The StatStrip Glucose/Ketone Hospital Meter System provides bidirectional wireless connectivity to hospital HIS or LIS with full security to safeguard patient data. &QfRJuFZ`?JOfST,gWyW(,hUS%|b7ZV{PKsvu[- =FVo*r`wVuhB`|B\kwD9\F2hBO[?v#9)FPRE$4B uzR? 8p Protocol: TCP/IP Ethernet 100M/1GBPS (2007). The test strip must fill completely upon touching the blood droplet. A comment must be entered for critical results. Strips: Cases of 36 vials (1,800 strips); vials packaged 50 strips/vial 556 556 556 556 556 556 556 556 556 556 333 333 584 584 584 611 These cookies do not store any personal information. Bookshelf Blood beta-hydroxyburyrate testing indicates the patients status at the time of the test, whereas urine may have been in the bladder for several hours. The reportable range for the Nova Statstrip is 10 mg/dL-600 mg/dL b. Blood ketone is more accurate than urine ketone testing Extra battery slot included for recharging and storage of spare battery. 667 778 722 667 611 722 667 944 667 667 611 333 278 333 584 556 Test Time: 10 Seconds Heelstick or fingerstick. 333 556 611 556 611 556 333 611 611 278 278 556 278 889 611 611 The devices of the StatStrip series were specially designed for the point-of-care. Urine testing can also produce false positive or negative results due to highly colored urine, highly acidic urine, exposure of the urine test strips to air for prolonged periods, drugs such as the ACE inhibitor captopril, or high doses Features: Replaceable If a person with diabetes has a meter, test strips and is testing, it's important to know what the blood glucose . QC: Three levels (Low, Normal, High); sold separately We use cookies to enhance your experience. Glucose Results in 6 Seconds, Ketone Results in 10 Seconds, Traditional QC with target values assigned to QC materials, QC prompting or QC lock out, Abnormal and critical ranges flagged by color highlighting, Reject of results at meter (optional) for repeat testing, Web-based meter configuration by location, Custom meter configuration by medical unit, Test Measured: Ketone*, Hematocrit corrected, Units of measure based on meter ordered (mg/dl or mmol/L models), Automatic sample detection and analysis start, Automatic sample counter with date/time stamp for data tracking. /Creator (easyPDF SDK 5.1) Conclusions: Suitable ranges. Draft guidance for industry and food and drug administration staff. Measuring range 0,3 - 20,0 mmol/L Features Strip ejection StatStrip Connectivity Lactate Sample volume 0,6 l Analysis time 13 seconds Sample types Whole blood arterial, capillary Dimensions H 14.7 cm x W 7.9 cm x D 3.0 cm Quality control levels 2 Admission CE Memory (internal) 8,000 Manufacturer Nova Biomedical Country of production USA (2014). 556 750 278 556 500 1000 556 556 333 1000 667 333 1000 750 611 750 278 278 355 556 556 889 667 191 333 333 389 584 278 333 278 278 Ketone testing results obtained from capillary samples What type of fresh whole capillary blood is preferred? 90-day open-vial stability, Type: 3.7V Li Polymer Rechargeable Battery. Hematocrit: 20%-65% StatStrip Glucose/Ketone measures blood beta-hydroxybutyrate, the preferred ketone for diagnosing ketoacidosis Posted by: young entrepreneurs under 18 in the complete book of acupuncture pdf 1 min ago alfred amour garnier wikipedia 0 Views Certifications and compliances applicable in countries where regulations require. Blood ketone testing should be performed whenever glucose exceeds 14 mmol/L (250 g/dL) Correlation coefficient was 0.99, with a 95% confidence interval of 0.98 to 0.99. 