But opting out of some of these cookies may have an effect on your browsing experience. Noyes et al. Test Reported: Ketone Nova Biomedical's StatStrip and StatStrip Xpress2 are glucose/ketone level measurement devices. Networkable point-of-care test strip system for the determination of hemoglobin and hematocrit. Light photons penetrating the skin can undergo multiple . Temperature: 15C- 40C (59F-104F) A comment must be entered for critical results. 2 levels. Networkable point-of-care test strip system for determining lactate. True or False specimen from EDTA, citrate, I skate and sodium fluoride sample tubes acceptable. Patient & QC Tests: 400 tests total (FIFO), Connectivity: 3 LED indicator lights showing connection status, transmit/receive data, and charging status. Test results will appear in 6 . StatStrip Glucose/Ketone measures blood beta-hydroxybutyrate, the preferred ketone for diagnosing ketoacidosis 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. Low blood sugar (hypoglycemia) episodes are common in people with Type 1 diabetes and people with Type 2 diabetes who take certain medications. This is a statement that no other glucose meter manufacturer can make. Life: 6-8 hours in use (approximately 40 tests w/barcode scans)/12-24 hours standby. No meter preparation or calibration coding steps are required. Do not use for pt testing. When using PDI Sani-cloth AF to disinfect, how many min the meter surface stay wet for? Test Strip Volume: 0.8 l Blood glucose levels of ICU patients are usually measured with a glucose meter. Healthcare providers most commonly use blood glucose tests to screen for Type 2 diabetes, which is a common condition. d. Bookshelf A1C testalso known as the haemoglobin A1C or HbA1c testis a simple blood test that measures your average blood sugar levels over the past 3 months. The test strip must fill completely upon touching the blood droplet. 11 0 obj DKA occurs in 65% of patients under the age of 19. But you can take steps to prevent Type 2 diabetes from developing. While fasting, the normal blood glucose ranges from 70 to 99 mg/dL (3.9 to 5.5 mmol/L). UL, CSA Standards Patented Technology. Battery Information: 0 8 0 obj 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.. Wireless connectivity saves time for the caregiver and allows for faster charting of results and clinical decision making to improve patient care. Since eating food affects blood sugar, fasting blood glucose tests show a more accurate picture of your baseline blood sugar. Whole Blood: Arterial, Venous, Capillary, Neonatal, Glucose Measurement Range: 556 556 556 556 556 556 556 549 611 556 556 556 556 500 556 500 2008 Nov;36(11):3062-6. doi: 10.1097/CCM.0b013e318186ffe6. FDA clears glucose monitoring system for use in hospital critical care units [Press release]. 2 levels. 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 Centers for Disease Control and Prevention (CDC). These products and services are provided for your convenience. 722 722 778 778 778 778 778 584 778 722 722 722 722 667 667 611 Accessibility 2.1.2. measurement of glucose in capillary, venous, arterial, and neonate whole blood. Measures ketones* with same meter Easy to use No meter preparation or calibration coding steps are required. 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. If your glucose blood test result reveals that you have high or low levels of glucose, it doesnt necessarily mean that you have a medical condition. 0.8 Microliter Sample for Ketone Hematocrit, Ascorbic Acid, Acetaminophen, Uric Acid, Maltose, Galactose, and Oxygen, Additional StatStrip Xpress Meter Features. You can expect the following during a venous glucose test, or blood draw: You can expect the following during a capillary blood glucose test (finger prick): Blood tests are a very common and essential part of medical testing and screening. This may feel like a small pinch. Phlebotomists typically perform venous blood glucose tests. Epub 2009 Sep 19. AzmanJaka/Getty Images. Capillary blood samples are not only preferred over urine samples to detect and monitor DKA, they are also easier to obtain and allow for immediate reflex testing of ketones whenever glucose Theyll disinfect your fingertip with an alcohol swab and prick it with a small needle called a lancet, which is usually contained within a small plastic device. If your fasting blood glucose level is 126 mg/dl (7.0 mmol/L) or higher on more than one testing occasion, it usually means you have diabetes. Your blood carries glucose to all of your bodys cells to use for energy. It has been proven to be safe and effective