BACTEC™ MGIT™ Instrument

User’s Manual
(for the BD BACTEC MGIT 960 and
BD BACTEC MGIT 320 instruments)


 Becton, Dickinson and Company
7 Loveton Circle
Sparks, MD 21152 USA

 Benex Limited
Pottery Road, Dun Laoghaire
Co. Dublin, Ireland

Australian Sponsor:
Becton Dickinson Pty Ltd..
4 Research Park Drive
Macquarie University Research Park
North Ryde, NSW 2113 Australia

MA0117(14) 2015-04
Catalog Number: 445876

English
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BD BACTEC MGIT Instrument 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 (1-2,

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

D 8/03 Preface (i, ii) Add CE marks

E 2004/06 Preface (i, ii); Sect. 6 (5, 6) Add column to Maintenance Log

Minor corrections to AST availability, corrective

action for E07, international contacts; add
procedure for reuniting separated liquid in
F 2009/07 All
thermometers; add step for second disk in 7.3;
add biohazard symbol; revise altitude spec.;
update M. kansasii to match insert

Update for software vers. 5.0 and MGIT 320

G 2010/01 All
instrument launch

H 2010/05 i - ii, vii, 4-21 Correct typographical error in figure name

Update for 960/320 floppy to USB upgrade/

(I)(10) 2013-03 All
conversion

(11) 2014-06 All AU address update

Added BD to product names

All
Updated biohazard symbol
1-9
Added equipment positioning caution
(12) 2015-01 2-3/3-3
Added cleaning warning
6-14, 6-18
Added note to contact BD for potential
6-19
hazardous cleaning verification

(13) 2015-01 All Consolidated print specs to one page

(14) 2015-15 All Minor typographical corrections.

BD, BD Logo and all other trademarks are property of Becton, Dickinson and Company.
ATCC is a trademark of American Type Culture Collection.
© Copyright Becton, Dickinson and Company, 1997 – 2015. All rights reserved. No part of this
publication may be reproduced, transmitted, transcribed, stored in retrieval systems, or translated
into any language or computer language, in any form or by any means, electronic, mechanical,
magnetic, optical, chemical, manual, or otherwise, without the prior written permission of BD, 7
Loveton Circle, Sparks, Maryland, 21152, United States of America.

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 Preface

Contents
1 – Introduction
1.1 System Overview .....................................................................................................................1-1
1.2 Instrument Overview ..............................................................................................................1-4
1.3 Manual Structure ....................................................................................................................1-8
1.4 Use of this Manual ..................................................................................................................1-8
1.5 Conventions ............................................................................................................................1-9
1.5.1 General ..........................................................................................................................1-9
1.5.2 Symbols Used on the Equipment ...................................................................................1-9
1.5.3 Notes, Cautions, and Warnings ...................................................................................1-10
1.6 Summary of Cautions and Warnings ....................................................................................1-11

2 – Installation
2.1 General ...................................................................................................................................2-1
2.2 Installation Policy ....................................................................................................................2-2
2.3 Instrument Specifications .......................................................................................................2-3
2.4 Instrument Setup ...................................................................................................................2-4
2.4.1 General ..........................................................................................................................2-4
2.4.2 Setup Parameters ..........................................................................................................2-4
2.4.3 Setup for Use with theBD EpiCenter™ System .............................................................2-10
2.5 Instrument Startup ...............................................................................................................2-10
2.6 Software Installation .............................................................................................................2-10
2.7 CLIA Compliance ..................................................................................................................2-11

3 – Controls and Indicators

3.1 General ...................................................................................................................................3-1
3.2 On/Off Switch .........................................................................................................................3-2
3.3 Keypad and LCD Display .........................................................................................................3-3
3.3.1 UP / DOWN ARROW Keys ...............................................................................................3-3
3.3.2 Soft Keys .....................................................................................................................3-3
3.3.3 SILENCE ALARM Key ......................................................................................................3-4
3.3.4 Alarm Indicator ..............................................................................................................3-4
3.3.5 Display Area ..................................................................................................................3-4
3.4 Floppy Disk Drive/USB Port ......................................................................................................3-5
3.4.1 Floppy Disk Indicator .....................................................................................................3-5
3.4.2 Floppy Disk Eject Button ................................................................................................3-6
3.5 Brightness/Contrast Dial ..........................................................................................................3-6

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BD BACTEC MGIT Instrument User’s Manual

Contents
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 Audible Tones and Alarms ....................................................................................................3-10
3.9 Printer ...................................................................................................................................3-10

4 – Operation
4.1 General ...................................................................................................................................4-1
4.2 Using the Instrument Interface ...............................................................................................4-2
4.3 Handling and Preparing BD BACTEC MGIT QC Tubes and Specimens .....................................4-3
4.3.1 Media Quality Control ...................................................................................................4-3
4.3.2 Specimen Preparation ....................................................................................................4-4
4.4 Daily Maintenance ..................................................................................................................4-4
4.5 Entering New Tubes ..............................................................................................................4-6
4.6 AST Testing ...........................................................................................................................4-10
4.6.1 AST Set Preparation .....................................................................................................4-10
4.6.2 Entering New AST Sets ................................................................................................4-12
4.6.3 Removing Completed AST Sets ....................................................................................4-14
4.6.4 Anonymous Sets ..........................................................................................................4-14
4.6.5 Error AST Sets ..............................................................................................................4-15
4.6.6 AST Results ..................................................................................................................4-16
4.7 Positive and Negative Specimens ..........................................................................................4-16
4.7.1 Notification of Positive Tubes .....................................................................................4-16
4.7.2 Removing Positive Tubes ............................................................................................4-17
4.7.3 Returning Positive Tubes to the Instrument for Further Testing ..................................4-18
4.7.4 Notification of Negative Tubes ....................................................................................4-18
4.7.5 Removing Negative Tubes ..........................................................................................4-19
4.8 Removing Ongoing Tubes .....................................................................................................4-21
4.9 Identifying Anonymous Tubes ..............................................................................................4-22
4.10 Resolving Station Errors ......................................................................................................4-24
4.11 Printing Reports ..................................................................................................................4-27
4.12 LIS Communications ...........................................................................................................4-28
4.13 Use with the BD EpiCenter™ System ...................................................................................4-29
4.14 Power Failures .....................................................................................................................4-30

