Glucose Meter The Nova StatStrip Xpress® meter is a nonconnectivity hospital meter that utilizes a modified glucose-oxidase-based amperometric detection system and a hematocrit correction test strip. Quick reference guide 8. Disinfection and Experimental Protocol $42.00. Lancets (10)* 5. StatStrip Xpress' 6-second analysis time, 1.2 microliter sample size, and simple operating steps make bedside glucose testing fast and easy. 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. please manually enter the Hospital (CR) Number .. without the express permission of the author or their Line Manager. Conventionally manufactured blood glucose test strips require the use of calibration codes, as the sensitivity can vary greatly between individual lots. The rank order of MARDs was similar but not identical in both ranges. Significant insulin dose errors may occur if blood glucose results are obtained from miscoded meters. Insert a test strip into the meter, gold tip in. • To begin QC Analysis and to turn the meter ON, insert a Glucose Test Strip into the meter. One of StatStrip`s four measuring wells measures hematocrit. The 1D/2D barcode scanner, conveniently located within the sample port allows for fast, error-free entry of operator and patient IDs. Statstrip Xpress 2 Glucose Hospital Meter System - k152986 2. StatStrip and StatStrip Xpress®2 Glucose Meters-Only . Only Contour test strips should be used with Contour meters. Only what is seen in photos also battery. Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof. StatStrip is the only bedside glucose meter to measure and eliminate glucose errors due to varying hematocrit levels. Recap vial. SKU: StatStrip Glucose/Ketone. StatStrip Novabiomedical.com All Courses ››. StatStrip Xpress2 Glucose Meter. Value Assignment Sheets. Take the battery cover off the back of the meter. No exception. The StatStrip design incorporates a feature to prevent glucose errors due to over-filling or under-filling of the sensor. Page 29 date and time: see the Lactate Meter Instructions for Use Manual. Boyd, J. et al. The results were plotted and correlated with each other very well (Fig. • The new glucose meter, manufactured by Nova Biomedical, is the StatStrip Xpress. _____ A. In order to help hospitals avoid the risk of glucose meter off-label use, Nova Biomedical’s technical support resources are ready to help you acquire the StatStrip Glucose Hospital Meter System. Postal Code. Press “Accept” Meter time out is 10 min. ***PLEASE READ*** $75.00. Blood glucose levels for people without diabetes are as follows: Adult Fasting 70-100 mg/dL Expected values for neonates (1 to 7 days old): 47 - 110 mg/dL 2. Nova Max Blood Glucose Monitor 2. TRUE Metrix Blood Glucose Test Strips 6 Boxes of 50 - 300 Total. Warranty Card 11. Patient Monitoring Devices. 1 2. Nova StatStrip Glucose Meter Training Fast Facts Revised 4/2020 . The StatStrip Glucose Control Solution is intended for use only with the StatStrip Glucose Hospital Meter Test Strips. This provides a virtually painless, yet fast and accurate test for lactate. The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria. The Nova StatStrip Xpress ® meter is a nonconnectivit y . Nova StatStrip Test: Strip Vials STATSTRIP VIALS: • Contain a desiccant to protect against humidity • Must be CLOSEDwith its lid when not in use • Store at room temperature between 15 to 40 degrees Centigrade (59 to 104 degrees Fahrenheit) • When opening a new vial of strips, write on vial: • Date Opened AND Date Expired • Expiration date is 180 days from opening or label expiration This important breakthrough is possible because of new, patented electrochemical technologies developed by Nova Biomedical. Page 7/28 Storage #I72. StatStrip technology elevates bedside glucose monitoring to a level of accuracy, precision, and patient safety that approaches the quality of central laboratory testing. ITT Access to the meter is by scanning personal Trust ID badge. In both normal and anemic ranges, the MARDs of the 2 most accurate meters (Contour Next and StatStrip Xpress) were similar and not statistically different (P > .05). 