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BD BACTEC FX40 User Manual

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BACTEC™ FX40
Instrument User’s Manual
Becton, Dickinson and Company
7 Loveton Circle
Sparks, Maryland 21152 USA
Benex Limited
Pottery Road, Dun Laoghaire
Co. Dublin, Ireland
Australian Sponsor:
Becton Dickinson Pty Ltd.
66 Waterloo Road
Macquarie Park NSW 2113
Australia
8090414(09) 2021-07
441980
English

bd.com/e-labeling

Table of Contents

Questions and Answers:

BD BACTEC FX40 Specifications

General IconGeneral
BrandBD
ModelBACTEC FX40
CategoryLaboratory Equipment
LanguageEnglish

Summary

1 Introduction

1.1 Intended Use

Describes the purpose of the BD BACTEC ™ FX40 instrument for detecting bacteria and fungi.

1.2 Principles of the Procedure

Explains the mechanism of microbial growth detection using fluorescence.

1.3 System Overview

Details the major features and capabilities of the BD BACTEC ™ FX40 instrument.

1.3.1 Instrument Overview

Provides a detailed description of the BD BACTEC ™ FX40 instrument's automated detection system.

1.3.2 Control Electronics

Lists the controllers responsible for instrument operation and analysis.

1.3.3 Incubation Subsystem

Describes the subsystem that maintains optimal temperature for culture vials.

1.3.4 Vial Agitation

Explains the vial agitation mechanism to ensure homogeneous distribution of nutrients.

1.3.5 Measurement Subsystem

Details the optical measurement process using LEDs and photo detectors.

1.3.6 Vial Presence Sensing

Describes the sensors that detect vial insertion and removal in each station.

1.3.7 Station Indicators

Explains the LED indicators that show vial status above each station.

1.3.8 Tablet PC / Touchscreen

Describes the user interface presented on the tablet PC for instrument operation.

1.3.9 USB Ports

Details the location and use of USB ports for peripheral connections.

1.3.10 Audible Alarm

Explains the audible alarm for system alerts and positive vials.

1.3.11 Barcode Scanner

Describes the peripheral barcode scanner for vial identification and entry.

1.3.12 Software and Operation Overview

Provides an overview of the tablet interface and instrument operations.

1.3.13 Media Overview

Lists and describes the various types of culture media available for the system.

1.3.14 Built-In Test

Explains the instrument's self-test routine upon power application.

1.3.15 Testing Overview

Describes the sequence of operations during the instrument's testing cycle.

1.4 Use of this Manual

1.5 Conventions

1.5.1 User Interface

Explains conventions used for screen buttons, prompts, and display names.

1.5.2 Symbols and Connections Used on the Equipment

Illustrates and describes the symbols and physical connections on the instrument.

1.5.3 Notes, Cautions, and Warnings

Defines the significance of NOTE, CAUTION, and WARNING messages.

2 Installation

2.1 General

Provides an overview of the installation and setup process for the instrument.

2.2 Instrument Specifications

Lists the physical, electrical, and environmental specifications of the instrument.

2.3 Instrument Installation

Details the requirements and procedures for installing the BD BACTEC ™ FX40 instrument.

2.3.1 Site Preparation

Outlines the necessary site conditions and preparations for instrument installation.

2.4 Software Setup

Guides the user through configuring instrument software parameters for laboratory use.

2.4.1 Lab Configuration

Explains how to set laboratory-specific parameters like language and protocol.

2.4.2 Reports Configuration

Details the configuration settings for printing and report parameters.

2.4.3 Instr(ument) Configuration

Describes how to configure settings unique to each instrument within a cluster.

2.4.4 LIS Configuration

Guides the setup of communications with a Laboratory Information System (LIS).

2.4.5 Time Configuration

Explains how to configure the instrument's date and time settings.

3 Controls and Indicators

3.1 General

Introduces the section describing the instrument's controls and indicators.

3.2 Power Switch

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

3.3 System Indicators

Explains the location and meaning of the instrument's system status indicators.

