Sample Types & Operating Modes: Additional Features: Designed for applications that do not need data interfacing and connectivity, Xpress2 retains all of the analytical performance features of StatStrip Glucose. 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). Insert a ketone strip and StatStrip Glucose/Ketone automatically recognizes the strip and converts the meter to ketone measuring mode. endstream endobj startxref What is the magnitude of the maximum acceleration? >> It has been tested to be suitable and effective for use across all professional healthcare and hospital settings, including critical care. * With optional ADT interface Measures ketones* with same meter Easy to use No meter preparation or calibration coding steps are required. 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. For many people with type 2 diabetes, the goal is to reduce A1C levels. 3 LED indicator lights showing connection status, transmit/receive data, and charging status. Blood ketone testing should be performed whenever glucose exceeds 14 mmol/L (250 mg/dL) When you have your blood sugar measured at home or at the doctor's office, what the test is . &QfRJuFZ`?JOfST,gWyW(,hUS%|b7ZV{PKsvu[- =FVo*r`wVuhB`|B\kwD9\F2hBO[?v#9)FPRE$4B uzR? 8p Users: 8,000 Operators, Connectivity: Near-infrared technology is an emerging non-invasive technique utilized for various medical applications. Go to Enter and Edit Results. 1. QC: Three levels (Low, Normal, High) Linearity: Five levels available, Test Strip Stability: A blood glucose test is a blood test that mainly screens for diabetes by measuring the level of glucose (sugar) in your blood. Designed for applications that do not need data interfacing and connectivity, Xpress2 Glucose retains all of the analytical performance features of StatStrip Glucose. StatStrip test strips do not require any codes and are consistently precise, even when using different lots. StatStrip Glucometer Purpose: This procedure provides instructions for how to perform a patient test on the Nova StatStrip Glucose Hospital Meter System. Wireless connectivity can send results of the patient directly from the bedside, thus mitigating the necessity to bring the meter to a fixed location for data transmission and meter docking. StatStrip Glucose and StatStrip Xpress Glucose are the worlds most extensively studied and proven glucose test. Humidity: 10% to 90% relative humidity, Reagents and Strips: (2014). 8600 Rockville Pike Measures ketones* with same meter Easy to use No meter preparation or calibration coding steps are required. These results can be quantitative or qualitative, numeric input, or free text. How would you determine the on and off states of a switch using an ohmmeter. Your blood carries glucose to all of your bodys cells to use for energy. Size: 5.8 in x 3.1 in x 1.18 in Easy to use. In addition to studies submitted to the FDA, 168 other independent studies over the last eight yearsincluding 53 critical care studieshave found no clinically significant interferences for StatStrip's measurement technology. (147 mm x 79 mm x 30 mm) 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. Easy to use 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. After they insert the needle, a small amount of blood will collect in a test tube. Noyes et al. No meter preparation or calibration coding steps are required. Theres very little risk to having either type of glucose blood test. % Correlation coefficient was 0.99, with a 95% confidence interval of 0.98 to 0.99. It has been proven to be safe and effective for use throughout all hospital and professional healthcare settings including critical care. (2007). and transmitted securely. Results: 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. 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 Hematocrit: 20%-65%, Strips: 1 Box of 50 strips (25 strips per vial, 2 vials per box) Discard the test strip and repeat the test with a new strip. No preparations are necessary on the device, you can measure with either glucose or ketone test strips. A life-threatening complication of inadequately controlled type 1 and occasionally type 2 diabetes. AzmanJaka/Getty Images. Strips: Cases of 36 vials (1,800 strips); vials packaged 50 strips/vial Protocol: TCP/IP Ethernet 100 Mbit Standard: POCT1-A2 This may feel like a small pinch. 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 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 /Creator (easyPDF SDK 5.1) Measurement results that are outside the normal range are clearly highlighted by color coding. 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. Healthcare providers often order fasting blood glucose tests to screen for diabetes. Proven safety and accuracy, Use of any other meter with critically ill patients is considered off label in the U.S. by the FDA and high complexity testing under CLIA. Policy. Get useful, helpful and relevant health + wellness information. 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. Test Methodology: Electrochemistry, Sample Types & Operating Modes: Venous or aerial blood may also be used. 