3.6 in x 2.3 in x 0.9 in (91 mm x 58 mm x 23 mm) Data Storage. The StatStrip Hemoglobin and Hematocrit Meter System (StatStrip Hb/Hct) is the only POC system to provide anemia screening and monitoring with measured, not calculated, Hb and Hct tests. Blood Glucose Monitors. 2. Oxygen 3. Opened vials are stable for 3 months 3. Their small 1.2 microliter sample size results in easy sample acquisition and minimal pain for the patient. • Eliminates glucose errors due to: hematocrit interference (hematocrit errors of 20 to 50% reported on every glucose meter system except for Nova’s StatStrip) electrochemica l interferences by: 1. Rapidfill electrochemically monitors the blood volume in each of the four measurement wells. 7, OGTT). +. Clinical Chemistry, 47(2), 209-214. This meter is calibrated to report plasma equivalence of glucose … Nova StatStrip Glucose Meter 2. StatStrip® Xpress Glucometer Specifications. Sentry Urinalysis Control comes in a formula that does not The CLIA-waived StatStrip Xpress glucoseglucose require any dilution or reconstitution and can be stored at monitor can be operated in situations wherewhere room temperature for 12 months, with glucose-meter interface capability is notnot 18-month stability at 2°C to 8°C. StatStrip and StatStrip Xpress®2 ... - Nova Biomedical Introduction This manual provides all necessary instructions for the routine operation and maintenance of the Nova StatStrip Xpress-i Glucose and ß-Ketone Hospital Meter. Lactate Plus Meter. 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. Meter (Analytic) Nova StatStrip Meter Overview¹: 1. Nova Biomedical Corporation. (2003). StatStrip Xpress Glucose/Ketone Meter A simplified version of the analyzer StatStrip Glucose with a minimal set of additional functions. Poster session presented at the meeting of the European Congress of Clinical Chemistry and Laboratory Medicine, Berlin, Germany. 9.Apply Sample screen Mix QC vial well. ... Nova Biomedical 42214 Stat Strip Xpress Glu-Test Strips 100/Box Lot of 3 Boxes. The operator can set the meter for local time and date, have the beeper On or Off, enable the sample counter, and set the date display format. Always adhere to Universal Safety Precautions. StatStrip Xpress. The Nova StatStrip Xpress Lactate Meter is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical lactate electrochemical test strips to measure lactate in a whole blood sample, a Quality Control (QC) solution, linearity, or proficiency solutions. Nova Biomedical StatStrip® Xpress Accurately monitor blood glucose levels that are free from interferences in laboratory animals. Blood was sampled from the tail. Dimensions: Weight: 78.5 g (2.77 oz) Size: 98 mm x 61 mm x 22.9 mm (3.9 in x 2… Blood lactate is the premier indicator of aerobic conditioning for athletes and coaches and a key predictor of performance. It has been prepared to help you at- tain optimum performance from your Meter. The OneTouch StatStrip Xpress Glucose Hospital Meter is a hand-held, battery-powered, in vitro diagnostic labora- tory instrument that works in conjunction with OneTouch StatStrip glucose test strips to measure glucose in a whole blood sample, a Quality … Add to enquiry. Statstrip Glucose Xpress Meter. It is the preferred reference for calibration of continuous glucose telemetry. Quality Control Analysis Using The StatStrip Meter R Evaluation of four hospital glucose meters. StatStrip® Glucose Xpress2, along with StatStrip® Glucose and StatStrip® Glucose Xpress are now the only three hospital glucose meters to be cleared by the FDA and proven to be safe and effective for use throughout all hospital and professional healthcare settings, including with critically ill patients. 400 glucose measurements or … 46. ratings, based on 46 reviews. … The European Society for Paediatric Endocrinology, Diabetes UK, the Canadian Diabetes Association, Australian Diabetes Association, and American Diabetes Association, concur that glucose level>14 mmol/L (250 mg/dL) combines with elevated blood ketone indicate DKA, a potentially life threatening complication of hyperglycemia. This meter is calibrated to report plasma equivalence of glucose concentration (mmol/liter). Owner’s Guide 9. 