BACTEC® MGIT™ 960

System
User’s Manual

Becton Dickinson and Company

Becton Dickinson Microbiology Systems
7 Loveton Circle
Sparks, Maryland 21152 USA

May, 1999
Document Number: MA-0117-D(prelim) Y E A R
Revision: C(prelim)
Catalog Number: 4405876
BACTEC® MGIT™ 960 System User’s Manual

Change History
Revision Date Pages Reason

New 9/97 All New product release

Preface, Sects. 1 & 4, 2-1 – 2-4,

A 6/98 5-3 – 5-4, 6-13 – 6-14, 7-5 – 7-10, FDA changes, other minor changes
App. E, I-1 – I-2

B 8/98 Preface (i-iv), Sect. 5 (11-12, 17-18) Changes for software vers. 2.00

Preface (i-iv), Sect. 2 (3-9), Sect. 4

C 5/99 (1-2, 17-19), Sect. 5 (All), Changes for software vers. 3.00
Sect. 7 (11-12)

BACTEC and BBL are registered trademarks, and MGIT is a trademark of Becton Dickinson and
Company.

© Copyright Becton Dickinson and Company, 1997 – 1999. All rights reserved. No part of this
publication may be reproduced, transmitted, transcribed, stored in retrieval systems, or translated
into any language or computer language, in any form or by any means, electronic, mechanical,
magnetic, optical, chemical, manual, or otherwise, without the prior written permission of Becton
Dickinson Microbiology Systems, 7 Loveton Circle, Sparks, Maryland, 21152, United States of
America.

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Contents
1 – Introduction
1.1 System Overview .....................................................................................................................1-1
1.2 Instrument Overview ..............................................................................................................1-3
1.3 Manual Structure ....................................................................................................................1-7
1.4 Use of this Manual ..................................................................................................................1-7
1.5 Conventions ............................................................................................................................1-8
1.5.1 General ..........................................................................................................................1-8
1.5.2 Symbols Used on the Equipment ...................................................................................1-8
1.5.3 Notes, Cautions, and Warnings .....................................................................................1-9
1.6 Summary of Cautions and Warnings ......................................................................................1-9

2 – Installation
2.1 General ...................................................................................................................................2-1
2.2 Installation Policy ....................................................................................................................2-2
2.3 Instrument Specifications .....................................................................................................2-2
2.4 System Setup .........................................................................................................................2-4
2.4.1 General ..........................................................................................................................2-4
2.4.2 Setup Parameters ..........................................................................................................2-4
2.4.3 Setup for Use with the EpiCenter™ System ...................................................................2-8
2.4.4 External Connections .....................................................................................................2-8
2.5 System Startup .......................................................................................................................2-8
2.6 Software Installation ...............................................................................................................2-9
2.7 CLIA Compliance ....................................................................................................................2-9

3 – Controls and Indicators

3.1 General ...................................................................................................................................3-1
3.2 On/Off Switch .........................................................................................................................3-3
3.3 Keypad and LCD Display .........................................................................................................3-3
3.3.1 DOWN /UP ARROW Keys ................................................................................................3-3
3.3.2 Soft Keys .....................................................................................................................3-4
3.3.3 SILENCE ALARM Key ......................................................................................................3-4
3.3.4 Alarm Indicator ..............................................................................................................3-4
3.3.5 Display Area ..................................................................................................................3-5
3.4 Floppy Disk Drive ....................................................................................................................3-5
3.4.1 Floppy Disk Indicator .....................................................................................................3-5
3.4.2 Floppy Disk Eject Button ................................................................................................3-5

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Contents
3.5 Brightness Dial ........................................................................................................................3-6
3.6 Barcode Scanner .....................................................................................................................3-6
3.7 Drawer Controls and Indicators ..............................................................................................3-7
3.7.1 Exterior Drawer Controls and Indicators ........................................................................3-7
3.7.2 Interior Drawer Indicators ..............................................................................................3-9
3.8 Circuit Breakers CB2 – CB7 ....................................................................................................3-10
3.9 Audible Tones and Alarms ....................................................................................................3-11
3.10 Printer .................................................................................................................................3-11

4 – Operation
4.1 General ...................................................................................................................................4-1
4.2 Using the Instrument Interface ...............................................................................................4-2
4.3 Handling and Preparing MGIT QC Tubes and Specimens .......................................................4-2
4.3.1 Media Quality Control ...................................................................................................4-3
4.3.2 Specimen Preparation ....................................................................................................4-3
4.4 Daily Maintenance ..................................................................................................................4-4
4.5 Entering New Tubes ..............................................................................................................4-6
4.6 Positive and Negative Specimens ............................................................................................4-8
4.6.1 Notification of Positive Tubes .......................................................................................4-8
4.6.2 Removing Positive Tubes ..............................................................................................4-8
4.6.3 Returning Positive Tubes to the Instrument for Further Testing ....................................4-9
4.6.4 Notification of Negative Tubes ......................................................................................4-9
4.6.5 Removing Negative Tubes ..........................................................................................4-10
4.7 Removing Ongoing Tubes .....................................................................................................4-11
4.8 Identifying Anonymous Tubes ..............................................................................................4-12
4.9 Resolving Station Errors ........................................................................................................4-14
4.10 Printing Reports ..................................................................................................................4-16
4.11 LIS Communications ...........................................................................................................4-18
4.12 Use with the EpiCenter System ...........................................................................................4-19
4.13 Power Failures .....................................................................................................................4-20

5 – Reference
5.1 General ...................................................................................................................................5-1
5.2 Software Menu Tree ...............................................................................................................5-2

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Contents
5.3 Display Types ........................................................................................................................5-3
5.3.1 Main Status Screen ........................................................................................................5-3
5.3.2 Main Activity Screen ......................................................................................................5-4
5.4 Icon Charts ...........................................................................................................................5-6
5.5 Reports .................................................................................................................................5-11
5.5.1 Unloaded Positives Report ...........................................................................................5-11
5.5.2 Unloaded Negatives Report .........................................................................................5-13
5.5.3 Unloaded Ongoings Report .........................................................................................5-15
5.5.4 Instrument Inventory Report .......................................................................................5-17
5.5.5 Quality Control Report .................................................................................................5-19

6 – Maintenance
6.1 General ...................................................................................................................................6-1
6.2 Routine Maintenance ..............................................................................................................6-2
6.2.1 Daily Maintenance .........................................................................................................6-2
6.2.2 Periodic Maintenance ....................................................................................................6-6
6.2.2.1 Air Filter Replacement ......................................................................................6-6
6.2.2.2 Calibrator Replacement ....................................................................................6-7
6.2.3 “As Needed” Maintenance ..........................................................................................6-10
6.2.3.1 Cleaning the Barcode Scanner Window ..........................................................6-10
6.2.3.2 Blocking a Station ...........................................................................................6-11
6.2.3.3 Unblocking a Station .....................................................................................6-12
6.2.3.4 Replacing a Barcode Label .............................................................................6-14
6.2.3.5 Decontamination .........................................................................................6-14
6.2.3.6 Reuniting Separated Mercury Columns on Thermometers ..............................6-15
6.3 Module Replacement ............................................................................................................6-16
6.3.1 General ........................................................................................................................6-16
6.3.2 Top Panel Removal ......................................................................................................6-16
6.3.3 Top Faceplate Removal ................................................................................................6-18
6.3.4 Bottom Faceplate Removal ..........................................................................................6-20
6.3.5 Barcode Scanner Replacement .....................................................................................6-20
6.3.6 Floppy Disk Drive Replacement ....................................................................................6-22
6.3.7 Liquid Crystal Display (LCD) Assembly Replacement ....................................................6-23
6.3.8 Speaker Replacement ..................................................................................................6-24

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Contents
7 – Troubleshooting
7.1 General ...................................................................................................................................7-1
7.1.1 Instrument Service .........................................................................................................7-1
7.2 Error/Alert Messages ............................................................................................................7-2
7.3 Write Data to Disk Function ................................................................................................7-12
Glossary and Abbreviations
Appendix A – Limited Warranty
Appendix B – Replacement Parts
Appendix C – Software Update Log
Appendix D – International Contacts
Appendix E – Supplemental Procedures
E.1 Reading BBL® MGIT™ 7 ml Tubes Manually
E.2 Reprocessing Contaminated BBL® MGIT™ 7 ml Tubes

Notes
Index
Reader Comment Card

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Figures
1-1 BACTEC® MGIT™ 960 Test Technology .................................................................................1-2
1-2 BACTEC® MGIT™ 960 Instrument .........................................................................................1-4
1-3 Main Status Screen ...............................................................................................................1-5
1-4 Symbols Used on the BACTEC® MGIT™ 960 Instrument .......................................................1-8

2-1 Main Status Screen ...............................................................................................................2-4

2-2 External Connections ............................................................................................................2-8

3-1 BACTEC® MGIT™ 960 Instrument Layout..............................................................................3-2

3-2 On/Off Switch .......................................................................................................................3-3
3-3 Keypad and LCD Display .......................................................................................................3-4
3-4 Floppy Disk Drive Controls and Indicators.............................................................................3-5
3-5 Brightness Dial and Barcode Scanner....................................................................................3-6
3-6 Drawer Release Latch............................................................................................................3-7
3-7 Exterior Drawer Indicators ....................................................................................................3-8
3-8 Station Status Indicators ......................................................................................................3-9
3-9 Circuit Breakers CB2 – CB7..................................................................................................3-10

4-1 How to Resolve Error Stations ............................................................................................4-15

5-1 Main Status Screen ...............................................................................................................5-4

5-2 Main Activity Screen .............................................................................................................5-5
5-3 Sample Unloaded Positives Report......................................................................................5-12
5-4 Sample Unloaded Negatives Report....................................................................................5-14
5-5 Sample Unloaded Ongoings Report....................................................................................5-16
5-6 Sample Instrument Inventory Report ..................................................................................5-18
5-7 Sample Quality Control Report ...........................................................................................5-20

6-1 Instument Maintenance Log .................................................................................................6-5

6-2 Air Filter Replacement...........................................................................................................6-6
6-3 Calibration Log .....................................................................................................................6-8
6-4 Calibrator Replacement (A)...................................................................................................6-9
6-5 Calibrator Replacement (B) ...................................................................................................6-9
6-6 Barcode Scanner Window...................................................................................................6-10
6-7 Top Panel Removal .............................................................................................................6-17
6-8 Top Faceplate Removal (A) .................................................................................................6-19
6-9 Top Faceplate Removal (B)..................................................................................................6-19
6-10 Barcode Scanner Removal (A) ............................................................................................6-21
6-11 Barcode Scanner Removal (B) ............................................................................................6-21
6-12 Floppy Disk Drive Replacement ..........................................................................................6-22
6-13 Liquid Crystal Display (LCD) Replacement ..........................................................................6-23
6-14 Speaker Replacement (A) ...................................................................................................6-24
6-15 Speaker Replacement (B) ...................................................................................................6-25

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viii MA-0117-D(Prelim)
 Introduction
1.1 System Overview
The BACTEC® MGIT™ 960 instrument is an in vitro diagnostic instrument designed and optimized
for the rapid detection of mycobacteria from clinical specimens (except blood and urine). Samples
are collected from patients, processed, and inoculated into BBL® MGIT™ 7 ml tubes (Mycobacteria
Growth Indicator Tube).
Microorganisms present in these specimens metabolize nutrients and oxygen in the culture. The
culture vials contain a fluorescent sensor that responds to the concentration of oxygen in the culture
medium. The instrument’s photo detectors measure the level of fluorescence, which corresponds to
the amount of oxygen consumed by organisms. Instrument detection of the presence of
microorganisms growing in the culture medium results from these fluorescence measurements.
(See Figure 1-1.)
The instrument automatically tests the tubes continuously. A row of Light Emitting Diodes (LEDs)
below the tubes illuminates, activating their fluorescent sensors. Then the instrument’s photo
detectors take the readings. A test cycle of all drawers is completed every 60 minutes. Positive
cultures are immediately flagged by an indicator light on the front of the drawer, an optional
audible alarm, and are displayed on the LCD screen.
When positive tubes are identified, the lab technologist removes them from the instrument for
confirmation of results, and for isolation and identification of the organism.

A single BACTEC® MGIT™ 960 instrument is capable of monitoring a total of 960 BBL® MGIT™ 7 ml
tubes. The tubes are arranged in three drawers, each of which holds up to 320 tubes, and are
continuously incubated. The practical capacity is typically 154 samples per week with a 6-week
protocol (115 samples per week with an 8-week protocol).

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➊ Organism metabolic activity consumes O2...

Which reacts with tube sensor.
➋
➌ LED activates fluorescent material in sensor.

➍ Photo detector reads fluorescence.

➎ Raw data from detector is sent to computer...

➏ Where positivity analysis is performed.

➐ Positive tube indicator lights, audible alarm

sounds, positive stations are displayed.

➊
O2

➋ +
Test
Results ➐
LED Photo
Detector

➌ ➍

Computer

Raw Data

➎ Positivity
Analysis

Figure 1-1 – BACTEC® MGIT™ 960 Test Technology

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Introduction

Major features of the BACTEC® MGIT™ 960 instrument include:

• Automated, continuous, unattended testing of cultures through non-invasive non-radiometric
fluorescent technology
• Minimum user interaction and handling
• Immediate notification of positives through a drawer indicator lamp, display on the LCD
screen, and an audible alarm (if enabled)
• Simple user interface, with picture icons to guide you through setup and routine operations
• Incubation for all cultures
• Spill/tube breakage containment

1.2 Instrument Overview

The BACTEC® MGIT™ 960 instrument is a self-contained unit that can continuously test up to 960
inoculated BBL® MGIT™ 7 ml tubes for the presence of mycobacteria. The instrument is modular in
design, with user interface and control electronics located in the top section, three drawers for the
incubation and testing of culture tubes, and power distribution and incubation electronics in the
bottom section.
The major instrument components are described in the following paragraphs and are shown in
Figure 1-2. Controls and indicators for these modules are discussed in Section 3 – Controls and
Indicators.
Drawers

Each of the three drawers holds up to 320 BBL® MGIT™ 7 ml tubes. The drawers are designated
A, B, and C, from top to bottom. Each drawer contains a sample measurement module that
consists of a number of components:
The tube rack – The wells in the rack, into which tubes are inserted, are called “stations.”
The detector assembly – Tube testing is performed by a moving detector assembly that sits
below the rack. The assembly has 16 detectors, one for each row of stations. The assembly
moves from left to right and back, taking test readings for each of the 20 station columns and
the calibrator tube column at the far left.
Drawer status indicators – Three lamps are located on the front of each drawer. One indicator
lights any time a positive tube exists in the drawer; one indicator lights any time an out of
protocol negative exists in the drawer; and one indicator lights to inform you that there is an
error station in the drawer.
Station status LEDs – Indicator LEDs are located at each station. The color (red, green, or orange)
and state (on, off, or flashing) indicate the various station statuses (such as positive, negative,
error, etc.).
Barcode Scanner
A barcode scanner is located on the front of the instrument to provide the ability to scan tube
labels for specimen identification. The scanner turns on automatically whenever the system is
ready (and expecting) to scan a barcode.
Floppy Disk
The floppy disk drive is provided to enable you to update system software and to save data to
disk for troubleshooting and system diagnostic purposes.

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Keypad and LCD Display

Floppy
Disk Barcode Scanner
Drive

Drawer Release (3 pl.)

Brightness Dial

Drawer Indicators (3 pl.)

On/Off Switch

Figure 1-2 – BACTEC® MGIT™ 960 Instrument

LCD Display and Keypad
The LCD Display is a 640 X 480 pixel Liquid Crystal Display that presents information 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 chart of system icons is
presented in Section 5 – Reference.
The keypad enables you to perform operations such as entering and removing tubes, adjusting
setup parameters, etc. Three of the keys, marked with screened icons, perform fixed functions
regardless of the current display or operation. Eight 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 represented by the icon, you press the corresponding soft key below the icon.
Computer
The system computer, located in the top section of the instrument, is responsible for tube
positivity analysis, instrument control, the Built-In Test (BIT), data storage, and the user interface.

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Introduction

External Ports
A port on the rear of the instrument is used to connect a printer. The other ports are for Field
Service diagnostic use. A network port is for future connections to other systems. See Figure 1-4.
System Software
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 key definition icon shown on the screen.
There are three basic types of displays:
Main Status Screen – When all the instrument drawers are closed, this screen appears. A
summary area shows the number of tubes that are positive, negative, ongoing, available, and
stations that are in error or anonymous. Also shown are the current date and time. Software
keys allow you to configure the setup parameters, perform routine daily maintenance, review
system errors, print reports, and check the instrument temperature. See Figure 1-3.
Configuration/Maintenance Screens – Accessible from the Main Status Screen, the
Configuration and Maintenance Screens allow you to set the protocol length, time and date and
their formats, audible alarm volume, instrument identification number, to select the desired
language for reports, verify the operation of all indicator lamps, block and unblock stations,
write data to a floppy disk, and to update system software.
Activity Screens – When an instrument drawer is opened, software key definitions appear that
enable you to enter new tubes; remove positive, negative, and ongoing tubes; identify
anonymous tubes; and resolve station error conditions.

Figure 1-3 – Main Status Screen

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Built-in-Test (Patent Pending)

The system software is designed to continuously monitor the electrical and optical performance
of all detectors simultaneously. This functionality, called BIT (for Built-in-Test), automatically
monitors each detector every hour for basic operational characteristics. These tests continually
verify that signal output for each detector is within design limits.
Two different signal levels are used to verify operation of the detector over the established signal
range. Tests are performed on dark readings (the output from the detector when its excitation
LEDs are off) and on fluorescence unit readings (the output from the detector when a tube 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 row 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 is calculated from actual calibration readings. Should an out of range reading occur, the
software declares that row in error. This may occur due to an electrical or optical component
failure.
Additionally, the fluorescence readings are evaluated for consistency while tubes are in stations.
If consecutive fluorescence unit readings vary by more than a predetermined amount, the row is
declared in error. This feature determines the stability and the acceptability of a row for use
during protocol.
These protection features verify that calibration has been maintained for all detectors within the
system, and insure that the user is alerted of electronic or optical changes or failures which may
be significant enough to affect results.
The function of BIT can be demonstrated by entering a tube into the instrument, and then
removing that tube from the station without scanning it out. The resulting error is the response
of the BIT function. You can resolve the error by using the “resolve station errors” soft key.
Instrument Calibration

Components in the BACTEC® MGIT™ 960 instrument are selected and designed to maintain
electrical and optical integrity throughout the product’s life. All BACTEC instruments are
calibrated at the factory prior to shipment. In addition, once per hour, each detector in the
detector assembly reads the calibrator tube present in its row. After the calibrator tube is read,
the readings are used by the Built-In-Test to verify that the detection system is in calibration. As
described above, any readings for a given calibrator that exceed the expected range cause the
system to automatically block the row from use. Detector failures are reported in the
instrument’s Quality Control Report.
Calibration verification can be provided by printing the Quality Control Report
(see Section 5.5.5 – Quality Control Report). CLIA regulations state that calibration must be
performed and documented a minimum of once every six months.

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Introduction

1.3 Manual Structure

This user’s manual contains the following sections:

Section 1 – Introduction – provides an overview of the BACTEC® MGIT™ 960 instrument and its
uses in the mycobacteriology laboratory, its major hardware and software components. An
overview of this manual’s structure and conventions is also included.

Section 2 – Installation – gives specifications for installation of the BACTEC® MGIT™ 960
instrument and instructions for 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 user system maintenance, including parts replacements.
Section 7 – Troubleshooting – provides a convenient guide for identifying 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, supplemental procedures, 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.

1.4 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® MGIT™ 960 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:
" Field Service 1–800–544–7434
For procedural, reagent, or software operation questions:
" Technical Services 1–800–638–8663
Comments or recommendations on this user’s manual may be expressed on the postage-paid Reader
Comment Card at the end of the manual, or send e-mail to [email protected].
International contacts are listed in Appendix D.
Other documentation which may be of interest to the user includes:

BBL® MGIT™ 7 ml Media Package Insert – This document contains important information on the
use, storage, inoculation, performance, and limitations of barcoded BBL® MGIT™ 7 ml tubes. It
is included with each carton of tubes, and is available upon request from the Technical Services
Department.

