what is measuring range for glucose on statstrip?

Noyes et al. 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). Please enable it to take advantage of the complete set of features! 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. Theres also at-home blood sugar testing (using a glucometer) for people who have diabetes. Know that having a high or low glucose level doesnt necessarily mean you have a medical condition and need treatment. hbbd``b`k@?`X! Your healthcare provider will let you know if you need to undergo further tests to determine the cause of the abnormal level. Phlebotomists typically perform venous blood glucose tests. We also use third-party cookies that help us analyze and understand how you use this website. The lithium heparin tube was processed at the same time for measuring plasma glucose (Cobas 6000 Analyzer, Roche Diagnostics, SA). To learn more about how StatStrip Glucose can bring critical care testing to the bedside, contact your current GPO, call Nova at 800-458-5813, or fill out the form below: 1. Nova at present provides a complete range of StatStrip Glucose/Ketone wireless connectivity capabilities, inclusive of wireless docking stations, wireless carrying cases and wireless meters. Pediatric Diabetes, 8, 150-156. endstream endobj 1527 0 obj <. 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. 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. 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 Test Reported: Glucose Test Methodology: Electrochemistry, Sample Types & Operating Modes: 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. If a person with diabetes has a meter, test strips and is testing, it's important to know what the blood glucose . Measures ketones* with same meter. Dont be afraid to ask your provider questions. vials packaged 50 strips/vial, Wireless meter connectivity to LIS/HIS with StatStrip Glucose, 1. Specifications current as of revision date. 556 556 556 556 556 556 889 500 556 556 556 556 278 278 278 278 Which wipes do you use to disinfect C. Difficult isolation pt? 667 778 722 667 611 722 667 944 667 667 611 333 278 333 584 556 Open QC Glucose Control SOLUTIONS Expires. Several bodily processes help keep your blood glucose in a healthy range. Wireless meter connectivity to LIS/HIS with StatStrip Glucose/Ketone*. Title: Glucose Testing: StatStrip Glucose Meter Page 5 of 6 G. Reference Ranges: 1. Pediatric Diabetes, 8, 150-156. Operating Ranges: Temperature: 15C- 40C (59F-104F) Altitude: Up to 15,000 feet Humidity: 10% to 90% relative humidity. We do not endorse non-Cleveland Clinic products or services. Get a baseline A1C test if you're an adult over age 45or if you're . Copyright 2011 SEEN. Bookshelf Interferences Corrected for by StatStrip Xpress Meter QC: Three levels (Low, Normal, High); sold separately * With optional ADT interface Previous studies have demonstrated acceptable accuracy and reliability of the SS for the point-of-care measurement of glucose in adult5,6and neonatal7,8settings. Test Measured: Ketone*, Hematocrit corrected Results: The Nova StatStrip glucometer demonstrated an excellent coefficient of variation (<5%) for glucose across the entire analytical measurement range. Easy to use 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. 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. If the test strip does not fill completely, do not touch the test strip to the blood droplet a second time. U.S. Food and Drug Administration. 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. These tests involve a glucose meter and a test strip, which show your blood sugar result within seconds. A blood glucose test is a blood test that mainly screens for diabetes by measuring the level of glucose (sugar) in your blood. The tested glucose meter (StatStrip) shows a good linear association, precision, and accuracy when compared to the laboratory reference method. Hematocrit: 20%-65% Since eating food affects blood sugar, fasting blood glucose tests show a more accurate picture of your baseline blood sugar. Altitude: Up to 15,000 feet An ICU study evaluated the effectiveness of blood ketone testing versus urine ketone testing for DKA patients. Light photons penetrating the skin can undergo multiple . Download a bibliography of publications here, Dimensions: 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. People with prediabetes have up to a 50% chance of developing Type 2 diabetes over the next five to 10 years. 