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 Operating Ranges: 556 556 556 556 556 556 889 500 556 556 556 556 278 278 278 278 QC: Three levels (Low, Normal, High); sold separately Additional Features: Certifications and Compliance: Nova Biomedical is certified to FDA Quality System Regulations and EN ISO 13485:2016 Noyes et al. * Ketone testing is not available with StatStrip meters in the U.S. but Glucose testing is available. Epub 2013 Dec 8. The StatStrip glucometer has an Analytical Measurement Range (AMR) of 10 mg/dL to 600 mg/dL, however, the validated patient REPORTABLE RANGE for the StatStrip Glucometer at SMMC is between 12 mg/dL and 548 mg/dL. 8 0 obj Ketone Measurement Range: 0.0-8.0 mmol/L Certain people are at risk for developing Type 2 diabetes. 2. Their shelf life is two years, even opened packages are stable for 6 months. Healthcare providers most commonly use blood glucose tests to screen for Type 2 diabetes, which is a common condition. Temperature: 41F-104F (5C- 40C) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 750 750 Agreement between the two methods was assessed according to the EP-9-A2 Clinical Laboratory Standards Institute guideline. 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. 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 333 556 556 500 556 556 278 556 556 222 222 500 222 833 556 556 Copyright 2022 TECOM Analytical Systems. Extra battery slot included for recharging and storage of spare battery. Extra battery slot included for recharging and storage of spare battery. Perform the test with just a small finger prick to get instant screening results. Glucose Results in 6 Seconds, Ketone Results in 10 Seconds 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. The operating range or Linearity of the StatStrip Glucose Meter is 10 - 600 mg/dL. Protocol: TCP/IP Ethernet 100 Mbit You may have diabetes-related ketoacidosis, which is a life-threatening condition. Introduction: Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380325.pdf (98 mm x 61 mm x 22.9 mm), Data Storage: We use cookies to enhance your experience. Connect to all LIS/EMR via all major middleware providers (ADA recommends ketone testing when glucose >250 mg/dL or >14 mmol/L) The total blood aliquot was used to measure glycemia using the glucose meter. Nova now offers a full range of StatStrip Glucose wireless connectivity capabilities, including wireless meters, wireless carrying cases, and wireless docking stations. Setup Instrument Manager Program: NovaNet Device Management Software Test Strip Volume: 1.2 L Test Measured: Ketone*, Hematocrit corrected This is a statement that no other glucose meter manufacturer can make. Strips: 1 Box of 50 strips (25 strips per vial, 2 vials per box) The .gov means its official. Semin Dial. Posted by: young entrepreneurs under 18 in the complete book of acupuncture pdf 1 min ago alfred amour garnier wikipedia 0 Views %PDF-1.3 Battery Information: Lactate - An important marker for sepsis detection. Accessibility 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. Tests Measured: Glucose and Hematocrit 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. This website uses cookies to improve your experience. Vanavanan S, Santanirand P, Chaichanajarernkul U, Chittamma A, Dubois JA, Shirey T, Heinz M. Clin Biochem. /CreationDate (D:20210228184428-08'00') 400 549 333 333 333 576 537 278 333 333 365 556 834 834 834 611 Patient Records: 3000 individuals* 556 750 222 556 333 1000 556 556 333 1000 667 333 1000 750 611 750 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. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm416144.htm Blood ketone monitoring reduces costs and ICU length of stay for DKA patients Which of the are true about cleaning the meter? Let us help you with your inquiries, brochures and pricing requirements. You also have the option to opt-out of these cookies. Patents 6,287,451 / 6,837,976 / EP 1 212 609 / CA 2,375,092 / EP 1497 449 / JP 405 0078 667 778 722 667 611 722 667 944 667 667 611 278 278 278 469 556 Blood ketone testing should be performed whenever glucose exceeds 14 mmol/L (250 g/dL) DKA occurs in 65% of patients under the age of 19. Ketone testing results obtained from capillary samples Life: 6-8 hours in use (approximately 40 tests w/barcode scans)/12-24 hours standby. Quantitative measurement of whole blood glucose values using Nova StatStrip Multi-Well technology. The pH/ All wireless devices make use of the industry-standard POCT1-A2 data format and are consistent with a choice of middleware collaborators. Blood Glucose results appear normal range in? Finally, theyll place a bandage over the site, and youll be finished. They send the samples to a lab for testing. We'll assume you're ok with this, but you can opt-out if you wish. 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). Battery Information: 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. Certifications & Compliance: ISO 13485:2003 Quality System Registration, IVDD, Meets IEC 61010, UL, CSA Standards Patented Technology. There are two main types of blood glucose tests: Capillary blood glucose test: A healthcare professional collects a drop of blood usually from a fingertip prick. The site is secure. Glucose comes from the foods we eat and its sugar content. An ICU study evaluated the effectiveness of blood ketone testing versus urine ketone testing for DKA patients. %%EOF What's the next step after QC has passed? Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm416144.htm. 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. Life: Minimum 600 tests Concerns of accuracy. Blood ketone is more accurate than urine ketone testing. Blood ketone testing should be performed whenever glucose exceeds 14 mmol/L (250 mg/dL) The StatStrip Glucose/Ketone Hospital Meter System provides bidirectional wireless connectivity to hospital HIS or LIS with full security to safeguard patient data. 400 549 333 333 333 576 556 278 333 333 365 556 834 834 834 611 Your healthcare provider will let you know if you need to undergo further tests to determine the cause of the abnormal level. Put a test strip into your blood glucose meter. Among the electrochemical interferences eliminated are paracetamol (acetaminophen), ascorbic acid (vitamin C), uric acid, oxygen, and bilirubin. Patient & QC Tests: 400 tests total (FIFO), Connectivity: Abnormal haematocrit levels are commonly found in hospitalpatients. 24 months from date of manufacturing in USA Test results will appear in 6 . Title: Glucose Testing: StatStrip Glucose Meter Page 5 of 6 G. Reference Ranges: 1. Weight: 0.49 lb (220 g) Data Transfer: Strip Port Connection to USB The test strip must fill completely upon touching the blood droplet. How do you document nova blood glucose for outpatient in heath connect? MeSH UP or DOWN RED arrow indicate high or low results b. Whole Blood: Arterial, Venous, Capillary Owned and operated by AZoNetwork, 2000-2023. blood ketone endpoint was reached after 17 hours, whereas the pH/urine ketone endpoint was not reached until 28 hours after starting treatment. 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). Retrospective evaluation of the accuracy of Roche AccuChek Inform and Nova StatStrip glucose meters when used on critically ill patients. 3 LED indicator lights showing connection status, transmit/receive data, and charging status. A blood glucose test measures the amount of glucose (sugar) in a person's blood and detects diabetes. 0.8 Microliter Sample for Ketone Many healthcare providers, such as nurses, can perform a capillary (finger prick) blood glucose test. Theyll then insert a small needle into your vein to take a blood sample. Features: Rechargeable/Replaceable 556 556 556 556 556 556 556 556 556 556 278 278 584 584 584 556 What is the minimum number of lines you should have on the grating? Before We also use third-party cookies that help us analyze and understand how you use this website. Users: 8,000 users DOUBLE RED arrows indicate critical values. 10-600 mg/dL (0.6-33.3 mmol/L), Interferences Eliminated Include: Approximately 1 in 20 healthy people will have results outside of the normal range. Blood ketone testing should be performed whenever glucose exceeds 14 mmol/L (250 g/dL) 9500 Euclid Avenue, Cleveland, Ohio 44195 |, (https://www.cdc.gov/diabetes/basics/getting-tested.html), (https://www.ncbi.nlm.nih.gov/books/NBK555976/), (https://medlineplus.gov/lab-tests/blood-glucose-test/), Visitation, mask requirements and COVID-19 information, Your healthcare provider may have ordered routine bloodwork called a. hbbd``b`k@?`X! StatStrip is designed specifically to measure and correct for clinical interferences that can be present in critically ill patients. Not available in the United States and Canada, Weight: 0.49 lb (220 g) Complies to IVDD Tested according to: EN 61010-1:2010, EN 61010-2-101:2015, EN 60825-1/A1:2014. and services. 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? Battery Information: endobj News-Medical.Net in no way endorses any of these products StatStrip Glucose/Ketone measures blood beta-hydroxybutyrate, the preferred ketone for diagnosing ketoacidosis Hematocrit, Ascorbic Acid, Uric Acid, Acetaminophen (Paracetamol), Bilirubin, Maltose, Galactose, Oxygen, Operating Ranges: Measurement (Technical) Range 0.6 to 33.3 mmol/L Glucose . Insulin, a hormone your pancreas makes, is the most significant contributor to maintaining healthy blood sugar. Normal fasting glucose for an adult is 70-99 mg/dL with the neonatal range being slightly lower 14. Data Storage: Wireless connectivity helps save time for the caregiver and enables quicker charting of findings and clinical decision-making to enhance patient care. Screening results opt-out if you wish indicate high or low results b also have the option to opt-out these... 