BD BACTEC FX User manual

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
 RxOnly

BD BACTEC™ FX Instrument User’s Manual
2
Change History
BD, the BD Logo, BACTEC, EpiCenter, Modem, and Synapsys are trademarks of Becton, Dickinson and
Company or its affiliates. © 2019 BD. All rights reserved.
No part of this publication may be reproduced, transmitted, transcribed, stored in retrieval systems, or
translated into any language or computer language, in any form or by any means, electronic, mechanical,
magnetic, optical, chemical, manual, or otherwise, without the prior written permission of BD, 7 Loveton
Circle, Sparks, MD, 21152, USA.
Revision Pages/Sections Reason
(07) 1, 2, 5, 6, 8, 9, 10, 11, 12
Deleted List of Figures. Deleted Manual
Structure section. Updated Use of this Manual
section. Removed Summary of Cautions and
Warnings section. References to Appendix, or
Appendices, were changed to Sections. Added
Preventative Maintenance statement to
Maintenance section. Updated user interface
descriptions.
Revision Date Change Summary
08 2019-03
Added new product information for Platelet
media types in the Introduction, Lab
Configuration, and Vial Operations sections.
09 2019-09
Converted printed instructions for use to
electronic format and added access information
to obtain the document from bd.com/e-labeling.
Added tabulated information on Vial Reentry
under Removing Positive, Negative and Ongoing
Vials section.

3
Table of Contents
1 –Introduction..................................................................................................................9
1.1 Intended Use............................................................................................................................... 9
1.2 Principles of the Procedure ......................................................................................................... 9
1.3 System Overview ...................................................................................................................... 11
1.3.1 Instrument Overview ................................................................................................... 11
1.3.2 Control Electronics...................................................................................................... 12
1.3.3 Incubation Subsystem................................................................................................. 13
1.3.4 Vial Agitation ............................................................................................................... 13
1.3.5 Measurement Subsystem ........................................................................................... 13
1.3.6 Vial Presence Sensing................................................................................................ 13
1.3.7 Station Indicators ........................................................................................................ 13
1.3.8 LCD and Touchscreen ................................................................................................ 13
1.3.9 USB Port/Flash Drive.................................................................................................. 13
1.3.10 Audible Alarm.............................................................................................................. 13
1.3.11 Barcode Scanners ...................................................................................................... 14
1.3.12 Software and Operation Overview .............................................................................. 14
1.3.13 Media Overview .......................................................................................................... 15
1.3.14 Built-In Test................................................................................................................. 16
1.3.15 Testing Overview ........................................................................................................ 16
1.4 Use of this Manual .................................................................................................................... 16
1.5 Conventions .............................................................................................................................. 17
1.5.1 User Interface .............................................................................................................17
1.5.2 Symbols and Connections Used on the Equipment.................................................... 17
1.5.3 Notes, Cautions, and Warnings .................................................................................. 19
2 –Installation .................................................................................................................21
2.1 General ..................................................................................................................................... 21
2.2 Instrument Specifications .......................................................................................................... 23
2.3 Instrument Installation ............................................................................................................... 24
2.3.1 Site Preparation .......................................................................................................... 24
2.4 Software Setup.......................................................................................................................... 25
2.4.1 Lab Configuration........................................................................................................ 26
2.4.2 Reports Configuration ................................................................................................. 30
2.4.3 Instr(ument) Configuration .......................................................................................... 32
2.4.4 LIS Configuration ........................................................................................................ 33
2.4.5 Time Configuration...................................................................................................... 38

