{"product_id":"edan-se-3012-holter-system","title":"EDAN SE-3012 Holter System","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN SE-3012\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3\/12-channel digital Holter recorder\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e paired with EDAN’s \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHolter Analysis Software\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, designed for continuous ambulatory ECG recording in hospital and clinic settings. It extends the SE-2003\/SE-2012 Holter platform with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBluetooth wireless data transfer\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, allowing recordings to be transmitted without physically removing the SD card, and is positioned as a complete acquisition-and-analysis system for departments that need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efull-disclosure ECG recording with pacemaker detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-3012 Series is covered under \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEU MDR 2017\/745 as a Class IIa medical device\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSE-3012 Holter System added to EDAN’s MDR certification portfolio on February 7, 2024\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"\"\u003e. The cleared intended use for the Holter System is to \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003erecord, analyze, display, edit, and generate reports of ambulatory ECG\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNo FDA 510(k) clearance specific to the SE-3012 model was identified in the public FDA database during preparation of this page\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; the FDA clearances found for EDAN Holter systems (K230184 and K251591) cover the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e“Holter ECG and ABP System”\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e trade name, not the SE-3012 designation specifically \u003c\/span\u003e\u003cspan class=\"\"\u003e. Availability and cleared claims vary by market; confirm local registration and labeling before purchase.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"1\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-b%E2%80%94cardiovascular-diagnostic-devices\/DQK\/K251591?_x_output_type_b6db407c4_=embedded_pdf#1#2#1\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPMN\/pmn.cfm?ID=K230184\" rel=\"noreferrer\" aria-label=\"3\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.edan.com.cn\/Uploads\/20240902022824_740381.pdf#7#20#7\" rel=\"noreferrer\" aria-label=\"27\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-3012 recorder supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e12-lead full-disclosure recording for 24–48 hours\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, or \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3-channel full-disclosure recording for 24–96 hours\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, on a single \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAAA alkaline battery\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"\"\u003e. With a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eLi-Fe battery\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, 3-channel recording extends to \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e7 days\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"\"\u003e. The device includes \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epacemaker pulse detection and recording\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and stores ECG data on a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eremovable SD card\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for transfer to the analysis workstation via \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSD card reader or direct USB connection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"\"\u003e. A \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epatient event marker\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e allows the wearer to flag symptomatic episodes or meaningful timestamps during the recording period \u003c\/span\u003e\u003cspan class=\"\"\u003e.\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#3#5#3\" rel=\"noreferrer\" aria-label=\"9\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#2#5#2\" rel=\"noreferrer\" aria-label=\"10\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-3012’s \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBluetooth configuration\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e enables wireless data transfer, reducing the need to physically handle the SD card between patient hook-up and analysis. The system ships with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e10-electrode ECG cable\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eUSB Type-C cable\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSD card and reader\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecarry belt\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003erechargeable lithium battery (3250 mAh)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e as standard. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHolter Analysis Software Kit\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is available as a separate line item, providing the review, editing, and reporting environment for the recorded data.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-3012 is built for facilities that need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ea flexible, full-disclosure Holter recorder with 3\/12-channel capability, pacemaker detection, extended battery options, and wireless data transfer\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—paired with EDAN’s analysis software for the review and reporting workflow.\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=\"\"\u003e3\/12-Channel Full-Disclosure Recording with Extended Duration\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-3012 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 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=\"\"\u003enon-compressed, full-disclosure ECG for 24–48 hours\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; in 3-channel mode, recording extends to \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24–96 hours on a standard AAA alkaline battery\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, or \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eup to 7 days with a Li-Fe battery\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"\"\u003e. This flexibility allows the same recorder to serve both comprehensive 12-lead studies and longer-duration rhythm surveillance depending on the clinical question.