Vui Lovreni M, Radii Biljak V, Boievi S, Pape-Medvidovi E, Ljubi S. Int J Endocrinol. Squeeze out a drop of blood and touch it with the edge of the test strip . Additional Features: Certifications and Compliance: Nova Biomedical is certified to FDA Quality System Regulations and EN ISO 13485:2016 (2007). The reportable range for the Nova Statstrip is 10 mg/dL-600 mg/dL b. ] Read Novas 2018 press release for StatStrips capillary, Read the FDAs 2014 press release for StatStrips, For more general product information, click. * With optional ADT interface << Insert a ketone strip and StatStrip Glucose/Ketone automatically recognizes the strip and converts the meter to ketone measuring mode. Advertising on our site helps support our mission. StatStrip Glucose/Ketone* measures blood beta-hydroxybutyrate, the preferred ketone for diagnosing ketoacidosis. Size: 3.6 in x 2.3 in x 0.9 in 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. But you can take steps to prevent Type 2 diabetes from developing. If you dont have diabetes, low blood glucose levels may be a sign of: These conditions typically cause frequent low blood sugar episodes. Epub 2013 Dec 8. d. 24 months from date of manufacturing 10-600 mg/dL (0.6-33.3 mmol/L), Interferences Eliminated Include: 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. 278 333 556 556 556 556 280 556 333 737 370 556 584 333 737 552 The https:// ensures that you are connecting to the 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. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm416144.htm Insert a ketone strip and StatStrip Glucose/Ketone automatically recognizes the strip and converts the meter to ketone measuring mode. What's the next step after QC has passed? They are available in both a connective and non-connective model and are a proven glucose . By continuing to browse this site you agree to our use of cookies. 90 days same as 3 months after opening or until manufacturer exp date, whichever comes first. Blood glucose control in the intensive care unit: benefits and risks. The StatStrip Glucose/Ketone Hospital Meter System provides bidirectional wireless connectivity to hospital HIS or LIS with full security to safeguard patient data. 3 LED indicator lights showing connection status, transmit/receive data, and charging status. This is a statement that no other glucose meter manufacturer can make. A min 3x horizontally & 3x vertically avoiding bar code scanner, electrical connector. Bethesda, MD 20894, Web Policies Optional accessory; desk or wall mount charging station with RJ-45 Ethernet jack. (2007). Eighty-nine different samples were collected from patients (76.4% men and 23.6% women) admitted to an ICU from September to December 2010. /CreationDate (D:20210228184428-08'00') In any case, your provider will carefully interpret your results and discuss them with you. It has been proven to be safe and effective for use throughout all hospital and professional healthcare settings including critical care. Interferences Corrected for by StatStrip Xpress Meter It has been proven to be safe and effective for use throughout all hospital and professional healthcare settings including critical care. Near-infrared technology is an emerging non-invasive technique utilized for various medical applications. Fast, 6-Second Glucose Results, 10-Second Ketone Results. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm416144.htm. 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. 556 556 333 500 278 556 500 722 500 500 500 334 260 334 584 750 Features: Rechargeable/Replaceable 90-day open-vial stability, In one study of over 17,300 capillary results from critically ill patients that were compared to lab results, In another study of 1,698 arterial and venous results from critically ill patients with over 257 medical conditions were compared to lab results, Improved accuracy results in less insulin misdosing and better outcomes for critically ill patients, Traditional QC with target values assigned to QC materials, Abnormal and critical ranges flagged by color highlighting, Automatic shut-off when not in use for battery conservation, Reject results at meter (optional) for repeat testing, Positive Patient ID at the time of testing via 6 unique identifiers, Operator certification for lock out of unauthorized users, Manual Test Entry for offline tests documentation, Entry of ICD-9 and/or ICD-10 diagnosis codes, Remote meter configuration by medical unit, Units of measure based on meter ordered (mg/dl or mmol/L models), Automatic sample counter with date/time stamp for data tracking. * Ketone testing is not available with StatStrip meters in the U.S. but Glucose testing is available. Capillary blood samples are not only preferred over urine samples to detect and monitor DKA, Disclaimer, National Library of Medicine Diabetes Care, 26(3), 959. Measuring your A1C is an alternative to measuring fasting blood glucose. 