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1.5 Conventions
1.5.1 General
Keys
The three keys that have fixed functions are the UP ARROW (Increase) key, the DOWN ARROW
(Decrease) 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. Eight 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 current soft key assignments at the
bottom of the screen. To perform the function represented by the icon, press the corresponding
soft key, located just below the icon defining it.

The three fixed function keys are always identified in your BACTEC® MGIT™ 960 manual 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., “tube entry” soft key).

1.5.2 Symbols Used on the Equipment

The following symbols appear on the BACTEC® MGIT™ 960 instrument:

Serial Port Network Port

Remote Alarm Port

Printer Port Keyboard Port

!
Figure 1-4 – Symbols Used on the BACTEC® MGIT™ 960 Instrument
Top figure: Symbols for Serial Port, Remote Alarm Port, Printer Port, Keyboard Port, and Network
Port; Center figure: Symbol for electrical hazard; Bottom figure: Symbol for “refer to
accompanying documentation” (specifically, the user’s manual) for instructions

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Introduction

1.5.3 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 significance:

NOTE

Important information about system use worthy of special attention is

presented as a NOTE.

CAUTION

Information on an activity which potentially could cause damage

to the instrument or system is presented as a CAUTION.

WARNING

INFORMATION ON AN ACTIVITY WHICH POTENTIALLY COULD CAUSE

INJURY TO THE USER IS PRESENTED AS A WARNING.

1.6 Summary of Cautions and Warnings

Protection provided by this equipment may be impaired if the equipment is used in a manner not
consistent with the instructions in this manual.
The handle on the rear of the instrument is not intended for lifting the instrument.
The intake filters at the bottom front 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.

The BACTEC® MGIT™ 960 system has been designed for the non-invasive detection of mycobacteria
so as to minimize risks associated with mycobacterial testing. However, to further reduce the risks of
accidental exposure to infectious agents, additional precautions should be taken.

It is strongly recommended that the BACTEC® MGIT™ 960 instrument be placed in the laboratory
used for routine culture of M. tuberculosis. For activities involving the propagation and manipulation
of M. tuberculosis or Mycobacterium species grown in culture, Biosafety Level 3 practice,
containment equipment, and facilities are required as recommended by CDC and NIH guidelines.
At a minimum, the instrument should be placed in a contained laboratory environment with
controlled access which has a tuberculosis exposure control plan.
The location should have surfaces which can be easily decontaminated using an appropriate topical
disinfectant.

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The instrument must not be placed in an open corridor or hallway that is accessible to the general
public or to the patient population.
It is mandatory that all system users become thoroughly familiar with all controls and indicators
before attempting to operate the instrument.
To avoid injury to fingers or hands, make sure that no one’s hands are holding a drawer handle
when another drawer is to be opened.
Specimen preparation must be done in a biological safety cabinet. Laboratory procedures involving
mycobacteria require special equipment and techniques to minimize biohazards.1
Pathogenic microorganisms including Hepatitis B Virus and Human Immunodeficiency Virus may be
present in specimens. “UNIVERSAL PRECAUTIONS”2,3 and local laboratory guidelines should be
followed in handling all items contaminated with blood or other body fluids.
In the event of tube leakage or breakage: 1) Close the instrument drawers; 2) Turn off the
instrument; 3) Vacate the area immediately; 4) Consult your facility/CDC guidelines. An inoculated
leaking or broken tube may produce an aerosol of mycobacteria, appropriate handling should be
observed.
If an inoculated tube 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. Tube should be discarded in an appropriate manner.
An inoculated leaking or broken tube may produce an aerosol of mycobacteria; appropriate
handling should be observed.
When the system notifies you of alerts and errors, you should immediately respond to the condition.
Instrument power should be turned off, and the power cord should be disconnected, before
beginning any module replacement procedure.
One person should stand at the front of the instrument and hold the top faceplate as the four
screws are removed. If left unsupported, the faceplate can fall when the fourth screw is loosened.
If any error sub-codes other than those listed here appear, note the sub-code and contact Becton
Dickinson for assistance.
If the recommended corrective actions do not solve the problem, contact Becton Dickinson.

1 Kent, P.T., and G.P. Kubica. 1985. Public health mycobacteriology: a guide for the level III laboratory. USDHHS. Centers for

Disease Control, Atlanta.

2 Recommendations for preventing transmission of Human Immu-nodeficiency Virus and Hepatitis B Virus to patients during

exposure-prone invasive procedures. MMWR 1991, Vol. 40, No. RR–8.

3 Bloodborne pathogens. Code of Federal Regulations, Title 29, Part 1910.1030, Federal Register 1991, 56:64175-64182.

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 Installation
2.1 General
The BACTEC® MGIT™ 960 system 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 specifications in room temperatures between 19° – 30° C
(66.2° – 86° F). Relative humidity should be between 30% and 80% (non-condensing). The left, rear,
and right sides of the instrument should be placed at least four inches from any wall. Environments
which exceed these limits could adversely effect the performance of the system components.
The drawers should maintain their temperatures to within plus 1.0° or minus 2.0° C of the
temperature controller’s setting (37° C). This accuracy can be assured only if the room temperature
meets the requirements given above.

WARNINGS

PROTECTION PROVIDED BY THIS EQUIPMENT MAY BE IMPAIRED IF

THE EQUIPMENT IS USED IN A MANNER NOT CONSISTENT WITH THE
INSTRUCTIONS IN THIS MANUAL.

THE HANDLE ON THE REAR OF THE INSTRUMENT IS NOT INTENDED

FOR LIFTING THE INSTRUMENT.

CAUTION

The intake filters at the bottom front 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.

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2.2 Installation Policy

The BACTEC® MGIT™ 960 system is to be installed by Becton Dickinson personnel only. Do not open
the shipping carton or the plastic pouch. The system must be unpacked by a qualified Becton
Dickinson representative or termination of the warranty may result.

WARNINGS

THE BACTEC® MGIT™ 960 SYSTEM HAS BEEN DESIGNED FOR THE
NON-INVASIVE DETECTION OF MYCOBACTERIA SO AS TO MINIMIZE
RISKS ASSOCIATED WITH MYCOBACTERIAL TESTING. HOWEVER, TO
FURTHER REDUCE THE RISKS OF ACCIDENTAL EXPOSURE TO
INFECTIOUS AGENTS, ADDITIONAL PRECAUTIONS SHOULD BE
TAKEN:
• IT IS STRONGLY RECOMMENDED THAT THE BACTEC® MGIT™ 960
INSTRUMENT BE PLACED IN THE LABORATORY USED FOR ROUTINE
CULTURE OF M. TUBERCULOSIS. FOR ACTIVITIES INVOLVING THE
PROPAGATION AND MANIPULATION OF M. TUBERCULOSIS OR
MYCOBACTERIUM SPECIES GROWN IN CULTURE, BIOSAFETY LEVEL 3
PRACTICE, CONTAINMENT EQUIPMENT, AND FACILITIES ARE
REQUIRED AS RECOMMENDED BY CDC AND NIH GUIDELINES.
• AT A MINIMUM, THE INSTRUMENT SHOULD BE PLACED IN A
CONTAINED LABORATORY ENVIRONMENT WITH CONTROLLED
ACCESS WHICH HAS A TUBERCULOSIS EXPOSURE CONTROL PLAN.
• THE LOCATION SHOULD HAVE SURFACES WHICH CAN BE EASILY
DECONTAMINATED USING AN APPROPRIATE TOPICAL DISINFECTANT.
• THE INSTRUMENT MUST NOT BE PLACED IN AN OPEN CORRIDOR
OR HALLWAY THAT IS ACCESSIBLE TO THE GENERAL PUBLIC OR TO
THE PATIENT POPULATION.

2.3 Instrument Specifications

Physical Dimensions

Height 53 in. (134.62 cm)

Width 36 in. (91.84 cm)

Depth 28 in. (71.12 cm)

4 in. (10.2 cm) Left, Rear, Right Sides

Clearance
48 in. (121.9 cm) Front

Weight (no tubes) 754 lb (342 kg)

(with 960 tubes) 794 lb (360.2 kg)

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Electrical Requirements

Input Voltage 95 – 130 or 180 – 264 VAC

10.0 Amp maximum

Input Current (Note: Installation requires a dedicated
15 Amp line)

Input Line Frequency 50 or 60 Hz ±3 Hz

Heat 4000 Btu/hr.

Environmental Requirements

Non-Operating Storage

Temperature –17.8° C – 65.0° C (0° F – 149° F)

Humidity 30% – 80% RH, non-condensing

Operating Conditions

19° C – 30° C (66.2° F – 86° F)

Temperature Microbiological efficacy may be
compromised above 32° C

Humidity 30% – 80% RH, non-condensing

Level Surface, No direct sunlight,

Locations
No direct heat

Altitude 0 to 10,000 ft (3,048 m) above sea level

Use of earthquake anchoring is strongly recommended in locations

susceptible to earthquake activity.

Installation Category II and Pollution Degree 2 as per IEC 664.

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2.4 System Setup

2.4.1 General
The BACTEC® MGIT™ 960 system is unpacked and installed by Becton Dickinson personnel. They will
interconnect all system components, power up the system, and verify its operation. The system ships
with all setup parameters preset to factory default values. However, before using the instrument for
culture testing, you should review the setup parameters to see if they are suitable for your
laboratory. These parameters are described in Section 2.4.2, and include:
• Test Protocol Duration
• Time Format and Time
• Date Format and Date
• Audible Alarm Volume
• Instrument Number
• Language (for instrument reports)
• Accession Barcoding Feature
• LIS Communications Feature
• Antimicrobic Susceptibility Testing (AST)
A summary of external system connections if provided in Section 2.4.3.

2.4.2 Setup Parameters

To review and/or adjust the instrument setup parameters, first make sure all instrument drawers are
closed. When the drawers are closed, a display like the one shown below appears (note that printer
and system alert icons may not be shown):

Figure 2-1 – Main Status Screen

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Installation

To enter 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 several setup displays (Test Protocol Duration)
appears. Press the “configuration” soft key to advance through the setup displays, or press the “exit”
soft key to exit configuration mode.
Any changes to configuration parameters are in effect from the time of the change forward. Also
note that any changes you make cannot be “cancelled” per se – if you change a value, you must
manually change the new value back to its previous state.
Test Protocol Duration
Select the length, in days, of the automated testing protocol. The default setting is
42 days. To increase or decrease the number of days, use the UP ARROW or DOWN
ARROW key. You can choose from 1 to 56 days.

Time and Time Format

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 decrease 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.
Date and Date Format
When this display is first accessed, the year value (at default, the right
field) is highlighted. To adjust the year, use 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 ARROW 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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Slash MM/DD/YY or DD/MM/YY or YY/MM/DD or

separators ( / ) MM/DD/YYYY DD/MM/YYYY YYYY/MM/DD

Hyphen MM–DD–YY or DD–MM–YY or YY–MM–DD or

separators ( – ) MM–DD–YYYY DD–MM–YYYY YYYY–MM–DD

Period MM.DD.YY or DD.MM.YY or YY.MM.DD or

separators ( . ) MM.DD.YYYY DD.MM.YYYY YYYY.MM.DD

Audible Alarm Volume

Select the volume of the instrument’s audible alarm. The default setting is 5,
which is at the middle 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 can choose from 0 (audible alarm off) to 10 (loudest).
Only the volume of “Alert” alarms (see Section 3.9 – Audible Tones and Alarms)
is affected by this setting.
Instrument Number
Select the instrument identification number. The default setting is 1. To increase or
decrease the instrument number, use the UP ARROW or DOWN ARROW key. You
can choose a number from 1 to 99. If there is only one instrument at your location,
you should leave this value set at 1.
Language
Select the language in which you want the instrument reports 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:
English
Spanish
French
Italian
German
Polish
Accession Barcoding
Select whether the Accession Barcoding feature is enabled (|) or disabled (O). The
default setting is disabled (O). When Accession Barcoding is enabled, the system
expects both a tube barcode sequence number and accession barcode to be
scanned during all tube entry and removal activities. The system stores both
barcode numbers to identify the tube. Note that your accession barcode may not
both begin with the numbers “43” AND be 12 characters long.

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Installation

LIS Communications
Set up parameters for communications with a Laboratory Information System (LIS).
Note that LIS Communications AND network (EpiCenter system) communications
CANNOT be enabled simultaneously. Changes to any LIS parameters require the
instrument to be rebooted to take effect. Use the “move to other field” soft key to
highlight successive fields (shown in reverse video).
Enable/Disable LIS Communications: Press UP or DOWN ARROW until | is displayed. To disable
LIS Communications, press UP or DOWN ARROW until O is displayed. When enabled, the
parameters discussed below appear on the screen.
Upload Results: Press UP or DOWN ARROW to select SOLICITED if you want the
BACTEC® MGIT™ 960 instrument to upload results to the LIS ONLY when requested by the LIS.
Select UNSOLICITED for the instrument to upload results automatically.
Consumable Tracking: Press UP or DOWN ARROW to select ENABLED if you want the
instrument to upload tube statuses of initial entry into and removal from the instrument. Select
DISABLED to withhold reporting of tube entry and removal.
Orphan Results: Press UP or DOWN ARROW to select ENABLED if you want to upload tube
results for “orphan” tubes (tubes without an associated Accession number). Select DISABLED to
withhold reporting of orphan tube statuses.
Frame Packing: Press UP or DOWN ARROW to select PACKED to upload information in multiple
records per frame. Select UNPACKED to upload one record per frame.
Baud Rate: Press UP or DOWN ARROW to select the desired baud rate. Select from 1200, 2400,
4800, 9600 (default), 19200.
Data Bits: Press UP or DOWN ARROW to select the number of data bits used in serial
communications with the LIS. Select from 7 or 8 (default).
Stop Bits: Press UP or DOWN ARROW to select the number of stop bits used in serial
communications with the LIS. Select from 1 (default) or 2.
Parity:Press UP or DOWN ARROW to select the method of parity check used in serial
communications with the LIS. Select from NONE (default), ODD, or EVEN.

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AST Setup

Enables setup of the MGIT 960 AST function. Refer to the BACTEC® MGIT™ 960 AST
Instructions for additional information. AST is not available for use in the USA.

2.4.3 Setup for Use with the EpiCenter™ System

Up to ten BACTEC® MGIT™ 960 instruments can be connected to the Becton Dickinson EpiCenter
Data Management System. EpiCenter provides advanced capabilities in data management, including
extended demographic data, comprehensive reporting features including a powerful database query
tool, bidirectional Laboratory Information System (LIS) communications, and long-term data
storage. Numerous BACTEC® MGIT™ 960 and comparative database query and statistical analysis
filters are included in the EpiCenter system.

The BACTEC® MGIT™ 960 instrument must be set up by a Becton Dickinson representative for use
with the EpiCenter system.

2.4.4 External Connections

Serial Port Network Port

Remote Alarm Port

Printer Port Keyboard Port

Figure 2-2 – External Connections

Top left: Serial Port; Top Middle: Remote Alarm Port; Top Left: Network Port;
Bottom Left: Printer Port; Bottom Right: Keyboard Port

2.5 System Startup

Whenever power is applied to the system, it 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 startup process is aborted. If not, the computer loads the operating
system and user interface, and tube testing begins automatically.

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Installation

2.6 Software Installation

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 Software Update Log in Appendix C
of the User’s Manual. Updated program software is furnished on 3 ½ inch floppy disk(s), labeled
“BACTEC® MGIT™ 960 SYSTEM SOFTWARE, Version y.yyz” (where “y.yy” is the software version
number, and “z” is the revision). The associated catalog number is also printed on the label.
To install a software update
1 Refer to Section 3.4 – Floppy Disk Drive, for operating cautions. Insert the update disk in
the floppy disk drive.
2 From the Main Status Screen, press the “maintenance” soft key.

3 The first of five maintenance function displays appears. Press the “maintenance” soft key
three more times, until the “update software” icon appears (display 4 of 5).

4 Press the “perform action” soft key to initiate the update.

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
indicator. When the update is complete, the user interface loads and you may proceed with normal
system operation.

2.7 CLIA Compliance

The efficacy of the BACTEC® MGIT™ 960 system has been proven in clinical evaluation (refer to the
BBL® MGIT™ media package insert). In accordance with CLIA requirements, mycobacterial detection
is classified as a Highly Complex Test. New BACTEC® MGIT™ 960 users should perform a method
verification evaluation prior to routine use of the system for testing patient specimens.

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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® MGIT™ 960 instrument. The overall layout of the instrument cabinet is shown in
Figure 3-1. Individual components are illustrated in figures accompanying the related text.

WARNING

IT IS MANDATORY THAT ALL SYSTEM USERS BECOME THOROUGHLY

FAMILIAR WITH ALL CONTROLS AND INDICATORS BEFORE
ATTEMPTING TO OPERATE THE INSTRUMENT.

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Keypad and LCD Display

Floppy
Disk Barcode Scanner
Drive

Drawer Release (3 pl.)

Brightness Dial

Drawer Indicators (3 pl.)

On/Off Switch

Figure 3-1 – BACTEC® MGIT™ 960 Instrument Layout

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Controls and Indicators

3.2 On/Off Switch

The system power (On/Off) rocker switch is on the front of the instrument at the bottom right
(See Figure 3-2). When in the “O” (Off) position, power is removed from the instrument. When in
the “|” (On) position, the switch illuminates green and power is applied to the instrument. Power
must be turned On for the incubator and culture testing modules to work. For normal operation, the
power should remain On at all times (except during some maintenance procedures).

On/Off Switch

Figure 3-2 – On/Off Switch

3.3 Keypad and LCD Display

The keypad and LCD display are located on the front of the instrument, at the top center. The keypad
is used to issue commands to the instrument. The LCD display presents setup and status
information, as well as the keypad definitions that allow you to perform routine operations.
See Figure 3-3.
The controls and indicators of the keypad and LCD display are presented in clockwise order from the
top right of the module.

3.3.1 DOWN /UP ARROW Keys

The DOWN and UP ARROW keys are located on the right 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 ARROW key, represented by an up arrowhead, is used to increase a
displayed value, or to scroll upward in a list.

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Display Area

DOWN/UP Arrow Keys

Alarm Indicator

SILENCE ALARM Key

Soft Keys

Figure 3-3 – Keypad and LCD Display

3.3.2 Soft Keys

The eight 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.

3.3.3 SILENCE ALARM Key

The SILENCE ALARM key is located on the left of the Keypad/LCD Display module. When pressed, it
turns off the audible alarm for the current “alert” alarm. It does not silence “drawer open” type
audible alarms, and it does not “clear” the error condition. (See Section 3.9 – Audible Tones and
Alarms, for an explanation of alarm types and tones.)

3.3.4 Alarm Indicator

The Alarm Indicator is located on the left side of the Keypad/LCD Display, above the SILENCE ALARM
key. This light illuminates yellow whenever the system encounters an error condition that requires
operator attention. The indicator remains on until the condition is corrected (even if the SILENCE
ALARM key is pressed).
When an alarm occurs, an icon (resembling the one on 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 directions in Section 7 – Troubleshooting. You can scroll through the error log with
the UP and DOWN ARROW keys.
If there is an audible alarm sounding, you can silence it by pressing the SILENCE ALARM key.

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Controls and Indicators

3.3.5 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. When the
instrument starts up, the Main Status Screen is displayed. Other displays appear as you perform
various operations.
The LCD Display is programmed to automatically dim after 5 minutes of inactivity. To return the
brightness to normal, press any key.
More information on displays is presented in Section 5 – Reference.

3.4 Floppy Disk Drive

The floppy disk drive is located on the front of the instrument, at top 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 3-4.

3.4.1 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.

3.4.2 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.

Floppy Disk Eject Button

Floppy Disk Indicator

Figure 3-4 – Floppy Disk Drive Controls and Indicators

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3.5 Brightness Dial

The Brightness Dial is located to the right of the LCD Display module, along the bottom edge of the
gray panel section. 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.
See Figure 3-5.

