MALDI Biotyper CA System
Contents
1. 4000 6000 8000 100 2000 14000 16000 A Simple Procedure for a Sophisticated Platform Innovative design leads to enhanced performance and productivity The MALDI Biotyper CA System workflow has been designed to be as robust and easy to perform as possible No previous experience with Mass Spectrometry is required The workflow has been streamlined and requires only a few simple steps to generate high quality microorganism identifications Our dedi cated microbiology software Select an isolated colony Export result to AST LIS Final review by come microbiologist Smear using any sterile transfer device MALDI Biotyper CA System Sample Workflow BETTA ET l a w O a O automates the process of acquiring the mass spectrum and performing the data base matching A report is then gener ated showing the microbial identification in a very easy to interpret traffic light color scheme Typically no more than an Isolated single colony from a culture plate is required the entire procedure requires only a few minutes to complete providing a report showing the closest matches to the extensive library of microorganisms oftware automatically generates MALDI TOF spectrum Spectrum instantly matched against reference database to give identification Easy to Use Software that is Dedicated to Microbiology The wizard A simple to use Rea2. MALDI Biotyper CA System e Clinical Application for Identification of Microorganisms MALDI TOF Innovation with Integrity f d f f better results To help answer key challenges in Clinical Microbiology Bruker has utilized its many years of experience to create the truly groundbreaking MALDI Biotyper CA System With its combination of perfor mance and utility the MALDI Biotyper CA System will revolutionize the way microbial identification is performed in the clinical microbiology laboratory Accuracy comparable to Nucleic Acid Sequencing i Much faster than traditional methods Cost effective Robust and easy to use A true benchtop system P a C IFWINS MInrnanraanieme ITVING MICFOOFrganiSsms p Nem Molecula ngerprint The MALDI Biotyper CA System identi fies microorganisms using MALDI TOF Matrix Assisted Laser Desorption loniza tion Time of Flight Mass Spectrometry to measure a unique molecular fingerprint of an organism Specifically the MALDI Biotyper CA System measures highly In Microbiology Every Minute Counts 4 abundant proteins that are found in all microorganisms The characteristic patterns of these highly abundant proteins are used to reliably and accurately identify a par ticular microorganism by matching the respective pattern with an extensive FDA cleared database to determine the identity of the microorganism Enterobacter aerogenes
3. Nitrogen Laser with 60Hz repetition rate WhisperMode Full Spectrum Resolution FSR with Ojil free membrane pre vacuum pump broadband focusing mode PAN and turbo pump FlashDetector Indication for use The Bruker Daltonics Inc MALDI Bio The MALDI Biotyper CA System is indi typer CA System is a qualitative in vitro cated for use in conjunction with other diagnostic mass spectrometer system clinical and laboratory findings to aid in for the identification of Gram negative the diagnosis of Gram negative bacterial bacterial colonies cultured from human infections specimens using matrix assisted laser desorption ionization time of flight MALDI TOF mass spectrometry technology The following organisms are claimed Achromobacter xylosoxidans Acinetobacter Iwoffii Acinetobacter radioresistens Acinetobacter ursingil Acinetobacter baumannii complex Acinetobacter baumannii Acinetobacter calcoaceticus Acinetobacter nosocomialis Acinetobacter pitti Aeromonas sp Aeromonas allosaccharophila Aeromonas caviae Aeromonas Culicicola Aeromonas hydrophila Aeromonas ichthiosmia Aeromonas veronii Aeromonas sobria Alcaligenes faecalis Burkholderia gladioli Burkholderia multivorans Burkholderia cepacia complex Burkholderia ambifaria Burkholderia anthina Burkholderia cenocepacia Burkholderia cepacia Burkholderia diffusa Burkholderia dolosa Burkholderia lata Burkholderia latens Burkholderia metallica Burkholderia pyrroci
4. Using a biostatistical algorithm this peak Low Confidence Identification 1 If this log score is obtained on a direct transfer follow with extraction preparation see User list is compared to reference peak lists of Manual O rga nN i sms i n th e refe rence data ba se a nd 2 toi is obtained on an extracted test organism report sample as Low Confidence a log score value between 0 00 and 3 00 is calculated No Organism Identification Possible refer to troubleshooting section in User Manual Th h Ig h er th log score va ue th e 1 If this log score is obtained on a direct transfer follow with extraction preparation see User higher the degree of similarity to a given wenn o o 2 If this log score is obtained on an extracted test organism report sample as No Identification organism in the reference FDA cleared database A log score value of gt 2 00 can be considered an excellent probabi lity for test organism identification at the species level The main spectra concept Reference Strain a reference database developed with the user in mind Enterobacter aerogenes ATCC 13048T THL Reference database entries in the MALDI Biotyper CA System are stored as Main Spectra MSP These MSPs are based on multiple measurements of a single defined strain to ensure that the true biological variability of an organism has been captured An unbiased sophisticated algorithm creates the MSP completely unsuper v