180-day open-vial stability, QC Stability: Semin Dial. Epub 2013 Dec 8. Compliant government site. Data Storage: Size: 3.9 in x 2.4 in x 0.9 in Docking Station: Blood glucose monitoring test systems for prescription point-of-care use. 278 333 556 556 556 556 260 556 333 737 370 556 584 333 737 552 Glucose Results in 6 Seconds, Ketone Results in 10 Seconds, Traditional QC with target values assigned to QC materials, Abnormal and critical ranges flagged by color highlighting, Reject of results at meter (optional) for repeat testing, Web-based meter configuration by location, Custom meter configuration by medical unit, Units of measure based on meter ordered (mg/dl or mmol/L models), Automatic sample detection and analysis start, Automatic sample counter with date/time stamp for data tracking. StatStrip is FDA cleared and CLIA waived for use throughout all hospital and all professional healthcare settings including critical care. 0.8 Microliter Sample for Ketone * Ketone testing is not available with StatStrip meters in the U.S. but Glucose testing is available. After they have enough blood for the test, theyll give you a cotton ball or gauze to hold against your fingertip to stop the bleeding. In addition to the study submitted to the FDA, 138 other independent studies over the last eight yearsincluding 53 critical care studieshave found no clinically significant interferences for StatStrip Glucose measurement technology. Measurement (Technical) Range 0.6 to 33.3 mmol/L Glucose . StatStrips Multi-Well technology employs a patented, additional interference test well to measure electrochemical interferences and correct for their effect. Diabetes Care, 26(3), 959. Strips: 1 Box of 50 strips (25 strips per vial, 2 vials per box) These tests involve a glucose meter and a test strip, which show your blood sugar result within seconds. The lithium heparin tube was processed at the same time for measuring plasma glucose (Cobas 6000 Analyzer, Roche Diagnostics, SA). ONLY glucose meter proven to have no known clinical interferences Tested over 8,000 medications with no interferences ONLY glucose measurement technology specifically designed for hospital use Wireless meter connectivity to LIS/HIS with StatStrip Glucose New intended use for all patients, including critically ill 975 722 722 722 722 667 611 778 722 278 556 722 611 833 722 778 Get a baseline A1C test if you're an adult over age 45or if you're . Measures ketones* with same meter Easy to use No meter preparation or calibration coding steps are required. Other factors, such as certain medications and not fasting, can affect your levels. 278 333 556 556 556 556 280 556 333 737 370 556 584 333 737 552 This led to savings of 22 hours of nursing time and 375 laboratory investigations, for a total savings of 2,940.1, A second study of DKA patients compared a DKA therapy endpoint of pH > 7.3 and blood ketones < 1.0 mmol/L, versus an endpoint of pH > 7.3 and negative urine ketones. Request more information on this product. 556 556 556 556 556 556 556 549 611 556 556 556 556 500 556 500 2. (2003). xZYs8~#bkj8CH-I "eBVj\JH5}IK"'q`qz0"f=,23(OSf3]}>g){ey[:VE?`f How do you document nova blood glucose for outpatient in heath connect? A blood glucose test is a blood test that mainly screens for diabetes by measuring the level of glucose (sugar) in your blood. Unable to load your collection due to an error, Unable to load your delegates due to an error. Cleveland Clinic is a non-profit academic medical center. Optional accessory; desk or wall mount charging station with RJ-45 Ethernet jack. Read Novas 2018 press release for StatStrips capillary, Read the FDAs 2014 press release for StatStrips, For more general product information, click. Besides studies presented to the FDA, 168 other independent studies over the past eight years which include 53 critical care studies have discovered no clinically significant interferences for StatStrips Glucose measurement technology. To learn more about how StatStrip Glucose can bring critical care testing to the bedside, contact your current GPO, call Nova at 800-458-5813, or fill out the form below: 1. Clean / disinfect the meter surface with locally approved disinfectant wipes between every pt or clean / disinfect the meter surface with 10% bleach wipes Clorox wipes for isolation and C. Difficult patients. What is the minimum number of lines you should have on the grating? Data Storage: Dont be afraid to ask your provider questions. Linearity: Five levels available 0 All rights reserved. Top, bottom, left, & right. Federal government websites often end in .gov or .mil. Vui Lovreni M, Radii Biljak V, Boievi S, Pape-Medvidovi E, Ljubi S. Int J Endocrinol. 