1. Medical diagnosis. Nova Medical Stat Strip Glucose Meter & Docking Station. Their small 1.2 microliter sample size results in easy sample acquisition and minimal pain for the patient. Unlike competitive glucose analyzers, StatStrip Xpress requires no calibration codes. 0.2 lbs (75 g) Dimensions. It has been prepared to help you at- tain optimum performance from your Meter. Average Rating: ( 4.9) out of 5 stars. The StatStrip Glucose Control Solution is intended for use only with the StatStrip Glucose Hospital Meter Test Strips. -. Now up your study game with Learn mode. Statstrip glucose control solutions 1. Results are reported only if all four measurement wells are filled with blood. Accuracy Comparable to the Gold Standard StatStrip Glucose/Ketone Connectivity Meter • Weight: 0.49 lb (220 g) • Size: 5.8 in x 3.1 in x 1.18 in; (147 mm x 79 mm x 30 mm) Glucose and Ketone Testing in One Meter: (ADA recommends ketone testing when glucose >250 mg/dL or >14 mmol/L) • Glucose Results in 6 Seconds, Ketone Results in 10 Seconds • 1.2 Microliter Sample for Glucose Please read this manual carefully. Xpress Manual - Nova Biomedical Introduction This manual provides all necessary instructions for the routine operation and maintenance of the Nova StatStrip Xpress-i Glucose and ß-Ketone Hospital Meter. Remove cap & wipe 1st drop. 2. Location of strip port 4. StatStrip Xpress also eliminates oxygen, maltose, galactose, and xylose interferences. StatStrip Xpress Glucose utilizes the same test strip measurement technology as StatStrip Glucose. Medical professionals make use of these examinations to locate out if you have diabetics issues: Not eating plasma sugar examination. The only insulin cool bag which can Insulin cool glucose high blood test for up to 45 hours. The doctor tests your blood sugar degrees after fasting for 8 hrs and it’s higher than 126 mg/dL. Application Lactate Plus device, which is enough only 0.7 L, allows the use of the finest, least traumatic lancets for sampling, simplifying the testing process in … StatStrip® and StatStrip Xpress®2 Glucose/Ketone Meters quantity. Nice work! $18.00. In vitro diagnostic medical device Similar devices from other manufacturers require from 5 to 25 ml of blood, which consequently causes more inconvenience to the patient. Then a flashing blood drop will display. StatStrip® test strips do not require any codes and are consistently precise, even when using different lots. Insert (Test)Strip screen Remove Test Strip from vial & insert into the strip port at the top of meter. Their small 1.2 microliter sample size results in easy sample acquisition and minimal pain for the patient. It will tell you what the meter … If discarding, dispose of the battery promptly. It has been prepared to help you at- tain optimum performance from your Meter. The StatStrip® and StatStrip Xpress®2 Glucose Meters, cleared by US FDA and Health Canada for use with all patients, are designed specifically … StatStrip® and StatStrip Xpress®2 Glucose/Ketone Meters. On May 20, 2015, the FDA cleared Nova’s StatStrip Xpress Glucose Hospital Meter System for use throughout all professional healthcare settings, including critical care. Proprietary Name: StatStrip Xpress 2 Glucose Hospital Meter System Common or Usual Name: Blood Glucose Meter Product Code: PZI Classification Name: Classification Name Class No. On/off and Sleep mode after 90 seconds 5. You just studied 39 terms! Blood glucose meter Nova Biomedical has unveiled a new hospital blood glucose meter for testing sit-uations where glucose meter interface capability is not needed. This manual is for the Nova Biomedical StatStrip Xpress™ Glucose Hospital Meter. Lancing device* 4. Nova StatStrip Glucose Meter • Reagent Requirements Nova StatStrip Glucose Test Strips Nova StatStrip Glucose Control Solution Storage Temperature Room Temperature (<40 °C) Room Temperature (<40 °C) Stability • Once Opened: 6 monthsor until manufacturer’s expiration date. Full description. ... Glucose meters from 9 urban, 2 suburban, and 1 rural hospital were surveyed. Point of Care Testing - Page Nova StatStrip™ and the StatStrip Xpress™ Glucose Meter 3101.1 3 of 19 Initial