for use throughout all hospital and professional healthcare settings including critical care. Protocol: TCP/IP Ethernet 100M/1GBPS An incorrectly entered calibration code can affect the displayed glucose value by up to 43%. What are the purpose of testing whole blood glucose by Nova Stat Strip? Theyll place your finger/the drop of blood against a test strip thats inserted into a glucometer. vials packaged 50 strips/vial, Wireless meter connectivity to LIS/HIS with StatStrip Glucose, 1. The blood ketone testing group of patients left the ICU 6.5 hours earlier than the urine ketone testing group. (98 mm x 61 mm x 22.9 mm), Data Storage: Normal results are displayed in BLUE. If your blood glucose test is part of a basic or comprehensive metabolic panel, you may also need to fast for several hours before your blood draw. 278 333 474 556 556 889 722 238 333 333 389 584 278 333 278 278 Tests: We use cookies to enhance your experience. Get useful, helpful and relevant health + wellness information. You may have diabetes-related ketoacidosis, which is a life-threatening condition. Put a test strip into your blood glucose meter. Strips: Cases of 36 vials (1,800 strips); vials packaged 50 strips/vial Hoedemaekers CW, Klein Gunnewiek JM, Prinsen MA, Willems JL, Van der Hoeven JG. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. official website and that any information you provide is encrypted Ketone Measurement Range: 0.0-8.0 mmol/L * Ketone testing is not available with StatStrip meters in the U.S. but Glucose testing is available. Agreement between the two methods was assessed according to the EP-9-A2 Clinical Laboratory Standards Institute guideline. 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. Strips: Cases of 36 vials (1,800 strips); vials packaged 50 strips/vial Test Time: 10 Seconds (2007). 2. Specifications subject to change without notice. Venous or aerial blood may also be used. Battery Information: Type: 3V Li Button Battery 90 days same as 3 months after opening or until manufacturer exp date, whichever comes first. Noyes et al. Bethesda, MD 20894, Web Policies HHS Vulnerability Disclosure, Help Nova Biomedical offers an extensive e-learning program for the re-certification of device users. A min 3x horizontally & 3x vertically avoiding bar code scanner, electrical connector. You also have the option to opt-out of these cookies. Certifications and Compliance: Nova Biomedical complies with the FDA Quality Systems Regulations and is certified to EN ISO 13485:2016. The American Diabetes Association recommends regular screening for anyone age 35 or older. Extra battery slot included for recharging and storage of spare battery. Reagents and Strips: POC Critical Glucose Values a. Cost effectiveness of the direct measurement of 3--hydroxybutyrate in the management of diabetic ketoacidosis in children [Letter to the editor]. Docking Station: What's the next step after QC has passed? A blood glucose test measures the amount of glucose (sugar) in a person's blood and detects diabetes. Only Glucose Meter to Measure and Correct Errors Caused by Electrochemical Interferences. Blood test reports, including blood glucose test reports, usually provide the following information: A healthy (normal) fasting blood glucose level for someone without diabetes is 70 to 99 mg/dL (3.9 to 5.5 mmol/L). Data Storage: Draft guidance for industry and food and drug administration staff. 333 556 611 556 611 556 333 611 611 278 278 556 278 889 611 611 16 0 obj Capillary blood. 70% Isopropyl alcohol may be use. Dual-band wireless connectivity provides complete security and encryption to ensure that patient data remains uncompromised. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm416144.htm Setup Instrument Manager Program: NovaNet Device Management Software Features: Replaceable In either of these cases, your provider will likely order a glycated hemoglobin test (A1c) before diagnosing you with prediabetes or diabetes. Operating Ranges: Temperature: 15C- 40C (59F-104F) Altitude: Up to 15,000 feet Humidity: 10% to 90% relative humidity. Reagents and Strips: Certifications and compliances applicable in countries where regulations require. If your fasting blood glucose level is 100 to 125 mg/dL (5.6 to 6.9 mmol/L), it usually means you have prediabetes. Lactate - An important marker for sepsis detection. Other factors, such as certain medications and not fasting, can affect your levels. /CreationDate (D:20210228184428-08'00') Near-infrared technology is an emerging non-invasive technique utilized for various medical applications. 