5. is not only quiet but virtually maintenance free Greatly enhanced sensitivity With the most sensitive detector technology available FlashDetector you will benefit from having the same high performance technology as large research grade instruments Powerful and Reliable Performance Benchtop Convenience microflex LT SH Mass Spectrometer Dimensions and Operating Parameters LxWxH 510 x 680 x 1093 mm 20 1 x 26 8 x 43 Weight 84 kg 185 Ib net weight Noise lt 30 dB under normal operating conditions Temp Range 10 30 C 50 86 F Operating Humidity 15 85 non condensing 30 C Full spectrum resolution Patented intelligent pulsed lon Extraction resolution and separation and mitigates across a wide protein mass range the need for unnecessarily long and bulky This unique technology enhances peak instrument flight tubes MALDI Biotyper CA System and Components Components The standard MALDI Biotyper CA System US IVD 48 Spot Target P N 604532 contains the following components US IVD BTS P N 604530 microflex LT SH mass spectrometer US IVD HCCA portioned P N 604531 P N 269944 Package Insert MALDI Biotyper CA MALDI Biotyper CA System desktop System User Manual computer running under Windows 7 P N 603291 P N 604941 Uninterruptible Power Supply UPS MALDI Biotyper CA System software P N 601463 P N 604512 Instrument microflex LT SH Mass Spectrometer
6. ised by extracting information about peak position intensity and frequency while employing very effective de noising and patented mass corrections to the peak data Unknowns are then compared to the MSP FDA cleared database using a Superior pattern matching approach that is based on true statistical multi variant analysis and includes peak positions intensities and frequencies ensuring the highest possible levels of accuracy and reproducibility across the complete range of microbes The Best Technology from the Market Leader in MALDI TOF HE A 7 The MALDI Biotyper CA System was developed by Bruker the industry leader in MALDI TOF technology These systems were designed as robust com pact high performance platforms intended for extensive and routine usage Many outstanding features have been incorporated into the MALDI Biotyper CA System to enhance performance simplify operation and extend system lifetime and utility A true bench top system A smart compact design that packs a punch with a throughput of 192 samples an hour The small access chamber allows for a rapid target insertion that elimina tes waiting time between runs Requires only a 110 V electrical outlet with very minimal heat output Silent and pleasant operation With WhisperMode you really have a system that can sit on a bench next to you almost silently By eliminating noisy oil based vacuum pumps the vacuum system
7. l Time Classification wizard guides you through setting up samples for analysis in just a few easy steps Automatic Calibration and Quality Control Check E lt Create a new Run Run definition Run name Picee eee lt a amp F Plate Id 1811000321_MBT_CA i Creator causer FLEX PC K l Description Urine Bench Test Organism definition 8213259 Urine Culture jas AG 18213260 Urine Culture 8213261 T rine Culture The MALDI Biotyper CA System microflex LT SH mass spectrometer is automatically checked using US IVD BTS Bacterial Test Standard before each use When the check is successful the system automatically begins the measurement process Run Results Report Target lo ona Position alue After the acquisition of the BTS1 BTS 1 Escherichia coli spectral dat has been 2 completed a Run Results BTS2 BTS 2 Escherichia coli ee Report can be generated 8213257 Escherichia coli The resultant report for each sample shows the Organism identification via a hyperlink Test Organism Label Organism Identification best match along with the respective matching score 8213261 Proteus vulgaris group Rigorous and Sophisticated Data Analysis Assures Accuracy Meaning of score values Score Values The spectrum of the unknown test Interpretation organism acquired through the MALDI Biotyper CA System Software is elec tronically transtormed into the peak list
8. nia Burkholderia seminalis Burkholderia stabilis Burkholderia vietnamiensis Citrobacter amalonaticus complex Citrobacter amalonaticus Citrobacter farmeri Citrobacter freundii complex Citrobacter braakii Citrobacter freundii Citrobacter gillenii Citrobacter murliniae Citrobacter werkmanii Citrobacter youngae Citrobacter rodentium Citrobacter sedlaki Citrobacter koseri Eikenella corrodens Enterobacter aerogenes Enterobacter cloacae complex Enterobacter asburiae Enterobacter cancerogenus Enterobacter cloacae Enterobacter hormaechel Enterobacter kobe Enterobacter ludwigii Escherichia coli Haemophilus influenzae Haemophilus parainfluenzae Bruker Daltonics Inc Billerica MA USA Phone 1 978 663 3660 Fax 1 978 667 5993 ms sales bdal com www bruker com Hafnia alvei Klebsiella pneumoniae Klebsiella_oxytoca Raoultella_ornithinolytica Moraxella_sg_Branhamella catarrhalis Moraxella_sg_Moraxella osloensis Morganella morganii Pantoea agglomerans Pasteurella multocida Proteus mirabilis Proteus vulgaris group Proteus hauseri Proteus penneri Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Pseudomonas fluorescens group Pseudomonas azotoformans Pseudomonas brenneri Pseudomonas cedrina Pseudomonas congelans Pseudomonas corrugata Pseudomonas extremorientalis Pseudomonas fluorescens Pseudomonas gessardii Pseudomonas libanensis Pseudomonas mandelii Pseudomonas marginali
9. s Pseudomonas migulae Pseudomonas mucidolens Pseudomonas orientalis Pseudomonas poae Pseudomonas rhodesiae Pseudomonas synxantha Pseudomonas tolaasii Pseudomonas trivialis Pseudomonas veronii Pseudomonas putida group Pseudomonas fulva Pseudomonas monteilii Pseudomonas mosselii Pseudomonas plecoglossicida Pseudomonas putida Salmonella sp Salmonella enterica ssp arizonae Salmonella enterica ssp bongori Salmonella enterica ssp diarizonae Salmonella enterica ssp enterica Salmonella enterica ssp houtenae Salmonella enterica ssp indica Salmonella enterica ssp salamae Serratia liquefaciens Serratia marcescens Stenotrophomonas maltophilia Yersinia enterocolitica Yersinia pseudotuberculosis BDAL 03 2014 1825980 Revision A
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