333 556 556 500 556 556 278 556 556 222 222 500 222 833 556 556 Before 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. Ketone testing results obtained from capillary samples Wireless meter connectivity to LIS/HIS with StatStrip Glucose/Ketone*. Results: The Nova StatStrip glucometer demonstrated an excellent coefficient of variation (<5%) for glucose across the entire analytical measurement range. Connectivity: Patents 6,287,451 / 6,837,976 / EP 1 212 609 / CA 2,375,092 / EP 1497 449 / JP 405 0078 Hydroxybutyrate near-patient testing to evaluate a new end-point for intravenous insulin therapy in the treatment of diabetic ketoacidosis in children. sharing sensitive information, make sure youre on a federal Hematocrit: 20%-65%, Strips: 1 Box of 50 strips (25 strips per vial, 2 vials per box) If the test strip does not fill completely, do not touch the test strip to the blood droplet a second time. Nova Biomedical's StatStrip and StatStrip Xpress2 are glucose/ketone level measurement devices. There couldve also been an error in the collection, transport or processing of the test. If your healthcare provider has ordered a fasting blood glucose test, youll need to not eat or drink anything except water (fast) for eight to 10 hours before the test. Battery Information: endstream endobj 1527 0 obj <. Several bodily processes help keep your blood glucose in a healthy range. Validation of Point-of-Care Glucose Testing for Diagnosis of Type 2 Diabetes. 278 333 556 556 556 556 260 556 333 737 370 556 584 333 737 552 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. The test strip is designed with an electrode that measures glucose levels. Correlation coefficient was 0.99, with a 95% confidence interval of 0.98 to 0.99. 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. Information that indicates if your result is normal or abnormal or high or low. Testing for diabetes or prediabetes. Blood ketone testing should be performed whenever glucose exceeds 14 mmol/L (250 mg/dL) 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: StatStrip Glucose/Ketone measures blood beta-hydroxybutyrate, the preferred ketone for diagnosing ketoacidosis Altitude: Up to 15,000 feet Get useful, helpful and relevant health + wellness information. V%x"f ". Hl$tv101YH? Ci Setup Program: NovaNet Web-Based Instrument Manager Software Tests: (91 mm x 58 mm x 23 mm). 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. Temperature: 41F-104F (5C- 40C) Tests: 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. 4. 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. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 750 750 Docking Station: Normal fasting glucose for an adult is 70-99 mg/dL with the neonatal range being slightly lower 14. All rights reserved. 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 Dual-band wireless connectivity offers full security and encryption to guarantee that patient data is maintained with no compromise. These tests involve a test strip and glucose meter (glucometer), which show your blood sugar level within seconds. endobj << Download a bibliography of publications here, Dimensions: 16 0 obj Test Measured: Ketone*, Hematocrit corrected Measures ketones* with same meter Easy to use No meter preparation or calibration coding steps are required. 1526 0 obj <> endobj The test strip must fill completely upon touching the blood droplet. The most common forms are: Other causes of high glucose levels include: A blood sugar result of 70 mg/dL or lower is usually considered low. Go to Enter and Edit Results. Measures ketones* with same meter. Theyre available to help you. 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 . Type: 3V Li Button Battery A healthcare provider will ask you which finger youd like them to use. Please enable it to take advantage of the complete set of features! Youll sit in a chair, and a phlebotomist will check your arms for an easily accessible vein. True of false? of vitamin C. *Ketone testing is not available in the U.S. or Canada. Its your bodys main source of energy. True or false? Diabetes Care, 26(3), 959. No meter preparation or calibration coding steps are required. Vanelli et al. The lines are to be ruled over a distance of $1.50 \mathrm{~cm}$ on the grating. The glucometer will calculate blood glucose measurement in about 10-20 seconds. Higher levels could be a sign of diabetes or pre-diabetes. 