Becton Dickinson Bactec 9050 System User Manual

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EC 90'0

ern Use s

Manual

BECTON DICKINSON AND COMPANY

BECTON DICKINSON MICROBIOLOGY SYSTEMS

7 Loveton Circle

Sparks, Maryland 21152 USA

June, 1998

Document Number MA-0103

Revision: D

Catalog Number:4405845

BECTON

DICKINSON

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Nor

BRISTOL-MYERS SQUIBB-LAWRENCEVILLE

TITLE: Bactec 9050
Automated Blood Culture

LABORATORY PROCEDURE

DATED: 3/13/98

AUTHOR: Trisha Cohen

REVIEW DATE:

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
a rate 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 Anaer obic/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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\me

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.

J IMITATIONS 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.

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.

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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

Preface

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

iV MA-0103-5

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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

Preface

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

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DACTEC® 9050 System User's Manual

Contents

6.3 Module Replacement

6.3.1

Front Cabinet Components

6.3.1.1 Damper Cylinder

6.3.1.2

6.3.1.3 Rotor

6.3.1.4

6.3.2 Front Panel Components

6.3.2.1 Front Panel Removal 68

6.3.2.2 Barcode Scanner Replacement 70

6.3.2.3 Floppy Disk Drive Replacement

6.3.2.4

6.3.3 Rear Cabinet Components

6.3.3.1 Rear Cabinet Shell

6.3.3.2 Electrical Guard

6.3.3.3 AC Power Distribution Board

6.3.3.4 Blower

Door Sensor Switch Replacement

RTD

Keypad/LCD Display Replacement

58

59

59

61

62

65

68

71

73

75

75

77

78

79

6.3.3.5 Computer Board

6.3.3.6 DC Power Distribution Board

6.3.3.7 Detector Board

6.3.3.8

6.3.3.9

6.3.3.10 I/O Board

6.3.3.11 Main Transformer

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

Fan

Heater 87

80

82

84

86

88

90

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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

Appendix 19 - International Contacts

Appendix E - Supplemental Forms 1 13

Glossary and Abbreviations 117

Index 123

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BACTEC® 9050 System User's Manual

Figures

Figure

I

2

3 Main Status Screen

4

5

6

7 On/Off Switch

8 Keypad and LCD Display

9

10 Entering New Vials

11

12 Removing Negative Vials

13 System Status Report

I4 Resolving Station Errors

15

Description Page

BACTEC Fluorescent Test Technology

BACTEC® 9050 Instrument

Symbols Used on the BACTEC® 9050 Instrument

Main Status Screen

BACTEC® 9050 Instrument Layout

Floppy Disk Drive Controls and Indicators

Removing Positive Vials

Identifying Anonymous Vials

2

4

6

9

15

22

23

24

27

33

35

37

39

41

43

16 Main Status Screen

I7

Main Activity Screen

18

Air Filter Replacement

19 Barcode Scanner Window

20 Damper Cylinder Removal

21 Door Sensor Switch Removal

22 Rotor Removal

23

Rotor Removal — Pushing Down Driver Motor

24 RTD Removal (A)

Viii MA-0103-13

47

49

55

56

60

61

63

64

66

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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

MA-0103-E3

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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.

MA-0103-. 1

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BACTEC 9050 System User's Manual

Figure 1 — 13ACTEC Fluorescent Test Technology

2

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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:

♦ Automa ted, 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

The BACTEC® 9050 instrument (hardware) components are described in the

*Ik

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.

MA-0103-B

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5ACTECD 9050 System User's Manual

Temp e r atu r e 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.
A comprehensive 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

A barcode 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.

4 MA-0103-D

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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. Al so 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.

6

MA-0 IX5-3

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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 — Tro ubleshoo ting — 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 - Introduction

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 Te ch ni c al Services 1-800-638-8656

International contacts are listed in Appendix D.

MA-010'3 7

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BACTEC® 9050 System User's Manual

Other documentation which may be of interest to the user includes:

BACTEC® 9050 Installation and Setup, MA-0102 - This document contains

important information about preparing your laboratory for, and installing

the BACTEC® 9050 instrument.

BACTEC® 9050 5-Minute OperatorTraining Guide, MA-0104 -This document

presents instructions on how to perform routine operations on the
BACTEC® 9050 instrument, in a step-by-step, interactive tutorial format.

BACTEC® Blood Collection Instructions, MA-0108 - This document presents

information on collection of specimens for use with the BACTEC® fluores-
cent instrument series.

BACTEC Media Package Inserts -These documents contain important infor-

mation on the use, storage, inoculation, performance,and limitations of each
type of BACTEC medium.They are included with each carton of media, and
are available upon request from the Technical Services Department.

1.6 Conventions

1.6.1 General

Keys

The four keys that have fixed functions are the UP ARROW (Increase) Key, the

DOWN ARROW (Decrease) Key, the HOME ROTOR Key, and the SILENCE
ALARM Key.These keys are marked with symbols representing their functions,
and operate identically regardless of the active display or operation. Six other

keys, the Software (Soft) Keys are teal in color, and have functions that vary
depending on the active display. Each display shows icons representing the cur-

rent Soft key assignments at the bottom of the screen.To perform the function

represented by the icon, press the corresponding Soft key.

The four fixed function keys are always identified in your BACTEC® 9050 docu-

mentation by CAPITAL LETTERS (e.g., SILENCE ALARM key).The software keys
are always identified by lowercase letters in quotes, and the words soft key (e.g.,
"vial entry" soft key).

End of Section

The end of each section of this manual is marked with an octagonal symbol. •

1.6.2 Symbols Used on the Equipment

The following symbols appear on the BACTEC® 9050 instrument:

8 MA-0'03-5

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1 - introduction

Ce

Figure 4 — Symbols Used on the BACTEC' 9050 Instrument

To p figure: Symbols for Sena! Port, Remote Alarm Port. Printer Port, Keyboard

Port, Power On and Off Center figure. Symbol for electrical ground connection:

Bottom figures: Left — Symbol for electrical hazard, Right - Symbol far "refer to

accompanying documentation" for instructions (specifically, the Maintenance

section of the user's manual)

-1`

1.6.3 Notes, Cautions, and Warnings

Throughout this manual, important information is presented in boxes offset from
the regular text, and is labeled as either a NOTE, CAUTION, or WARNING.
These messages are formatted as shown below and bear the following signifi-
cance:

NOTE

Important information about system use worthy of special

attention is presented as a NOTE.

MA - 0103

CAUTION

Information on an activity which potentially could

cause damage to the instrument or system is presented

as a CAUTION.

9

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BACTEC® 9050 System User's Manual

1.7 Summary of Warnings and Cautions

Special messages presented in this manual which relate to operator and instru-
ment safety,and which appear as CAUTION and WARNING boxes in the manual,
are summarized below. Please read this section completely before you begin to
operate your BACTEC® 9050 instrument.

For all instruments with serial numbers from 1000 — 1695, parts replacements
should be performed by service personnel only. Instrument power should be

turned off, and the power cord should be disconnected, before beginning any

module replacement procedure.

The intake filters on the sides of the instrument must remain unobstructed at all

times. Restricted air flow may cause excessive temperatures in the instrument,

which can affect organism recovery and possibly cause hardware malfunctions.

Because of its size and weight, two persons should lift the BACTEC® 9050 in-
strument.

It is mandatory that all system users become thoroughly familiar with all controls

and indicators before attempting to operate the instrument.

The door sensor helps protect you from possible injury from the movement of

the rotor. Do not tamper with the door sensor in any way, or attempt to defeat

its function.

Never attempt to insert or remove vials when the rotor is in motion.

"Universal Precautions"' should be followed in handling all items contaminated

with blood or other body fluids.

' Recommendations for Prevention of HIV Transmission in Health Care Set-
tings. MMWR 1987; 36 (Supplement #2S): (Inclusive Page Numbers).

Vials should be handled with extreme care at all times, and should not be forced

into or out of stations.Vial necks are susceptible to breakage if they are struck

against another object.

When the system notifies you of alerts and errors, you should immediately re-

spond to the condition.

All maintenance and repair other than the procedures described in Section 6 —

Maintenance, must be performed by qualified service personnel. For all instru-

ments with serial numbers from 1000 — 1695, parts replacements should be

performed by service personnel only.

All portions of the body that could possibly come in contact with the affected

instrument surfaces must be completely covered before beginning the decon-

tamination process.

After the rotor is removed, DO NOT lay it down on either the front or back

sides. (On the rear, the tabs can snap off.) Stand the rotor upright and wedge

both sides so it does not roll.

If any error sub-codes other than those listed here appear, contact Field Service
for assistance.

If the recommended corrective actions do not solve the problem, contact Bec-

•

ton Dickinson at the numbers provided in Appendix D.

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MA-0103-5

1- Introduction

WARNIN GS/CA UTIONS relating to the use of BACTEC MYCO/F

LYTI C culture vials with the BACTEC 9050 instrument:

Biosafety Level 2 practice, containment equipment, and facilities are recom-
mended for preparing acid-fast stains and for culturing clinical specimens.
For activities involving the propagation and manipulation of Mycobacterium
tuberculosis or Mycobacterium species grown in culture, Biosafety Level 3
practice, containment equipment,and facilities are required as recommended
by CDC.

Because an inoculated leaking or broken vial may produce an aerosol of
mycobacteria, including M. tuberculosis or other bacteria, appropriate han-
dling should be observed.

