{"product_id":"edan-se-2012-holter-recorder","title":"EDAN SE-2012 Holter Recorder","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN SE-2012\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e12-channel flagship recorder in EDAN‘s SE-2003\/SE-2012 Holter System\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, designed for extended ambulatory ECG recording in patients who need full 12-lead coverage without the constraints of a bedside monitor. It pairs a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003erecorder weighing approximately 50 g (without battery)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e with EDAN’s \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHolter Analysis Software\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, forming a complete acquisition-and-analysis workflow for clinics, cardiology practices, and hospital ECG departments.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-2012 is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA-cleared under 510(k) K151787 (January 27, 2016)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e as part of the SE-2003\/SE-2012 Holter System. Its cleared intended use covers \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003erecording, analysis, display, editing, and report generation of ambulatory ECG\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, for \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eadult and pediatric patients, including infants weighing less than 10 kg\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with analysis results offered to physicians \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eon an advisory basis only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The cleared indications cover \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eevaluation of symptoms suggesting arrhythmia or myocardial ischemia, ST segment changes, drug response in patients taking anti-arrhythmic medications, and patients with pacemakers\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"1\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K151787#tutorial\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eWhere the SE-2012 differs from the 3-channel SE-2003 is its \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003edual recording architecture\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e: it can capture \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efull-disclosure 12-lead ECG for 24–48 hours\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e using a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e10-electrode cable\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, or switch to \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3-channel ECG for 24–96 hours\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e using \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e7- or 5-electrode cables\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. This allows one recorder to serve both comprehensive 12-lead studies and longer-duration 3-channel rhythm surveillance, depending on the clinical question. The recorder is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIP27-rated\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for water and dust protection, supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ereal-time waveform display\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e on an OLED screen, and includes an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eevent marker button\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for flagging symptomatic episodes\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"2\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#5#2\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K151787#tutorial\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-2012 is built for facilities that need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ea single Holter platform capable of both 12-lead diagnostic depth and extended 3-channel recording\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, backed by a mature analysis software suite covering \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003earrhythmia, ST segment, atrial fibrillation, HRV, HRT, and pacemaker detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"4\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K151787#tutorial\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan class=\"\"\u003eKey Features \u0026amp; Benefits\u003c\/span\u003e\u003c\/h2\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eDual-Mode Recording: 12-Lead Depth or Extended 3-Channel Duration\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-2012 supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ethree lead configurations\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e: \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e10-electrode standard 12-lead mode\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e7-electrode 3-channel mode\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e5-electrode 3-channel mode\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. In 12-lead mode, it records \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efull-disclosure 12-lead ECG for 24–48 hours\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; in 3-channel mode, recording can extend to \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24–96 hours\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. This dual capability means the same recorder can be deployed for detailed 12-lead analysis or for longer rhythm surveillance without purchasing a second device.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"5\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#5#2\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eIP27 Waterproof and Approximately 50 g Lightweight Design\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIP27 rating\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e provides water and dust protection, supporting easy cleaning and reducing the risk of accidental water damage during daily wear\u003c\/span\u003e\u003cspan class=\"\"\u003e. At approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e50 g (without battery)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , the recorder is designed for patient comfort during multi-day recordings, minimizing the burden of carrying the device through normal activities\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"7\"\u003e\u003ca href=\"https:\/\/edanusa.com\/product\/se-2012-12-channel-holter-system\/\" rel=\"noreferrer\" aria-label=\"22\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eReal-Time Waveform Display and Patient Event Marker\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe recorder includes a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e1.46-inch OLED screen\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ereal-time waveform display\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, allowing setup confirmation and signal-quality checks at the point of application\u003c\/span\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eevent marker button (M)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e lets patients flag symptomatic episodes or meaningful timestamps—such as exercise onset or sleep—so those periods receive focused attention during review\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"9\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K151787#tutorial\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/edanusa.com\/product\/se-2012-12-channel-holter-system\/\" rel=\"noreferrer\" aria-label=\"22\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eHolter Analysis Software with Multi-Parameter Review Tools\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe included software supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efull-disclosure waveform review, automatic and manual editing, arrhythmia analysis, ST-segment analysis with myocardial ischemia evaluation, atrial fibrillation analysis, HRV analysis, and HRT analysis\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. Graphical assistive tools—\u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eR-R Histogram, Waveform Superposition Heat Map, and Lorenz Plot (Poincaré Plot)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e —help users locate and select abnormal beats efficiently during long recordings\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"11\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K151787#tutorial\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/edanusa.com\/product\/se-2012-12-channel-holter-system\/\" rel=\"noreferrer\" aria-label=\"22\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003ePacemaker Detection Aligned with Cleared Indications\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-2012 supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epacemaker pulse detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, aligning with its cleared indication for \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eevaluation of patients with pacemakers\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. This allows the same platform to serve both general arrhythmia evaluation and pacemaker patient follow-up.