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<p class="MsoNormal"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">Dear EEGLAB List,<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">some comments from a manufacturer of active electrodes…:<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">The initial question/assumption was: “..my understanding is that none of the devices with active electrodes have any standard approval…(CE/FDA)”<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">Active Electrodes are electrically operated, so they can not be sold legally without a “standard approval”.<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">Within the EU, these products need to carry the so called CE mark and a declaration of conformity has to be issued by the manufacturer.<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">Here you can find a short overview about the (extremely comprehensive and detailed) regulation:<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D"><a href="http://en.wikipedia.org/wiki/CE_marking">http://en.wikipedia.org/wiki/CE_marking</a><o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">A manufacturer declares in his sole responsibility that the product complies with the applicable EU regulations/guidelines/standards.<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">The CE mark has to be present on the product and you should find this information on every manufacturer’s website.<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">(e.g.
<a href="http://www.brainproducts.com/productdetails.php?id=42">http://www.brainproducts.com/productdetails.php?id=42</a>, click on technical specification tab and scroll down)<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">To mention other main manufacturers of active electrodes as well:<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">To my best knowledge, Biosemi and G.Tec (and we, Brain Products) all carry the CE mark on their products and sell their active electrode amplifiers
with the “standard approval”, means they are CE marked.<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">In the US, the FDA is not really the exact counterpart, since FDA is a governmental institution which regulates the market (for similar and additional
purposes).<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">Clinical products (or better: products which are intended to be used for medical applications) are under strict control of the FDA.<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">(So FDA is an institution whereas CE is the product marking as a result of the conformity evaluation process. FCC is kind of comparable to CE but
originally/mainly for wireless products)<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">Research products (within the US) have to meet other regulations and are part of the IRB process which was mentioned already.<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">Medical products within the EU need to carry a 4 digit number next to the CE mark (e.g. CE 0123). The number indicates the Notified Body.<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">Products to be intended for research applications “just” have to carry the CE mark (without number) within the EU.<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">The CE-marking procedure was mainly established (besides other things) to increase product safety.<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">A related question to think of is:<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">Can I use a non-medical EEG amplifier (without medical CE) with active electrodes in my (University)Hospital (or medical environment) for sole research
applications (within the EU)?<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">The European Court of Justice has decided: YES!<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">Hope this added value to the discussion.<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">Best regards,<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D">Alex<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="EN-US" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><b><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif"">Von:</span></b><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif""> eeglablist-bounces@sccn.ucsd.edu [mailto:eeglablist-bounces@sccn.ucsd.edu]
<b>Im Auftrag von </b>Makoto Miyakoshi<br>
<b>Gesendet:</b> Donnerstag, 26. März 2015 20:14<br>
<b>An:</b> Eriksen, Jeffrey :LGS Neurodiagnostics; geoff@emotiv.co<br>
<b>Cc:</b> eeglablist@sccn.ucsd.edu<br>
<b>Betreff:</b> Re: [Eeglablist] active electrodes<o:p></o:p></span></p>
<p class="MsoNormal"><o:p> </o:p></p>
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<p class="MsoNormal">Dear Geoff and Jeff,<o:p></o:p></p>
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<p class="MsoNormal"><o:p> </o:p></p>
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<p class="MsoNormal">Thank you for your expert knowledge and quick responses!<o:p></o:p></p>
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<p class="MsoNormal"><o:p> </o:p></p>
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<p class="MsoNormal">> Any device which has US safety certifications and FCC Part 15 certification can be used safely on human subjects. <o:p></o:p></p>
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<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">> Many EEG systems are sold in the USA with FDA clearance for clinical use</span><o:p></o:p></p>
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<p class="MsoNormal"><o:p> </o:p></p>
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<p class="MsoNormal">This is very good to know. Maybe my knowledge was based on very old information.<o:p></o:p></p>
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<p class="MsoNormal"><o:p> </o:p></p>
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<p class="MsoNormal">Makoto<o:p></o:p></p>
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<p class="MsoNormal"><o:p> </o:p></p>
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<p class="MsoNormal">On Thu, Mar 26, 2015 at 11:09 AM, Eriksen, Jeffrey :LGS Neurodiagnostics <<a href="mailto:JEriksen@lhs.org" target="_blank">JEriksen@lhs.org</a>> wrote:<o:p></o:p></p>
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<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US" style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Any and all:</span><span lang="EN-US"><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US" style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"> </span><span lang="EN-US"><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US" style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">FDA clears devices for general safety and efficacy for clinical use in the USA but does
