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 Ketone testing results obtained from capillary samples A CGM is inserted under the skin and measures interstitial glucose continually for about 14 days. Bethesda, MD 20894, Web Policies You need to consume carbohydrates (sugar) to treat hypoglycemia, such as a banana or apple juice. 2010 Mar-Apr;23(2):157-62. doi: 10.1111/j.1525-139X.2010.00702.x. Blood glucose control in the intensive care unit: benefits and risks. There couldve also been an error in the collection, transport or processing of the test. Test Strip Volume: 0.8 l >> 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. 556 556 556 556 556 556 889 500 556 556 556 556 278 278 278 278 3 LED indicator lights showing connection status, transmit/receive data, and charging status. True or false? Theyre available to help you. It has been proven to be safe and effective for use throughout all hospital and professional healthcare settings including critical care. 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. Accuracy of bedside glucose measurement from three glucometers in critically ill patients. 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. Certifications and compliances applicable in countries where regulations require. 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: You may be having symptoms of high blood sugar or low blood sugar, which could indicate diabetes or another condition. 16 0 obj vials packaged 50 strips/vial, Wireless meter connectivity to LIS/HIS with StatStrip Glucose, 1. An incorrectly entered calibration code can affect the displayed glucose value by up to 43%. The test can involve a finger prick or a blood draw from your vein. Only Bedside Glucose Meter to Measure and Correct Glucose Errors Caused by Abnormal Haematocrit Levels. 2. 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. QC: Three levels (Low, Normal, High); sold separately Once opened, control solutions and test strips must be dated with open and expiration date. Hematocrit, Ascorbic Acid, Acetaminophen, Uric Acid, Maltose, Galactose, and Oxygen, Additional StatStrip Xpress Meter Features. A life-threatening complication of inadequately controlled type 1 and occasionally type 2 diabetes. Blood ketone monitoring reduces costs and ICU length of stay for DKA patients The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin, Dr. Dodell says. Recently, there have been many attempts to utilize NIR technology for the continues monitoring of blood glucose levels through the skin. Results: 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. Features: Replaceable Higher levels could be a sign of diabetes or pre-diabetes. Glucose Results in 6 Seconds, Ketone Results in 10 Seconds 1. If you have elevated blood glucose levels (hyperglycemia), it usually indicates diabetes. (ADA recommends ketone testing when glucose >250 mg/dL or >14 mmol/L) Measurement (Technical) Range 0.6 to 33.3 mmol/L Glucose . Testing for diabetes or prediabetes. If a person with diabetes has a meter, test strips and is testing, it's important to know what the blood glucose . 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. U.S. Food and Drug Administration. Continuous glucose monitoring devices (CGMs) are another option for this. Cost effectiveness of the direct measurement of 3--hydroxybutyrate in the management of diabetic ketoacidosis in children [Letter to the editor]. 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). Blood ketone testing should be performed whenever glucose exceeds 14 mmol/L (250 g/dL) QC: Three levels (Low, Normal, High) Conventionally manufactured blood glucose test strips require the use of calibration codes, as the sensitivity can vary greatly between individual lots. Tests Measured: Glucose and Hematocrit Hoedemaekers CW, Klein Gunnewiek JM, Prinsen MA, Willems JL, Van der Hoeven JG. 11 0 obj What's the next step after QC has passed? Disclaimer, National Library of Medicine Networkable point-of-care test strip system for determining lactate. Test Time: 6 Seconds An official website of the United States government. Results: 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). 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. 556 556 556 556 556 556 556 556 556 556 333 333 584 584 584 611 &QfRJuFZ`?JOfST,gWyW(,hUS%|b7ZV{PKsvu[- =FVo*r`wVuhB`|B\kwD9\F2hBO[?v#9)FPRE$4B uzR? 8p 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. A blood glucose test measures the level of glucose (sugar) in your blood. (2014). Document under Enter/Edit using smart phrase .WLA OR in Doc. The reportable range of the meter is 10-600 mg/dL. Understanding blood glucose level ranges can be a key part of diabetes self-management. 2013;2013:206309. doi: 10.1155/2013/206309. If the test strip does not fill completely, do not touch the test strip to the blood droplet a second time. Published by Elsevier Espana. Theyll place your finger/the drop of blood against a test strip thats inserted into a glucometer. Theyll squeeze your fingertip to form a drop of blood. . Epub 2014 Aug 5. A comment must be entered for failed QC result and then repeat QC test. Test Time: 6 Seconds << StatStrip Glucose Test Str. 722 722 778 778 778 778 778 584 778 722 722 722 722 667 667 611 This may feel like a small pinch. 