BD BACTEC™ FX Instrument User’s Manual
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3 – Controls and Indicators ............................................................................................ 41
3.1 General ..................................................................................................................................... 41
3.2 Power Switch ............................................................................................................................ 43
3.2.1 Location ...................................................................................................................... 43
3.2.2 Operation .................................................................................................................... 43
3.3 System Indicators...................................................................................................................... 44
3.3.1 Location ...................................................................................................................... 44
3.3.2 Indication..................................................................................................................... 44
3.4 Drawer Handles ........................................................................................................................ 45
3.4.1 Location ...................................................................................................................... 45
3.4.2 Operation .................................................................................................................... 45
3.5 Barcode Scanner ...................................................................................................................... 45
3.5.1 Location ...................................................................................................................... 45
3.5.2 Operation .................................................................................................................... 45
3.6 LCD/Touchscreen ..................................................................................................................... 46
3.6.1 Location ...................................................................................................................... 46
3.6.2 Operation .................................................................................................................... 46
3.7 Station Indicators ...................................................................................................................... 47
3.7.1 Location ...................................................................................................................... 47
3.7.2 Indication..................................................................................................................... 47
3.8 USB Ports ................................................................................................................................. 48
3.9 Audible Tones and Alarms ........................................................................................................ 48
3.10 Onscreen Keyboard .................................................................................................................. 48
3.11 Digital Thermometer.................................................................................................................. 49
3.12 Remote Alarm ........................................................................................................................... 51
3.13 Printer........................................................................................................................................ 51
4 –Operation................................................................................................................... 53
4.1 General ..................................................................................................................................... 53
4.2 Using the Instrument ................................................................................................................. 53
4.2.1 Touchscreen, Fields, and Buttons .............................................................................. 53
4.2.2 Status Display .............................................................................................................54
4.2.3 Instrument and Drawer Layout.................................................................................... 55
4.2.4 Vial and Station Statuses and States.......................................................................... 55
4.3 Daily Maintenance..................................................................................................................... 59
4.4 Collecting and Preparing Specimens ........................................................................................ 60
4.5 Entering Vials ............................................................................................................................ 61

Contents
5
4.6 Recalling, Entering, and Modifying Data ................................................................................... 64
4.6.1 General ....................................................................................................................... 64
4.6.2 Vial Data ..................................................................................................................... 64
4.6.3 Specimen Data ........................................................................................................... 66
4.6.4 Patient Data ................................................................................................................ 68
4.7 Testing Vials.............................................................................................................................. 70
4.8 Printing Reports ........................................................................................................................ 70
4.9 Removing Positive, Negative, and Ongoing Vials ..................................................................... 71
4.10 Responding to Alarms and Errors .............................................................................................76
4.11 Power Failures .......................................................................................................................... 76
4.12 Operation with a BD EpiCenter System .................................................................................... 76
4.12.1 Normal Operations...................................................................................................... 76
4.12.2 Isolation Mode............................................................................................................. 78
4.12.3 Degraded Mode Operations........................................................................................ 80
5 – Reference.................................................................................................................83
5.1 General ..................................................................................................................................... 83
5.2 Software Tree............................................................................................................................ 83
5.3 Status Display ........................................................................................................................... 84
5.3.1 Positive Removal Display ........................................................................................... 86
5.3.2 Negative Removal Display .......................................................................................... 88
5.3.3 ID(entify) Anonymous Display..................................................................................... 90
5.3.4 Vial Entry Display........................................................................................................ 92
5.3.5 System Alerts Display ................................................................................................. 95
5.3.6 Drawer View Display................................................................................................... 97
5.3.7 Culture – Patient Display ............................................................................................ 99
5.3.8 Culture – Specimen Display...................................................................................... 101
5.3.9 Culture – Vial Display................................................................................................ 104
5.3.10 Plot Display ............................................................................................................... 107
5.4 Reports Menu.......................................................................................................................... 109
5.4.1 Affected Vials ............................................................................................................ 111
5.4.2 Alert List .................................................................................................................... 113
5.4.3 Contaminant Vials..................................................................................................... 114
5.4.4 Culture Summary ...................................................................................................... 115
5.4.5 Current Inventory ...................................................................................................... 117
5.4.6 Current Negatives Report ......................................................................................... 119
5.4.7 Current Positives Report........................................................................................... 121
5.4.8 Loaded Vials ............................................................................................................. 122
5.4.9 Maintenance QC ....................................................................................................... 124
5.4.10 No Growth Accession ............................................................................................... 126
5.4.11 Orphan Vials ............................................................................................................. 127
5.4.12 Partially Seated Stations........................................................................................... 129