If an inoculated vial is found to be leaking or is accidentally broken during
collection or transport, use the established procedure in your facility for
dealing with mycobacterial spills. As a minimum, "Universal Precautions"
should be employed.Vial should be discarded in an appropriate manner. In
the rare instance where a vial is found to have leaked contents into the
instrument proper, or if a vial is accidently broken, turn off the instrument
immediately.Vacate the affected area. Contact your facility's Safety or Infec-

tion Control Officer(s). Determine the necessity of turning off or modifying
the settings of the air handling units serving the affected area. Do not return
to the area until any potential aerosols have settled or have been removed
by appropriate ventilation. Becton Dickinson Microbiology Systems should
be notified by calling 1-800-544-7434 in the U.S.A. or the appropriate Becton
Dickinson representative in your area. Guidelines for proper handling of
accidental mycobacterial contamination due to breakage of culture tubes or
broth suspensions have been issued by the CDC.'

If recovery of mycobacteria is intended, CDC-NIH guidelines strongly rec-
ommend that the test instrument be placed in the mycobacteriology labo-
ratory where the additional safety issues that the recovery of mycobacteria
present can be addressed.

•

-01(),5 11

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BACTEC® 9050 System User's Manual

•••••••.'

12 MA-010 3-D

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O

Installation and

Setup

2.1 General Requirements

The BACTEC® 9050 instrument should be installed in an area that is free from
undue vibration, direct sunlight, high humidity, dust, temperature extremes, and
corrosive or explosive vapors or gases.The system will operate within specifica-
tions in room temperatures between 18.3° — 32.0° C (65° — 89.6° F). Relative
humidity should be between 10% and 90% (non-condensing). Clearances on all
sides should be at least 12 inches. Environments which exceed these limits could
adversely effect the performance of the system components.

The incubator should maintain its temperature to within plus or minus 1.5° C of
the temperature setting (35° C).This accuracy can be assured only if the room
temperature meets the requirements given above.

MA-01)7,:

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13

BACTEC 9050 System User's Manual

2.2 Instrument Specifications

Physical Dimensions

Height 28.5 in (72.4 cm)

Width

Depth

Weight (no vials)

(with vials)

Clearance Requirements

Left side

Right side

Back

Top

Optimum bench height

Electrical Requirements

24 in (61 cm)

25.5 in (64.8 cm)

103 lb (46.7 kg)

118 . 5 lb (53.8 kg)

12 in (30.5 cm)

12 in (30.5 cm)

12 in (30.5 cm)

12 in (30.5 cm)

30 -- 36 in (77 — 92 cm)

Input Voltage

Input Current

Input line Frequency

Heat

14

100 — 117 Volts A C (± 10%) or

220 240 Volts AC (± 10%)

3 Amp maximum

50 or 60 Hz

1200 Btu/hr

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Environmental Requirements

Non-Operating Storage

2 — Installation and Setup

Temperature

Humidity

-4° F to 140° F (-20° C to 60° C)

10% to90% non-condensing

Operating Conditions

Temperature

Humidity

Locations

Altitude

Use of earthquake anchoring is strongly recommended in locations susceptible

to earthquake activity.

Installation Category Hand Pollution Degree 2 as per IEC 664.

65° F to 89.6° F (18.3° C to 32° C)

10% to 90% non-condensing

Level surface, No direct sunlight, No

direct heat

0 to 10,000 ft (3,048 M) above sea

level

MA-0103-D

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15

BACTEC 9050 System User's Manual

2.3 Installation

Complete instructions on unpacking and installation of the BACTEC® 9050 instru-
ment are provided in the separate document titled BACTEC 9050 Installation and
Setup, MA-0102.

CAUTION

The intake filters on the sides of the instrument must

remain unobstructed at all times. Restricted air flow

may cause excessive temperatures in the instrument,

which can affect organism recovery and possibly cause

hardware malfunctions.

2.4 Instrument Setup

2.4.1 General

The BACTEC® 9050 instrument ships with all setup parameters preset to fac-
tory default values. Before using the instrument for blood culture testing, you
should review the instrument setup parameters to see if they are suitable for
your laboratory.These parameters are described in Section 2.4.2— Setup Param-
eters, and include:

♦ Test Protocol Duration

♦ Time Format and Time

♦ Date Format and Date

♦ Audible Alarm Volume

♦ Instrument Number

♦ DVE (Delayed Vial Entry) Media Thresholds (feature not available for

use in the USA)

♦ Language (for System Status Report)

16

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2 - Installation and Setup

After reviewing and adjusting the setup parameters, you should carefully review
the material in the BACTEC® 9050 5-Minute Operator Training Guide, MA-0104.
This one-page guide will familiarize you with routine use of the BACTEC® 9050
instrument.

When you are familiar with system operation, you may proceed with automated
BACTEC® culture testing.

2.4.2 Setup Parameters

To review and/or adjust the instrument setup parameters, first make sure the

instrument door is closed.When the door is closed, a display like the one shown
below appears (note that printer and system alert icons may not be shown):

Figure 5 — Main Status Screen

Any changes to configuration parameters are in effect from the time of the change

forward. Changes do not affect vials that are currently being tested (Ongoing

vials). Also note that any changes you make cannot be "cancelled" per se — you
must manually change the new value back to its previous value.

To e n te r configuration mode, press the soft key corresponding to the icon shown
below (the "configuration" soft key). (For a complete listing of system icons, see
Section 5 — Reference.)

When you enter configuration mode, the first of nine setup displays (Test Proto-
col Duration) appears.

Tes t Protocol Duration (1/9)

6 There are three test protocol duration settings: General media, Myco-

sis/IC—F* medium, and Myco/F Lytic medium.When this display is first
accessed, the test protocol for general media (all media types other

than Mycosis/IC—F* and Myco/F Lytic) is highlighted.The default setting
is 5 days.To increase or decrease the number of days for general media, use the UP
ARROW or DOWN ARROW key. You can choose from 4 to 7 days.

* Not available for use in USA (more)

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BACTEC' 9050 System User's Manual

To adjust the test protocol duration for Mycosis/IC—F medium (not available for
use in the USA) press the "move to other field" soft key to highlight that field.
Use the UP ARROW or DOWN ARROW key to increase or decrease the dis-
played value.You can choose from 5 to 42 days.The default value is 14 days.

To adjust the test protocol duration for Myco/F Lytic medium, press the "move
to other field" soft key to highlight that field. Use the UP ARROW or DOWN
ARROW key to increase or decrease the displayed value.You can choose from 5
to 42 days.The initial default value is 42 days.The recommended testing protocol
for the following organisms are: 7 days for yeast, 30 days for fungi, and 42 days for
mycobacteria.

Press the "configuration" soft key to advance to the next setup display, or press
the "exit" soft key to exit configuration mode.

Time and Time Format (2/9)

23-01-94

12:2 4

01/23/99

12,24

When this display is first accessed, the minutes value is
highlighted.To adjust the minutes, use the UP ARROW or
DOWN ARROW key to increase or decrease the displayed
value.

To adjust the hours value, press the"move to other field" soft key to highlight the

hours field. Use the UP ARROW or DOWN ARROW key to increase or de-

crease the displayed value.

To adjust the time format, press the "format' soft key (shown above).The default

time format (colon separated) is shown. Continue to press the "format" soft key

to rotate among the format choices until the desired selection is shown.You can
choose among period ( . ) or comma ( , ) or colon ( ; ) separators.

Press the "configuration" soft key to advance to the next setup display, or press

the "exit" soft key to exit configuration mode.

Date and Date Format (3/9)

23-.01-94

II

12:2 4

.:::1123/94 fault, the right field) is highlighted.To adjust the year, use

When this display is first accessed, the year value (at de-

12,24 the UP ARROW or DOWN ARROW key to increase or

decrease the displayed value.

To adjust the day value (at default, the middle field), press the "move to other
field" soft key to highlight the day field. Use the UP ARROW or DOWN AR-
ROW key to increase or decrease the displayed value.

To adjust the month value (at default, the left field), press the "move to other
field" soft key to highlight the month field. Use the UP ARROW or DOWN
ARROW key to increase or decrease the displayed value.

To adjust the date format, press the "format" soft key (shown above).The default

date format (MM/DD/YY) is shown. Continue to press the "format" soft key to

rotate among the format choices until the desired selection is shown.You can

choose from the following:

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MA-0103-0

2 - Installation and Setup

Slash

separators ( / )

Hyphen

separators ( - )

Period

separators ( . )

Press the "configuration" soft key to advance to the next setup display, or press
the "exit" soft key to exit configuration mode.

Audible Alarm Volume (4/9)

can choose from 0 (audible alarm off) to 10 (loudest).

Press the "configuration" soft key to advance to the next setup display, or press
the "exit" soft key to exit configuration mode.

Instrument Number (5/9)

1 2 3

MM/DD/YY or
MM/DD/YYYY

MM-DD-YY or
MM-DD-YYYY

MM.DD.YY or
MM.DD.YYYY

Select the volume of the instrument's audible alarm.The default set-
ting is 5, which is at the center of the volume range.To increase or
decrease the volume, use the UP ARROW or DOWN ARROW key
(a sample volume tone sounds each time you adjust the setting).You

Select the instrument identification number.The default setting is I.
To increase or decrease the instrument number, use the UP AR-
ROW or DOWN ARROW key.You can choose a number from I
to 99. If there is only one instrument at your location, you should
leave this value set at I .

DD/MM/YY or
DD/MM/YYYY

DD-MM-YY or
DD-MM-YYYY

DD.MM.YY or
DD.MM.YYYY

YY/MM/DD or
YYYY/MM/DD

YY-MM-DD or
YYYY-MM-DD

YY.MM.DD or
YYYY.MM.DD

Press the "configuration" soft key to advance to the next setup display, or press
the "exit" soft key to exit configuration mode.

DVE Media Thresholds (6/9)

This feature is not available for use in the USA. For information on

On

DVE

Language (7/9)

MA-0103--D

use internationally, refer to the BACTECe 9050 Delayed Vial Entry In-

structions, MA-01 13.