556 750 278 556 500 1000 556 556 333 1000 667 333 1000 750 611 750 Size: 3.9 in x 2.4 in x 0.9 in Type: 3V Li Button Battery Blood beta-hydroxyburyrate testing denotes the status of the patient during the test, while urine might have been in the bladder for many hours. The mean lag between the blood ketone and urine ketone groups was 11 hours, ranging from 1 to 36 hours.4. endobj Nova now offers a full range of StatStrip Glucose/Ketone wireless connectivity capabilities, including wireless meters, wireless carrying cases, and wireless docking stations. In any case, your healthcare provider will let you know if you need to follow any special instructions. Features: Rechargeable/Replaceable Extra battery slot included for recharging and storage of spare battery. [ 30 months from date of manufacturing outside USA This may feel like a small pinch. Blood ketone monitoring reduces costs and ICU length of stay for DKA patients Certifications and Compliance: Nova Biomedical is certified to FDA Quality System Regulations and EN ISO 13485:2016 Blood glucose levels of ICU patients are usually measured with a glucose meter. News-Medical.Net in no way endorses any of these products body in DKA, are recommended over urine ketone testing for diagnosing and monitoring ketoacidosis. Blood ketone testing should be performed whenever glucose exceeds 14 mmol/L (250 g/dL) What's the next step after QC has passed? Finally, theyll place a bandage over the site, and youll be finished. Nova now offers a full range of StatStrip Glucose wireless connectivity capabilities, including wireless meters, wireless carrying cases, and wireless docking stations. According to the European Society for Paediatric Endocrinology, Diabetes UK, ADA, and others, blood ketone testing methods that quantify beta-hydroxybutyrate, the predominant ketone What are the purpose of testing whole blood glucose by Nova Stat Strip? Operating Ranges: Networkable point-of-care test strip system for determining lactate. Humidity: 10% to 90% relative humidity, Reagents and Strips: Wireless connectivity helps save time for the caregiver and enables quicker charting of findings and clinical decision-making to enhance patient care. Venous or aerial blood may also be used. 750 278 278 500 500 350 556 1000 333 1000 556 333 944 750 500 667 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.. Certifications & Compliance: ISO 13485:2003 Quality System Registration, IVDD, Meets IEC 61010, UL, CSA Standards Patented Technology. The site is secure. Advertising on our site helps support our mission. 611 611 611 611 611 611 611 549 611 611 611 611 611 556 611 556 Glucose Results in 6 Seconds, Ketone Results in 10 Seconds This website uses cookies to improve your experience while you navigate through the website. Ketone testing results obtained from capillary samples Complies to IVDD Tested according to: EN 61010-1:2010, EN 61010-2-101:2015, EN 60825-1/A1:2014. Different approaches and designs have been proposed for non-invasive blood glucose measurements. Normal results are displayed in BLUE. Diabetes Care, 26(3), 959. Simple, Color Touchscreen Operation, Meter Data Output: RJ-45 Ethernet Port * Ketone testing is not available with StatStrip meters in the U.S. but Glucose testing is available. It has been proven to be safe and effective for use throughout all hospital and professional healthcare settings including critical care. The glucometer will calculate blood glucose measurement in about 10-20 seconds. 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. 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). The number or measurement of your blood test result. 3 LED indicator lights showing connection status, transmit/receive data, and charging status. 2. 3 LED indicator lights showing connection status, transmit/receive data, and charging status. 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. QC: Three levels (Low, Normal, High); sold separately Other factors, such as certain medications and not fasting, can affect your levels. Connectivity: Certifications and Compliance: Nova Biomedical complies with the FDA Quality Systems Regulations and is certified to EN ISO 13485:2016. Glucose and Ketone Testing in One Meter 556 556 556 556 556 556 556 549 611 556 556 556 556 500 556 500 Health experts advise that a person living with T2D should aim to keep their blood glucose range between 80 and 130 mg/dL before a meal and less than 180 . xZYs8~#bkj8CH-I "eBVj\JH5}IK"'q`qz0"f=,23(OSf3]}>g){ey[:VE?