BD BACTEC™ FX Instrument User’s Manual
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5.4.13 Pending..................................................................................................................... 131
5.4.14 Unloaded Negative Vials........................................................................................... 133
5.4.15 Unloaded Positive Vials ............................................................................................ 135
5.4.16 Unloaded Vials.......................................................................................................... 136
5.5 Maintenance............................................................................................................................ 138
5.5.1 Test Display .............................................................................................................. 138
5.5.2 Block/Unblock Stations Display ................................................................................ 140
5.5.3 Utilities Display..........................................................................................................141
5.5.3.1 Upgrade Software ..................................................................................... 142
5.5.3.2 Save DB and Log ...................................................................................... 142
5.5.3.3 Save Log ................................................................................................... 142
5.5.3.4 Reboot....................................................................................................... 142
5.5.3.5 Change Password ..................................................................................... 142
5.5.3.6 BD Utilities................................................................................................. 143
5.6 Configuration........................................................................................................................... 143
5.6.1 Lab ............................................................................................................................ 143
5.6.2 Reports Display......................................................................................................... 143
5.6.3 Instrument Display .................................................................................................... 143
5.6.4 LIS Display................................................................................................................143
5.6.5 Time .......................................................................................................................... 143
6 – Maintenance........................................................................................................... 145
6.1 General ................................................................................................................................... 145
6.2 Routine Maintenance .............................................................................................................. 145
6.2.1 Daily Maintenance .................................................................................................... 145
6.2.2 As Needed Maintenance........................................................................................... 146
6.2.2.1 Blocking Stations....................................................................................... 146
6.2.2.2 Unblocking Stations................................................................................... 147
6.2.3 Cleaning Air Filters.................................................................................................... 147
6.2.4 Replacing Vial Barcode Labels ................................................................................. 151
6.2.5 Cleaning and Decontamination................................................................................. 152
6.3 Maintenance – Test................................................................................................................. 153
6.4 Maintenance – Utilities Menu .................................................................................................. 153
6.4.1 Upgrade Software ..................................................................................................... 154
6.4.2 Save DB and Log...................................................................................................... 154
6.4.3 Save Log...................................................................................................................155
6.4.4 Reboot ...................................................................................................................... 155
6.4.5 Change Password..................................................................................................... 155
6.4.6 BD Utilities ................................................................................................................ 155
7 – Troubleshooting...................................................................................................... 157
7.1 General: Instrument Service ................................................................................................... 157
7.2 Error/Alert Messages ............................................................................................................. 157

Contents
7
7.3 Unusable Stations, Affected Vials, and Partially
Seated Vials ............................................................................................................................ 179
7.3.1 General ..................................................................................................................... 179
7.3.2 Unusable Stations..................................................................................................... 179
7.3.3 Affected Vials ............................................................................................................ 181
7.3.4 Partially Seated Stations........................................................................................... 181
7.4 Barcode Scanner .................................................................................................................... 183
8 – Limited Warranty ....................................................................................................185
9 – Contacts .................................................................................................................187
10 – Replacement Parts ...............................................................................................189
11 – Glossary ...............................................................................................................191

BD BACTEC™ FX Instrument User’s Manual
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9
1 – Introduction
1.1 Intended Use
The BD BACTEC™ FX instrument is designed for the rapid detection of bacteria and fungi in clinical
specimens, blood, and blood products. Samples are drawn from patients or bagged blood/blood
products and injected directly into BD BACTEC culture vials, which are placed into the instrument for
incubation and testing.
1.2 Principles of the Procedure
When microorganisms are present in culture vials, they metabolize nutrients in the culture medium,
releasing carbon dioxide into the medium. A dye in the sensor at the bottom of the vial reacts with
CO2. This modulates the amount of light that is absorbed by a fluorescent material in the sensor. A
photo detector at each station measures the level of fluorescence, which corresponds to the amount of
CO2released by organisms. Then the measurement is interpreted by the system according to
preprogrammed positivity parameters.
At system start-up, the onboard computer performs self-diagnostics and downloads operating
instructions to the drawer rows. Then the instrument(s) automatically begin testing. Light Emitting
Diodes (LEDs) behind the vials illuminate the rows, activating the vials’ fluorescent sensors. After a
warm-up period, the instrument’s photo detectors then take the readings. A test cycle of all rows is
completed every ten minutes. Positive cultures are immediately flagged by an indicator light on the
front of the instrument, an audible alarm, and are displayed on the LCD display.
When positive vials are identified, the lab technologist pulls them from the instrument for confirmation
of results, and for isolation and identification of the organism.

BD BACTEC™ FX Instrument User’s Manual
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This is an example:
Figure 1-1 shows the growth and detection process.
Figure 1-1 – BD BACTEC FX Fluorescent Technology
Organism metabolic activity releases CO2...
LED
Photo
Detector
Test Readings
Positivity Analysis
Row Board
Positive Test Results
indicated multiple ways
Which reacts with dye in vial sensor.
Positive vial is announced by audible alert, onscreen
indications, and the Positive Vial system indicator.
And positivity analysis is performed.
Raw data from detector is analyzed by row board ...
Photo detector reads fluorescence.
LED activates fluorescent material in sensor.
Fluorescence is modulated by dye in the sensor.