Select the language in which you want the System Status Report to

print.The default setting is English.To scroll through the available
selections, use the UP ARROW or DOWN ARROW key.You can
choose from the following language selections:

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BACTEC® 9050 System User's Manual

English

Spanish

French

German

Italian

Chinese

Japanese

Polish

Press the "configuration" soft key to return to the first setup display, or press the
"exit" soft key to exit configuration mode.

Save Data to Disk (8/9)

1 pi111 Nit Under certain circumstances, Becton Dickinson will advise you to

sert a blank,formatted, write-enabled floppy disk in the disk drive.Then press the
"perform action" soft key.

Update Software (919)

Manual Updated program software is furnished on 3-112 inch floppy disk(s), la-

beled "BACTEC® 9050 System Software,Version y.yyz" (where "y.yy" is the soft-
ware version number, and "z" is the revision).The associated catalog number is
also printed on the label.

To install a software update, insert the floppy disk containing the new software
into the disk drive, then press the "perform action" soft key to initiate the up-
date. The system reboots and then immediately begins to update the system
software (provided the disk is formatted, is not write-protected*, and contains
either the same or a later version of system software). The names of any files
being updated appear on the LCD Display, as well as a progress indication.When
the update is complete, the user interface loads and you may proceed with nor-
mal system operation.

save system data to a floppy disk.These circumstances include some
error conditions and system malfunctions. To use the function, in-

111 From time to time, updated versions of the system software may

be provided to you. New software should be installed as soon as it
is received, and logged on the form in Appendix C of this User's

* Note that write-protection does not have to be disabled with version

1.1 or later of system software

2.5 System Start-up

Whenever power is applied to the instrument, the system is initialized, performs

self-diagnostics, and reports any problems to the error file. If any files are missing
or corrupted which would prevent proper operation of the system, the start-up
process is aborted, If not, the computer loads the operating instructions and
begins culture testing.

•

20 MA-010:3-1)

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Controls and Indicators

3.1 General

This section describes the meaning and use of the controls and indicators of the

BACTEC® 9050 instrument.The overall layout of the instrument cabinet is shown
in Figure 6. Individual components are illustrated in figures accompanying the
related text.

MA-0103-E5

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13ACTEC® 9050 System User's Manual

Figure 6 - I3ACTEC' 9050 Instrument Layout

22

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MA-0103-5

3 - Controls and Indicators

3.2 On/Off Switch

The system power (On/Off) rocker switch is on the rear of the instrument at the
bottom right (see Figure 7).When in the "0" (Off) position, power is removed
from the instrument. When in the "1" (On) position, power is applied to the
instrument. Power must be turned on for the incubator, agitator, and culture
testing modules to work. For normal operation, the power should remain On at
all times (except during some maintenance procedures).

Figure 7 - On/Off Switch

3.3 Keypad and LCD Display

The keypad and LCD display are located on the front of the BACTEC® 9050
instrument, at the bottom center.The keypad is used to enter information and
issue commands to the instrument.The LCD display presents setup and status
information. See Figure 8.

The controls and indicators of the keypad and LCD display are presented in
clockwise order from the top right of the module.

MA-0103-5

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BACTEC® 9050 System User's Manual

Figure 8 — Keypad and LCD Display

3.3.1 SILENCE ALARM Key

The SILENCE ALA RM key is located at the top right of the Keypad/LCD Display
module. When pressed, it turns off the audible alarm for the current "alert"
alarm. It does not silence "door open" type audible alarms. (See Section 3.7—
Audible Tones and Alerts, for an explanation of alarm types and tones.)

3.3.2 HOME ROTOR Key

The HOME ROTOR key is located on the right side of the Keypad/LCD Display
module, below the SILENCE ALARM key. When pressed, it causes the rotor in
the instrument to return to the"home" position, with the temperature standard
bottles in the 12:00 position. The HOME ROTOR key is active only when the
instrument door is closed and the rotor is in motion.

It is not necessary to home the rotor prior to opening the door. However, you
may find it easier to locate vial stations when the rotor is homed, since the
rotor's position then corresponds to the representation in the display.

Note that if vial testing is in progress when the HOME ROTOR key is pressed,
those test results are discarded.

24

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3 - Controls and Indicators

3.3.3 Alarm Indicator

The Alarm indicator is located on the right side of the Keypad/LCD Display, at

the bottom. This light flashes yellow whenever the system encounters an error
condition that requires operator attention.The indicator continues to flash until
the condition is corrected.

When an alarm occurs, an icon (resembling the one above the Alarm Indicator)
appears in the soft key assignments area of the Main Status Screen. Press the soft
key corresponding to the System Alert icon.The first error code is shown on the
display. Correct any error conditions as soon as possible by following the direc-
tions on the door placard and in Section 7 -Troubleshooting.

If there is an audible alarm sounding, you can silence it by pressing the SILENCE

ALARM Key.

3.3.4 Brightness Dial

The Brightness Dial is located below the Keypad/LCD Display, at the center. It is
a knurled rotary dial. Rotate the dial clockwise to increase the overall brightness
of the LCD Display screen. Rotate counterclockwise to reduce the brightness. It
is not uncommon to have to change the brightness setting if you change your
viewing angle.

3.3.5 Soft Keys

The six software (soft) keys are located near the bottom of the Keypad/LCD

Display, at the center. These keys are teal colored. None of the keys has a fixed
function - the functions of the keys 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 represented by the icon, press the
corresponding soft key.

A complete icon legend is provided in Section 5 - Reference.

3.3.6 New Positive Indicator

The New Positive Indicator is located on the left side of the Keypad/LCD Display,
at the bottom.This light flashes red whenever a new positive culture is detected.
The indicator continues flashing until all positive vials are removed from the
instrument. Refer to Section 4.5 for information on removing positive vials.

If there is an audible alarm sounding, you can silence it by pressing the SILENCE
ALARM Key.

3.3.7 DOWN /UP ARROW Keys

The DOWN and UP ARROW keys are located on the left side of the Keypad/

LCD Display. The DOWN ARROW key, represented by a down arrowhead, is
used to decrease a displayed value, or to scroll downward in a list.The UP AR-
ROW key, represented by an up arrowhead, is used to increase a displayed value,
or to scroll upward in a list.

MA-0103-5

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BACTEC° 9050 System User's Manual

3.3.8 Display Area

The Display area is located at the center of the Keypad/LCD Display. It is used to

present information to you, and to show the soft key definitions that allow you
to perform routine operations.

The LCD Display is programmed to automatically dim after 5 minutes of inactiv-

ity.To return the brightness to normal, press one of the unassigned keys (such as
the rightmost soft key).

More information on displays is presented in Section 5 — Reference.

3.4 Door Interlock Switch

When the door of the instrument is opened, a door switch senses the condition
(see Figure 6).This switch tells the system to immediately stop the rotor drive
motor,start the door open timer, and discard the results of any tests in progress.

-I

Because vial test results of tests in progress are discarded when the door is

opened, door openings should be minimized if possible.

3.5 Floppy Disk Drive

The floppy disk drive is located on the front of the instrument, at bottom left. Its
primary purposes are to enable you to save data to floppy disk, and to perform
software updates when they are released. See Figure 9.

3.5.1 Floppy Disk Indicator

The Floppy Disk Drive Indicator light is on the left side of the drive below the

insertion slot. When off it indicates that no activity is occurring in the drive.
When on or flashing, it indicates that the disk drive is accessing a floppy disk. Do

not attempt to eject a floppy disk while this indicator is lit.

26

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3 - Controls and Indicators

3.5.2 Floppy Disk Eject Button

The floppy disk drive eject button is located to the lower right of the insertion
slot.When a floppy disk is inserted fully into the slot, this button extends itself.To
remove a disk, fully depress the eject button. Do not attempt to eject a

floppy disk while the floppy disk indicator is lit.

Figure 9 - Floppy Disk Drive Controls and Indicators

3.6 Barcode Scanner

The barcode scanner is located to the right of the Keypad/LCD Display module.
When the door is opened and an activity is initiated (e.g., entering new vials,
removing positive vials, etc.), the scanner turns on and is ready to read a vial
barcode.

To scan a vial barcode, place the vial in the alignment block in front of the scanner.
If necessary, rotate the vial slightly until the acknowledgment beep sounds (indi-
cating that the barcode was scanned successfully).

MA-0105-E5

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BACTEC® 9050 System User's Manual

3.7 Audible Tones and Alarms

Eight different types of sounds are generated by the BACTEC® 9050 instrument
as you perform operations. Each of the sounds is unique.These tones are de-
signed to keep you informed about various operational states of the instrument.

•

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MA-0103-B

Operation

4.1 General

This section describes routine operation of the BACTEC® 9050 instrument.The
following major topics are discussed:

♦ Preparing Specimens

♦ Daily Checks

♦ Entering New Vials

♦ Positive and Negative Specimens

♦ Printing System Status Reports

♦ Resolving Station Errors

♦ Identifying Anonymous Vials

These topics are offered in a general logical order which might fit the workflow
of the average laboratory. Some of the operations. such as daily checks, may be
done at your convenience. Other operations, like monitoring the system for new
positives and alarm conditions, should be ongoing throughout the day.

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29

BACTEC® 9050 System User's Manual

4.2 Preparing Specimens

Collection

Specimens should be collected aseptically from the patient and inoculated into
the vials. Refer to the appropriate Media Package Insert for specific recommenda-
tions on specimen collection.Vials should be labeled and sent to the laboratory
at once.Additional information is also provided in the BACTEC® Blood Collection

Instructions, MA-0 108.

