tDCS waveform Similarly for other waveforms (tPCS, tACS ,tRNS, tODCS), current ramps up to set INTENSITY in 30 seconds and ramps down in 30 seconds.
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Page 36: Stimulation Procedure
1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Stimulation Procedure 1) Confirm that the WAVEFORM, FREQUENCY, DURATION, INTENSITY, and POLARITY are set to the desired values, SHAM is set to its desired setting, and the RELAX slider is set to full current. - Page 37 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual shut down during stimulation. It is the responsibility of the operator to ensure that the SMARTscan-ES quality reading is appropriate for a given application during stimulation. Note that the SMARTscan ES indication is not available during stimulation for tRNS.
- Page 38 When the subject is connected to the device, turning the power on or off is not recommended. Please use Soterix Medical 1x1 tES Low-Intensity Stimulator only as directed by this document. Failure to do so might result in an unexpected outcome. Do not modify the equipment without prior authorization of the manufacturer.
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Page 39: Specifications And Warranty
1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Specifications -- 34 Warranty — 35 Maintenance and Specifications, Warranty Disposal — 36 and Definition of Symbols Definition of Symbols Used — 37 Used This chapter is comprised of the following sections:... -
Page 40: Electrical And Operating Characteristics
1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Specifications Electrical and Operating Characteristics Power source: 2, 9V Alkaline batteries Battery life (with fresh batteries): 3 hrs 5 standard modes –DC (tDCS and tODCS) and non-DC (tPCS, tACS, tRNS) Adjustable frequencies up to 200 Hz with 0.5 Hz resolution Adjustable duration up to 40 minutes Adjustable current intensity up to ±2,000 µA... -
Page 41: Warranty
Soterix Medical Limited Warranty This Limited Warranty provides the following assurance to the first purchaser of the Soterix Medical Inc. 1x1 tES Low-Intensity Stimulator Model 2001, hereafter referred to as “Equipment”: (1) Should the Equipment fail to function within normal tolerances due... -
Page 42: Obtaining Warranty Service
This Limited Warranty gives the purchaser specific legal rights. The purchaser may also have other rights, which vary within specific regions. (4) No person has any authority to bind Soterix Medical Inc. to any representation, condition, or warranty except this Limited Warranty. Obtaining Warranty Service Warranty service of this Equipment can be obtained by returning the Equipment, carriage paid and insured, to Soterix Medical. -
Page 43: Definition Of Symbols Used
Medical 1x1 tES Low-Intensity Stimulator, as this will void your warranty. Do not disinfect the Soterix Medical 1x1 tES Low-Intensity Stimulator Return the device to Soterix Medical for disposal when the device is no longer required. Do not throw the Soterix Medical 1x1 tES Low-Intensity Stimulator in generic waste. - Page 44 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Keep Dry. Protect from Water. Device runs on DC current. Operate between 10 C – 43 C (50 F – 110 ° ° ° ° 4 3 C 1 0 C Serial Number...
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Page 45: Further Information
Further Information In this chapter, you can find: Bibliography: Here is a selection of peer-reviewed articles that Soterix Medical has found to be relevant to tES practices. Contact Information: This section houses a list of all the ways Soterix Medical can be contacted. -
Page 46: Bibliography
1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Bibliography The following bibliography includes a selection of peer-reviewed publications. This is not a comprehensive list of all tES studies, but includes a representative list as of the date of the publication of this manual. The... - Page 47 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual hand motor function by anodal transcranial direct current stimulation. Neurosci Lett. 2006;404(1-2):232-6. Boggio PS, Ferrucci R, Rigonatti SP, Covre P, Nitsche M, Pascual- Leone A, Fregni F. Effects of transcranial direct current stimulation on working memory in patients with Parkinson's disease.