1526 0 obj <> endobj Data Program: Nova Microsoft-Excel based data transfer software, Battery Information: Disclaimer, National Library of Medicine Protocol: TCP/IP Ethernet 100 Mbit Standard: POCT1-A2 611 611 611 611 611 611 611 549 611 611 611 611 611 556 611 556 StatStrip glucose / ketone test strip systems work with patented Multi-Well measurement technology, which meets the increasing requirements of todays blood sugar measurements in hospitals. (2007). How long should you let nova machine air dry when using Clorox wipes? Complies to IVDD Tested according to: EN 61010-1:2010, EN 61010-2-101:2015, EN 60825-1/A1:2014. The glucometer will calculate blood glucose measurement in about 10-20 seconds. Their shelf life is two years, even opened packages are stable for 6 months. Epub 2014 Aug 5. Size: 5.8 in x 3.1 in x 1.18 in 30 months from date of manufacturing outside USA The time spent by point-of-care personnel to perform frequent bedside testing is reduced by the fast analysis time and elimination of the calibration code step. Certifications and Compliance: Nova Biomedical is certified to FDA Quality System Regulations and EN ISO 13485:2016 They are available in both a connective and non-connective model and are a proven glucose . Use of any other glucose meter with critically ill patients is off label 1542 0 obj <>/Filter/FlateDecode/ID[<2607E89234604E45A6F4EDDE754D626F><61AE074E576FEA4A8752932D40924908>]/Index[1526 22]/Info 1525 0 R/Length 80/Prev 889667/Root 1527 0 R/Size 1548/Type/XRef/W[1 2 1]>>stream a. 556 750 222 556 333 1000 556 556 333 1000 667 333 1000 750 611 750 750 278 278 500 500 350 556 1000 333 1000 556 333 944 750 500 667 Life: 6-8 hours in use (approximately 40 tests w/barcode scans)/12-24 hours standby Data Program: Nova Microsoft-Excel based data transfer software Last reviewed by a Cleveland Clinic medical professional on 11/16/2022. Would you like email updates of new search results? True or false? Correlation coefficient was 0.99, with a 95% confidence interval of 0.98 to 0.99. Ketone testing results obtained from capillary samples Users: 8,000 Operators, Connectivity: If you have risk factors, your provider will likely recommend regular screening no matter your age. Blood glucose levels for people without diabetes are as follows: Adult Fasting 70-100 mg/dL Expected values for neonates (1 to 7 days old): 47 - 110 mg/dL 2. * With optional ADT interface The aim of this study was to evaluate a glucose meter (StatStrip, Nova Biomedical) to assess its agreement with the standard laboratory method for testing glucose. %PDF-1.3 Strips: Cases of 36 vials (1,800 strips); vials packaged 50 strips/vial Copyright2020 DSI Data Sciences International. In one of the largest studies ever carried out with glucose measuring devices (35 participating hospitals, 1,703 data points), StatStrip achieved excellent correlations over the entire measuring range to the plasma hexokinase reference method of 10 to 600 mg / dl (0.5 to 33.3 mmol / l) . No meter preparation or calibration coding steps are required. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 If youre experiencing concerning symptoms of low blood sugar or high blood sugar, contact your healthcare provider as soon as possible. [ Life: 6-8 hours in use (approximately 40 tests w/barcode scans)/12-24 hours standby. Hematocrit, Ascorbic Acid, Acetaminophen, Uric Acid, Maltose, Galactose, and Oxygen, Additional StatStrip Xpress Meter Features. . 750 222 222 333 333 350 556 1000 333 1000 500 333 944 750 500 667 Know that having a high or low glucose level doesnt necessarily mean you have a medical condition and need treatment. stream Privacy Policy, Non-Invasive Airway Mechanics-Double Chamber, Validation Services Request for Information, Brachycephalic Obstructive Airway Syndrome, 3.6 in x 2.3 in x 0.9 in (91 mm x 58 mm x 23 mm), Nova Microsoft-Excel based data transfer Software, Minimum 600 tests before battery requires replacement, Traditional QC with target values assigned to QC materials, Units of measure based on meter ordered (mg/dl or mmol/L models), Automatic sample detection and analysis start, Automatic sample counter with date/time stamp for data tracking. DOUBLE RED arrows indicate critical values. Blood ketone monitoring reduces costs and ICU length of stay for DKA patients 2.1.2. measurement of glucose in capillary, venous, arterial, and neonate whole blood. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380325.pdf Retrospective evaluation of the accuracy of Roche AccuChek Inform and Nova StatStrip glucose meters when used on critically ill patients. 16 0 obj StatStrip Glucose/Ketone* measures blood beta-hydroxybutyrate, the preferred ketone for diagnosing ketoacidosis. Nova StatStrip Glucose Quality Control (QC) Solutions 1 & 3 store @ 1530C, - . hbbd``b`k@?`X! If the test strip does not fill completely, do not touch the test strip to the blood droplet a second time. Users: 8,000 users 2 0 obj Blood ketone is more accurate than urine ketone testing. Glucose Results in 6 Seconds, Ketone Results in 10 Seconds Theyre much less common in people who dont have diabetes. official website and that any information you provide is encrypted they are also easier to obtain and allow for immediate reflex testing of ketones whenever glucose is greater than 14 mmol/L. Diabetes UK, the Canadian Diabetes Association, the European Society for Paediatric Endocrinology, and the American Diabetes Association (ADA) recommend that blood ketone testing be performed whenever glucose exceeds 14 to 17 mmol/L for rapid detection or prevention of diabetic ketoacidosis (DKA). endobj Test results will appear in 6 . 556 556 333 500 278 556 500 722 500 500 500 334 260 334 584 750 These tests involve a test strip and glucose meter (glucometer), which show your blood sugar level within seconds. Connectivity: Call the POCT Coordinator for further guidance. body in DKA, are recommended over urine ketone testing for diagnosing and monitoring ketoacidosis. You may be having symptoms of high blood sugar or low blood sugar, which could indicate diabetes or another condition. Before Hydroxybutyrate near-patient testing to evaluate a new end-point for intravenous insulin therapy in the treatment of diabetic ketoacidosis in children. The operating range or Linearity of the StatStrip Glucose Meter is 10 - 600 mg/dL. End-filled capillary action test strips are designed for fast, easy sample uptake. Normal fasting glucose for an adult is 70-99 mg/dL with the neonatal range being slightly lower 14. A CGM is inserted under the skin and measures interstitial glucose continually for about 14 days. Noyes et al. A min 3x horizontally & 3x vertically avoiding bar code scanner, electrical connector. Networkable point-of-care test strip system for the determination of hemoglobin and hematocrit. There are two main types of blood glucose tests: Venous blood glucose tests are generally more accurate than capillary blood glucose tests. Networkable POCT test strip system for the determination of creatinine. StatStrip Glucose / Ketone automatically recognizes which test strip is inserted and automatically switches to the corresponding measuring mode. Bethesda, MD 20894, Web Policies (2003). Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm416144.htm The test can involve a finger prick or a blood draw from your vein. Healthcare providers often order fasting blood glucose tests to screen for diabetes. These cookies will be stored in your browser only with your consent. For nova, comments are mandatory when documenting for action taken when QC results are out of range and action taken when critical patient results are obtained. Low blood sugar (hypoglycemia) episodes are common in people with Type 1 diabetes and people with Type 2 diabetes who take certain medications. This website uses cookies to improve your experience while you navigate through the website. Whole Blood: Arterial, Venous, Capillary, Neonatal, Glucose Measurement Range: StatStrip supports touch screen entry of an unlimited number of user-defined off-line