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 Preface

Contents
5 – Reference
5.1 General ...................................................................................................................................5-1
5.2 Software Menu Tree ...............................................................................................................5-1
5.3 Display Types ........................................................................................................................5-2
5.3.1 Main Status Screen ........................................................................................................5-2
5.3.2 Main Activity Screen ......................................................................................................5-4
5.4 Icon Charts ...........................................................................................................................5-7
5.5 Reports .................................................................................................................................5-13
5.5.1 Unloaded Positives Report ...........................................................................................5-13
5.5.2 Unloaded Negatives Report .........................................................................................5-15
5.5.3 Unloaded Ongoings Report .........................................................................................5-17
5.5.4 Instrument Inventory Report .......................................................................................5-19
5.5.5 Quality Control Report .................................................................................................5-22
5.5.6 Unloaded AST Set Report ............................................................................................5-24

6 – Maintenance
6.1 General ...................................................................................................................................6-1
6.2 Routine Maintenance ..............................................................................................................6-1
6.2.1 Daily Maintenance .........................................................................................................6-1
6.2.2 Periodic Maintenance ....................................................................................................6-6
6.2.2.1 Air Filter Replacement ......................................................................................6-6
6.2.2.2 Calibrator Replacement ....................................................................................6-8
6.2.3 “As Needed” Maintenance ..........................................................................................6-12
6.2.3.1 Cleaning the Barcode Scanner Window ..........................................................6-12
6.2.3.2 Blocking a Station ...........................................................................................6-13
6.2.3.3 Unblocking a Station .....................................................................................6-14
6.2.3.4 Replacing a Barcode Label .............................................................................6-16
6.2.3.5 Decontamination .........................................................................................6-16
6.2.3.6 Reuniting Separated Thermometer Liquid (Mercury and Non-Mercury) .........6-17

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 ................................................................................................7-15

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BD BACTEC MGIT Instrument User’s Manual

Contents
8 – Glossary and Abbreviations
9 – Limited Warranty
10 – Replacement Parts
11 – Software Update Log
12 – International Contacts
13 – Supplemental Procedures
13.1 Reading BD BBL MGIT 7 mL Tubes Manually ........................................................................13-1
13.1.1 Preparation of Interpretive Manual MGIT Positive Control Tube .................................13-2
13.1.2 Preparation of Interpretive Manual MGIT Negative Control Tube ...............................13-2
13.1.3 Reading Tubes Manually .............................................................................................13-2
Notes
Index
Reader Comment Card

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 Preface

Figures
1-1 BD BACTEC™ MGIT™ Instrument Test Technology................................................................1-3
1-2 BD BACTEC MGIT Instruments (Left: 960; Right: 320) ..........................................................1-5
1-3 Main Status Screen (BD BACTEC MGIT 320 shown, AST enabled) .........................................1-6
1-4 Symbols Used on the BD BACTEC™ MGIT™ Instrument ........................................................1-9
1-5 Ports and Port Symbols......................................................................................................1-10
1-6 Printer Port with USB Capability .........................................................................................1-10

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

2-2 AST Set Definitions ...............................................................................................................2-8
2-3 LIS Configuration Display....................................................................................................2-10

3-1 BD BACTEC MGIT Instrument Layout ....................................................................................3-2

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

4-1 Soft Keys with Drawers Closed (typical) ................................................................................4-2

4-2 Soft Keys with Drawer Open (typical) ...................................................................................4-2
4-3 Drawer Temperature Display (MGIT 960 shown) ..................................................................4-6
4-4 Tube Entry Display – Accession Barcoding Disabled..............................................................4-7
4-5 Tube Entry Display – Accession Barcoding Enabled...............................................................4-9
4-6 AST Carrier (5-tube set).......................................................................................................4-11
4-7 AST Tube Rack ....................................................................................................................4-11
4-8 AST Set Login Display .........................................................................................................4-13
4-9 Remove Positive Tubes Display ...........................................................................................4-17
4-10 Remove Negative Tubes Display (single tube removal) .......................................................4-19
4-11 Remove Negative Tubes Display (batch tube removal)........................................................4-20
4-12 Remove Ongoing Tubes Display..........................................................................................4-21
4-13 Identify Anonymous Tubes Display .....................................................................................4-23

4-14 How to Resolve Error Stations ...........................................................................................4-26

4-15 Reports Menu ....................................................................................................................4-27

5-1 Main Status Screen (for BD BACTEC MGIT 320 instrument with AST
and Network enabled)..........................................................................................................5-4
5-2 Main Activity Screen .............................................................................................................5-6
5-3 Sample Unloaded Positives Report (shown for BD BACTEC MGIT 960) ...............................5-14
5-4 Sample Unloaded Negatives Report (shown for BD BACTEC MGIT 960)..............................5-16
5-5 Sample Unloaded Ongoings Report (shown for BD BACTEC MGIT 960)..............................5-18
5-6 Sample Instrument Inventory Report (shown for BD BACTEC MGIT 320) ............................5-20
5-7 Sample Inventory AST Set Report (shown for BD BACTEC MGIT 960) .................................5-21
5-8 Sample Quality Control Report (shown for BD BACTEC MGIT 960) .....................................5-23
5-9 Sample Unloaded AST Set Report (shown for BD BACTEC MGIT 960) .................................5-25

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BD BACTEC MGIT Instrument User’s Manual

Figures
6-1 Instrument Maintenance Log ............................................................................................... 6-5
6-2 BD BACTEC MGIT 960 Air Filter Replacement ....................................................................... 6-7
6-3 BD BACTEC MGIT 320 Air Filter Replacement – Filter Location ............................................. 6-7
6-4 BD BACTEC MGIT 320 Air Filter Replacement – Filter Removal ............................................. 6-7
6-5 Calibration Log .................................................................................................................. 6-10
6-6 Location of Calibrators....................................................................................................... 6-11
6-7 Calibrator Replacement (A) ................................................................................................ 6-11
6-8 Calibrator Replacement (B) ................................................................................................ 6-12
6-9 Barcode Scanner Window .................................................................................................. 6-12

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 1 – Introduction
1.1 System Overview
The BD BACTEC MGIT 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 col-
lected from patients, processed, and inoculated into BD BBL MGIT 7 mL tubes (Mycobacteria Growth
Indicator Tube).
Microorganisms present in these specimens metabolize nutrients and oxygen in the culture tube.
The culture tubes 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 corre-
sponds 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.)
BD BACTEC MGIT Instruments are available in a high volume, 3-drawer configuration capable of
testing a total of 960 tubes simultaneously (BD BACTEC MGIT 960), and a lower volume, 1-drawer
instrument capable of testing a total of 320 tubes simultaneously (BD BACTEC MGIT 320).
The instrument automatically tests the tubes. 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 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 con-
firmation of results, and for isolation and identification of the organism.
A single BD BACTEC MGIT 960 instrument is capable of monitoring a total of 960 BD BBL MGIT 7 mL
tubes. The tubes are arranged in three drawers, each of which holds up to 320 tubes, and are con-
tinuously incubated. The practical capacity of a BD BACTEC MGIT 960 instrument is typically 154
samples per week with a 6-week protocol (115 samples per week with an 8-week protocol). A
BD BACTEC MGIT 320 instrument holds 320 tubes in a single drawer.
In addition to detection of mycobacteria, the BD BACTEC MGIT Antimicrobial/Drug Susceptibility
Testing (AST or DST) system is a rapid qualitative procedure for susceptibility testing of Mycobacte-
rium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide.

