{"product_id":"edan-se-601a-electrocardiograph-monochrome-screen","title":"EDAN SE-601A Electrocardiograph (Monochrome Screen)","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN SE-601A\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003emonochrome-display configuration within the SE-601 Series\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, a line of \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eportable, multi-channel electrocardiographs\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e designed for routine 12-lead ECG acquisition in hospitals, clinics, and primary care settings. It combines \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esimultaneous 12-lead acquisition\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3.5-inch STN monochrome LCD (192 × 64 dots)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eone-touch operation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eintegrated thermal printer\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e that produces \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e6-channel reports\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e on folded thermal paper.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-601 Series is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA-cleared under 510(k) K131503 (February 25, 2014)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and the earlier \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eK093869 (2009)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , both covering the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSE-601A, SE-601B, and SE-601C models\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The cleared intended use states the device \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eacquires ECG signals from adult and pediatric patients through body surface ECG electrodes\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eintended for use in hospitals or healthcare facilities by doctors and trained healthcare professionals\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. Critically, the cleared labeling specifies that the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003einterpreted ECG with measurements and interpretive statements is only intended for use on adult patients and is offered on an advisory basis only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The FDA summary notes \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e“No clinical data provided”\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; substantial equivalence was supported by bench testing, including software testing, risk analysis, safety testing, performance testing, and environmental testing\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"1\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K131503\" rel=\"noreferrer\" aria-label=\"18\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-601A’s 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 rate\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCMRR ≥ 140 dB\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e0.01–300 Hz frequency response\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The device acquires \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eall 12 leads simultaneously\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and prints \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e6-channel reports\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e on \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efolded thermal paper (110 mm × 140 mm)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e at \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e5–50 mm\/s paper speeds\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSEMIP software\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e provides automatic measurements and interpretation for adult patients, with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHeart Rate Variability (HRV) analysis\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003etwo-step exercise testing\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e referenced in the FDA device description\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"5\"\u003e\u003ca href=\"https:\/\/www.somatechnology.com\/pdfFiles\/Edan-SE-601-EKG-machine.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"9\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K131503\" rel=\"noreferrer\" aria-label=\"18\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eFor workflow, the SE-601A supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eone-touch operation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ealphanumeric keyboard\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for patient information entry\u003c\/span\u003e\u003cspan class=\"\"\u003e. The device stores \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eapproximately 50 ECG records internally\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with data transfer via \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eLAN, Wi-Fi (optional), or serial port\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ebuilt-in rechargeable lithium-ion battery (14.8 V, 2200 mAh)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supports nearly \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e6 hours of normal operation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eabout 2 hours of continuous printing in MANU mode\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, or approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e280 ECG reports of 3×4+1 rhythm in AUTO mode\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e5-hour charge time\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"10\"\u003e\u003ca href=\"https:\/\/www.somatechnology.com\/pdfFiles\/Edan-SE-601-EKG-machine.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"9\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/1444872\/Edan-Se-601a.html?page=123\" rel=\"noreferrer\" aria-label=\"14\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K131503\" rel=\"noreferrer\" aria-label=\"18\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-601A 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, classified under \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eRule 10\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, certified through \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eTÜV SÜD Product Service GmbH (CE 0123)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e under certificate \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eG10 091264 0025 Rev. 03\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. It is classified as \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eClass I with internal power supply, CF type with defibrillation-proof applied part\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"13\"\u003e\u003ca href=\"https:\/\/aslnapoli2nord.portaleamministrazionetrasparente.it\/moduli\/downloadFile.php?file=oggetto_allegati\/25899114621313250O__Odichiarazioni_conformita.pdf#1#13#1\" rel=\"noreferrer\" aria-label=\"20\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-601A is built for facilities that need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ea compact, FDA-cleared 12-lead acquisition ECG device with a monochrome preview display, integrated 6-channel thermal printing, and battery-backed portability\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—the most accessible configuration within the SE-601 Series, without the color or touchscreen displays of the SE-601B\/C models.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan class=\"\"\u003eKey Features \u0026amp; Benefits\u003c\/span\u003e\u003c\/h2\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e3.5-Inch Monochrome LCD for Waveform Preview\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3.5-inch STN monochrome LCD (192 × 64 dots)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e displays the ECG waveform in real time before recording, allowing the clinician to confirm signal quality and electrode contact at the point of acquisition\u003c\/span\u003e\u003cspan class=\"\"\u003e. The monochrome display is the defining feature that distinguishes the SE-601A from the color-screen SE-601B (5.7-inch, 320 × 240) and touchscreen SE-601C (5.7-inch, 640 × 480) configurations within the same Series.