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. 667 778 722 667 611 722 667 944 667 667 611 333 278 333 584 556 Setup Program: NovaNet Web-Based Instrument Manager Software, Temperature: 41F-104F (5C- 40C) Extra battery slot included for recharging and storage of spare battery. How long should you let nova machine air dry when using PDI Sami Cloth AF? Blood ketone testing should be performed whenever glucose exceeds 14 mmol/L (250 mg/dL). Test Time: 6 Seconds The lines are to be ruled over a distance of $1.50 \mathrm{~cm}$ on the grating. Squeeze out a drop of blood and touch it with the edge of the test strip . Among the electrochemical interferences eliminated are paracetamol (acetaminophen), ascorbic acid (vitamin C), uric acid, oxygen, and bilirubin. This site complies with the HONcode standard for trustworthy health information: verify here. A comment must be entered for failed QC result and then repeat QC test. Size: 5.8 in x 3.1 in x 1.18 in This website uses cookies to improve your experience while you navigate through the website. /Length 2610 Published by Elsevier Espana. UL, CSA Standards Patented Technology. /ModDate (D:20210228184428-08'00') Normal fasting glucose for an adult is 70-99 mg/dL with the neonatal range being slightly lower 14. Blood glucose monitoring test systems for prescription point-of-care use. Get a baseline A1C test if you're an adult over age 45or if you're . 1526 0 obj <> endobj We also use third-party cookies that help us analyze and understand how you use this website. The mean lag between the blood ketone and urine ketone groups was 11 hours, ranging from 1 to 36 hours.4. Disinfecting Meter. Certifications & Compliance: ISO 13485:2003 Quality System Registration, IVDD, Meets IEC 61010, UL, CSA Standards Patented Technology. Humidity: 10% to 90% relative humidity, Reagents and Strips: Test Methodology: Electrochemistry, Sample Types & Operating Modes: Battery Information: You may have slight tenderness or a bruise at the site of the blood draw or finger prick, but this usually resolves quickly. 556 750 222 556 333 1000 556 556 333 1000 667 333 1000 750 611 750 Extra battery slot included for recharging and storage of spare battery. (2003). 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 . blood ketone endpoint was reached after 17 hours, whereas the pH/urine ketone endpoint was not reached until 28 hours after starting treatment. Type: 3.7V Li Polymer Rechargeable Battery Diabetes Care, 26(3), 959. How do you document nova blood glucose for outpatient in heath connect? Epub 2013 Dec 8. 333 556 556 500 556 556 278 556 556 222 222 500 222 833 556 556 Capillary blood glucose tests show the results within seconds via the glucometer. Connect to hospital ADT via NovaNet Device Management software. The test strip is designed with an electrode that measures glucose levels. Features: Rechargeable/Replaceable 400 549 333 333 333 576 556 278 333 333 365 556 834 834 834 611 Hematocrit, Ascorbic Acid, Uric Acid, Acetaminophen (Paracetamol), Bilirubin, Maltose, Galactose, Oxygen, Operating Ranges: Life: Minimum 600 tests Measures ketones* with same meter Easy to use No meter preparation or calibration coding steps are required. The pH/ Use of any other glucose meter with critically ill patients is considered off-label in the U.S. by the FDA and high complexity testing under CLIA. 1015 667 667 722 722 667 611 778 722 278 500 667 556 833 722 778 556 556 556 556 556 556 556 556 556 556 333 333 584 584 584 611 The site is secure. A blood glucose test is a blood test that mainly screens for diabetes by measuring the level of glucose (sugar) in your blood. Epub 2014 Aug 5. Blood ketone testing should be performed whenever glucose exceeds 14 mmol/L (250 mg/dL) Capillary blood samples are not only preferred over urine samples to detect and monitor DKA, Hydroxybutyrate near-patient testing to evaluate a new end-point for intravenous insulin therapy in the treatment of diabetic ketoacidosis in children. 2009 May;37(5):1769-76. doi: 10.1097/CCM.0b013e3181a19ceb. 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 Several bodily processes help keep your blood glucose in a healthy range. Crit Care Med. 722 722 722 722 722 722 1000 722 667 667 667 667 278 278 278 278 These cookies do not store any personal information. In addition, a hospital must obtain patient consent to perform off-label testing. 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. According to the European Society for Paediatric Endocrinology, Diabetes UK, ADA, and others, blood ketone testing methods that quantify beta-hydroxybutyrate, the predominant ketone (2014, September 24). 