{"product_id":"edan-se-12-12-channel-electrocardiograph","title":"EDAN SE-12 12-Channel Electrocardiograph","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN SE-12\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e12-channel resting electrocardiograph\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e designed for routine clinical ECG acquisition in hospitals, clinics, and diagnostic centers. It pairs a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efoldable 5.7-inch LCD screen\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efull alphanumeric keyboard\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, giving clinicians a compact, keyboard-driven workflow for patient information entry and simultaneous 12-lead acquisition\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-12 series is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA-cleared under 510(k) K171942 (January 24, 2018)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eK102830 (December 2, 2010)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSE-12 explicitly listed among the covered models\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e in both clearances\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 (beginning at birth through 21 years of age) 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. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003einterpreted 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 device is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eintended to aid clinical decision-making, not replace professional judgment\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The FDA summary for K171942 states \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e“No clinical data”\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; evidence consisted of bench testing per \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIEC 60601-2-25:2011\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, biocompatibility per \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eISO 10993-1\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, electrical safety\/EMC per \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIEC 60601-1 \/ IEC 60601-1-2\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and software verification\/validation\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"2\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K171942\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K102830#tutorial\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe signal chain includes a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24-bit A\/D converter\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e16,000 Hz sampling frequency\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCMRR \u0026gt; 140 dB\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecomprehensive digital filters\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e to support signal clarity in routine clinical environments\u003c\/span\u003e\u003cspan class=\"\"\u003e. The SE-12 includes \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e120-second real-time waveform freezing and review\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epacemaker signal detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eautomatic measurements and interpretation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e with the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eGlasgow ECG interpretation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e algorithm referenced in EDAN product literature. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSE-12 Express\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e variant adds \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoptional stress ECG functionality\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for exercise testing with compatible treadmills, bicycles, and blood pressure monitors; the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSE-12 (standard model) does not include stress testing\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and is positioned for \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eroutine resting ECG\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"7\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K171942\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K102830#tutorial\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-12 stores \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eapproximately 200–800 ECG records internally\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (source-dependent), with data transfer via \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eRS-232, Ethernet, or USB\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and report export in \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePDF, SCP, FDA-XML, and DICOM\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e formats where configured\u003c\/span\u003e\u003cspan class=\"\"\u003e. The device is powered by \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAC mains (100–240 V, 50\/60 Hz)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e or a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e2,500 mAh lithium-ion battery\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The SE-12 is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eClass I with internal battery, Type CF applied part\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and carries \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCE marking as a Class IIa medical device under EU MDR 2017\/745\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, certified through \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eTÜV SÜD (CE 0123)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e under certificate \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eG10 091264 0025 Rev. 01\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"10\"\u003e\u003ca href=\"https:\/\/platformazakupowa.pl\/file\/get_new\/1725279900phpk0gTkS66d5ae9c02a4a.pdf#7#9#7\" rel=\"noreferrer\" aria-label=\"12\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K102830\" rel=\"noreferrer\" aria-label=\"34\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-12 is built for facilities that need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ea reliable, FDA-cleared 12-channel ECG platform for routine resting ECG workflows\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with a compact foldable display, keyboard input, integrated thermal printing, and network-ready data management through the optional \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSE-1515 Data Management System\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan class=\"\"\u003eKey Features \u0026amp; Benefits\u003c\/span\u003e\u003c\/h2\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e5.7-Inch Foldable LCD with Full Keyboard\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e5.7-inch foldable LCD screen\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e displays all 12 waveforms and folds down for transport or storage, reducing the device footprint between uses\u003c\/span\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efull alphanumeric keyboard\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supports efficient patient information entry and direct workflow commands, which can be faster than touch-only operation during high-throughput ECG sessions.