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"10\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#2#5#2\" rel=\"noreferrer\" aria-label=\"10\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eBluetooth Wireless Data Transfer Configuration\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-3012 is available in a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBluetooth-enabled configuration\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, allowing recorded data to be transmitted wirelessly to the analysis system without removing the SD card. This reduces handling steps between patient hook-up and review, and supports faster patient turnover in busy Holter clinics. The standard configuration also supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSD card reader and direct USB\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e data transfer for departments that prefer physical media \u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"11\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#3#5#3\" rel=\"noreferrer\" aria-label=\"9\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003ePacemaker Pulse Detection\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-3012 includes \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epacemaker pulse detection and recording\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e as part of the Holter System’s acquisition capabilities \u003c\/span\u003e\u003cspan class=\"\"\u003e. This allows the recorder to capture and mark pacemaker stimuli alongside the surface ECG, supporting review of patients with implanted pacemakers during the recording period.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"12\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#2#5#2\" rel=\"noreferrer\" aria-label=\"10\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003ePatient Event Marker for Symptom Correlation\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eA \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epatient event marker\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e on the recorder allows the wearer to flag symptomatic episodes or meaningful timestamps—such as exercise onset or sleep—during the recording period \u003c\/span\u003e\u003cspan class=\"\"\u003e. These marked events help the reviewing clinician focus on specific periods when the recording is analyzed.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"13\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#2#5#2\" rel=\"noreferrer\" aria-label=\"10\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e24-Bit Signal Chain with Selectable Sampling Rates\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-3012’s acquisition chain includes a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24-bit A\/D converter\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esampling frequency of 25.6 kHz\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for the SE-2003\/SE-2012 platform, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eselectable sample rates of 128, 256, 512, or 1024 Hz\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for EDAN file formats \u003c\/span\u003e\u003cspan class=\"\"\u003e. The recorder is designed for \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003elow power consumption\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, supporting extended recording durations on battery power \u003c\/span\u003e\u003cspan class=\"\"\u003e.\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#3#5#3\" rel=\"noreferrer\" aria-label=\"9\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#2#5#2\" rel=\"noreferrer\" aria-label=\"10\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSD Card Storage and USB Connectivity\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eRecorded ECG data is stored on a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eremovable SD card\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (1 GB included, with 32 GB and 64 GB options available) and transferred to the analysis system via \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSD card reader or USB Type-C cable\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"\"\u003e. The SD card-based workflow allows the recorder to be cleared for the next patient while the previous recording is analyzed, supporting department throughput.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"17\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#3#5#3\" rel=\"noreferrer\" aria-label=\"9\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eComplete Accessory Set for Immediate Deployment\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-3012 ships standard with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e10-electrode ECG cable (IEC, HDMI port, 0.87–1.17 m)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eUSB Type-C cable\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSD card (1 GB) and reader\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecarry belt\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003edisposable ECG electrodes (50 pcs)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003erechargeable lithium battery (3250 mAh)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecarry bag\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003euser manuals\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHolter Analysis Software Kit\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is available as a separate line item, providing the review and reporting environment. Optional \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e7-electrode and 5-electrode cables\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e are available for 3-channel configurations.\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\/12-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=\"\"\u003eRegulatory Status\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eEU MDR 2017\/745 Class IIa; SE-3012 Holter System added to MDR portfolio 2024\/02\/07 \u003c\/span\u003e\u003cspan class=\"\"\u003e; \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eno FDA 510(k) specific to SE-3012 identified\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; FDA Holter clearances cover “Holter ECG and ABP System” trade name \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"18\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-b%E2%80%94cardiovascular-diagnostic-devices\/DQK\/K251591?