Healthcare providers rely on more than a single blood glucose test to diagnose diabetes or another condition. The site is secure. This is a statement that no other glucose meter manufacturer can make. True or false? 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Glucose control in the intensive care unit. Hydroxybutyrate near-patient testing to evaluate a new end-point for intravenous insulin therapy in the treatment of diabetic ketoacidosis in children. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 750 750 Every 24 hours check performance statstrip meter/whenever problems such has storage, operator, and instrument. People with Type 1 diabetes especially need to monitor their blood sugar multiple times a day to effectively manage the condition. 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. 556 556 556 556 556 556 556 556 556 556 278 278 584 584 584 556 Read Novas 2018 press release for StatStrips capillary, Read the FDAs 2014 press release for StatStrips, For more general product information, click. In order to help hospitals avoid the risk of glucose meter off-label use, Nova Biomedicals technical support resources are ready to help you acquire the StatStrip Glucose Hospital Meter System. Insert a ketone strip and StatStrip Glucose/Ketone automatically recognizes the strip and converts the meter to ketone measuring mode. Test Methodology: Electrochemistry, Sample Types & Operating Modes: Wireless connectivity saves time for the caregiver and allows for faster charting of results and clinical decision making to improve patient care. Karon BS, Blanshan CT, Deobald GR, Wockenfus AM. The test can involve a finger prick or a blood draw from your vein. Linearity: Five levels available, Test Strip Stability: 2 0 obj Diabetes Technol Ther. Wireless connectivity helps save time for the caregiver and enables quicker charting of findings and clinical decision-making to enhance patient care. Eighty-nine different samples were collected from patients (76.4% men and 23.6% women) admitted to an ICU from September to December 2010. These cookies do not store any personal information. How long does it take for the nova machine to read the results? 3 LED indicator lights showing connection status, transmit/receive data, and charging status. A blood glucose test is a blood test that mainly screens for diabetes by measuring the level of glucose (sugar) in your blood. Blood ketone is more accurate than urine ketone testing You also have the option to opt-out of these cookies. Healthcare providers often order fasting blood glucose tests to screen for diabetes. Altitude: Up to 15,000 feet * With optional ADT interface Operating Ranges: Temperature: 15C- 40C (59F-104F) Altitude: Up to 15,000 feet Humidity: 10% to 90% relative humidity DKA occurs in 65% of patients under the age of 19. Hematocrit, Ascorbic Acid, Acetaminophen, Uric Acid, Maltose, Galactose, and Oxygen, Additional StatStrip Xpress Meter Features. StatStrip Glucose / Ketone automatically recognizes which test strip is inserted and automatically switches to the corresponding measuring mode. Measures ketones* with same meter. Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. Nova Biomedical offers an extensive e-learning program for the re-certification of device users. QC Tests: 200 tests 1. A blood glucose test measures the level of glucose (sugar) in your blood. In this user-friendly point-of-care system, all users can be easily managed, all QC and patient data are recorded and reports can also be created. If you dont have diabetes, low blood glucose levels may be a sign of: These conditions typically cause frequent low blood sugar episodes. % Docking Station: Ketone testing results obtained from capillary samples 556 750 222 556 333 1000 556 556 333 1000 667 333 1000 750 611 750 Conclusions: Glu: whole blood arterial, venous, capillary, neonatal | Ket: whole blood, venous, capillary, CE, FDA (for all patients, including intensive care patients), Glucose 10 600 mg / dl (0.6 33.3 mmol / L) Ketones 0.1 7.0 mmol / L, Touchscreen, barcode scanner, strip ejection, docking station (optional), Networking via Novanet (ASTM, HL7 or POCT01-A2). 278 333 556 556 556 556 260 556 333 737 370 556 584 333 737 552 GDH-FAD = glucose dehydrogenase with flavin-adenine dinucleotide Mut Q-GDH = glucose dehydrogenase with pyrroloquinolinequinone modified to eliminate maltose interference References: A Baxter report Interim 1, 33541 Determination of potential interference of icodextrin and its metabolites on human blood glucose measurement using chosen glucometers. Abnormal haematocrit levels are commonly found in hospitalpatients. It is mandatory to procure user consent prior to running these cookies on your website. (2007). All 3 meter strip technologies represented the latest version provided for hospital use at the time of the study available. Previous studies have demonstrated acceptable accuracy and reliability of the SS for the point-of-care measurement of glucose in adult5,6and neonatal7,8settings. An A1c shows your average blood sugar over a few months. Insulin, a hormone your pancreas makes, is the most significant contributor to maintaining healthy blood sugar. 