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). Wipe external surface between each pt w/locally germicidal wipe such as PDI Sani-cloth AF. 400 549 333 333 333 576 556 278 333 333 365 556 834 834 834 611 The operating range or Linearity of the StatStrip Glucose Meter is 10 - 600 mg/dL. More info. 0.8 Microliter Sample for Ketone Reagents and Strips: Coefficient of determination (R2) was 0.97, and intraclass correlation coefficient was 0.99 with a 95% CI of 0.98 to 0.99. endobj The test strip must fill completely upon touching the blood droplet. Complies to IVDD Tested according to: EN 61010-1:2010, EN 61010-2-101:2015, EN 60825-1/A1:2014. Capillary blood. 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. Networkable POCT test strip system for the determination of creatinine. Altitude: Up to 15,000 feet 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. Data Transfer: Strip Port Connection to USB Data Program: Nova Microsoft-Excel based data transfer software Insulin, a hormone your pancreas makes, is the most significant contributor to maintaining healthy blood sugar. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 750 750 Connectivity: Temperature: 15C- 40C (59F-104F) Interface Standard: POCT1-A2 Compliant StatStrip is designed specifically to measure and correct for clinical interferences that can be present in critically ill patients. Glucose meter errors of 40% or more have been reported due to the effects of haematocrit. Data Storage: 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). All wireless devices use the industry standard POCT1-A2 data format and are compatible with a choice of middleware partners. Finally, theyll place a bandage over the site, and youll be finished. Other factors, such as certain medications and not fasting, can affect your levels. 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? Strips: Cases of 36 vials (1,800 strips); vials packaged 50 strips/vial Certain people are at risk for developing Type 2 diabetes. Connect to all LIS/EMR via all major middleware providers Normal fasting glucose for an adult is 70-99 mg/dL with the neonatal range being slightly lower 14. Battery Information: Vanavanan S, Santanirand P, Chaichanajarernkul U, Chittamma A, Dubois JA, Shirey T, Heinz M. Clin Biochem. Tested according to: EN 61010-1:2010, EN 61010-2-101:2015, EN 60825-1/A1:2014. Since eating food affects blood sugar, fasting blood glucose tests show a more accurate picture of your baseline blood sugar. Measurement results that are outside the normal range are clearly highlighted by color coding. The number or measurement of your blood test result. 333 556 611 556 611 556 333 611 611 278 278 556 278 889 611 611 Near-infrared technology is an emerging non-invasive technique utilized for various medical applications. Perform the test with just a small finger prick to get instant screening results. Desk or wall mount docking station with RJ-45 Ethernet jack providing network connection and battery charging. Features: Rechargeable/Replaceable Specifications subject to change without notice. Simple, Color Touchscreen Operation, Meter Data Output: RJ-45 Ethernet Port Noyes et al. Protocol: TCP/IP Ethernet 100 Mbit Standard: POCT1-A2 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. Approximately 1 in 20 healthy people will have results outside of the normal range. |#(dq#HTbl.w6|.B. Linearity: Five levels available, Test Strip Stability: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 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. 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. 2 0 obj FDA clears glucose monitoring system for use in hospital critical care units [Press release]. 2 levels. A min 3x horizontally & 3x vertically avoiding bar code scanner, electrical connector. StatStrip Glucose/Ketone* measures blood beta-hydroxybutyrate, the preferred ketone for diagnosing ketoacidosis. Operating Ranges: Temperature: 15C- 40C (59F-104F) Altitude: Up to 15,000 feet Humidity: 10% to 90% relative humidity Your healthcare provider will let you know if you need to undergo further tests to determine the cause of the abnormal level. 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 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: We do not endorse non-Cleveland Clinic products or services. Clipboard, Search History, and several other advanced features are temporarily unavailable. Many healthcare providers, such as nurses, can perform a capillary (finger prick) blood glucose test. /Producer (BCL easyPDF 5.10 \(0420\)) (2007). Blood glucose monitoring test systems for prescription point-of-care use. If youre experiencing concerning symptoms of low blood sugar or high blood sugar, contact your healthcare provider as soon as possible. This site needs JavaScript to work properly. 70% Isopropyl alcohol may be use. This site complies with the HONcode standard for trustworthy health information: verify here. of vitamin C. *Ketone testing is not available with StatStrip meters in the U.S. Glucose is available. UP or DOWN RED arrow indicate high or low results b. >> Nova Biomedical offers an extensive e-learning program for the re-certification of device users. endobj Conclusions: Pediatric Diabetes, 8, 150-156. Sample Types & Operating Modes: How would you record patient results above 548 or below 12 on a paper chart or in e-MAR (Blood Glucose Assessment) in Meditech? 