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BD BACTEC MGIT Instrument User’s Manual

The routine AST set consists of a Growth Control tube and a tube for each drug, as well as a bar-
coded tube carrier that holds the set. The carrier barcode provides set size and identification. A tube
rack capable of holding up to 55 AST tubes in various set combinations is available for tube setup
and transport. Large or small AST carrier sets can be placed in the rack.
The MGIT AST system is based on growth of the Mycobacterium tuberculosis strain under test as
measured by the instrument. AST sets are entered into the BD BACTEC MGIT Instrument and are
tested automatically. Analysis of fluorescence in a drug containing tube is compared to the fluores-
cence of the Growth Control (GC) tube to determine susceptibility results.
Capacity of the BD BACTEC MGIT Instrument when used for AST or mixed growth and AST testing is
variable and depends upon the number of growth tubes and AST sets (and their associated sizes).
Major features of the BD BACTEC MGIT Instrument include:
• Automated, 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
• Containment of liquid within the drawer from tube breaks or spills

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 1 – Introduction

Organism metabolic activity consumes O2...

Which reacts with tube sensor.

LED activates fluorescent material in sensor.

Photo detector reads fluorescence.

Raw data from detector is sent to computer...

Where positivity analysis is performed.

Positive tube indicator lights, audible alarm

sounds, positive stations are displayed.

or

Test
Photo
Results
LED Detector

Positivity
Analysis

Raw Data

Computer

Figure 1-1 – BD BACTEC™ MGIT™ Instrument Test Technology

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BD BACTEC MGIT Instrument User’s Manual

1.2 Instrument Overview

The BD BACTEC MGIT Instrument is a self-contained unit that can automatically test inoculated BD
BBL MGIT 7 mL tubes for the presence of mycobacteria. The instrument is modular in design, with
user interface, control electronics, power distribution, and incubation electronics modules. Drawers
are used for the incubation and testing of culture tubes.
The instruments are shown in Figure 1-2. Major instrument components are described in the follow-
ing paragraphs. Controls and indicators for these modules are discussed in Section 3 – Controls and
Indicators.
Drawers
Each drawer holds up to three hundred twenty BD BBL MGIT 7 mL tubes. The drawers are desig-
nated A, B, and C, from top to bottom (BD BACTEC MGIT 320 has only drawer A). 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 indica-
tor 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 instrument
is ready (and expecting) to scan a barcode.
Floppy Disk Drive/USB Port
The floppy disk drive or USB port is provided to enable you to update instrument software and
to save data to disk or USB for troubleshooting and system diagnostic purposes.

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 1 – Introduction

Figure 1-2 – BD BACTEC MGIT Instruments (Left: 960; Right: 320)

LCD and Keypad

The LCD is a 640 X 480 pixel Liquid Crystal Display that presents information about instrument
status and function key definitions that enable you to perform instrument operations. Key defi-
nitions and status information are identified by picture icons that represent the type of informa-
tion or operation that can be performed. A comprehensive chart of instrument 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 are software (soft) keys whose
functions vary depending on the current active display. Each display shows icons representing
the current soft key assignments at the bottom of the screen. To perform the function repre-
sented by the icon, you press the corresponding soft key below the icon.
Computer
The instrument 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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BD BACTEC MGIT Instrument User’s Manual

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 connections to other systems. See Figure 1-4.
Instrument Software
The instrument 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 instrument operations are performed by
pressing the 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. When AST is enabled, the number of ongoing and
completed AST sets is shown. Also shown are the current date and time. Software keys allow
you to configure the setup parameters, perform routine daily maintenance, review instrument
errors, print reports, and check the instrument temperature. See Figure 1-3.
Configuration/Maintenance Screens – Accessible from the Main Status Screen, the Config-
uration and Maintenance Screens allow you to set the protocol length, time and date and
their formats, audible alarm volume, instrument identification number, select the desired
language for reports, verify the operation of all indicator lamps, block and unblock stations,
write data to a floppy disk or USB flash drive, and update instrument software.
Activity Screens – When an instrument drawer is opened, software key definitions appear
that enable you to enter new tubes and new AST sets (when AST is enabled); remove posi-
tive, negative, and ongoing tubes; remove completed AST sets; identify anonymous tubes;
and resolve station error conditions.

Figure 1-3 – Main Status Screen (BD BACTEC MGIT 320 shown, AST enabled)

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 1 – Introduction

Built-in-Test
The instrument software is designed to continuously monitor the electrical and optical perfor-
mance of all detectors simultaneously. This functionality, called BIT (for Built-in-Test), automati-
cally 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 fail-
ure.
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 dur-
ing protocol.
These protection features verify that calibration has been maintained for all detectors within the
instrument, 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 BD BACTEC MGIT Instrument are selected and designed to maintain electrical
and optical integrity throughout the product’s life. All BD BACTEC MGIT instruments are cali-
brated 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 read-
ings are used by the Built-In-Test to verify that the detection instrument is in calibration. As
described above, any readings for a given calibrator that exceed the expected range cause the
instrument to automatically block the row from use. Detector failures are reported in the instru-
ment’s Quality Control Report.
Calibration verification can be provided by printing the Quality Control Report (see Section 5.5.5 –
Quality Control Report). Please refer to applicable CLIA regulations or your local guidelines for
guidance on calibration.