3.6 Barcode Scanner

The barcode scanner is located to the right of the Keypad/LCD Display module. When a drawer is
opened and an activity is initiated (e.g., entering new tubes, removing positive tubes, etc.), the
scanner turns on and is ready to read a tube barcode. See Figure 3-5.
To scan a tube barcode, place the tube in the alignment block in front of the scanner. If necessary,
rotate the tube slightly until the acknowledgment beep sounds (indicating that the barcode was
scanned successfully).

Barcode Scanner

Brightness Dial

Figure 3-5 – Brightness Dial and Barcode Scanner

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Controls and Indicators

3.7 Drawer Controls and Indicators

3.7.1 Exterior Drawer Controls and Indicators
There is one control on each of the three drawers: the drawer release latch (see Figure 3-6). In
addition, there are three indicators on the front panel of each of the three drawers (see Figure 3-7).
These indicators inform you of certain conditions within the individual drawer. These controls and
indicators are described below.
Drawer Release Latch

WARNING

TO AVOID INJURY TO FINGERS OR HANDS, MAKE SURE THAT NO

ONE’S HANDS ARE HOLDING A DRAWER HANDLE WHEN ANOTHER
DRAWER IS TO BE OPENED.

The drawer release latch is located on the rear of the teal drawer handle. The latch keeps the
drawer closed for normal operation. To open the drawer, depress the latch (toward you) and
slowly pull the drawer open. When closing a drawer, be sure you push it completely closed and
the latch locks the drawer into place. (This may be checked by gently pulling the drawer handle
toward you without depressing the release latch.)

(Top View – Front of Instrument)

Drawer Release Latch

Figure 3-6 – Drawer Release Latch

Positive Tube Indicator
The positive tube indicator is leftmost of the three drawer indicators. It is marked with a “plus
sign,” and illuminates red to inform you that one or more positive tubes are present in the
drawer. The indicator remains lit until all positive tubes are removed through the Remove
Positive Tubes operation (see Section 4.6.2).

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Negative Tube Indicator

The negative tube indicator is the center of the three drawer indicators. It is marked with a
“minus sign,” and illuminates green to inform you that one or more negative (out of protocol)
tubes are present in the drawer. The indicator remains lit until all negative tubes are removed
through the Remove Negative Tubes operation (see Section 4.6.5).
Error Station Indicator
The error station indicator is rightmost of the three drawer indicators. It is marked with a
“exclamation point,” and illuminates yellow to inform you that one or more error stations are
present in the drawer. The indicator remains lit until all error stations are resolved through the
Resolve Station Errors operation (see Section 4.9).

Positive Indicator Error Station Indicator

Negative Indicator

Figure 3-7 – Exterior Drawer Indicators

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Controls and Indicators

3.7.2 Interior Drawer Indicators

Each station has a set of LED indicators that inform you of the station’s status. The status indicators
are located at the bottom left of each station. See Figure 3-8. The color (red, green, or orange) and
state (on, off, or flashing) indicate the conditions shown in the table below for a given station.

Station Indicators

Figure 3-8 – Station Status Indicators

GREEN RED ORANGE CONDITION

Station Indicators

ON Off Off Place tube in this station

Flashing Off Off Out of protocol negative tube

Flashing Flashing Off Positive tube

Off Flashing Off Error station

Off Off Flashing Ongoing tube ready for removal

Off Off ON Anonymous tube

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3.8 Circuit Breakers CB2 – CB7

Circuit breakers CB2 through CB7 are located behind the lower faceplate (front) of the instrument.
These circuit breakers are two-position, pushbutton type breakers that extend themselves when
tripped. To reset a tripped circuit breaker, push the button back in. Circuit breaker assignments are
as follows:
CB2 DC Power (5V, ±15V)
CB3 Blower
CB4 Heater
CB5 24 VDC Output
CB6 24 VDC Input
CB7 24 VDC Input
(Circuit breaker CB1 is the main power breaker [On/Off Switch] and is discussed in Section 3.2.)
For instructions on removal of the lower faceplate, see Section 6.3.4 – Bottom Faceplate Removal.
Circuit Breakers CB2, CB3, CB4...
...and CB5, CB6, CB7

(Circuit Breaker CB1 [On/Off Switch])

Figure 3-9 – Circuit Breakers CB2 – CB7

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Controls and Indicators

3.9 Audible Tones and Alarms

Eight different types of sounds are generated by the BACTEC® MGIT™ 960 instrument as you
perform operations. Each of the sounds is unique. These tones are designed to keep you informed
about various operational states of the instrument.

Type Example Sound

Informational

Acknowledge Scanning a barcode Single short high beep

In Configuration mode, the Three tones progressing from

Sample audible alert
audible alert volume was adjusted high to low (“Figaro”)

Activity complete All positive tubes are removed Three short fast high beeps

Drawer closed Drawer was closed Two short fast high beeps

Alarm

Short high beep then short

Activity error Unexpected barcode scanned low beep – sequence repeated
four times

Single medium beep – one

Alert New positive tube second on, three seconds off,
repeating

Drawer has remained open longer Loud shrill trills. Each

Drawer alarms than 10 minutes, is ajar, or more condition named at left has a
than one drawer is open slightly different trill.

3.10 Printer
For an explanation of controls and indicators on the printer, refer to the manufacturer’s operating
instructions furnished separately.

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 Operation
4.1 General
This section describes the normal operation of the BACTEC® MGIT™ 960 system. The following
major topics are discussed:
• Preparing Specimens
• Using the Instrument Interface
• Daily Maintenance
• Entering New Tubes
• Positive and Negative Specimens
• Removing Ongoing Tubes
• Identifying Anonymous Tubes
• Responding to Alarms and Errors
• Printing Reports
• LIS Communications
• Use with the EpiCenter™ System
• Power Failures
These topics are offered in a general logical order which might fit the workflow of the average
laboratory. Some of the operations (such as printing reports and performing maintenance), may be
done at your convenience. Other operations, like monitoring the indicator lamps for new positives
and alarm conditions, should be ongoing throughout the day.

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4.2 Using the Instrument Interface

The Liquid Crystal Display (LCD) presents all the information needed to monitor instrument and
station status, to enter and remove tubes, set up the instrument, print reports, and perform routine
instrument maintenance. The information is presented in the form of picture icons that graphically
represent the information (such as a clock to indicate the current time, a plus sign to represent
positive tubes, etc.). The top region of the display presents instrument and station status
information that is always in view and is updated every few seconds. The middle region of the
display presents information and prompts for the operation currently being performed. At the
bottom of the display, a series of icons shows the current software (soft) key definitions. Display
regions are discussed in greater detail in Section 5 – Reference.
All the operations you perform at the instrument are initiated by pressing soft keys. Soft key
definitions depend initially on whether the drawers are open or closed. When all the drawers are
closed, a series of soft keys are presented that allow you to perform system-wide activities (such as
setting date and time, protocol length, reviewing system errors, etc.). When one of the drawers is
opened, a new series of soft key definitions appears that allows you to perform tube entry and
removal activities. As you initiate these tube entry and removal activities, the prompts in the main
body (middle region) of the display guide you through the operations, and new soft keys may
appear that present additional options. To perform the function represented by a soft key definition
icon, you press the corresponding soft key below the icon. All the icon definitions are presented in
Section 5 – Reference.
In addition to the soft keys, three hard keys, themselves marked with screened icons, perform fixed
functions regardless of the current display or operation. The SILENCE ALARM key quiets any audible
alerts, and the UP and DOWN ARROW keys are used to scroll through lists or to increase or decrease
values.

4.3 Handling and Preparing MGIT QC Tubes and Specimens

WARNINGS
SPECIMEN PREPARATION MUST BE DONE IN A BIOLOGICAL SAFETY CABINET. LABORATORY
PROCEDURES INVOLVING MYCOBACTERIA REQUIRE SPECIAL EQUIPMENT AND TECHNIQUES
TO MINIMIZE BIOHAZARDS.1
PATHOGENIC MICROORGANISMS INCLUDING HEPATITIS B VIRUS AND HUMAN
IMMUNIDEFICIENCY VIRUS MAY BE PRESENT IN SPECIMENS. “UNIVERSAL PRECAUTIONS”2,3
AND LOCAL LABORATORY GUIDELINES SHOULD BE FOLLOWED IN HANDLING ALL ITEMS
CONTAMINATED WITH BLOOD OR OTHER BODY FLUIDS.
IN THE EVENT OF TUBE LEAKAGE OR BREAKAGE: 1) CLOSE THE INSTRUMENT DRAWERS; 2)
TURN OFF THE INSTRUMENT; 3) VACATE THE AREA IMMEDIATELY; 4) CONSULT YOUR
FACILITY/CDC GUIDELINES.
IF AN INOCULATED TUBE 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. TUBE SHOULD BE DISCARDED IN AN APPROPRIATE MANNER.
AN INOCULATED LEAKING OR BROKEN TUBE MAY PRODUCE AN AEROSOL OF
MYCOBACTERIA; APPROPRIATE HANDLING SHOULD BE OBSERVED.

1, 2, 3 Ibid.

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4.3.1 Media Quality Control

Upon receipt of a new shipment or lot number of BBL® MGIT™ 7 ml tubes, it is suggested that
suspensions of the ATCC control organisms be prepared in Middlebrook 7H9 Broth.
1 From solid media cultures less than 15 days old, prepare a suspension in Middlebrook 7H9
Broth.
2 Allow the suspension to sit for 20 minutes.
3 Transfer the supernatant to an empty, sterile tube and allow to sit for an additional 15
minutes.
4 Transfer the supernatant to another empty, sterile tube.
5 Using a nephelometer, adjust the suspension to a turbidity comparable to a 0.5 McFarland
standard.
6 Dilute the control organism suspensions following the dilution scheme outlined in the table
below.
7 Inoculate the BBL® MGIT™ 7 ml tubes following the procedure in the media package insert.
The BBL® MGIT™ 7 ml tubes should be detected as instrument positive within the time frame shown
in the table below. If the QC BBL® MGIT™ 7 ml tubes do not give the expected results, do not use the
remaining tubes of the lot until you have contacted Becton Dickinson Technical Services (in the USA,
1–800–638–8663).

Dilution of 0.5 Days to

Species ATCC® Number McFarland Instrument
Suspension in Saline Positivity

M. tuberculosis 27294 1:500 6 – 10

M. kansasii 12478 1:50000 7 – 11

M. fortuitum 6841 1:5000 1–3

4.3.2 Specimen Preparation

Collection
All specimens should be collected and transported as recommended by the CDC, the Clinical
Microbiology Procedures Handbook, or your laboratory procedure manual. Specimens should be
labeled and sent to the laboratory at once.
Preparation and Transport
Specimens should be decontaminated, concentrated, digested, and inoculated according to the
BBL® MGIT™ 7 ml Media Package Insert. After specimens have been prepared, they should be
placed in a standard test tube rack and taken to the instrument. Tubes should be entered into
the instrument as soon as possible.

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4.4 Daily Maintenance

Each day several simple maintenance procedures should be performed. The best time to perform
maintenance is first thing in the morning, but it may be done any time you find convenient. The
following procedures should be performed:
1 Check the printer’s paper supply. If the paper supply is low or exhausted, replace the paper
as explained in the manufacturer’s operating instructions.
2 Verify the operation of the drawer and station indicator lamps. To perform lamp verification,
make sure all the drawers are closed. When the drawers are closed, the Main Status screen
appears:

Press the “maintenance” soft key:

Press the “test indicators” soft key:

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Press the “test drawer indicators” soft key:

All three external indicator lamps on all three drawers should light, as well as the instrument Alarm
indicator. If any does not, contact Becton Dickinson to arrange replacement of the indicator.
Open drawer A. The soft key definitions now change to allow tests of station status LEDs. Press
the “test green LEDs” soft key:

All the green LEDs at all the stations should light. If any does not, you should block the station(s)
as described in Section 6.2.3.2 – Blocking a Station. Press the “test green LEDs” soft key again
to extinguish the green LEDs.
Now press the “test red LEDs” soft key:

All the red LEDs at all the stations should light. If any does not, you should block the station(s) as
described in Section 6.2.3.2 – Blocking a Station. Press the “test red LEDs” soft key again to
extinguish the red LEDs.
Repeat the tests of red and green station status LEDs for drawers B and C.
3 Check the thermometer readings of the Temperature QC tubes. If your manual readings are
within +1.0°/–2.0° C of 37° C, the controller and heaters are operating within the expected
range.
4 From the main status screen, press the “temperature” soft key to access drawer temperature
readings. Verify that the temperature is currently within 1.5° C of the manual reading for
each of the drawers. (More information on performing temperature verification is provided
in Section 6.2.)

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4.5 Entering New Tubes

Tubes should be placed in the instrument on the same day that the specimen is decontaminated,
processed, and inoculated.
Before placing tubes into the instrument, you should always scan their barcodes and assign them to
their stations through the tube entry operation. If the tubes are not scanned prior to placement in
the instrument, they become anonymous tubes, and must be identified through the “identify
anonymous” operation before other states (such as positive or negative) can be displayed.
To enter new tubes into the instrument – Accession Barcoding Disabled

These instructions should be used to enter new BBL® MGIT™ 7 ml tubes into the instrument if the
Accession Barcoding feature (see Section 2.4.2) is disabled. If Accession Barcoding is enabled, see
the alternate instructions below.
1 Take the new cultures to the instrument. Open the desired drawer.
2 Press the “tube entry” soft key.

3 The barcode scanner turns on and the barcode icon appears in the main body of the display,
signaling that the instrument is ready to read a tube barcode sequence number. Scan the
tube’s barcode label. (To scan a tube barcode, place the tube in the alignment block in front
of the scanner with the barcode label facing the scanner. If necessary, rotate the tube
slightly so the scanner can read the label. The system beeps once to indicate a good scan.)
4 The assigned station is shown in the main body of the display (along with the scanned
sequence number). In addition, the station LEDs of the assigned station illuminate GREEN.
5 Carefully and completely insert the tube into the station.
6 Repeat Steps 3 – 5 for each of the new cultures you want to enter.

NOTE

Once the tubes are placed in stations, they should not be twisted or
turned. Tubes should not be removed except in the following conditions:

Removal of positive

Removal of negative

Reassign if station becomes bad

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To enter new tubes into the instrument – Accession Barcoding Enabled

These instructions should be used to enter new BBL® MGIT™ 7 ml tubes into the instrument if the
Accession Barcoding feature (see Section 2.4.2) is enabled.
1 Take the new cultures to the instrument. Open the desired drawer.
2 Press the “tube entry” soft key.

3 The icon in the main body of the display shows an arrow pointing to the upper barcode (the
tube sequence number), and the barcode scanner turns on. This signals that the instrument
is ready to read a tube barcode sequence number. Scan the tube’s barcode label. (To scan a
tube barcode, place the tube in the alignment block in front of the scanner with the barcode
label facing the scanner. If necessary, rotate the tube slightly so the scanner can read the
label. The system beeps once to indicate a good scan.)
4 The icon in the main body of the display now shows an arrow pointing to the lower barcode
(the accession number), and the barcode scanner remains on. This signals that the
instrument is ready to read an accession barcode. Either scan the accession barcode label, or
press the “no accession barcode available” soft key.
5 The assigned station is shown in the main body of the display (along with the scanned tube
sequence and accession numbers). In addition, the station LEDs of the assigned station
illuminate GREEN.
6 Carefully and completely insert the tube into the station.
7 Repeat Steps 3 – 6 for each of the new cultures you want to enter.

NOTE

Once the tubes are placed in stations, they should not be twisted or
turned. Tubes should not be removed except in the following conditions:

Removal of positive

Removal of negative

Reassign if station becomes bad

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4.6 Positive and Negative Specimens

With the BACTEC® MGIT™ 960 instrument, tubes are typically held for 42 days before they are
autoclaved and discarded as negative. Clinical performance of the BACTEC® MGIT™ 960 system was
established using a 42-day protocol. Each laboratory should set the protocol length based on its
own policies and conditions; the protocol length may be extended to 56 days.
If an instrument positive tube is determined to be smear negative for either mycobacteria or
contaminants, the tube may be re-entered into the instrument. The system allows re-entry of
instrument positive tubes for up to 5 hours after their removal. If the tube is returned to the
instrument (via the “tube entry” operation), positivity routines are reset, the start of protocol date is
retained, and testing on the tube resumes. If the tube is not returned within the 5-hour re-entry
window, the station then becomes available, and the associated data is removed from the
database.

4.6.1 Notification of Positive Tubes

The system notifies you of new positive cultures in several ways:
• POSITIVE indicator lamp on the front of the drawer illuminates
• In the Summary window (top right), the tube count for each drawer appears next to the
filled circle with a plus sign icon

• When the drawer is opened, the “remove positive tubes” soft key appears in the soft key
definition area of the screen (see below)
• Until the condition is acknowledged, the audible alert sounds (if enabled)

4.6.2 Removing Positive Tubes

1 Press the SILENCE ALARM key to quiet the audible alarm. Open the appropriate drawer.
2 Press the “remove positive tubes” soft key.

3 All the positive stations illuminate with FLASHING GREEN, FLASHING RED indicators. Remove
one of the positive tubes.
4 The barcode scanner turns on and the barcode icon appears in the main body of the display,
signaling that the instrument is ready to read a tube barcode sequence number. Scan the
positive tube’s barcode label. The LEDs at this station extinguish.
5 Repeat Steps 4 – 5 to remove additional positive tubes. The POSITIVE indicator on the front
of the drawer (and at the top of the instrument) does not extinguish until all positive vials
are removed.

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6 When all positive tubes are removed, the instrument beeps three times, the barcode scanner
turns off, and the “ok” icon appears in the main body of the display.
7 All instrument positive tubes should be stained for AFB and subcultured upon removal from the
instrument. Tubes should remain at room temperature while they are out of the instrument.

4.6.3 Returning Positive Tubes to the Instrument for Further Testing

The system allows you to return a pulled positive tube to the instrument for further testing for up to
five hours after removal. Even though the re-entry window is up to five hours, tubes should be
returned to the instrument as soon as possible. Instrument positive tubes should be stained for AFB
and subcultured upon removal from the instrument, and should remain at room temperature while
they are out of the instrument.
The re-entry feature resets positivity routines, retains the start of protocol date, and continues to test
the tube as an ongoing culture. If the tube is not returned within the five-hour re-entry window, all
previous data is discarded.
To return a pulled positive tube to the instrument for further testing, open the door. Press the “tube
entry” soft key. Next scan the tube’s barcode label. Place the tube in the indicated station (this may
differ from the original station). Previous data is retained only in the following circumstances:
• You return the tube within the required time frame
• You scan the barcode sequence number label to re-enter the tube
• You return the tube to the same instrument from which it was removed
If you do not use the “tube entry” operation to re-enter the vial, it becomes Anonymous at the next
drawer scan, and the previous test results are removed from the database if it is not identified within
the 5-hour period. If a tube is not returned within the re-entry window, it may be entered (or
identified) as a new culture, and the protocol setting can be reduced to the number of days
remaining in the original test protocol. If you adjust the protocol for a returned tube, be sure to
set the protocol setting back to the setting established within your laboratory (recommended
42 – 56 days).

4.6.4 Notification of Negative Tubes

Negative cultures exist either as ongoing negatives (in protocol) or out-of-protocol negatives. You
are notified of these conditions as follows:
• Ongoing Negatives – In the summary region of the display, the ongoing tube count for each
drawer appears next to the filled circle icon

• Out-of-Protocol Negatives – In the summary region of the display, the tube count for each
drawer appears next to the filled circle with a minus sign icon

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4.6.5 Removing Negative Tubes

Out of protocol negative tubes may be removed either singly or in a batch mode. The difference is as
follows:
• In batch negative removal, first you press the “remove negative tubes” soft key, then you
press the “remove negative tubes – batch” soft key. This tells the system that you are
removing all final negative cultures from the instrument. You do not have to scan any tube
barcode labels.
• In single-tube negative removal, first you press the “remove negative tubes” soft key, then
you scan the barcode label of each negative tube you remove.
Tubes that are removed through the “remove negative tubes” operation are deleted from the
database.
To remove negative tubes
1 Open the appropriate drawer.
2 Press the “remove negative tubes” soft key.