Preparation

At least one aerobic culture vial and one anaerobic culture vial should be pre-
pared.To prepare a vial, remove the plastic flip cap and clean the exposed rubber
septum with 70% isopropyl alcohol. Use a separate swab for each vial. Inoculate
the vial with the appropriate volume of sample (refer to the Media Package Insert
for specific information on vial inoculation).

4.2.1 Media Quality Control

Refer to the specific culture media package insert for Quality Control recom-
mendations.

30

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4 - Operation

4.3 Daily Checks

Each day several simple system checks should be done.

The following checks should be made:

• Check the temperature readout on the instrument's LCD display.Verify
that the temperature is currently at 35° C ±1.5° C. Also check the
reading on the temperature QC vial. If the readings are not 35° C
±1.5° C, refer to the instructions in Section 7 -Troubleshooting.

• If you have an optional printer, check its paper supply. If the paper
supply is low or exhausted, replace the paper.

4.4 Entering New Vials

After specimens have been prepared, they should be scanned and placed in the
instrument as soon as possible. However, all BACTEC® fluorescent series instru-
ments (9240, 9120, 9050) have delayed vial positivity criteria that provide for
routine delays caused by vial transport, overnight lab closures, etc. The system
accommodates the following delay conditions:

For Plus Aerob ic/F, Plus Anae robic/F, PEDS Plus/F, and Lytic/10 AnaerobidF Media
Types:

• Up to 20 hours if vials are incubated prior to entry in the instrument, or

+ Up to 48 hours if vials are not incubated (i.e., held at room temperature)

For Standard Aerobic/F and Standard Anaerobic/F Media Types:

• Up to 12 hours if vials are incubated prior to entry in the instrument, or

• Up to 48 hours if vials are not incubated (i.e., held at room temperature)

Before placing vials into the instrument, you should always scan their barcodes

and place them in their assigned stations through the vial entry activity. Certain

media types use different positivity criteria, and the system can only apply these
criteria if the vial label - in which the media type is encoded - is scanned (or the
media type is entered manually). In addition, if the vials are not assigned to their
stations prior to placement in the instrument, they become anonymous vials, and
must be identified before other states (such as positive, negative, etc.) can be
displayed.Anonymous vial identification involves the removal and reinsertion of
vials, which can result in an increase of false positive rates.Therefore anonymous

vial loading into the instrument should be minimized.

There are two ways to enter new vials into the instrument:

• By scanning the vial barcode when the "barcode scanner ready" icon
appears

♦ By manually selecting the medium type if the vial barcode cannot be

scanned by pressing the "no barcode" soft key

MA-01();±,-b

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BACTEC® 9050 System User's Manual

Both methods are explained in Figure 10.

Prior to placing vials into stations, visually inspect all vials for positives. Evidence
of microbial growth includes hemolysis, turbidity, and excess gas pressure (caus-
ing the vial septum to bulge outward).All such vials should be treated as posi-
tives; they should be stained and subcultured.

To enter new vials in the instrument:

Ta k e the new cultures to the instrument. Open the instrument door. Follow the
procedure shown in Figure 10.

NOTES

When scanning vial barcodes, place the vial in the alignment
block in front of the scanner with the barcode label facing the
scanner. If necessary, rotate the vial slightly so the scanner can
read the labei.The system beeps once to indicate a good scan.

32

Station assignments are calculated by the system software to

balance the rotor. In order to maintain rotor balance, you

should always enter vials into the instrument as described in

Figure 10, and place the vials where the system indicates.

When inserting vials into stations, carefully push the vial into

the station. Press against the shoulders to insure that the vial is

fully seated in the station.

Once the vials are placed in stations, they should not be twisted

or turned.Vials should not be removed except in the following

conditions:

• Removal of positive

• Removal of negative

• Reassign if station becomes bad

• Identification of anonymous vials

Any vial reassigned to a new station should be subcultured

immediately.

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Press "vial entry' soft key

11.

(Vial entry display appears)

I 0 1 I -I-1.

4 - Operation

Vial barcode can be scanned

(Station is allocated.)

gt 5 i+ Al2

**

OK 010* %c°60k8S°

■

(Vial is assigned to station and will begin to
test shortly. System returns you to *

•

Vial barcode cannot in scanned

•

(System asks media type.)

Std Aerobic

OK 0 1411 %:1)“ . •

. hen

(Activity picks up at ** )

oo 0

••• • •
. •

0

(Vial is not assigned to station. System'
returns you to * . )

1111111111111=111111111

■

Figure 10 - Entering New Vials

MA-0103-5

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13ACTEC® 9050 System User's Manual

4.5 Positive and Negative Specimens

4.5.1 General

Many positive cultures will be detected in the first 24 hours after inoculation,but
ongoing negative vials must still be kept for several days to assure maximum
recovery.With the BACTEC® 9050 instrument, vials are typically held for 5 - 7
days before they are discarded as negative. Each laboratory should set the proto-
col length based on its own policies and conditions.Your protocol length can be
from 4 - 7 days.

A subculture and a Gram stain should be performed from each positive vial. In

most cases, organisms will be seen and a preliminary report can be made to the
physician. Preliminary antimicrobial susceptibility and identification procedures
may also be set up from fluid in the culture vials.The results from these prelimi-
nary tests should be confirmed by using standardized laboratory procedures.

The system allows re-entry of instrument-positive vials for up to 3 hours after
their removal (subject to the conditions described in Section 4.5.3).The re-entry
feature resets positivity routines, retains previous test readings, and continues to
test the vial as an ongoing culture.

For a maximum yield of isolates, negative cultures may be stained and/or subcul-

tured during the test period or immediately prior to their disposal.

4.5.2 Notification of Positive and Negative Vials

The system notifies you of new positive cultures in several ways:

♦ New Positive indicator lamp on the front of the instrument flashes.

♦ On the Main Status display, the station is displayed as a filled circle with

a plus sign (+) in it, and the positives total in the Summary reflects the

number of positives in the instrument.

♦ When the door is opened, the "remove positives" soft key appears in

the soft key assignment area of the LCD Display.

♦ Until silenced, the audible alarm sounds (if enabled).

Negative cultures may exist as ongoing negatives (in protocol) and out-of-proto-
col negatives.You are notified of these conditions as follows:

♦ Ongoing Negatives - On the Main Status display, the station is dis-

played as a filled circle.

♦ Out-of-Protocol Negatives - On the Main Status display, the station is

displayed as a filled circle with a minus sign (-) in it.Also, the negatives
count in the Summary reflects the number of final negatives in the
instrument. No audible alarm sounds for notification.When the door
is opened, the "remove negatives" soft key appears in the soft key as-
signment area of the LCD Display.

34

MA-0103-5

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4- Operation

4.5.3 Removing Positive Vials

Press the SILENCE ALARM key to silence the audible alarm. Open the instru-
ment door. Follow the procedure shown in Figure I I.

Press "remove positives" soft key

se

If vial was originally entered by scanning If vial was originally entered manually (by selec-
barcode, the following display appears: ting media type), the following display appears:

+?Loaa ek4

1 lee

or 1111

Repast unti elpeintives are removed.
Thin press `exitsoft key.

•

Figure 11 - Removing Positive Vials

+A A22 MI6

°

MA-0103-b

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35

BACTEC® 9050 System User's Manual

NOTE

The New Positive indicator remains lit until all new positive
vials are removed through the Remove Positives operation.

Instrument positive vials can be returned to the instrument for

additional testing subject to the conditions described below.

Returning Positive Vials to the Instrument for Further Testing

The system allows you to return a pulled positive vial — if the vial was originally
scanned into the instrument — for up to 3 hours after removal (or until the vial
goes out of protocol, whichever is earlier).The re-entry feature resets positivity
routines, retains previous test readings,and continues to test the vial as an ongo-
ing culture. If the vial is not returned within the 3-hour re-entry window, previ-
ous test results are discarded. If the vial was manually entered (by selecting me-
dia type), the system treats it as a new vial if it is removed and subsequently re-
entered.

The following precautions should be observed when using the vial re-entry fea-
ture. Instrument-positive vials should be subcultured and Gram stained upon

removal from the instrument. Even though a 3-hour re-entry window exists for

the return of a vial to an ongoing status, the vial should be returned to the

instrument as soon as possible.Vials should remain at room temperature while

they are out of the instrument.

To return a pulled positive vial to the instrument for further testing, open the

door. Press the "vial entry" soft key. Next scan the vial's barcode label. Place the
vial in the indicated station (this may differ from the original station). Previous
test results are retained only in the following circumstances:

♦ You originally scanned the vial barcode when entering it in the instru-

ment.

• You return the vial within the required time frame.

♦ You scan the vial label to re-enter the vial.

* You return the vial to the same instrument from which it was removed.

If you do not use the vial entry activity to re-enter the vial, it becomes An ony-
mous at the next test cycle, and the previous test results are removed from the
database if it is not identified within the 3-hour period.

36

MA-0103-E3

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4 - Operation

4.5.4 Removing Negative Vials

Open the instrument door. Follow the procedure shown in Figure 12.

Press "remove negatives" soft key

■

If vial was originally entered by scanning If vial was originally entered manually (by selec
barcode, the following display appears: ting media type), the following displayappears

+A A22 ctv •• e°043 .°0°

C$$4400

4E. 03'0*

Figure 12 - Removing Negative Vials

'SD

0,4460

I' A A22 liieb,

v.040

1•.°1* ocmot)

Ope,o•

nomenems.

MA-0103-8 37

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13ACTEC® 9050 System User's Manual

4.6 Printing System Status Reports

If your system is configured with an optional printer, you can print a System
Status Report that provides information about current and recently removed
culture vials.The report is divided into three main sections:the top section con-
tains information about the instrument, the middle section contains information
on vials currently in the instrument, and the bottom section contains informa-
tion on vials removed in the past 24 hours.

