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BD BACTEC FX User Manual

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BACTEC™ FX
Instrument User’s Manual
Becton, Dickinson and Company
7 Loveton Circle
Sparks, MD 21152 USA
Benex Limited
Pottery Road, Dun Laoghaire
Co. Dublin, Ireland
Australian Sponsor:
Becton Dickinson Pty Ltd.
4 Research Park Drive
Macquarie University Research Park
North Ryde, NSW 2113 Australia
8005110(09) 2019-09
441427
English

bd.com/e-labeling
KEY-CODE: 8005110

R
x
Only

Table of Contents

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BD BACTEC FX Specifications

General IconGeneral
CategoryLaboratory Equipment
ManufacturerBD (Becton, Dickinson and Company)
IncubationContinuous
User InterfaceTouchscreen
DimensionsVaries by model
WeightVaries by model
Power Requirements100-240V AC, 50/60Hz
Detection TechnologyFluorescence
ConnectivityLIS Connectivity
Sample TypesBlood, Sterile Body Fluids
CapacityVaries by model (e.g., FX40, FX80, FX200)

Summary

1 – Introduction

1.1 Intended Use

Describes the purpose of the BD BACTEC™ FX instrument for detecting bacteria and fungi.

1.2 Principles of the Procedure

Explains the mechanism of microbial growth detection using fluorescence in culture vials.

1.3 System Overview

Details the major features and configurations of the BD BACTEC FX instrument.

1.3.1 Instrument Overview

Provides a comprehensive overview of the instrument's automated detection system and its components.

1.3.2 Control Electronics

Lists the controllers responsible for instrument analysis and operation, including temperature and agitation.

1.3.3 Incubation Subsystem

Describes the subsystem designed to maintain optimal temperature for culture vial contents.

1.3.4 Vial Agitation

Explains how vials are agitated to ensure homogeneous distribution of nutrients and by-products.

1.3.5 Measurement Subsystem

Details the subsystem that optically activates vial sensors and collects fluorescent light.

1.3.8 LCD and Touchscreen

Details the instrument's color Liquid Crystal Display and its touchscreen functionality.

1.3.10 Audible Alarm

Explains the audible alarm's function for system alerts and positive vials, including loudness settings.

1.3.11 Barcode Scanners

Describes the location and function of barcode scanners for vial identification and accession scanning.

1.3.13 Media Overview

Lists and describes the various media types available for use with the BD BACTEC FX system.

1.3.14 Built-In Test

Explains the initial built-in test performed by subsystems to ensure proper operation upon power application.

1.3.15 Testing Overview

Details the instrument's testing cycle, including light, temperature, and dark readings, and positivity algorithms.

1.4 Use of this Manual

Guides the user on how to best utilize the manual for instrument operation and maintenance.

1.5 Conventions

Explains conventions used in the manual for clarity, such as screen button formatting and typeface.

1.5.2 Symbols and Connections Used on the Equipment

Identifies and illustrates the various symbols and connection ports found on the BD BACTEC FX instrument.

1.5.3 Notes, Cautions, and Warnings

Explains the significance of NOTES, CAUTIONS, and WARNINGS presented in the manual.

3 – Controls and Indicators

3.1 General

Introduces the section that describes the meaning and use of instrument controls and indicators.

3.2 Power Switch

Details the location and operation of the instrument's power switch.

3.3 System Indicators

Describes the location and meaning of the system indicators that display instrument states.

3.4 Drawer Handles

Describes the location and operation of the drawer handles for accessing instrument compartments.

3.5 Barcode Scanner

Details the location and operation of the instrument's barcode scanners for vial identification.

3.6 LCD/Touchscreen

Describes the location and operation of the instrument's Liquid Crystal Display and touchscreen.

3.7 Station Indicators

Describes the LED indicators at each station that provide vial or station status information.

3.8 USB Ports

Describes the location and primary purposes of the instrument's USB ports.

3.9 Audible Tones and Alarms

Explains the variety of sounds generated by the instrument to inform users of operational states.

3.10 Onscreen Keyboard

Describes how alphanumeric fields activate an onscreen keyboard for data entry.

4 – Operation

4.1 General

Introduces the section on routine operation of the BD BACTEC FX instrument.

4.2 Using the Instrument

Provides instructions for routine operation of the instrument using its interface.

4.2.1 Touchscreen, Fields, and Buttons

Explains how the LCD presents information and how to interact with touchscreen elements for operations.

4.2.2 Status Display

Describes the main display showing instrument and station status, and initiating activities.

4.2.4 Vial and Station Statuses and States

Defines vial and station statuses and how they are indicated on displays and through icons.

4.3 Daily Maintenance

Outlines the simple daily maintenance procedures to ensure reliable instrument performance.

4.5 Entering Vials

Details the procedures for entering vials into the instrument using two different methods.