3 All the final negative stations illuminate with FLASHING GREEN indicators.
4 The barcode scanner turns on and the barcode icon appears in the main body of the display,
signaling that the instrument is ready to read a tube barcode sequence number.
5 To remove all negative tubes (batch removal), press the “remove negatives – batch” soft
key. Re-move all the tubes in the indicated stations. The barcode scanner turns off, so you
cannot­scan any of the tube barcode labels. Do not close the drawer until you have
removed all the tubes in the FLASHING GREEN stations. When all negative tubes are
removed, press the “ok” soft key. Be sure to remove all the tubes in the FLASHING GREEN
stations; any tubes you leave in the drawer will become anonymous at the next drawer test,
and will have to be identified before you can remove them. Once identified, they are treated
as newly entered tubes.

To remove negative tubes one at a time, remove the desired tubes and scan their barcode
labels. Continue to scan and remove all the desired individual negative tubes.
6 When all negative tubes are removed, the instrument beeps three times, and the “ok” icon
appears in the main body of the display.

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4.7 Removing Ongoing Tubes

From time to time, you may need to remove one or more ongoing (in-protocol) tubes from the
instrument. By using the “remove ongoing tubes” operation, you can remove ongoing tubes
without causing the assigned station to go into an error condition. However, like the “remove
negative tubes” operation, any tubes removed are deleted from the database, and cannot be re-
entered as ongoing cultures. ( If a removed ongoing tube is re-entered, the system treats it as a new
tube.) If an ongoing tube must be removed and you know it is going to be returned imminently, it
may be preferable to simply physically remove the tube from the station, allow the station to go into
error, return the tube as soon as possible, and resolve the station error.
To remove an ongoing tube
1 Open the appropriate drawer.
2 Press the “remove ongoing tubes” soft key.

3 The oldest ongoing station illuminates with FLASHING ORANGE indicators. In addition, a
display similar to the following appears (showing the same station as is flashing):

The information appearing in the main body of the display includes the station number,
barcode sequence number, accession number (if applicable), time in protocol, and current
growth unit.
4 The barcode scanner turns on and the barcode icon appears in the main body of the display,

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BACTEC® MGIT™ 960 System User’s Manual

signaling that the instrument is ready to read a tube barcode sequence number.
5 If the station from which you want to remove the ongoing tube is the one displayed,
remove this tube and scan its barcode sequence number. If this is not the correct station,
use the UP or DOWN ARROW key to scroll through the list of ongoing stations until the
desired station appears. Then remove the desired tube and scan its barcode sequence
number.
6 Repeat Step 5 for any additional ongoing tubes you want to remove.
7 Ongoing tubes that are removed should either be subcultured to solid media (and the
BBL® MGIT™ 7 ml tube discarded according to facility guidelines), or should be incubated
offline at 37° C and manually read each day until the end of the testing protocol. (See
Appendix E – Supplemental Procedures, for information on reading tubes manually.)

4.8 Identifying Anonymous Tubes

An anonymous tube is one which is physically in a station, but has not been assigned to that station
through the “tube entry” operation (e.g., an unremoved out of protocol negative tube). You are
notified that anonymous tubes exist as follows: the anonymous count in the Summary window
increments, and the “identify anonymous tubes” soft key definition appears when the drawer is
opened. It is very important that when the system notifies you of anonymous tubes, you identify
them as soon as possible. The anonymous state supersedes all others, which means that tubes 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 tube must be identified to the system.
The Identify Anonymous function enables you to locate anonymous tubes in the instrument and
assign them to stations.
To identify anonymous tubes – Accession Barcoding Disabled

These instructions should be used to identify anonymous BBL® MGIT™ 7 ml tubes in the instrument
if the Accession Barcoding feature (described in Section 2.4.2) is disabled. If Accession Barcoding is
enabled, see the alternate instructions below.
1 Open the desired drawer.
2 Press the “identify anonymous tubes” soft key.

3 The first anonymous station is shown in the main body of the display, and the ORANGE
station indicator at this station illuminates. In addition, the barcode scanner turns on and
the barcode icon appears in the main body of the display, signaling that the instrument is
ready to read a tube barcode sequence number.
4 Scan the tube’s barcode label. The scanned sequence number is now assigned to this
station. In addition, the station LEDs of the assigned station illuminate GREEN.

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5 The next anonymous station is now shown in the main body of the display. Repeat Step 4 for
each of the anonymous tubes in the drawer. For anonymous tubes in other drawers, repeat
the procedure from Step 1 – 4.
To identify anonymous tubes – Accession Barcoding Enabled

These instructions should be used to identify anonymous BBL® MGIT™ 7 ml tubes in the instrument
if the Accession Barcoding feature (described in Section 2.4.2) is enabled.
1 Open the desired drawer.
2 Press the “identify anonymous tubes” soft key.

3 The first anonymous station is shown in the main body of the display, and the ORANGE
station indicator at this station illuminates.The icon in the main body of the display shows
an arrow pointing to the upper barcode (the tube sequence number), and the barcode
scanner turns on. This signals that the instrument is ready to read a tube barcode sequence
number.
4 Scan the tube’s barcode label.
5 The icon in the main body of the display now shows an arrow pointing to the lower barcode
(the accession number), and the barcode scanner remains on. This signals that the
instrument is ready to read an accession barcode. Either scan the accession barcode label, or
press the “no accession barcode available” soft key.
6 The scanned sequence number is now assigned to this station. In addition, the station LEDs
of the assigned station illuminate GREEN.
7 The next anonymous station is now shown in the main body of the display. Repeat Step 4 –
5 for each of the anonymous tubes in the drawer. For anonymous tubes in other drawers,
repeat the procedure from Step 1 – 6.

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4.9 Resolving Station Errors

As you perform activities at the BACTEC® MGIT™ 960 instrument, and as tube testing progresses,
system alerts and errors may occur. Different types of alerts and errors are flagged by one or more of
the following: “E” error codes, audible tones, the System Alert icon appearing on the LCD display,
the Error Station indicator on the drawer illuminating, or the instrument’s System Alert indicator
illuminating. 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 numbered 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 the System Alert indicator to illuminate, and can be reviewed by pressing the
“system alert” soft key (see below). The errors must be reviewed to clear the system alert condition.

Activity errors represent “E” type error codes numbered in the 30’s. These errors (such as scanning
an unexpected barcode) cause the activity error icon to appear on the activity screen (e.g., remove
positives, remove negatives, etc.). They do not put the system into an alert condition (though they
are reported in the system alert log). These errors can frequently be cleared by simply performing
the activity correctly (such as scanning the correct barcode).

Station errors (type E12) can occur from a number of causes. These errors are reported in the system
alert log, the Station Alert indicator on the drawer illuminates, and the resolve errors icon on the
Main Activity screen appears (if there are no anonymous vials). The general operation of resolving
error stations is shown in Figure 4-1. Specific suggestions for resolving error stations are provided in
Section 7.2 – Error/Alert Messages, under error code E12.
All the “E” type error codes are discussed in detail in Section 7.2 – Error/Alert Messages. The
audible tones are discussed in Section 3.9 – Audible Tones and Alarms.

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Open drawer and

MA-0117-D(Prelim)
press “resolve
station errors”
soft key

(First error station is shown)

➋

Press UP ARROW or
➌ Will the DOWN ARROW to resolve
Is the tube Can the tube
NO NO tube be
in the be returned YES next station error. When
returned
station? now? tube is ready to be
later?
returned, repeat
procedure from first step.
YES YES NO

Figure 4-1 – How to Resolve Error Stations

Scan the tube
barcode and Press “force station
return tube available” soft key
to station

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4.10 Printing Reports

The following reports can be selected for printing:
• Unloaded Positives – a list of all positive tubes removed from the system since the last time
the report was printed and confirmed (up to a maximum of 500 unloaded tubes)
• Unloaded Negatives – a list of all negative tubes removed from the system since the last time
the report was printed and confirmed (up to a maximum of 500 unloaded tubes)
• Unloaded Ongoings – a list of all ongoing (in protocol) tubes removed from the system since
the last time the report was printed and confirmed (up to a maximum of 500 unloaded
tubes)
• Instrument Inventory – a list of all current station assignments (excluding Available stations),
either for the whole instrument or for individual drawers
• Quality Control – a list of the status of all the detectors in the instrument with the date and
time of their last verification, as well as a list of blocked stations
To print a report
1 From the main status screen, press the “print reports” soft key.

2 The report selection screen appears.

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3 Press the soft key that corresponds to the desired report.

Unloaded Unloaded Unloaded Instrument QC Report

Positive Tubes Negative Ongoing Inventory
Tubes Tubes

4 For the “unloaded tubes” reports, you are asked to confirm that the selected report printed.

or

(Note that the specific report icon appears in the blank area at the top left of the icon.)
You must press one of these two confirmation icons to print any other “unloaded tubes”
reports. If you press the “ok” soft key, the information contained in the report is
removed from the database.
The specific reports are discussed in greater detail in Section 5 – Reference.

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4.11 LIS Communications

The LIS Communications feature provides a method for the BACTEC® MGIT™ 960 instrument to
upload information to a compatible Laboratory Information System (LIS). LIS Communications can
be configured to upload test results, tube entry and removal, and isolate and specimen records from
the instrument to the LIS.
The LIS Communications function is based on the American Society of Testing and Materials (ASTM)
LIS Communications Standards (1381 and 1394), and is compatible with a number of popular LIS
systems. For specific information on which LIS systems are compatible, contact your local Becton
Dickinson representative. The LIS Vendor Interface Specification (available upon request) provides
complete details on the BACTEC® MGIT™ 960 implementation of LIS Communications.
Several configuration parameters, highlighted below in bold italics type, are explained below.
LIS Communication is able to send results from the instrument to the LIS (upload), but does not
accept downloaded data from the LIS, nor does it query the LIS for information. The instrument can
be set up to upload results automatically (unsolicited upload), or to only send results when the LIS
requests them (solicited upload). If the instrument is configured for unsolicited upload, it still
responds to requests from the LIS for results (solicitations or queries). If the instrument is configured
for unsolicited uploads, the LIS must always be ready to receive data from the instrument.
Consumable tracking enables the instrument to report information to the LIS relating to the entry
and removal of tubes from the instrument. This includes scanning a tube and accession barcode
during Tube Entry or Identify Anonymous, resolving error stations, removing a tube, reentering a
tube for further testing, etc. Finally, you can select whether or not to report results to the LIS for
orphan tubes (no accession/specimen information attached).
A list of setup parameters is presented below:

Option Selections Purpose

Enable instrument to
LIS Communications Enable or Disable
communicate with LIS

Select whether instrument

Upload Results Solicited or Unsolicited sends data to LIS automatically
or only on request

Select whether instrument

uploads tube status information
Consumable Tracking Enable or Disable
(entry into and removal from
instrument)

Select whether instrument

Orphan Results Enable or Disable uploads results for orphan tubes
(no specimen record attached)

A number of technical parameters relating to communications between the two systems can
also be set in LIS Configuration. It is recommended that these parameters not be set without
consulting your local Becton Dickinson representative and your LIS vendor.

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NOTE

If the BACTEC® MGIT™ 960 instrument is connected to a LIS, it cannot

be connected to the EpiCenter™ system. However, if the
BACTEC® MGIT™ 960 instrument is connected to EpiCenter, then a LIS
connection can be established via EpiCenter.

4.12 Use with the EpiCenter™ System

For comprehensive operating instructions for the EpiCenter™ system, refer to the EpiCenter™ System
User’s Manual, L–000550. Please note the following regarding use of the BACTEC® MGIT™ 960
instrument with the EpiCenter™ system:

• The BACTEC® MGIT™ 960 instrument obtains its date and time settings from the EpiCenter
system. If you need to correct the system date or time, perform the correction at the
EpiCenter™ system. The instrument will synchronize time within 10 minutes.
• Do not include any of the following characters in accession numbers entered at the
instrument:
* ? [ ] ! #
• Immediately after installation of the EpiCenter™ system, the Entry Date and Time (Start of
Protocol) of all tubes in the instrument will shift due to clock/time synchronization with the
EpiCenter system. This occurs only after new installations and only for tubes currently in the
instrument(s).
• The state of the link with the EpiCenter™ system is indicated on the Main Status screen by
one of two icons: network link okay, shown below left; and network link not okay, shown
below right.

• If the BACTEC® MGIT™ 960 instrument is connected to a LIS, it cannot be connected to the
EpiCenter™ system. However, if the BACTEC® MGIT™ 960 instrument is connected to
EpiCenter™, then a LIS connection can be established via EpiCenter.™

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4.13 Power Failures

The information in the BACTEC® MGIT™ 960 instrument 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 BBL® MGIT™ 7 ml tube testing occurs until power is restored.
When power is restored, the times that power was lost and restored are noted in the system alert
log and can be viewed on the LCD display (note that if multiple power failures occur, only the latest
is retained in the alert log). BBL® MGIT™ 7 ml tube testing resumes when power is restored.

If power is lost to the BACTEC® MGIT™ 960 instrument for more than 24 hours, it is strongly
recommended that all BBL® MGIT™ 7 ml tubes in the instrument be removed and incubated offline
at 37° C. These tubes must be read manually throughout the eight week protocol according to the
supplemental procedure in Appendix E.
You may, at your option, connect the system to an Uninterruptible Power Supply (UPS). Use of a UPS
may help prevent interruptions to testing.

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5.1 General
This section presents reference material on the BACTEC® MGIT™ 960 instrument user interface. The
following information is presented:
• Software menu tree
• Display types and regions
• Icon Charts
• Reports

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5.2 Software Menu Tree

The following is a hierarchical list of all 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 Audible Alert Volume (Section 2.4.2)
Set Instrument Number (Section 2.4.2)
Set Language for Reports (Section 2.4.2)
Accession Barcoding Enable/Disable (Section 2.4.2)
Laboratory Information System (LIS) Communications Enable/Disable (Section 2.4.2)
Maintenance
Test Lamps (Section 6.2.1)
Block/Unblock Stations (Section 6.2.3.2 and 6.2.3.3)
Write Data to Disk (Section 7.3)
Update Software (Section 2.6)
Replace Calibrator Tube(s) (Section 6.2.2.2)
Print Reports (Section 4.10)
Unloaded Positive Tubes Report (Section 5.5.1)
Unloaded Negative Tubes Report (Section 5.5.2)
Unloaded Ongoing Tubes Report (Section 5.5.3)
Instrument Inventory Report (Section 5.5.4)
QC Report (Section 5.5.5)
Review System Alert List (Section 3.3.4, 7.2)
Temperature Display (Section 6.2.1)
Main Activity Screen (Door Open)
Tube Entry (Section 4.5)
Remove Positive Tubes (Section 4.6)
Remove Negative Tubes (Section 4.6)
Identify Anonymous Tubes (Section 4.8)
Resolve Station Errors (Section 4.9)
Remove Ongoing Tubes (Section 4.7)

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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.

5.3.1 Main Status Screen

The Main Status screen (Figure 5-1) is displayed when all the instrument drawers are closed. This
screen presents up to five 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 system setup parameters
• The “maintenance” icon, where you can perform instrument indicator lamp verifications,
block and unblock stations, write data to floppy disk, and update system software.
• The “review system alert” icon, which allows you to review any system alerts that may have
occurred or that may still exist.
• The “print reports” icon. This icon appears only if your printer is attached, turned on, and
online.
• The “temperature” icon, which allows you to view the current temperatures in the drawers.
In addition, system and station status information is always in view at the top of the screen. The
following information is presented:
• Instrument number
• Current date
• Current time
• LIS Indicator (if LIS Communications is enabled)
• Last station assigned during “tube entry” operation
• Summary region, showing status of drawers, number of tubes that are positive, negative,
ongoing, available, and stations that are in error, anonymous, or blocked (note that
summary counters may total greater than 960 because tubes can have multiple statuses)
The main body of the display often presents icons that guide you through the operation or setup
you are performing.
The soft key assignment area (very bottom of the screen) shows the current soft key definitions.
These definitions change as you access different functions and screens. The Main Status screen icons
are described in the first set of bullets above.

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Last Station Assigned in the Tube Entry

Current Date Drawer and Status

Instrument
Number
Current
Time
Summary
LIS
Enabled

Main Body

Soft Key Assignments

Figure 5-1 – Main Status Screen

5.3.2 Main Activity Screen

The Main Activity screen (Figure 5-2) is displayed when any of the instrument drawers is opened.
This screen presents up to six icons at a time representing soft key definitions that allow you to
perform tube- and station-related activities. These icons are as follows:

• The “tube entry” icon, which allows you to enter new BBL® MGIT™7 ml tubes for testing.
• The “remove positive tubes” icon. This icon appears only if there are positive tubes in the
instrument. It allows you to remove these positive tubes.
• The “remove negative tubes” icon. This icon appears only if there are final (out-of-protocol)
negative tubes in the instrument. It allows you to remove these negative tubes.
• The “identify anonymous tubes” icon. This icon appears only if there are anonymous tubes
in the instrument. It allows you to identify these anonymous tubes 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 tubes. It allows you to resolve the error stations.
• The “remove ongoing tubes” icon. This icon appears only if there are ongoing negative
tubes in the instrument. It allows you to remove these ongoing tubes.
In addition, system and station status information is always in view at the top of the screen. The
following information is presented:
• Instrument number
• Current date

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• Current time
• LIS Indicator (if LIS Communications is enabled)
• Last station assigned during “tube entry” operation
• Summary region, showing status of drawers, number of tubes that are positive, negative,
ongoing, available, and stations that are in error, anonymous, or blocked (note that
summary counters may total greater than 960 because tubes can have multiple statuses)
The main body of the display presents icons that guide you through the operation or setup you are
performing.
The soft key assignment area (very bottom of the screen) shows the current soft key definitions.
These definitions change as you access different functions and screens. The Main Activity screen
icons are described in the first set of bullets above.

Last Station Assigned in the Tube Entry

Drawer and Status
Current Date
Instrument
Number
Current
Time
Summary
LIS
Enabled

Main Body

Soft Key Assignments

Figure 5-2 – Main Activity Screen

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5.4 Icon Charts

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

Instrument Status Icons (top left of screen)

Icon Meaning Icon Meaning

Current date Current time

Network link okay Network link down

LIS active

Station Status Icons (top right of screen)

Icon Meaning Icon Meaning

Negative station Positive station

Ongoing station Empty (available) station

Error station Anonymous station

Blocked station

Drawer Status Icons (top right of screen)

Icon Meaning Icon Meaning

Drawer (A, B, or C) normal Drawer (A, B, or C) offline

Drawer (A, B, or C) loading

Drawer (A, B, or C) testing
software

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Main Status Screen Icons

Icon Meaning Icon Meaning

Configuration setups Maintenance functions

Review system alerts Print reports

Temperature display

Configuration Icons

Icon Meaning Icon Meaning

Set protocol length Set time

Set date/time format Set date

Set audible alert volume Set instrument number

Set report language English language

Spanish language French language

Italian language German language

Polish language Chinese language (future)

Accession barcoding
Japanese language
enable/disable

LIS enable/disable

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Alert/Error Notification Icons

Icon Meaning Icon Meaning

System alert Activity error or instrument full

Problem with disk inserted or no

Disk full, insert another one
disk is inserted

Power was removed at this time Power was restored at this time

Maintenance Icons

Icon Meaning Icon Meaning

Test indicators Test drawer indicators

Test green station indicators Test red station indicators

Block/unblock stations function Block stations

Unblock stations Copy data to disk

Replace calibrator tubes

Update software
function

Replace single calibrator tube Replace all calibrators in drawer

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Action/Navigation Icons

Icon Meaning Icon Meaning

Confirm your selection/

operation, also activity Cancel your selection/operation
complete

Value can be adjusted up/down Move to other field

Perform the desired action Exit the curent operation/level

Force station available Scroll up or increase value

Scroll down or decrease value

Print Reports Icons

Icon Meaning Icon Meaning

Print reports Unloaded Positive Tubes Report

Unloaded Negative Tubes Unloaded Ongoing Tubes

Report Report

Instrument Inventory Report Quality Control Report

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Activity Icons

Icon Meaning Icon Meaning

Tube entry Barcode scanner is ready

Scan tube sequence # barcode Scan tube accession barcode

Accession barcode not available Reassociate accession barcode

Identify anonymous tubes Resolve station errors

Remove positive tubes Remove ongoing tubes

Remove negative tubes Remove negative tubes – batch

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5.5 Reports
Five instrument reports are available for printing. The reports are as follows:
• Unloaded Positives – a list of all positive tubes removed from the system since the last time
the report was printed and confirmed (up to a maximum of 500 unloaded tubes)
• Unloaded Negatives – a list of all negative tubes removed from the system since the last time
the report was printed and confirmed (up to a maximum of 500 unloaded tubes)
• Unloaded Ongoings – a list of all ongoing (in protocol) tubes removed from the system since
the last time the report was printed and confirmed (up to a maximum of 500 unloaded
tubes)
• Instrument Inventory – a list of all current station assignments (excluding Available stations),
either for the whole instrument or for individual drawers
• Quality Control – a list of the status of all the detectors in the instrument with the date and
time of their last verification, as well as a list of blocked stations
Each of the reports is discussed in greater detail in the sections that follow.