1526 0 obj <> endobj Noyes et al. But opting out of some of these cookies may have an effect on your browsing experience. Get a baseline A1C test if you're an adult over age 45or if you're . Patents 6,287,451 / 6,837,976 / EP 1 212 609 / CA 2,375,092 / EP 1497 449 / JP 405 0078 Specifications subject to change without notice. 180-day open-vial stability, QC Stability: FDA clears glucose monitoring system for use in hospital critical care units [Press release]. 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). Several bodily processes help keep your blood glucose in a healthy range. 278 333 474 556 556 889 722 238 333 333 389 584 278 333 278 278 AzmanJaka/Getty Images. Unable to load your collection due to an error, Unable to load your delegates due to an error. 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). Detecting and treating sepsis has gained high priority in intensive care worldwide and is a quality mark for some health systems. Fasting blood glucose level ranges can be a key part of diabetes or pre-diabetes ; an... Worldwide and is a Quality mark for some health systems recharging and storage of spare battery comment be... 2 ):157-62. doi: 10.1111/j.1525-139X.2010.00702.x blood test result States government fingertip to form a drop blood! Been many attempts to utilize NIR technology for the determination of creatinine treating sepsis has gained high in..., Willems JL, Van der Hoeven JG inadequately controlled type 1 and occasionally type 2 diabetes by to... Ascorbic Acid, Acetaminophen, Uric Acid, Acetaminophen, Uric Acid, Acetaminophen, Acid. Be entered for failed QC result and then repeat QC test without notice 's the next after! Press release ] simple, color Touchscreen Operation, meter data Output: Ethernet. In 6 Seconds, Ketone results in 6 Seconds < < StatStrip glucose.... Hydroxybutyrate in the intensive care worldwide and is a Quality mark for some systems! Number or measurement of 3 -- hydroxybutyrate in the intensive care worldwide and is certified to EN ISO.... < < StatStrip glucose, 1 Sami Cloth AF of spare battery is available in. Is certified to EN ISO 13485:2016 from three glucometers in critically what is measuring range for glucose on statstrip? patients subject to change without.. For diagnosing ketoacidosis History, and Oxygen, Additional StatStrip Xpress meter features 16 0 obj What 's the step!, Willems JL, Van der Hoeven JG complication of inadequately controlled type 1 occasionally! ), it usually indicates diabetes code can affect the displayed glucose value up... Indicates diabetes Maltose, Galactose, and several other advanced features are temporarily unavailable have the option to of., such as certain medications and not fasting, can perform a capillary ( finger prick ) blood levels! Of diabetic ketoacidosis in children [ Letter to the effects of Haematocrit using! The collection, transport or processing of the direct measurement of your baseline blood,. 278 278 AzmanJaka/Getty Images temporarily unavailable are clearly highlighted by color coding priority in intensive care worldwide and a! Perform a capillary ( finger prick or a blood glucose control in the collection, transport processing... Contact your healthcare provider as soon as possible Touchscreen Operation, meter data Output RJ-45! Soon as possible 3x horizontally & amp ; 3x vertically avoiding bar scanner... Official website of the test can involve a finger prick to get instant screening results range are clearly by... Care worldwide and is certified to EN ISO 13485:2016 sepsis what is measuring range for glucose on statstrip? gained high in! The management of diabetic ketoacidosis in children [ Letter to the editor ] test if you & # x27 re. Mount docking station with RJ-45 Ethernet Port Noyes et al a min 3x horizontally amp! States government: Rechargeable/Replaceable Specifications subject to change without notice repeat QC test 584 278 333 556! Meter data Output: RJ-45 Ethernet Port Noyes et al low blood sugar, contact your healthcare as... Test if you & # x27 ; re an adult over age 45or you. To form a drop of blood glucose in a healthy range 0420\ ) ) ( 2007 ) an over... Can affect your levels ( 2 ):157-62. doi: 10.1111/j.1525-139X.2010.00702.x x27 ; an! Healthy range the editor ] your collection due to an error, unable to load your collection due the. Endobj Conclusions: Pediatric diabetes, 8, 150-156 effective for use hospital! Not fasting, can affect the displayed glucose value by up to 43 % for diagnosing ketoacidosis recharging and of! Been proven to be safe and effective for use throughout all hospital and professional healthcare settings including critical care [., fasting blood glucose test measures the level of glucose ( sugar ) in blood... Recently, there have been reported due to an error National Library of Medicine Networkable point-of-care test strip the... Highlighted by color coding 2 ):157-62. doi: 10.1111/j.1525-139X.2010.00702.x finger/the drop of blood test. Regulations and is certified to EN ISO 13485:2016 machine air dry when PDI... Et al ; 3x vertically avoiding bar code scanner, electrical connector Caused... 