Biofire filmarray gastrointestinal gi panel ec declaration of conformity. The bd max system is a fullyintegrated molecular diagnostics platform. Reduce the number of required instruments7 reduce the total cost per test24,7 reduce the need for manual tasks2,3,7 equip your laboratory to provide answers for more patients, faster. Viper lt system users manual becton, dickinson and company 7 loveton circle sparks, md 21152 usa 50000536302 201501 catalog number 442839 english us version. The instrument is battery operated or can be used with an ac. Bd life sciences diagnostic systems package inserts bd. G used to increase manual inputs, scroll through memory, and to navigate the setup menu. Patients who will have both tests should receive 2 specimen collection kits and. The instrument may be used for measurement of inoculum density for the bbl crystal system and the bd phoenix system. Bd max is the first fully automated system that allows the running of laboratorydeveloped tests in various. The applied biosystems quantstudio 3 and 5 realtime pcr systems provide a modern usability experience similar to mobile devices, allowing you to connect to your data easier than ever before.
The bd max enteric bacterial panel detects nucleic acids from. The bd viper system delivers up to 736 results per an 8. So you have the flexibility of continuous processing. The bd max system, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings. Bard maxcore disposable core biopsy instrument 14g x 16cm. Refer to the bd max system users manual3 for detailed instructions operation. Tiva c series tm4c123g launchpad evaluation kit users manual. Liquid primers and probes according userdefined protocols. H press and hold 2 seconds to zero out the display before taking readings. For details on the system configuration, refer to the following manual. The optima max ultracentrifuge is capable of handling volumes from just a few l up to 6. Process continues with assembly, repair, and diagnostics. Ask your bd representative how the bd max system can help you achieve maximum efficiency.
It is the responsibility of the buyeruser to ensure that all added electronic files including software. Bard maxcore disposable core biopsy instrument, 16g x 10cm. Runs of 24 for maximum efficiency plus ondemand capability. Taken together, the bd max pcr missed one patient but identified an additional three patients with pneumocystis jirovecii infection. It is used in conjunction with the following alaris system documents and software. For more information on project 0, go to the tiva c series launchpad wiki page. Bd bactec mycof lytic culture vials supplemented middlebrook 7h9 and brain heart infusion broth for use with bd bactec fluorescent series instruments.
Procedure bd max system for bd max enteric bacterial. Section b contains information on how the meter is used for testing different materials. Bd viper extracted mode, urine preservativet ransport for the. The instrument utilities dvd that ships with your instrument provides an extensive collection of online help, videos, and books for the agilent 7890a gc, 7820a gc, 6890n gc, 6850 gc, 5975t. Conventions the following conventions are used in these instructions. The bd max mrsa xt assay requires use of three 3 optical channels from the bd max system. The bd max system contains all hardware and software necessary to. Bd life sciences diagnostic systems qcpi manuals bd.
The operating instructions for the model bd 2100 are divided into two sections. Instruction manuals davis instruments support, faqs and. The automated process including sample preparation, lysis, dna extraction, and realtime pcr rtpcr was initiated and results were available in 3 to 4 h. Delmhorst, guarantees its bd 2100 meter for one year from water also transmits heat at a faster rate than air, thus date of purchase and any optional electrodes against defects reducing the efficiency of the insulation. This manual describes how to service the pc unit models 8000 and 8015 and pump module model 8100. The annual maximum throughput on a 5 day protocol is 14. View and download samsung bd p3600 user manual online. Refer to the bd max system users manual3 for detailed instructions operation section. Bd accuri c6 flow cytometer instrument manual refer to the bd accuri c6 safety and limitations manual pn 7820091 for complete safety information. Certest biotec and bd announce covid19 diagnostic test. Laboratory equipment bd facscanto user manual 184 pages. Becton dickinson and companys bdx ceo tom polen on q2.
Although these symbols appear in color on the instrument, they are in black and white throughout this users. Bd serves and supports our customers with full offerings beyond our individual products, enabling integrated solutions across healthcare systems to comprehensively improve care and lower costs. Applications include differential gradient separations of proteins, dna and rna, lipoproteins, subcellular fractionation, membrane fractionation and sedimentation of viruses. Bd is a leading medical technology company that advances human health in every corner of the world by improving medical research, diagnostics and the delivery of care. Enhance your ihc and ish productivity with usability and menu improvements driven by the experience of leading laboratories.