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSimultaneous 12-Lead Acquisition with 24-Bit Signal Chain\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-12 acquires \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eall 12 leads simultaneously\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e through body surface electrodes. The signal chain includes a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24-bit A\/D converter\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e16,000 Hz sampling frequency\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCMRR \u0026gt; 140 dB\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, parameters oriented toward capturing low-amplitude cardiac signals with high fidelity in routine clinical settings\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"16\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K171942\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eGlasgow Interpretation with Advisory Labeling\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-12 includes \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eautomatic ECG measurements and interpretation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eGlasgow ECG interpretation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e algorithm referenced in EDAN product literature. Per the cleared labeling under \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eK171942 \/ K102830\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003einterpreted 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 the device \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eis intended to aid clinical decision-making, not replace professional judgment\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"17\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K171942\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e120-Second Waveform Freezing and Review\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe device supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e120 seconds of real-time waveform freezing and review\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, allowing the clinician to pause and examine a captured segment before printing or storing. This is useful for confirming arrhythmia episodes, reviewing pacemaker activity, or checking signal quality before committing to a report.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eBuilt-In Thermal Recorder\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-12 includes an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eintegrated thermal dot-matrix recorder\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for 12-channel reports on \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e210 mm or 215 mm Z-fold or roll paper\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The printer is part of the main unit, so acquisition and hard-copy documentation happen in a single step\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"19\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K102830#tutorial\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eInternal Storage and Multi-Format Export\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-12 stores \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eECG records internally\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (approximately 200–800 records, source-dependent), with data transmission to a PC via \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eRS-232, Ethernet, or USB\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. Reports can be exported in \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePDF, SCP, FDA-XML, and DICOM\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e formats where the corresponding software options are configured. Integration with the optional \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSE-1515 Data Management System\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supports bidirectional worklist and report communication, HIS\/EMR\/PACS connectivity via \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHL7\/DICOM\/GDT\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and centralized ECG review across multiple devices.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"20\"\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K102830\" rel=\"noreferrer\" aria-label=\"34\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eRechargeable Li-Ion Battery with AC\/DC Power\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e2,500 mAh lithium-ion battery\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supports operation away from mains power, with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAC mains (100–240 V, 50\/60 Hz)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e operation when available. This supports mobile use across examination rooms and wards without requiring a dedicated power outlet at every location.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSE-12 vs SE-12 Express: Clear Differentiation\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSE-12 (standard model)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is designed for \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eroutine resting ECG\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSE-12 Express\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e adds \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoptional stress ECG functionality\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for exercise testing with compatible treadmills, bicycles, and blood pressure monitors\u003c\/span\u003e\u003cspan class=\"\"\u003e. This configuration distinction allows facilities to select the model that matches their clinical scope—resting ECG only, or resting plus exercise testing—without paying for stress capability they do not need.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSafety Classification: Class I, Type CF, CE IIa\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-12 is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eClass I with internal battery\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eType CF applied part\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, designed to \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIEC 60601-1, IEC 60601-1-2, and IEC 60601-2-25\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e standards\u003c\/span\u003e\u003cspan class=\"\"\u003e. It carries \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCE marking as a Class IIa medical device under EU MDR 2017\/745\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, certified through \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eTÜV SÜD (CE 0123)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e under certificate \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eG10 091264 0025 Rev. 01\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"22\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K171942\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/platformazakupowa.pl\/file\/get_new\/1725279900phpk0gTkS66d5ae9c02a4a.pdf#7#9#7\" rel=\"noreferrer\" aria-label=\"12\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan class=\"\"\u003eTechnical Specifications\u003c\/span\u003e\u003c\/h2\u003e\n\u003cdiv class=\"ds-scroll-area ds-scroll-area--show-on-focus-within ds-scroll-area--enabled _1210dd7 c03cafe9\"\u003e\n\u003cdiv class=\"ds-scroll-area__gutters\"\u003e\n\u003cdiv class=\"ds-scroll-area__horizontal-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"ds-scroll-area__vertical-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ctable\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eSpecification\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eDetail\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDevice Type\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e12-channel resting electrocardiograph\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA Clearance\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eK171942 (January 24, 2018); K102830 (December 2, 2010)\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 via body surface electrodes\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=\"\"\u003e5.7-inch foldable LCD, 320 × 240 resolution (SE-12 standard model)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eInput\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eFull alphanumeric keyboard\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eA\/D Resolution\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:\/\/fda.innolitics.com\/device\/K171942\" rel=\"noreferrer\" aria-label=\"1\" 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 Rate\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e16,000 Hz\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"26\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K171942\" rel=\"noreferrer\" aria-label=\"1\" 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=\"\"\u003eCMRR\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e\u0026gt; 140 dB\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePacemaker Detection\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSupported\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eWaveform Review\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e120-second real-time freezing and review\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eInterpretation\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eAutomatic measurements and interpretation; Glasgow ECG interpretation referenced; \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eadvisory basis only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e per cleared labeling\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"28\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K171942\" rel=\"noreferrer\" aria-label=\"1\" 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=\"\"\u003eInternal Storage\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eApproximately 200–800 ECG records (source-dependent)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eRecorder\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eIntegrated thermal dot-matrix; 210 mm \/ 215 mm Z-fold or roll paper\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eData Transfer \/ Export\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eRS-232, Ethernet, USB; PDF, SCP, FDA-XML, DICOM where configured\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"29\"\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K102830\" rel=\"noreferrer\" aria-label=\"34\" 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=\"\"\u003eStress ECG\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cstrong\u003e\u003cspan class=\"\"\u003eNot available on SE-12 standard model\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (available on SE-12 Express)\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=\"\"\u003eAC 100–240 V, 50\/60 Hz; 2,500 mAh lithium-ion battery\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSafety Classification\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eClass I, internal battery, Type CF applied part\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"31\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K171942\" rel=\"noreferrer\" aria-label=\"1\" 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=\"\"\u003eSafety Standards\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eIEC 60601-1; IEC 60601-1-2; IEC 60601-2-25:2011\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCE Marking\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eClass IIa, EU MDR 2017\/745, TÜV SÜD CE 0123 (Certificate G10 091264 0025 Rev. 01)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"32\"\u003e\u003ca href=\"https:\/\/platformazakupowa.pl\/file\/get_new\/1725279900phpk0gTkS66d5ae9c02a4a.pdf#7#9#7\" rel=\"noreferrer\" aria-label=\"12\" 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\n\u003cspan class=\"\"\u003eAdult and pediatric patients (beginning at birth through 21 years of age)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"34\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K171942\" rel=\"noreferrer\" aria-label=\"1\" 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 Use\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\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 healthcare professionals; interpreted ECG with measurements and interpretive statements offered on an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eadvisory basis only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"35\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K171942\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\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-12?\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-12 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 FDA-cleared 12-channel ECG for routine resting workflows\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSE-12 explicitly listed in K171942 and K102830; cleared for adult and pediatric patients\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed simultaneous 12-lead acquisition with a compact, foldable display\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e12-lead simultaneous acquisition; 5.7-inch foldable LCD\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed efficient patient information entry without relying on touch menus\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eFull alphanumeric keyboard for direct input\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 low-amplitude cardiac signals\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e24-bit A\/D, 16,000 Hz sampling, CMRR \u0026gt; 140 dB\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed to review captured waveforms before committing to a report\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e120-second real-time waveform freezing and review\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed integrated thermal printing at the point of care\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eBuilt-in thermal dot-matrix recorder; 210 mm \/ 215 mm paper options\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed HIS\/EMR\/PACS integration and centralized ECG management\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eRS-232\/Ethernet\/USB; PDF\/SCP\/FDA-XML\/DICOM export; optional SE-1515 for HL7\/DICOM\/GDT connectivity\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed to choose between resting-only and stress-capable configurations\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSE-12 for routine resting ECG; SE-12 Express adds optional stress ECG\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed a device with CE MDR Class IIa certification for European markets\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eCE marked under EU MDR 2017\/745, TÜV SÜD CE 0123\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":46503648395308,"sku":null,"price":2699.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/EDANSE-1212-ChannelElectrocardiograph.png?v=1792992282","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-se-12-12-channel-electrocardiograph","provider":"Global Healthcare Medical","version":"1.0","type":"link"}