The top section presents the following system/instrument information:

♦ Report Name

♦ Product Name

♦ Date and time that the report was requested

♦ Instrument number

♦ Incubator temperature

♦ System software version

♦ Ring status (E indicates good, X indicates bad , and ? indicates an un-

known state)

The middle section (Current Vials) presents the following information on vials
currently in the instrument:

♦ Station Number (the sort order of the report)

♦ Vial Barcode Sequence Number (if vial was entered manually by select-

ing media type, the last 8 digits are indicated with hyphens; digits 3 and
4 indicate the selected or scanned media type)

♦ Vial Status (+ indicates positive, = indicates ongoing,_ indicates nega-

tive, ? indicates anonymous [Sequence Number appears blank], and !
indicates error)

♦ Start of Protocol Date and Time

♦ Protocol Length

♦ End Date andTime (for positives, the Date and Time that system flagged

positive; for negatives, the end of protocol Date and Time; for ongoing,
error, and anonymous, blank)

♦ Time to Detection in hours and hundredths of hours for positive vials

The bottom section (Removed Vials) presents ali of the fields named directly
above except Station Number.Vials that have been removed from the instrument

in the 24 hours preceding the report request time are included in this section.

38

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4 - Operation

In order for the report to print correctly, you must set your printer to skip
printing across the perforation. Consult your printer operating manual for in-
structions on how to set this feature in the printer.

To Print the System Status Report

From the Main Status Screen, press the "print report" soft key.The icon appears
on the display only if a printer is attached to the system, is turned on, and is
online.

01 I System Status Report 10

01 Becton Dickinson BACTEC 9050 i ()

L Datehime Instrument Tem_perature Version Rini GA: A B C

iv1 12/16/96 11:34 1 35.0° C V1.00A a X a

01 Current Vials IC

0 'Station Sequence #

1 All 000000001313

()I ;',1223 000000003712

c)! 2: 0000

01

000000006397

000000006543

I B26 000000009449

01

Seguence # Status Start date/time Protocol

01

000000006111 _ 12/10/96 13:13 5
000000007654

I

0,

Status Start dateitime Protocol

_

12/11/96 11: 22

!

12/13/96 11: 23
.2/14/96

=

- 12/14/96 22:34
+ 12/14/96 22:34
?

12/15/96 15:16

22:33

I+

Removed Vials (24

+ 12/13/96 21:12 5 12/16/96 21:34 72.37

End datelime

5 12/16/96
5

5

12/16/96

5

TTD (tours)..1 0

11: 22

10:34

Hours) L,

End date/time TTD (ours)'

12/15/96 13:13 -I 0

36.00

10

li

,...)

I

0

MA-0103-5

Figure 13 - System Status Report

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BACTEC® 9050 System User's Manual

4.7 Resolving Station Errors

As you perform activities at the BACTEC' 9050 instrument, and as vial testing
progresses, system alerts and errors may occur. Different types of alerts and
errors are flagged by either"E" error codes, audible tones, the System Al ert icon
appearing, or the System Alert indicator flashing (or a combination of these).

Generally, the more serious the condition, the more ways the system notifies

you of the problem.

CAUTION

When the system notifies you of alerts and errors, you

should immediately respond to the condition.

System alerts, which comprise all "E" type error codes except those in the 30's,
are reported in the system alert log.These errors cause the system alert icon to
appear on the Main Status screen, and can be reviewed by pressing the "system
alert" soft key.The errors must be reviewed to clear the system alert condition.

Activity errors (such as scanning an unexpected barcode) cause the activity er-

ror icon to appear on the activity screen (e.g., remove positives, remove nega-
tives, etc.).They do not put the system into an alert condition, and can frequently

be cleared by simply performing the activity correctly (such as scanning the cor-

rect barcode).

Station errors (type E12) can occur from a number of causes.These errors are

reported in the system alert log, and are also flagged by the appearance of the

resolve errors icon on the Main Activity screen.The general operation of resolv-

ing error stations is shown in Figure 14. Specific suggestions for resolving error

stations are provided in Section 7.2 - Error Messages, under error code E12.

All the "E" type error codes are discussed in detail in Section 7.2 - Error Mes-

sages.The audible tones are discussed in Section 3.7 -Audible Tones and Alerts.

40

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4 - Operation

Press "resolve errors" soft key

■

(The first error station is shown)

Vial is not missing and b arcade can be scanned Vial is missing or barcode cannot be scanned

g' B28

.44012813EIBOO

1.40

r

Determine cause of 'E" type error (see Section

7 -T roubleshooting

A! B28

• +0

.4.. •

0

•

.1 • • • •

'•

• ".•••

11111111■11111•1111

! B2 •.°08g etg,°

44eleeeeeee • 0 t

00000

(System asks for confirmation that error
was corrected.)

(System asks for confirmation that error

was corrected.)

•

le or ■

MA-0103-5

se

•

Figure 14 - Resolving Station Errors

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SACTEC' 9050 System User's Manual

4.8 Identifying Anonymous Vials

An anonymous vial is one which is physically in a station but has not been as-

signed to that station through the Vial Entry activity. It is very important that

when the system notifies you of anonymous vials (anonymous count in Summary

window increments and Identify Anonymous icon appears when door is opened),

you identify them as soon as possible.The anonymous state supersedes all oth-

ers, which means that vials that are anonymous may in fact also be positive, out-

of-protocol, in error, etc. However, before any other status can be displayed, the

anonymous vial must be identified to the system.

The Identify Anony mous function enables you to locate anonymous vials in the

instrument and assign them to stations.

To Identify Anonym ous Vials

Open the instrument door.

Follow the steps in Figure 15.

Note that because the removal and reinsertion of vials can result in an increase

of false positive rates, anonymous vial loading into the instrument should be

minimized.

42

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MA-0103--E3

Press "Identify anonymous" soft key

•

(Identify anonymous display appears)

_a O93goctg

8o er,o

&ow%

4 — Operation

Vial barcode can 176 scanned Vial barcode cannot be scanned

(station is allocated.)

ma 5 A? A23 it

**

OK KO IW 141

Locate anonymous station specified

se

(Vial is now assigned to station. If there are
additional anonymous vials, 5y5L6m returns
you to * .)

•

1**1819

°o

coee

(System asks media type.)

Std AeroPi c:

OK

•

MUM

Chen.or

(Activity picks up at ** )

'410*.ne

MA-0105-43

(Vial i5 not assigned to station. System
returns you to * . )

Figure 15 - Identifying Anonymous Vials

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BACTEC® 9050 System User's Manual

4.9 Power Failures and Manual Operation

The information in the system is stored in memory until a power failure occurs.
When a power failure occurs, the data is transferred into non-volatile RAM. Data
in NVRAM is maintained by a long-life battery.After the data is transferred, the
system is completely shut down. No vial testing occurs until power is restored.

When power is restored, the times that power was lost and restored are noted
in the system alert list and can be viewed on the display (note that if multiple
power failures occur, only the latest is retained in the alert list). Culture vial
testing resumes when power is restored.

For the period of time that power is out, the system misses one test reading for
each ten minutes of power outage. Although unlikely, missed readings can result
in detection failures.Therefore if testing is interrupted for longer than forty min-
utes, to ensure maximum recovery it is recommended that you perform a sub-
culture on ongoing culture vials.

Yo u may, at your option, connect the system to an Uninterruptible Power Supply
(UPS). Use of a UPS may help prevent interruptions to testing, or - if the UPS is
connected to an emergency power line - the necessity of subculturing vials in
the event of a sustained power failure.

•

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MA-0103-6

Reference

5.1 General

This section presents reference material on the BACTEC® 9050 user interface.
The following information is presented:

♦ Software menu tree

♦ Display types and regions

♦ Icon Charts

MA-0103-13

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45

BACTEC° 9050 System User's Manual

5.2 Software Menu Tree

The following is a hierarchical list of ail displays/functions in the system. The
sections where these activities are discussed in detail are noted in parentheses.

Main Status Screen (Door Closed)

Configuration

Set Test Protocol Duration (Section 2.4.2)

Set Time Format and/or Time (Section 2.4.2)

Set Date Format and/or Date (Section 2.4.2)

Set Aud ible Alarm Volume (Section 2.4.2)

Set Instrument Number (Section 2.4.2)

Set DVE (Delayed Vial Entry) Media Threshold (feature not available
for use in the USA; international users refer to MA-01 I3, BACTEC®

9050 Delayed Viol Entry Instructions)

Set Language for Report (Section 2.4.2)

Write Data to Disk (Section 2.4.2)

Update Software (Section 2.4.2)

Print Report (Section 4.6)

Review System Alert List (Section 4.7, 7.2)

Main Activity Screen (Door Open)

Vial Entry (Section 4.4)

Remove Positives (Section 4.5.3)

Remove Negatives (Section 4.5.4)

Identify Ano nymous (Section 4.8)

Resolve Station Errors (Section 4.7,7.2)

5.3 Display Types

There are two main types of display screens.When the instrument door is closed,
the Main Status screen (Section 5.3.1) is displayed. When the door is open, the
Main Activity screen (Section 5.3.2) is displayed.

46

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Li

5 - Reference

5.3.1 Main Status Screen

The Main Status screen (Figure 16) is displayed when the instrument door is
closed.This screen presents up to three icons representing soft key definitions
that allow you to perform system level activities.These icons are as follows:

♦ The "configuration" icon, where you can access seven setup parameters, the

write data to disk function, and the update software function.

♦ The"print report" icon.This icon appears only if you have an optional printer,

it is attached, turned on, and online.

♦ The "review system alert" icon, which allows you to review any system

alerts that may have occurred or that may still exist.

