{"product_id":"edan-sa-10-ambulatory-blood-pressure-monitor-with-analysis-software","title":"EDAN SA-10 Ambulatory Blood Pressure Monitor with Analysis Software","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN SA-10\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24-hour ambulatory blood pressure monitor (ABPM)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e designed to record systolic and diastolic blood pressure and pulse over a programmed monitoring period, then transfer the stored measurements to a PC for clinician review and analysis. It is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA-cleared under 510(k) K210139 (October 1, 2021)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e as part of the SA-series ambulatory blood pressure monitor family, classified as \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eClass II, Product Code DXN (21 CFR 870.1130)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"1\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K210139\" rel=\"noreferrer\" aria-label=\"3\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe cleared intended use states the device is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecapable of measuring systolic and diastolic blood pressures and pulse of adults and pediatrics (\u0026gt;12 years) over a preprogrammed period of time\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with measurements stored in the monitor and transferable to an analysis system via \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ewired or wireless transmission\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. It is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eintended for use as an aid or adjunct to diagnosis and treatment\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"2\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K210139\" rel=\"noreferrer\" aria-label=\"3\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SA-10 was clinically validated in a peer-reviewed study published in \u003c\/span\u003e\u003cem\u003e\u003cspan class=\"\"\u003eBlood Pressure Monitoring\u003c\/span\u003e\u003c\/em\u003e\u003cspan class=\"\"\u003e (2022). The study, conducted according to the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAAMI\/ESH\/ISO Universal Standard (ISO 81060-2:2018)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , concluded that the SA-10 \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epassed all requirements of the Universal Standard in the general population and can be recommended for clinical use\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. For validation criterion 1, the mean ± SD of the differences between the test device and reference readings was \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e−0.59 ± 4.04 mmHg (systolic) \/ −1.79 ± 4.39 mmHg (diastolic)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"3\"\u003e\u003ca href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/35438083\/#1\" 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 SA-10 weighs approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e160–170 g (without batteries)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , measures \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e106 × 62 × 27 mm\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and is powered by \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003etwo AA alkaline batteries\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. It stores up to \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e300 blood pressure measurements\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and carries an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIP22 rating\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for dust and water protection \u003c\/span\u003e\u003cspan class=\"\"\u003e. The included \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eanalysis software\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e provides day\/night BP profiles, circadian analysis, statistical summaries, and pie chart analysis for reviewing the recorded data.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SA-10 is built for clinicians who need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ea compact, validated ABPM recorder with analysis software\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for evaluating blood pressure outside the clinic setting, where office measurements alone may not reflect a patient’s typical daily pattern.\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=\"\"\u003eFDA-Cleared and Clinically Validated to AAMI\/ESH\/ISO Standard\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SA-10 carries \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA 510(k) clearance under K210139\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for the SA-series ambulatory blood pressure monitor models \u003c\/span\u003e\u003cspan class=\"\"\u003e. It has also been evaluated in an independent clinical validation study published in \u003c\/span\u003e\u003cem\u003e\u003cspan class=\"\"\u003eBlood Pressure Monitoring\u003c\/span\u003e\u003c\/em\u003e\u003cspan class=\"\"\u003e (2022), which assessed the device according to the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAAMI\/ESH\/ISO Universal Standard (ISO 81060-2:2018)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e . The study included \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e105 recruited subjects (97 in final analysis)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and reported mean differences of \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e−0.59 ± 4.04 \/ −1.79 ± 4.39 mmHg (systolic\/diastolic)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , with criterion 2 SD values of \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3.10\/3.80 mmHg\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The authors concluded the SA-10 \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epassed all requirements of the Universal Standard and can be recommended for clinical use\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\/K210139\" rel=\"noreferrer\" aria-label=\"3\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/35438083\/#1\" rel=\"noreferrer\" aria-label=\"8\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e24-Hour Recording with 300-Measurement Memory\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SA-10 is designed to record blood pressure and pulse over a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epreprogrammed monitoring period\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, storing up to \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e300 measurements\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e in onboard memory \u003c\/span\u003e\u003cspan class=\"\"\u003e. This capacity supports typical 24-hour ABPM protocols with programmed intervals, allowing the clinician to review a full day’s blood pressure profile after the wear period.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eOscillometric Measurement with Motion Resistance\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SA-10 uses the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoscillometric method with step deflation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for non-invasive blood pressure measurement \u003c\/span\u003e\u003cspan class=\"\"\u003e. EDAN’s proprietary algorithm is described as offering \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eexcellent motion resistance performance\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eauto re-measurement on failed measurement attempts\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003edata protection from power outage\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—features intended to support data continuity during ambulatory wear \u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"8\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K210139\" rel=\"noreferrer\" aria-label=\"3\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eWide Measurement Range\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SA-10 has a blood pressure measurement range of \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e10 mmHg to 290 mmHg\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, supporting use across a broad range of adult and pediatric (\u0026gt;12 years) presentations \u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eCompact and Lightweight for Daily Wear\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eAt approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e160–170 g without batteries\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e106 × 62 × 27 mm\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, the SA-10 is designed for patient comfort during a full day of wear \u003c\/span\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIP22 rating\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e provides protection against dust and water, supporting routine use in home and clinical settings.