Hemocue pds configuration tool hemocue 201 dm systems. High readings 2459 patient problem no known impact or consequence to patient 2692 event date 04072017. Hemocue glucose 201 microcuvette is a modified glucose dehydrogenase method described by banauch et al. The hemocue glucose 201 dm system provides labquality. Hemocue glucose 201 systems medline industries, inc. The hemocue glucose 201 dm analyzer offers features like qc lockout and built in barcode scanning for patient id. The hemocue glucose 201 dm analyzer with blo od plasma conversion multiplies the measured whole blood glucose value by a factor of 1. The system consists of the hemocue glucose 201 dm analyzer, the hemocue 201 dm docking station and. Performance report hemocue glucose 201 rt systems this document summarizes the performance of the hemocue glucose 201 rt system and the hemocue glucose 201 dm rt system. Reduced manual entry errors industry leading 3 year warranty efficient and secure workflow with data management and connectivity with its unique cuvette technology, the hemocue glucose 201 dm system gives you high accuracy at the pointofcare.
The hemocue glucose 201 dm system complies with the ivd medical device directive 9879ec and carries the ce mark. For installation, setup and other vital information, consult the hemocue hb 201 dm reference manual. With its unique cuvette technology, the hemocue glucose 201 dm rt system gives you accuracy at the point of care while minimising the risk of spreading infection. The hemocue glucose 201 dm system is an analyzer, not a meter. Plus, you have the added controls and productivity.
Read and follow this operating manual and the hemocu e glucose 201 microcuvettes package insert to attain optimum performance and safety. Hemocue 201 dm mmoll 0 0 5 10 15 20 25 5 10 15 20 25 hemocue glucose 201 dm vs vista 1500, individual replicates. We have 1 hemocue glucose 201 rt manual available for free pdf download. The hemocueglucose 201 dm system provides labquality glucose results at the pointofcare data management features1 include. Hemocue pointofcare systems are available to test blood glucose, hba1c, urine albumin, hb and white blood cells with five part differential counts. Manuals and user guides for hemocue glucose 201 rt. The affected units in the field will be corrected in accordance with a rework procedure that has been established by hemocue ab. Hemocue glucose 201 dm system diagnoses diabetes with glucose test.
The hemocue hb 201 dm system brings your practice labquality hemoglobin results at the pointofcare, with added controls and advanced data management capabilities, including qc lockout and builtin barcode scanning to support data integrity and privacy, along with bidirectional communication and flexible settings. The unique microcuvette technology gives high accuracy and reduces. The corrective action consists of an update of the configuration settings on the the affected hemocue glucose 201 dm and hb 201 dm analyzers that are in the field. Hemocue glucose 201 with plasma conversion operating manual the hemocueglucose 201 analyzer with plasma conversion provides laboratory quality analysis of glucose in whole blood, easily, quickly and conveniently. Measuring instruments blood glucose meter medical equipment laboratory equipment personal care products. Measurements are normally taken from the finger but alternative site testing is allowed and it is intended for both professional use and selfmeasurement. Hemocue 201 dm systems allow healthcare providers to ensure the authorized and appropriate use of hemocue analyzers. Page 50 glucose 201 analyzer limitations of the procedure, see the hemocue glucose 201 the analyzer can be stored at 0 50 c 32 122 f. The hemocue hb 201 dm system is a compact, portable, yet versatile, hemoglobin measuring system. Refer to the troubleshooting section of the operating manual if problems arise. Device problems incorrect, inadequate or imprecise resultor readings 1535. The accuracy of the system allows them to be used for screening and diagnosing diabetes mellitus and gestational diabetes. In fact, the results are so accurate theyre used for screening and diagnosing diabetes mellitus and gestational diabetes, and have been used in.