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BD BACTEC MGIT Instrument User’s Manual

1.3 Manual Structure

This user’s manual contains the following sections:
Section 1 – Introduction – provides an overview of the BD BACTEC MGIT Instrument and its
uses in the mycobacteriology laboratory, its major hardware and software components. An over-
view of this manual’s structure and conventions is also included.
Section 2 – Installation – gives specifications for installation of the BD BACTEC MGIT Instrument
and instructions for instrument setup.
Section 3 – Controls and Indicators – explains the use and meaning of all controls and indica-
tors of the instrument.
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 instrument maintenance, including parts replace-
ment.
Section 7 – Troubleshooting – provides a convenient guide for identifying and correcting
instrument malfunctions.
The Glossary explains several instrument and computer terms used in this manual, as well as
abbreviations.
Sections 9 – 13 contain warranty information, supplemental procedures, replacement parts list,
a software update form, and a listing of BD 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 BD BACTEC MGIT 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 instrument. Should a question arise which is not answered in this manual, please contact the
following parties (USA):
For assistance with questions regarding: procedures, reagent information, or mechanical, electrical,
or software performance problems:
 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 LabelingDD@bd.com.
International contacts are listed in Section 12.
Other documentation which may be of interest to the user includes:
BD BBL MGIT 7 mL Media Package Insert – This document contains important information on the
use, storage, inoculation, performance, and limitations of barcoded BD BBL MGIT 7 mL tubes.
Package inserts are either included with each carton of tubes, or are available by request from
the Technical Services Department or at www.bd.com/ds.

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 1 – Introduction

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, have functions that vary depending on the active display. Each dis-
play 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 BD BACTEC MGIT Instrument manual
by CAPITAL LETTERS (e.g., SILENCE ALARM key). The software keys are always identified by low-
ercase letters in quotes, and the words soft key (e.g., “tube entry” soft key).
Screens, Reports, and Instrument Photos
Throughout this manual, instrument screens (displays) are shown. The manual may depict
screens and reports from a BD BACTEC MGIT 320 or 960 instrument. The only difference
between screens and reports in the 2 systems is the number of drawers and total number of sta-
tions shown. BD BACTEC MGIT 320 screens show 1 drawer (A), whereas BD BACTEC MGIT 960
screens show 3 drawers (A, B, and C) in the status area (top right of screen).
Likewise, some photographs depict a BD BACTEC MGIT 320 instrument and some photographs
depict a BD BACTEC MGIT 960 instrument. Unless an operational difference is noted in the text,
all instrument controls and indicators operate the same for the 2 types of instrument.

1.5.2 Symbols Used on the Equipment

The following symbols appear on the BD BACTEC MGIT Instrument:


 


Figure 1-4 – Symbols Used on the BD BACTEC™ MGIT™ Instrument

Left figure: Symbol for electrical hazard; Middle figure: Symbol for “refer to accompanying
documentation” (specifically, the user’s manual) for instructions;
Right figure: Symbol for biohazard

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BD BACTEC MGIT Instrument User’s Manual

The following figures represent ports and port symbols found on the back panel of the instrument:

Serial Port Remote Alarm Port Network Port

Printer Port Keyboard Port

Figure 1-5 – Ports and Port Symbols

Top figure: Symbols for Serial Port, Remote Alarm Port, Parallel Printer Port ,Keyboard Port and
Network Port (960 shown; 320 has same ports arranged differently).

Figure 1-6 – Printer Port with USB Capability

The instrument’s back panel (960 shown) is the same as the top figure except for the printer port
which has been configured for USB capability.

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 instrument use worthy of special atten-

tion 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.

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 1 – Introduction

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 BD BACTEC MGIT 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 BD BACTEC MGIT Instrument 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 BD BACTEC MGIT 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 practices, containment
equipment, and facilities are required as recommended by CDC and NIH guidelines.1
At a minimum, the instrument should be placed in a contained laboratory environment which has
controlled access and 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.
This equipment has been designed and tested CISPR 11 Class A. In a domestic environment it may
cause radio interference in which case you may need to take measures to mitigate the interference.
The electromagnetic environment should be evaluated prior to operation of the device.
Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g.,
unshielded intentional RF sources) as these may interfere with the proper operation.
All instrument users should become thoroughly familiar with all controls and indicators before
attempting to operate the instrument.
Do not attempt to eject a floppy disk while the floppy disk indicator is lit.
To avoid injury to fingers or hands, make sure that all hands are clear of moving parts when any
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.1,2
Pathogenic microorganisms, including Hepatitis viruses and Human Immunodeficiency Virus, may be
present in clinical specimens. “Standard Precautions”1,3-5 and institutional guidelines should be fol-
lowed in handling all items contaminated with blood and other body fluids.
In the event of tube leakage or breakage: 1) Close the instrument drawer(s); 2) Turn off the instru-
ment; 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 preparation or handling,
use the established procedure in your facility for dealing with mycobacterial spills.
An inoculated leaking or broken tube may produce an aerosol of mycobacteria; appropriate han-
dling should be observed.

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BD BACTEC MGIT Instrument User’s Manual

Make sure that all caps are screwed on the tubes securely before placing them in the AST carrier.
It is strongly recommended that you prepare the AST specimens with the tubes in the tube rack. If a
cap is not secure and the AST Set carrier is lifted, the affected tube will be captured by the tube rack.
When the instrument notifies you of alerts and errors, you should immediately respond to the condition.
All maintenance and repair other than the procedures described in Section 6.2 – Routine Mainte-
nance must be performed by qualified service personnel.
When replacing the air filters, use appropriate procedures for handling potentially hazardous mate-
rial.
Handle instruments with care. Wear safety glasses and gloves before proceeding.
If any error sub-codes other than those listed here appear, note the sub-code and contact BD for
assistance.
If the recommended corrective actions do not solve the problem, contact BD.

1 U.S. Department of Health and Human Services. 2007. Biosafety in microbiological and biomedical laboratories,
HHS Publication (CDC), 5th ed. U.S. Government Printing Office, Washington, D.C.
2 Kent, P.T., and G.P. Kubica. 1985. Public health mycobacteriology: a guide for the level III laboratory. USDHHS. Cen-
ters for Disease Control, Atlanta.
3 Clinical and Laboratory Standards Institute. 2005. Approved Guideline M29-A3. Protection of laboratory workers
from occupationally acquired infections, 3rd ed. CLSI, Wayne, Pa.
4 Garner, J.S. 1996. Hospital Infection Control Practices Advisory Committee, U.S. Department of Health and Human
Services, Centers for Disease Control and Prevention. Guideline for isolation precautions in hospitals. Infect. Control
Hospital Epidemiol. 17:53-80.
5 Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of
workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning
of Article 16(1) of Directive 89/391/EEC). Official Journal L262, 17/10/2000, p. 0021-0045.

