Becton, Dickinson and Company Bactec 9050 User manual
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EC 90'0
ern Use s
Manual
BECTON DICKINSON AND COMPANY
BECTON DICKINSON MICROBIOLOGY SYSTEMS
7Loveton Circle
Sparks, Maryland 21152 USA
June, 1998
Document Number MA-0103
Revision: D
Catalog Number:4405845
BECTON
DICKINSON
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BRISTOL-MYERS SQUIBB-LAWRENCEVILLE
LABORATORY PROCEDURE
TITLE: Bactec 9050
Automated Blood Culture
DATED: 3/13/98
AUTHOR: Trisha Cohen REVIEW DATE:
Nor
OVERVIEW:
The detection of microorganisms in a patient's blood has diagnostic and prognostic
importance. Bacteria enter the blood from extravascular sites such as the genitourinary tract,
respiratory tract, abscesses, surgical wound infections and other miscellaneous sites either
directly or via the lymphatic vessels. When bacteria enter and/or multiply in the bloodstream at
arate that exceeds the capacity of the reticuloendothelial system to remove them, bacteremia
results.
Blood cultures are essential in the diagnosis and treatment of the etiologic agents of sepsis.
Bacterial sepsis constitutes one of the most serious infectious diseases and therefore the
expeditious detection and identification of blood borne bacterial pathogens is an important
function of the clinical diagnostic laboratory..
The Bactec 9050 instrument is designed for the rapid detection of microorganisms in clinical
cultures of blood. The sample to be tested is inoculated into the vial which is entered into the
Bactec 9050 for incubation and periodic reading. Each vial contains a sensor which detects
increases in CO, produced by the growth of microorganisms. The sensor is monitored by the
instrument every ten minutes for an increase in its fluorescence, which is proportional to the
amount of CO, present. A positive reading indicates the presumptive presence of viable
microorganisms in the vial.
N4... MATERIALS LIST:
A. Media
1. Bactec Peds Plus/F Culture Vial
Optimum blood volume for each vial is 1-5 mL.
Each vial contains:
a. 40mL Enriched Soybean-Casein digest broth.
b. 0.02% SPS
c. Resins
d. CO,
e. 0,
f. Sensor for CO, detection
2. Bactec Plus Anaerobic/F Culture Vial
Optimum blood volume for each vial 8-l0mL; 3-10 mL is acceptable
Each vial contains:
a. 25 mL pre-reduced enriched Soybean-Casein digest broth
b. 0.05% SPS
c. Resins
d. CO, and N, (which support the growth of anaerobic microorganisms)
e. Sensors for CO, detection
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PROCEDURE
Now
vow
Specimen labeling:
Each vial should be labeled with the appropriate patient information:
•Patient Identification
•Laboratory Log Number
•Patient Location
•Date and Time of Collection
•Collector's Initials
•Site of Venipuncture
Fntering new vials:
•Press the 'Vial Entry' key.
•Scan vial barcode by placing the vial in the alignment block in front of the scanner with the
barcode facing the scanner. Rotate the vial slightly in front of the scanner. The system
beeps once to indicate a successful scan.
NOTE: If the vial barcode cannot be read, press the 'No Barcode' key. Select the vial
media by using the Up/Down arrow keys. Press the 'Ok' key to confirm media type.
•Insert the vial into position indicated on the LCD display.
•If default protocol is acceptable, press `Ok' key.
NOTE: To modify the protocol length for a particular vial, select the 'Change Protocol'
key. Select the desired protocol length using the Up/Down arrow keys. Press 'Ok' to
confirm protocol length.
•Verify that all information is correct and that vial has been inserted into the indicated station.
Press 'Ok' key to confirm.
•Repeat the above steps for each new vial. Then Press the 'Exit' key.
Positive Vials:
A. Notification of the presence of presumptive positive vials
•An audible alarm sounds if configured to a volume > O.