3.4 Door Handle

Describes the location and operation of the instrument's door handle.

3.5 Barcode Scanner

Details the location and operation of the barcode scanner.

3.6 Tablet PC / Touchscreen

Explains the location and operation of the tablet PC interface.

3.7 Station Indicators

Describes the location and meaning of indicators for each vial station.

3.8 USB Ports

Details the location and function of the instrument's USB ports.

3.9 Audible Tones and Alarms

Explains the different sounds generated by the instrument for notifications.

3.10 Onscreen Keyboard

Describes the onscreen keyboard and its operation for data input.

3.11 Remote Alarm

Provides information on the BD Remote Alarm unit.

3.12 Printer

Notes the connection requirements for a local printer.

4 Operation

4.1 General

Introduces the section on routine operation of the BD BACTEC ™ FX40 instrument.

4.2 Using the Instrument

Provides instructions on interacting with the instrument via the tablet interface.

4.2.1 Touchscreen, Fields, and Buttons

Explains how to use the touchscreen for instrument operations.

4.2.2 Status Display

Describes the main display showing instrument and station status.

4.2.3 Instrument Layout

Details the instrument's configuration, racks, rows, and station numbering.

4.2.4 Vial and Station Statuses and States

Explains the meaning of vial and station statuses and how they are indicated.

4.3 Daily Maintenance

Outlines the essential daily maintenance procedures for the instrument.

4.4 Collecting and Preparing Specimens

Provides guidance on safe specimen collection and preparation for testing.

4.5 Entering Vials

Details the procedures for entering vials into the instrument.

4.6 Recalling, Entering, and Modifying Data

Guides users on managing patient, specimen, and vial data within the system.

4.6.2 Vial Data

Explains how to recall and modify vial records by location or sequence number.

4.6.3 Specimen Data

Details how to recall, add, and modify specimen information.

4.6.4 Patient Data

Explains how to add, recall, and modify patient identification data.

4.7 Testing Vials

Describes the automatic vial testing process and positive vial indication.

4.8 Printing Reports

Lists the available reports that can be printed from the instrument.

4.9 Removing Positive, Negative, and Ongoing Vials

Details the procedures for removing different types of vials from the instrument.

4.10 Responding to Alarms and Errors

Provides guidance on how to respond to system alerts and error messages.

4.11 Power Failures

Explains instrument behavior and user actions during power loss.

4.12 Operation with a BD EpiCenter™ System

Describes instrument operations when connected to the BD EpiCenter ™ system.

4.12.1 Normal Operations

Outlines normal data exchange and operations in an EpiCenter ™ configuration.

4.12.2 Isolation Mode

Explains the instrument's behavior and limitations when disconnected from the tablet.

4.12.3 Degraded Mode Operations

Details the limited operations available when the instrument is in degraded mode.

5 Reference

5.1 General

Introduces reference material on the instrument's user interface.

5.2 Software Tree

Presents a hierarchical list of instrument displays and functions.

5.3 Status Display

Describes the status display and its associated buttons and indicators.

5.3.1 Positive Removal Display

Details the display for removing positive vials and viewing related vial information.

5.3.2 Negative Removal Display

Explains the display for removing negative vials and their information.

5.3.3 ID(entify) Anonymous Display

Guides on identifying ongoing anonymous and positive anonymous vials.

5.3.4 Vial Entry Display

Describes the display used for entering vials into the instrument.

5.3.5 System Alerts Display

Explains how to view, manage, and print system alerts.

5.3.6 View Stations Display

Provides an iconic view of all instrument stations and their current statuses.

5.3.7 Culture – Patient Display

Details the display for patient-related information and specimen searching.

5.3.8 Culture – Specimen Display

Explains how to add or recall information on specimens (accessions).

5.3.9 Culture – Vial Display

Describes how to view or enter information about individual vials.

5.3.10 Plot Display

Explains how to generate line graphs of test readings for specific vials.

5.4 Reports Menu

Lists and describes the various reports that can be selected and printed.