Certification for the StatStrip Xpress meter consists of completing or have completed the certification for the Nova StatStrip meter plus attend a hands on training session for the Xpress meter. New New New. StatStrip Glucose Hospital Meter Test Strips are working cor-rectly. Location of barcode reader (laser caution-never point toward eyes) 3. StatStrip is the only bedside glucose meter to measure and eliminate glucose errors due to varying hematocrit levels. You may also access electronic Value Assignment Sheets (eVAS). What to do: Check your test strip bottle to … Category: Medical Equipment & Devices. The Nova StatStrip Xpress Glucose Hospital Meter is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical glucose electrochemical test strips to measure glucose in a whole blood sample, a Quality Control (QC) solution, linearity, or proficiency solutions. Show when buttons and touch screen are interchangeable 6. Show when buttons and touch screen are interchangeable 6. Location of barcode reader (laser caution-never point toward eyes) 3. Designed for applications that do not need data interfacing and connectivity, Xpress2 Glucose retains all of the analytical performance features of StatStrip Glucose. The control solution contains a measured amount of glucose that reacts with the StatStrip Glucose Hospital Meter … FSA and HSA eligible. _____ A. The Nova StatStripT blood glucose monitoring system is used for neonatal testing of whole blood glucose in neonates. hospital POC glucose meter StatStrip in accuracy and precision of blood glucose measurement. StatStrip Glucose Test Strips Safety Precautions 1. 3. 2.4.3 The ketone test strips are stable for 3 months after opening. Content on … All segments of the screen will display for 2 seconds. Included with battery that was replaced in 2020. Screen is locked because we do not have Operator ID. Title: Glucose Testing: StatStrip Glucose Meter Page 5 of 6 G. Reference Ranges: 1. The number of test strips in the package: 50 strips in a tube, the tube 2 in the package – glucose; 25 strips in a tube, the tube 2 in the package – ketones. Pay attention to the blue dialog bar at the top of the meter b. • Once Strip is inserted, the meter will show a Flashing Blood Droplet indicating it has turned on and ready for analysis. StatStrip Glucose Hospital Meter Test Strips are working cor-rectly. 1. Blood glucose was measured by glucometer (StatStrip Xpress meter) immediately before and at 15, 30, 60, 90, 120, and 180 min after glucose administration. Test strip errors often occurs when there is a problem with the test strip, or when the environment in which the test strip is used is below or above the operating range. $199.00 + shipping + shipping + shipping. Level 1 (or 2) Confirm QC lot on vial. The introduction of StatStrip Xpress provides hospitals a choice of glucose monitors with or without a connectivity solution using the same Multi-Well test strip. The primary cause for change is to replace old meters that are providing questionable results and less than satisfactory customer service support from the current manufacturer with meters that are currently used by most System hospitals. Glucose Monitoring for Life Science Research. • (Important: only trained staff may use the glucose meters. glucose monitoring. One of StatStrip`s four measuring wells measures hematocrit. Log Book 10. StatStrip Glucose Control Solutions 3. Miscoded meters can lead to glucose errors as large as 50%. Over 35 hospital correlation and interference studies have validated StatStrip lab-like analytical performance across a wide glucose range of 10 to 600 g/dL StatStrip also eliminates calibration codes required of all other hospital meters. 75 g (2.65 oz) Intended Use The Nova StatStrip Xpress-i Glucose and ß-Ketone Hos-pital Meter System is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative measurement of Glucose (Glu) in fresh capillary, venous, arterial, and … Level 1 (low) and Level 3 (high) 2. If so, do not bid on this item unless you are an authorized purchaser. Less pain. Concerns of accuracy. Every 24 hours check performance statstrip meter/whenever problems such has storage, operator, and instrument. Blood glucose and lactate levels were measured using an Aviva Accu-Check glucometer and a Novabio StatStrip Xpress lactate meter, respectively. Hospital blood glucose meter. Results are on par with central laboratory testing. Weight. 