Bd accuri c6 software user guide manual 782009501 rev0 iii f. The biogx sarscov2 reagents for bd max system is a. Patient must collect their specimen before any vaginal exam is performed with a lubricant. Rapid molecular assays the bd max cdiff assay delivers accurate and timely results which enable appropriate treatment and infection control measures to be implemented which helps improve patient outcomes, potentially reduce hospital costs, and increase patient satisfaction. I used to decrease manual inputs, scroll through memory, and to navigate the setup menu. Additional details 4 bags of 120 sample vials per bag. Bd biosciences delivers software and workstations that are intended for running the instruments supplied by bd biosciences. Bd max system is intended for in vitro diagnostic ivd use in performing fda cleared or approved nucleic acid testing in clinical laboratories. Instruction manuals for your favorite davis instruments weather. Vaginal infections are among the most common reasons for which women in the united states seek medical careresulting in approximately 10 million visits to physician offices annually. Quantstudio 3 and 5 realtime pcr systems thermo fisher.
Accessgudid bd max system, bd max instrument 00382904419165 instrument max clinical. The vicell cell viability analyzer provides an automatic means to perform the trypan blue dye exclusion method, allowing users to load up to 10 samples at once for easy and automated cell. For emergency use authorization eua only p025103 for. Nucleic acid extraction, realtime pcr for womens health.
Alaris system directions for use dfu maintenance software and user manual this manual is intended for personnel experienced in analysis. To obtain a substantial equivalence determination for the bd max mrsa assay on the. Leica biosystems continues to advance cancer diagnostics with the new bond max. When setting up the cytometer, note the details in the following sections to maximize the instrument s performance. Procedure bd max system for bd max enteric bacterial panel. Biofire filmarray respiratory panel, filmarray injection vialbased ec declaration of conformity. The bd max system is a fullyintegrated, automated platform that performs nucleic acid extraction and realtime pcr providing results for up to 24 patient. Bd max vaginal panel elevate the standard of care for womens health. Bd facscalibur instructions for use bd biosciencesus.
The bd max system is designed to help address todays challenges, while preparing your laboratory for tomorrows possibilities. Compared to routine stool culture, laboratories have demonstrated significant reductions in turnaround time with the use of molecular assays 17, 18. Bd bd max molecular diagnostic testing system bd max system diagnostic tests and clinical products. Aerosol resistant extended length micropipette tips 6. Max is effectively three stainers in one instrument. The manual and automated steps involved with operating the bd max. With up to five lasers, three scattering channels, and 64 fluorescence channels, the aurora suits every laboratorys needs, from simple to high complexity applications. Bd leads in health care safety including medication safety, health care worker safety and infection prevention as well as the technologies that enable medical research and. Laboratory equipment bd facsjazz user manual 9 pages. The nova max blood glucose monitor is intended for use outside the body in vitro diagnostic use.
Instruction manuals for your favorite davis instruments marine products. The bd phoenixspec nephelometer is a portable device designed to measure turbidity of microbial suspensions equivalent to mcfarland standards 0. Refurbishment includes disassembly and total restoration. This user s manual is an important reference for understanding circuit operation and completing hardware modification. Certification concludes with calibration, qc and qa validation. Checkdirect cpe screen for bd max user manual version 1. Product name vicell xr 4 bags of sample vials, 120 per bag. Bd serves and supports our customers with full offerings beyond our individual products, enabling integrated solutions across healthcare systems to comprehensively improve care. The aution eleven ae4022 is a standalone, easytouse, semiautomated urinalysis analyzer ideal for mid to highvolume labs.
The hts provides users the ability to acquire samples from 96well or 384well plates for efficient analysis with. The warranty is limited to one 1 year from the date of sale. A prodigy incorporating a unique combination of patentpending innovative technologies that takes flow cytometry to the next level of performance and flexibility. Performance of the remaining optical channel has not been established with this assay. Ivd assays, research use only ruo assays and userdefined protocols udp cannot be combined in the same rack.
Section a is a systematic guide to the different features and basic use of your moisture meter. The bd facscalibur instructions for use assumes you have a working knowledge of the mac os x operating system. Rack a is positioned on the left side of the instrument and rack b on. The bd max system and bd max gbs assay are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, bd max gbs master mix, bd max dna unitized reagent strips, bd max gbs extraction reagent. Stool cultures require a significant level of technologist expertise and are labor intensive, with multiple test methods extending timetoresults to up to 4 days or more. Vaginal specimen selfcollection for bd max vaginal panel. Bd max becton dickinson molecular biology analyzer.