•The New Positive Indicator on the front of the instrument flashes red.
•The 'Remove Positives' key appears in the LCD display when the door is open.
•On the main status display. that station with the positive vial is displayed as a filled circle
with a plus sign in it, and the positive total in the summary region reflects the number of
positives in the instrument.
B. Removal of positive vials
•Press the 'Silence Alarm' key to acknowledge the alarm.
•Open instrument door and press the `Remove Positives' key.
•LCD display identifies the positive vial by position and the barcode number is also
displayed.
•Remove vial from the station and scan the vial barcode. Repeat the above steps until all
positives are removed (three beeps indicates all positives have been removed).
•Press the 'Exit" key.
NOTE: A subculture and a Gram stain should be performed from each presumptive
positive vial.
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Negative Vials.
A. Removal
•Open instrument door
•Press the 'Remove Negatives' key.
•LCD display identifies negative vials by position and the vial barcode number is also
displayed.
•Remove the vial from the station and scan the vial barcode.
•Repeat the above steps until all negatives are removed (three beeps indicate the process is
complete).
•Press the 'Exit' key and close door.
JIMITATIONS OF THE PROCEDURE:
Contamination
Care must be taken to prevent contamination of the sample during collection and inoculation
into the Bactec vials. A contaminated sample will give you a positive reading, but this does not
indicate a clinically significant result.
Recovery of SPS Sensitive and Fastidious Organisms from Blood Samples
Because blood can neutralize the toxicity of SPS toward organisms sensitive to SPS (such as
some Neisseria species), the presence of optimum volumes of blood, based on media type,
benefits the recovery of these organisms.
Some fastidious organisms, such as Haemophilus species, require growth factors, such as
NAD, or factor V, which are provided by the blood specimen. If the blood specimen volume is
3.0 mL or less Bactec Peds Plus, an appropriate supplement may be required for recovery of
these organisms. Bactec Brand FOS (catalog #4402153) or Horse serum and Defibrillated sheep
blood may be used as nutritional supplements.
\me
fleneral Considerations
Optimum recovery of isolates will be achieved by adding the appropriate volume of blood for
the type of vial inoculated. Use of lower or higher volumes may adversely affect recovery
and/or detection time. Blood may contain antimicrobials or other inhibitors which may slow or
prevent the growth of microorganisms. False negative readings may result when certain
organisms do not produce enough CO, to be detected by the system or if significant growth has
occurred before placing the vial into the system. False positivity may occur when the white
blood cell count is high.
DUALITY CONTROL:
Each case of media has a certificate indicating that the media lot has been tested. However,
the laboratory should also test each shipment of media through use of a positive and negative
vial test. The positive vial should be inoculated with 1.0 ml of a 0.5 MacFarland standard of
either Escherichia coli or Staphylococcus aureus. This vial and an uninoculated vial should be
placed into the machine and tested. The inoculated vial should he detected as positive within 72
hours. The negative control vials should remain negative throughout the entire testing protocol.