_x_output_type_b6db407c4_=embedded_pdf#1#2#1\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPMN\/pmn.cfm?ID=K230184\" rel=\"noreferrer\" aria-label=\"3\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.edan.com.cn\/Uploads\/20240902022824_740381.pdf#7#20#7\" rel=\"noreferrer\" aria-label=\"27\" 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=\"\"\u003eLead Configurations\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e10-electrode 12-lead; 7-electrode 3-channel; 5-electrode 3-channel \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"21\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#2#5#2\" rel=\"noreferrer\" aria-label=\"10\" 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=\"\"\u003e12-Lead Recording Duration\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e24–48 hours, non-compressed, full-disclosure (AAA alkaline) \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"22\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#2#5#2\" rel=\"noreferrer\" aria-label=\"10\" 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=\"\"\u003e3-Channel Recording Duration\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e24–96 hours (AAA alkaline); up to 7 days (Li-Fe) \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"23\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#2#5#2\" rel=\"noreferrer\" aria-label=\"10\" 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=\"\"\u003eStorage\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eSD card (1 GB included; 32 GB\/64 GB options) \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"24\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#3#5#3\" rel=\"noreferrer\" aria-label=\"9\" 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=\"\"\u003eData Transfer\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSD card reader; USB Type-C; Bluetooth (optional configuration)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eA\/D Converter\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e24-bit \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"25\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#2#5#2\" rel=\"noreferrer\" aria-label=\"10\" 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=\"\"\u003eSampling Frequency\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e25.6 kHz (platform) \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"26\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#2#5#2\" rel=\"noreferrer\" aria-label=\"10\" 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=\"\"\u003eSample Rate Settings (EDAN format)\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e128 \/ 256 \/ 512 \/ 1024 Hz \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"27\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#3#5#3\" rel=\"noreferrer\" aria-label=\"9\" 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=\"\"\u003ePacemaker Detection\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eSupported \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"28\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#2#5#2\" rel=\"noreferrer\" aria-label=\"10\" 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=\"\"\u003eEvent Marker\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003ePatient-activated \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"29\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#2#5#2\" rel=\"noreferrer\" aria-label=\"10\" 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=\"\"\u003ePower\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eAAA alkaline (standard); Li-Fe (extended 3-channel recording); rechargeable Li-ion 3250 mAh included\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\n\u003cspan class=\"\"\u003eLCD for parameter setting and waveform preview \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"30\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#2#5#2\" rel=\"noreferrer\" aria-label=\"10\" 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=\"\"\u003eStandard Accessories\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e10-electrode ECG cable (IEC, HDMI); USB Type-C cable; SD card 1 GB + reader; carry belt; disposable electrodes (50 pcs); Li-ion battery 3250 mAh; carry bag; manuals\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eOptional Accessories\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e7-electrode \/ 5-electrode ECG cables (IEC\/AHA); SD cards (32\/64 GB); Bluetooth configuration\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=\"\"\u003eRecord, analyze, display, edit, and generate report of ambulatory ECG \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"31\"\u003e\u003ca href=\"https:\/\/www.edan.com.cn\/Uploads\/20240902022824_740381.pdf#7#20#7\" rel=\"noreferrer\" aria-label=\"27\" 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=\"\"\u003eIntended Patient Population\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eAdult and pediatric patients (per Holter System intended use)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eContraindications\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eRefer to local labeling; confirm availability and claims for specific markets\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-3012?\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-3012 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 a Holter recorder that supports both 12-lead and extended 3-channel studies\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e10-electrode 12-lead (24–48 h) or 7\/5-electrode 3-channel (24–96 h; up to 7 days with Li-Fe)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed to review pacemaker patients during ambulatory recording\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003ePacemaker pulse detection and recording \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"32\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#2#5#2\" rel=\"noreferrer\" aria-label=\"10\" 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=\"\"\u003eNeed flexible data transfer options\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSD card reader, USB Type-C, and Bluetooth configuration\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 wear period\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003ePatient event marker for symptom correlation \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"33\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#2#5#2\" rel=\"noreferrer\" aria-label=\"10\" 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=\"\"\u003eNeed extended recording duration for intermittent events\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eUp to 96 hours on AAA alkaline; up to 7 days on Li-Fe for 3-channel \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"34\"\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/69312373\/upload_00000175_1749849623456.pdf?version=1.0\u0026amp;fileId=69313251#2#5#2\" rel=\"noreferrer\" aria-label=\"10\" 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=\"\"\u003eNeed a complete system with analysis software\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eHolter Analysis Software Kit available as separate line item; standard accessory set for immediate deployment\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed MDR Class IIa certification for European markets\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSE-3012 Holter System added to EDAN MDR portfolio 2024\/02\/07\u003cspan\u003e \u003c\/span\u003e\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":46507541299244,"sku":null,"price":3599.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/EdanSE-3012HolterSystem.png?v=1793019047","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-se-3012-holter-system","provider":"Global Healthcare Medical","version":"1.0","type":"link"}