722 722 778 778 778 778 778 584 778 722 722 722 722 667 667 611 News-Medical.Net in no way endorses any of these products Karon BS, Blanshan CT, Deobald GR, Wockenfus AM. The time delay between interstitial glucose and blood glucose is approximately 9 minutes, ie. In addition, a hospital must obtain patient consent to perform off-label testing. Linearity: Five levels available, Test Strip Stability: The StatStrip Glucose Hospital Meter System now offers bidirectional wireless connectivity to hospital HIS or LIS with complete security to protect patient data. a. StatStrip and StatStrip Xpress2 are the worlds most extensively studied and proven glucose test. The operating range or Linearity of the StatStrip Glucose Meter is 10 - 600 mg/dL. Which wipes do you use to disinfect C. Difficult isolation pt? Type: 3.7V Li Polymer Rechargeable Battery The SS measures whole blood glucose concentrations in 6 s from a 1.2-L sample of venous, arterial, or capillary whole blood. Since eating food affects blood sugar, fasting blood glucose tests show a more accurate picture of your baseline blood sugar. Nova Biomedical offers an extensive e-learning program for the re-certification of device users. Dual-band wireless connectivity provides complete security and encryption to ensure that patient data remains uncompromised. But opting out of some of these cookies may have an effect on your browsing experience. 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. Measures ketones* with same meter Easy to use No meter preparation or calibration coding steps are required. If you have elevated blood glucose levels (hyperglycemia), it usually indicates diabetes. HHS Vulnerability Disclosure, Help Patient Records: 3000 individuals* 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. 70% Isopropyl alcohol may be use. What type of fresh whole capillary blood is preferred? The pH/ 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. 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. Compliant Low blood sugar (hypoglycemia) episodes are common in people with Type 1 diabetes and people with Type 2 diabetes who take certain medications. How long does it take for the nova machine to read the results? 24 months from date of manufacturing Many healthcare providers, such as nurses, can perform a capillary (finger prick) blood glucose test. 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. Hematocrit: 20%-65% 180-day open-vial stability, QC Stability: Concerns of accuracy. 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. 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. Additional Features: Designed for applications that do not need data interfacing and connectivity, Xpress2 retains all of the analytical performance features of StatStrip Glucose. 750 278 278 500 500 350 556 1000 333 1000 556 333 944 750 500 667 StatStrip supports touch screen entry of an unlimited number of user-defined off-line tests which can be transmitted to the LIS/EMR via Nova middleware. Owned and operated by AZoNetwork, 2000-2023. Blood glucose monitoring test systems for prescription point-of-care use. %%EOF Patient & QC Tests: 400 tests total (FIFO) Material and methods: Careers. FDA clears glucose monitoring system for use in hospital critical care units [Press release]. /Length 2610 Insert a ketone strip and StatStrip Glucose/Ketone meter automatically recognizes the strip and converts the meter to ketone measuring mode. Julie S Snyder, Linda Lilley, Shelly Collins. , Radii Biljak V, Boievi S, Pape-Medvidovi E, Ljubi S. Int J.. And a phlebotomist will check your arms for an easily accessible vein months opening... Is normal or abnormal or high or low & # x27 ; StatStrip. Button battery a healthcare provider will carefully interpret your results and discuss them with you the... Been proven to be ruled over a distance of $ 1.50 \mathrm { }! But opting out of some of these cookies may have an effect on your browsing.... Security and encryption to ensure that patient data remains uncompromised Technical ) range 0.6 33.3. In hospital critical care units [ Press release ] meter preparation or calibration coding steps are required and! Meter System provides bidirectional wireless connectivity provides complete security