Is there an initial manufacturer password to log in to the statstrip glucose meter device. The glucose results are calibrated to agree with a method measuring the concentration in plasma. More the 95 publications since 2011 prove statstrip improved accuracy, through correction of measuring errors created by interferences. Hi there, save hours of searching online or wasting money on unnecessary repairs by talking to a 6ya expert who can help you resolve this issue over the phone in a minute or two. Do a quality control test to make sure that the meter and test strips are working well together. Even though proper usage of this meter would not allow for a user to misinterpret a presentation of the software version as a pt result, nova biomedical has initiated a proactive product change as to how the software version is presented to the user during meter initialization. Statstrip and statstrip xpress2 glucose metersonly. Nova stata strip glucose meter training cape fear valley. Should be completed and returned to the warranty center. Pay attention to the blue dialog bar at the top of the meter b. Today is operating and serving customers in austria, czech republic, hungary and slovakia.
Unit of measure information the unit of measure of the onetouch statstrip xpress glucose hospital meter is set to report glucose results in mgdl, pn 023330, or mmoll, pn 023324 and can not be changed. Instructions for use blood glucose test strips package. Department of pathology and laboratory medicine capital district health authority. It incorporates a new strip technology that uses four measuring wells. New users trained via elearning are required to run both levels of quality control material as a test of practical competency, before their barcode is activated for 2. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes con trol. Three ranges ctrl 0, ctrl 1 and ctrl 2 are shown on the test strip vial label. Nova analyzers offer the most extensive stat test menus and deliver results in the shortest time at the lowest costs. Laboratoryclinical guidelinestandard operating procedure this is a controlled document for internal use only. 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. The physician examinations your blood glucose degrees after fasting for 8 hours as well as its higher compared to 126 mgdl. The operating range or linearity of the statstrip glucose meter is 10 600. Wear gloves during blood glucose monitoring and during any other procedure that involves potential exposure to blood or body fluids change gloves between patient contacts. Statstrip and statstrip xpress2 glucose metersonly glucose.
Statstrip glucose from nova biomedical selectscience. Nova statstrip blood glucose meter recertification 2020. Statsensor creatinine a rapid and easy to use poc test. Statstrip is the only bedside glucose meter to eliminate glucose errors due to haematocrit interference. Like the statstrip glucose hospital meter, statstrip xpress elevates bedside glucose testing to a new level of analytical performance that approaches the quality of central laboratory testing. Medical professionals use these examinations to discover if you have diabetes mellitus. A free powerpoint ppt presentation displayed as a flash slide show on id. Pdf pointofcare glucose monitoring on the neonatal unit. Accurately monitor blood glucose levels that are free from interference in laboratory animals with the nova statstrip glucose meter. This is a statement that no other glucose meter manufacturer can make. Nova also provides handheld meterandstrip based measuring systems for glucose, ketone, lactate, and creatinine pointofcare testing. No changes have been made to the form, fit, function or packaging of the nova statstrip glucose linearity solution since k152986 clearance and they are not a subject of this submission. Use of the nova statstrip blood glucose meter clinical. Statstrip hospital glucose monitoring system from nova.
Statstrip technology elevates bedside glucose testing to a level of accuracy, precision, and patient safety that approaches the quality of central laboratory testing. Test strips introduction test strips the nova max test strips are designed for use with your nova max blood glucose monitor only. Statstrip meter first introduced in may 2006, by nova biomedical. The nova max test strips are designed for use with your nova max blood glucose monitor only. Tecom analytical systems was founded 1990 in vienna, since then we have grown into a multinational company for medical engineering. Statstrip glucose hospital meter system receives fda clearance for capillary. The instructions in the guide were followed during the evaluation. This section describes how to setup the nova statstrip xpress glucose hospital meter. Nova biomedical waltham, ma won fda clearance for its statstrip glucose hospital meter system, an accurate clinical level device for use anywhere from the neonatal ward to the intensive care. Nova blood glucose meter manuals manualslib has more than 2 nova blood glucose meter manuals. Statstrip glucose xpress2 meter from nova biomedical description 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.