5.5.1 Unloaded Positives Report

The Unloaded Positives Report lists all the positive tubes removed from the system since the last time
the report was printed and confirmed (up to a maximum of 500 unloaded positive, negative, and
ongoing tubes). When the report printing is confirmed, the records for these unloaded tubes are
removed (deleted) from the system. This is why you are asked to confirm that the report did
successfully print.
You can print the Unloaded Positives Report by pressing the soft keys below the following icons:

to access report selection to print the report

A sample Unloaded Positives Report is shown in Figure 5-3.

The Unloaded Positives Report provides the following information:
Report Header
Title (Unloaded Positives Report)
Instrument number
Current date and time
Current drawer temperatures
Current system software version
Page number

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Main Body of Report

Tube Position – in the form D/RCC, where D is the drawer letter (A, B, or C), R is the Row
(A through S, omitting I, O, and Q),and CC is the column (01 to 20)
Accession Number – the scanned accession barcode number, if one exists
Sequence Number – the scanned tube barcode sequence number
Growth Unit – the final growth unit reading
Tube Status – + for positive, +T for threshold positive
TTD – the time to detection, in the form D;HH, where D represents the number of days
and HH the number of hours from the start of protocol (when the first instrument test
occurred) to the time the instrument declared the tube positive
Date Positive – the date on which the tube was declared positive
Protocol Length – the number of days of the assigned testing protocol
Start of Protocol – the date and time of the first instrument test

BACTEC MGIT 960

Unloaded Positives Report
Instrument Current Temperature Software Page
Number Date/Time A B C Version Number
1 10/17/98 23:59 36.5 C 37.1 C 36.8 C V2.00Y 1

Tube Accession Sequence Growth Tube Date Protocol Start of

Position Number Number Unit Status TTD Positive Length Protocol
A/A01 1313 4399887766 3175 + 3;12 10/17/98 42 10/14/98 01:22
A/A12 1317 4399112233 484 + 6;4 10/17/98 42 10/11/98 14:54
A/A20 2345 4399223366 147 + 4;14 10/17/98 42 10/13/98 03:45
A/B03 5372 4399774499 2695 + 11;22 10/17/98 42 10/06/98 00:13
A/B06 5166 4399445566 102 + 8;1 10/17/98 42 10/09/98 22:00
A/B17 2742 4399886633 2241 + 7;23 10/17/98 42 10/10/98 01:30
A/B20 6255 4399000011 0 +T 14;9 10/17/98 42 10/03/98 08:12
A/C08 9475 4399558800 1583 + 20;3 10/17/98 42 09/27/98 18:43
A/C19 8266 4399660088 1999 + 13;2 10/17/98 42 10/01/98 20:20
A/D03 2667 4399338855 2120 + 7;20 10/17/98 42 10/10/98 01:33
A/D14 9119 4399227711 695 + 2;16 10/17/98 42 10/15/98 04:55
. . . . . . . . .
. . . . . . . . .
. . . . . . . . .

Figure 5-3 – Sample Unloaded Positives Report

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5.5.2 Unloaded Negatives Report

The Unloaded Negatives Report lists all the negative tubes removed from the system since the last
time the report was printed and confirmed (up to a maximum of 500 unloaded positive, negative,
and ongoing tubes). When the report printing is confirmed, the records for these unloaded tubes are
removed (deleted) from the system. This is why you are asked to confirm that the report did
successfully print.
You can print the Unloaded Negatives Report by pressing the soft keys below the following icons:

to access report selection to print the report

A sample Unloaded Negatives Report is shown in Figure 5-4.

The Unloaded Negatives Report provides the following information:
Report Header
Title (Unloaded Negatives Report)
Instrument number
Current date and time
Current drawer temperatures
Current system software version
Page number
Main Body of Report
Tube Position – in the form D/RCC, where D is the drawer letter (A, B, or C), R is the Row
(A through S, omitting I, O, and Q),and CC is the column (01 to 20). This is the sort order
of the report.
Accession Number – the scanned accession barcode number, if one exists
Sequence Number – the scanned tube barcode sequence number
Growth Unit – the final growth unit reading
TIP – the time in protocol, in the form D;HH, where D represents the number of days and
HH the number of hours from the start of protocol (when the first instrument test
occurred) to the time the tube completed protocol
Removal Date – the date on which the tube was removed from the instrument
Protocol Length – the number of days of the assigned testing protocol
Start of Protocol – the date and time of the first instrument test

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BACTEC MGIT 960

Unloaded Negatives Report
Instrument Current Temperature Software Page
Number Date/Time A B C Version Number
1 10/17/96 23:59 36.5 C 37.1 C 36.8 C V1.03E 1

Tube Accession Sequence Growth Removal Protocol Start of

Position Number Number Unit TIP Date Length Protocol
A/A02 1314 4399887767 0 42;5 10/17/96 42 09/06/96 08:12
A/A03 1315 4399887768 0 42;5 10/17/96 42 09/06/96 08:12
A/A04 1316 4399887769 0 42;5 10/17/96 42 09/06/96 08:12
A/A05 1318 4399887770 3 42;5 10/17/96 42 09/06/96 08:12
A/A06 1319 4399887771 0 42;5 10/17/96 42 09/06/96 08:12
A/A07 1320 4399887772 0 42;5 10/17/96 42 09/06/96 08:12
A/A08 1321 4399887773 0 42;5 10/17/96 42 09/06/96 08:12
A/A09 1322 4399887774 0 42;5 10/17/96 42 09/06/96 08:13
A/A10 1323 4399887775 0 42;5 10/17/96 42 09/06/96 08:13
A/A11 1324 4399887776 0 42;5 10/17/96 42 09/06/96 08:13
A/A13 1326 4399887777 5 42;5 10/17/96 42 09/06/96 08:13
. . . . . . . .
. . . . . . . .
. . . . . . . .

Figure 5-4 – Sample Unloaded Negatives Report

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5.5.3 Unloaded Ongoings Report

The Unloaded Ongoings Report lists all the ongoing tubes removed from the system since the last
time the report was printed and confirmed (up to a maximum of 500 unloaded positive, negative,
and ongoing tubes). When the report printing is confirmed, the records for these unloaded tubes are
removed (deleted) from the system. This is why you are asked to confirm that the report did
successfully print.
You can print the Unloaded Ongoings Report by pressing the soft keys below the following icons:

to access report selection to print the report

A sample Unloaded Ongoings Report is shown in Figure 5-5.

The Unloaded Ongoings Report provides the following information:
Report Header
Title (Unloaded Ongoings Report)
Instrument number
Current date and time
Current drawer temperatures
Current system software version
Page number
Main Body of Report
Tube Position – in the form D/RCC, where D is the drawer letter (A, B, or C), R is the Row
(A through S, omitting I, O, and Q),and CC is the column (01 to 20). This is the sort order
of the report.
Accession Number – the scanned accession barcode number, if one exists
Sequence Number – the scanned tube barcode sequence number
Growth Unit – the last growth unit reading
TIP – the time in protocol, in the form D;HH, where D represents the number of days and
HH the number of hours from the start of protocol (when the first instrument test
occurred) to the time the tube was removed from the instrument
Removal Date – the date on which the tube was removed from the instrument
Protocol Length – the number of days of the assigned testing protocol
Start of Protocol – the date and time of the first instrument test

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BACTEC MGIT 960

Unloaded Ongoings Report
Instrument Current Temperature Software Page
Number Date/Time A B C Version Number
1 10/17/96 23:59 36.5 C 37.1 C 36.8 C V1.03E 1

Tube Accession Sequence Growth Removal Protocol Start of

Position Number Number Unit TIP Date Length Protocol
C/B02 1513 4399223344 0 40;4 10/17/96 42 09/08/96 11:12
C/B03 1514 4399223345 0 40;4 10/17/96 42 09/08/96 11:12
C/B04 1515 4399223346 0 40;4 10/17/96 42 09/08/96 11:12
C/B05 1516 4399223347 0 40;4 10/17/96 42 09/08/96 11:12
C/B06 1517 4399223348 0 40;4 10/17/96 42 09/08/96 11:12
C/B07 1518 4399223349 4 40;4 10/17/96 42 09/08/96 11:12
C/B08 1519 4399223350 0 40;4 10/17/96 42 09/08/96 11:12
C/B09 1520 4399223351 0 40;4 10/17/96 42 09/08/96 11:13
C/B10 1521 4399223352 0 40;4 10/17/96 42 09/08/96 11:13
C/B11 1522 4399223353 0 40;4 10/17/96 42 09/08/96 11:13
C/B13 1523 4399223354 0 40;4 10/17/96 42 09/08/96 11:13
. . . . . . . .
. . . . . . . .
. . . . . . . .

Figure 5-5 – Sample Unloaded Ongoings Report

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5.5.4 Instrument Inventory Report

The Instrument Inventory Report provides a complete inventory listing of all the tubes currently in
the instrument. You can select a report for all drawers, or for any individual drawer. Available
stations are not reported.
You can print the Instrument Inventory Report by pressing the soft keys below the following icons:

to access report selection to print the report

From this point, additional soft keys allow you to select which drawer(s) to report.
A sample Instrument Inventory Report is shown in Figure 5-6.
The Instrument Inventory Report provides the following information:
Report Header
Title (Instrument Inventory Report)
Instrument number
Current date and time
Current drawer temperatures
Current system software version
Page number
Main Body of Report
Tube Position – in the form D/RCC, where D is the drawer letter (A, B, or C), R is the Row
(A through S, omitting I, O, and Q),and CC is the column (01 to 20). This is the sort order
of the report.
Accession Number – the scanned accession barcode number, if one exists
Sequence Number – the scanned tube barcode sequence number
Growth Unit – the last growth unit reading
Tube Status – = for ongoing, + for positive, +T for threshold positive, – for negative, ?
for anonymous, ! for error
TIP/TTD – the time in protocol or time to detection, in the form D;HH, where D
represents the number of days and HH the number of hours from the start of protocol
(when the first instrument test occurred) to the time the tube was removed from the
instrument or declared positive. If asterisks appear in this field, it indicates that the value
is not available.
Protocol Length – the number of days of the assigned testing protocol
Start of Protocol – the date and time of the first instrument test

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BACTEC MGIT 960

Instrument Inventory Report
Instrument Current Temperature Software Page Drawer
Number Date/Time A B C Version Number Number
1 10/17/98 23:59 36.5 C 37.1 C 36.8 C V2.00Y 1 A

Tube Accession Sequence Growth Tube TIP/ Protocol Start of

Position Number Number Unit Status TTD Length Protocol
A/A01 1713 4399223366 0 = 40;5 42 09/08/98 14:12
A/A02 1714 4399223367 0 ? 40;5 42 09/08/98 14:12
A/A03 1715 4399223368 0 = 40;5 42 09/08/98 14:12
A/A04 1716 4399223369 0 = 40;5 42 09/08/98 14:12
A/A05 1717 4399223370 3213 + 40;5 42 09/08/98 14:12
A/A06 1718 4399223371 4 = 40;5 42 09/08/98 14:12
A/A07 1719 4399223372 0 ! 40;5 42 09/08/98 14:12
A/A08 1720 4399223373 0 = 40;5 42 09/08/98 14:13
A/A09 1721 4399223374 0 – 42;5 42 09/06/98 06:13
A/A10 1722 4399223375 48 +T 42;5 42 09/06/98 06:13
A/A11 1723 4399223376 0 – 42;5 42 09/06/98 06:13
. . . . . . . .
. . . . . . . .
. . . . . . . .

Figure 5-6 – Sample Instrument Inventory Report

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5.5.5 Quality Control Report

The Quality Control Report lists the status of all the detectors in the instrument with the date and
time of their last verification. The report also lists all manually blocked stations. This report can be
used to comply with CLIA requirements for instrument quality control.
You can print the Quality Control Report by pressing the soft keys below the following icons:

to access report selection to print the report

A sample Quality Control Report is shown in Figure 5-7.

The Quality Control Report provides the following information:
Report Header
Title (Quality Control Report)
Instrument number
Current date and time
Current drawer temperatures
Current system software version
Page number
Retention date (the date until which the report should be retained for CLIA compliance)
Detector Status
Row Designation – in the form D/R, where D is the drawer letter (A, B, or C) and R is the
Row (A through S, omitting I, O, and Q). This is the sort order of this section of the
report.
Sensor/Row Status – ' for pass, X for fail, ? for unknown
Test Date/Time – the date and time of the detector verification test
Manually Blocked Stations
A list of stations that have been blocked through the Block Stations function, in the form
D/RCC, where D is the drawer letter (A, B, or C), R is the Row (A through S, omitting I, O,
and Q),and CC is the column (01 to 20). This is the sort order of this section of the
report.
Technologist’s Signature/Date
Space is provided for the laboratory technologist to sign and date the report.

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BACTEC MGIT 960

Quality Control Report
Instrument Current Temperature Software Page Retention
Number Date/Time A B C Version Number Date
1 10/17/96 23:59 36.5 C 37.1 C 36.8 C V1.03E 1 10/17/98

Detector Status
Row Sensor / Row Test
Designation Status Date/Time
A/A ' 10/17/96 12:00
A/B X 10/17/96 12:00
A/C ?
. . .
. . .
. . .
C/S ' 10/17/96 12:00

Manually Blocked Stations

A/J15

END OF BLOCKED STATIONS

Technologist's Signature / Date

Figure 5-7 – Sample Quality Control Report

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 Maintenance
6.1 General
The BACTEC® MGIT™ 960 instrument requires minimal maintenance from the user to provide
reliable performance. Daily verifications include: checking the incubator temperature, printer paper
supply, and verifying indicator lamp operation. Routine preventive maintenance consists only of a
monthly changing or cleaning of the cabinet air filters and replacement of calibrator vials when they
expire. 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.

WARNING

ALL MAINTENANCE AND REPAIR OTHER THAN THE PROCEDURES

DESCRIBED IN SECTION 6.2 – ROUTINE MAINTENANCE AND
SECTION 6.3 – MODULE REPLACEMENT, MUST BE PERFORMED BY
QUALIFIED SERVICE PERSONNEL.

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6.2 Routine Maintenance

6.2.1 Daily Maintenance
Each day several simple maintenance procedures should be performed. The best time to perform
maintenance is first thing in the morning, but it may be done any time you find convenient. An
instrument maintenance log is provided in Figure 6-1. The following procedures should be
performed:
1 Check the printer’s paper supply. If the paper supply is low or exhausted, replace the paper
as explained in the manufacturer’s operating instructions.
2 Verify the operation of the drawer and station indicator lamps. To perform lamp verification,
make sure all the drawers are closed. When the drawers are closed, the Main Status screen
appears:

Press the “maintenance” soft key:

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Maintenance

Press the “test indicators” soft key:

Press the “test drawer indicators” soft key:

All three external indicator lamps on all three drawers should light, as well as the instrument
Alarm indicator. If any does not, contact Becton Dickinson to arrange replacement of the
indicator.
Open drawer A. The soft key definitions now change to allow tests of station status LEDs.
Press the “test green LEDs” soft key:

All the green LEDs at all the stations should light. If any does not, you should block the sta-
tion(s) as described in Section 6.2.3.2 – Blocking a Station. Press the “test green LEDs” soft
key again to extinguish the green LEDs.
Now press the “test red LEDs” soft key:

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All the red LEDs at all the stations should light. If any does not, you should block the sta-
tion(s) as described in Section 6.2.3.2 – Blocking a Station. Press the “test red LEDs” soft
key again to extinguish the red LEDs.
Repeat the tests of red and green station status LEDs for drawers B and C.
3 Three thermometers in special tubes are provided for temperature verification (QC) of
instrument incubation. It is at the discretion of each laboratory to determine if they wish to
perform temperature QC, at what frequency, and which stations. Three thermometers/tubes
enable you to place one in each drawer, if desired.
DO NOT FILL ANY OF THE TUBES WITH LIQUID. The most accurate readings of drawer incuba-
tion are obtained without liquid in the special tube.
It is recommended that the accuracy of the thermometer be verified against a calibrated lab
thermometer to insure the validity of the temperature verification.
Note that drawer openings and closings can affect the temperature of tubes, including the
temperature QC tube. It is strongly recommended that temperature verification be per-
formed first thing in the morning. If not, select a time when the drawers have remained
closed for a few hours. This will provide the most accurate readings of tube temperatures.
Select the drawer to be verified and the station into which you want to place the tempera-
ture QC tube. To prevent the system from trying to test the temperature QC tube in this sta-
tion, you should block it from use. See Section 6.2.3.2 – Blocking a Station, for
instructions on how to perform this activity.
After the desired station is blocked, place the tube/thermometer into the station. The ther-
mometer is already inserted in the tube and should not be removed – temperatures can be
read through the tube.
If your manual reading is within +1.0°/–2.0° C of 37° C, the controller and heaters are oper-
ating within their specifications. The instrument’s temperature controller is designed to
maintain cabinet temperatures within this range.
If you move the tube/thermometer to a different station, remember to unblock the current
station (Section 6.2.3.3 – Unblocking a Station) and to block the new station you select.
4 From the Main Status screen, press the “temperature” soft key to view drawer temperature
readings. Verify that the drawer temperatures are currently within 1.5° C of the manual
readings for each of the drawers. If the readings are not within this range, refer to the
instructions in Section 7 – Troubleshooting.

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Maintenance

BACTEC® MGIT™ 960 Maintenance Log

For Month of_________________
Check Temperature
Check Drawer Check Station
Check Probes
Indicators Indicators
Date Print (37.0° C + 1°/-2° C) Initials
Paper A B C
A B C A B C
R/G R/G R/G
1 / / /
2 / / /
3 / / /
4 / / /
5 / / /
6 / / /
7 / / /
8 / / /
9 / / /
10 / / /
11 / / /
12 / / /
13 / / /
14 / / /
15 / / /
16 / / /
17 / / /
18 / / /
19 / / /
20 / / /
21 / / /
22 / / /
23 / / /
24 / / /
25 / / /
26 / / /
27 / / /
28 / / /
29 / / /
30 / / /
31 / / /

Figure 6-1 – Instument Maintenance Log

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6.2.2 Periodic Maintenance

6.2.2.1 Air Filter Replacement

WARNING

WHEN REPLACING THE AIR FILTERS, USE APPROPRIATE PROCEDURES

FOR HANDLING POTENTIALLY HAZARDOUS MATERIAL.