- Page 48 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Bolognini N, Pascual-Leone A, Fregni F. Using non-invasive brain stimulation to augment motor training-induced plasticity. J Neuroeng Rehabil. 2009;6:8. Bolognini N, Vallar G, Casati C, Latif LA, El-Nazer R, Williams J, Banco E, Macea DD, Tesio L, Chessa C, Fregni F. Neurophysiological and behavioral effects of tDCS combined with constraint-induced movement therapy in poststroke patients.
- Page 49 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Edwards DJ, Krebs HI, Rykman A, Zipse J, Thickbroom GW, Mastaglia FL, Pascual-Leone A, Volpe BT. Raised corticomotor excitability of M1 forearm area following anodal tDCS is sustained during robotic wrist therapy in chronic stroke. Restor Neurol Neurosci.
- Page 50 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Fregni F, Boggio PS, Mansur CG, Wagner T, Ferreira MJL, Lima M, Rigonatti, Marcolin MA, Freedman SD, Nitsche MA, Pascual-Leone A: Transcranial direct current stimulation unaffected hemisphere in stroke patients. Neuroreport 2005;16:1551-1555.
- Page 51 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Galvez V, Alonzo A, Martin D, Mitchell P, Sachdev P, Loo C. Hypomania induction in a bipolar II patient with transcranial Direct Current Stimulation (tDCS). Journal of ECT 2011; 27(3):256-258 Giglia G, Mattaliano P, Puma A, Rizzo S, Fierro B, Brighina F.
- Page 52 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual motor task in the human brain: an fMRI study. Neurosci Lett. 2009;460(2):117-20. Javadi AH, Cheng P, Walsh V. Short duration transcranial direct current stimulation (tDCS) modulates verbal memory. Brain Stimul. 2011; Javadi AH, Walsh V. Transcranial direct current stimulation (tDCS) of the left dorsolateral prefrontal cortex modulates declarative memory.
- Page 53 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Lemon R: Effects of transcranial DC stimulation over the human motor cortex on corticospinal and transcallosal excitability. Exp Brain Res 2004;156:439-443. Ladeira A, Fregni F, Campanhã C, Valasek CA, De Ridder D, Brunoni AR, Boggio PS.
- Page 54 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual McKinley RA, Bridges N, Walters CM, Nelson J. Modulating the brain at work using noninvasive transcranial stimulation. Neuroimage. 2012 Jan 2;59(1):129-37. Monti A, Cogiamanian F, Marceglia S, Ferrucci R, Mameli F, Mrakic- Sposta S, Vergari M, Zago S, Priori A.
- Page 55 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual current stimulation of the human motor cortex. J Physiol 2005;568: 291-303. Ohn SH, Park CI, Yoo WK, Ko MH, Choi KP, Kim GM, Lee YT, Kim YH. Time-dependent effect of transcranial direct current stimulation on the enhancement of working memory.
- Page 56 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Riedel P, Kabisch S, Ragert P, von Kriegstein K. Contact dermatitis after transcranial direct current stimulation. Brain Stimul. 2011; Roche N, Lackmy A, Achache V, Bussel B, Katz R. Effects of anodal tDCS on lumbar propriospinal system in healthy subjects.
- Page 57 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual primary motor cortex. Neuropsychol Rehabil. 2011 Oct;21(5):650- 107. Teo F, Hoy KE, Daskalakis ZJ, Fitzgerald PB. Investigating the Role of Current Strength in tDCS Modulation of Working Memory Performance in Healthy Controls. Front Psychiatry. 2011;2:45.
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Page 58: Contact Information
1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Contact Information Soterix Medical Inc. 160 Convent Avenue ,ST-142 New York, NY 10031 Tel: 212-650-8260 Fax: 212-315-3232 Email: contact@soterixmedical.com Internet: www.SoterixMedical.com Authorized Representative for the European Community: mdi Europa GmbH Langenhagener Str. 71... - Page 59 1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual Thank you for purchasing a Soterix Medical 1x1 Transcranial Electrical Low-Intensity Stimulator Model 2001. If you arrive at a problem, or have any questions, comments, or concerns, please feel free to contact us at SoterixMedical.com Manufacturer Soterix Medical,Inc.
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