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSimultaneous 12-Lead Acquisition with 6-Channel Report Printing\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-601A 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, then prints \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e6-channel reports\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e on \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efolded thermal paper (110 mm × 140 mm)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e at selectable paper speeds of \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e5, 6.25, 10, 12.5, 25, or 50 mm\/s\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ebuilt-in thermal dot-matrix recorder\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is part of the main unit, so acquisition and hard-copy documentation happen in a single step. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eExternal USB printer support\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is available for 12-channel report printing on standard paper\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"16\"\u003e\u003ca href=\"https:\/\/www.somatechnology.com\/pdfFiles\/Edan-SE-601-EKG-machine.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"9\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e24-Bit Signal Chain with 16,000 Hz Sampling and 140 dB CMRR\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-601A uses a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24-bit A\/D converter\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e2.52 μV\/LSB resolution\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e16,000 Hz sampling rate\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCMRR ≥ 140 dB\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003einput impedance ≥ 100 MΩ (10 Hz)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e0.01–300 Hz frequency response\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. EDAN and its distributors position these parameters as supporting \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eweak signal detection, noise rejection, and pediatric ECG capture\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. These are \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esignal-chain specifications\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; clinical value depends on proper electrode placement and clinician review.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"19\"\u003e\u003ca href=\"https:\/\/www.somatechnology.com\/pdfFiles\/Edan-SE-601-EKG-machine.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"9\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSEMIP Interpretation for Adult Patients, Advisory Only\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-601A includes \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSEMIP software\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for automatic ECG measurements and diagnostic interpretation\u003c\/span\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eThis interpretive function is cleared for adult patients only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e under the FDA labeling and is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoffered to clinicians on an advisory basis only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—it supports, but does not replace, clinician analysis and diagnosis\u003c\/span\u003e\u003cspan class=\"\"\u003e. The FDA device description also references \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHeart Rate Variability (HRV) analysis\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003etwo-step exercise testing\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e as part of the SE-601 Series software capabilities\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"20\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K131503\" rel=\"noreferrer\" aria-label=\"18\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eOne-Touch Operation and Alphanumeric Keyboard\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-601A supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eone-touch operation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—a single action can initiate acquisition and printing—alongside an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ealphanumeric keyboard\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for patient information entry\u003c\/span\u003e\u003cspan class=\"\"\u003e. This combination is intended to reduce interaction time for staff who perform ECGs intermittently and to support efficient workflow in high-turnover clinical settings.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eApproximately 50 ECG Internal Storage with LAN\/Wi-Fi Connectivity\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-601A stores \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eapproximately 50 ECG records internally\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. Data can be transferred to a PC via \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eLAN, Wi-Fi (optional module), or serial port\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoptional SE-1515 Data Management System\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supports bidirectional worklist and report communication\u003c\/span\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eReport export\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e in PDF, SCP, FDA-XML, and DICOM formats is referenced in EDAN product literature, with PDF support noted for the SE-601B\/C configurations and optional formats available across the Series.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"24\"\u003e\u003ca href=\"https:\/\/www.somatechnology.com\/pdfFiles\/Edan-SE-601-EKG-machine.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"9\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K131503\" rel=\"noreferrer\" aria-label=\"18\" 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=\"\"\u003e14.8 V, 2200 mAh lithium-ion battery\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supports nearly \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e6 hours of normal operation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eabout 2 hours of continuous printing in MANU mode\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, or approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e280 ECG reports of 3×4+1 rhythm in AUTO mode\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e5-hour charge time\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The device can also operate on \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAC mains (100–240 V, 50\/60 Hz)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"26\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/1444872\/Edan-Se-601a.html?page=123\" rel=\"noreferrer\" aria-label=\"14\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSafety Classification: Class I, CF Type, Defibrillation-Proof\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-601A is classified as \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eClass I with internal power supply, CF type with defibrillation-proof applied part\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, designed to \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEN 60601-1, EN 60601-1-2, and EN 60601-2-25\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e standards per the EU Declaration of Conformity\u003c\/span\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCF (Cardiac Floating)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e classification indicates a high degree of patient isolation suitable for direct cardiac contact applications.