In addition, system and station status information is always in view.The following
information is presented:

♦ Current date

♦ Current time

♦ Current instrument temperature in degrees and tenths of degrees Celsius

♦ Summary region, showing number of vials that are positive, negative, ongo-

ing, available, and stations that are in error, anonymous, or blocked (note
that summary counters may total greater than 50 because vials can have
multiple statuses)

♦ Rotor representation, showing the locations of the various vial statuses

when the rotor is in the "home" position (with the temperature standards
at the 12:00 position)

Figure 16 - Main Statue Screen

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BACTEC® 9050 System User's Manual

5.3.2 Main Activity Screen

The Main Activ ity screen (Figure 17) is displayed when the instrument door is
open.This screen presents up to four icons at a time representing soft key defi-
nitions that allow you to perform vial- and station-related activities.These icons
are as follows:

♦ The "vial entry" icon, which allows you to enter new culture vials for testing.

♦ The "remove positives" icon. This icon appears only if there are positive

vials in the instrument. It allows you to remove these positive vials.

♦ The "remove negatives" icon. This icon appears only if there are final (out-

of-protocol) negative vials in the instrument. It allows you to remove these

negative vials.

♦ The "identify anonymous vials" icon. This icon appears only if there are

anonymous vials in the instrument. It allows you to identify these anony-

mous vials so that the system can apply the correct positivity criteria and

display any underlying statuses.

♦ The "resolve station errors" icon.This icon appears only if there are error

stations in the instrument and there are no anonymous vials. It allows you
to resolve the error stations.

In addition, system and station status information is always in view.The following
information is presented:

♦ Current date

♦ Current time

♦ Current instrument temperature in degrees and tenths of degrees Celsius

♦ Summary region, showing number of vials that are positive, negative, ongo-

ing, available, and stations that are in error, anonymous, or blocked (note

that summary counters may total greater than 50 because vials can have

multiple statuses)

48

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5 - Reference

Figure 17 - Main Activity Screen

5.4 Icon Charts

The following charts show all the icons that appear in the system.The icons are
arranged in groups of where during system operation they appear.

Station Status Icons

Icon

•

•

•

Main Status Screen Icons

Icon Meaning Icon

M - 1 avi - L3

Meaning Icon Meaning

Negative station

Ongoing station

Error station

Blocked station

Te mp e r at u r e readout

Print report

•

0

1=I=11 Configuration/Utility Setups

Positive station

Empty (available) station

Anonymous station

Meaning

Review System Alert s

49

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ESACTEC® 9050 System User's Manual

Rotor Status Icons

Icon Meaning

Te mp e r a tu r e standards

Rotor is at home
position

Alert/Error Notification Icons

Icon Meaning Icon Meaning

Activity error or
instrument full

Problem with disk
inserted or no disk

is inserted

Activity Icons

Icon Meaning Icon Meaning

Icon

Meaning

Rotor is in intermediate
position

Rotor is rotating

System alert

Power was removed

at this time

Power was restored
at this time

50

Vial entry

Remove positives

Resolve station errors

No barcode to scan -
enter vial medium type
manually

Set individual vial protocol

Remove negatives

Identify anonymous

Barcode Scanner is ready

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Media Type Icons (for manual vial entry)

5 — Reference

Icon

25mL Plus Aerobic

25mL Plus Anaerobic

4OmL Plus Aerobic

40mL Plus Anaerobic

PEDS

Lytic

lAy•cos I s-IC'

MYCOIF LYTIC

Std Aerobic

Std Anaerobic

Miscellaneous Actio ns Icons

Icon

OK

Meaning Icon Meaning

Confirm your
selection/operation

Meaning

BACTEC Plus Aerob ic/F medium (25 ml)

BACTEC Plus Anaer obic/F medium (25 ml)

BACTEC Plus Aerob ic/F medium (40 ml)

BACTEC Plus Anaer obic/F medium (40 ml)

PEDS Plus/F medium

Lytid I 0 Ana erobic/F medium

Mycosis IC/F medium (not available for use in USA)

Myco/F Lytic medium

BACTEC Standard/ I 0 Aerob idF medium

BACTEC Standard Anaer obic/F medium

Cancel your
selection/operation

• +0

Scroll down or
decrease value

Perform the
desired action

Move to other
field (right)

Force station available

4.

Scroll up or
increase value

Move to other
field (left)

Val ue can be
adjusted up/down

Exit the current operation

51

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BACTEC° 9050 System User's Manual

Configuration Icons

Icon

•••

Polski

AEROBIC Aerob ic threshold

Meaning

Set Protocol duration

Set date

Set speaker volume

Set report language

Spanish language

Italian language

Japanese language

Polish language

Icon

23-01-99

12:29

01123/94 Set time or date format

12,29

Meaning

Set time

Set instrument number

1 2 3

English

Deutsch

Francais

On

English language

Chinese language

German language

French language

Set DVE threshold

DVE

ANAEROBIC

Anaerobic threshold

•

52

Copy data to disk

Writing data to disk

9050I

Update software

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Maintenance

6.1 General

The BACTEC® 9050 instrument requires minimal maintenance from the user to
provide reliable performance. Daily verifications include: checking the incubator tem-
perature and printer paper supply (if configured). Routine preventive maintenance
consists only of a monthly changing or cleaning of the cabinet air filters.All other
procedures are on an "as needed" basis.Any maintenance or repair not described in
this section should be performed by Becton Dickinson personnel only.

Note that if testing is interrupted for longer than forty minutes in performing
any maintenance procedure. to ensure maximum recovery it is recommended
that you perform a subculture on ongoing culture vials.

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53

BACTEC° 9050 System User's Manual

6.1.1 Instrument Symbols

Left: Symbol for electrical ground connection; Center: Symbol for electrical haz-

ard, Right: Symbol for "refer to accompanying documentation" for instructions

(specifically, the Maintenance section of the user's manual)

6.2 Routine Maintenance

Each day the following checks should be made:

♦ Check the temperature readout on the instrument's LCD display.Verify

that the temperature is currently at 35° C ±1.50 C. Also check the

reading on the temperature QC vial. If the readings are not 35° C
± 1.5° C, refer to the instructions in Section 7 -Troubleshooting.

♦ If you have an optional printer, check its paper supply. If the paper

supply is low or exhausted, replace the paper.

6.2.1 Air Filter Replacement

Change or clean the air filters on both sides of the instrument monthly. If the

instrument's environment is especially dusty, check the filter more frequently.
These filters must remain clean and unobstructed; restricted air flow may cause
the vials to reach excessive temperatures, which can affect organism recovery
and possibly cause hardware malfunctions or failures.The filters can be cleaned
and reused. See Figure 18.

Required Materials

New or clean air filters

To Replace the Ai r Filters

1 The air filters are located on the sides of the instrument near the bottom.

To remove a filter, lift it up slightly, then pivot the bottom outward. Lower
the filter out of the filter housing.

2 Wash the filter in a solution of warm, soapy water. Dry it thoroughly and

place it on a paper towel (if you are going to reuse it immediately).

3 Replace the filter by sliding the top up into the filter housing. Pivot the

bottom in toward the instrument, and lower the filter into place.

54

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6 - Maintenance

Figure 16 - Air Filter Replacement

6.2.2 Temperature Verification (QC)

A thermometer and special vial are provided for temperature verification (QC)
of instrument incubation. It is recommended that the accuracy of the thermom-
eter be verified against a calibrated lab thermometer to insure the validity of the
temperature verification.

The temperature control circuitry is designed to maintain the cabinet tempera-
ture at 35° C ±1.5° C. If your manual reading is within 1.5° C of the setpoint (35°
C), the controller and heaters are operating within their specifications.

The temperature vial is mounted in a bracket on the inside of the instrument
door (see Figure 2).

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BACTEC° 9050 System User's Manual

6.2.3 Barcode Scanner Window

There are no user-serviceable parts in the barcode scanner. The only required
periodic maintenance is to clean the scanner's window.To clean the window, use
a damp, lint-free, non-abrasive cloth. Dry the window with a dry lint-free non-
abrasive cloth.

(Front of

ri✓t ru rner t.;

&AL T-1-11 lt T-1:‘21

Cc.14: ;.,.:..1•lr•r'r

Figure 19 - Barcode Scanner Window

56

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MA-0103-E3

6 - Maintenance

6.2.4 Decontamination

A situation requiring biological decontamination of one or more stations can
occur at any time.The priority in this situation is to first limit the extent of the
contamination and then to decontaminate the station or replace the rotor if
complete decontamination cannot be accomplished. If there any doubts that the
affected station(s) cannot be completely decontaminated, the rotor should be
replaced.

To Decontaminate a Station or Rotor

The solution recommended to clean the affected surface should be at least a I 0
per cent household bleach solution.All surfaces must be thoroughly washed with
the freshly prepared bleach solution so the surfaces are "glistening wet" If you
are not sure of the extent of the contamination, thoroughly wash the entire
exterior of the Rotor with the freshly prepared bleach solution. Proceed in the

following manner to decontaminate a station or Rotor if a vial should break in a

station.

1 Wear gloves and a gown, completely covering any body surfaces that could

possibly come in contact with the affected instrument surfaces.

2 Carefully remove broken glass with forceps, one piece at a time.

3 Completely absorb the contaminated spill (gauze pads are most effective).

4 Ap ply the bleach solution to the affected surfaces so the surfaces are"glis-

tening wet."

5 Absorb the applied solution with gauze pads or paper towels.

6 Thoroughly dry all wet surfaces.

7 Discard ALL cleanup materials with biohazardous waste.

MA-0105-5

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BACTEC° 9050 System User's Manual

6.3 Module Replacement

The BACTECa 9050 instrument has been designed and tested for troublefree
performance. However, in the event of a malfunction, most of the major system
components can be replaced. Procedures for removing and replacing compo-
nents are provided in the sections that follow.