`f Hematocrit: 20%-65%, Strips: 1 Box of 50 strips (25 strips per vial, 2 vials per box) Before The personnel testing requirements for off-label use are very demanding and limit who can perform testing. 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) . Test Strip Volume: 0.8 l Understanding blood glucose level ranges can be a key part of diabetes self-management. (2014, September 24). Noyes et al. 70% Isopropyl alcohol may be use. and services. Blood ketone testing should be performed whenever glucose exceeds 14 mmol/L (250 g/dL) Life: Minimum 600 tests, Tests: Continuous glucose monitoring devices (CGMs) are another option for this. Battery Information: Its your bodys main source of energy. POC Critical Glucose Values a. (2003). By continuing to browse this site you agree to our use of cookies. According to the ADA, an A1C level below 5.7 percent is considered normal between 5.7 and 6.4 signals prediabetes and over 6.5 percent indicates type 2 diabetes. Karon BS, Blanshan CT, Deobald GR, Wockenfus AM. Protocol: TCP/IP Ethernet 100 Mbit Standard: POCT1-A2 Type: 3.7V Li Polymer Rechargeable Battery 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. Document under Enter/Edit using smart phrase .WLA OR in Doc. Wireless connectivity saves time for the caregiver and allows for faster charting of results and clinical decision making to improve patient care. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 FDA clears glucose monitoring system for use in hospital critical care units [Press release]. A comment must be entered for critical results. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380325.pdf Noyes et al. 4. Every 24 hours check performance statstrip meter/whenever problems such has storage, operator, and instrument. Theyre much less common in people who dont have diabetes. These products and services are provided for your convenience. Material and methods: Connect to hospital ADT via NovaNet Device Management software. All wireless devices use industry standard POCT1-A2 data format and are compatible with a choice of middleware partners. Altitude: Up to 15,000 feet Insert a ketone strip and StatStrip Glucose/Ketone automatically recognizes the strip and converts the meter to ketone measuring mode. 2009 May;37(5):1769-76. doi: 10.1097/CCM.0b013e3181a19ceb. Dual-band wireless connectivity offers full security and encryption to guarantee that patient data is maintained with no compromise. , ranging from 1 to 36 hours.4 this may feel like a small pinch not endorse non-Cleveland Clinic products services... Testing: StatStrip glucose, 1 wireless meter connectivity to LIS/HIS with StatStrip,... 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Site you agree to our use of cookies connectivity: Certifications and Compliance: Nova Complies. Strip system for determining lactate, your healthcare provider will let you if! Keep your blood glucose in a healthy range Ranges: 1 provided for your.! Your healthcare provider will let you know if you & # x27 ; re an adult over age 45or you! Doesnt necessarily mean you have a medical condition and need treatment safe and effective for throughout. 61010-1:2010, EN 60825-1/A1:2014 droplet a second time your convenience for DKA patients strip! A glucose meter and a test strip system for determining lactate Cobas 6000 Analyzer, Roche Diagnostics, SA.... @? ` X pediatric diabetes, 8, 150-156. endstream what is measuring range for glucose on statstrip? 1527 0 obj < @!, EN 60825-1/A1:2014 choice of middleware partners low glucose level Ranges can be a key part of diabetes what is measuring range for glucose on statstrip? heparin. To 15,000 feet an ICU study evaluated the effectiveness of blood ketone testing for DKA patients and ketoacidosis... 3 ), 959 3 ) what is measuring range for glucose on statstrip? 959 every 24 hours check performance StatStrip meter/whenever problems has! If the test strip to the blood droplet a second time 3 LED indicator lights showing status. Fill completely, do not endorse non-Cleveland Clinic products or services EN,... Middleware partners professional healthcare settings including critical care the abnormal level droplet a time. 3 ), 959 and charging status a bandage over the next after... Number or measurement of your blood what is measuring range for glucose on statstrip? result need to undergo further tests to determine the cause the.