{"product_id":"edan-ise-1210-electrocardiograph","title":"EDAN iSE-1210 Electrocardiograph","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN iSE-1210\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e12-lead resting electrocardiograph built on a tablet-style platform\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, designed for ECG acquisition in hospitals, clinics, emergency departments, and first-aid settings. It pairs a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e10.1-inch full-touch LCD screen (1920 × 1200)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e with a chassis that weighs \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e1.2 kg without the handle or thermal printer\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e1.4 kg with the handle\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—making it practical for bedside use, mobile rounds, and point-of-care ECG workflows where a cart-mounted system would be impractical\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"1\"\u003e\u003ca href=\"https:\/\/edanusa.com\/wp-content\/uploads\/sites\/12\/2024\/03\/iSE_ECG_Specification_V1.2_20230508.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"22\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe iSE-1210 is part of the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eiSE series (iSE-1210 and iSE-1810)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, which received \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA 510(k) clearance under K212278 on April 7, 2022\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (Product Code DPS, Class 2)\u003c\/span\u003e\u003cspan class=\"\"\u003e. The cleared intended use covers \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eacquisition of ECG signals from adult and pediatric patients through body surface ECG electrodes\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, for use \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ein hospitals or healthcare facilities by doctors and trained healthcare professionals\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, to \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ehelp users analyze and diagnose heart disease\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. Per the cleared labeling, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ethe interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"2\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K212278?_x_output_type_b6db407c4_=embedded_pdf#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 iSE-1210 acquires \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e12 leads simultaneously\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e through a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDE12 sampling box\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24-bit A\/D conversion\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e64,000 Hz sampling frequency per channel\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efrequency response of 0.01–350 Hz\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—parameters oriented toward high-fidelity signal capture\u003c\/span\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSEMIP algorithm\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e processes acquired signals to generate measurements and interpretive statements, and the platform includes \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epacemaker analysis\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e with detection of pacemaker pulses as narrow as \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e30 μs and 500 μV\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (DE12 configuration)\u003c\/span\u003e\u003cspan class=\"\"\u003e. The iSE series also supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBrugada syndrome ECG pattern identification\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e through the SEMIP algorithm, presented as an interpretive aid to cardiologists.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"5\"\u003e\u003ca href=\"https:\/\/edanusa.com\/wp-content\/uploads\/sites\/12\/2024\/03\/iSE_ECG_Specification_V1.2_20230508.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"22\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eStorage capacity reaches \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e100,000 ECG examinations\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (10-second DAT records with files), and the system supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eWi-Fi, Ethernet, and 4G network transmission\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e alongside \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSCP, FDA-XML, DICOM (encapsulated PDF and ECG waveform), PDF, JPG, BMP, PNG, and TIFF report formats\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003erechargeable lithium-ion battery (15.2 V, 3,550 mAh)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e provides \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003emore than 8 hours of operating time\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and charges in \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e≤ 5 hours\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"7\"\u003e\u003ca href=\"https:\/\/edanusa.com\/wp-content\/uploads\/sites\/12\/2024\/03\/iSE_ECG_Specification_V1.2_20230508.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"22\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe iSE-1210 is built for facilities that need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ea lightweight, tablet-style 12-lead ECG device with touchscreen operation, high-resolution signal acquisition, and network-ready data management\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—without the footprint of a conventional ECG cart.\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=\"\"\u003eTablet-Style Design at 1.2 kg (Body Only)\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe iSE-1210 is engineered around a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003etablet-like form factor\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e10.1-inch full-touch LCD (1920 × 1200)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e serving as both display and primary control surface\u003c\/span\u003e\u003cspan class=\"\"\u003e. The base chassis weighs \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e1.2 kg without handle or thermal printer\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e1.4 kg with the handle\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e2.3 kg when configured with the thermal printer\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The optional \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ehandle\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecarrying case\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e support transport between rooms, bedsides, and emergency scenes.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"9\"\u003e\u003ca href=\"https:\/\/edanusa.com\/wp-content\/uploads\/sites\/12\/2024\/03\/iSE_ECG_Specification_V1.2_20230508.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"22\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e12-Lead Simultaneous Acquisition with High-Resolution Signal Chain\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe iSE-1210 acquires \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e12 leads simultaneously\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e through the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDE12 sampling box\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24-bit A\/D conversion\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e64,000 Hz sampling frequency per channel\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003einput impedance ≥ 100 MΩ\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCMRR ≥ 140 dB (AC on)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efrequency response of 0.01–350 Hz (−3 dB)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supports capture of low-frequency ST-segment information and higher-frequency components within the diagnostic ECG bandwidth\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"11\"\u003e\u003ca href=\"https:\/\/edanusa.com\/wp-content\/uploads\/sites\/12\/2024\/03\/iSE_ECG_Specification_V1.2_20230508.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"22\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSEMIP Algorithm with Advisory Interpretive Statements\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSEMIP algorithm\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e generates \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003emeasurements, graphical presentations, and interpretive statements\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e from acquired ECG signals\u003c\/span\u003e\u003cspan class=\"\"\u003e. Per the cleared labeling, these interpreted outputs are \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoffered to clinicians on an advisory basis only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—they are intended to support, not replace, clinician analysis and diagnosis\u003c\/span\u003e\u003cspan class=\"\"\u003e. The platform also supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBrugada syndrome ECG pattern identification\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e through SEMIP, presented as an interpretive aid.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"13\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K212278?