Change or clean the air filters behind the bottom faceplate monthly. If the instrument’s environment
is especially dusty, check the filters more frequently. These filters must remain clean and
unobstructed; restricted air flow may cause the instrument interior 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 6-2.
Required Material
New or clean air filters
To Replace the Air Filters
1 The air filters are located behind the instrument’s bottom faceplate. To remove the
faceplate, grasp the faceplate along its bottom edge at the finger holes. Gently but firmly
pull straight out. The faceplate will pop free with medium force.
2 To remove a filter, lift it up slightly, then pivot the bottom outward. Lower the filter out of
the filter housing.
3 Wash the filter in a mycobactericidal disinfectant. Place it on a paper towel and dry it
thoroughly (if you are going to reuse it immediately).
4 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.
5 To replace the faceplace, hold it in place (the cutout should surround the On/Off Switch) and
firmly press in toward the instrument. The faceplate will snap into place.

• Lift filter up slightly

• Pivot bottom outward
• Lower filter out of housing

Figure 6-2 – Air Filter Replacement

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Maintenance

6.2.2.2 Calibrator Replacement

Calibrator tubes, located in stations in the far left column of each drawer, must be replaced prior to
their expiration. Expiration replacement involves removing and replacing all the calibrator tubes in
the drawer. Becton Dickinson personnel may also recommend replacing individual calibrator tubes as
a means of troubleshooting possible detector malfunctions for a given row. A calibration log is
provided in Figure 6-3.
Calibrator tube replacement is a two-stage process: first you physically replace the actual calibrator tubes,
and second you inform the system software that you have replaced them. See Figures 6-4 and 6-5.
Required Materials
New calibrator tube(s)
To Replace Calibrator Tubes
1 Open the desired instrument drawer. The calibrator tubes are located beneath a protective
cover in the leftmost column of stations in each drawer. To remove the protective cover, lift
the four black push-pull fasteners that hold it in place. Then lift the cover off.
2 Remove the desired calibrator tube(s) and dispose of them in accordance with your
institution’s policies and procedures.
3 Place the new calibrator tube(s) in the calibrator station(s).
4 Close the drawer. Insure that all instrument drawers are closed. From the Main Status screen,
press the “maintenance” soft key.

Press the “maintenance” soft key four more times, until the maintenance display numbered
5/5 (replace calibrator tubes) appears. The following icon is shown in the main body of the
display:

5 Open the desired drawer. If you are replacing all the calibrators in the drawer, make sure the
display reads X/*00 (where X is the drawer letter) and press the “ok” soft key. If you are
replacing only one (or more than one, but less than all) calibrator tube, use the UP ARROW
or DOWN ARROW key to change the row value that is displayed. When the correct row
appears, press the “ok” soft key:

or

Repeat the selection process if more than one (but less than all) calibrator tube is replaced.
This step informs the system software that one or more calibrators have been replaced.
6 Close the drawer. Repeat Step 5 for the other drawers if necessary.
7 Press the “exit” soft key when complete.

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BACTEC® MGIT™ 960 Calibration Log

Calibrator Current Lot Number/ New Lot Number/
Date Replaced
Station Expiration Date Expiration Date
A/A00
A/B00
A/C00
A/D00
A/E00
A/F00
A/G00
A/H00
A/J00
A/K00
A/L00
A/M00
A/N00
A/P00
A/R00
A/S00
B/A00
B/B00
B/C00
B/D00
B/E00
B/F00
B/G00
B/H00
B/J00
B/K00
B/L00
B/M00
B/N00
B/P00
B/R00
B/S00
C/A00
C/B00
C/C00
C/D00
C/E00
C/F00
C/G00
C/H00
C/J00
C/K00
C/L00
C/M00
C/N00
C/P00
C/R00
C/S00

Figure 6-3 – Calibration Log

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Maintenance

Lift 4 black
push-pull
fasteners

Figure 6-4 – Calibrator Replacement (A)

Remove calibrator vials

and replace with new ones

Figure 6-5 – Calibrator Replacement (B)

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6.2.3 “As Needed” Maintenance

6.2.3.1 Cleaning the Barcode Scanner Window
There are no user-serviceable parts in the barcode scanner. After a period of use, you may find that
the barcode scanner does not seem to scan barcode labels as easily as before. If this happens, you
can try to solve the problem by cleaning 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.

Barcode Scanner Window

Figure 6-6 – Barcode Scanner Window

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Maintenance

6.2.3.2 Blocking a Station

Blocking a station designates the station as unavailable for testing. Some stations are blocked
automatically by the system (e.g., when a detector fails). You may occasionally need to manually
block a station, such as to place a temperature QC tube in it.
To Block a Station
1 Make sure all the drawers are closed. When the drawers are closed, the Main Status screen
appears:

2 Press the “maintenance” soft key:

3 Press the “maintenance” soft key again, until the maintenance display numbered 2/5 (block/
unblock stations) appears. The following icon is shown in the main body of the display:

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4 Open the desired drawer. The “block station” soft key now appears in the soft key definition
area.

5 Press the “block station” soft key. The first unblocked station in the drawer now appears in
the main body of the display. Initially, the column value of the station is highlighted. If the
column value is not correct, press the UP ARROW or DOWN ARROW key until the correct
column number appears. If the row value is not correct, press the “move to other field” soft
key to highlight the row value. Then press the UP ARROW or DOWN ARROW key to change
the row value until the correct row number appears.
6 When the correct station number is displayed, press the “block station” soft key to block the
station. Repeat Step 5 if neccessary to block additional stations.
7 If necessary, insert a bad station plug into any stations you block to prevent their inadvertent
use.
8 When all the desired stations are blocked, press the “exit” soft key.
6.2.3.3 Unblocking a Station
Unblocking a station returns a blocked station (which was unavailable for testing) to service. Note
that stations that were blocked automatically by the system (e.g., when a detector fails) cannot be
unblocked unless the detector or calibrator is replaced. Stations that you blocked manually (such as
to place a temperature QC tube in it) can be unblocked through the Unblock Station function.
To Unblock a Station
1 Make sure all the drawers are closed. When the drawers are closed, the Main Status screen
appears:

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Maintenance

2 Press the “maintenance” soft key:

3 Press the “maintenance” soft key again, until the maintenance display numbered 2/5 (block/
unblock stations) appears. The following icon is shown in the main body of the display:

4 Open the desired drawer. The “unblock station” soft key now appears in the soft key
definition area.

5 Press the “unblock station” soft key. The first blocked station in the drawer now appears in
the main body of the display. Initially, the column value of the station is highlighted. If the
column value is not correct, press the UP ARROW or DOWN ARROW key until the correct
column number appears. If the row value is not correct, press the “move to other field” soft
key to highlight the row value. Then press the UP ARROW or DOWN ARROW key to change
the row value until the correct row number appears.
6 When the correct station number is displayed, press the “unblock station” soft key to
unblock the station. Repeat Step 5 if neccessary to unblock additional stations.
7 Be sure to remove any bad station plugs you may have previously inserted for stations you
are unblocking.
8 When all the desired stations are unblocked, press the “exit” soft key.

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6.2.3.4 Replacing a Barcode Label

Extra barcode labels are included in the instrument start-up kit. These labels can be used to replace
damaged or unreadable labels on culture tubes. The barcode labels contain sequence numbers
which uniquely identify each tube. Note that once a tube is assigned to a station, the tube’s
sequence number cannot be changed. Therefore, barcode labels should only be replaced before the
tube is entered in the instrument.
Required Materials
New barcode label
To Apply a New Barcode Label
1 Insure that the area where the defective label is located is clean and dry. If the old label is
wrinkled or creased, peel off as much as possible to make a smooth surface on which to
apply the new label.
2 Peel off the new barcode label. Verify that the new label is printed clearly and that no
smears, smudges, or other markings obstruct the lines of the bar code.
3 Press the new label into place, being careful not to create any bubbles or ridges in the bar
code area.
6.2.3.5 Decontamination

WARNING

IN THE EVENT OF TUBE LEAKAGE OR BREAKAGE:

1) CLOSE THE INSTRUMENT DRAWERS;
2) TURN OFF THE INSTRUMENT;
3) VACATE THE AREA IMMEDIATELY;
4) CONSULT YOUR FACILITY/CDC GUIDELINES.

AN INOCULATED LEAKING OR BROKEN TUBE MAY PRODUCE

AN AEROSOL OF MYCOBACTERIA; APPROPRIATE HANDLING
SHOULD BE OBSERVED.

If a leakage or spill is limited to the surface of the drawer tube holder, the top surface can be cleaned
with mycobactericidal disinfectant. It is recommended that the instrument be turned off during any
cleaning activity to reduce the potential of aerosol production.
If a leakage or spill is discovered in any drawer and the instrument has not yet been turned off,
immediately turn off the instrument power switch. Close the affected drawer, follow the previous
recommendations as stated in the WARNING box, and contact Becton Dickinson.
Documentation of decontamination must be presented to a Becton Dickinson representative upon
request prior to any service.

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Maintenance

6.2.3.6 Reuniting Separated Mercury Columns on Thermometers

If the mercury column in your temperature QC thermometer becomes separated, the techniques
below can be used to reunite the mercury.
1 Should there be a separation in the upper part of the capillary or in the expansion chamber
at the top, put the bulb in boiling water. Allow the mercury column and the separation to
enter the expansion chamber. Remove the thermometer from the boiling water, and quickly
tap it on the surface of a large rubber stopper so that the separation joins with the main
column while in the expansion chamber. Allow to cool, and re-examine the thermometer
before putting into service.
2 Should separation occur in the lower portion of the column, cool the bulb in a mixture of
methanol and dry ice. Allow the mercury column and the separation to retreat into the bulb.
Keep the thermometer in an upright position. As soon as the mercury column and the
separation enter the cone of the bulb (upper portion), remove the thermometer from the
mixture, and swing it in a short arc to reunite the mercury. Permit the bulb to warm up, and
the column to re-enter the capillary tube before touching the bulb. Check to make sure the
column is united before putting the thermometer into service.

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BACTEC® MGIT™ 960 System User’s Manual

6.3 Module Replacement

6.3.1 General
The BACTEC® MGIT™ 960 instrument has been designed and tested for troublefree performance.
However, in the event of a malfunction, several of the major system components can be replaced.
Procedures for removing and replacing components are provided in the sections that follow.
Replacement modules may be swapped for failed modules which are then returned 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.

WARNING

INSTRUMENT POWER SHOULD BE TURNED OFF, AND THE POWER

CORD SHOULD BE DISCONNECTED, BEFORE BEGINNING ANY
MODULE REPLACEMENT PROCEDURE.

The following module replacement instructions are provided:

• Top Panel Removal
• Top Faceplate Removal
• Bottom Faceplate Removal
• Barcode Scanner
• Floppy Disk Drive
• LCD Display
• Speaker

6.3.2 Top Panel Removal

The instrument’s top panel must be removed to replace any of the other components or modules in
this section. Refer to Figure 6-7.
Required Materials
Medium flat head screwdriver
Medium phillips screwdriver

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Maintenance

To Remove the Top Panel

1 The four screws that hold the top panel to the instrument’s frame are located along the rear
edge of the top panel. Loosen the four screws with the screwdriver (they are captive
fasteners and should be loosened, not removed).
2 When the screws are loosened, slide the top panel rearward until the front lip clears the top
edge of the top faceplate.
3 Lift the top panel up and off the instrument.
4 Remove the four phillips screws and washers attaching the inner panel to the frame. Use the
flat head screwdriver to lift one of the panel’s corners, then lift the panel off.
5 Replace the top panel by reversing the above steps.

• Unscrew 4 screws
• Pull panel rearward and lift off

(Rear of Instrument)

Figure 6-7 – Top Panel Removal

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BACTEC® MGIT™ 960 System User’s Manual

6.3.3 Top Faceplate Removal

The instrument’s top faceplate must be removed to replace the LCD display assembly. Refer to
Figures 6-8 and 6-9.
Required Materials
Medium flat head screwdriver
To Remove the Top Faceplate
1 Remove the top panel as described in Section 6.3.2 – Top Panel Removal.
2 Unplug the two cables that connect the floppy disk drive to the Control Electronics Module.
Disconnect these cables at the disk drive.
3 Unplug the six cables that connect the other top faceplate components to the Control
Electronics Module. Four of these cables are connected at points J8, J11, J13, and J16 (the
“J” numbers are stencilled in white on the board). The other two cables connect to the
middle board of the three piggyback stack boards and the “J” designations may not be
visible.
4 Unscrew the four screws that hold the top faceplate to the instrument’s frame.

CAUTION
One person should stand at the front of the instrument and hold the
top faceplate as the four screws are removed. If left unsupported, the
faceplate can fall when the fourth screw is loosened.

5 Replace the top faceplate by reversing the above steps. When plugging cables back into the
Control Electronics Module, be sure you carefully align the cable connectors with the
connectors on the board, and that you plug the correct cables into the correct connectors.

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Maintenance

Unplug 6 cables

(Toward front
of instrument)

Figure 6-8 – Top Faceplate Removal (A)

Unscrew 4 screws while supporting faceplate

Figure 6-9 – Top Faceplate Removal (B)

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6.3.4 Bottom Faceplate Removal

The instrument’s bottom faceplate must be removed to replace the air filters and to access circuit
breakers CB2 – CB7.
To Remove the Bottom Faceplate
1 To remove the faceplate, grasp the faceplate along its bottom edge at the finger holes.
Gently but firmly pull straight out. The faceplate will pop free with medium force.
2 To replace the faceplace, hold it in place (the cutout should surround the On/Off Switch) and
firmly press in toward the instrument. The faceplate will snap into place.

6.3.5 Barcode Scanner Replacement

The barcode scanner is mounted in the top faceplate on the right side (when facing the front of the
instrument). Refer to Figures 6-10 and 6-11.
Required Materials
Medium flat head screwdriver
Small phillips screwdriver
To Replace the Barcode Scanner
1 Remove the top panel as described in Section 6.3.2 – Top Panel Removal.
2 The cable that connects the scanner to the Control Electronics Module is held in place by
two small phillips screws. This cable connects to the board at point J16, and is located on
the right side of the module when facing the front of the instrument. Unscrew the phillips
screws and unplug the cable.
3 Unscrew the two flat head screws that hold the scanner mounting bracket to the top
faceplate. (These screws should be completely loosened but not removed.) Remove the
scanner.
4 Replace the scanner by reversing the above steps.

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Maintenance

Unplug cable

(Toward front
of instrument)

Figure 6-10 – Barcode Scanner Removal (A)

Unscrew 2 screws

Figure 6-11 – Barcode Scanner Removal (B)

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6.3.6 Floppy Disk Drive Replacement

The floppy disk drive is mounted in the top faceplate on the left side (when facing the front of the
instrument). Refer to Figure 6-12.
Required Materials
Medium flat head screwdriver
To Replace the Floppy Disk Drive
1 Remove the top panel as described in Section 6.3.2 – Top Panel Removal.
2 The cables that connect the floppy disk drive are located on the right side of the module
when facing the rear of the instrument, and are labeled J1 and J2. Disconnect these cables
at the disk drive.
3 Unscrew the three flat head screws that hold the floppy disk drive mounting bracket to the
instrument’s frame. (These screws should be completely loosened but not removed.)
Remove the floppy disk drive.
4 Replace the floppy disk drive by reversing the above steps. When plugging cables back into
the Control Electronics Module, be sure you carefully align the cable connectors with
the connectors on the drive.

Loosen 3 screws

Unplug 2 cables

Figure 6-12 – Floppy Disk Drive Replacement

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Maintenance

6.3.7 Liquid Crystal Display (LCD) Assembly Replacement

The LCD Assembly is mounted in the center of the top faceplate. Refer to Figure 6-13.
Required Materials
Medium flat head screwdriver
Medium phillips screwdriver
To Replace the LCD
1 Remove the top panel as described in Section 6.3.2 – Top Panel Removal.
2 Remove the top faceplate as described in Section 6.3.3 – Top Faceplate Removal.
3 Lay the faceplate face down on a soft surface.
4 Remove the 4 screws that hold the LCD Assembly to the faceplate. Remove the LCD Assembly.
5 Replace the LCD Assembly by reversing the above steps. When replacing the four screws, do
not tighten any of the screws until all four have been inserted in place.

Remove 4 screws

Figure 6-13 – Liquid Crystal Display (LCD) Replacement

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6.3.8 Speaker Replacement

The speaker is mounted to the right of the LCD display (when facing the front of the instrument).
Refer to Figures 6-14 and 6-15.
Required Materials
Medium flat head screwdriver
Medium phillips screwdriver
To Replace the Speaker
1 Remove the top panel as described in Section 6.3.2 – Top Panel Removal.
2 Locate the cable from the speaker to the Control Electronics Module. The cable plugs into a
small connector on the front edge of the board (connector J11 – see Figure 6-12). Unplug
this cable.
3 Unscrew the four phillips screws that hold the speaker to the cabinet frame. Remove the
speaker.
4 Replace the speaker by reversing the above steps.

Unplug
cable

(Toward front
of instrument)

Figure 6-14 – Speaker Replacement (A)

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Maintenance

Unscrew 4 phillips screws

Figure 6-15 – Speaker Replacement (B)

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 Troubleshooting
7.1 General
7.1.1 Instrument Service
If your BACTEC® MGIT™ 960 instrument malfunctions or operates unusually in any way, you may
initially attempt to solve the problem by following the recommendations in this section. All other
servicing attempts will terminate the responsibility of the manufacturer under the terms of the
warranty.
If you cannot repair a system malfunction, contact your local Becton Dickinson representative
(contact numbers are listed in Appendix D).
This section discusses error messages, which appear when the system has encountered a known
problem. These messages are listed in numerical order, along with possible causes of the message
and corrective actions.

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7.2 Error/Alert Messages

CAUTION
When the system notifies you of alerts and errors, you should
immediately respond to the condition.

When the system encounters an alert or error condition, the error code (EXX, where XX is a two-digit
number) is either displayed on the screen or written into the system alert log. The error code is an
abbreviation for the conditions described in the listing below.
Codes in the E30 series (E30, E31, etc.) are displayed on the screen when they occur. (They also cause
the Activity Error tone to sound [sequence of short high beep and short low beep repeated four
times].) These are activity (or “workflow”) types of errors. In most cases, this means that some action
you have performed was not what the system expected, but you can usually perform the correct
action, as recommended below, without exiting the current operation. These activity errors are
flagged by the Activity Error icon:

System alerts, which comprise all error codes except those in the E30 series, are reported in the
system alert log. These errors cause the Alert tone (medium beep on for one second, off for 3
seconds, repeating) to sound (if it is enabled). Also the System Alert icon appears on the Main Status
screen. The errors must be reviewed to clear the system alert condition. The system alert log can be
viewed from the Main Status screen by pressing the “system alert” soft key:

The error messages are listed in numerical order. Error sub-codes are 8-digit numeric codes that
appear below the EXX readout on the system alert log. The sub-codes indicate specific conditions
detected. Many sub-codes are listed in the “Possible Causes” and “Corrective Actions” sections
below.

CAUTION
If any error sub-codes other than those listed here appear, note the
sub-code and contact Becton Dickinson for assistance.
If the recommended corrective actions do not solve the problem,
contact Becton Dickinson.

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Troubleshooting

E01 Positivity algorithms reset

The software algorithms that determine tube positivity have been reset. This message is
informational.
POSSIBLE CAUSE(S)
• Another E type of error code (such as E02, E05, etc.) precedes the occurrence of E01.
CORRECTIVE ACTION(S)
* E01 is an informational message, and requires no corrective action per se. It is important
that whenever an error condition occurs, you acknowledge the error by reviewing the
system alert log, and take the recommended corrective action (if any).

E02 Temperature alarm

An incubator or drawer temperature is too high (02, 08, 20, or 40) or too low (01, 04, 10). Any of
these numbers can appear in the 8-digit subcode in any of the following positions: zzyyxxww, where
zz represents a condition for Drawer C, yy a condition for Drawer B, xx a condition for Drawer A, and
ww a condition for the cabinet air. (For example, code E01 might show subcode 01202000, meaning
there is a high temperature condition in Drawers C, B, and A.)
POSSIBLE CAUSE(S)
• Drawer was kept open too long.
• Room temperature is not within recommended range, or other environmental specification
is not being met (such as instrument sitting in direct sunlight).
• Air filters are dirty, restricting fresh air intake.
CORRECTIVE ACTION(S)
* Check current air and plate temperatures on LCD display (Configuration display #2) to see if
temperature is still too high or too low.
* Minimize number and duration of drawer openings.
* Make sure environmental specifications are met (see Section 2 – Installation).
* Clean or replace air filters.
* Check temperature QC tubes to see if manual readings agree with displayed readings.

