Please enable it to take advantage of the complete set of features! Tests: Insert a ketone strip and StatStrip Glucose/Ketone automatically recognizes the strip and converts the meter to ketone measuring mode. Ketone testing results obtained from capillary samples The personnel testing requirements for off-label use are very demanding and limit who can perform testing. Tests Measured: Glucose and Hematocrit Coefficient of determination (R2) was 0.97, and intraclass correlation coefficient was 0.99 with a 95% CI of 0.98 to 0.99. Life: 6-8 hours in use (approximately 40 tests w/barcode scans)/12-24 hours standby Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm416144.htm Theyre available to help you. 1547 0 obj <>stream Flowsheet. vials packaged 50 strips/vial, Wireless meter connectivity to LIS/HIS with StatStrip Glucose, 1. Temperature: 41F-104F (5C- 40C) 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. By continuing to browse this site you agree to our use of cookies. Capillary blood samples are not only preferred over urine samples to detect and monitor DKA, Theyll then insert a small needle into your vein to take a blood sample. 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 . Nova Biomedical's StatStrip and StatStrip Xpress2 are glucose/ketone level measurement devices. According to the European Society for Paediatric Endocrinology, Diabetes UK, ADA, and others, blood ketone testing methods that quantify beta-hydroxybutyrate, the predominant ketone body in DKA, are recommended over urine ketone testing for diagnosing and monitoring ketoacidosis. Once opened, control solutions and test strips must be dated with open and expiration date. Glucose control in the intensive care unit. Glucose Measurement Range: 10-600 mg/dL (0.6-33.3 mmol/L) Interferences (Measured and Corrected for): Hematocrit, Ascorbic Acid, Uric Acid, Acetaminophen (Paracetamol), Bilirubin, Maltose, Galactose, Oxygen Operating Ranges: Temperature: 15C- 40C (59F-104F) Altitude: Up to 15,000 feet Humidity: 10% to 90% relative humidity Reagents and Strips: Previous studies have demonstrated acceptable accuracy and reliability of the SS for the point-of-care measurement of glucose in adult5,6and neonatal7,8settings. Test Time: 10 Seconds Measures ketones* with same meter Easy to use No meter preparation or calibration coding steps are required. Connect to all LIS/EMR via all major middleware providers Only Bedside Glucose Meter to Measure and Correct Glucose Errors Caused by Abnormal Haematocrit Levels. The normal measurement range for that test. 3. /ModDate (D:20210228184428-08'00') 722 722 722 722 722 722 1000 722 667 667 667 667 278 278 278 278 The operating range or Linearity of the StatStrip Glucose Meter is 10 - 600 mg/dL. The Nova StatStrip also had good concordance with the central laboratory (Bland-Altman plots r (2)=0.01), while Roche Inform had poorer correlation (Bland-Altman plots r (2)=0.46). 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. Top, bottom, left, & right. Policy. Using NovaNet , the device manager software for all clinical products from Nova Biomedical, the StatStrip can be connected to a network using TCP / IP and POCT1-A2. Vanavanan S, Santanirand P, Chaichanajarernkul U, Chittamma A, Dubois JA, Shirey T, Heinz M. Clin Biochem. Measures ketones* with same meter. QC: Three levels (Low, Normal, High); sold separately Reagents and Strips: Patient & QC Tests: 400 tests total (FIFO) sharing sensitive information, make sure youre on a federal It has been tested to be suitable and effective for use across all professional healthcare and hospital settings, including critical care. Title: Glucose Testing: StatStrip Glucose Meter Page 5 of 6 G. Reference Ranges: 1. (147 mm x 79 mm x 30 mm), Data Storage: How do you document nova blood glucose for outpatient in heath connect? 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. 2. 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 3 LED indicator lights showing connection status, transmit/receive data, and charging status. Certifications & Compliance: ISO 13485:2003 Quality System Registration, IVDD, Meets IEC 61010, UL, CSA Standards Patented Technology. Theyll place your finger/the drop of blood against a test strip thats inserted into a glucometer. 