BIOMIC V3 Microbiology System Product Specifications

Transcription

1 READER HARDWARE BIOMIC V3 Microbiology System Product Specifications Dimensions: Width: 34 cm (13.5 in) - Shipping Width: 58 cm (23 in) Height: 47 cm (13 in) - Shipping Height: 46 cm (18 in) Depth: 33 cm (18 in) - Shipping Depth: 44 cm (17.5 in) Weight: Weight: 13.6 kg (30 lbs) Shipping Weight: 18 kg (40 lbs) Voltage: Volts Hz Loading System for Test Plates and ID Panels: Drawer fits most sizes of test plates and ID panels Adapter rings available for unique test plate sizes Adapter trays available for ID Panels Image Capture: Full color digital camera High Resolution 1280 x 1024 pixels Unlimited number of test plate and panel images may be saved and printed Image Precision: 0.10 mm for colony size detection and zone diameter reading 0.15 mm for colony size discrimination Lighting: Non-breakable LED light source Lifespan 100,000+ hours Over sample lighting Under sample lighting Darkfield illumination Ultraviolet (optional) Cabinet Design: Closed cabinet No ambient light interference Monitor: 15 inch Touch Screen Mounted to reader cabinet CE, UL, and FCC certified Calibration: Zone diameter measurement Color verification Calibration required after software installation and if system is physically moved Environmental Requirements: Temperature: C Humidity: 0-90% Similar to requirements for personal computer operation Maintenance: No routine maintenance required Contains no motors, no scanners, no mirrors, no moving parts, no breakable light source Software Compatibility: BIOMIC V3 and TRINITY TM V3 software modules Giles Scientific Inc. Page 1 of 7 M

2 HARDWARE ACCESSORIES AND DOCUMENTS Bar Code Reader Electronic Caliper (optional): Linked to the computer by USB cable Measuring range: 0-150mm Resolution: 0.01mm Precision: 0.02mm Repeatability:0.01mm Measurement unit: millimeter Calibration Template Test Plate/ID Panel Adapters (optional): 90 mm Test Plate Adapter Ring (custom sizes available) API 32 (biomerieux) ID Panel RapID TM (Remel) ID Panel Crystal TM (Becton Dickinson) ID Panel Power Supply with Cord: 12 Volt Power supply UL and CE certified USB 2.0 Cable Software CD Installation and Quick Reference Guide Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation protocol documents ANTIBIOTIC SUSCEPTIBILITY TESTING (AST) Test Plates Read: Up to 150 mm round Reading Time: Less than 1 second per test plate Testing Method: Antibacterial disk diffusion Antifungal disk diffusion Minimum Inhibitory Concentration (MIC) determined by the continuous agar gradient around each disk accurately calibrated against reference dilution method MICs Strip based MICs (e.g. Etest ) CLSI (Clinical and Laboratory Standards Institute) guidelines in the software: M2, M100 - Performance Standards for Antimicrobial Disk Susceptibility Tests M31 - Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated from Animals M44 - Method for Antifungal Disk Diffusion Susceptibility Testing for Yeasts; Approved Guideline M7 - Method for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically - Sixth Edition M45 - Method for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria M42 - Methods for Antimicrobial Disk Susceptibility Testing of Bacteria Isolated from Aquatic Animals M49 - Methods for Broth Dilution Susceptibility Testing of Bacteria Isolated from Aquatic Animals Annual CLSI software guideline updates available via website download BSAC (British Society of Antimicrobial Chemotherapy) guidelines in the software: Standardized Disc Susceptibility Testing Method Annual BSAC software guideline updates available via website download EUCAST (European Committee on Antimicrobial Susceptibility Testing) guidelines in the software: EUCAST expert rules in antimicrobial susceptibility testing Annual EUCAST software guideline updates available via website download Page 2 of 7 M

3 US FDA, United States of America Food and Drug Administration: 510(k) Reviewed - K and K Test Plate Samples/Media: Bacteria Yeast Fastidious or poor growth bacteria species Clear Media Opaque Media Blood Agar Media with alpha, beta and gamma hemolysis Zone Reading Accuracy: 97% (Defined as the percent of tests where readings were within 3 mm of manual reading) Zone Reading Reproducibility: 98% (Defined as percentage of duplicate zone diameter readings differed by <= 3mm) Image Enhancement Feature: Contrast enhancement for dark or blood plates Growth enhancement for low growth, fastidious organisms Antibiotic Strip Automated Reading and Interpretation: Etest (biomerieux) M.I.C.Evaluator (Oxoid) MIC Test Strip (Licofilchem) D-Test: Automated reading and interpretation for detection of inducible clindamycin resistance AST Test Results: Review test endpoints on an enlarged digital color image on-screen Adjust measurements on screen as required View test result interpretations on screen Saved results are accessible by query with date, specimen number, organism, patient number or name Giles Scientific Inc. IDENTIFICATION TESTING (ID) Commercial ID Panels Read: API 10, API 20 and API 32 (biomerieux) RapID (Remel) Crystal (Becton Dickinson) Reading Time: Less than 1 second per ID panel Chromogenic Agar: Reads and interprets colonies of bacteria and yeast on various commercial brands of chromogenic agar plates (e.g. CHROMagar from BD) to identify species CLSI guidelines in the software: M35 - Abbreviated Identification of Bacteria and Yeast. M50 - Quality Control for Commercial Microbial Identification Systems. ID Test Results: Automatically reads color, turbimetric and fluorescent test reactions Review the ID panel test results on screen Adjust results of the ID panel +/- wells as required Automatic organism identification look-up View color image of test panel on screen Saved results are accessible by query with date, specimen number, organism, patient number or name Page 3 of 7 M

