{"product_id":"edan-sa-20-holter-ecg-and-abp-2-in-1-system","title":"EDAN SA-20 Holter ECG and ABP 2-in-1 System","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN SA-20\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e2-in-1 ambulatory recorder\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e that combines \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHolter ECG\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eambulatory blood pressure monitoring (ABPM)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e in a single device—a configuration that allows clinicians to review \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003earrhythmia events and blood pressure trends in parallel\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, rather than correlating data from two separate recorders after the fact.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SA-20 received \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA 510(k) clearance under K230184 (September 25, 2023)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , classified as \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eClass II, Product Code DSH, 21 CFR 870.2800\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (Medical Magnetic Tape Recorder)\u003c\/span\u003e\u003cspan class=\"\"\u003e. The cleared intended use states the device \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eacquires, stores, and displays ambulatory ECG signals from adult and pediatric patients\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecapable of measuring systolic and diastolic blood pressures of adults and pediatrics (\u0026gt;12 years) over a preprogrammed period of time\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. It is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eintended to be used by trained personnel under the direction of doctors\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"1\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K230184\" 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 recorder is built around \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3\/12-lead digital ECG recording with pacemaker detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eblood pressure measurement range of 10–290 mmHg\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eovertime and overpressure protection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eup to 48 hours of recording on two AA batteries\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—all in an enclosure weighing approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e200 g\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e with an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIP22 rating\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e when used with the carrying pouch\u003c\/span\u003e\u003cspan class=\"\"\u003e. ECG sampling is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e25.6 ksps with 24-bit A\/D conversion\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and the device stores ECG waveforms and BP measurements on an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003einternal SD card\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"5\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K230184\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.cardiodepot.it\/516-596-holter-pressori-ed-ecg-edan-sa-20-2-in-1.html#\/758-modele-con_software_versatile_abp_4_bracciali_1_cavo_per_ecg_holter\" rel=\"noreferrer\" aria-label=\"8\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e2-in-1 analysis software\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eECG review (QRS template classification, Lorenz plots, automatic ST evaluation, automatic AFib segment detection)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e alongside \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBP analysis (AASI, day\/night BP profile, morning surge and BP variability, pie and histogram charts)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecombined Holter ECG and BP view\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e that places cardiac events and blood pressure trends on the same timeline\u003c\/span\u003e\u003cspan class=\"\"\u003e. The SA-20 can also be used as an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eindependent Holter ECG or ABPM recorder\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e depending on clinical need\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"8\"\u003e\u003ca href=\"https:\/\/mobile.hospimedica.com\/expo\/product\/19768\/2-in-1-holter-abpm-analysis-system-model-sa-20\" rel=\"noreferrer\" aria-label=\"9\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SA-20 is built for clinicians who need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecardiac rhythm and blood pressure data from the same wear period, reviewed in a single software environment\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—without coordinating two devices, two wear schedules, and two data exports.\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=\"\"\u003eTrue 2-in-1 Recording: ECG and Blood Pressure in One Device\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SA-20 records \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eambulatory ECG and non-invasive blood pressure simultaneously\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e or independently, depending on the clinical question. The FDA-cleared device description notes that the SA-20 Series \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecombines ambulatory ECG Holter and BP monitor\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, acquiring ECG via \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esurface electrodes\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and blood pressure via the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoscillometric method\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. This allows a single wear period to generate both datasets, rather than requiring the patient to wear separate Holter and ABPM devices on different days.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"10\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K230184\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eFDA-Cleared Intended Use with Explicit Patient Boundaries\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eK230184\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e clearance defines the SA-20’s use for \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eadult and pediatric patients requiring ambulatory ECG and\/or non-invasive blood pressure monitoring\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBP measurement cleared for patients over 12 years of age\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The clearance also specifies \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003econtraindications\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e: \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epatients with erratic, accelerated, or mechanically controlled irregular heart rhythms; unsupervised children or patients with limited cognitive abilities (strangulation risk); and intensive care or surgical settings\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eABP is not for pregnant or pre-eclamptic patients\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. These boundaries are presented here exactly as cleared, so buyers can confirm clinical suitability before purchase.