333 556 611 556 611 556 333 611 611 278 278 556 278 889 611 611 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. StatStrip and StatStrip Xpress2 are the worlds most extensively studied and proven glucose test. To learn more about how StatStrip Glucose can bring critical care testing to the bedside, contact your current GPO or call Nova at 800-458-5813. Hydroxybutyrate near-patient testing to evaluate a new end-point for intravenous insulin therapy in the treatment of diabetic ketoacidosis in children. Data Storage: 8600 Rockville Pike Symptoms of diabetes and high blood sugar include: If you or your child have these symptoms in addition to vomiting, deep labored breathing and/or confusion, go to the nearest emergency room as soon as possible. Vanelli et al. We use cookies to enhance your experience. Heelstick or fingerstick. Complies to IVDD Tested according to: EN 61010-1:2010, EN 61010-2-101:2015, EN 60825-1/A1:2014. Epub 2009 Sep 19. Did you know that the improved measurement accuracy by correcting measurement errors caused by interference has been confirmed by more than 95 publications since 2011? StatStrips Multi-Well technology employs a patented, additional interference test well to measure electrochemical interferences and correct for their effect. You need to consume carbohydrates (sugar) to treat hypoglycemia, such as a banana or apple juice. Noyes et al. PMC Patents 6,287,451 / 6,837,976 / EP 1 212 609 / CA 2,375,092 / EP 1497 449 / JP 405 0078 True of false? 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. Wireless meter connectivity to LIS/HIS with StatStrip Glucose/Ketone*. Cleaning Meter. V%x"f ". Hl$tv101YH? Ci 2. 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 Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm416144.htm Perform the test with just a small finger prick to get instant screening results. 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 Whole Blood: Arterial, Venous, Capillary /Producer (BCL easyPDF 5.10 \(0420\)) Seeing an abnormal test result can be stressful. Certifications and Compliance: Nova Biomedical complies with the FDA Quality Systems Regulations and is certified to EN ISO 13485:2016. Measures ketones* with same meter Easy to use No meter preparation or calibration coding steps are required. Pediatric Diabetes, 8, 150-156. Epub 2014 Aug 5. Desk or wall mount docking station with RJ-45 Ethernet jack providing network connection and battery charging. Know that having a high or low glucose level doesnt necessarily mean you have a medical condition and need treatment. 722 722 722 722 722 722 1000 722 667 667 667 667 278 278 278 278 Centers for Disease Control and Prevention (CDC). But you can take steps to prevent Type 2 diabetes from developing. Coefficient of determination (R2) was 0.97, and intraclass correlation coefficient was 0.99 with a 95% CI of 0.98 to 0.99. The lines are to be ruled over a distance of $1.50 \mathrm{~cm}$ on the grating. 2.1.2. measurement of glucose in capillary, venous, arterial, and neonate whole blood. Noyes et al. The time delay between interstitial glucose and blood glucose is approximately 9 minutes, ie. If youre experiencing concerning symptoms of low blood sugar or high blood sugar, contact your healthcare provider as soon as possible. Bethesda, MD 20894, Web Policies Glucose Reference Ranges: Configuration Normal Range Critical Results Neonate (<28 days) 2.6 to 7.0 mmol/L <2.0 mmol/L >20.0 mmol/L Non-Neonate (28 days) 4.0 to 7.0 mmol/L <2.6 mmol/L >25.0 mmol/L 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 . (2014). ] A single low blood sugar test result usually isnt a cause for concern in people who dont have diabetes. of vitamin C. *Ketone testing is not available with StatStrip meters in the U.S. Glucose is available. 30 months from date of manufacturing outside USA The lithium heparin tube was processed at the same time for measuring plasma glucose (Cobas 6000 Analyzer, Roche Diagnostics, SA). Intended Use The Nova StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiplepatient use for the - quantitative determination of whole blood glucose. The operating range or Linearity of the StatStrip Glucose Meter is 10 - 600 mg/dL. An incorrectly entered calibration code can affect the displayed glucose value by up to 43%. >> According to the ADA, an A1C level below 5.7 percent is considered normal between 5.7 and 6.4 signals prediabetes and over 6.5 percent indicates type 2 diabetes. No meter preparation or calibration coding steps are required. Test Reported: Ketone Go to Enter and Edit Results. Recently, there have been many attempts to utilize NIR technology for the continues monitoring of blood glucose levels through the skin. By continuing to browse this site you agree to our use of cookies. Crit Care Med. Extra battery slot included for recharging and storage of spare battery. True or False specimen from EDTA, citrate, I skate and sodium fluoride sample tubes acceptable. Networkable point-of-care test strip system for determining lactate. Suitable ranges. While fasting, the normal blood glucose ranges from 70 to 99 mg/dL (3.9 to 5.5 mmol/L). 