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 2 – Installation
2.1 General
The BD BACTEC MGIT Instrument should be installed in an area that is free from undue vibration,
direct sunlight, high humidity, dust, temperature extremes, and corrosive or explosive vapors or
gases. The instrument will operate within specifications in room temperatures/humidity shown in
Section 2.3. The left, rear, and right sides of the instrument should be placed according to the Clear-
ance Specification below (Section 2.3). Environments which exceed these limits could adversely
effect the performance of the instrument components.
The drawers should maintain their temperatures to within plus 1.0 ° or minus 2.0 °C of the tempera-
ture controller’s setting (37 °C). This accuracy can be assured only if the room temperature meets the
requirements given below.

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 BD BACTEC MGIT

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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BD BACTEC MGIT Instrument User’s Manual

2.2 Installation Policy

The BD BACTEC MGIT Instrument is to be installed by BD personnel only. Do not open the shipping
carton or the plastic pouch. The instrument must be unpacked by a qualified BD representative or
termination of the warranty may result.

WARNINGS
THE BD BACTEC MGIT INSTRUMENT HAS BEEN DESIGNED FOR THE NON-INVASIVE
DETECTION OF MYCOBACTERIA SO AS TO MINIMIZE RISKS ASSOCIATED WITH MYCO-
BACTERIAL TESTING. HOWEVER, TO FURTHER REDUCE THE RISKS OF ACCIDENTAL
EXPOSURE TO INFECTIOUS AGENTS, ADDITIONAL PRECAUTIONS SHOULD BE TAKEN:
• IT IS STRONGLY RECOMMENDED THAT THE BD BACTEC MGIT INSTRUMENT BE
PLACED IN THE LABORATORY USED FOR ROUTINE CULTURE OF M. TUBERCULOSIS.
FOR ACTIVITIES INVOLVING THE PROPAGATION AND MANIPULATION OF M. TUBERCU-
LOSIS OR MYCOBACTERIUM SPECIES GROWN IN CULTURE, BIOSAFETY LEVEL 3 PRAC-
TICES, CONTAINMENT EQUIPMENT, AND FACILITIES ARE REQUIRED AS
RECOMMENDED BY CDC AND NIH GUIDELINES.1
• AT A MINIMUM, THE INSTRUMENT SHOULD BE PLACED IN A CONTAINED LABORA-
TORY ENVIRONMENT WHICH HAS CONTROLLED ACCESS AND A TUBERCULOSIS EXPO-
SURE 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.
1 IBID.

CAUTION
This equipment has been designed and tested CISPR 11 Class A. In a domestic
environment it may cause radio interference in which case you may need to take
measures to mitigate the interference.
The electromagnetic environment should be evaluated prior to operation of the
device.
Do not use this device in close proximity to sources of strong electromagnetic
radiation (e.g., unshielded intentional RF sources) as these may interfere with the
proper operation.

CAUTION
The instrument must be positioned in such a manner that allows the user quick
access to the power controls.

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 2 – Installation

2.3 Instrument Specifications

Physical
MGIT 960 MGIT 320 MGIT 320 Stand
Dimensions
Height 53 in. (134.62 cm) 25 in. (63.5 cm) 27.7 in. (70.4 cm)

Width 36 in. (91.84 cm) 36 in. (91.5 cm) 34.6 in. (87.8 cm)

Depth 32 in. (81.28 cm) 28.5 in. (72.4 cm) 33.4 in. (84.8 cm)
4 in. (10.2 cm) Left, Rear, 0.5 in. (1.27 cm) Left,
Clearance Right Sides Rear, Right Sides N/A
48 in. (121.9 cm) Front 48 in (121.9 cm) Front
Weight (no tubes) 754 lb (342 kg) 302 lb (137.3 kg) 139 lb (63.0 kg)

(fully loaded with tubes) 794 lb (360.2 kg) 315 lb (142.9 kg) N/A

Electrical Requirements MGIT 960 MGIT 320

Input Voltage 110 – 117/220 – 240 VAC ±10% 100 – 240 VAC ±10%
10.0/5.0 Amp
Input Current (Note: Installation requires a 6.0 Amp
dedicated 15 Amp line)
Input Line Frequency 50/60 Hz 50 /60 Hz

Heat 4000 Btu/hr. 2500 Btu/hr

Environmental
MGIT 960 MGIT 320
Requirements
Non-Operating Storage
Temperature -17.8 °C – 65.0 °C (0° F – 149 °F) -17.8 °C – 65.0 °C (0° F – 149 °F)

Humidity 30% – 80% RH, non-condensing 20% – 80% RH, non-condensing

Operating Conditions
19 °C – 30 °C (66.2° F – 86 °F) 19 ° – 32 °C (66.2 °F – 89.6 °F)
Temperature
Microbiological efficacy may be compromised above 32 °C

Humidity 30% – 80% RH, non-condensing 20% – 80% RH, non-condensing

Level Surface, No direct sunlight, No Level Surface, No direct sunlight, No direct
Locations
direct heat heat
Altitude Evaluated for safety to 2,000 m (6562 ft) Evaluated for safety to 2,000 m (6562 ft)

Use of earthquake anchoring is strongly recommended in locations susceptible to earthquake activity.

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

The MGIT 320 complies with the emissions and immunity requirements of IEC/EN 6.326-2-6.

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BD BACTEC MGIT Instrument User’s Manual

2.4 Instrument Setup

2.4.1 General
The BD BACTEC MGIT Instrument is unpacked and installed by BD personnel. They will interconnect
all system components, power up the instrument, and verify its operation. The instrument ships with
all setup parameters preset to factory default values. However, before using the instrument for cul-
ture 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
• Antimicrobic Susceptibility Testing (AST) Default Sets
• LIS Communications Feature

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 (actual display
may differ slightly):

Figure 2-1 – Main Status Screen

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 2 – Installation

To enter configuration mode, press the soft key corresponding to the icon shown below (the “con-
figuration” soft key). (For a complete listing of instrument 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 (growth and
detection testing). 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. For AST testing protocols, refer to the
appropriate package insert.

Time and Time Format

When this display is first accessed, the minutes value is high-

lighted. 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. Note that
time cannot be changed when BD EpiCenter communications is enabled.