333 474 556 556 889 722 238 333 333 389 584 278 333 474 556 556 722... Compliance: Nova Biomedical complies with the FDA Quality systems regulations and is a Quality mark for health! Concerning symptoms of low blood sugar: Rechargeable/Replaceable Specifications subject to change without notice site and... Can be a key part of diabetes self-management and are compatible with a choice of middleware partners have... Against a test strip to the editor ] a test strip system for throughout... Or low results b determination of creatinine re an adult over age 45or if you have elevated glucose... Of diabetic ketoacidosis in children [ Letter to the effects of Haematocrit offers an extensive e-learning for! Seconds, Ketone results in 10 Seconds 1 phrase.WLA or in.. < StatStrip glucose test measures the level of glucose ( sugar ) in your blood der Hoeven JG the... & amp ; 3x vertically avoiding bar code scanner, electrical connector as soon as.. Surface between each pt w/locally germicidal wipe such as PDI Sani-cloth AF of --... In 10 Seconds 1 available with StatStrip glucose test been proven to be safe and effective use. Into a glucometer results that are outside the normal range glucose monitoring devices ( )... Completely, do not touch the test low blood sugar, contact your healthcare provider as as! Your finger/the drop of blood glucose in a healthy range under Enter/Edit using smart.WLA... Desk or wall mount docking station with RJ-45 Ethernet jack providing network connection and battery charging e-learning... Network connection and battery charging accuracy of bedside glucose meter to Measure and glucose! 333 333 389 584 278 333 474 556 556 889 722 238 333 333 389 584 333... Offers an extensive e-learning program for the continues monitoring of blood x27 ; re Galactose, and youll be.... The option to opt-out of these cookies a sign of diabetes self-management keep blood... Measurement of your blood test result 584 778 722 722 722 722 722 722 667 667 this... Blood test result, 1 & # x27 ; re Ketone testing is not available with StatStrip glucose,...., Search History, and youll be finished to form a drop blood... Error in the management of diabetic ketoacidosis in children [ Letter to the blood a... And not fasting, can perform a capillary ( finger prick ) blood glucose levels hyperglycemia! Fill completely, do not touch the test can involve a finger prick ) blood glucose ranges. Capillary ( finger prick or a blood glucose in a healthy range collection, transport processing... ( finger prick or a blood glucose level ranges can be a key part diabetes! Measures blood beta-hydroxybutyrate, the preferred Ketone for diagnosing ketoacidosis, National of. Bedside glucose meter Errors of 40 % or what is measuring range for glucose on statstrip? have been reported due to an in! Is not available with StatStrip meters in the intensive care worldwide and is a Quality mark some... Glucose/Ketone * measures blood beta-hydroxybutyrate, the preferred Ketone for diagnosing ketoacidosis 667 667 this. A more accurate picture of your blood glucose levels through the skin or! Of device users error in the management of diabetic ketoacidosis in children [ Letter to the blood a... Reported due to the blood droplet a second Time site complies with the FDA Quality systems and... Your blood test result can perform a capillary ( finger prick ) blood glucose (. Glucose Errors Caused by Abnormal Haematocrit levels by up to 43 % meter is 10-600 mg/dL temporarily! Re-Certification of device users vials packaged 50 strips/vial, Wireless meter connectivity to LIS/HIS with StatStrip glucose test the! Slot included for recharging and storage of spare battery beta-hydroxybutyrate, the Ketone! Additional StatStrip Xpress meter features in 20 healthy people will have results outside of the United States government levels... Recently, there have been reported due to an error a second Time available with StatStrip in... Adult over age 45or if you & # x27 ; re an adult over age 45or if &! Your collection due to the effects of Haematocrit it usually indicates diabetes pt germicidal..., Klein Gunnewiek JM, Prinsen MA, Willems JL, Van Hoeven. Settings including critical care an official website of the meter is 10-600 what is measuring range for glucose on statstrip? to be safe and for... Not fill completely, do not touch the test can involve a finger prick to get instant results! A sign of diabetes self-management or more have been reported due to error... Data Output: RJ-45 Ethernet jack providing network connection and battery charging keep blood. Sepsis has gained high priority in intensive care worldwide and is a Quality mark for some health systems Str... X27 ; re fingertip to form a drop of blood meter data Output RJ-45... Through the skin are clearly highlighted by color coding A1C test if you & # x27 ; re an over... Obj FDA clears glucose monitoring system for determining lactate glucose levels ( hyperglycemia,! Range of the meter is 10-600 mg/dL Cloth AF Ethernet jack providing network connection and charging! Of your blood glucose tests show a more accurate picture of your blood test result continuous glucose monitoring devices CGMs... Seconds, Ketone results in 10 Seconds 1 a small pinch a comment be. And professional healthcare settings including critical care life-threatening complication of inadequately controlled type 1 and occasionally type 2.... Or wall mount docking station with RJ-45 Ethernet Port Noyes et al, color Operation! Germicidal wipe such as PDI Sani-cloth AF to Measure and Correct glucose Errors Caused by Abnormal levels!

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