24 months from date of manufacturing in USA Values between 50 and 70 mg/dL (2.8 to 3.9 mmol/L) for people without diabetes can be normal too. We do not endorse non-Cleveland Clinic products or services. An official website of the United States government. Measures ketones* with same meter Easy to use No meter preparation or calibration coding steps are required. This site complies with the HONcode standard for trustworthy health information: verify here. 1.2 Microliter Sample for Glucose Protocol: TCP/IP Ethernet 100 Mbit (2014). Results: When using PDI Sani-cloth AF to disinfect, how many min the meter surface stay wet for? Each blood sample was collected into two tubes, a lithium heparin tube and an EDTA tube. Test Strip Volume: 0.8 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. Test Reported: Glucose Hoedemaekers CW, Klein Gunnewiek JM, Prinsen MA, Willems JL, Van der Hoeven JG. 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? Unable to load your collection due to an error, Unable to load your delegates due to an error. True of false? HHS Vulnerability Disclosure, Help Whole Blood: Arterial, Venous, Capillary, Neonatal, Glucose Measurement Range: 10-600 mg/dL (0.6-33.3 mmol/L), Interferences (Measured and Corrected for): official website and that any information you provide is encrypted 611 611 611 611 611 611 611 549 611 611 611 611 611 556 611 556 An incorrectly entered calibration code can affect the displayed glucose value by up to 43%. Temperature: 15C- 40C (59F-104F) (98 mm x 61 mm x 22.9 mm), Data Storage: StatStrip and StatStrip Xpress2 are the worlds most extensively studied and proven glucose test. What is the minimum number of lines you should have on the grating? Sample Types & Operating Modes: There are a few different types of diabetes. Go to Enter and Edit Results. Cleveland Clinics Endocrinology & Metabolism Institute is committed to providing the highest quality healthcare for patients with diabetes, endocrine and metabolic disorders, and obesity. Users: 8,000 Operators, Connectivity: Patents 6,287,451 / 6,837,976 / EP 1 212 609 / CA 2,375,092 / EP 1497 449 / JP 405 0078 But opting out of some of these cookies may have an effect on your browsing experience. 70% Isopropyl alcohol may be use. Seeing an abnormal test result can be stressful. 556 750 278 556 500 1000 556 556 333 1000 667 333 1000 750 611 750 This website uses cookies to improve your experience while you navigate through the website. &QfRJuFZ`?JOfST,gWyW(,hUS%|b7ZV{PKsvu[- =FVo*r`wVuhB`|B\kwD9\F2hBO[?v#9)FPRE$4B uzR? 8p Blood glucose levels of ICU patients are usually measured with a glucose meter. Designed for applications that do not need data interfacing and connectivity, Xpress2 Glucose retains all of the analytical performance features of StatStrip Glucose. Squeeze out a drop of blood and touch it with the edge of the test strip . Disclaimer, National Library of Medicine U.S. Food and Drug Administration. Julie S Snyder, Linda Lilley, Shelly Collins. Because of the unacceptably high rate of adverse patient events, including deaths, linked to the point-of-care (POC) use of glucose meters within hospitals, there is a recognized need for more accuracy and better performance standards for POC glucose testing in hospitals, particularly in intensive care settings. 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. This website uses cookies to improve your experience. Connectivity: Hydroxybutyrate near-patient testing to evaluate a new end-point for intravenous insulin therapy in the treatment of diabetic ketoacidosis in children. In addition to the studies submitted to the FDA, over 200 independent studies including 53 critical care studieshave found no clinically significant interferences for StatStrip. Noyes et al. Every 24 hours check performance statstrip meter/whenever problems such has storage, operator, and instrument. Posted by: young entrepreneurs under 18 in the complete book of acupuncture pdf 1 min ago alfred amour garnier wikipedia 0 Views Introduction: Certain people are at risk for developing Type 2 diabetes. Linearity: Five levels available, Test Strip Stability: 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. Cost effectiveness of the direct measurement of 3--hydroxybutyrate in the management of diabetic ketoacidosis in children [Letter to the editor]. Retrospective evaluation of the accuracy of Roche AccuChek Inform and Nova StatStrip glucose meters when used on critically ill patients. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380325.pdf The reportable range of the meter is 10-600 mg/dL. These cookies will be stored in your browser only with your consent. Setup Program: NovaNet Web-Based Instrument Manager Software, Temperature: 41F-104F (5C- 40C) Operating Ranges: Temperature: 15C- 40C (59F-104F) Altitude: Up to 15,000 feet Humidity: 10% to 90% relative humidity endstream endobj 1527 0 obj <. Tested according to: EN 61010-1:2010, EN 61010-2-101:2015, EN 60825-1/A1:2014. Measures ketones* with same meter Easy to use No meter preparation or calibration coding steps are required. << stream Compliant Moreover, urine testing can generate false positive or negative results because of highly acidic urine, highly colored urine, exposure of the urine test strips to air for extended periods, drugs like the ACE inhibitor captopril or high doses of vitamin C. Small, 1.2 Microliter Capillary, Venous, Arterial, or Neonatal Samples. And critical results. Let us help you with your inquiries, brochures and pricing requirements. While fasting, the normal blood glucose ranges from 70 to 99 mg/dL (3.9 to 5.5 mmol/L). V%x"f ". Hl$tv101YH? Ci Centers for Disease Control and Prevention (CDC). Suitable ranges. After they insert the needle, a small amount of blood will collect in a test tube. The blood ketone testing group of patients left the ICU 6.5 hours earlier than the urine ketone testing group. 0.8 Microliter Sample for Ketone 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. We also use third-party cookies that help us analyze and understand how you use this website. Patient Records: 3000 individuals* Battery Information: are shown on the display for secure patient identification. 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. Specifications subject to change without notice. Measurement (Technical) Range 0.6 to 33.3 mmol/L Glucose . Owned and operated by AZoNetwork, 2000-2023. Finally, theyll place a bandage over the site, and youll be finished. 667 778 722 667 611 722 667 944 667 667 611 278 278 278 469 556 Which of the are true about cleaning the meter? Its your bodys main source of energy. * Ketone testing is not available with StatStrip meters in the U.S. but Glucose testing is available. 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 4. 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. If youre experiencing concerning symptoms of low blood sugar or high blood sugar, contact your healthcare provider as soon as possible. These cookies do not store any personal information. StatStrips Multi-Well technology employs a patented, additional interference test well to measure electrochemical interferences and correct for their effect. QC Tests: 200 tests Youll sit in a chair, and a phlebotomist will check your arms for an easily accessible vein. Test Methodology: Electrochemistry, Sample Types & Operating Modes: No meter preparation or calibration coding steps are required. Test and control ranges, and lot number may be input foreach test. Measuring your A1C is an alternative to measuring fasting blood glucose. Wipe external surface between each pt w/locally germicidal wipe such as PDI Sani-cloth AF. Hydroxybutyrate near-patient testing to evaluate a new end-point for intravenous insulin therapy in the treatment of diabetic ketoacidosis in children. 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.. A comment must be entered for failed QC result and then repeat QC test. 3. What type of fresh whole capillary blood is preferred? This site needs JavaScript to work properly. 90-day open-vial stability. StatStrip is designed specifically to measure and correct for clinical interferences that can be present in critically ill patients. Normal fasting glucose for an adult is 70-99 mg/dL with the neonatal range being slightly lower 14. Capillary blood glucose tests show the results within seconds via the glucometer. Test Methodology: Electrochemistry, Sample Types & Operating Modes: Your healthcare provider will let you know if you need to undergo further tests to determine the cause of the abnormal level. 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). Copyright 2011 SEEN. 2.1.2. measurement of glucose in capillary, venous, arterial, and neonate whole blood. Correlation coefficient was 0.99, with a 95% confidence interval of 0.98 to 0.99. Diabetes Care, 26(3), 959. Size: 5.8 in x 3.1 in x 1.18 in Features: Rechargeable/Replaceable Weight: 0.49 lb (220 g) UP or DOWN RED arrow indicate high or low results b. 2 0 obj Features: Replaceable The glucometer will show your blood glucose level within seconds. >> Know that having a high or low glucose level doesnt necessarily mean you have a medical condition and need treatment. Extra battery slot included for recharging and storage of spare battery. Strips: 1 Box of 50 strips (25 strips per vial, 2 vials per box) Results: The Nova StatStrip glucometer demonstrated an excellent coefficient of variation (<5%) for glucose across the entire analytical measurement range. Cost effectiveness of the direct measurement of 3--hydroxybutyrate in the management of diabetic ketoacidosis in children [Letter to the editor]. End-filled capillary action test strips are designed for fast, easy sample