_x_output_type_b6db407c4_=embedded_pdf#tutorial\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003ePacemaker Analysis with High-Frequency Sampling\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe iSE-1210 supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epacemaker pulse detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with the DE12 configuration capturing pacemaker amplitudes from \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e±500 μV to ±700 mV\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and pulse widths from \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e30 μs to 2.0 ms\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. A \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esampling rate as high as 80 kHz\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is cited in EDAN’s product literature for pacemaker analysis, supporting detection of narrow pacemaker pulses that may be missed at lower sampling rates.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"15\"\u003e\u003ca href=\"https:\/\/edanusa.com\/wp-content\/uploads\/sites\/12\/2024\/03\/iSE_ECG_Specification_V1.2_20230508.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"22\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e100,000-Examination Storage and Multi-Format Export\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe iSE-1210 stores \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eup to 100,000 ECG examinations\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (10-second DAT records with files)\u003c\/span\u003e\u003cspan class=\"\"\u003e. Report export formats include \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSCP, FDA-XML, DICOM (encapsulated PDF), DICOM (ECG waveform), PDF, JPG, BMP, PNG, and TIFF\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eWi-Fi (2.4 GHz and 5 GHz), Ethernet, and 4G network transmission\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. Optional \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDICOM Worklist\/Storage\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHL7\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e upgrades support direct communication with hospital information systems.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"16\"\u003e\u003ca href=\"https:\/\/edanusa.com\/wp-content\/uploads\/sites\/12\/2024\/03\/iSE_ECG_Specification_V1.2_20230508.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"22\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e\u0026gt;8-Hour Battery with Fast Recharge\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e15.2 V, 3,550 mAh lithium-ion battery\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e provides \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003emore than 8 hours of operating time\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and recharges in \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e≤ 5 hours\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. This supports a full clinic day or extended bedside use without mains power, with the power adapter (19 V) available for recharging between uses.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"18\"\u003e\u003ca href=\"https:\/\/edanusa.com\/wp-content\/uploads\/sites\/12\/2024\/03\/iSE_ECG_Specification_V1.2_20230508.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"22\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eModular Configuration Options\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe iSE-1210 supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoptional configurations\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e including a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ehandle\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epad mode\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ethermal recorder\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (with 210 mm × 12 m thermal recording paper). \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eOptional software upgrades\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e include \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCalculated VCG, VCG Kit, TVCG, SAECG\/VLP (Ventricular Late Potentials), HRV\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDICOM Worklist\/HL7\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e communication, allowing the platform to be tailored to departmental needs.\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-lead resting electrocardiograph (iSE series)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAcquisition\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e12 leads simultaneous (DE12 sampling box); 18-lead available on iSE-1810 (DE18)\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=\"\"\u003e10.1-inch LCD full-touch screen, 1920 × 1200 resolution\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=\"\"\u003e24-bit\u003c\/span\u003e\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\u003cspan class=\"\"\u003e64,000 Hz per channel\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=\"\"\u003e0.01–350 Hz (−3 dB)\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≥ 100 MΩ (10 Hz)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCMRR\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e≥ 140 dB (AC on); ≥ 123 dB (AC off)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePacemaker Detection (DE12)\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eAmplitude ±500 μV to ±700 mV; width 30 μs to 2.0 ms\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=\"\"\u003eUp to 100,000 ECG examinations (10 s DAT with files)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eReport Formats\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSCP, FDA-XML, DICOM (encapsulated PDF), DICOM (ECG waveform), PDF, JPG, BMP, PNG, TIFF\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eConnectivity\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eWi-Fi (2.4\/5 GHz), Ethernet, 4G; optional DICOM Worklist\/Storage, HL7\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBattery\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e15.2 V, 3,550 mAh Li-ion; \u0026gt;8 h operating time; ≤5 h charge time\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=\"\"\u003e1.2 kg (body, no handle\/thermal printer); 1.4 kg (with handle); 2.3 kg (with thermal printer)\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=\"\"\u003e270 × 170 × 28 mm (no handle\/printer); 270 × 230 × 52 mm (with handle)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eOptional Hardware\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eHandle, pad mode, thermal recorder (210 mm × 12 m paper)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eOptional Software\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eCalculated VCG, VCG Kit, TVCG, SAECG\/VLP, HRV, DICOM Worklist\/HL7\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\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=\"\"\u003eAcquisition of ECG signals via body surface electrodes to help analyze and diagnose heart disease in hospitals or healthcare facilities by doctors and trained professionals; interpretive statements advisory only (FDA 510(k) K212278)\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 (iSE series: K212278, April 7, 2022); CE MDR Class IIa (Edan QMS certificate covering electrocardiographs, device group Z120503); 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 iSE-1210?\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=\"\"\u003eiSE-1210 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 lightweight ECG device for bedside, clinic, and mobile use\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e1.2 kg body (1.4 kg with handle) in a tablet-style form factor\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed high-resolution signal acquisition for diagnostic ECG\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e24-bit A\/D, 64 kHz sampling, 0.01–350 Hz frequency response, CMRR ≥ 140 dB\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed touchscreen operation and a large viewing area\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e10.1-inch 1920 × 1200 full-touch LCD\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed pacemaker pulse detection with narrow pulse widths\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eDE12 pacemaker detection from 30 μs and ±500 μV\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed extensive on-board storage without a separate workstation\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eUp to 100,000 ECG examinations stored on the device\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed HIS\/EMR and network integration\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eWi-Fi, Ethernet, 4G; SCP\/FDA-XML\/DICOM\/PDF\/JPG export; optional DICOM Worklist and HL7\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed extended battery runtime for mobile workflows\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e\u0026gt;8 hours operating time; ≤5 hours charge\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed optional advanced ECG analysis modules\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eCalculated VCG, TVCG, SAECP\/VLP, HRV, and DICOM\/HL7 upgrades available\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":46459725938732,"sku":null,"price":3799.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/EdaniSE-1210Electrocardiograph.png?v=1792745124","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-ise-1210-electrocardiograph","provider":"Global Healthcare Medical","version":"1.0","type":"link"}