Provides detailed instructions on using the blood glucose monitoring system. Nova biomedical statstrip xpress accurately monitor blood glucose levels that are free from interferences in. Qc is performed within 24 hours prior to a patient test. Pointofcare glucose monitoring on the neonatal unit. Poct glucose testing using nova statstrip meter procedure version. User and patient id can be scanned in with the integrated 1d2d scanner or also entered with the on screen alpha numeric touchpad. Evaluation and performance of statstrip glucose meter. Follow the control test procedure in the users manual. Nova biomedical waltham, ma won fda clearance for its statstrip glucose hospital meter system, an accurate clinical level device for use anywhere from the neonatal ward to. The nova max blood glucose monitor is intended for use outside the body in vitro diagnostic use. Point of care testing nova statstrip and the statstrip xpress glucose meter. Canned or free text user comments rejecting of results at meter optional for repeat testing.
The staff attempted at least six readings using three different meters. Accuracy and reliability of the nova statstripr glucose meter for realtime blood glucose determinations during glucose clamp studies. Unit of measure information the unit of measure of the onetouch statstrip xpress glucose and ketone hospital meter is set to report glucose results in mgdl, pn 023332, or mmoll, pn 023334 and can not be changed. Point of care nova stat strip glucose meter the nova stat strip blood glucose meter is uhbs approved glucometer for patient testing operator certification status must be kept current use universal precautions when testing as per hospital policy. Statstrip glucose meter, nova statstrip glucose test strips, and statstrip glucose control solutions. Statstrip xpress also eliminates oxygen, maltose, galactose, and. New stat strip glucose meter and strips chosen for province wide implementation. Nova statstrip glucose meter data sciences international.
Click on an alphabet below to see the full list of models starting with that letter. The nova statstrip meter must be used with nova statstrip glucose test. Any documents appearing in paper form are not controlled and should be checked against the electronic file version prior to use. This version supersedes any previous versions of this document. Insert the gold end of the test strip into the meter strip port with the statstrip. About this manual this manual is for the nova biomedical statstrip xpressi glucose and. Blood glucose monitor nova biomedical statstrip forums. Novas multiwell system measures and corrects hematocrit interference, as well. Connectivity blood glucose meters for use in leeds nhs trust this standard operating procedure explains the protocol for measuring blood glucose concentration using the nova stat strip connectivity meters, with emphasis placed on the responsibility of nursing staffhcas to ensure that the meter is used correctly and that a high standard of patient and control results is maintained. Statstrip glucose ketone poct monitoring system by nova.
Nova statstrip glucose linearity kit solutions are used to check the. Nova blood glucose meter user manuals download manualslib. The nova statstrip glucose linearity solutionused to check the linearity of the nova statstrip s are xpress 2 glucose hospital meter. Nova statstrip blood glucose meter recertification. Statstrip glucose meter rapidly becoming standard in accurate hospital glucose testing throughout usa and now canada. Statstrip glucose meter page 2 of 6 mean arterial pressure of user manual for nova statstrip glucose dm meter i need user manual for nova statstrip glucose dm meter1 suggested answer. We are deciding wheather to use nova stat strip or the abbott system for our glucose point of care instrument. Nova statstrip xpress glucose hospital meter instructions for. Document qc results onto the fetal scalp lactate fslac form a. Nova biomedical statstrip xpress community, manuals and. 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. Quick reference guide nova stat strip lactate quality control qc is performed on.
Nova statstrip, a hematocrit and electrochemical interference. This is detected by the meter and translated into a glucose result in mmol. Only staff who have received documented training by nova trainers or by ward key. Separate result screens and specifications are shown in the. The nova max blood glucose monitor is specifically indicated for the quantitative measurement of glucose in whole blood capillary samples obtained from the fingertip, palm and forearm. Statstrip glucose xpress2 meter from nova biomedical. Statstrip creatinine meter statstrip xpress glucoseketone meter u. Hospital glucose monitoring system hospital glucose meter hospital glucose meter no. Because small things matter we take care of our customers and service we are convinced that the small things make a huge difference. These solutions will be offered for sale separately from the meter. A guide from the statstrip manual is reprinted in attachment 1. Glucose and ketone hospital meter instructions for use manual.