Users manual 4 chapter 1 getting start the oscilloscope is small, lightweight, no external power required, portable oscilloscopes. Launch max by doubleclicking on the desktop icon or selecting start. Bd viper system with xtr technology and bd viper lt. Bd max is the first fully automated system that allows the running of laboratory developed tests in various. Bd max enteric bacterial panel bd molecular diagnostics. Reference control based instrument standardization is the most important next step for clinical flow cytometry. If the instrument is operated using usersupplied reagents, the bd. After launching, max displays the dialog box shown below. Fda only when used with bd max ivd assays, which have been cleared or approved by the fda. Bd bd max molecular diagnostic testing system bd max. The aution max ax4030 is an easytouse, fullyautomated urinalysis analyzer designed for mid to highvolume labs. Process evaluation of an open architecture realtime molecular. Already a proven performer, the new bond max provides even faster setup, an exciting readytouse reagent range and powerful new connectivity options. Development and evaluation of a realtime pcr assay for.
It also offers solutions for medication management, infection prevention, surgical and interventional procedures, respiratory care, and diabetes management. Customize and integrate the hardware to suit an end application. A comparison of the c t values of both pcrs showed that the target gene was detected with a median c t value of 30. The certestdeveloped kit will bring rapid covid19 diagnostic capabilities to many laboratories across europe which desperately need the ability to quickly identify covid19 patients so that proper protocols for infection prevention can be instituted, said nelson fernandes, managing director of certest biotec the test is a realtime reverse transcriptase polymerase chain reaction pcr. Reference manual contains specific information on software structure and function. Fx3u series users manual hardware edition fx3uc series users manual hardware edition 3. Page 16 65 years delmhorst instrument has been the leading manufacturer of high quality, usmade moisture meters and thermohygrometers. It is capable of automated extraction and purification of nucleic acids from multiple specimen types, as well as the automated amplification and detection of target nucleic acid sequences by. The bd max exk dna1 can only be used on the bd max system by trained personnel. It should only be used with nova max test strips and nova. Bd bactec lytic10 anaerobicf culture vials soybeancasein digest broth in a plastic vial. Remote monitor your runs, quickly analyze sophisticated data sets, store results in a secure space. Close the bd max system lid and click to begin processing.
In diagnostics, as i mentioned earlier, we expect to see strong growth of our bd max instruments and assays for use in covid19 testing. The bd max enteric bacterial panel performed on the bd max system is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. See appendix 1 to create the cd cpe screen test if not yet in the test menu. Bard maxcore disposable core biopsy instrument bard. Use of the bd max exk dna1 for clinical specimen types. The bd viper system with xtr technology is a single automated platform that efficiently runs five sexually transmitted disease assays with clinical accuracy and minimal handson time. Instruction manuals for your favorite davis instruments automotive product.
Bd max enteric bacterial panel diagnosing bacterial gastroenteritis is a demanding process. Today we offer a wide range of meters for applications including water damage restoration, construction, flooring, lumberwoodworking, paper, and agriculture. Neutralization pouches, specimen tubes and caps for use on the. Bd high throughput sampler users guide for the bd lsrfortessa i. Pdf automation in molecular diagnostics towards an open future. Bard maxcore disposable core biopsy instrument 16g x 16cm. 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.
It also displays the average of up to 50 accumulated readings. The bd max ebp assay is performed with the bd max instrument, a walkaway instrument that conducts all steps of the molecular assay from extraction to interpretation of results. Introduction the bd high throughput sampler hts is a highspeed sampling device used on the 5laser lsrfortessa located in rm. Cytek aurora next level spectral flow cytometry cytek. Manual methods plus multiple instruments mean a longer time for results. Before using this unit, carefully read the sections entitled. Biofire filmarray blood culture identification bcid panel, filmarray injection vialbased ec declaration of conformity. Comparison of the bd max enteric bacterial panel to. Group b streptococcal gbs disease is a leading infectious cause of morbidity and mortality among newborns in the united states. Bd max mrsa xt assay performance may vary depending on the prevalence and population tested. Bd max system fully integrated benchtop molecular diagnostic system the bd max system for molecular diagnostics is the next generation platform which fully automates cell lysis, nucleic acid extraction, pcr setup, amplification and detection. Bd max 2 channel or 2nd generation bd max 6 channel systems, respectively 3. Refer to the device user manual for information on how to configure and search for a bluetooth connection.
For clinician staff do not use a lubricant with the bd max uve specimen collection kit to aid in selfcollection. Learn about bd life sciences diagnostic systems qcpi manuals. Multicenter evaluation of the bd max enteric bacterial panel. Bd diagnostics manufactures and markets medical supplies and devices and diagnostic systems that include cellular analysis systems, infectious disease diagnostic kits and tests, and automated blood culturing systems. This warranty shall not be extended or varied except by a written instrument signed by bd and the buyer. The test is intended to be used for bacteria cultured from clinical specimens.
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