4 TESTING CENTER Single Test Plate or ID Panel Reading: Read and Record: Less than 1 second per test Batch Test Plate and ID Panel Reading: Read, Review and Record: 6 plates per minute Test Plate and ID Panel Images: High resolution 1280 x 1024 pixel full color Saved in electronic format for a (user specified) number of days or permanently Test Drug Panels: User creates test antibiotic disk panels to match changing formulary and physician needs Test Entry: Touch screen Bar code LIS/LIMS worklist download Keyboard Mouse LIS/LIMS Interface: ASTM protocol VITEK TM equivalent protocol Data Export: Delimited Text WHONET format Microsoft Excel Microsoft Access Languages: English Chinese (Simplified) Chinese (Traditional) German Italian French Spanish Portuguese Russian Romanian Custom System Access (4 Levels): Administrator Power User User Read-Only Training modules included in software: Centers for Disease Control and Prevention (CDC), USA Antibiotic Susceptibility Test Training Program IDTree software module training for CLSI simple rapid species identification test schemes CACMLE, Colorado Association for Continuing Medical Laboratory Education Microbiology Mystery Theater Help & Support: Product Manual and Help search by table of contents, index or keyword On screen instructions show step-by-step procedures Printed Installation and Quick Reference Guide provided Customer Support 24 hours per day / 7 days per week by telephone or Page 4 of 7 M

5 RESISTANCE MONITORING CENTER Expert Rules: 2500 rules based on the human and animal CLSI, BSAC (UK), EUCAST, French, German and published recommendations. Automatically checks all tests for unlikely results, ESBL (screening & confirmatory), MRSA, inducible clindamycin resistance (D-Test) and other resistance mechanisms. Verifies that all test results are adequately quality controlled. Predefined rules can be turned ON or OFF. Users may define their own rules to selectively report test results. Epidemiology Reports: CLSI M39 Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data. Flexible Report Templates Customize Reports Save Commonly Used Reports QUALITY CONTROL CENTER Features: Antibiotic Disk QC Testing Identification Panel QC Testing Etest, M.I.C Evaluator, MIC Test Strip QC Testing Thymidine Control QC Testing Disk Lots Received Log (including manufacturer, lot number, expiration date) Media Lots Received Log (including manufacturer, lot number, expiration date) ID Panel Lots Received Log (including manufacturer, lot number, expiration date) Reagent QC Testing, Read and Record with option to save up to 3 images per test Predefined Report Formats: QC Cumulative Summary QC Detailed Summary QC Zone Trend Graph New Lot QC Summary MIC QC Cumulative Summary QC Annual Trend Graph QC Comment Summary QC Abbreviated Thymidine Control Test Summary Methods: Based on CLSI, CAP (College of American Pathologists), and JCAHO (Joint Commission on the Accreditation of Healthcare Organizations) COLONY COUNTING Petri Plate Samples/Media: Bacteria Yeast Transparent Opaque Colored Blood Agar 3M Petrifilm Page 5 of 7 M

6 Spiral Inoculated Ames Phage/Plaque Pour Plate Filter Membrane/Grid Define Plate Area for Reading: Entire Plate Half Plate Quadrants Custom defined Accuracy: Smallest detectable colony diameter: 0.1 mm Smallest colony size discrimination: 0.15 mm Counting Options: Differentiate by size (up to 10 size ranges may be defined and counted simultaneously) Differentiate by color (up to 256 colors or shades may be defined and counted) Automatically separate touching colonies into multiple counts Divide large colonies into multiple counts Adjust sensitivity, exposure, and lighting parameters Recall common counting formats Adjust counted area to exclude plate rims and ridges Calculates end concentrations on spiral inoculated plates Colonies are marked on-screen by color Manual include and exclude colonies Guidelines: Follows Aerobic Plate Count Guidelines in the US-FDA Bacteriological Analytical Manual (BAM), the US-FDA preferred laboratory procedure for microbiological analysis of food and cosmetics Meets 21 CFR Part 11 (Code of Federal Registry) electronic signature requirements with multi-level access controls and full audit trails Meets GLP (Good Laboratory Practices) requirements COMPUTER REQUIREMENTS (NOT INCLUDED WITH BIOMIC V3) Processor: Pentium 4 or equivalent (minimum), Core 2 Duo (recommended for optimal performance) RAM: 512 meg (minimum) 2 gig (recommended) Operating System: Windows XP, Windows Vista, or Windows 7 USB 2.0 ports: 3 available (minimum) Serial Port: 1 LIS connection Internet Connection: Strongly recommended Surge Protector STANDARDS Manufacturing Quality and Product safety are audited by internal company procedures consistent with: ISO 13485: 2003 Page 6 of 7 M

7 US-FDA Good Manufacturing Practices GMP/QSR Regulations Council Directive 98/97 EC for in vitro diagnostic medical devices: Conforms SERVICE CONTRACT AND WARRANTY (RENEWABLE ANNUALLY) Live technical support: 7 days per week via telephone and including LIS/LIMS interface support (LIS/LIMS provider may charge a separate fee) Hardware Warranty: One Year Software updates via website download: New BIOMIC V3 product features New CLSI, BSAC, and EUCAST guidelines Page 7 of 7 M