Page 3 of 3
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Preface
Contents
1— Introduction
.1 BACTEC® 9050 Overview 1
.2 Instrument Overview 3
1.3 Software Overview 5
1.3.1 Built-in-Test (Patent Pending) 6
.4 Manual Structure 7
1.5 Use of this Manual 7
1.6 Conventions 8
1.6.1 General 8
1.6.2 Symbols Used on the Equipment 8
1.6.3 Notes, Cautions, and Warnings 9
1.7 Summary of Warnings and Cautions 10
2 - Installation and Setup
2.1 General Requirements 1 I
2.2 Instrument Specifications 12
2.3 Installation 14
2.4 Instrument Setup 14
2.4.1 General 14
2.4.2 Setup Parameters I 5
2.5 System Start-up 19
3— Controls and Indicators
3.1 General 2I
3.2 On/Off Switch23
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BACTEC® 9050 System User's Manual
Contents
3.3 Keypad and LCD Display23
3.3.1 SILENCE ALARM Key24
3.3.2 HOME ROTOR Key24
3.3.3 Alarm Indicator 25
3.3.4 Brightness Dial25
3.3.5 Soft Keys25
3.3.6 New Positive Indicator25
3.3.7 DOWN /UP ARROW Keys25
3.3.8 Display Area26
3.4 Door Interlock Switch26
3.5 Floppy Disk Drive26
3.5.1 Floppy Disk Indicator26
3.5.2 Floppy Disk Eject Button27
3.6 Barcode Scanner27
3.7 Audible Tones and Alarms28
4- Operation
4.1 General29
4.2 Preparing Specimens30
4.2.1 Media Quality Control 30
4.3 Daily Checks31
4.4 Entering New Vials 3I
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Preface
Contents
4.5 Positive and Negative Specimens34
4.5.1 General 34
4.5.2 Notification of Positive and Negative Vials34
4.5.3 Removing Positive Vials 35
4.5.4 Removing Negative Vials 37
4.6 Printing System Status Reports38
4.7 Resolving Station Errors40
4.8 Identifying Anonymous Vials42
4.9 Power Failures and Manual Operation44
5— Reference
5.1 General45
5.2 Software Menu Tree46
5.3 Display Types46
5.3.1 Main Status Screen47
5.3.2 Main Activity Screen48
5.4 Icon Charts49
6— Maintenance
6.1 General 53
6.1.1 Instrument Symbols54
6.2 Routine Maintenance54
6.2.1 Air Filter Replacement54
6.2.2 TemperatureVerification (QC)55
6.2.3 Barcode Scanner Window56
6.2.4 Decontamination 57
MA-0103-D V
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DACTEC® 9050 System User's Manual
6.3 Module Replacement 58
6.3.1 Front Cabinet Components 59
6.3.1.1 Damper Cylinder 59
6.3.1.2 Door Sensor Switch Replacement 61
6.3.1.3 Rotor 62
6.3.1.4 RTD 65
6.3.2 Front Panel Components 68
6.3.2.1 Front Panel Removal 68
6.3.2.2 Barcode Scanner Replacement 70
6.3.2.3 Floppy Disk Drive Replacement 71
6.3.2.4 Keypad/LCD Display Replacement 73
6.3.3 Rear Cabinet Components 75
6.3.3.1 Rear Cabinet Shell 75
6.3.3.2 Electrical Guard 77
6.3.3.3 AC Power Distribution Board 78
6.3.3.4 Blower 79
6.3.3.5 Computer Board 80
6.3.3.6 DC Power Distribution Board 82
6.3.3.7 Detector Board 84
6.3.3.8 Fan 86
6.3.3.9 Heater 87
6.3.3.10 I/O Board 88
6.3.3.11 Main Transformer 90
Contents
6.3.3.12 On/Off Switch, Line Filter, and Interlock Switch , 92
6.3.3.13 Power Supply (5V / +I 5V / —15V) Board93
6.3.3.14 Power Supply (40V) Board94
vi MA-0103-8
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Preface
Contents
7 - Troubleshooting
7.1 General95
7.1.1 Instrument Service95
7.1.2 Instrument Symbols95
7.2 Error/Alert Messages96
Appendix A - Limited Warranty 105
Appendix 5 - Replacement Parts 107
Appendix C - Software Update Log 109
Appendix19 - International Contacts
Appendix E - Supplemental Forms 1 13
Glossary and Abbreviations 117
Index 123
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BACTEC® 9050 System User's Manual
Figure Description Page
IBACTEC Fluorescent Test Technology 2
2BACTEC® 9050 Instrument 4
3Main Status Screen 6
4Symbols Used on the BACTEC® 9050 Instrument 9
5Main Status Screen 15
6BACTEC® 9050 Instrument Layout 22