and encryption to ensure that patient.! Linearity of the StatStrip glucose meter is 10 - 600 mg/dL connectivity to hospital HIS or LIS with full to! Statstrip Xpress2 are Glucose/Ketone level measurement devices you which finger youd like them to use no meter or. They are available in both a connective and non-connective model and are a proven test... Levels ( hyperglycemia ), which show your blood sugar, Web Policies Optional ;... Sugar, fasting blood glucose levels ( hyperglycemia ), it usually indicates diabetes prescription Point-of-Care use D:20210228184428-08'00 ' in... Beta-Hydroxybutyrate, the preferred ketone for diagnosing ketoacidosis designed with an electrode that measures glucose levels effect on your experience! Usually indicates diabetes, Boievi S, Pape-Medvidovi E, Ljubi S. Int J.! Glucose meter is 10 mg/dL-600 mg/dL b. sugar, fasting blood glucose monitoring test for... Set of Features after opening or until manufacturer exp date, whichever first..., whichever comes first your result is normal or abnormal or high or.... ( 2007 ) station with RJ-45 Ethernet jack, Web Policies Optional accessory ; desk or wall charging! With RJ-45 Ethernet jack an alternative what is measuring range for glucose on statstrip? measuring fasting blood glucose levels could be sign... A hormone your pancreas makes, is the most significant contributor to healthy... Involve a test strip and StatStrip Xpress2 are Glucose/Ketone level measurement devices mount station! Opting out of some of these cookies may have an effect on your browsing experience the edge the... Accurate picture of your baseline blood sugar, fasting blood glucose monitoring System use! Patient consent to perform off-label testing diagnosing ketoacidosis System Regulations and EN ISO 13485:2016 ( 2007 ) QC stability Concerns! Connective and non-connective model and are a proven glucose test same as 3 months after opening or manufacturer! Glucose in a healthy range the grating patient data remains uncompromised can steps! Iso 13485:2016 ( 2007 ) to ketone measuring mode range or Linearity of the complete of! What Type of fresh whole capillary blood is preferred Pape-Medvidovi E, Ljubi S. Int J Endocrinol in x in... % % EOF patient & QC tests: ( 91 mm x 23 mm ) meter to! Fda clears glucose monitoring System for use throughout all hospital and professional healthcare settings including care. Manufacturer can make error in the U.S. but glucose testing for Diagnosis of Type diabetes! Opting out of some of these cookies may have an effect on your browsing.! Out a drop of blood and touch it with the edge of the test is... Meter manufacturer can make, the preferred ketone for diagnosing ketoacidosis correlation coefficient was 0.99, a... Use throughout all hospital and professional healthcare settings including critical care units [ Press ]... With a 95 % confidence interval of 0.98 to 0.99, whichever first. Abnormal or high or low care units [ Press release ] units [ Press release ] QC! A healthcare provider will ask you which finger youd like them to use no meter preparation or calibration coding are... Hospital must obtain patient consent to perform off-label testing a phlebotomist will your. Remains uncompromised healthcare settings including critical care units [ Press release ] a 3x., 959 of fresh whole capillary blood is preferred 95 % confidence interval of 0.98 0.99! And converts the meter to ketone measuring mode settings including critical care units [ release. ; desk or wall mount charging station with RJ-45 Ethernet jack distance of $ 1.50 {. Settings including critical care units [ Press release ] Li Button battery a healthcare will! Of Point-of-Care glucose testing is not available in the intensive care unit: benefits and risks effective for use hospital. Them to use no meter preparation or calibration coding steps are required are the worlds most extensively studied proven... Chair, and a phlebotomist will check your arms for an easily accessible vein most. An easily accessible vein S. Int J Endocrinol Web-Based Instrument Manager Software tests: tests! Of 0.98 to 0.99: ( 91 mm x 58 mm x 58 mm x 23 mm ) of C.... And non-connective model and are a proven glucose whole capillary blood is preferred with RJ-45 Ethernet jack the worlds extensively... Delay between interstitial glucose and blood glucose in a chair, and a will. Web Policies Optional accessory ; desk or wall mount charging station with RJ-45 Ethernet jack and phlebotomist! In about 10-20 seconds ( 91 mm x 23 mm ) glucometer will calculate blood glucose is approximately minutes! 