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"27\"\u003e\u003ca href=\"https:\/\/aslnapoli2nord.portaleamministrazionetrasparente.it\/moduli\/downloadFile.php?file=oggetto_allegati\/25899114621313250O__Odichiarazioni_conformita.pdf#1#13#1\" rel=\"noreferrer\" aria-label=\"20\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eRegulatory Status: FDA-Cleared, CE IIa, China NMPA\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-601 Series is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA-cleared under K131503 and K093869\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for adult and pediatric ECG acquisition, with interpretive statements cleared for \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eadult patients only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The device carries \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCE marking as a Class IIa medical device under EU MDR 2017\/745 (Rule 10)\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. 03\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and is covered by \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eChina NMPA registration\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for the SE-601A\/601B\/601C models\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"28\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K131503\" rel=\"noreferrer\" aria-label=\"18\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/aslnapoli2nord.portaleamministrazionetrasparente.it\/moduli\/downloadFile.php?file=oggetto_allegati\/25899114621313250O__Odichiarazioni_conformita.pdf#1#13#1\" rel=\"noreferrer\" aria-label=\"20\" 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=\"\"\u003e6-channel resting electrocardiograph (12-lead simultaneous acquisition)\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=\"\"\u003eK131503 (February 25, 2014); K093869 (2009); Class II, 21 CFR 870.2340, Product Code DPS\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=\"\"\u003e3.5-inch STN monochrome LCD, 192 × 64 dots\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=\"\"\u003eAlphanumeric keyboard; one-touch operation\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eA\/D Converter\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e24-bit; 2.52 μV\/LSB resolution\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSampling Rate\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e16,000 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\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=\"\"\u003e0.01–300 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=\"\"\u003eTime Constant\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e≥ 3.2 s\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eGain\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e2.5, 5, 10, 20, 10\/5 mm\/mV, AGC\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=\"\"\u003eSEMIP software; \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecleared for adult patients only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; offered on an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eadvisory basis only\u003c\/span\u003e\u003c\/strong\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eReferenced Analysis\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eHeart Rate Variability (HRV); two-step exercise testing\u003c\/span\u003e\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 50 ECG records\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=\"\"\u003eBuilt-in thermal dot-matrix; 110 mm × 140 mm folded paper; 6-channel report printing; 5–50 mm\/s\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eExternal Printer\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eUSB printer support for 12-channel reports on standard paper (optional)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eData Transfer\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eLAN; Wi-Fi (optional); serial port\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=\"\"\u003e14.8 V, 2200 mAh Li-ion; ~6 h normal operation; ~2 h continuous printing (MANU); ~280 reports (AUTO 3×4+1 rhythm); 5 h charge\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePower\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eAC 100–240 V, 50\/60 Hz\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDimensions \/ Weight\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e310 × 322 × 101 mm; approximately 2.6 kg (excluding paper and 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\u003cspan class=\"\"\u003eClass I, internal power supply, CF type, defibrillation-proof\u003c\/span\u003e\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=\"\"\u003eEN 60601-1:2006+A2:2021; EN 60601-1-2:2015+A1:2021; EN 60601-2-25:2015\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\u003cspan class=\"\"\u003eClass IIa, Rule 10, EU MDR 2017\/745; TÜV SÜD CE 0123 (Certificate G10 091264 0025 Rev. 03)\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\n\u003cspan class=\"\"\u003eAdult and pediatric patients for ECG acquisition; \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003einterpretive statements and measurements for adult patients only\u003c\/span\u003e\u003c\/strong\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=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efor adult patients only\u003c\/span\u003e\u003c\/strong\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-601A?\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-601A 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-lead acquisition ECG at an accessible configuration\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSE-601A covered under K131503 and K093869; monochrome display reduces cost while retaining 12-lead acquisition and 6-channel printing\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 compact 6-channel output\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e12-lead simultaneous acquisition; 6-channel reports on 110 mm × 140 mm folded paper\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 routine and pediatric ECG\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e24-bit A\/D; 16,000 Hz sampling; CMRR ≥ 140 dB; 0.01–300 Hz; input impedance ≥ 100 MΩ\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed fast, keyboard-driven workflow\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eOne-touch operation; alphanumeric keyboard for patient information entry\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed on-screen interpretation support with clear labeling\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eSEMIP software; \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eadult patients only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; \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\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed internal storage and network connectivity\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e~50 ECG records; LAN, Wi-Fi (optional), serial port; optional SE-1515 data management\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed portable use with battery backup\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e14.8 V, 2200 mAh battery; ~6 h normal operation; 2.6 kg (excluding paper and battery); AC\/DC power\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed a device designed for direct cardiac contact applications\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eCF type, defibrillation-proof classification\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed FDA, CE MDR, and China NMPA regulatory coverage\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eFDA K131503\/K093869; CE IIa (TÜV SÜD CE 0123); China NMPA registration\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":46504180318252,"sku":null,"price":1799.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/EDANSE-601AElectrocardiograph_MonochromeScreen.png?v=1792999065","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-se-601a-electrocardiograph-monochrome-screen","provider":"Global Healthcare Medical","version":"1.0","type":"link"}