The BD FocalPoint™ GS Imaging System is a comprehensive cervical cancer screening system that integrates automated slide processing with a computer-assisted review station. It comprises two main components: the BD FocalPoint™ Slide Profiler and the BD FocalPoint™ GS Review Station.
Function Description:
The system is designed to assist in the screening of BD SurePath™ Liquid-based Pap Test slides for the detection of squamous carcinoma, adenocarcinoma, and their usual precursor conditions. The BD FocalPoint™ Slide Profiler performs initial automated screening, classifying slides based on the likelihood of abnormality. It identifies up to 25% of successfully processed slides as requiring no further review and at least 15% for a second manual review (Directed QC). The BD FocalPoint™ GS Review Station then receives this processed data, including slide identification, ranking, specimen quality indicators, associated cell pattern images, and field of view (FOV) coordinates, to facilitate computer-assisted slide review by a cytotechnologist or pathologist.
Important Technical Specifications:
BD FocalPoint™ Slide Profiler:
- Dimensions (L x W x H): 44 in. × 28.5 in. × 51.25 in. (112 cm × 72 cm × 130 cm) with hood closed; 44 in. × 28.5 in. × 68.5 in. (112 cm × 72 cm × 174 cm) with hood open.
- Weight: 770 lb/350 kg.
- Power Requirements: VAC 100–240 (Universal); 50/60 Hz (Switch).
- Operating Power Consumption: 1,200 VA.
- Microscope Objectives: 0.75NA 20×, 0.2NA 4×.
- Light Source: Mercury-xenon arc lamp.
- Video Camera: Prosilica GE1910, Toshiba Teli CS8310 BCi (one or more).
- Operating Temperature Range: 18–30 °C.
- Operating Humidity Range: 20–80% relative humidity, non-condensing.
- Altitude: 0–2,000 meters above sea level.
- Warm-up Time: Less than 20 minutes for system initialization.
- Tray Capacity: 36 trays.
- Slide Capacity: 288 slides.
- Estimated Slide Throughput: Approximately 6 minutes per conventional slide; approximately 4 minutes per BD SurePath™ slide (throughput varies by hardware/software configurations).
- Supported Barcode Formats: Interleaved 2-of-5, Code 128 A, B, and C, Code 39 and Code 39 Full ASCII, EAN 128, DataMatrix, PDF417, Aztec compact.
BD FocalPoint™ GS Review Station:
- Electrical Specifications (Stage Controller): Operating Voltage 110/230 volts, Operating Frequency 50/60 Hz, Current 0.35/0.18 Amps.
- Electrical Specifications (Microscope): Operating Voltage 100–240 VAC, Operating Frequency 50/60 Hz, Current (Nikon 55i) 0.60–1.20 Amps, (Nikon Eclipse Ci-L) 0.185–0.37 Amps, (Olympus BX43) 0.20–0.40 Amps.
- Electrical Specifications (Flat Panel Monitor Power Supply): Operating Voltage 110/230 volts, Operating Frequency 50/60 Hz, Current 1.5/0.75 Amps.
- Electrical Specifications (Computer Power Supply): Operating Voltage 100-120/220-240 VAC, Operating Frequency 50/60 Hz, Current (max) 8/4 Amps.
- Monitor: 17-inch LCD color display.
- CPU: PC Compatible device (ARK1120) or 3rd/2nd Generation Intel® Core Celeron™ Mobile (DFI M90-515).
- I/O Interface: Serial Ports (2 x RS232 for ARK1120, 1 x RS232 for DFI M90-515), USB Interface (4 x USB 2.0 compliant for ARK1120, 4 x USB 3.0, 4 x USB 2.0/1.1 for DFI M90-515).
- Printer: PCL- or PostScript-Compatible laser printer.
- Operating Temperature: Processor 0–40 °C/32–104 °F, Monitor 0–40 °C/32–104 °F.
- Operating Humidity Range: Processor 95% @ 40 °C, Monitor 10–90% (non-condensed).