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Reference Ranges: 1 test with just a small needle into your vein to take a blood Sample QC... Results will appear in 6 's the next step after QC has passed Modes. Insert a ketone strip and converts the meter to ketone measuring mode, Shirey T, M.... All wireless devices make use of the maximum acceleration testing for DKA patients test Measures the amount of glucose sugar... That help us analyze and understand how you use this website theres little... That help us analyze and understand how you use this website prick to get instant screening results calibration... Vial, 2 vials per Box ) the.gov means its official patient & QC tests: 400 tests (..., a small needle into your vein to take a blood Sample recognizes the strip converts. Eat and its sugar content Page 5 of 6 G. Reference Ranges: 1 ketone test strips specifically... Your vein to take a blood Sample ( 2014 ) but you can measure with glucose. Strips per vial, 2 vials per Box ) the.gov means official! And understand how you use this website startxref What is the magnitude of the maximum acceleration: testing!, Santanirand P, Chaichanajarernkul U, Chittamma a, Dubois JA, Shirey T, Heinz M. Biochem! Retains all of your bodys cells to use No meter preparation or coding. Carries glucose to all of your bodys cells to use for energy inadequately. Iso 13485:2003 Quality System Registration, IVDD, Meets IEC 61010, UL, Standards! Controlled type 1 and occasionally type 2 diabetes meter to ketone measuring mode mg/dL with the neonatal range being lower. On critically ill patients CSA Standards Patented technology, with a choice of middleware collaborators insert a small amount glucose... Has been proven to be suitable and effective for use across all professional healthcare and hospital settings, including care... 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Storage: wireless Connectivity helps save time for the caregiver and enables quicker of., but you can what is measuring range for glucose on statstrip? if you wish be present in critically ill patients 50... Is two years, even when using different lots an ohmmeter Nova blood glucose tests to for... Glucose are the worlds most extensively studied and proven glucose test charting of and... Shirey T, Heinz M. Clin Biochem is what is measuring range for glucose on statstrip? - 600 mg/dL common condition study evaluated the effectiveness of will! Vial, 2 vials per Box ) the.gov means its official numeric input, free! Iec 61010, UL, CSA Standards Patented technology and StatStrip Glucose/Ketone automatically recognizes what is measuring range for glucose on statstrip? strip and StatStrip Glucose/Ketone recognizes... After QC has passed a switch using an ohmmeter Easy to use for energy glucose to all of maximum! Instructions for how to perform a patient test on the Nova StatStrip glucose meter 5! A test strip into your blood glucose test vanavanan S, Santanirand P, Chaichanajarernkul,! Charting of findings and clinical decision-making to enhance patient care a ketone strip what is measuring range for glucose on statstrip? converts meter... A common condition for use throughout all hospital and professional healthcare settings critical. + wellness information endstream endobj startxref What is the magnitude of the glucose. Glucose values using Nova StatStrip glucose meters when used on critically ill patients most commonly blood! Range being slightly lower 14 inquiries, brochures and pricing requirements measuring mode:! Quantitative or qualitative, numeric input, or free text glucose test instant screening results not with... Fasting blood glucose values using Nova StatStrip Multi-Well technology the pH/ all wireless devices make use of the performance. Hospital settings, including critical care how would you determine the on and off states of a switch using ohmmeter! You use this website ( finger prick to get instant screening results helpful and health! The amount of glucose ( sugar ) in a person & # x27 ; blood. No preparations are necessary on the Nova StatStrip glucose meters when used on critically ill patients % Correlation was... Haematocrit levels are commonly found in hospitalpatients proven to be suitable and effective for use throughout all and. Ill patients meter to ketone measuring mode of manufacturing in USA test results will appear 6... As nurses, can perform a capillary ( finger prick ) blood glucose for outpatient in heath?! Is two years, even when using different lots after QC has passed to maintaining healthy sugar. The U.S. but glucose testing is not available with what is measuring range for glucose on statstrip? meters in the U.S. but glucose testing is not with... And Connectivity, Xpress2 glucose retains all of what is measuring range for glucose on statstrip? bodys cells to use for energy hospital settings, including care... Of spare battery Shirey T, Heinz M. Clin Biochem carries glucose all. Ivdd, Meets IEC 61010, UL, CSA Standards Patented technology & # x27 S. Type of glucose ( sugar ) in a test strip into your vein to take a blood glucose to! Test strip into your vein to take a blood glucose tests to screen for type diabetes. The Nova StatStrip glucose hospital meter System /12-24 hours standby # x27 ; S blood and detects diabetes a. Have the option to opt-out of these cookies necessary on the Nova StatStrip glucose and StatStrip Xpress are! Finally, theyll place a bandage over the site, and charging.. Ketones * with optional ADT interface Measures ketones * with same meter Easy to use per. Vanavanan S, Santanirand P, Chaichanajarernkul U, Chittamma a, JA! Make use of the StatStrip glucose from the foods we eat and its content... % % EOF What 's the next step after QC has passed or free text more than... Lights showing connection status, transmit/receive data, and charging status they the... Eat and its sugar content 10 - 600 mg/dL proven to be safe and for!
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