7On/Off Switch 23
8Keypad and LCD Display 24
9Floppy Disk Drive Controls and Indicators 27
10 Entering New Vials 33
11 Removing Positive Vials 35
12 Removing Negative Vials 37
13 System Status Report 39
I4 Resolving Station Errors 41
15 Identifying Anonymous Vials 43
16 Main Status Screen 47
I7 Main Activity Screen 49
18 Air Filter Replacement 55
19 Barcode Scanner Window 56
20 Damper Cylinder Removal 60
21 Door Sensor Switch Removal 61
22 Rotor Removal 63
23 Rotor Removal— Pushing Down Driver Motor 64
24 RTD Removal (A) 66
Figures
Viii MA-0103-13
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Preface
Figures
Figure Description Page
25 RTD Removal (B) 67
26 RTD Removal (C) 67
27 Front Panel Removal (A) 68
28 Front Panel Removal (B) 69
29 Barcode Scanner Removal 70
30 Floppy Disk Drive Removal 71
31 Floppy Disk Drive Pin 1 Identification (typical) 72
32 Keypad/LCD Display Removal (A) 73
33 Keypad/LCD Display Removal (B) 74
34 Rear Cabinet Shell Removal (A) 75
35 Rear Cabinet Shell Removal (B) 76
36 Electrical Guard Removal77
37 AC Distribution Board Removal 78
38 Blower Removal79
39 Computer Board Removal81
40 DC Power Distribution Board Removal83
41 Detector Board Removal85
42 Fan Removal86
43 Heater Removal 88
44 I/O Board Removal89
45 Main Transformer Removal (A)90
46 Main Transformer Removal (B) 91
47 Main Transformer Removal (C) 91
48 Power Supply (5V/± I 5V) Removal93
49 Power Supply (40V) Removal94
S
MA-010343 iX
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E3ACTEC® 9050 System User's Manual
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0
Introduction
1.1 BACTEC® 9050 Overview
The BACTEC® 9050 instrument is designed for the rapid detection of bacteria
and fungi in clinical cultures of blood. Samples are drawn from patients and in-
jected directly into BACTEC culture vials.Vials are then entered into the instru-
ment as soon as possible to insure performance efficacy.
When microorganisms are present, they metabolize nutrients in the culture me-
dium, releasing carbon dioxide into the medium.A dye in the sensor reacts with
CO2.This modulates the amount of light that is absorbed by a fluorescent mate-
rial in the sensor.The instrument's photo detectors measure the level of fluores-
cence, which corresponds to the amount of CO2 released by organisms. Then
the measurement is interpreted by the system according to preprogrammed
positivity parameters. (See Figure I.)
At system start-up, the BACTEC® 9050 instrument performs self-diagnostics
and loads its operating instructions.Then the instrument begins automated test-
ing.A row of Light Emitting Diodes (LEDs) behind the vials illuminate, activating
the vials' fluorescent sensors.The instrument's photo detectors then take the
readings.A test cycle is completed every ten minutes. Positive cultures are imme-
diately flagged by an indicator light on the front of the instrument, an optional
audible alarm, and are displayed on the LCD screen.
When positive vials are identified, the lab technologist pulls them from the in-
strument for confirmation of results, and for isolation and identification of the
organism.
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BACTEC 9050 System User's Manual
Figure 1— 13ACTEC Fluorescent Test Technology
2MA-0103-5
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1- Introduction
An instrument is capable of monitoring a total of 50 BACTEC® culture vials.The
practical capacity is 5 culture sets per day with a 5-day test protocol.The vials are
arranged in 3 concentric rings designated A, B, and C.The vials are continuously
incubated at 35° C, and are agitated for maximum recovery of organisms.
