{"product_id":"edan-se-2003-holter-recorder","title":"EDAN SE-2003 Holter Recorder","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN SE-2003\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3-channel digital Holter recorder\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e designed for continuous ambulatory ECG recording in adult and pediatric patients, including infants weighing less than 10 kg\u003c\/span\u003e\u003cspan class=\"\"\u003e. It pairs a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003erecorder weighing approximately 50 g\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, giving clinics and hospitals a compact, waterproof recording solution for extended cardiac rhythm surveillance\u003c\/span\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=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/edanusa.com\/product\/se-2003-3-channel-holter-system\/\" rel=\"noreferrer\" aria-label=\"5\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-2003 is part of the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSE-2003\/SE-2012 Holter System\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, which received \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA 510(k) clearance under K151787 (January 27, 2016)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"\"\u003e. Its cleared intended use covers \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003erecording, analyzing, displaying, editing, and reporting ambulatory ECG\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 system is indicated for evaluation of \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esymptoms suggesting arrhythmia or myocardial ischemia, ST segment changes, response to anti-arrhythmic medications, and pacemaker function\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"3\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K151787#tutorial\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe recorder captures \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3-channel ECG\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e at sampling rates of \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e128–1024 Hz\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and stores data on a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eremovable SD flash card\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; the SE-2003 has a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e192-hour (8-day) recording capacity\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. It 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 a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e1.92-inch full-color screen\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, 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 during the recording period\u003c\/span\u003e\u003cspan class=\"\"\u003e. Power is supplied by a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esingle AAA battery\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, supporting up to \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e8 days of recording\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e depending on configuration and sampling rate\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"6\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K151787#tutorial\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/edanusa.com\/product\/se-2003-3-channel-holter-system\/\" rel=\"noreferrer\" aria-label=\"5\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-2003 is built for facilities that need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ea lightweight, waterproof Holter recorder with extended recording capacity and a mature analysis software platform\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—the acquisition end of a complete ambulatory ECG workflow, with the analysis tools required to review, edit, and report recorded data.\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=\"\"\u003eApproximately 50 g, IP27 Waterproof Recorder\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eAt approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e50 g (excluding battery)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , the SE-2003 is designed for patient comfort during multi-day recordings, reducing the burden of wearing a Holter device during normal daily activities\u003c\/span\u003e\u003cspan class=\"\"\u003e. The \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 routine use\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"11\"\u003e\u003ca href=\"https:\/\/edanusa.com\/product\/se-2003-3-channel-holter-system\/\" rel=\"noreferrer\" aria-label=\"5\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eUp to 8 Days of Recording on a Single AAA Battery\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-2003 supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eup to 8 days of continuous ECG recording\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e on a single \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAAA battery\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, depending on sampling rate and configuration\u003c\/span\u003e\u003cspan class=\"\"\u003e. This extended capacity allows clinicians to capture longer monitoring periods without device replacement, which can be relevant when intermittent or low-frequency events are being evaluated.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"13\"\u003e\u003ca href=\"https:\/\/edanusa.com\/product\/se-2003-3-channel-holter-system\/\" rel=\"noreferrer\" aria-label=\"5\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eReal-Time Waveform Display and 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=\"\"\u003e1.92-inch full-color 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 the user to confirm signal quality at setup and during recording\u003c\/span\u003e\u003cspan class=\"\"\u003e. An \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eevent marker button (M)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e lets the patient flag symptomatic episodes, drawing attention to specific timestamps when the recording is later reviewed\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"16\"\u003e\u003ca href=\"https:\/\/edanusa.com\/product\/se-2003-3-channel-holter-system\/\" rel=\"noreferrer\" aria-label=\"5\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e3-Channel ECG Acquisition with SD Card Storage\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-2003 records \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3-channel ECG\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and stores data on a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eremovable SD flash card\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, supporting transfer to a PC for analysis via the Holter software\u003c\/span\u003e\u003cspan class=\"\"\u003e. Sampling rates of \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e128–1024 Hz\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e8\/12\/16\/18-bit A\/D conversion\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e are available, with a frequency response of \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e0.05–60 Hz\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The recorder is compatible with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e7-electrode and 5-electrode ECG cables\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e in IEC or AHA configurations\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"17\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K151787#tutorial\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/edanusa.com\/product\/se-2003-3-channel-holter-system\/\" rel=\"noreferrer\" aria-label=\"5\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eHolter Analysis Software with Extensive Review Tools\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe included \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHolter Analysis Software\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e provides \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efull-disclosure waveform review, automatic and manual editing of patient data, arrhythmia analysis, ST-segment analysis, atrial fibrillation analysis, and HRT analysis\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. Additional graphical 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 during review\u003c\/span\u003e\u003cspan class=\"\"\u003e. The software also supports a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecustomizable toolbar\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, allowing users to organize commonly used functions into a preferred workflow\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"20\"\u003e\u003ca href=\"https:\/\/edanusa.com\/product\/se-2003-3-channel-holter-system\/\" rel=\"noreferrer\" aria-label=\"5\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003ePacemaker Detection and Broad Clinical Indications\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-2003 supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epacemaker 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. The system’s cleared indications also cover \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003earrhythmia and myocardial ischemia symptom evaluation, ST segment changes, and drug response in patients taking anti-arrhythmic medications\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"24\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K151787#tutorial\" rel=\"noreferrer\" aria-label=\"1\" 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 include \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 extend the analysis toolkit for specific clinical or research interests\u003c\/span\u003e\u003cspan class=\"\"\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=\"\"\u003e3-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 Channels\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e3-channel ECG\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eRecording Capacity\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eUp to 192 hours (8 days) on SE-2003 (configuration-dependent)\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 flash 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=\"\"\u003e1.92-inch full-color 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=\"\"\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; up to 8 days recording\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 (excluding 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 76 mm × 49 mm × 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=\"\"\u003eECG Cable Options\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e7-electrode or 5-electrode; IEC or AHA\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\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eHolter Analysis Software: full disclosure, arrhythmia analysis, ST analysis, AFib analysis, HRT, R-R Histogram, Waveform Superposition Heat Map, Lorenz Plot\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\u003cspan class=\"\"\u003eRecording, analysis, display, editing, and reporting of ambulatory ECG; analysis results advisory only (FDA 510(k) K151787)\u003c\/span\u003e\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-2003?\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-2003 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=\"\"\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 recorder with IP27 protection and single AAA battery\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed extended recording capacity for intermittent events\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eUp to 8 days (192 hours) of 3-channel ECG recording\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 during setup and recording\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e1.92-inch full-color 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 during the recording\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 review and reporting\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eHolter Analysis Software with full disclosure, arrhythmia\/ST\/AFib analysis, and graphical review tools\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed to standardize on existing ECG cable formats\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e7-electrode or 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 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 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":46436722278444,"sku":null,"price":2999.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/EDANSE-2003HolterRecorder.png?v=1792591391","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-se-2003-holter-recorder","provider":"Global Healthcare Medical","version":"1.0","type":"link"}