5.4.1 Affected Vials

Lists vials with incubation failures or extended gaps in test readings.

5.4.2 Alert List

Provides a report of the latest 100 instrument alerts.

5.4.3 Contaminant Vials

Lists vials marked as contaminants.

5.4.4 Culture Summary

Lists total counts for contaminant, positive, and negative cultures.

5.4.5 Current Inventory

Lists all vials currently present in the instrument's stations.

5.4.6 Current Negatives

Lists all negative vials (out-of-protocol and manual) in the instrument.

5.4.7 Current Positives

Lists all positive vials (instrument, manual, anonymous) in the instrument.

5.4.8 Loaded Vials

Lists vials loaded into the instrument during a selected time period.

5.4.9 Maintenance QC Report

Reports on drawer temperatures, blocked stations, and system LED status.

5.4.10 No Growth Accession

Lists accessions with vials showing no growth in a selected time interval.

5.4.11 Orphan Vials

Lists vials in the database that have no associated accession number.

5.4.12 Partially Seated Stations

Lists vials believed to be partially seated in their stations.

5.4.13 Pending Report

Lists vials logged in at Culture display but not yet placed in the instrument.

5.4.14 Unloaded Negative Vials

Lists negative vials removed but not reentered within a specified time.

5.4.15 Unloaded Positive Vials

Lists positive vials removed but not reentered within a specified time.

5.4.16 Unloaded Vials

Lists vials removed from the instrument but not reentered within a specified time.

5.5 Maintenance

Provides access to instrument maintenance tests and utilities.

5.5.1 Test Display

Enables performance of daily instrument maintenance tests.

5.5.2 Block/Unblock Stations Display

Allows blocking and unblocking of instrument stations.

5.5.3 Utilities Display

Provides access to software upgrade, save log, and reboot functions.

6 Maintenance

6.1 General

Outlines routine maintenance requirements and responsibilities.

6.2 Routine Maintenance

Details the scheduled maintenance procedures for the instrument.

6.2.1 Daily Maintenance

Lists the essential daily checks and procedures for instrument upkeep.

6.2.2 Monthly Maintenance

Describes monthly maintenance tasks, including air filter cleaning.

6.2.2.1 Cleaning Air Filters

Provides instructions for cleaning and replacing the instrument's air filters.

6.2.3 As Needed Maintenance

Covers maintenance tasks performed based on specific conditions.

6.2.3.1 Blocking Stations

Explains how to block stations that fail to light or detect vials correctly.

6.2.3.2 Unblocking Stations

Details the procedure for unblocking a previously blocked station.

6.2.4 Replacing Vial Barcode Labels

Guides on replacing damaged or unreadable vial barcode labels.

6.2.5 Cleaning and Decontamination

Provides procedures for cleaning and decontaminating the instrument after spills.

6.2.6 Cleaning the Barcode Scanner Window

Instructs on cleaning the barcode scanner window for optimal performance.

6.2.7 Reuniting Separated Fluid in Thermometer

Describes techniques for reuniting separated liquid in the temperature QC thermometer.

6.3 Maintenance – Test

Accesses instrument maintenance tests and QC report printing.

6.4 Maintenance – Utilities Menu

Provides access to software upgrade, save log, and reboot functions.

7 Troubleshooting

7.1 General

Introduces troubleshooting procedures for instrument malfunctions.

7.1.1 Instrument Service

Provides recommendations for solving common instrument issues.

7.2 Error/Alert Messages

Lists and explains system error and alert messages and corrective actions.

7.3 Unusable Stations, Affected Vials, and Partially Seated Vials

Addresses system alerts related to unusable, affected, or partially seated vials.

7.3.2 Unusable Stations

Explains how to address stations marked as unusable by the system.

7.3.3 Affected Vials

Guides on managing vials marked as affected due to system alerts.

7.3.4 Partially Seated Stations

Details how to resolve conditions where vials may be partially seated.

8 Limited Warranty

9 Contacts

10 Replacement Parts

11 Glossary

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