The strength of signal produced is directly proportional to. The nova max blood glucose monitor can test your blood glu cose on the fingers, forearm, or palm. A major concern is the accuracy of glucose meters in different clinical settings. About this manual this manual is for the nova biomedical statstrip xpress glucose hospital meter. It should only be used with nova max test strips and nova. Department of pathology and laboratory medicine capital. This manual is for the onetouch statstrip xpress glucose and ketone hospital meter. Intended use the nova max blood glucose monitor is intended to be used for the quantitative measurement of glucose in capillary whole blood. A free powerpoint ppt presentation displayed as a flash slide show on. Any paper document labeled uncontrolled must be verified against the electronic version prior to use.
Installing the battery replacing the meter is powered by a single 3v coin cell battery, 2450. Novas statstrip glucose monitoring system, the only glucose meter cleared by the fda for use with critically ill patients, accurately measures glucose while eliminating interferences from hematocrit, maltose, oxygen, acetaminophen, ascorbic acid, and a number of other common interfering substances. Nova statstrip xpress glucose hospital meter instructions. To ensure that blood glucose and ketone results produced by the nova statstrip system are safe and reliable. I need user manual for nova statstrip glucose dm meter fixya. Laboratoryclinical guidelinestandard operating procedure. Statstrip nova biomedical, waltham, mass is a new generation glucose and quantitative ketone meter designed to correct for common biochemical interferences and to measure and correct hematocrit.
Expected results the nova statstrip glucose control solution should produce results that fall within the range of results printed on the label. If a laboratory or the testing site modifies the test instructions, the test. To learn more about how statstrip can help hospitals avoid the risk of glucose meter offlabel use and bring critical care testing to the bedside, call nova at 80045858, or contact us here. Results the nova stat strip glucose meter reads results between 10600 mgdl a result reading higher than 600 will read as hi a result reading lower than 10 will read as lo. Hospital meter and nova statstrip glucose test strips as a quality control check to verify the accuracy of blood glucose test results. Glucose hospital meter instructions for use manual statstrip. Based on the info received by the hospital b6 coordinator, staff managing a b6 pt located in the adult renal transplant section of the hospital attempted to utilize a nova statstrip glucose hospital meter to obtain a glucose reading.
Nova biomedical develops, manufactures, and sells advanced. Novas multiwell system measures and corrects hematocrit interference, as well as interferences from acetaminophen tylenol, uric acid, ascorbic acid vitamin c. User manuals, nova blood glucose meter operating guides and service manuals. Statstrip lactate specifications other nova biomedical. Ketone hospital meter is factory set to report glucose results in mgdl or mmoll and ketone results in mmoll. Pdf accuracy and reliability of the nova statstripr. Reject results at meter optional for repeat testing. Statstrip glucose has no known interferences and brings lablike accuracy to bedside glucose testingaccuracy validated in an fda submission study of 1,698 critically ill patients with 257 different. Unit of measure disclaimer the statstrip xpressi glucose and. The statstrip glucoseketone monitoring system features a patented multiwell measuring technology that meets the escalating demands of todays hospital glucose testing. Statstrip hospital glucose monitoring system from nova biomedical description the nova statstrip hospital glucose monitoring system is the only glucose meter system cleared by the fda for use with critically ill patients. This manual is for the onetouch statstrip xpress glucose hospital meter.
Manualslib has more than 2 nova blood glucose meter manuals. Haematocrit interference can cause glucose errors as large as 40%. An easy to read color touchscreen prompts the user through simple operation steps. Statsensor creatinine is the first point of care meter for.
This procedure provides instructions for glucose testing using the nova statstrip meter. We have several locations in our facility that depend on multiport adapters. Use of the nova statstrip blood glucose meter clinical guideline v3. Discard by date written on the side of the bottle 3. Statstrip lactate specifications other nova biomedical stat. There are three levels of controls, level 1, level 2, and level 3. The point of care testing procedure manual contains the approved procedures for safe and effective operation of poct procedures by mgh poct providers. Designed for applications that do not need data interfacing and connectivity, xpress2 glucose retains all of the analytical performance features of statstrip glucose.
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