{"product_id":"edan-ise-1810-electrocardiograph","title":"EDAN iSE-1810 Electrocardiograph","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN iSE-1810\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e18-lead configuration within EDAN’s iSE series\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e of tablet-style resting electrocardiographs, designed for comprehensive cardiac assessment that includes \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eright precordial and posterior wall coverage\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e through simultaneous 18-lead acquisition\u003c\/span\u003e\u003cspan class=\"\"\u003e. It shares 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 and tablet-like form factor of the iSE-1210, but replaces the DE12 sampling box with the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDE18 sampling box\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, enabling \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esimultaneous acquisition of 18 leads\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e rather than the standard 12\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"1\"\u003e\u003ca href=\"https:\/\/vigourmedstore.com\/products\/edan-ise-with-18-channel-configuration-10-touch-screen-with-wifi-and-bluetooth-direct-communication-with-emr-his-via-hl7-dicom-fda-xml-and-sim-card-slot?pr_prod_strat=e5_desc\u0026amp;pr_rec_id=37740e464\u0026amp;pr_rec_pid=9047596269808\u0026amp;pr_ref_pid=9047584997616\u0026amp;pr_seq=uniform\" rel=\"noreferrer\" aria-label=\"16\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe iSE-1810 is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA-cleared under 510(k) K212278 (April 7, 2022)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e as part of the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eiSE series (iSE-1210, iSE-1810)\u003c\/span\u003e\u003c\/strong\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 help users \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eanalyze 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. The FDA summary explicitly notes that \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eno clinical data were submitted\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; substantial equivalence was supported by non-clinical bench testing, electrical safety, electromagnetic compatibility, performance testing, and software validation\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"3\"\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 DE18 sampling box provides \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 , with a \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. The iSE-1810 also supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoptional leadwire kits for the extended 18-lead positions\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (C7\/C8\/C9\/C3R\/C4R\/C5R and V7\/V8\/V9\/V3R\/V4R\/V5R), allowing departments to add posterior and right-sided coverage as clinical needs require.\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=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eStorage 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 (2.4\/5 GHz), Ethernet, and 4G\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e transmission, alongside \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSCP, FDA-XML, DICOM (encapsulated PDF and ECG waveform), PDF, JPG, BMP, PNG, and TIFF\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e report formats\u003c\/span\u003e\u003cspan class=\"\"\u003e. The \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.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"6\"\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=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe iSE-1810 is built for facilities that need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e18-lead diagnostic depth in a portable, touch-operated ECG device\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—supporting right ventricular and posterior wall assessment without moving to a cart-based system, and integrating into hospital IT workflows through network connectivity and optional DICOM\/HL7 communication.\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=\"\"\u003eSimultaneous 18-Lead Acquisition with DE18 Sampling Box\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe iSE-1810 acquires \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e18 leads simultaneously\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e through the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDE18 sampling box\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, extending standard 12-lead coverage to include \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eright precordial (V3R–V5R) and posterior (V7–V9) positions\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. This supports cardiac assessment that requires views beyond the conventional 12-lead set, while retaining the option to run standard 12-lead studies with compatible leadwire kits. The DE18 box uses \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 kHz per-channel sampling\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 for high-resolution signal capture\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"8\"\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=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/vigourmedstore.com\/products\/edan-ise-with-18-channel-configuration-10-touch-screen-with-wifi-and-bluetooth-direct-communication-with-emr-his-via-hl7-dicom-fda-xml-and-sim-card-slot?pr_prod_strat=e5_desc\u0026amp;pr_rec_id=37740e464\u0026amp;pr_rec_pid=9047596269808\u0026amp;pr_ref_pid=9047584997616\u0026amp;pr_seq=uniform\" rel=\"noreferrer\" aria-label=\"16\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eTablet-Style Form Factor at 1.2 kg (Body Only)\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe iSE-1810 shares the iSE series enclosure: \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 with the optional thermal printer\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. 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 serves as the primary control surface, and the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ezero-button design\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e simplifies disinfection between patients\u003c\/span\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 wards, clinics, and emergency settings.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"10\"\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=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/vigourmedstore.com\/products\/edan-ise-with-18-channel-configuration-10-touch-screen-with-wifi-and-bluetooth-direct-communication-with-emr-his-via-hl7-dicom-fda-xml-and-sim-card-slot?pr_prod_strat=e5_desc\u0026amp;pr_rec_id=37740e464\u0026amp;pr_rec_pid=9047596269808\u0026amp;pr_ref_pid=9047584997616\u0026amp;pr_seq=uniform\" rel=\"noreferrer\" aria-label=\"16\" 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 (V1.92)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e processes acquired ECG signals to generate \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003emeasurements, graphical presentations, and interpretive statements\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. Per the cleared labeling, these interpretive 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. EDAN’s literature also describes \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=\"12\"\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 Detection with DE18-Specific Parameters\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe iSE-1810 supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epacemaker pulse detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e through the DE18 configuration, with amplitude detection from \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e±750 μV to ±700 mV\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and pulse widths from \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e50 μs to 2.0 ms\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. This is distinct from the DE12 specification on the iSE-1210, and reflects the different sampling front-end used in the 18-lead configuration.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"14\"\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=\"13\" 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-1810 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\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e transmission\u003c\/span\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=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"15\"\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\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=\"13\" 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 \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e19 V power adapter\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e 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=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eModular Configuration and Optional Advanced Analysis\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe iSE-1810 supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoptional hardware 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 (210 mm × 12 m 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\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"19\"\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=\"13\" 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=\"\"\u003e18-lead \/ 12-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=\"\"\u003e18 leads simultaneous (DE18 sampling box); 12-lead kits also available\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; zero-button design\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 (DE18)\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eAmplitude ±750 μV to ±700 mV; width 50 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); China NMPA registration (粤械注准20202070380); CE MDR Class IIa quality system certificate covers electrocardiographs under device group Z120503 (TÜV SÜD G10 091264 0025 Rev. 01); 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-1810?\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-1810 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 right precordial and posterior wall coverage in a portable ECG\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSimultaneous 18-lead acquisition via DE18 sampling box\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed high-resolution signal capture 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 with zero-button design\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 the 18-lead front-end\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eDE18 pacemaker detection from 50 μs and ±750 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":46459739471916,"sku":null,"price":4399.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/EdaniSE-1810Electrocardiograph.png?v=1792745268","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-ise-1810-electrocardiograph","provider":"Global Healthcare Medical","version":"1.0","type":"link"}