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"11\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K230184\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e3\/12-Lead ECG with Pacemaker Detection\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SA-20 supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3-lead and 12-lead digital ECG recording\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epacemaker detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e included\u003c\/span\u003e\u003cspan class=\"\"\u003e. ECG is sampled at \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e25.6 ksps with 24-bit A\/D conversion\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and the device records and stores ECG waveforms on an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003einternal SD card\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The recorder ships with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e7-electrode HolterABP ECG cable\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e as standard, with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e10-electrode and 5-electrode cables\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e available separately for different lead configurations.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"13\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K230184\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.cardiodepot.it\/516-596-holter-pressori-ed-ecg-edan-sa-20-2-in-1.html#\/758-modele-con_software_versatile_abp_4_bracciali_1_cavo_per_ecg_holter\" rel=\"noreferrer\" aria-label=\"8\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eUp to 48 Hours of Recording on Two AA Batteries\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SA-20 records for \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eup to 48 hours\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e on \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003etwo AA alkaline batteries\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, supporting extended ambulatory monitoring without recharging or battery swaps mid-study\u003c\/span\u003e\u003cspan class=\"\"\u003e. At approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e200 g\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, the recorder is designed for patient comfort during multi-day wear, with rounded edges and an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIP22 rating when used with the carrying pouch\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e10–290 mmHg BP Range with Overtime and Overpressure Protection\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SA-20’s blood pressure measurement range extends from \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e10 mmHg to 290 mmHg\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eovertime and overpressure protection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e intended to support patient safety during extended monitoring sessions\u003c\/span\u003e\u003cspan class=\"\"\u003e. Systolic measurement is specified as \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e25–290 mmHg\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and diastolic as \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e10–250 mmHg\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e1 mmHg resolution\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e2-in-1 Software: ECG Events and BP Trends on One Timeline\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe analysis software places \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eECG arrhythmia events and ST segment changes alongside blood pressure trends\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e in a combined view, reducing the need for time-matching or screen switching between separate ECG and BP reports\u003c\/span\u003e\u003cspan class=\"\"\u003e. ECG analysis tools include \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eQRS template classification, Lorenz plots, automatic ST evaluation and reanalysis, automatic AFib segment detection, and atrial tachycardia identification via the SVE function\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; BP analysis tools include \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAASI (Ambulatory Arterial Stiffness Index), day\/night BP profile, morning surge and BP variability analysis, BP histograms and pie charts, and a data table\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e that supports linked review of ECG waveforms at specific BP measurement times\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"21\"\u003e\u003ca href=\"https:\/\/mobile.hospimedica.com\/expo\/product\/19768\/2-in-1-holter-abpm-analysis-system-model-sa-20\" rel=\"noreferrer\" aria-label=\"9\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eFlexible Configuration and Upgrade Path\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SA-20 can be configured with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoptional Vector ECG, Ventricular Late Potentials, T-wave Alternans, and Waterfall Plot\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e analysis functions. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eOptional 10-electrode and 5-electrode ECG cables\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003emultiple cuff sizes (XS, S, M, L)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e allow the recorder to adapt to different lead protocols and patient arm circumferences. A \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHolter ABP 2-in-1 Analysis Software Kit\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is available as a separate line item, with an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA-specific kit\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e shipped separately to meet regulatory requirements.