“move to other field” soft key

“format” soft key

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.

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BD BACTEC MGIT Instrument User’s Manual

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 dis-
played value. Note that date cannot be changed when BD EpiCenter communications is enabled.

“move to other field” soft key

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:

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.

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 2 – Installation

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
Español
Français
Italiano
Deutsch
Polski

Accession Barcoding

Select whether the Accession Barcoding feature is enabled (|) or disabled (O)
by pressing the UP ARROW or DOWN ARROW key. The default setting is
disabled (O). When Accession Barcoding is enabled, the instrument expects
both a tube barcode sequence number and accession barcode to be scanned
during all tube entry and some removal activities. The instrument 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.

Set AST Default Sets

This option only appears if AST is enabled.

It enables you to configure a default AST set for each AST carrier size used (2-,
3-, 4-, 5-, and 8-tube). The default AST set is automatically displayed when a
new AST carrier barcode label is scanned.

To begin setting default AST sets, press the “perform action” soft key.

“perform action” soft key

A new series of soft keys enables you to select the 2-tube carrier, 3-tube carrier, etc. Press
the soft key corresponding to the desired carrier size.

“3-tube carrier” soft key

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BD BACTEC MGIT Instrument User’s Manual

The current default AST set configuration, which is always set number 1 (of X), is shown.
Press the UP ARROW or DOWN ARROW to scroll through the available AST set defini-
tions. When the configuration appears that you wish to make the default set, press the
“make default AST set” soft key. (Note that as you scroll through the defined sets, the
current default set is indicated with a check mark.)

“make default AST set” soft key

To set a new default for a different carrier size, press the “exit” soft key until you are
back at the carrier size selection display. Press the soft key corresponding to the desired
carrier size, and continue as described in the previous paragraph.
A table of all defined AST sets is shown below.

Carrier
AST Set Configurations
Size
1/9 2/9 3/9 4/9 5/9 6/9 7/9 8/9 9/9
2 Tube GC GC GC GC GC GC GC GC GC
0.1 I 1.0 S 4.0 S 0.4 I 1.0 R 5.0 E 7.5 E Undefined Drug1 #1 100.0 Pza
1/9 2/9 3/9 4/9 5/9 6/9 7/9 8/9 9/9

3 Tube GC GC GC GC GC GC GC GC GC
0.1 I 5.0 E 1.0 S 4.0 S 4.0 S 0.4 I Undefined Drug1 #1 0.1 I 1.0 S
0.4 I 7.5 E 4.0 S 0.4 I 7.5 E 7.5 E Undefined Drug1 #2 1.0 R 5.0 E
1/9 2/9 3/9 4/9 5/9 6/9 7/9 8/9 9/9
GC GC GC GC GC GC GC GC GC
4 Tube 0.1 I 1.0 S 1.0 S 1.0 S 0.1 I 1.0 S 5.0 E 4.0 S Undefined Drug1 #1
0.4 I 0.1 I 0.1 I 1.0 R 1.0 R 4.0 S 7.5 E 0.4 I Undefined Drug1 #2
1.0 R 5.0 E 1.0 R 5.0 E 5.0 E 1.0 R 1.0 R 7.5 E Undefined Drug1 #3
1/6 2/6 3/6 4/6 5/6 6/6
GC GC GC GC GC GC
5 Tube 1.0 S 1.0 S 1.0 S 0.1 I 0.1 I Undefined Drug1 #1
0.1 I 4.0 S 4.0 S 0.4 I 0.4 I Undefined Drug1 #2
1.0 R 0.1 I 5.0 E 5.0 E 1.0 R Undefined Drug1 #3
5.0 E 0.4 I 7.5 E 7.5 E 5.0 E Undefined Drug1 #4
8 Tube 1/4 2/4 3/4 4/4

GC GC GC GC
1.0 S 1.0 S 1.0 S Undefined Drug1 #1
4.0 S 4.0 S 4.0 S Undefined Drug1 #2
0.1 I 0.1 I 0.1 I Undefined Drug1 #3
0.4 I 0.4 I 0.4 I Undefined Drug1 #4
1.0 R 5.0 E Undefined Drug1 #1 Undefined Drug1 #5
5.0 E 7.5 E Undefined Drug1 #2 Undefined Drug1 #6
7.5 E No Drug2 Undefined Drug1 #3 Undefined Drug1 #7
All values in μg/mL GC=Growth Control S = Streptomycin R = Rifampin I = Isoniazid E = Ethambutol
PZA = Pyrazinamide
1 Undefined Drugs – Only GUs are reported; all undefined drugs set to “Unspecified” at EpiCenter system if connected
2 No Drug – No GUs or susceptibility are reported

Figure 2-2 – AST Set Definitions

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 2 – Installation

LIS Communications

Set up parameters for communications with a Laboratory Information System

(LIS). Note that LIS Communications AND BD 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.

“move to other field” soft key

Enable/Disable LIS Communications: To enable 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
BD BACTEC MGIT 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 instru-
ment. 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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BD BACTEC MGIT Instrument User’s Manual

Figure 2-3 – LIS Configuration Display

2.4.3 Setup for Use with theBD EpiCenter™ System

One or more BD BACTEC MGIT Instruments can be connected to the BD EpiCenter Data Manage-
ment System. The BD 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 stor-
age. Numerous BD BACTEC MGIT Instrument and comparative database query and statistical analysis
filters are included in the EpiCenter system.
The BD BACTEC MGIT Instrument must be set up by a BD representative for use with the
BD EpiCenter system.

2.5 Instrument Startup

Whenever power is applied to the instrument, 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 oper-
ation of the instrument, the startup process is aborted. If not, the computer loads the operating sys-
tem and user interface, and tube testing begins automatically.

2.6 Software Installation

From time to time, updated versions of the instrument software may be provided to you. New soft-
ware should be installed as soon as it is received, and logged on the Software Update Log in Section
11 of the User’s Manual. Updated program software is furnished on 3 ½ inch floppy disk(s) or a USB
flash drive labeled “BD BACTEC MGIT SYSTEM SOFTWARE, Version y.yyz” (where “y.yy” is the soft-
ware version number, and “z” is the revision). The associated catalog number is also printed on the
label.

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 2 – Installation

To install a software update:

1 Refer to Section 3.4 – Floppy Disk Drive/USB Port, for operating cautions. Insert the
update disk or USB flash drive in the floppy disk drive or USB Port.
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).

or

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

The instrument reboots and then immediately begins to update the instrument software (provided
the medium is formatted, is not write-protected, and contains either the same or a later version of
instrument 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 instrument operation.

