Patient care supplies kimberly clark alere hemopoint cholestech 10991. Jun 02, 2006 the coaguchek xs method was more likely to underestimate the inr, relative to the laboratory, particularly at inr values of coaguchek xs tests differed by 15% compared with the corresponding laboratory inr. The coaguchek xs system uses fresh capillary or nonanticoagulated venous whole blood. The coaguchek xs system kit consists of different components. Coaguchek xs plus point of care testing operators manual this is a cliawaived system. Roche coaguchek xs meter ptinr testing 04837975001. It will help you get comfortable with the coaguchek xs meter and the testing procedure. The system includes the coaguchek xs plus meter, coaguchek xs pt test strips and optional liquid coaguchek xs pro pt controls. The coaguchek xs plus or xs pro meter displays the control range, the reading obtained and an evaluation of the result inside or outside of the control range. Fda grants cliawaived status to coaguchek xs plus system. The procedures for setting up the meter can be found in the coaguchek xs. Inr selftesting with the coaguchek portable coagulation monitoring system provides patients with freedom, allowing them to test virtually anywhere at any time, without having to visit a healthcare provider.
Coaguchek xs in antiphospholipid antibody syndrome apl patients. Used with the coaguchek xs series devices to monitor oral anticoagulation treatments. All three coaguchek xs devices use the same testing technology. Medical coaguchek xs monitors henry schein medical.
User manuals, guides and specifications for your roche coaguchek xs plus blood glucose meter, measuring instruments, medical equipment. Food and drug administration fda has granted clinical laboratory improvement amendments cliawaived status to the roche coaguchek xs plus system. The coaguchek xs system user manualis a comprehensive guide. This program will help you get comfortable with the coaguchek xs meter and the testing procedure. Use by lot number for in vitro diagnostic use this product fulfils the requirements of directive 9879ec on in vitro diagnostic medical devices. You can apply the blood sample to the strip either from the top or from the left or right sides, whichever you find most convenient. The pointofcare anticoagulation monitor offers connectivity and data management tools to help healthcare professionals manage ptinr blood clotting time testing. The coaguchek xs plus makes it easy to manage warfarin patients.
How to fix forward head posture 3 easy exercises from a chiropractor. Coaguchek inrange is the connected selftesting meter that enables patients to test their ptinr whenever, wherever for confident control of their vitamin k antagonist vka therapy. The test strips are easy to handle and apply blood to, making it easy to get your results rapidly. We have 12 roche coaguchek xs system manuals available for free pdf download. First, within 15 seconds of pricking the fingertip with a lancet, a drop of blood 10 mcl is applied to the center of the application well. With this coaguchek xs system getting started guide by the meter, follow the steps to perform your first test. Roche coaguchek xs plus manuals and user guides, blood. Page 1 p o i n t c a r e t e s t i n g coaguchek xs plus operators manual page 2 on the packaging, on the type plate of the instrument and in the manual you may encounter the following symbols, shown here with their meaning. Standards each lot of test strips is calibrated to a reference lot that is traceable to the who international reference preparations. Demonstrate the correct procedure for collecting fingerprick blood sample 4. Accurate and flexible technology a smart way to test. The inr is a laboratory measurement used to determine the effects of oral anticoagulants warfarin on the clotting system. Update on coaguchek xs pt test strips starting on october 31st, 2018, roche began shipping new coaguchek xs pt test strips which are not affected by the urgent medical device recall.
Roche diagnostics 5021537001 mckesson medicalsurgical. To be certified in the procedure and, therefore, be considered a valid operator. Coaguchek xs plus checklist after completion of training for inr testing on the coaguchek xs plus, the accredited user should know how to do the following. Roche coaguchek xs plus method and sample collection ie. Several resources are available to help you use and maintain the coaguchek xs system. If you are using test strips from a new, unopened container, you must change the test strip code chip. In whole blood testing the mean coefficient of variation of the coaguchek xs plus pt determination was claimed to be in the range of 1. The coaguchek xs plus system is used to monitor coagulation bloodclotting values prothrombin time, pt, quick value with coaguchek xs pt test strips. Coaguchek xs system training dvd about 15 minutes the coaguchek xs system training dvd provides an overview of the system, setting up the meter, testing procedure, and maintenance.
Typically this training will be handled by them once the devices are on site due to the extensive data management and configuration capabilities these instruments offer. Database contains 5 roche coaguchek xs plus manuals available for free online viewing or downloading in pdf. This test strip is for use on the coaguchek inrange meter. The getting started guide shows you how to perform your first coagulation test on the coaguchek xs meter. The coaguchek xs method was more likely to underestimate the inr, relative to the laboratory, particularly at inr values of 15% compared with the corresponding laboratory inr.
Error messages section of the user manual for an explanation of this error. The coaguchek monitor is a handheld device that is used to measure the international normalised ratio inr in individuals taking warfarin. Coaguchek xs pt controls box 4 buy online from marne. Easy to handle provides fast inr readings apply capillary blood sample either on top, or from either side of strip 2 box sizes to suit your practices needs supplied in.
Roche coaguchek xs inr test strips ama medical products. Each box of test strips has its own code chip that you insert into the meter. The meter guides you through the test step by step using the symbols and instructions in the display. Doctors, nurses or any other medical professionals directly involved in the diagnosis and treatment of patients. So the coaguchek xs plus and pro produce results equivalent to those obtained with reference laboratory methods and also compare closely to the patients device, the coaguchek xs. Check with your local roche team for training on the coaguchek xs plus and pro. Then, as necessary, refer to the user manual or quick reference guide. The threenumber code on the test strip container must match the. Fda grants cliawaived status to coaguchek xs plus system for. The coaguchek xs system video is for new users of the coaguchek xs system. With this coaguchek xs system getting startedguide by the meter, follow the steps to perform your first test. The coaguchek xs plus system makes coagulation testing easy. Roche coaguchek xs meter ptinr testing 04837975001 4837975001.