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. StatStrip technology elevates bedside glucose monitoring to a level of accuracy, precision, and patient safety that approaches the quality of central laboratory testing. Please read this manual carefully. Using another battery may present a risk of fire or explosion. Unlike competitive glucose analyzers, StatStrip Xpress requires no calibration codes. Color Touch screen, 6 second analysis time, 1.2 microliter sample volume 2. Quality specifications for glucose meters: Assessment by simulation modeling of errors in insulin dose. Submitter’s statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials StatStrip Xpress has a six-second analysis time using a 1.2 microliter sample size. On/off and Sleep mode after 90 seconds 5. Test Strips: The StatStrip Glucose Hospital Meter Test Strips are intended for use with the StatStrip Xpress 2 Glucose Hospital Meter System. No changes have been made to the form, fit, function or packaging of StatStrip Glucose Hospital Test Strips since KMeter 152986 clearance and they are not a subject of this submission. Control Solutions: StatStrip and StatStrip Xpress®2 ... - Nova Biomedical Introduction This manual provides all necessary instructions for the routine operation and maintenance of the Nova StatStrip Xpress-i Glucose and ß-Ketone Hospital Meter. Nova Max Blood Glucose Control Solution, Normal (1 bottle)* 6. Unit of Measure Information The unit of measure of the StatStrip Xpress Glucose Hospital Meter is factory set to the standards in the country of use. Novabiomedical.com DA: 22 PA: 15 MOZ Rank: 40. The stability of the test strips and quality control: 24 months from the date 90 days after the opening of the tube. A non-Contour test strip may have been used. SKU: 56508 Categories: Clinical Diagnostics, Glucose Monitoring, Point of Care Testing Tags: Glucose… 180 days same as 6months after opening or until manufacturer exp date, whichever comes first. StatStrip Xpress 2 GLU. Fast Analysis Time. 2 levels. 1 Symbols The following are symbols that are used in this manual, on insert sheets, on the product packaging and labelling, and on the meter. D. Running a Patient Sample 1. Measures and Eliminates Hematocrit Interferences StatStrip is the only bedside glucose meter to measure and eliminate glucose errors due to varying hematocrit levels. This needed. ... Nova Biomedical StatStrip Glucose Meter With Battery Docking Station And Charger. The Meter either reports glucose results in mg/dL, 43404, or mmol/L, 44321, and can not be changed. 9 Nov 2016 2.1 INTENDED USE. The new, low-cost StatStrip™ Xpress hospital blood glucose meter from Nova Biomedical, Waltham, Mass, provides the analytical performance of the company’s patented Multi-Well™ test strip for testing situations where glucose meter interface capability is not needed. 2. Apply using 2nd drop QC solution. Use of the Nova Statstrip Blood Glucose Meter Clinical Guideline V3.1 Page 4 of 14 2.4.2 The glucose test strips are stable for 6 months after opening. StatStrip And StatStrip Xpress®2 . StatStrip Hospital Meter 0.1-7.0 mmol/L StatStrip Xpress Meter 0.0-8.0 mmol/L Interferences, Measured and Corrected: Haematocrit, Ascorbic Acid, Uric Acid, Paracetamol, Bilirubin, Maltose, Galactose, Oxygen Test Strip & QC Stability: 24 months from date of manufacture 3 months open-vial stability StatStrip Glucose … (2009, September). Simpson, P. A., Tirimacco, R., & Tideman, P. A. Installing the Battery (Replacing) The meter is … MA 02454-9141 Phone Number (781) 894-0800 More products from this supplier. 30 Day Warranty. Dec. 28, 2009 - PRLog-- Nova Biomedical’s StatStrip® Xpress™ glucose monitor has been granted CLIA-waived status from the U.S. Food and Drug Administration.StatStrip Xpress is Nova’s non-connectivity companion meter to the CLIA-waived StatStrip Hospital Glucose Meter. 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