2.7 CLIA Compliance

Refer to the BD BBL MGIT media package insert for clinical performance data. In accordance with
CLIA requirements, mycobacterial detection is classified as a Highly Complex Test. New BD BACTEC
MGIT Instrument users should perform a method verification evaluation prior to routine use of the
instrument for testing patient specimens.

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BD BACTEC MGIT Instrument User’s Manual

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 3 – Controls and Indicators
3.1 General
This section describes the meaning and use of the controls and indicators of the BD BACTEC MGIT
Instrument. The overall layout of the instrument cabinet is shown in Figure 3-1. Individual compo-
nents are illustrated in figures accompanying the related text.

WARNING
ALL INSTRUMENT USERS SHOULD BECOME THOROUGHLY FAMILIAR
WITH ALL CONTROLS AND INDICATORS BEFORE
ATTEMPTING TO OPERATE THE INSTRUMENT.

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BD BACTEC MGIT Instrument User’s Manual

Keypad and LCD Display

Floppy Disk Drive Barcode Scanner

or USB Port

Brightness/Contrast Dial Drawer Release (1 per drawer)

Drawer Indicators
(1 set per drawer)

On/Off Switch

Figure 3-1 – BD BACTEC MGIT Instrument Layout

3.2 On/Off Switch

The instrument 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).

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 3 – Controls and Indicators

On/Off Switch

Figure 3-2 – On/Off Switch

CAUTION
The instrument must be positioned in such a manner that allows the
user quick access to the power controls.

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 informa-
tion, 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 UP / DOWN ARROW Keys

The UP and DOWN ARROW keys are located on the right side of the Keypad/LCD Display. The UP
ARROW key, represented by an up arrowhead, is used to increase a displayed value, or to scroll
upward in a list. The DOWN ARROW key, represented by a down arrowhead, is used to decrease a
displayed value, or to scroll downward in a list.

3.3.2 Soft Keys

The eight software (soft) keys are located near the bottom of the Keypad/LCD Display, at the center.
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.

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BD BACTEC MGIT Instrument User’s Manual

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 3.8 – Audible Tones and
Alarms, for an explanation of alarm types and tones.)

Alarm UP/DOWN
Indicator Arrow Keys
Display Area

SILENCE
ALARM Key

Soft Keys

Figure 3-3 – Keypad and LCD

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 instrument 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.

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 var-
ious operations.
The LCD Display is programmed to automatically dim after 5 minutes of inactivity. To return the

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 3 – Controls and Indicators

brightness to normal, press any key.

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

3.4 Floppy Disk Drive/USB Port

Some instruments are configured with a floppy disk drive 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.
Some instruments are configured with a USB port in the same location. The USB port enables the
same functions to be performed as the floppy disk drive. USB ports have no associated controls or
indicators. Some USB flash drives contain a built-in indicator LED that flashes while the drive is being
accessed.

Figure 3-4 – USB Drive

Figure above shows a USB Port. Some instruments are configured with a floppy disk drive in the
same location.

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.

CAUTION
Do not attempt to eject a floppy disk while the floppy disk indicator
is lit.

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BD BACTEC MGIT Instrument User’s Manual

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.

Floppy Disk Indicator Floppy Disk Eject Button

Figure 3-5 – Floppy Disk Drive Controls and Indicators

3.5 Brightness/Contrast Dial

The Brightness/Contrast 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 decrease the
overall brightness of the LCD Display screen for the BD BACTEC MGIT 320 instrument, or the contrast
of the BD BACTEC MGIT 960 instrument. Rotate counterclockwise to increase the brightness for the
BD BACTEC MGIT 320 instrument, or the contrast of the BD BACTEC MGIT 960 instrument. It is not
uncommon to have to change the brightness/contrast setting if you change your viewing angle.
See Figure 3-6.

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 scan-
ner turns on and is ready to read a tube barcode. See Figure 3-6.
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). If Accession Barcoding is enabled, the instrument beeps twice in acknowledg-
ment.

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 3 – Controls and Indicators

Barcode Scanner

Brightness/Contrast Dial

Tube Alignment Block

Figure 3-6 – Brightness Dial and Barcode Scanner

3.7 Drawer Controls and Indicators

3.7.1 Exterior Drawer Controls and Indicators
There is one control on each of the drawers: the drawer release latch (see Figure 3-7). In addition,
there are three indicators on the front panel of each drawer (see Figure 3-8). These indicators inform
you of certain conditions within the drawer. These controls and indicators are described below.
Drawer Release Latch

WARNING
TO AVOID INJURY TO FINGERS OR HANDS, MAKE SURE THAT ALL
HANDS ARE CLEAR OF MOVING PARTS WHEN ANY DRAWER IS TO BE
OPENED.

The drawer release latch is located on the rear of the 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.)

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BD BACTEC MGIT Instrument User’s Manual

(Top View – Front of Instrument)

Drawer Release Latch

Figure 3-7 – Drawer Release Latch

Positive Tube/Completed AST Set 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 Posi-
tive Tubes operation (see Section 4.7.2).
When the AST feature is enabled, the positive indicator also indicates the presence of one or
more completed AST sets (in addition to indicating positive BD BBL MGIT 7 mL growth tubes in
the drawer). When there is an AST set in error, both the Positive and Error indicators light simul-
taneously (because error AST sets are forced to complete status).
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 4.7.5).
Error Station Indicator
The error station indicator is rightmost of the three drawer indicators. It is marked with an
“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 4.10).

Positive / Error
Completed AST Station
Indicator Indicator

Negative
Indicator

Figure 3-8 – Exterior Drawer Indicators

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 3 – 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 3-9. The color (red, green, or orange) and
state (on, off, or flashing) indicate the conditions shown in the table below for a given station.
When the AST feature is enabled, the station indicators illuminate in the same pattern as with indi-
vidual BD BBL MGIT 7 mL tubes. However, with AST tube sets, all the stations for the set illuminate or
flash. The leftmost station is ALWAYS the assigned location of the set’s Growth Control tube.