not care about research use. UL/CSA/ETC etc. certifies electrical safety specifically. You are covered legally for research use by your institutions IRB process, which should address the electrical safety issue and not care about FDA or clinical use.</span><span lang="EN-US"><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US" style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"> </span><span lang="EN-US"><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US" style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">In Europe I believe the CE regulates devices for general safety and efficacy, as well
as electrical safety specifically, combining the roles of FDA and UL.</span><span lang="EN-US"><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US" style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"> </span><span lang="EN-US"><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US" style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Many EEG systems are sold in the USA with FDA clearance for clinical use and that have
up to 256 channels with electrode caps or nets that use variants of the 10-20, 10-10, or 10-5 system, or uniform geodesic spacing as the EGI produces. Some of these have active electrodes. Now it may be the case that the FDA does not clear any active electrode
system for clinical use in the USA, but that has no impact on using them for research, as your IRB should take care of assuring their electrical safety.</span><span lang="EN-US"><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US" style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"> </span><span lang="EN-US"><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US" style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">-Jeff Eriksen</span><span lang="EN-US"><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US" style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Portland, OR</span><span lang="EN-US"><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US" style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"> </span><span lang="EN-US"><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><b><span lang="EN-US" style="font-size:10.0pt;font-family:"Tahoma","sans-serif"">From:</span></b><span lang="EN-US" style="font-size:10.0pt;font-family:"Tahoma","sans-serif"">
<a href="mailto:eeglablist-bounces@sccn.ucsd.edu" target="_blank">eeglablist-bounces@sccn.ucsd.edu</a> [mailto:<a href="mailto:eeglablist-bounces@sccn.ucsd.edu" target="_blank">eeglablist-bounces@sccn.ucsd.edu</a>]
<b>On Behalf Of </b>Makoto Miyakoshi<br>
<b>Sent:</b> Thursday, March 26, 2015 10:31 AM<br>
<b>To:</b> Friedman Doron<br>
<b>Cc:</b> <a href="mailto:eeglablist@sccn.ucsd.edu" target="_blank">eeglablist@sccn.ucsd.edu</a><br>
<b>Subject:</b> Re: [Eeglablist] active electrodes</span><span lang="EN-US"><o:p></o:p></span></p>
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<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US"> <o:p></o:p></span></p>
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<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US">Dear Doron,<o:p></o:p></span></p>
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<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US"> <o:p></o:p></span></p>
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<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US">Interesting topic. I heard a rumor that the FDA-approved EEG recorder in US (I don't know which) supports only the classical 10-20 system channels... I could
be wrong though. Anyone on the list please tell us what you know about this. I'm curious to know too. Thank you.<o:p></o:p></span></p>
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<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US"> <o:p></o:p></span></p>
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<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US">Makoto<o:p></o:p></span></p>
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<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US"> <o:p></o:p></span></p>
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<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US">On Mon, Mar 23, 2015 at 2:10 PM, Friedman Doron <<a href="mailto:doronf@idc.ac.il" target="_blank">doronf@idc.ac.il</a>> wrote:<o:p></o:p></span></p>
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<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US">Hi,<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US">This is not directly related to EEGLAB but perhaps of interest to many of us: my understanding is that none of the devices with active electrodes have any standard
approval, such as CE (Europe) or FDA (US). Does that mean all of us who are using them in research labs are not covered legally? And what about commercial applications, such as neurofeedback?
<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US">Thx<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US"> <o:p></o:p></span></p>
<p style="mso-margin-top-alt:5.0pt;margin-right:0cm;margin-bottom:0cm;margin-left:36.0pt;margin-bottom:.0001pt">
<span lang="EN-US">-</span><span lang="EN-US" style="font-size:7.0pt"> </span>
<span lang="EN-US">d<o:p></o:p></span></p>
<p class="MsoNormal" dir="RTL" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;text-align:right;direction:rtl;unicode-bidi:embed">
<span lang="EN-US" dir="LTR"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US">Dr. Doron Friedman</span><span lang="AR-SA" dir="RTL"><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US">Senior Lecturer<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US">Sammy Ofer School of Communications<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US">Office phone number:
<a href="tel:%2B972-9-9527654" target="_blank">+972-9-9527654</a><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US">Room C225, Sammy Ofer building<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US">The Interdisciplinary Center, Herzliya<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US">PO Box 167, 46150<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US">Director, Advanced Reality Lab<o:p></o:p></span></p>
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<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span lang="EN-US">Makoto Miyakoshi<br>
Swartz Center for Computational Neuroscience<br>
Institute for Neural Computation, University of California San Diego<o:p></o:p></span></p>
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<p class="MsoNormal">Makoto Miyakoshi<br>
Swartz Center for Computational Neuroscience<br>
Institute for Neural Computation, University of California San Diego<o:p></o:p></p>
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