The https:// ensures that you are connecting to the Necessary cookies are absolutely essential for the website to function properly. Networkable POCT test strip system for the determination of creatinine. Tests Measured: Glucose and Hematocrit Patient Tests: 1,000 tests Blood ketone testing should be performed whenever glucose exceeds 14 mmol/L (250 mg/dL) Put a test strip into your blood glucose meter. Use of any other glucose meter with critically ill patients is off label Insert a ketone strip and StatStrip Glucose/Ketone automatically recognizes the strip and converts the meter to ketone measuring mode. %PDF-1.6 % The test strip must fill completely upon touching the blood droplet. 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 Operating Ranges: A min 3x horizontally & 3x vertically avoiding bar code scanner, electrical connector. 90-day open-vial stability. Battery Information: Federal government websites often end in .gov or .mil. An A1c shows your average blood sugar over a few months. This is a statement that no other glucose meter manufacturer can make. 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. Results: The Nova StatStrip glucometer demonstrated an excellent coefficient of variation (<5%) for glucose across the entire analytical measurement range. Blood Glucose results appear normal range in? Theyll place your finger/the drop of blood against a test strip thats inserted into a glucometer. How would you record patient results above 548 or below 12 on a paper chart or in e-MAR (Blood Glucose Assessment) in Meditech? Test Time: 6 Seconds Epub 2014 Aug 5. Continuous glucose monitoring devices (CGMs) are another option for this. /Creator (easyPDF SDK 5.1) Complies to IVDD. 611 611 389 556 333 611 556 778 556 556 500 389 280 389 584 750 The most extensively studied and proven glucose measurement technology 750 222 222 333 333 350 556 1000 333 1000 500 333 944 750 500 667 Life: 6-8 hours in use (approximately 40 tests w/barcode scans)/12-24 hours standby. Dual-band wireless connectivity provides complete security and encryption to ensure that patient data remains uncompromised. Approximately 1 in 20 healthy people will have results outside of the normal range. Blood ketone monitoring reduces costs and ICU length of stay for DKA patients Hyperglycemic patients admitted to Intensive care units (ICUs) have higher morbidity and mortality than normoglycemic patients. (147 mm x 79 mm x 30 mm) Patient & QC Tests: 400 tests total (FIFO) If you have risk factors, your provider will likely recommend regular screening no matter your age. Normal results are displayed in BLUE. All wireless devices use industry standard POCT1-A2 data format and are compatible with a choice of middleware partners. FDA clears glucose monitoring system for use in hospital critical care units [Press release]. 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. Top, bottom, left, & right. government site. Specifications subject to change without notice. Measuring your A1C is an alternative to measuring fasting blood glucose. 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 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. 0.8 Microliter Sample for Ketone In one of the largest studies ever carried out with glucose measuring devices (35 participating hospitals, 1,703 data points), StatStrip achieved excellent correlations over the entire measuring range to the plasma hexokinase reference method of 10 to 600 mg / dl (0.5 to 33.3 mmol / l) . This category only includes cookies that ensures basic functionalities and security features of the website. An official website of the United States government. [ True or false? Top, bottom, left, & right. Connectivity: Easy to use Type: 3.7V Li Polymer Rechargeable Battery Patents 6,287,451 / 6,837,976 / EP 1 212 609 / CA 2,375,092 / EP 1497 449 / JP 405 0078 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. endobj a. 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 StatStrip is FDA cleared and CLIA waived for use throughout all hospital and all professional healthcare settings including critical care. Accessibility The pH/ 556 750 222 556 333 1000 556 556 333 1000 667 333 1000 750 611 750 Blood ketone testing should be performed whenever glucose exceeds 14 mmol/L (250 g/dL) They are available in both a connective and non-connective model and are a proven glucose . Simple, Color Touchscreen Operation, Meter Data Output: RJ-45 Ethernet Port Theyre much less common in people who dont have diabetes. Vanelli et al. Hoedemaekers CW, Klein Gunnewiek JM, Prinsen MA, Willems JL, Van der Hoeven JG. %PDF-1.3 The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin, Dr. Dodell says. 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 For many people with type 2 diabetes, the goal is to reduce A1C levels. All 3 meter strip technologies represented the latest version provided for hospital use at the time of the study available. Capillary blood samples are not only preferred over urine samples to detect and monitor DKA, 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. How long should you let nova machine air dry when using Clorox wipes? Battery Information: Before You also have the option to opt-out of these cookies. (91 mm x 58 mm x 23 mm). In any case, your provider will carefully interpret your results and discuss them with you. People with Type 1 diabetes especially need to monitor their blood sugar multiple times a day to effectively manage the condition. UL, CSA Standards Patented Technology. Whole Blood: Arterial, Venous, Capillary Call the POCT Coordinator for further guidance. Data Transfer: Strip Port Connection to USB 556 750 278 556 500 1000 556 556 333 1000 667 333 1000 750 611 750 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 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. *-hydroxybutyrate This led to savings of 22 hours of nursing time and 375 laboratory investigations, for a total savings of 2,940.3, 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. An ICU study evaluated the effectiveness of blood ketone testing versus urine ketone testing for DKA patients. Capillary blood glucose tests show the results within seconds via the glucometer. You may have slight tenderness or a bruise at the site of the blood draw or finger prick, but this usually resolves quickly. Operating Ranges: Temperature: 15C- 40C (59F-104F) Altitude: Up to 15,000 feet Humidity: 10% to 90% relative humidity StatStrip test strips do not require any codes and are consistently precise, even when using different lots. body in DKA, are recommended over urine ketone testing for diagnosing and monitoring ketoacidosis. Features: Rechargeable/Replaceable Use the smart phrase .wlapoct. 