- Altitude: 0–2,000 meters above sea level.
Usage Features:
- Guided Screening: The GS Review Station provides rapid data retrieval and navigation to locations of interest (LOI) on the slide, presenting up to 10 FOVs most likely to contain abnormal cells.
- Slide Selection: Slides can be selected for review by scanning a barcode, typing an accession number, or choosing from a slide list.
- Navigation: Users can navigate through FOVs using a mouse (wheel for forward/backward, left-click with wheel for first/last field), an optional foot pedal, or dedicated navigation buttons (First FOV, Back, Forward, Last FOV).
- Screening Modes: The system supports various screening modes including FOV only, FOV Review triaged to full slide review (FSR), and full slide review when no FOVs are presented (Process Review or incomplete processing).
- Electronic Dotting: In Screen mode, users can capture and store x/y coordinates for additional areas of interest by clicking the middle mouse button or pressing the Page Down key. Dots can be marked as "Most Significant Dots" and removed.
- Slide Status and Ranking: Slides are assigned icons and colors based on their processing and interpretation status (e.g., Not Reviewed, Ready For Signout, Awaiting Further Review, Awaiting QC Review, Multiple Runs). Slides are ranked based on the likelihood of abnormality into quintiles.
- Evaluation Function: After screening, users can select "Eval" to complete an interpretation form, choosing primary evaluations, adequacy of specimen, and non-neoplastic descriptive findings from editable lists. The "No Eval" function allows skipping the interpretation form if external systems are used.
- QC Review Option: Notifies users of slides designated for QC Review by the Slide Profiler. These slides are assigned an "Awaiting QC Review" status and can only be finalized using the QC Mode application.
- Reporting: The system generates various data management and statistical reports (Summary, Custom, QC, Archive, Process Review, Rerun) that can be customized, previewed, and printed. Reports can be sorted by rank, barcode, or date, and displayed in slide or tray layouts.
- Archive Utility: Transfers slide data to a separate directory on the server, which can then be moved to external media for long-term storage. Archived data is read-only but can be viewed.
- LIS Interface: A toggle button allows access to the Laboratory Information System (LIS) application on the Review Station for patient and slide information, and direct entry of final results.
Maintenance Features:
- Maintenance Schedule: A comprehensive schedule outlines weekly, bi-monthly/monthly, and as-needed tasks.
- Cleaning:
- Slide Trays: Weekly cleaning with lint-free swabs and 70% Isopropyl alcohol to remove dirt and debris.
- Calibration Plate: Cleaned when the instrument is in ERROR mode due to dirt, using a cleaning kit and glass cleaning solution.
- Monitor: Cleaned with lint-free cloth and non-alcohol-based glass cleaner.
- Outer Surfaces: Wiped with lint-free cloth and non-abrasive household cleaning solution.
- Mouse: Trackball or optical mouse cleaned periodically with lint-free cloth and cleaner.
- Air Filter Inspection: Weekly inspection to ensure protection from excessive dust. Replacement by BD Technical Service and Support if dirty.
- Printer Maintenance: Includes toner cartridge replacement and occasional cleaning, as per the printer's manual.
- Backup Media Management: Daily automatic backups to a removable USB flash drive (USB 2.0, 4GB or greater). BD recommends alternating backup media daily and archiving monthly to prevent data loss and storage space exhaustion.
- System Integrity (SI) Monitoring: Automated tests performed before the first tray and after each succeeding tray to monitor system performance, calibration, and image analysis. SI results are logged and can be printed for quality assurance.
- Slide Rejection Rate Monitoring: Usage statistics are monitored monthly to track the number of slides rejected as unsuitable for scanning, helping identify and correct slide preparation issues.
- Troubleshooting Guide: Provides solutions for common issues such as software errors, automatic backup failures, printer problems, and stage movement issues. BD Technical Service and Support contact information is provided for unresolved problems.
- System Shutdown/Restart: Procedures for safely powering down and restarting the instrument and workstation components.
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