Hemocue glucose systems are portable spectrophotometers, developed for professional use, that deliver labaccurate results. The effect of increasing exercise intensity on oxygen consumption, diffusing capacity, pulmonary capillary blood volume, membrane diffusing capacity, and ipava score is shown in table 1. Pointofcare hemoglobin analyzer, promotion hemocue hb 201 dm clia waived. The three levels of control are designed to provide values in the abnormal low, normal, and abnormal high ranges. Technical support at 18004267256 for more detailed instruction. The systems give immediate results with laboratory accuracy. Utilization of a conversion factor allows the measured whole blood result to be displayed as a plasma equivalent glucose value. Not available in the us, for corresponding us product see. Being light and portable, as well as having a mains power option, the hemocue hb 201 system is equally suited for both static and mobile use. The hemocue glucose 201 dm system was reported to have presented a single low measurement result that was compared to a laboratory result. Blood glucose test data management hemocue glucose 201 dm. With data management you gain higher efficiency and optimized workflow. Summary the hemocue glucose 201 rt systems are based on a glucose dehydrogenase method and consist of a small dedicated analyzer and a unique disposable microcuvette.
Vo 2, dl co, vc, and dm increase in response to increasing power output figure 2 shows a representative calculation of vc and dm using the multiple f i o 2dl co technique during exercise. Assessment of pulmonary capillary blood volume, membrane. Any other use of the system than recommended by the manufacturer may impair the safety. Hemocue glucose 201 dm system with its unique cuvette technology, the hemocue glucose 201 dm system gives you accuracy at the point of care while minimizing the risk of spreading infection. Oct 07, 2010 the corrective action consists of an update of the configuration settings on the the affected hemocue glucose 201 dm and hb 201 dm analyzers that are in the field. Providing results closely correlated with a reference lab method, the hemocue glucose 201 dm system is cleared for supplementing the clinical evidence in the diagnosing of diabetes. This operating manual provides the basic instructions for routine use as well as technical specifications. The system consists of the hemocue hb 201 dm analyzer, the hemocue dm docking station and the hemocue hb 201.
Event type injury event description the blood glucose on a b6 child has been measured with the hemocue glucose 201 dm rt system using a capillary specimen. Hemocue glucose 201 dm analyzer, hemocue glucose 201 microcuvettes, glucotrol aq. The unique microcuvette technology gives high accuracy and reduces contamination risks. Or is also stable for 30 days when stored in the refrigerator at 28oc. The hemocue glucose 201 system is an analyzer, not a meter. Hemocue provides reliable and accurate test systems for blood glucose and quantitative screening for microalbuminuria at the point of care. Hemocue glucose 201 dm instructions for use manual 60 pages. The hemocue glucose 201 rt system can be used for monitoring of neonatal blood glucose levels, but should not be used on critically ill neonates in neonatal intensive care settings. By means of a wide range of settings and definable options, the systems can be made to prompt the operator for identification, lot numbers, quality control and other required information during analysis. Data entry touchscreen display and builtin barcode scanner interface capabilities interface with existing network using poct1a cic standard with our dms software. Through bidirectional communication and flexible settings, the system offers a complete data management solution for glucose testing. Batches of hemocue glucose 201 microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approx. Pointofcare testing renal and cardiovascular hemocue.
Hemocue glucose 201 dm system in diabetes diagnostics, the hemocue glucose 201 dm system is used to measure blood glucose levels. Class 2 device recall hemocue ab glucose 201 dm analyzer. With data management you gain higher efficiency in everything from patient management to billing. It is ideally suited for health care facilities that require central lab quality values within a few minutes, at the point of care location. Adapter, glucose 201 microcuvettes, eurotrol glucose control solution, high and low, 1 vial. Many clinicians may be unaware of many glucose strip meters being cleared only for use on known diabetics.