Coaguchek xs system knowledge test check t if the statement is true or f if the statement is false. May 15, 2014 coaguchek xs in antiphospholipid antibody syndrome apl patients the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Coaguchek xs pt test strips allows users of anticoagulation medications or blood thinners such as coumadin and warfarin to monitor and determine the coagulation of blood in the privacy of their own home. Manuals and user guides for roche coaguchek xs system. The coaguchek xs system is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The included code chip contains all relevant lotspecific information to perform a quality control test. This manual contains the information you need to operate and care for the coaguchek xs plus system. A handling video to help you set up your coaguchek xs plus and begin testing. This training manual was created by the roche diagnostics technical.
Biomedical researchers, academics, and others engaged in medical research. Policy and procedures for point of care testing using the. Coaguchek xs in antiphospholipid antibody syndrome apl. The aim of this document is to describe the procedure for using the coaguchek xs plus inr meter, including any limitations of such procedures. The waiver means that the monitoring technology may now be used in a. Coumadin, marevan is an anticoagulant a substance that. Roche coaguchek xs plus operators manual pdf download. Roche coaguchek xs system user manual pdf download. The future is now with the next wave in poc ptinr testing, the brand new coaguchek xs system that utilizes exclusive advanced technology to aid in providing the most accurate results, while offering the versatility and control that health care personnel require to manage with confidence an abundance of anticoagulated patients. Coaguchek xs plus handling 01 system overview youtube. We have remained at the forefront of medicine by fostering a culture of collaboration, pushing the boundaries of medical research, educating the brightest medical minds and maintaining an unwavering commitment to the diverse communities we serve. Training dvd the coaguchek xs system dvd is for new users of the coaguchek xs system.
The coaguchek xs will be used by the nursing staff of the internal medicine. These topics will be covered in depth during the remainder of the training session. Operators manual for a quick reference to possible solutions. The result is automatically saved as a control reading in the memory of the meter. Oct 11, 20 a handling video to help you set up your coaguchek xs plus and begin testing. Getting started the getting started guide shows you how to perform your first coagulation test on the coaguchek xs meter. Universal precautions should be observed through all phases of the testing procedure. The blood mixes with the reagents on the test strip, and the meter determines when the blood clots. User manual, procedures manual, training manual, getting started, stepbystep manual. Ptinr whole blood using coaguchek xs plus or pro test system. Coaguchek xs plus policy and procedure manual roche. Coaguchek xs plus meter coaguchek xs pt test strip and test strip code chip coaguchek lancet 04348150001 follow manufacturers instructions for use.
Testing procedure coaguchek s is easy to use, necessitating only three steps, and provides results in just one minute. Comparison of international normalized ratio measurement. How to use coaguchek xs for inr monitoring youtube. Coaguchek xs in antiphospholipid antibody syndrome apl patients the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Clean the monitor as recommended in the coaguchek users manual, and repeat the test. Box of 48 2 x tube of 24 strips coding chip include. Coaguchek xs test strips ptinr testing wilburn medical usa. This document should be read in conjunction with the coaguchek xs plus operators manual supplied with the instrument together with relevant bhrut policies. Coaguchek xs plus operator manual, roche diagnostics gmbh d68298 mannheim, germany 200911 coaguchek xs pro operator manual, roche diagnostics, 201 boul, armandfrappier, laval, quebec, h7v 4a2 canada 201010 coaguchek xs operator manual, roche diagnostics, 201 boul, armandfrappier, laval, quebec, h7v 4a2 canada 201103. How to fix forward head posture 3 easy exercises from a chiropractor duration. The video will help you get comfortable with the coaguchek xs meter and the testing procedure. Read the accu chek softclix lancet device package insert. The coaguchek xs system dvd is for new users of the coaguchek xs system.
No coaguchek xs inrs differed from their corresponding laboratory inrs by 20%. Step by step guide how to get started with the coaguchek xs. The coaguchek xs plus can store 2,000 test results and 500 optional quality control results. Purpose and scope the purpose of this document is to describe the procedure for performing an inr test using the roche coaguchek xs plus analyser. Coaguchek device inr test machine information myvmc. Medical staff and other persons using the coaguchek xs plus instrument to perform measurements for more than one patient must be aware that any object coming into contact with human blood is a. Coaguchek xs pt control solution ref 04696522190 x4 5. Accuracy and clinical utility of the coaguchek xs portable. User manual this coaguchek xs system user manual is a. Builtin wireless, bluetooth technology allows you to be connected to your patients, who can now transmit their ptinr results from their meter to you. Listing a study does not mean it has been evaluated by the u.
The meter displays the results in about one minute. If results are still unacceptable, call rocheboehringer mannheim technical service at 18004284674, 24 hours a day, 365 days a year. Coaguchek xs pt controls box 4 buy online from marne medical. Coaguchek xs pro pt test strip package insert, 0596771600102, 2010. The coaguchek xs plus uses a human recombinant thromboplastin isi 1. This coaguchek xs system user manual is a comprehensive guide. This procedure provides instruction on how to perform the liquid quality. Coaguchek softclix lancing device for single patient use only accuchek safet pro plus for use in multiple patients settings coaguchek softclix lancets bag of 10 carrying case users manual quick. The coaguchek xs plus system the coaguchek xs plus system is used to monitor coagulation bloodclotting values prothrombin time, pt, quick value with coaguchek xs pt test strips. You only need to insert the code chip, power the meter on, insert the test strip, and apply a small blood sample. Ptinr testing is done to determine the clotting tendency of blood.
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