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. Size: 5.8 in x 3.1 in x 1.18 in 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. No meter preparation or calibration coding steps are required. Normal fasting glucose for an adult is 70-99 mg/dL with the neonatal range being slightly lower 14. Pediatric Diabetes, 8, 150-156. /CreationDate (D:20210228184428-08'00') End-filled capillary action test strips are designed for fast, easy sample uptake. These products and services are provided for your convenience. Theres also at-home blood sugar testing (using a glucometer) for people who have diabetes. 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.. 3. PMC Blood glucose levels of ICU patients are usually measured with a glucose meter. Blood ketone monitoring reduces costs and ICU length of stay for DKA patients Linearity: Five levels available, Test Strip Stability: Nova StatStrip Glucose Quality Control (QC) Solutions 1 & 3 store @ 1530C, - . Reagents and Strips: The operating range or Linearity of the StatStrip Glucose Meter is 10 - 600 mg/dL. Get a baseline A1C test if you're an adult over age 45or if you're . Life: Minimum 600 tests Higher levels could be a sign of diabetes or pre-diabetes. Draft guidance for industry and food and drug administration staff. Measures ketones* with same meter Easy to use No meter preparation or calibration coding steps are required. Dont be afraid to ask your provider questions. These results can be quantitative or qualitative, numeric input, or free text. A healthcare provider will ask you which finger youd like them to use. Test Strips available in cases of 1800 or boxes of 100. 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. A 1.2 microliter sample size results in less pain for the patient and sampling from central venous or arterial lines, eliminates the fingerstick. Venous or aerial blood may also be used. QC: Three levels (Low, Normal, High); sold separately Blood ketone testing should be performed whenever glucose exceeds 14 mmol/L (250 mg/dL) StatStrip Glucometer Purpose: This procedure provides instructions for how to perform a patient test on the Nova StatStrip Glucose Hospital Meter System. StatStrip glucose / ketone test strip systems work with patented Multi-Well measurement technology, which meets the increasing requirements of todays blood sugar measurements in hospitals. Size: 5.8 in x 3.1 in x 1.18 in Different approaches and designs have been proposed for non-invasive blood glucose measurements. 400 549 333 333 333 576 537 278 333 333 365 556 834 834 834 611 Abnormal haematocrit levels are commonly found in hospitalpatients. Insert a ketone strip and StatStrip Glucose/Ketone meter automatically recognizes the strip and converts the meter to ketone measuring mode. The tested glucose meter (StatStrip) shows a good linear association, precision, and accuracy when compared to the laboratory reference method. 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. >> 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). Correlation coefficient was 0.99, with a 95% confidence interval of 0.98 to 0.99. blood ketone endpoint was reached after 17 hours, whereas the pH/urine ketone endpoint was not reached until 28 hours after starting treatment. StatStrip Lactate/Hemoglobin & Hematocrit, Docking station (for connectivity models), Time savings through more efficient worklfow, Data available in real time in LIS and HIS, Quality assurance through networked user and patient management. Fast, 6-Second Glucose Results, 10-Second Ketone Results. Data Storage: 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 Once opened, control solutions and test strips must be dated with open and expiration date. Cleveland Clinic is a non-profit academic medical center. Features: Rechargeable/Replaceable Strips: 1 Box of 50 strips (25 strips per vial, 2 vials per box) But you can take steps to prevent Type 2 diabetes from developing. Diabetes Care, 26(3), 959. Nova now offers a full range of StatStrip Glucose wireless connectivity capabilities, including wireless meters, wireless carrying cases, and wireless docking stations. Measures ketones* with same meter Easy to use No meter preparation or calibration coding steps are required. Optional accessory; desk or wall mount charging station with RJ-45 Ethernet jack. And critical results. 400 549 333 333 333 576 556 278 333 333 365 556 834 834 834 611 Conclusions: There are a few different types of diabetes. 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). Glucose is a simple version of sugar which comes from the food we eat. they are also easier to obtain and allow for immediate reflex testing of ketones whenever glucose is greater than 14 mmol/L. Specifications current as of revision date. 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. Light photons penetrating the skin can undergo multiple . The personnel testing requirements for off-label use are very demanding and limit who can perform testing. Hematocrit: 20%-65%, Strips: 1 Box of 50 strips (25 strips per vial, 2 vials per box) (98 mm x 61 mm x 22.9 mm), Data Storage: Weight: 0.49 lb (220 g) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 All wireless devices use the industry standard POCT1-A2 data format and are compatible with a choice of middleware partners. 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. These cookies do not store any personal information. |#(dq#HTbl.w6|.B. If you have elevated blood glucose levels (hyperglycemia), it usually indicates diabetes. The aim of this study was to evaluate a glucose meter (StatStrip, Nova Biomedical) to assess its agreement with the standard laboratory method for testing glucose. endstream endobj 1527 0 obj <. 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.