Replacement modules may be swapped for failed modules which are then re-
turned to Becton Dickinson. Credit is then applied towards the replacement
module. Only replacement parts supplied by Becton Dickinson should be used in
the procedures described in this section.

Module replacement instructions are organized in the following groups:

Front Cabinet Components (Damper Cylinder, Door Sensor Switch, Rotor, RTD

[temperature sensor]) - Section 6.3.1

Front Panel Components (Barcode Scanner, Floppy Disk Drive, Keypad/LCD

Display) - Section 6.3.2

Rear Cabinet Components (AC and DC Power Distribution Boards, Blower,

Computer Board, Detector Board, Fan, Heater, I/O Board, Main Transformer,
On/Off Switch, +5V/± I5V and 40V Power Supply Boards) - Section 6.3.3

58

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6 - Maintenance

6.3.1 Front Cabinet Components

Front cabinet components include the door damper cylinder, the door sensor
switch, the rotor, and the RTD.

6.3.1.1 Damper Cylinder

To replace the damper cylinder, follow the steps below and refer to Figure 20.

Required Materials

Small Flathead Screwdriver

To Remove the Damper Cylinder

I Begin the removal at the end of the damper cylinder near the bottom cen-

ter of the door interior. Pry the metal clip off with a small flathead screw-
driver.

2 Pull the clip out of the hole.

3 Snap the cylinder's cap off the ball.

4 Repeat these steps for the other end (near the instrument interior) and

remove the damper cylinder.

5 Reverse the steps to replace the damper cylinder.When snapping the cap

over the ball, be sure to reinforce ball from the bottom.

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59

13ACTEC® 9050 System User's Manual

1, of

t.(-)LT.0-•

•

• 4

• .1 r. . • I
5:,-•:,•;/:

•

• . •

60

Figure 20 - Damper Cylinder Removal

MA-0103-B

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6 - Maintenance

6.3.1.2 Door Sensor Switch Replacement

To replace the door sensor switch, follow the steps below. Refer to Figure 21.

Required Materials

Medium Phillips Screwdriver

To Replace the Door Sensor Switch

1 Remove the front panel (Section 6.3.2.1).

2 Reach up inside the interior of the instrument through Keypad/LCD Dis-

play hole to find the Door Sensor Switch. (Some people may find it easier to
remove the barcode scanner [see Section 6.3.2.2] and reach up through
that hole).

3 Squeeze the tabs on each side of the switch together and push the switch

forward.

4 Disconnect the wires and remove the switch.

5 When replacing the switch, reconnect either wire to either inside termi-

nal - do not plug the wires onto the outer two terminals on the switch.

Figure 21 - Door Sensor Switch Removal

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61

3ACTEC® 9050 System User's Manual

6.3.1.3 Rotor

The rotor may need to be removed in order to replace the RTD (temperature
sensor) module, to clean up if a culture vial breaks, etc. See Figures 22 and 23.

Required Materials

No tools required

NOTES

Removing and replacing the rotor requires two people.

If the rotor is replaced, all vials should be subcultured.

To Remove the Rotor

1 Remove the rear cabinet shell (see Section 6.3.3.1).

2 Open the instrument door.

3 Remove the magnetic disk covering the hub.

4 Unscrew the hubcap (turn counterclockwise).

5 Grasp the rotor by placing your fingers in empty vial stations (try to distrib-

ute your grasp evenly among the wells).

6 When you are ready to remove the rotor, the second person should push

the driver motor down (see Figure 23).

7 Wiggle the rotor out of the instrument.

CAUTION

After the rotor is removed, DO NOT lay it down on

either the front or back sides. (On the rear, the tabs can

snap off.) Stand the rotor upright and wedge both sides

8 When you are ready to replace the rotor, the second person should again

push the driver motor down.

9 Wiggle the rotor back into the instrument. Note that the magnetic disk

covering the hub fits in one orientation only- a small notch in the disk must
be placed surrounding a metal tab on the rotor.

62

so it does not roll.

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6 - Maintenance

MA-0103-S

Figure 22 - Rotor Removal

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64

Figure 23 - Rotor Removal - Pushing Down Driver Motor

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6 - Maintenance

6.3.1.4 RID

The RTD (resistance temperature device, or temperature sensor) is located be-
hind the rotor on the right side (facing the front).To remove the RTD, follow the
steps below and refer to Figures 24, 25, and 26.

Required Materials

Small Phillips Screwdriver

To Remove the RTE)

1 Remove the rotor (Section 6.3.1.3) and rear cabinet shell (Section 6.3.3.1).

2 Unscrew the small phillips screw on the black mounting clip.

3 Push the rubber grommet in the through-hole through to the front of the

instrument.

4 Unplug the maroon 3-wire connector from the I/O Board (located near the

front end of the I/O Board).

5 Feed the RTD cable through the through-hole to the front of the instru-

ment and remove the RID.

6 Replace the RTD by reversing the above steps. Be sure to replace the rub-

ber grommet in the through-hole.

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65

ESACTEC® 9050 System User's Manual

66

Figure 24 - RIP Removal (A)

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....... ............

Figure 25 - RIP Removal (D)

6 - Maintenance

ir;

MA-0103-13

pore-1.-ildu • hrn.+;if

'10If

Figure 26 - RIP Removal (C)

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BACTEC® 9050 System User's Manual

6.3.2 Front Panel Components

6.3.2.1 Front Panel Removal

The front panel, which is located at the bottom of the instrument, must be re-
moved to replace the Barcode Scanner, Floppy Disk Drive, or Keypad/LCD Dis-
play. Refer to Figures 27 and 28.

Required Materials

Medium Phillips Screwdriver

Small Flathead Screwdriver

To Remove the Front Panel

1 Unscrew the two phillips screws under the Keypad/LCD Display.

2 Disconnect the wide flat ribbon cable by pulling outward on the tabs at the

connector's end.

3 Disconnect the d-shaped connector (use the small flathead screwdriver to

loosen the screw locks).

4 Disconnect the barcode scanner and remove the panel assembly.

5 Replace the front panel by reversing the above steps. Be sure to reattach all

cables when replacing the front panel.

Figure 27 - Front Panel Removal (A)

68

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MA-0103-E5

Figure 28 - Front Panel Removal (8)

6 Maintenance

MA-0103-E3 69

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BACTEC® 9050 System User's Manual

6.3.2.2 Barcode Scanner Replacement

To replace the barcode scanner, follow the steps below. Refer to Figure 29.

Required Materials

Phillips Screwdriver (some instruments require Flathead Screwdriver instead)

To Replace the barcode Scanner

1 Remove the front panel (Section 6.3.2.1).

2 Remove the four phillips screws. (Some instruments have captive fasteners

that are designed to be loosened by hand or with a flathead screwdriver.

3 Remove the whole scanner/bracket assembly.

4 Replace the assembly by reversing the above steps.

70

Figure 29 — Darcode Scanner Removal

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6 - Maintenance

6.3.2.3 Floppy Disk Drive Replacement

To replace the floppy disk drive, follow the steps below. Refer to Figures 30 and

31.

Required Materials

Phillips Screwdriver (some instruments require Flathead Screwdriver instead)

To Replace the Floppy Disk Drive

I Remove the front panel (Section 6.3.2.1).

2 Remove the four phillips screws. (Some instruments have captive fasteners

that are designed to be loosened by hand or with a flathead screwdriver.

3 Remove the whole floppy disk drive/bracket assembly.

4 Unplug the small red/black cable.

5 Unplug the flat ribbon cable and remove the drive assembly.

6 To replace the drive, reattach the small red/black cable to the new drive.

MA-0103-f3

Front of Instrument [Front Panel Removed])

Figure 30 - Floppy Disk Drive Removal

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BACTEC® 9050 System User's Manual

Figure 31 - Floppy Disk Drive Pin 1 Identification (typical)

7 Before attaching the flat ribbon cable, you must identify Pin I on the disk

drive. Locate the cable socket on the drive assembly. Locate the pins on the
printed circuit board that correspond to the pins of the cable socket. Lo-
cate the Pin I designation (marked by white number "I ") on the printed
circuit board (not the connector). Align the dark blue strand of the flat
ribbon cable with Pin I of the printed circuit board, and plug in the cable.

Note that in most cases, the dark blue strand will be oriented at the center
of the board. However , this orientation can vary among different disk drive
manufacturers. It is important to verify the location of Pin I on the drive's
pc board. If necessary, you can peel the plastic shield away from the disk
drive (as shown in Figure 31) to see better.

.3 Insert the new drive/bracket and tighten the fasteners.

72

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6 - Maintenance

6.3.2.4 Keypad/LCD Display Replacement

The Keypad/LCD Display is part of the front panel assembly.The entire assembly
must be replaced. Refer to Figures 32 and 33.

Required Materials

Medium Phillips Screwdriver

Small Flathead Screwdriver

To Remove the Front Panel

1 Unscrew the two phillips screws under the Keypad/LCD Display.

2 Disconnect the wide flat ribbon cable.

3 Disconnect the d-shaped connector (use the small flathead screwdriver to

loosen the screw locks).

4 Disconnect the barcode scanner and remove the panel assembly.

5 Replace the front panel by reversing the above steps. Be sure to reattach all

cables when replacing the front panel.