4.6 Recalling, Entering, and Modifying Data

Explains how to recall, enter, and modify patient, specimen, and vial data within the instrument.

4.7 Testing Vials

Explains the automatic and continuous nature of vial testing, including interruption conditions.

4.9 Removing Positive, Negative, and Ongoing Vials

Guides users on the procedures for removing positive and negative vials, including single and batch removal.

5 – Reference

5.1 General

Introduces the reference material covering the instrument's user interface screens, icons, reports, and functions.

5.2 Software Tree

Presents a hierarchical list of instrument displays and functions with cross-references to detailed sections.

5.3 Status Display

Provides general information about system and station status, and lists operations initiated from the Status display.

5.3.1 Positive Removal Display

Describes the display that appears when initiating the remove positive vials activity.

5.3.2 Negative Removal Display

Details the display shown when initiating the remove negative vials activity.

5.3.3 ID(entify) Anonymous Display

Explains the display that enables identification of ongoing and positive anonymous vials.

5.3.4 Vial Entry Display

Describes the display used for entering vials into the instrument and the current drawer status.

5.3.5 System Alerts Display

Shows a list of system alerts that have occurred, including their details and management options.

5.3.6 Drawer View Display

Provides an iconic view of all drawer stations, showing the status of each station dynamically.

5.3.7 Culture – Patient Display

Displays patient-related information for specimens and is used for searching attached patient records.

5.3.8 Culture – Specimen Display

Enables adding or recalling information on specimens (accessions) and managing vial associations.

5.3.9 Culture – Vial Display

Used to view or enter information about individual vials and perform specialized vial functions.

5.3.10 Plot Display

Enables generating line graphs or plots of test readings for specified non-pending stations.

5.4 Reports Menu

Lists the reports available for printing and how to access the Reports menu.

5.4.1 Affected Vials

Lists vials with incubation or test reading failures within the last 30 days.

5.4.2 Alert List

Lists the latest 100 instrument alerts with details on time, description, and status.

5.4.9 Maintenance QC

Reports on drawer temperatures, blocked stations, and maintenance activities.

5.5 Maintenance

Introduces the maintenance procedures for the instrument, including test and utilities functions.

5.5.1 Test Display

Enables performance of daily instrument maintenance tests, checking indicators, and printing reports.

5.5.2 Block/Unblock Stations Display

Allows blocking or unblocking stations in drawers, often due to indicator failures.

5.5.3 Utilities Display

Provides access to utilities like software upgrades, saving data, rebooting, and password changes.

5.5.3.4 Reboot

Explains how to reboot the main FX computer to restore communications.

5.5.3.5 Change Password

Guides users on how to change the Supervisor password.

5.6 Configuration

Outlines the configuration settings accessible through different displays like Lab, Reports, Instrument, LIS, and Time.

5.6.1 Lab

Refers to Section 2.4.1 for detailed information on the Configuration - Lab display settings.

5.6.2 Reports Display

Refers to Section 2.4.2 for detailed information on the Configuration - Reports display settings.

5.6.5 Time

Refers to Section 2.4.5 for detailed information on the Configuration - Time display settings.

6 – Maintenance

6.1 General

Highlights the system's low maintenance requirements and the need for authorized service personnel for complex tasks.

6.2 Routine Maintenance

Outlines daily maintenance procedures to ensure reliable performance.

6.2.1 Daily Maintenance

Lists specific daily checks for indicators, temperature, and printer supply.

6.2.2 As Needed Maintenance

Covers maintenance tasks performed based on specific needs or conditions.

6.2.2.1 Blocking Stations

Details how to block stations that fail indicators or do not detect vials correctly.

6.2.3 Cleaning Air Filters

Explains the importance of clean air filters and how to clean or replace them.

6.4 Maintenance – Utilities Menu

Lists the functions accessible through the Maintenance – Utilities menu.

6.4.1 Upgrade Software

Details the process for upgrading the instrument software via USB.

6.4.2 Save DB and Log

Explains how to save the vial database and event log files to a flash drive.

7 – Troubleshooting

7.1 General: Instrument Service

Advises on initial troubleshooting steps and when to contact local BD representatives for service.

7.2 Error/Alert Messages

Discusses error messages and codes, including their possible causes and corrective actions.

7.3 Unusable Stations, Affected Vials, and Partially Seated Vials

Addresses conditions where stations are unusable, vials are affected, or vials are partially seated.

7.3.2 Unusable Stations

Details how hardware issues mark stations as Unusable to prevent incorrect test readings.

7.3.3 Affected Vials

Explains how alerts can lead to vials being marked as Affected, recommending subculturing for optimal recovery.

7.3.4 Partially Seated Stations

Addresses messages indicating potentially partially seated vials and how to resolve them.

7.4 Barcode Scanner

Provides guidance on configuring another instrument's barcode reader if one malfunctions.

9 – Contacts

10 – Replacement Parts

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