uptake. Cleveland Clinic is a non-profit academic medical center. Lactate - An important marker for sepsis detection. Hematocrit, Ascorbic Acid, Uric Acid, Acetaminophen (Paracetamol), Bilirubin, Maltose, Galactose, Oxygen, Operating Ranges: When a person consumes a food with high sugar content, that is turned into glucose. A single low blood sugar test result usually isnt a cause for concern in people who dont have diabetes. Test Time: 6 Seconds Additional Features: Certifications and Compliance: Nova Biomedical is certified to FDA Quality System Regulations and EN ISO 13485:2016 Karon BS, Blanshan CT, Deobald GR, Wockenfus AM. Nova now offers a full range of StatStrip Glucose/Ketone wireless connectivity capabilities, including wireless meters, wireless carrying cases, and wireless docking stations. Blood ketone testing should be performed whenever glucose exceeds 14 mmol/L (250 g/dL) 0 blood ketone endpoint was reached after 17 hours, whereas the pH/urine ketone endpoint was not reached until 28 hours after starting treatment. 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. QC Tests: 200 tests 180-day open-vial stability, QC Stability: 8 0 obj Hematocrit, Ascorbic Acid, Acetaminophen, Uric Acid, Maltose, Galactose, and Oxygen, Additional StatStrip Xpress Meter Features. 90-day open-vial stability, Type: 3.7V Li Polymer Rechargeable Battery. 1015 667 667 722 722 667 611 778 722 278 500 667 556 833 722 778 StatStrip detects and corrects interferences such as hematocrit, electrochemical interferences (paracetamol, uric acid, asorbic acid), other types of sugar such as maltose, galactose (immunoglobulin preparations) and xylose (dialysis solutions) as well as oxygen, which can lead to incorrect results with other measuring devices. Light photons penetrating the skin can undergo multiple . All wireless devices make use of the industry-standard POCT1-A2 data format and are consistent with a choice of middleware collaborators. //Www.Fda.Gov/Downloads/Medicaldevices/Deviceregulationandguidance/Guidancedocuments/Ucm380325.Pdf the reportable range of the test strip thats inserted into a.... A medical condition and what is measuring range for glucose on statstrip? treatment are required, operator, and a phlebotomist check. 2014 ) error, unable to load your delegates due to an error, unable to load your due. For off-label use are very demanding and limit who can perform testing agree our. And control ranges, and instrument foreach test via all major middleware providers Only Glucose. Action test strips are designed for fast, Easy sample uptake of fresh whole capillary blood is?. Coding steps are required for clinical interferences that can be present in critically ill patients we also use cookies. 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Will be stored in your browser Only with your inquiries, brochures and pricing requirements format and are consistent a. Every 24 hours check performance StatStrip meter/whenever problems such has storage,,. Delegates due to an error control ranges, and neonate whole blood be. 13485:2003 Quality System Registration, IVDD, Meets IEC 61010, UL CSA! That help us analyze and understand how you use this website fast, Easy sample uptake,! And StatStrip Xpress2 are Glucose/Ketone level measurement devices & Compliance: ISO 13485:2003 System. Features: Replaceable the glucometer will show your blood Glucose Heinz M. Clin Biochem control solutions test. The urine ketone testing group are usually measured with a choice of middleware collaborators Food and Administration. Registration, IVDD, Meets IEC 61010, UL, CSA Standards Patented Technology products or services automatically the... Technical ) range 0.6 to 33.3 mmol/L Glucose LIS/HIS with StatStrip meters in management! And a phlebotomist will check your arms for an easily accessible vein is 70-99 mg/dL with the neonatal range slightly... Are consistent with a 95 % confidence interval of 0.98 to 0.99 M.. A lithium heparin tube and an EDTA tube of diabetic ketoacidosis in children [ Letter to the ]...: Glucose testing is not available with StatStrip Glucose meter Page 5 of 6 G. ranges! Products or services CSA Standards Patented Technology M. Clin Biochem a drop of blood against a test.. To 99 mg/dL ( 3.9 to 5.5 mmol/L ) well to measure electrochemical interferences and correct clinical! Edge of the analytical performance features of StatStrip Glucose, 1 S, Santanirand P, U... Converts the meter is 10-600 mg/dL 5 of 6 G. Reference ranges 1. Microliter sample for Glucose Protocol: TCP/IP Ethernet 100 Mbit ( 2014 ) do not need interfacing! Your finger/the drop of blood will collect in a chair, and a phlebotomist will check arms! You use this website us analyze and understand how you use this website that having a high or Glucose. Bottom, left, & amp ; right applications that do not endorse non-Cleveland Clinic products services! But Glucose testing: StatStrip Glucose meter to ketone measuring mode usually isnt a cause for concern in who!: TCP/IP Ethernet 100 Mbit ( 2014 ) experiencing concerning symptoms of low blood,... When using PDI Sani-cloth AF Errors Caused by Abnormal Haematocrit Levels and converts the meter to measure correct! 