MA-0103-13

"I- 1111p .');

Figure 32 — Keypad/LCD Display Removal (A)

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13ACTEC® 9050 System User's Manual

Figure 33 - Keypad/LCD Display Removal (13)

74 MA-0103-5

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6 - Maintenance

6.3.3 Rear Cabinet Components

6.3.3.1 Rear Cabinet Shell

The rear cabinet shell must be removed to gain access to the following internal
components:AC and DC Power Distribution Boards, Blower, Computer Board,
Detector Board, Fan, Heater, I/O Board, Main Transformer, On/Off Switch, +5V/
± I 5V and 40V Power Supply Boards, RTD. See Figures 34 and 35,

Required Materials

Medium Phillips Screwdriver

To Remove the Rear Cabinet Shell

1 The rear cabinet shell is held to the instrument frame by 5 phillips screws

with flat washers.

2 There is one screw on each side of the instrument toward the bottom rear.

Remove these two screws and flat washers.

3 The other three screws are on the rear of instrument. One is at the top

center of the rear panel.There is also one screw on the far right of the rear
panel and one on the far left, approximately halfway down. Remove these
three screws and flat washers.

4 Lift the rear cabinet shell off the frame.

Figure 34 - Rear Cabinet Shell Removal (A)

MA-0103-E3

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13ACTEC® 9050 System User's Manual

•••••110'

Figure 35 - Rear Cabinet Shell Removal (13)

5 Replace the cabinet shell by reversing the above steps.When replacing the

shell, be sure the metal clips (there is one at each screw location) are in
place around the screw hole.

76

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6 - Maintenance

6.3.3.2 Electrical Guard

The electrical guard must be removed to access the Power Supply Boards, the
AC and DC Distribution Boards, and the MainTransformer.To remove the guard,
follow the steps below and refer to Figure 36.

Required Materials

Small Phillips Screwdriver

To Remove the Electrical Guard

I Remove the 2 small phillips screws from the top edge of the guard.

2 Remove the small phillips screw from the lower rear edge of the guard.

3 Lift the guard up as far as possible, then move it rearward away from the

instrument.

4 Replace the guard by reversing the above steps. DO NOT OVERTIGHTEN

THE SCREWS WHEN REPLACING THE GUARD.

Figure 36 - Electrical Guard Removal

MA-0105- 17:5 77

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BACTEC® 9050 System User's Manual

6.3.33 AC Power Distribution Board

The AC Power Distribution Board is located in the right electronics compart-
ment (facing the rear). It is mounted vertically, and contains four large relays and
two large transformers.To remove the board, follow the steps below and refer
to Figure 37. Fuses Fl and F2 are Type T (slow blow) rated 100 mA, 250VAC.

Required Materials

5/1: Hex Nut Driver

To Replace the AC Power Distribution Board

1 Remove the rear cabinet shell as described in Section 6.3.3.1.

2 Remove the Electrical Guard as described in Section 6.3.3.2.

3 Rock out the two cable connectors at the bottom right of the board.

4 Squeeze the tabs and rock out the cable connector at the bottom left of the

board and the cable connector at the far left of the board.

5 Disconnect the cable at the top right of the board by pulling outward on the

tabs to loosen it, then pull the cable free of the connector.

6 Remove the six nuts that hold the board to the chassis upright and remove

the board.

7 Replace the board by reversing the steps above.

Spread Tabs i -.?,

i_L-----...------------3-1

and Rock --- -4

1 Connector Out

r. -- - : ii

Figure 37 - AC Distribution Board Removal

78

;. 0

• , ;

MA-0103-b

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6- Maintenance

6.3.3.4 Blower

The blower is located to the left of center facing the rear of the instrument. It is
a large cylindrical black module.To remove the blower, follow the steps below
and refer to Figure 38.

Required Materials

Small Phillips Screwdriver

To Replace the Blower

1 Remove the rear cabinet shell as described in Section 6.3.3. 1 .

2 Unplug the large black cable from the bulkhead fitting.

3 Remove the four small phillips screws that hold the blower assembly in

place and remove the blower.

4 To replace the blower, reverse the above steps.

Figure 38 - slower Removal

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79

DACTEC' 9050 System User's Manual

6.3.3.5 Computer Board

The computer board is a small piggyback board mounted at the rear of the larger

I/O Board on the bottom of the left electronics compartment. To remove the
computer board, follow the steps below and refer to Figure 39.

Required Materials

No tools required

To Replace the Computer board

1 Remove the rear cabinet shell as described in Section 6.3.3.1.

2 You can remove the computer board without removing the I/O board, but

it is easier and safer to replace the computer board with the I/O board out
of the instrument See Section 6,3.3.10 for instructions on removing the I/O
board.

3 Disconnect the three ribbon cables on the front side of the board by rock-

ing them off.

4 Disconnect the ribbon cable on rear side of board.

5 Lift the computer board up off the I/O board.

6 Replace the computer board by reversing the above steps.When replacing

the computer board, note that it fits on the I/O board in one orientation

only. Be sure to carefully align the computer board's pins with the sockets

on the I/O board.

✓

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MA-0103-13

6 - Maintenance

F. -on! of (.:ompii vr-

r—n ••- -

7,...:: t''' i:1 .. •/ '

. •-,-,. :-; .

..,. . 1111^ ....

MN.

Figure 39 - Computer Board Removal

•—i ditid-t ..ula 'IQ

--_

- - tb• "

Rem- PtC:;:iurnit cr. ✓c:Ir[i

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81

BACTEC® 9050 System User's Manual

6.3.3.6 DC Power Distribution Board

The DC Power Distribution Board is mounted on a bracket horizontally beneath
the two power supply boards.To remove the board, follow the steps below and

refer to Figure 40.

Required Materials

5/16" Hex Nut Driver

To Replace the DC Power Distribution Board

1 Remove the rear cabinet shell as described in Section 6.3.3.1.

2 Remove the Electrical Guard as described in Section 6.3.3.2.

3 Remove the cables and wire harnesses from the retaining clips below the

board/mounting bracket assembly.

4 Unplug the 2 connectors at the front of the board by rocking them out.

5 Unplug the 2 connectors at the rear of the board by rocking them out.

6 For the ribbon cable on the rear of the board, push the tabs outward and

rock out the connector.

7 Remove the three nuts on vertical mounting bracket. One nut is at the top

center and the other two are at the extreme left and right sides. Be sure
you remove the correct nuts. Remove the board. Note that the board re-

mains attached to the mounting bracket.

8 Replace the board by reversing the above steps. Note that the connector

labeled "TEST" is not used.

8.2

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6 - Maintenance

Unplug 2 Cornice 1 or:.

o.ug J Conner t Or,

Figure 40 - PC Power Distribution Board Removal

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83

13ACTEC" 9050 System User's Manual

6.3.3.7 Detector board

The detector board sits behind the rotor but is designed to be removed from

the rear of the instrumentTo remove the detector board follow the steps below

and refer to Figure 41.

Required Materials

Medium Phillips Screwdriver

Flashlight (optional)

Medium Flathead Screwdriver (optional)

To Remove the Detector Board

1 Remove the rear cabinet shell as described in Section 6.3.3.1.

2 Reach through the area in the center of the instrument (beneath the fan) to

where the detector board is mounted. (You can use the flashlight to illumi-

nate the area.)

3 Disconnect the ribbon cable connector (left side when facing the board

from the rear) on the board by flipping the tabs outward and rocking the

connector out,

4 Loosen the four black knurled captive fasteners (there is one on each cor-

ner) and remove the board.You should be able to turn by the fasteners by

hand, but you can use a flathead screwdriver if you prefer.

5 Replace the board by reversing the steps above. Be sure to fit the board

over the two guide pins.

84

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6 - Maintenance

Remove Cable (A) from Connector (5)

Figure 41 - Detector board Removal

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BACTEC® 9050 System User's Manual

6.3.3.8 Fan

To replace the fan, follow the steps below and refer to Figure 42.

Required Materials

Small Phillips Screwdriver

To Replace the Fan

1 Remove the rear cabinet shell as described in Section 6.3.3.1.

2 Unplug the two quick disconnect wires on the right side of the fan assembly.

Note that the gray wire is attached to the rear terminal, and the blue wire
is attached to the front terminal.

3 Disconnect the ground wire on the top of the fan assembly. Unscrew the

small phillips screw, and remove it and the flat washer.The ring terminal is
attached to the ground wire, and beneath it is an external star washer. Save
this mounting hardware for reattaching the ground wire later.

4 Remove the four small phillips screws that hold the fan to the chassis and

remove the fan.

5 Replace the fan by reversing the above steps. Be sure you place one finger

guard on each side of the fan itself.Also be sure to replace the hardware and

wires in the following order: the external star washer, the ground wire ring
lug, the flat washer, and the phillips screw.

Figure 42 - Fan Removal

86

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MA-0103-D

`.. 6.3.3.9 Heater

The heater is located in the left electronics compartment near the top of the

instrument.To replace the heater, follow the steps below and refer to Figure 43.

The thermal over-temperature switch is a manual reset type.This switch should

only operate in an abnormal condition. It is rated for 10 cycles of operation.

Required Materials

5/i6" Nut Driver

To Replace the Heater

1 Remove the rear cabinet shell as described in Section 6.3.3.1.

2 Disconnect the heater cable from its connection on the chassis upright.

3 Remove the four 5/16" nuts that hold the assembly to the blower duct work.

4 When removing the heater assembly, be sure the insulation clears the top

sheet metal.

5 Transfer the cable from the old assembly to the new heater, one connection

at a time. Note that the black wire is an internal connection and does not
have to be disconnected. Be sure you connect the yellow wire to the lower

left terminal, the orange wire to the terminal on the reset button, and the

green/yellow (ground) wire to the bottom right stud. Note that the extra

hardware attaching the ground wire should be placed, from front to rear:
external star washer, the ground wire's ring lug, the flat washer, and the lock

washer.

6- Maintenance

6 To replace the heater, insert in with the widest part downward. Replace the

four nuts. Plug the cable back into the chassis upright connector.

MA-0105-3

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