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eAnalysis Software for Comprehensive Review\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe included \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eanalysis software\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (referred to as \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSmart ABPM View\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e in FDA documentation) supports clinician review of recorded data. Features described in EDAN literature and product documentation include \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eday\/night BP profiles\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecircadian analysis\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003estatistical summaries\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epie chart analysis\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—tools intended to help identify periods when blood pressure values are above configured limits and to summarize measurement trends throughout the day \u003c\/span\u003e\u003cspan class=\"\"\u003e. The software allows clinicians to edit, display, and analyze the recorded data, and the ABPM function is described as providing \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003elongitudinal blood pressure data\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e to assist physicians in managing hypertension or other cardiovascular conditions \u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"12\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K210139\" rel=\"noreferrer\" aria-label=\"3\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eWired and Wireless Data Transfer\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eStored measurements can be transferred to the analysis system via \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eUSB or Bluetooth\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"\"\u003e. An \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoptional Bluetooth module\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is available for configurations requiring wireless transfer.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"14\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K210139\" rel=\"noreferrer\" aria-label=\"3\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eFlexible Cuff Options\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SA-10 supports reusable adult cuffs in multiple sizes: \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eXS (16–21.5 cm)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eS (20.5–28 cm)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eM (27–35 cm)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eL (34–43 cm)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e . The size M cuff is included as standard, with other sizes available separately. Four cuff sizes were used in the clinical validation study, covering arm circumferences from 16 cm to 43 cm \u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"15\"\u003e\u003ca href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/35438083\/#1\" rel=\"noreferrer\" aria-label=\"8\" 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=\"\"\u003eAmbulatory blood pressure monitor (ABPM) 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=\"\"\u003eK210139 (October 1, 2021); Class II, Product Code DXN, 21 CFR 870.1130 \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"16\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K210139\" rel=\"noreferrer\" aria-label=\"3\" 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=\"\"\u003eMeasurement Method\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eOscillometric, step deflation \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"17\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K210139\" rel=\"noreferrer\" aria-label=\"3\" 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=\"\"\u003eMeasurement Range\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e10–290 mmHg\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eMemory Capacity\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eUp to 300 measurements\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\n\u003cspan class=\"\"\u003eUSB; Bluetooth (optional module) \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"20\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K210139\" rel=\"noreferrer\" aria-label=\"3\" 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=\"\"\u003eOLED screen (0.96-inch per distributor documentation)\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 × AA alkaline batteries\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\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 160–170 g (without batteries)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDimensions\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eApproximately 106 × 62 × 27 mm\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=\"\"\u003eSoftware Features\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eDay\/night BP profile; circadian analysis; statistical summary; pie chart analysis; data edit\/display\/analyze \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"24\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K210139\" rel=\"noreferrer\" aria-label=\"3\" 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=\"\"\u003eClinical Validation\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003ePassed AAMI\/ESH\/ISO Universal Standard (ISO 81060-2:2018); mean difference −0.59 ± 4.04 \/ −1.79 ± 4.39 mmHg (systolic\/diastolic) \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"25\"\u003e\u003ca href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/35438083\/#1\" 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=\"\"\u003eIntended Patient Population\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eAdults and pediatric patients (\u0026gt;12 years) \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"26\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K210139\" rel=\"noreferrer\" aria-label=\"3\" 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=\"\"\u003eMeasurement of systolic\/diastolic blood pressure and pulse over a preprogrammed period; stored measurements transferable to analysis system; intended as an aid or adjunct to diagnosis and treatment \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"27\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K210139\" rel=\"noreferrer\" aria-label=\"3\" 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 SA-10?\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-10 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 an ABPM with independent clinical validation\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003ePassed AAMI\/ESH\/ISO Universal Standard (ISO 81060-2:2018) in a peer-reviewed study \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"28\"\u003e\u003ca href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/35438083\/#1\" 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=\"\"\u003eNeed FDA-cleared ABPM for clinical use\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eFDA 510(k) K210139 cleared for SA-series ABPM \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"29\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K210139\" rel=\"noreferrer\" aria-label=\"3\" 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=\"\"\u003eNeed 24-hour recording with adequate memory\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eUp to 300 measurements stored onboard\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePatients need a comfortable device for daily wear\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eApproximately 160–170 g; compact 106 × 62 × 27 mm enclosure\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed analysis tools for day\/night and circadian patterns\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eIncluded software with day\/night BP profile, circadian analysis, statistics, and pie charts \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"32\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K210139\" rel=\"noreferrer\" aria-label=\"3\" 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=\"\"\u003eNeed flexible data transfer options\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eUSB standard; optional Bluetooth module\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed cuff size flexibility\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eXS, S, M, and L reusable adult cuffs; four sizes used in validation study \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"33\"\u003e\u003ca href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/35438083\/#1\" 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=\"\"\u003eNeed a device for adults and pediatric patients over 12\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eCleared intended use covers adults and pediatrics (\u0026gt;12 years)\u003cspan\u003e \u003c\/span\u003e\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":46459821129772,"sku":null,"price":1999.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/EDANSA-10AmbulatoryBloodPressureMonitorwithAnalysisSoftware.png?v=1792748054","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-sa-10-ambulatory-blood-pressure-monitor-with-analysis-software","provider":"Global Healthcare Medical","version":"1.0","type":"link"}