Document

Giles Scientific Inc.
Specifications of the BIOMIC V3 System
1. BIOMIC V3 is of a high-resolution 1280 x 1024 pixel color digital image analysis system.
2. BIOMIC V3 contains a uniform non-breakable light source over and under the test sample, including
darkfield and optional ultraviolet lighting. 3. BIOMIC V3 includes a built-in 15” touch-screen monitor to facilitate and speed test-reading
4. BIOMIC V3 requires no maintenance . It has no motors or mechanical moving parts.
It requires no adjustments or lubrication. Software upgrades are available at least annually. 5. BIOMIC V3 instantly reads and interprets patient antibiotic disk susceptibility test and quality
control plates including fastidious poor-growth organisms on clear, opaque or blood agar plates. 6. BIOMIC V3 provides the unique software program, IDTreeTM, outlining procedures to enable rapid
bacteria and yeast final species identification of 85-90% of clinical isolates in several minutes at
very low cost. These procedures utilize non-proprietary methods and materials recommended by the
CLSI (US NCCLS) M35 document which specifies >95% accuracy. Commercial test kits can be used
to identify the remaining 10-15% of organisms, as required.
7. BIOMIC V3 instantly reads and interprets commercial bacteria and yeast species identification test
kits from API (bioMerieux), RapID & Microbact (REMEL-OXOID) and Crystal (BD).
8. BIOMIC V3 instantly reads and interprets colonies of bacteria and yeast on various commercial
brands of chromagenic agar (CHROMagar) plates to identify species.
9. BIOMIC V3 follows recommended methods of the CLSI (Clinical Laboratory Standards Institute-
NCCLS) reference documents #: M2 A7, M100, M31, M39 and M35, which are updated annually in
the software.
10. BIOMIC V3 read disks, plated-media and identification kits regardless of brand. No proprietary
disposable materials or reagents are required in antibiotic disks or rapid CLSI (NCCLS)
identification methods.
11. BIOMIC V3 determines antibacterial and antifungal MICs (minimum inhibitory concentrations)
automatically from the continuous agar gradient around each disk which are accurately calibrated against CLSI (NCCLS) reference dilution method MICs. 12. BIOMIC V3 records and interprets Etest MICs by CLSI document M100 category.
13. BIOMIC V3 Expert-System has over 2500 rules based on CLSI (NCCLS) documents, publications
and experts that automatically check all readings for unlikely test results, ESBL (screening & confirmatory), MRSA, inducible clindamycin resistance (D-test) and other mechanisms. It verifies that all test results are adequately quality controlled. Users can turn off pre-defined rules, create new rules, and define selective test result reporting. 14. High-resolution digital color images of antibiotic disk test plates and identification kits are saved for
the working day for review and can be saved in electronic format permanently. 15. BIOMIC V3 digital image analysis reading and MIC results were successfully reviewed by US FDA
510(k), a requirement to sell in the USA. BIOMIC V3 is the only antibiotic disk test system to meet
this requirement.
16. Many international journal publications document the accuracy and reliability of BIOMIC systems
since 1984. It is the best evaluated and most widely published microbiology image analysis reader system globally. 17. Microbiologists may review BIOMIC V3 digital color images, adjust measurements, and have
access to test results on screen. Saved results are accessible by query with date, specimen number, organism, patient numbers or name. Giles Scientific Inc.
18. BIOMIC V3 has a built-in LIS (Lab/Hospital Information System) interface. Test results can be
transferred to a host LIS computer in standard ASTM format. It is readily interfaced to any LIS system. 19. BIOMIC V3 accepts test specimen by barcode reader entry. When this is combined with the
optional LIS-worklist download feature, it greatly speeds the plate reading workflow, eliminating transcription and typing errors. 20. BIOMIC V3 data can be exported in delimited text or WHONET format and analyzed in Access or
21. BIOMIC V3 complies with CLSI M39 guidelines in its extensive epidemiology-infection control
reports program. It provides flexible formats, and users can create epidemiology reports and save
formats for common use.
22. BIOMIC V3 instructions are on the touch-screen show step-by-step procedures. It has an extensive
and visual Training and Help system accessible by table of contents, index and key word. A printed
Installation Manual and Product Setup Guide-Abbreviated Product Manual are provided with the
system.

BIOMIC V3 Image Analysis System Specifications:

Reader Resolution
Color digital camera at 1280 x 1024 pixels Reader Precision 1
Reader Accuracy 2
Reproducibility 3
Plate Sizes
Up to 150mm Round and up to 120mm square Species Identification Kits
Up to 28 cm including RapID , API, Crystal & Microbact Image Analysis Speed Per Test
Overall Tests Read Per Hour
Signal Interface
Windows Plug & Play
Minimum Computer Requirements
Pentium -III , 256 Meg RAM, Windows 98 2nd ed, ME, 2000 Optimal Computer Requirements
(source locally)
Monitor (built-in)
15” flat LCD touch screen with true color 8 W (powered by computer via Firewire) for cabinet 100-240Volts 50-60 Hz Included Accessories
Calibration template, 90mm diameter & ID -kit adapter rings. Firewire interface card, 2 meter Firewire cable Software CD, Product Manual Dimensions (WxHxD)
Operating Environment
1 Precision refers to reading disk test zone diameters by the BIOMIC V3 image analysis system. Zone diameter is rounded to the closest millimeter for interpretation. 2 Defined as the percent tests where readings were within 3mm of manual reading. 3 Defined as percent of duplicate zone diameter readings differed by <=3mm

Source: http://www.euritmicgrup.ro/UserFiles/File/PDF-uri%20produse/205_en_GILES%20-%20Biomic.pdf