Pointofcare glucose analyzer promotion hemocue glucose 201 dm clia waived. In diabetes diagnostics, the hemocue glucose 201 dm system is used to measure blood glucose levels. The hemocue glucose 201 dm sends results to host system by using the clsi poct1a communication. Providing results closely correlated with a reference lab method, the hemocue glucose 201 system is cleared for supplementing the clinical evidence in the diagnosing of diabetes. Device problem high test results 2457 patient problems hypoglycemia 1912. Poct pointofcare testing glucose diabetes care hemocue. Please read the relevant operating manual9 for the analyzer for proper use of the system. Class 2 device recall hemocue glucose 201 microcuvettes. With its unique cuvette technology, the hemocue glucose 201 dm rt system gives you the highest accuracy at the point of care. By means of a wide range of settings and definable options, the systems can be made to prompt the operator for identification, batch numbers, quality. The hemocue glucose 201 analyzer with plasma conversion multiplies the measured whole blood glucose value by a factor of 1.
In combination with other hemocue tests such as hba1c and urine albumin, you can build a complete pointofcare testing diabetes portfolio. Hemocue b4 received a complaint on hemocue glucose 201 dm from hemocue b6. Seite 1 operating manual bedienungsanleitung manuel dutilisation gebruiksaanwijzing. With its unique cuvette technology, the hemocue glucose 201 dm rt. Measures blood glucose levels in the diabetes diagnosis. Diabetes diagnosis hemocue glucose 201 dm system radiometer. Hemocue glucose 201 microcuvettes are available in individual packages or in vials. Operating manual hemocue glucose 201 rt operating manual 104 pages.
The pds configuration tool is not equivalent to hemocue 201 dm dms software. With its unique cuvette technology, the hemocue glucose 201 dm system gives you accuracy at the point of care. The hemocue glucose 201 dm system is a compact, portable, yet versatile, blood glucose measuring system. This manual contains stepbystep instructions for the routine use of the. The hemocue glucose 201 dm rt is a clinically validated and 3star blood glucose meter. The results can be printed directly via an external printer or downloaded to a pc. The hemocue hb 201 dm system provides labquality hemoglobin results by means of a wide range of settings and definable options, the system the hb 201 dm unit stores 4000 patientstat tests, 500 qc tests and 50. Open up the package and unpack the contents on a dry and stable surface. Plus, you have the added controls and productivity means made possible with advanced data management. Hemocue albumin 201 system used for early detection of microalbuminuria and ideal within diabetes care and hypertension treatment. Hemocue glucose 201 microcuvettes 110718 with its unique microcuvette technology, the hemocue glucose 201 system gives you the highest accuracy. Hemocue 201 glucose promo kit with analyzer mg dl, glucose dmu docking station, basic connect software, glucose 201 microcuvettes, individually packaged, 50box, glucotrolaq solution, 1 vial each of high and low. Always write the open date, initials, and new expiration date on the vial. Hemocue hemoglobin 201 dm systems the hemocue 201 dm systems for hemoglobin with data management functions allow healthcare providers to ensure the authorized and appropriate use of the analyzers.
This reference manual contains instructions for settings, quality assessment, patient testing, and troubleshooting of the hemocue hb 201 dm analyzer, as well as installation of the. With its unique cuvette technology, the hemocue glucose 201 dm system gives you accuracy at. Operating manual bedienungsanleitung manuel dutilisation. An open vial is stable for 30 days when stored at room temperature. The hemocue glucose 201 dm analyzer is only to be used. Read and follow this operating manual and the hemocue glucose 201 microcuvettes package insert to attain optimum performance and safety. The pds configuration tool is provided by hemocue for configuration of ip address settings in primary docking stations for hemocue 201 dm systems. Capillary, venous or arterial whole blood may be used.
Intended use quantitative determination of glucose in whole blood using a specially designed analyzer, the hemocue glucose 201 analyzer with plasma conversion. Gebruiksaanwijzing manuel dutilisation bedienungsanleitung. With its unique cuvette technology, the hemocue glucose 201 dm system gives you the highest accuracy at the point of care while reducing the risk of spreading infection. The hemocue glucose 201 microcuvettes are for in vitro diagnostic use only. Manufacturer narrative hemocue glucose 201 dm measured 3. Hemocue glucose 201 dm system measures blood glucose levels to diagnose diabetes.
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