400 549 333 333 333 576 537 278 333 333 365 556 834 834 834 611 Linearity: Five levels available Easy to use What is the minimum number of lines you should have on the grating? /Producer (BCL easyPDF 5.10 \(0420\)) There are three main reasons why you may need a blood glucose (sugar) test: The most common use of a blood glucose test is to screen for Type 2 diabetes (T2D), which is a common condition. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm416144.htm. Mean whole blood glucose level measured by the glucose meter was 126.53+49.28 mg/dL (range, 33.5-431 mg/dL), while mean plasma glucose value measured by the laboratory reference method was 138.13+78.6 mg/dL (range, 43-451 mg/dL). Use of any other glucose meter with critically ill patients is off label 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Additional Features: Designed for applications that do not need data interfacing and connectivity, Xpress2 retains all of the analytical performance features of StatStrip Glucose. 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. 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? Necessary cookies are absolutely essential for the website to function properly. Last reviewed by a Cleveland Clinic medical professional on 11/16/2022. Humidity: 10% to 90% relative humidity Connect to all LIS/EMR via all major middleware providers Protocol: TCP/IP Ethernet 100 Mbit A single low blood sugar test result usually isnt a cause for concern in people who dont have diabetes. Measurement results that are outside the normal range are clearly highlighted by color coding. 24 months from date of manufacturing in USA c. If HI is displayed, the glucose result is >600 mg/dL 2. ] No preparations are necessary on the device, you can measure with either glucose or ketone test strips. Wipe external surface between each pt w/locally germicidal wipe such as PDI Sani-cloth AF. [ endobj If you have elevated blood glucose levels (hyperglycemia), it usually indicates diabetes. 611 611 389 556 333 611 556 778 556 556 500 389 280 389 584 750 what is measuring range for glucose on statstrip? Experiencing significant stress, such as from surgery or trauma. Patient Records: 3000 individuals* No meter preparation or calibration coding steps are required. The StatStrip Glucose/Ketone Hospital Meter System provides bidirectional wireless connectivity to hospital HIS or LIS with full security to safeguard patient data. Wireless connectivity can transmit patient results directly from the bedside, alleviating the need to bring the meter to a fixed location for meter docking and data transmission. Cost effectiveness of the direct measurement of 3--hydroxybutyrate in the management of diabetic ketoacidosis in children [Letter to the editor]. In any case, your provider will carefully interpret your results and discuss them with you. Altitude: Up to 15,000 feet a. 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 . Complies to IVDD Tested according to: EN 61010-1:2010, EN 61010-2-101:2015, EN 60825-1/A1:2014. StatStrip and StatStrip Xpress2 are the worlds most extensively studied and proven glucose test. QC: Three levels (Low, Normal, High); sold separately Measures ketones* with same meter Easy to use No meter preparation or calibration coding steps are required. Your provider will also order a blood glucose test if you have symptoms of high blood sugar (hyperglycemia) or low blood sugar (hypoglycemia). 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. Tests Measured: Glucose and Hematocrit When using clorox wipes to disinfect, how many min the meter surface stay wet for? Two particles, each with a charge of magnitude 12 nC, are at two of the vertices of an equilateral triangle with edge length 2.0 m. What is the magnitude of the electric field at the third vertex if one charge is positive and the other is negative? Blood Glucose results appear Low or High range in? Diabetes Technol Ther. 400 glucose measurements or QC tests: Measurement Range and Units : U.S. 10-900 mg/dL: Outside U.S. 1-50 mmol/L: Blood Glucose Measurement: Sample Volume Required: 1.2uL : Time to Glucose Results: 6 seconds : Connectivity: Data Transfer: Strip Port Connection to USB: Data Program: Nova Microsoft-Excel based data transfer Software: Battery Information: Type: 3V Li Button Battery Certain people are at risk for developing Type 2 diabetes. Results: The Nova StatStrip glucometer demonstrated an excellent coefficient of variation (<5%) for glucose across the entire analytical measurement range. Cleaning Meter. 556 556 556 556 556 556 889 500 556 556 556 556 278 278 278 278