\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=\"\"\u003e2-in-1 Holter ECG and ambulatory blood pressure (ABP) recorder with analysis software\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\n\u003cspan class=\"\"\u003eK230184 (September 25, 2023); Class II, Product Code DSH, 21 CFR 870.2800\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"22\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K230184\" 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=\"\"\u003eAcquire, store, display ambulatory ECG from adult and pediatric patients; measure systolic\/diastolic BP in adults and pediatrics (\u0026gt;12 years) over a preprogrammed period; use by trained personnel under physician direction\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"23\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K230184\" 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=\"\"\u003eContraindications (FDA)\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eErratic\/accelerated\/mechanically controlled arrhythmias; unsupervised children or patients with limited cognitive abilities (strangulation risk); intensive care or surgical settings; ABP not for pregnant or pre-eclamptic patients\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"24\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K230184\" 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=\"\"\u003eECG Channels\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e3-lead and 12-lead digital recording; pacemaker detection\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"25\"\u003e\u003ca href=\"https:\/\/www.cardiodepot.it\/516-596-holter-pressori-ed-ecg-edan-sa-20-2-in-1.html#\/758-modele-con_software_versatile_abp_4_bracciali_1_cavo_per_ecg_holter\" rel=\"noreferrer\" aria-label=\"8\" 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=\"\"\u003eECG Sampling\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e25.6 ksps; 24-bit A\/D conversion\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"26\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K230184\" 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=\"\"\u003eECG Frequency Response\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e0.05–60 Hz (per distributor specification)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBlood Pressure Method\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eOscillometric\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"28\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K230184\" 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=\"\"\u003eBP Measurement Range\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e10–290 mmHg overall; Systolic 25–290 mmHg; Diastolic 10–250 mmHg; 1 mmHg resolution\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eRecording Duration\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eUp to 48 hours on two AA alkaline batteries\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\n\u003cspan class=\"\"\u003eInternal SD card; USB interface\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"31\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K230184\" 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=\"\"\u003eDisplay\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eColor screen with real-time waveform and NIBP display\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=\"\"\u003eApproximately 200 g\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIngress Protection\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eIP22 (with carrying pouch)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eStandard ECG Cable\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e7-electrode HolterABP cable, IEC, snap, reusable\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eOptional ECG Cables\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e10-electrode; 5-electrode (IEC or AHA)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCuff Sizes\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eXS 16–21.5 cm; S 20.5–28 cm; M 27–35 cm (standard); L 34–43 cm\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eECG Analysis (Software)\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eQRS template classification; Lorenz plots; automatic ST evaluation and reanalysis; automatic AFib segment detection; SVE function for atrial tachycardia; batch re-tag and dynamic learning\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBP Analysis (Software)\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eAASI; day\/night BP profile; morning surge and BP variability; BP histogram and pie chart; data table with linked ECG review; posture detection (not available in FDA area)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"36\"\u003e\u003ca href=\"https:\/\/www.cardiodepot.it\/516-596-holter-pressori-ed-ecg-edan-sa-20-2-in-1.html#\/758-modele-con_software_versatile_abp_4_bracciali_1_cavo_per_ecg_holter\" rel=\"noreferrer\" aria-label=\"8\" 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=\"\"\u003eOptional Upgrades\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eVector ECG; Ventricular Late Potentials; T-wave Alternans; Waterfall Plot\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=\"\"\u003e2 × 1.5 V AA alkaline batteries\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 SA-20?\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=\"\"\u003eSA-20 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 ECG and blood pressure data from the same wear period\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e2-in-1 recorder captures both simultaneously or independently in one device\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed a single review environment for cardiac events and BP trends\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e2-in-1 software places ECG arrhythmia\/ST events alongside BP trends on one timeline\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed extended ambulatory recording without battery changes\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eUp to 48 hours on two AA batteries\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed pacemaker detection in a compact Holter recorder\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e3\/12-lead ECG with pacemaker detection\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed a wide BP range for diverse adult presentations\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e10–290 mmHg measurement range with overtime and overpressure protection\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed flexible lead and cuff configurations\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e7\/10\/5-electrode cable options; XS through L cuff sizes\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed clear regulatory boundaries before purchase\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eFDA K230184 clearance with explicit contraindications listed above\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":46460297740332,"sku":null,"price":4699.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/EDANSA-20HolterECGandABP2-in-1System.png?v=1792750238","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-sa-20-holter-ecg-and-abp-2-in-1-system","provider":"Global Healthcare Medical","version":"1.0","type":"link"}