Major features of the BACTEC® 9050 instrument include:
♦Automated, continuous, unattended testing of cultures through non-
invasive fluorescent technology
♦Minimum user interaction and handling
♦Immediate notification of positives through an indicator lamp, indica-
tion on the LCD display, and an audible alarm
♦Simple user interface, with picture icons to guide you through setup
and routine operations
♦Incubation and agitation for all cultures
♦Proven BACTEC® culture media
1.2 Instrument Overview
*Ik
The BACTEC® 9050 instrument (hardware) components are described in the
following paragraphs and are shown in Figure 2. Controls and indicators for these
modules are discussed in Section 3 - Controls and Indicators.
The major subsystems of the instrument include the following:
Rotor
The rotor contains 50 wells called "vial stations," into which vials are placed for
incubation and testing.The rotor contains three rings of vial stations designated
A, B, and C. Each station is numbered uniquely (I - 50), but the system provides
the ring letter designation (A, B, or C) to help you quickly identify where to place
or remove vials. One row of stations (one station in each ring) contains the test
LEDs that activate vial sensors and the photo detectors which take the actual
readings.
The rotor is mounted at a 20° angle and rotates to provide agitation to culture
vials.Agitation of cultures can improve both time to detection and recovery of
organisms. The rotor's drive motor stops agitation when the cabinet door is
opened.
The temperature inside the instrument is preset to maintain the internal tem-
perature at 35° C ± 1.5° C. Over- and under-temperature alarm setpoints are
preset at 35.5° C and 34.5° C, respectively.
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5ACTECD 9050 System User's Manual
Temperature L.)tandards
Vial Stations Rotor
Figure 2 - 13ACTEC'" 9050 Instrument
Keypad and LCD Display
The LCD Display is a 240 X 64 pixel Liquid Crystal Display that presents informa-
tion about system status and function key definitions that enable you to perform
system operations. Key definitions and status information are identified by picture
icons that represent the type of information or operation that can be performed.
Acomprehensive list of system icons is presented in Section 5— Reference.
The keypad enables you to perform operations such as entering and removing
vials,adjusting setup parameters,etc. Four of the keys, marked with printed icons,
perform fixed functions regardless of the current display or operation. Six other
keys, teal in color, are software (soft) keys whose functions vary depending on
the current active display. Each display shows icons representing the current Soft
key assignments at the bottom of the screen. To perform the function repre-
sented by the icon, you press the corresponding Soft key below the icon.
Barcode Scanner
Abarcode scanner is located on the front of the instrument to provide the
ability to scan vial labels for specimen identification.The scanner turns on auto-
matically whenever a barcode needs to be scanned.
Computer
The system computer stores all the system software, including the software
which controls instrument operations and the user interface, which enables you
to perform instrument operations, view vial statuses, print reports, etc.
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1- Introduction
Floppy Disk Drive
A floppy disk drive is located on the front of the instrument to enable the instal-
lation of software updates and to copy important data files to floppy disk.
External Ports
Ports on the rear of the instrument allow the user to connect an optional Re-
mote Alarm unit and an optional printer.Two other ports are for Field Service
diagnostic use.
Instrument Calibration
Components of the BACTEC® 9050 instrument are selected and designed to
maintain electrical and optical integrity throughout the product's life.All instru-
ments are calibrated at the factory prior to shipment, and should not require
recalibration during the usable life of the instrument, unless certain components
are replaced. Calibration helps to insure that any fluorescent series medium vial
in any station will have initial and final fluorescent values within a specified range.
1.3 Software Overview
The system software presents a simplified user interface on the LCD Display,
with picture icons to represent all the functions, operations, setup parameters,
and status conditions (see Section 5 - Reference for charts of all icons). Routine
system operations are performed by pressing the teal soft key that corresponds
to the definition shown on the screen.
There are three basic types of displays:
Main Status Screen - When the instrument door is closed, this screen
appears. It shows the number of vials that are positive, negative, ongo-
ing, available, and stations that are in error or anonymous. Also shown
are the current date and time and the instrument temperature. Soft-
ware keys allow you to configure the setup parameters, review system
errors, or print the System Status Report. See Figure 3.