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"14\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#5#2\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K151787#tutorial\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eOptional Advanced Analysis Modules\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eOptional software upgrades extend the analysis toolkit with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eVector ECG, Ventricular Late Potentials, T-wave Alternans, and Waterfall Plot\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e functions, allowing departments to tailor the platform to specific clinical or research interests.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eStandardized Cable and Accessory Ecosystem\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-2012 ships standard with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e12-lead ECG cable\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and is compatible with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e7-electrode and 5-electrode cables\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e in \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIEC or AHA\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e configurations, supporting facilities that have standardized on a particular electrode format\u003c\/span\u003e\u003cspan class=\"\"\u003e. A carry belt, USB cable, and disposable electrodes are included as standard accessories.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"16\"\u003e\u003ca href=\"https:\/\/edanusa.com\/product\/se-2012-12-channel-holter-system\/\" rel=\"noreferrer\" aria-label=\"22\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan class=\"\"\u003eTechnical Specifications\u003c\/span\u003e\u003c\/h2\u003e\n\u003cdiv class=\"ds-scroll-area ds-scroll-area--show-on-focus-within ds-scroll-area--enabled _1210dd7 c03cafe9\"\u003e\n\u003cdiv class=\"ds-scroll-area__gutters\"\u003e\n\u003cdiv class=\"ds-scroll-area__horizontal-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"ds-scroll-area__vertical-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ctable\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eSpecification\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eDetail\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDevice Type\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e12-channel \/ 3-channel digital Holter recorder with analysis software\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eRecording Modes\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e12-lead (10-electrode); 3-channel (7-electrode or 5-electrode)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e12-Lead Recording Duration\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e24–48 hours, full-disclosure, non-compressed\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3-Channel Recording Duration\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e24–96 hours, full-disclosure, non-compressed\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eStorage\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eRemovable SD\/microSD flash card (capacity per included card)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDisplay\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e1.46-inch OLED with real-time waveform display\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSampling Rate\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e128–1024 Hz\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eA\/D Conversion\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e8, 12, 16, 18-bit\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFrequency Response\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e0.05–60 Hz\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eInput Impedance\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e≥ 20 MΩ\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePower\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSingle AAA battery (alkaline or Li-Fe; Li-Fe supports extended recording per labeling)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIngress Protection\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eIP27 (water and dust protected)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eWeight\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eApproximately 50 g (without battery)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDimensions\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eApproximately 68 × 53 × 16 mm (per published specifications)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEvent Marker\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eYes, patient-activated event marking\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePacemaker Detection\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSupported\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSoftware Functions\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eFull disclosure; arrhythmia analysis; ST segment analysis; AFib\/AFlut analysis; HRV; HRT; pacemaker analysis; R-R Histogram; Waveform Superposition Heat Map; Lorenz Plot; customizable toolbar\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eOptional Upgrades\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eVector ECG; Ventricular Late Potentials; T-wave Alternans; Waterfall Plot\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIntended Patient Population\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eAdult and pediatric patients, including infants weighing less than 10 kg\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIntended Use\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eRecording, analysis, display, editing, and report generation of ambulatory ECG; analysis results advisory only; use by trained personnel under physician direction (FDA 510(k) K151787)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"17\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K151787#tutorial\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eRegulatory Status\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eFDA 510(k) cleared (SE-2003\/SE-2012 Holter System: K151787, January 27, 2016); availability and cleared claims vary by market\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003ch2\u003e\u003cspan class=\"\"\u003eWhy Choose the EDAN SE-2012?\u003c\/span\u003e\u003c\/h2\u003e\n\u003cdiv class=\"ds-scroll-area ds-scroll-area--show-on-focus-within ds-scroll-area--enabled _1210dd7 c03cafe9\"\u003e\n\u003cdiv class=\"ds-scroll-area__gutters\"\u003e\n\u003cdiv class=\"ds-scroll-area__horizontal-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"ds-scroll-area__vertical-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ctable\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eClinical or Operational Challenge\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eSE-2012 Solution\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed both 12-lead diagnostic depth and extended rhythm surveillance\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eDual-mode recording: 12-lead for 24–48 hours, or 3-channel for 24–96 hours\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePatients need a comfortable recorder for multi-day wear\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eApproximately 50 g (without battery), IP27 water\/dust protection\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed to confirm signal quality at setup and during recording\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eOLED screen with real-time waveform display\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed to flag symptomatic episodes for focused review\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003ePatient-activated event marker button\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed a mature analysis platform for arrhythmia, ST, AFib, and HRV\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eHolter Analysis Software with full disclosure, multiple analysis modules, and graphical assistive tools\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed pacemaker evaluation capability\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003ePacemaker detection supported under cleared indications\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed to match existing ECG cable formats\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e12-lead, 7-electrode, and 5-electrode cables in IEC or AHA configurations\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed to extend analysis for specific clinical interests\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eOptional Vector ECG, Ventricular Late Potentials, T-wave Alternans, and Waterfall Plot upgrades\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e","brand":"Global Healthcare Medical","offers":[{"title":"Default Title","offer_id":46436751474732,"sku":null,"price":3199.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/EDANSE-2012HolterRecorder.png?v=1792591788","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-se-2012-holter-recorder","provider":"Global Healthcare Medical","version":"1.0","type":"link"}