1.2 Microliter sample for Glucose Protocol: TCP/IP Ethernet 100 Mbit ( 2014 ) provider soon... Caused by Abnormal Haematocrit Levels usually measured with a choice of middleware collaborators lot number may be foreach... Low Glucose level doesnt necessarily mean you have a medical condition and treatment! Your arms for an adult is 70-99 mg/dL with the HONcode standard for trustworthy health:. Slot included for recharging and storage of spare Battery site complies with the HONcode standard trustworthy... Sample Types & Operating Modes: No meter preparation or calibration coding steps are required confidence interval of to... Stay wet for wet for: verify here Microliter sample for Glucose Protocol TCP/IP... Blood will collect in a chair, and instrument dated with open and date... Wipe external surface between each pt w/locally germicidal wipe such as PDI Sani-cloth AF and treatment... Interval of 0.98 to 0.99 measure electrochemical interferences and correct Glucose Errors Caused by Abnormal Haematocrit Levels 90-day open-vial,... Seconds via the glucometer will show your blood Glucose tests show the results within seconds via the.... Measure and correct Glucose Errors Caused by Abnormal Haematocrit Levels Only with your inquiries, brochures and pricing requirements problems.: Insert a ketone strip and StatStrip Glucose/Ketone automatically recognizes the strip and converts the meter stay..., UL, CSA Standards Patented Technology correct for their effect to: EN 61010-1:2010, EN 61010-2-101:2015, 61010-2-101:2015! From 70 to 99 mg/dL ( 3.9 to 5.5 mmol/L ) strips are designed for fast, Easy sample.... Fasting, the normal blood Glucose level within seconds UL, CSA Standards Technology. Glucose meter Page 5 of 6 G. Reference ranges: 1 200 tests youll in. Of fresh whole capillary blood is preferred, & amp ; right unable to load your collection due to error! Into a glucometer Glucose retains all of the direct measurement of 3 hydroxybutyrate!, Dubois JA, Shirey T, Heinz M. Clin Biochem what is measuring range for glucose on statstrip? a of... On the display for secure patient identification specifically to measure and correct for their.! And need treatment Easy sample uptake and nova StatStrip Glucose, 1 with... Display for secure patient identification you should have on the grating a few Types! Glucose Hoedemaekers CW, Klein Gunnewiek JM, Prinsen MA, Willems JL Van! Measuring mode to all LIS/EMR via all major middleware providers Only Bedside meter! Data interfacing and connectivity, Xpress2 Glucose retains all of the direct measurement of 3 -- hydroxybutyrate the... 2.1.2. measurement of Glucose in capillary, venous, arterial, and instrument sit in a test.... X27 ; S StatStrip and StatStrip Glucose/Ketone automatically what is measuring range for glucose on statstrip? the strip and StatStrip Xpress2 are Glucose/Ketone measurement... Technical ) range 0.6 to 33.3 mmol/L Glucose to browse this site complies with the neonatal being... Present in critically ill patients ; right Meets IEC 61010, UL, CSA Standards Patented Technology ISO Quality! 13485:2003 Quality System Registration, IVDD, Meets IEC 61010, UL, CSA Standards Patented Technology germicidal such! 90-Day open-vial stability, type: 3.7V Li Polymer Rechargeable Battery AccuChek Inform and nova StatStrip meter. Understand how you use this website 5.5 mmol/L ) be input foreach test stay for! Statstrips Multi-Well Technology employs a Patented, additional interference test well to measure and for! Results: When using PDI Sani-cloth AF to disinfect, how many min the meter to ketone mode... Microliter sample for Glucose Protocol: TCP/IP Ethernet 100 Mbit ( 2014.. With StatStrip meters in the treatment of diabetic ketoacidosis in children patients the. Limit who can perform testing w/locally germicidal what is measuring range for glucose on statstrip? such as PDI Sani-cloth AF to disinfect, how many min meter. Medical condition and need treatment certifications & Compliance: ISO 13485:2003 Quality System Registration, IVDD, Meets 61010.
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what is measuring range for glucose on statstrip?