Configuration Screens -Accessible from the Main Status Screen,the Con-
figuration Screens allow you to set the protocol length, the time and
time format, the date and date format, the audible alarm volume, the
instrument identification number, the DVE (Delayed Vial Entry) thresh-
old (feature not available for use in the USA), to select the desired
language for reports, to write data to a floppy disk, and to update sys-
tem software.
Activity Screens -When the instrument door is opened, software key defi-
nitions appear that enable you to enter new vials, remove positive vials,
remove negative vials, identify anonymous vials, and resolve station er-
ror conditions.
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BACTEC") 9050 System User's Manual
Figure 3— Main Status Screen
1.3.1 Built-in-Test (Patent Pending)
The system software is designed to continuously monitor the electrical and op-
tical performance of all stations simultaneously.This functionality, called BIT (for
Built-in-Test), automatically monitors each station every ten minutes for basic
operational characteristics.These tests continually verify that signal output for
each station is within design limits; this includes both empty stations and stations
with ongoing vials.
Two different signal levels are used to verify operation of the station over the
established signal range.Tests are performed on dark readings (the output from
the station when its excitation LEDs are off) and on fluorescence unit readings
(the output from the station when a vial is present and the excitation LEDs are
on).
Dark readings are evaluated to be below a maximum established range.When
they exceed that range, the software declares the station in error. High dark
readings may indicate a light leak in the cabinet or an electrical failure within the
instrument.
Fluorescence unit readings are evaluated to be within a specified maximum and
minimum range which has been established for the instrument during calibration
at the factory. Should an out of range reading occur, the software declares that
station in error.This may occur due to an electrical or optical component failure.
Additionally, the fluorescence readings are evaluated for consistency while vials
are in stations. If consecutive fluorescence unit readings vary by more than a
predetermined amount, the station is declared in error.This feature determines
the stability and the acceptability of a station for use during protocol.
These protection features verify that calibration has been maintained for all sta-
tions within the system, and insure that the user is alerted of electronic or opti-
cal changes or failures which may be significant enough to affect results.
The function of BIT can be demonstrated by entering a vial into the instrument,
and then removing that vial from the station without scanning it out.The result-
ing error is the response of the BIT function.The user may resolve the error by
using the resolve errors soft key.
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1- Introduction
1.4 Manual Structure
This user's manual contains the following sections:
Section I— Introduction—provides an overview of the BACTEC® 9050
instrument and its uses in the microbiology laboratory, its major hard-
ware and software components. An overview of this manual's struc-
ture and conventions is also included.
Section 2— Installation—gives specifications for installing the BACTEC®
9050 instrument and instrument setup.
Section 3 — Controls and Indicators— explains the use and meaning of
all controls and indicators of the system.
Section 4— Operation—provides instructions for routine daily activities.
Section 5— Reference—provides reference material on the user interface.
Section 6— Maintenance—explains all system maintenance, including
parts replacements. Depending on the serial number of your instru-
ment, some parts replacements should be performed by service per-
sonnel only.
Section 7— Troubleshooting—provides a convenient guide for identify-
ing and correcting system malfunctions.
The Glossary explains several instrument and computer terms used in this
manual, as well as abbreviations.
The Appendices contain warranty information, replacement parts list, a
software update form, and a listing of Becton Dickinson international
contacts.
The Index provides a listing of major topics and associated page numbers.
1.5 Use of this Manual
This user's manual is designed as a reference tool for technologists, supervisors,
and other personnel who operate and maintain the BACTEC° 9050 instrument
on a regular basis. Every attempt has been made to include all information which
would be required during normal use and maintenance of the system. Should a
question arise which is not answered in this manual, please contact the following
parties (USA):
For assistance with mechanical, electrical, or software performance problems:
IT Field Service 1-800-544-7434
For procedural or software operation questions:
IT Technical Services 1-800-638-8656
International contacts are listed in Appendix D.
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Table of contents