E04 Flash cache error

POSSIBLE CAUSE(S)
• System encountered a software error.
CORRECTIVE ACTION(S)
* Write data to disk (see Section 7.3) and call Becton Dickinson.

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BACTEC® MGIT™ 960 System User’s Manual

E05 Calibration error

A calibrator tube reading is out of tolerance (see chart to determine which calibrator). Below the E05
readout, three sub-codes are shown. The first row of sub-codes represents Drawer A, the second
row of sub-codes represents Drawer B, and the third row of sub-codes represents Drawer C. If the
sub-code 00000000 appears in the row, there is no problem in that drawer. If any numbers appear
in the row, refer to the chart below to determine which row within the drawer has caused the
problem. If a number other than those in the chart appears, contact Becton Dickinson.
SAMPLE CALIBRATION ERROR READOUT
E05 (Calibration error code)
00000001 (Sub-code for Drawer A; per chart, indicates Row A failure)
00000000 (Sub-code for Drawer B; indicates no calibrator failure)
00000040 (Sub-code for Drawer C; per chart, indicates Row G failure)

POSSIBLE CAUSE(S)
• Calibrator tube failure.
• Debris or spilled media inside instrument is affecting calibration readings.
CORRECTIVE ACTION(S)
* Check that there is no debris or spilled media inside instrument. Clean if necessary.
* If error recurs, replace calibrator tube at the row as indicated by the sub-code in the chart
below.

Row A: 00000001 Row E: 00000010 Row J: 00000100 Row N: 00001000

Row B: 00000002 Row F: 00000020 Row K: 00000200 Row P: 00002000

Row C: 00000004 Row G: 00000040 Row L: 00000400 Row R: 00004000

Row D: 00000008 Row H: 00000080 Row M: 00000800 Row S: 00008000

E06 Detector Error

POSSIBLE CAUSE(S)
• Detector assembly motion was impeded.
• One of the station, home, or end flags was not read by the detector.
CORRECTIVE ACTION(S)
* Look for and if necessary remove any object impeding motion of detector assembly.

7–4 MA-0117-D(Prelim)
 )
Troubleshooting

E07 Power supplies high/low

POSSIBLE CAUSE(S)
• Temporary electrical anomaly.
CORRECTIVE ACTION(S)
* Reboot instrument.

E08 Drawer voltage high/low

POSSIBLE CAUSE(S)
• Temporary electrical anomaly.
• Line voltage is out of spec.
• Air filters are dirty, restricting fresh air intake.
CORRECTIVE ACTION(S)
* Reboot instrument.
* Check/correct line voltage to instrument.
* Clean or replace air filters.

E09 No tests in over 4 hours

POSSIBLE CAUSE(S)
• Instrument has been off for longer than 4 hours.
• Four consecutive test cycles were missed (e.g., due to drawer openings).
• System clock was set more than 4 hours ahead.
CORRECTIVE ACTION(S)
* 20000000 – Investigate why no tests have occurred in 4 hours. If this error occurs and none
of the above events happened, use the “write data to disk function” (see Section 7.3) and
contact Becton Dickinson.

E10 Database corruption

POSSIBLE CAUSE(S)
• Database checksum test failed.
CORRECTIVE ACTION(S)
* Write data to disk (see Section 7.3) and call Becton Dickinson.
* 00000002, 00000008 – All tubes should be incubated offline and read manually according
to the procedure in Appendix E.

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BACTEC® MGIT™ 960 System User’s Manual

E11 Printer error

POSSIBLE CAUSE(S)
• Printer paper is jammed or exhausted.
• Printer cable is disconnected during printing.
• Printer power is turned off during printing.
• Printer was taken offline during printing.
CORRECTIVE ACTION(S)
20000000
* Check paper and clear jam or add paper if necessary.
* Check printer cables (power and communications), reattach if necessary.
* Turn printer power on.
* Place printer online.
* Request report again. It will not resume printing automatically when error condition is
corrected. .

E12 Station error

NOTE

The E12 message is the corresponding System Alert to the Resolving

Station Errors activity discussed in Section 4.9.

POSSIBLE CAUSE(S)
00000001, 00000002, 00000004, 00000008, 00000020
• System cannot detect a tube in a station where one should be. The tube may not be seated
in the station completely, or may have been pulled out of the instrument without being
scanned out.
• Tube is in a row in which a calibrator tube failed.
CORRECTIVE ACTION(S)
* If tube is in station, or was removed but you have now located it, use the “resolve station
errors” activity (Section 4.9) to scan the tube barcode label. If the station was in a
“hardware” error condition (such as with errors E05 and E06), the current station will be
blocked from use and the tube will be relocated to a new station (if one is available). If the
station was in a “software” error condition (error E12 with any of the sub-codes listed
above), the error condition is cleared after you scan the barcode label and confirm the error
resolution.
* If the tube cannot be located, press the “force station available” soft key. This forces the
tube’s protocol to be terminated and clears the error condition. Tubes that are cleared in
this manner are given the following status on reports: tubes with a status of positive are
reported as positives; tubes with a status of negative are reported as negatives; tubes with a
status of ongoing are reported as errors.

7–6 MA-0117-D(Prelim)
 )
Troubleshooting

* Always be sure tubes are fully seated when placing them into stations.
* To avoid station errors, always use one of the tube removal activities (such as remove
positive tubes or remove negative tubes) to scan the tube out of the station when you
remove it. .

E13 Power Failure

POSSIBLE CAUSE(S)
• Power was removed from instrument.
CORRECTIVE ACTION(S)
* Message is informational. If multiple power failures have occurred, only the latest one is
reported in the alert list. Note the power failure and restore times in your instrument log.
* If power is lost to the BACTEC® MGIT™ 960 instrument for more than 24 hours, it is strongly
recommended that all BBL® MGIT™ 7 ml tubes in the instrument be removed and incubated
offline at 37° C. These tubes must be read manually throughout the eight week protocol
according to the supplemental procedure in Appendix E.

E30 Unexpected tube was scanned

POSSIBLE CAUSE(S)
• During the remove positive tubes, remove negative tubes, or resolve station errors activities,
the tube barcode you scanned is not the one the system expected for the station. Either you
pulled a tube from a different station than the one specified; or more than one tube has
been placed in the wrong station.
CORRECTIVE ACTION(S)
* If the station is still displayed on the activity screen, verify that you pulled the tube from the
specified station. If you did not (you will know because a tube is still in that station), press
the “exit” soft key, then press the “tube entry” soft key. Scan the tube barcode label and
place the tube where the system indicates. If there is a tube in the indicated station, do
not remove that tube to “swap” locations. Go to + below.
* If you pulled the tube from the specified station, then multiple tubes may be misplaced. You
must determine how many tubes are misplaced, and where they are located. It may be
helpful to print an Instrument Inventory Report for the drawer, add a column labeled “actual
station,” and relabel the existing station column as “assigned station.” If you prefer, you can
draw a chart, with one column labeled “tube sequence number,” a second column labeled
“assigned station,” and a third column labeled “actual station.”
Write down the tube sequence number of the tube that was just removed. Write the station
specified on the activity screen in the “actual station” column.
Press the “exit” soft key, then press the “tube entry” soft key. Scan the tube barcode label,
and write the station in the “assigned station” column of your chart. There will be a tube in
this station.

+ Place the first misplaced tube aside – its results must be confirmed manually (either
through AFB stain or reading manually as described in Appendix E). Tube test results cannot
be transferred reliably among multi-station misplacements.

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BACTEC® MGIT™ 960 System User’s Manual

Remove the tube from the station currently displayed on the tube entry screen. Write this
tube sequence number on the chart, as well as the actual station. Now scan the current tube
barcode label. Write the station now displayed in the “assigned station” column. Place this
tube aside for manual confirmation/reading.
Go to the station now displayed. If there is a tube in this station, repeat the steps in the
previous paragraph. Continue to do so until the actual station matches the assigned station,
or until there is no tube in the assigned station. When one of these conditions occurs, you
have probably reached the end of the tube misplacements.
* All tubes involved in misplacement scenarios must be confirmed manually (either stained for
AFB or incubated offline and read manually as described in Appendix E). Keep the tubes at
room temperature until the next test cycle, when the station errors are flagged.
* When the next test cycle or drawer scan occurs, any stations from which tubes were
removed will go into error. Resolve all the station errors as described above under error E12
and in Section 4.9 after the misplaced tubes have been tested manually.

E31 Diskette error

POSSIBLE CAUSE(S)
• Floppy disk is not inserted.
• Floppy disk is not formatted.
• Floppy disk is write-protected.
• Floppy disk is full.
CORRECTIVE ACTION(S)
* Insert formatted floppy disk.
* Move write-protect tab toward center of floppy disk.
* Use a new floppy disk.

E32 Drawer full

POSSIBLE CAUSE(S)
• During Tube Entry or Resolve Station Errors, the system tried to allocate a station in the
current drawer but found that none are available.
CORRECTIVE ACTION(S)
* Try entering the tube in another drawer (with available stations). If there are no available
stations in other drawers, remove final negative tubes (or optionally, ongoing tubes near the
end of protocol) if any exist. If room cannot be made, the tube should be tested manually.

7–8 MA-0117-D(Prelim)
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Troubleshooting

E33 Moved tube with no error

POSSIBLE CAUSE(S)
• The system has detected a tube in a station that does not have a tube assigned to it (i.e., an
anonymous tube). When you are identifying anonymous tubes, the system does not expect
a known barcode to be scanned (if it knows the barcode, that means the tube was
previously scanned in and assigned to a different station). Scanning a known barcode during
the identify anonymous activity causes this error to occur. The two main causes of the error
are: 1) you pulled a tube from a different station than the one specified in the identify
anonymous screen; or 2) more than one tube has been placed in the wrong station.
CORRECTIVE ACTION(S)
* To correct the error condition, you have to determine: 1) whether you pulled the wrong tube
or tubes have been misplaced; 2) if tubes are misplaced, where does the instrument think
they should be; and 3) where tubes are actually located.
* If the station is still displayed on the identify anonymous screen, verify that you pulled the
tube from the specified station. If you did not (you will know because a tube is still in that
station), press the “exit” soft key, then press the “tube entry” soft key. Scan the tube
barocde label and place the tube where the system indicates. If there is a tube in the
indicated station, do not remove that tube to “swap” locations. Go to + below.
* If you pulled the tube from the specified station, then multiple tubes may be misplaced. You
must determine how many tubes are misplaced, and where they are located. It may be
helpful to print an Instrument Inventory Report, add a column labeled “actual station,” and
relabel the existing station column as “assigned station.” If you prefer, you can draw a chart,
with one column labeled “tube sequence number,” a second column labeled “assigned
station,” and a third column labeled “actual station.”
Write down the tube sequence number of the tube that was just removed. Write the station
specified on the identify anonymous screen in the “actual station” column.
Press the “exit” soft key, then press the “tube entry” soft key. Scan the tube barcode label,
and write the station in the “assigned station” column of your chart. There will be a tube in
this station.

+ Place the first misplaced tube aside – its results must be confirmed manually (either
through AFB stain or reading manually as described in Appendix E). Tube test results cannot
be transferred reliably among multi-station misplacements.
Remove the tube from the station currently displayed on the tube entry screen. Write this
tube sequence number on the chart, as well as the actual station. Now scan the current tube
label. Write the station now displayed in the “assigned station” column. Place this tube aside
for manual confirmation/reading.
Go to the station now displayed. If there is a tube in this station, repeat the steps in the pre-
vious paragraph. Continue to do so until the actual station matches the assigned station, or
until there is no tube in the assigned station. When one of these conditions occurs, you have
probably reached the end of the tube misplacements.
* All tubes involved in misplacement scenarios must be confirmed manually (either stained for
AFB or incubated offline and read manually as described in Appendix E). Keep the tubes at
room temperature until the next test cycle, when the station errors are flagged.

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BACTEC® MGIT™ 960 System User’s Manual

* When the next test cycle or drawer scan occurs, any stations from which tubes were
removed will go into error. In addition, the anonymous station that began the problem is
still anonymous. Go to the identify anonymous activity, and recall the anonymous vial that
originally generated this error. Scan one of your spare barcode labels, then discard it. Allow
this station to go into error too, then resolve all the station errors as described above under
error E12 and in Section 4.9 after the misplaced tubes have been tested manually.

E34 Update error

POSSIBLE CAUSE(S)
• During a software update, an error occurred.
CORRECTIVE ACTION(S)
00000000, 00000002, 00000003
* Return to the “update software” operation and repeat the software update.
00000001
* You cannot install an older version of software than is currently on the instrument.

E35 Incorrect drawer

POSSIBLE CAUSE(S)
• The tube you just scanned belongs in a drawer other than the one currently open.
CORRECTIVE ACTION(S)
* Place the problem tube aside and complete the operation you are currently performing.
Then open the next drawer, press the “tube entry” soft key, and scan the barcode label of
the problem tube. If the error recurs, repeat this step for the third drawer, which is where
the tube should reside.

E37 Barcode scan order incorrect

POSSIBLE CAUSE(S)
• You just scanned a tube barcode sequence number when the system expected a barcode
accession number, or vice versa. (The accession barcode feature must be enabled for this
error to occur.)
CORRECTIVE ACTION(S)
* The icon in the main body of the display shows which barcode the system expects you to
scan. The arrow pointing to the upper barcode indicates that the tube barcode sequence
number (preprinted on the BBL® MGIT™ tube label) is expected:

7–10 MA-0117-D(Prelim)
 )
Troubleshooting

The arrow pointing to the lower barcode indicates that the accession barcode sequence
number is expected:

To prevent the error from occurring, always scan the type of barcode the system is prompt-
ing you to scan.

E38 No floppy disk in the drive

POSSIBLE CAUSE(S)
• During the write data to disk function, the system could not detect a floppy disk in the disk
drive.
CORRECTIVE ACTION(S)
* If a disk is in the disk drive, eject it and insert a blank, formatted, write-enabled disk in the
disk drive. Repeat the write data to disk operation.

E39 Floppy full, insert another blank disk

POSSIBLE CAUSE(S)
• During the write data to disk function, the system filled the current floppy disk but has more
data left to write.
CORRECTIVE ACTION(S)
* Eject and label the current disk and insert another blank, formatted, write-enabled disk in
the disk drive.

E40 Network Error

The instrument was unable to communicate with the EpiCenter™ system.

POSSIBLE CAUSE(S)
• EpiCenter™ system is not running.
CORRECTIVE ACTION(S)
* Start EpiCenter™ system.
POSSIBLE CAUSE(S)
• Hardware problem between systems, such as disconnected cable between instrument and
EpiCenter™ workstation, bad NIC in workstation or instrument, etc.
CORRECTIVE ACTION(S)
* Look for obvious source of problem such as disconnected cable. If no obvious source exists,
contact Becton Dickinson.

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BACTEC® MGIT™ 960 System User’s Manual

E43 LIS must be rebooted

POSSIBLE CAUSE(S)
• Change was made to LIS enable/disable status or to one of the LIS parameters. Instrument
must be rebooted for changes to take effect.
CORRECTIVE ACTION(S)
* Press “OK” soft key to reboot instrument and implement changes, or press “not okay” soft
key to cancel changes.

E45 Drawer Error

POSSIBLE CAUSE(S)
00000002 – One of the drawers is not completely closed.
CORRECTIVE ACTION(S)
* Push the drawer closed.

E50 Internal software error

POSSIBLE CAUSE(S)
• System encountered a software error.
CORRECTIVE ACTION(S)
* Write data to disk (see Section 7.3) and call Becton Dickinson.

7.3 Write Data to Disk Function

Under certain circumstances, Becton Dickinson will advise you to save (write) system data to a floppy
disk. These circumstances include some error conditions and system malfunctions. To save data to
disk, follow the steps below:
1 Press the “maintenance” soft key. The instrument enters maintenance mode. Press the
“maintenance” soft key (below left) two more times, until the “write data to disk” icon
(below right, screen 3 of 5) appears.

2 Insert a blank, formatted, write-enabled floppy disk in the disk drive.

3 Press the “perform action” soft key.

7–12 MA-0117-D(Prelim)
 )
Troubleshooting

4 An hourglass icon appears while the information is being written to the disk.

5 When the activity is complete, the system beeps three times. Remove the floppy disk by
pressing the disk eject button.

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7–14 MA-0117-D(Prelim)
 l
Glossary and
Abbreviations
Below are some terms used within this manual which may be unfamiliar to the casual computer
user. Most terms are described within the context of the BACTEC® MGIT™ 960 system, rather than
in the strictly technical sense.

anonymous tube Anonymous tubes are those which have been placed in the
instrument without being assigned their location through Tube
Entry (have not been scanned into the instrument). Tests are
ongoing, but no other status (such as positive, negative, error)
can be indicated for anonymous tubes until they are identified to
the system.

applications The portion of the program which performs specific dedicated

functions such as controlling hardware devices.

background task An operation performed by the system which is often invisible to

the user and does not require operator interaction.

bit An abbreviation for “binary digit,” which is the elemental unit of

information in a computer. The value of a bit can be either 1 or 0.
All data used by the computer is in the form of bytes, made up of
bit combinations. Also an acronym (BIT) for Built-In Test, a patent
pending method of station performance verification.

blocked station A station in the instrument which encounters an out-of-range

reading. Stations can be blocked manually or automatically when
the instrument assumes the hardware has failed in the station
and blocks the station from use (if there is no tube assigned to
it).

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BACTEC® MGIT™ 960 System User’s Manual

boot To start a computer or instrument. May refer to physically turning

on the unit’s power, in addition to the Operating System starting
itself (or “boot-strapping”).

buffer A short-term storage region. A buffer can exist in the computer’s

memory, in the database, etc.

byte A unit of data consisting of eight bits of information. A byte is

often used as the unit of measure of computer memory or disk
storage capacity. Common compound forms of the term include
kilobyte (1,024 bytes) and megabyte (1,048,576 bytes).

database A file or files containing specific pieces of like information to

which a program refers.

date Dates can be customized by the user in the Configuration

function. You can select the order of day, month, and year values,
and select among several separators for those values.

DD Designation for the day of the month (1 to 31).

default A default is a predefined field response which can usually be

changed. Sometimes the default entry represents the “safe”
condition. Sometimes, the manufacturer anticipates a “most
common response,” and creates a default to save the user time.

disabled Not active or not communicating.

diskette Synonym for “floppy disk.” A floppy disk, or diskette, is a

medium on which computer information is magnetically
encoded. For this reason, floppy disks should always be stored
away from any sources of magnetic interference, such as
computer monitors, power supplies, etc.

dot matrix Used to describe a type of printer technology. A dot matrix

printer possesses a print head consisting of a rectangular matrix
of retracting pins. Characters are formed by an array of these pins
striking a print ribbon adjacent to the paper.

download Transmission of information from a higher-level component to a

lower-level one.

D/RCC Designation within the manual for the station. “D” represents the
drawer letter (A, B, or C), “R” represents the row (A – S, omitting
I, O, and Q), and “CC” represents the column (01 – 20).

enabled Active or communicating.

field An area on a display containing a discrete piece of information.

The collective of responses to fields is a file, or record.

file A file is a discrete, unified collection of information. Some of the

many different types of files include: configuration records,
program files, error logs, etc.

G–2 MA-0117-D(Prelim)
 l
Glossary and Abbreviations

flash or flash mem- A type of computer memory.

ory

floppy disk Synonym for “diskette.” A floppy disk, or diskette, is a medium

on which computer information is magnetically encoded. For this
reason, floppy disks should always be stored away from any
sources of magnetic interference, such as computer monitors,
power supplies, etc.

foreground task The currently active display or operation, with which the user is
interacting.

format For floppy disks, formatting erases any existing information on

the disk and prepares the disk to receive data from the type of
computer system on which it is being used (e.g., IBM-PC®, Apple
Macintosh®, etc.).

hardware The physical components of a system. The LCD display, floppy

disk drives, cables, interface boards, etc. represent the system
hardware. Compare to “software.”