556 556 556 556 556 556 556 556 556 556 333 333 584 584 584 611 Strips: Cases of 36 vials (1,800 strips); vials packaged 50 strips/vial 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). We do not endorse non-Cleveland Clinic products or services. (2003). Blood ketone is more accurate than urine ketone testing. Policy. * Ketone testing is not available with StatStrip meters in the U.S. but Glucose testing is available. StatStrip is FDA cleared and CLIA waived for use throughout all hospital and all professional healthcare settings including critical care. Easy to use. Cost effectiveness of the direct measurement of 3--hydroxybutyrate in the management of diabetic ketoacidosis in children [Letter to the editor]. Prick your fingertip with the meter's tiny needle (called a lancet). FDA clears glucose monitoring system for use in hospital critical care units [Press release]. 667 667 667 667 667 667 1000 722 667 667 667 667 278 278 278 278 a. A min 3x horizontally & 3x vertically avoiding bar code scanner, electrical connector. Type: 3.7V Li Polymer Rechargeable Battery Data Transfer: Strip Port Connection to USB The American Diabetes Association (ADA), the European Society for Paediatric Endocrinology, the Canadian Diabetes Association and Diabetes UK suggest that blood ketone testing should be carried out whenever glucose surpasses 14 to 17 mmol/L for quickly detecting or preventing diabetic ketoacidosis (DKA). POC Critical Glucose Values a. How would you record patient results above 548 or below 12 on a paper chart or in e-MAR (Blood Glucose Assessment) in Meditech? are shown on the display for secure patient identification. Measurement results that are outside the normal range are clearly highlighted by color coding. Continuous glucose monitoring devices (CGMs) are another option for this. and services. %%EOF 722 722 778 778 778 778 778 584 778 722 722 722 722 667 667 611 Temperature: 41F-104F (5C- 40C) The American Diabetes Association recommends regular screening for anyone age 35 or older. 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. [ StatStrip test strips do not require any codes and are consistently precise, even when using different lots. Linearity: Five levels available Document under Enter/Edit using smart phrase .WLA OR in Doc. Once opened, test strips are good for 180 days and control solutions are good for 90 days or until manufacturer's printed expiration date whichever comes first. QC: Three levels (Low, Normal, High); sold separately Insert a ketone strip and StatStrip Glucose/Ketone meter automatically recognizes the strip and converts the meter to ketone measuring mode. Only Glucose Meter to Measure and Correct Errors Caused by Electrochemical Interferences. Certain people are at risk for developing Type 2 diabetes. You are making a diffraction grating that is required to separate the two spectral lines in the sodium D doublet, at wavelengths $588.9950$ and $589.5924 \mathrm{~nm}$, by at least $2.00 \mathrm{~mm}$ on a screen that is $80.0 \mathrm{~cm}$ from the grating. they are also easier to obtain and allow for immediate reflex testing of ketones whenever glucose is greater than 14 mmol/L. Vui Lovreni M, Radii Biljak V, Boievi S, Pape-Medvidovi E, Ljubi S. Int J Endocrinol. Operating Ranges: Temperature: 15C- 40C (59F-104F) Altitude: Up to 15,000 feet Humidity: 10% to 90% relative humidity. Disinfecting Meter. Docking Station: 278 278 355 556 556 889 667 191 333 333 389 584 278 333 278 278 More info. Necessary cookies are absolutely essential for the website to function properly. A comment must be entered for critical results. 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. Whole Blood: Arterial, Venous, Capillary, Neonatal, Glucose Measurement Range: This led to savings of 22 hours of nursing time and 375 laboratory investigations, for a total savings of 2,940.3, 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. It has been proven to be safe and effective for use throughout all hospital and professional healthcare settings including critical care. 180-day open-vial stability, QC Stability: Life: Minimum 600 tests, Tests: The operating range or Linearity of the StatStrip Glucose Meter is 10 - 600 mg/dL. 2009 May;37(5):1769-76. doi: 10.1097/CCM.0b013e3181a19ceb. 24 months from date of manufacturing in USA
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