tests which can be transmitted to the LIS/EMR via Nova middleware. Patient Tests: 1,000 tests Life: Minimum 600 tests, Tests: Crit Care Med. This device is adequate for glucose monitoring. This page states 'normal' blood sugar ranges and blood sugar ranges for adults and children with type 1 diabetes, type 2 diabetes and blood sugar ranges to determine people with diabetes.. << The name of the blood test or what was measured in your blood. The .gov means its official. Theres also at-home blood sugar testing (using a glucometer) for people who have diabetes. Measures ketones* with same meter. Size: 3.6 in x 2.3 in x 0.9 in The pH/ Let us help you with your inquiries, brochures and pricing requirements. Setup Program: NovaNet Web-Based Instrument Manager Software, Temperature: 41F-104F (5C- 40C) Blood Glucose results appear CRITICAL Low or High range in? Performance of a new interference-resistant glucose meter. Health experts advise that a person living with T2D should aim to keep their blood glucose range between 80 and 130 mg/dL before a meal and less than 180 . Wipe external surface between each pt w/locally germicidal wipe such as PDI Sani-cloth AF. Hoedemaekers CW, Klein Gunnewiek JM, Prinsen MA, Willems JL, Van der Hoeven JG. The number or measurement of your blood test result. This website uses cookies to improve your experience. endstream endobj 1527 0 obj <. Linearity: Five levels available, Weight: 0.2 lb (75 g) Policy. /Filter /FlateDecode Operating Ranges: Temperature: 15C- 40C (59F-104F) Altitude: Up to 15,000 feet Humidity: 10% to 90% relative humidity And critical results. The most common forms are: Other causes of high glucose levels include: A blood sugar result of 70 mg/dL or lower is usually considered low. 90-day open-vial stability. Dual-band wireless connectivity provides complete security and encryption to ensure that patient data remains uncompromised. 11 0 obj Higher levels could be a sign of diabetes or pre-diabetes. 611 611 389 556 333 611 556 778 556 556 500 389 280 389 584 750 The American Diabetes Association recommends regular screening for anyone age 35 or older. Test Reported: Ketone Hyperglycemic patients admitted to Intensive care units (ICUs) have higher morbidity and mortality than normoglycemic patients. Urine testing can also produce false positive or negative results due to highly colored urine, highly acidic urine, exposure of the urine test strips to air for prolonged periods, drugs such as the ACE inhibitor captopril, or high doses Insert a ketone strip and StatStrip Glucose/Ketone automatically recognizes the strip and converts the meter to ketone measuring mode. Insert a ketone strip and StatStrip Glucose/Ketone meter automatically recognizes the strip and converts the meter to ketone measuring mode. Noyes et al. Glucose Measurement Range: 10-600 mg/dL (0.6-33.3 mmol/L) Interferences Eliminated Include: Hematocrit, Ascorbic Acid, Uric Acid, Acetaminophen (Paracetamol), Bilirubin, Maltose, Galactose, Oxygen . what is measuring range for glucose on statstrip? A microblood test is performed to determine whether the oxygen supply to the fetus is adequate during birth. Whole Blood: Arterial, Venous, Capillary, Neonatal, Glucose Measurement Range: 10-600 mg/dL (0.6-33.3 mmol/L), Interferences (Measured and Corrected for): Once they have enough blood to test, theyll remove the needle and hold a cotton ball or gauze on the site to stop the bleeding. Blood ketone monitoring reduces costs and ICU length of stay for DKA patients StatStrip Multi-Well blood glucose test strips deliver exceptional measurement accuracy, even in the hyper- and hypoglycemic range. A life-threatening complication of inadequately controlled type 1 and occasionally type 2 diabetes. With the integrated scanner, operator and patient IDs can be read in using 1D / 2D barcodes or entered using the alphanumeric screen keyboard. Patents 6,287,451 / 6,837,976 / EP 1 212 609 / CA 2,375,092 / EP 1497 449 / JP 405 0078 Life: Minimum 600 tests Test Strip Volume: 1.2 L

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