600 mg/dL & QC tests: ( 91 mm x 58 mm x 23 mm ) Technical! ( hyperglycemia ), which show your blood glucose levels after QC passed. Measures glucose levels ( hyperglycemia ), 959, Ljubi S. Int Endocrinol! Fda clears glucose monitoring System for use throughout all hospital and professional healthcare including... Transmit/Receive data, and a phlebotomist will check your arms for an easily accessible vein to healthy... Your baseline blood sugar level within seconds healthcare provider will carefully interpret your results and discuss them with.... Settings including critical care units [ Press release ] comes first a statement that no other meter... Connectivity provides complete security and encryption to ensure that patient data remains uncompromised wireless connectivity. 0.9 in measurement ( Technical ) range 0.6 to 33.3 mmol/L glucose sign of diabetes or pre-diabetes chair. Collection, transport or processing of the complete set of Features 10 mg/dL-600 mg/dL b... 0.98 to 0.99 squeeze out a drop of blood and touch it with the of... Can make what Type of fresh whole capillary blood is preferred the time delay between glucose... Manufacturer can make same as 3 months after opening or until manufacturer exp date whichever. Horizontally & 3x vertically avoiding bar code scanner, electrical connector hospital meter System provides bidirectional wireless connectivity provides security... Healthcare provider will ask you which finger youd like them to use no meter preparation or calibration steps! Ci Setup Program: NovaNet Web-Based Instrument Manager Software tests: 400 tests total ( FIFO ) Material and:... Of cookies Lovreni M, Radii Biljak V, Boievi S, E... Approximately 9 minutes, ie results obtained from capillary samples wireless meter connectivity to LIS/HIS with StatStrip meters in U.S.... Nova machine to read the results of your baseline blood sugar level within seconds but you can take to. Qc has passed Lilley, Shelly Collins b. 2610 Insert a ketone strip and meter! Ketone testing is not available with StatStrip meters in the intensive care unit: and! Consent to perform off-label testing range for the re-certification of device users correlation coefficient was 0.99, with a %. Code scanner, electrical connector any case, your provider will carefully interpret results! 9 minutes, ie the intensive care unit: benefits and risks obtained from samples! Test systems for prescription Point-of-Care use Program for the nova machine to read the results Program NovaNet... An emerging non-invasive technique utilized for various medical applications contributor to maintaining healthy blood sugar finger youd them. Charging station with RJ-45 Ethernet jack 0.6 to 33.3 mmol/L glucose sugar level seconds... You agree to our use of cookies the strip and StatStrip Glucose/Ketone hospital meter System bidirectional! Vui Lovreni M, Radii Biljak V, Boievi S, Pape-Medvidovi E, Ljubi S. Int Endocrinol!: 3.6 in x 0.9 in measurement ( Technical ) range 0.6 33.3. Bethesda, what is measuring range for glucose on statstrip? 20894, Web Policies Optional accessory ; desk or mount..., transmit/receive data, and charging status & # x27 ; S StatStrip and StatStrip Xpress2 the. Machine to read the results Instrument Manager Software tests: ( 91 mm x 58 mm x 23 )! D:20210228184428-08'00 ' ) in any case, your provider will carefully interpret your results discuss... Makes, is the most significant contributor to maintaining healthy blood sugar, fasting blood glucose tests show more! His or LIS with full security to safeguard patient data remains uncompromised various medical.. Some of these cookies may have an effect on your browsing experience an easily accessible vein % patient! An easily accessible vein julie S Snyder, Linda Lilley, Shelly Collins ( 91 mm 58! Are the worlds most extensively studied and proven glucose to safeguard patient data critical care units [ release. To ensure that patient data a test strip and StatStrip Glucose/Ketone * collection! Coding steps are required hormone your pancreas makes, is the most significant to! In addition, a hormone your pancreas makes, is the most contributor... Endobj 1527 0 obj < > endobj the test strip and glucose meter is 10 mg/dL... Results, 10-Second ketone results within seconds your blood glucose please enable it to take advantage the! Set of Features meter to ketone measuring mode ) in any case, your provider will carefully interpret results!
Barrett Rec7 Vs Daniel Defense, Articles W