HH Designation for the hour of the day in 24-hour military (or

international) format.

initialize To start up and provide fundamental instructions. When a system

is initialized, generally its memory is checked and cleared, its
“state of health” is verified, and it is prepared for routine
activities. Similarly, when a disk (floppy or hard) is initialized, its
information is cleared (erased), and it is formatted (i.e. given its
fundamental instructions on where to store information).

interface A go-between. The user interface for the BACTEC® MGIT™ 960
system is the displays, icons, and soft keys through which you
view information and perform activities.

kilobyte 1,024 bytes. Abbreviated “kb” or sometimes “k.” See also “byte.”

LCD Liquid Crystal Display. A type of display technology with

characters composed of black dots against a gray background.

LED Light Emitting Diode. A type of indicator light.

megabyte 1,048,576 bytes. Usually abbreviated “MB.” See also “byte.”

MGIT™ Mycobacteria Growth Indicator Tube, a trademarked product of

Becton Dickinson.

MM Designation for the month of the year in numeric form (1 to 12),

or for the minutes of the hour (01 to 59).

positive A tube is deemed positive if, during its test, it meets the
predefined criteria of the system software. These criteria relate to
the measurement of fluorescence in the tube sensor over one or
more test readings.

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BACTEC® MGIT™ 960 System User’s Manual

program A software utility.

prompt A message from the system relating to the current activity. For
many of the activities you perform, the LCD displays offer
prompts in the form of icons in the main body of the screen.

Pulled Positive Any positive tube which has been removed through the Remove
Positive tubes operation can be placed back in the instrument for
further testing for up to 5 hours after removal (or until it goes
out of protocol, whichever comes first). During this re-entry
window of time, the tube is referred to as a “Pulled Positive.”

reboot To restart a device. Rebooting may sometimes be recommended

to clear the system’s memory, to unfreeze a system which will not
respond to keypad input, etc.

software The instructions and information used by a computer to function.

Software is the “mind” and hardware is the “body” of a
computer.

soft keys The eight teal keys below the LCD display whose functions vary
with each display. The functions are defined by the software, thus
the name.

station An individual well in a drawer that holds a BBL® MGIT™ tube.

subsystem A part of the whole system. A drawer is a subsystem of the

BACTEC® MGIT™ 960 system.

time Time is entered and displayed in 24-hour military (or

international) format (e.g., 8:00 p.m. is indicated by 20:00).

upload Transmission of data from a lower-level component to a higher-

level one.

VAC Volts Alternating Current.

YY or YYYY Designation for the year.

G–4 MA-0117-D(Prelim)
 Limited Warranty
f
This warranty gives you specific legal rights. Additionally, you may have other rights that vary from
region to region.

The BACTEC® MGIT™ 960 system is warranted to be free from defects in materials and workmanship
for a period of one year following delivery. Becton Dickinson’s sole responsibility under this warranty
shall be to repair or replace any instrument or its components (except for expendable supplies such
as printer cartridges, paper, or filters) which under normal operating conditions, prove to be
defective within one year of delivery.
Becton Dickinson Microbiology Systems will furnish new or remanufactured components upon its
option. All replacements shall meet new part specifications. Replaced components become the
property of Becton Dickinson.
It is understood that the equipment covered by this Agreement has been installed in accordance
with the recommendations and instructions in the BACTEC® MGIT™ 960 System User’s Manual.

Any damage to a BACTEC® MGIT™ 960 system resulting from the insertion or removal of cables that
connect this instrument to systems other than those approved or supplied by Becton Dickinson or
the failure of the owner to maintain reasonable care and precautions in the operation and
maintenance of the system will void this warranty and terminate the obligations of the
manufacturer as stated herein.
This warranty is in lieu of all other warranties, whether express or implied, including but not limited
to, warranties of merchantability, or fitness for a particular use. In no event will Becton Dickinson
Microbiology Systems be liable for indirect, incidental or consequential damages.

MA-0117-D(Prelim) A–1
BACTEC® MGIT™ 960 System User’s Manual

A–2 MA-0117-D(Prelim)
 Replacement Parts
g
The following items may be ordered by contacting your local Becton Dickinson representative at the
numbers in Appendix D.

Item

Barcode Labels (BBL® MGIT™ tube, 500)

Catalog Number

4405874

Barcode Scanner 4405893

Cable, Ethernet 4405884

Cable, Printer 4405401

Cable, Serial 4405883

Calibrator Kit (17 tubes) 4405871

Cartridge, Laser Printer 4405886

Control Electronics Module 4405891

Filters, Air (square) JO 04379

Filters, Air (rectangular) 4405888

Floppy Disks, High Density, Formatted (10) 4405847

Floppy Disk Drive 4405894

Guide, Quick Reference 4405885

Line Conditioner, North America 4405877

MA-0117-D(Prelim) B–1
BACTEC® MGIT™ 960 System User’s Manual

Item Catalog Number

Line Conditioner, Europe 4405881

Line Conditioner, Japan 4405927

LCD Display 4405892

Manual, BACTEC® MGIT™ 960 System User’s (ea.) 4405876

Plug, Bad Station (10) 4405873

Printer, Laser 4405882

Sign, “Drawer Disabled” 4405875

Thermometer, Temperature QC (ea.) 4405872

Uninterruptible Power Supply (UPS), Europe (1.3 kVA) 4405879

Uninterruptible Power Supply (UPS), Japan (1.3 kVA) 4405878

Uninterruptible Power Supply (UPS), North America (1.3 kVA) 4405880

B–2 MA-0117-D(Prelim)
 Software Update Log

Received Version
h
Whenever you receive a software update, please take a moment to log it below. This can assist you
and Becton Dickinson personnel in identifying software revision levels, potential software problems,
etc.

Date Software Date

Installed
Installed
By
Notes

MA-0117-D(Prelim) C–1
BACTEC® MGIT™ 960 System User’s Manual

C–2 MA-0117-D(Prelim)
 International Contacts

Becton Dickinson de
Mexico, S.A. de C.V.
Monte Pelvoux 111 • 9th Floor
Col. Lomas de Chapultepec
i Becton Dickinson
Becton Dickinson and Company
2464 South Sheridan Way
Mississauga, Ontario
11000 Mexico D.F. Canada L5J 2M8
Voice: 52 5 237 1200 • Fax: 52 5 237 1287 Voice: (905) 855-5663 • Fax: (905) 855-6583

Becton Dickinson Becton Dickinson

Asia Pacific Division European Divisions
30 Tuas Avenue 2 5 Chemin des Sources • BP 37
Singapore 639461 38241 Meylan CEDEX France
Voice: (65) 8610633 • Fax: (65) 8601590 Voice: 33 4 76 416464 • Fax: 33 4 76 418560

Nippon Becton Dickinson Co., Ltd. Becton Dickinson

Akasaka DS Building Microbiology Systems
5–26 Akasaka 8-chome 7 Loveton Circle
Minato-ku, Tokyo 107 Sparks, Maryland 21152
Japan USA
Voice: (81) 3 54138181 • Fax (81) 3 54138144 Voice: (410) 316-4000 • Fax: (410) 316-4826
Toll-Free: Technical Services: 1-800-638-8663
Becton Dickinson Field Service: 1-800-544-7434
Latin America Diagnostics Division
Rua Alexandre Dumas 1976
04717-004 Sao Paulo, S.P. Brazil
Voice: (55) 11 5459833 • Fax: (55) 11 2478644

MA-0117-D(Prelim) D–1
BACTEC® MGIT™ 960 System User’s Manual

D–2 MA-0117-D(Prelim)
E.1
Supplemental Procedures
Reading BBL®
jMGIT™ 7 ml Tubes Manually
A situation may arise where it is necessary to remove one or more ongoing negative BBL® MGIT™
7 ml tubes from the instrument and to incubate them offline. These tubes should then be read
manually using an ultraviolet (UV) transilluminator (365 nm) or a Wood’s lamp with a longwave
bulb or blacklight.

NOTE

Once BBL® MGIT™ 7 ml tubes have been removed from the

BACTEC® MGIT™ 960 instrument for offline incubation, they must be
read offline throughout the eight week protocol. The tubes must not be
returned to the BACTEC® MGIT™ 960 instrument.

WARNING

TO AVOID EXPOSING YOUR EYES TO POTENTIALLY DAMAGING

ULTRAVIOLET LIGHT, WEAR PROTECTIVE GLASSES WHEN
OBSERVING FLUORESCENCE.

Use of Positive and Negative Control tubes is only for the interpretation of fluorescence and is not
intended as a control for the performance of the media. The procedure that follows is for the
manual reading of tubes only, not for entry of controls into the instrument.

MA-0117-D(Prelim) E–1
BACTEC® MGIT™ 960 System User’s Manual

E.1.1 Preparation of Interpretive Positive Control Tube

1 Empty the broth from an uninoculated BBL® MGIT™ 7 ml tube.
2 Label the tube as a Positive Control and record the date.
3 Prepare a 0.4% sodium sulfite solution (0.4 g in 100 ml sterile distilled or deionized water).
Discard the unused portion.
4 Add 5 ml of sodium sulfite solution to the tube, replace the cap, tighten, and allow the tube
to stand for a minimum of 1 hour at room temperature before use.
5 Positive Control tubes can be used many times. Each Positive Control tube can be used for
up to four weeks when stored at room temperature.

E.1.2 Preparation of Interpretive Negative Control Tube

An unopened, uninoculated BBL® MGIT™ 7 ml tube is used as a negative control.

E.1.3 Reading Tubes Manually

A Positive Control and a Negative Control are important to correctly interpreting results.
1 Remove the tubes from the incubator. Place the tubes on the UV light next to a Positive
Control tube and an uninoculated tube (Negative Control). It is recommended that one rack
of tubes at a time (4 by 10 tubes) be placed on the UV light. Normal room light is preferred.
Avoid reading tubes in a sunlit room or in a darkened room.
2 Visually locate BBL® MGIT™ 7 ml tubes that show bright fluorescence. Fluorescence is
detected as a bright orange color in the bottom of the tube and also an orange reflection on
the meniscus. The BBL® MGIT™ 7 ml tube should then be taken out of the rack and
compared to Positive Control and Negative Control tubes. The Positive Control should show
a high amount of fluorescence (very bright orange color). The Negative Control should have
very little or no fluorescence. If fluorescence in the BBL® MGIT™ 7 ml tube looks more like
the Positive Control, it is a positive tube. If it looks more like the Negative Control, it is a
negative tube. Growth can also be detected by the presence of a non-homogeneous
turbidity, small grains or flakes in the culture medium.
3 Positive tubes should be stained for acid-fast bacilli. AFB smear-negative tubes should be
checked for bacterial contamination. Subcultures for identification and drug susceptibility
testing may be performed using fluid from the BBL® MGIT™ 7 ml tube.
4 Negative tubes should continue to be read up to eight weeks or longer depending on the
type of specimen and the past experience of the laboratory. Alternative reading schedules
may be established. Failure to read the tubes for several days, such as during weekends or
holidays, may delay the detection of positive tubes, but will not otherwise adversely affect
the performance of the media. Tubes should be visually checked for the presence of turbidity
and small grains or granules before discarding. Negative BBL® MGIT™ 7 ml tubes cannot be
reused. If mycobacteria growth is suspected, follow the instructions given in the media
package insert.

E–2 MA-0117-D(Prelim)
 j
Supplemental Procedures

E.2 Reprocessing Contaminated BBL® MGIT™ 7 ml

Tubes
In the event of the overgrowth of a BBL® MGIT™ 7 ml tube by a non acid-fast microorganism,
decontamination followed by inoculation of new culture media may be performed. Reprocessing is
strongly recommended if the original specimen source cannot be easily recollected, e.g., tissue
specimens.
Reprocessing requires the same fundamental considerations as the decontamination of specimens.
Both procedures are based on the relative resistance of the acid-fast bacteria to severe physical/
chemical treatment compared to other microorganisms. The acid-fast bacteria must be re-
concentrated and reinoculated into fresh culture media following treatment with a decontaminating
agent.

1 Add the contents of the contaminated BBL® MGIT™ 7 ml tube to a 50 ml plastic centrifuge
tube.
2 Add 8 ml NALC-NaOH solution to the centrifuge tube. With the cap tightened, vortex the
tube for 5 to 20 seconds.
3 Allow the tube to stand for 15 to 20 minutes. Do not treat for more than 20 minutes.
4 Add 35 ml sterile phosphate buffer pH 6.8. Replace the cap and mix the contents.
5 Concentrate the specimen in a centrifuge at a speed of 3,000 x g for 15 minutes.
6 Carefully decant the supernatant fluid from the pellet. Resuspend the pellet using a sterile
Pasteur pipette with sterile phosphate buffer pH 6.8.
7 Inoculate 0.5 ml of the suspension to a new BBL® MGIT™ 7 ml tube. Also add a drop (0.1 ml)
of the suspension to a 7H10 agar plate or other mycobacterial solid agar or egg-based
medium.
The routine inoculation of solid media is especially important for optimal recovery of mycobacteria
from tissue specimens as these specimen types are particularly susceptible to sporadic organism
recovery.

MA-0117-D(Prelim) E–3
BACTEC® MGIT™ 960 System User’s Manual

E–4 MA-0117-D(Prelim)
 Notes

MA-0117-D(Prelim) Notes–1
BACTEC® MGIT™ 960 System User’s Manual

Notes–2 MA-0117-D(Prelim)
A
accession barcoding setup, 2-6
alarm volume setup, 2-6
alarms, 3-11
alerts, 3-11, 7-2
n
Index
D
database
save to disk, 7-12
date format setup, 2-5–2-6
date setup, 2-5
decontamination, 6-14
anonymous tube displays
definition, G-1 hierarchy, 5-2
identifying, 4-13 types, 5-3–5-5
arrow keys, 3-3 drawers
error station indicator, 3-8
B negative tube indicator, 3-8
overview, 1-3
barcode scanner positive tube indicator, 3-7
how to scan, 3-6 release latch, 3-7
overview, 1-3
Becton Dickinson E
how to contact, D-1 E01 error, 7-3
blocked station E02 error, 7-3
E04 error, 7-3
definition, G-1
E05 error, 7-4
C E06 error, 7-4
E07 error, 7-5
calibration E08 error, 7-5
calibrator replacement, 6-9 E09 error, 7-5
overview, 1-6 E10 error, 7-5
E11 error, 7-6
cautions, 1-10
E12 error, 7-6
circuit breakers E13 error, 7-7
assignments, 3-10 E30 error, 7-7
CLIA compliance, 2-9 E31 error, 7-8

MA-0117-D(Prelim) I–1
BACTEC® MGIT™ 960 System User’s Manual

E32 error, 7-8

E33 error, 7-9
M
E34 error, 7-10 maintenance, 6-13
E35 error, 7-10 "as needed", 6-10–6-15
E37 error, 7-10 air filter replacement, 6-6
E38 error, 7-11 barcode label replacement, 6-14
E39 error, 7-11 blocking stations, 6-11–6-12
E45 error, 7-12 calibrator replacement, 6-7–6-9
E50 error, 7-12 daily, 4-4–4-5, 6-2–6-4
entering new tubes, 4-6–4-7
decontamination, 6-14
error messages, 7-2
log, 6-5, 6-8
error stations
indicator, 3-8 periodic, 6-6
external ports, 1-5 scanner window, 6-10
thermometer mercury, 6-15
F unblocking stations, 6-12–6-13
MGIT tubes (BBL® MGIT™)
floppy disk
eject button, 3-5 barcode replacement, 6-14
indicator, 3-5 entering, 4-6–4-7
overview, 1-3 how to scan, 3-6
interpretive negative controls, E-2
H interpretive positive controls, E-2
how to leakage or breakage, 6-14
enter new tubes, 4-6–4-7 media quality control, 4-3
identify anonymous tubes, 4-12–4-13 negative indication, 3-8
print reports, 4-16–4-17 positive indication, 3-7
remove negatives, 4-10 reading manually, E-1
remove ongoing tubes, 4-11–4-12 reprocessing contaminated tubes, E-3
remove positives, 4-8–4-9 status indicator, 3-9
resolve station errors, 4-14–4-15
return positives for further testing, 4-9 N
use the instrument (general), 4-2 negative tube indicator, 3-8
I negatives
batch removal, 4-10
icons, 5-6–5-10 indication, 3-8
instrument number setup, 2-6 notification, 4-9

K removing, 4-10

keypad O
alarm indicator, 3-4
On/Off switch, 3-3
arrow keys, 3-3
naming conventions, 1-8
overview, 1-4
P
SILENCE ALARM key, 3-4 positive tube indicator, 3-7
soft(ware) keys, 3-4 positives
indication, 3-7
L notification, 4-8
language setup, 2-6 removing, 4-8–4-9
LCD display returning for further testing, 4-9
automatic dimming, 3-5 power failures, 4-1
brightness dial, 3-6 power switch, 3-3
display types, 5-3–5-5 protocol setup, 2-5

I–2 MA-0117-D(Prelim)
 n Index

R maintenance log, 6-5, 6-8

overview, 1-4, 1-5, 1-6
replacement parts, B-1 periodic maintenance, 6-6–6-9
reports photograph, 1-4
Instrument Inventory, 5-17–5-18 placement warnings, 2-2
printing, 4-16–4-17 power failures, 4-1
Quality Control, 5-19–5-20 replacement parts, B-1–B-2
Unloaded Negatives, 5-13–5-14 service, 7-1
Unloaded Ongoings, 5-15–5-16 setup, 2-4–2-8
Unloaded Positives, 5-11–5-12 software installation, 2-9
software update log, C-1
S startup, 2-8
save data to disk, 7-12 summary of cautions and warnings, 1-9–1-10
service symbols used on the equipment, 1-8
warning, 6-1 warranty, A-1
setup, 2-4–2-8
soft keys T
assignment area, 5-5 teal keys, 3-4
definition, G-4 test protocol setup, 2-4
icons, 5-6–5-10 time format setup, 2-5
location, 3-4 time setup, 2-5
software
display regions, 5-4–5-5 V
display types, 5-3–5-5
volume setup, 2-6
general operation, 4-2
icons, 5-6–5-10
installation, 2-9
W
menu tree, 5-2 warnings, 1-10
overview, 1-5 warranty, A-1
reports, 5-11 write data to disk, 7-12
update log, C-1
specifications
electrical, 2-3
environmental, 2-3
physical, 2-2
specimen
collection, 4-3
contamination, E-3
preparation, 4-2–4-3
stations
blocking, 6-11–6-12
error indicator, 3-8
resolving errors, 4-15
status indicators, 3-9
unblocking, 6-12–6-13system
alerts and errors, 7-2
Built-In-Test, 1-6
cabinet layout, 3-2
CLIA compliance, 2-9
daily maintenance, 6-2–6-4
decontamination, 6-14
external ports, 1-5
features, 1-3
installation, 2-1

MA-0117-D(Prelim) I–3
BACTEC® MGIT™ 960 System User’s Manual

I–4 MA-0117-D(Prelim)
 Reader Comment Card
BACTEC® MGIT™ 960 System User’s Manual (MA-0117)
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Chapters
Table of Contents * * * * *
Introduction * * * * *
Installation * * * * *
Controls and Indicators * * * * *
Operation * * * * *
Reference * * * * *
Maintenance * * * * *
Troubleshooting * * * * *
Index * * * * *
Appendices * * * * *
General
Organization/order of information * * * * *
Ease of finding information * * * * *
Clarity of information * * * * *
Completeness of information * * * * *
Accuracy of information * * * * *
Diagrams – Quantity * * * * *
Diagrams – Quality * * * * *
Diagrams – Usefulness * * * * *
Overall appearance * * * * *
Explanation of hardware * * * * *
Explanation of software * * * * *
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