Station
Indicators

Figure 3-9 – Station Status Indicators

Indicator Color State Meaning

All indicators Off Available station

Place tube in this station /

Green On
Place AST set in these stations

Out of protocol negative tube /

Green Flashing
AST set complete

Green / Red Flashing Positive tube

Red Flashing Error station

Orange Flashing Ongoing tube ready for removal

Orange On Anonymous tube

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BD BACTEC MGIT Instrument User’s Manual

3.8 Audible Tones and Alarms

Eight different types of sounds are generated by the BD BACTEC MGIT Instrument as you perform
operations. Each of the sounds is unique. These tones are designed to keep you informed about var-
ious 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.

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

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 4 – Operation
4.1 General
This section describes the normal operation of the BD BACTEC MGIT Instrument. The following major
topics are discussed:
• Using the Instrument Interface (Section 4.2)
• Preparing Specimens (Section 4.3)
• Daily Maintenance (Section 4.4)
• Entering New Tubes (Section 4.5)
• AST Testing (Section 4.6)
• Positive and Negative Specimens (Section 4.7)
• Removing Ongoing Tubes (Section 4.8)
• Identifying Anonymous Tubes (Section 4.9)
• Resolving Station Errors (Section 4.10)
• Printing Reports (Section 4.11)
• LIS Communications (Section 4.12)
• Use with the BD EpiCenter™ System (Section 4.13)
• Power Failures (Section 4.14)
These topics are offered in a general logical order which might fit the workflow of the average labo-
ratory. 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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BD BACTEC MGIT Instrument User’s Manual

4.2 Using the Instrument Interface

The Liquid Crystal Display (LCD) presents all the information needed to monitor instrument and sta-
tion 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 pos-
itive tubes, etc.). The top region of the display presents instrument and station status information
that is always in view and is refreshed 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 defini-
tions 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 instrument-wide activities (such as set-
ting date and time, protocol length, reviewing instrument errors, etc.). See Figure 4-1.

Figure 4-1 – Soft Keys with Drawers Closed (typical)

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. See Figure 4-2.

Figure 4-2 – Soft Keys with Drawer Open (typical)

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 addi-
tional options. To perform the function represented by a soft key definition icon, you press the corre-
sponding 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.

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 4 – Operation

4.3 Handling and Preparing BD BACTEC 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.1,2

PATHOGENIC MICROORGANISMS, INCLUDING HEPATITIS VIRUSES AND

HUMAN IMMUNODEFICIENCY VIRUS, MAY BE PRESENT IN CLINICAL
SPECIMENS. “STANDARD PRECAUTIONS”1,3-5 AND INSTITUTIONAL
GUIDELINES SHOULD BE FOLLOWED IN HANDLING ALL ITEMS
CONTAMINATED WITH BLOOD AND OTHER BODY FLUIDS.
IN THE EVENT OF TUBE LEAKAGE OR BREAKAGE: 1) CLOSE THE INSTRUMENT
DRAWER(S); 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 BRO-
KEN DURING PREPARATION OR HANDLING, USE THE ESTABLISHED PROCE-
DURE IN YOUR FACILITY FOR DEALING WITH MYCOBACTERIAL SPILLS.
AN INOCULATED LEAKING OR BROKEN TUBE MAY PRODUCE AN AEROSOL OF
MYCOBACTERIA; APPROPRIATE HANDLING SHOULD BE OBSERVED.
1-5 Ibid.

4.3.1 Media Quality Control

Upon receipt of a new shipment or lot number of BD BBL MGIT 7 mL tubes, it is suggested that sus-
pensions of the ATCC™ control organisms be prepared in Middlebrook 7H9 Broth. Refer to the
media package insert for additional information on QC testing.
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 min-
utes.
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 BD BBL MGIT 7 mL tubes following the procedure in the media package insert.
The BD BBL MGIT 7 mL tubes should be detected as instrument positive within the time frame shown
in the table below. If the QC BD BBL MGIT 7 mL tubes do not give the expected results, do not use
the remaining tubes of the lot until you have contacted BD Technical Services (in the USA, 1-800-
638-8663; outside the USA, contact your local BD representative).

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BD BACTEC MGIT Instrument User’s Manual

Media QC Testing

Dilution of Days to
ATCC™
Species 0.5 McFarland Instrument
Number
Suspension in Saline Positivity

M. tuberculosis 27294 1:500 6 – 10

M. kansasii 12478 1:50000 6 – 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
BD 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.

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 fol-
lowing 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 drawers are closed. When the drawers are closed, the Main Status screen
appears.

Press the “maintenance” soft key:

Press the “test drawer indicators” soft key:

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 4 – Operation

All three external indicator lamps on each drawer should light, as well as the instrument
Alarm indicator. If any does not, contact BD to arrange replacement of the indicator.
Open drawer A. The soft key definitions now change to allow tests of station status LEDs.
The Maintenance – Test Indicators display appears:

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:

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 (BD BACTEC MGIT
960 only).
3 Check the thermometer reading(s) of the Temperature QC tube(s). If your manual readings
are within +1.0°/–2.0 °C of 37 °C, the controller and heaters are operating within the
expected range.

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BD BACTEC MGIT Instrument User’s Manual

4 From the Main Status screen, press the “temperature” soft key to view drawer temperature
reading(s). Verify that the drawer temperature(s) is/are currently within 1.5 °C of the manual
(thermometer) readings for each drawer. If the readings are not within this range, refer to
the instructions in Section 7 – Troubleshooting.

Figure 4-3 – Drawer Temperature Display (MGIT 960 shown)

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 anon-
ymous” operation before some other activities (such as resolving error stations/sets or removing
completed AST sets) can be initiated.
To enter new tubes into the instrument – Accession Barcoding Disabled:
These instructions should be used to enter new BD 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.

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 4 – Operation

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 instrument 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 LED of the assigned station illuminates GREEN.

Figure 4-4 – Tube Entry Display – Accession Barcoding Disabled

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.

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BD BACTEC MGIT Instrument User’s Manual

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 tube

Removal of negative tube

Reassign tube if station becomes bad

To enter new tubes into the instrument – Accession Barcoding Enabled:

These instructions should be used to enter new BD 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 instrument 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.

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 4 – Operation

This signals that the instrument is ready to read an accession barcode. Either scan the acces-
sion barcode label, or press the “accession barcode not 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 LED of the assigned station illumi-
nates GREEN.

Figure 4-5 – Tube Entry Display – Accession Barcoding Enabled

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 tube

Removal of negative tube

Reassign tube if station becomes bad

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BD BACTEC MGIT Instrument User’s Manual

4.6 AST Testing

4.6.1 AST Set Preparation
BD BBL MGIT 7 mL tubes should be placed in the appropriate size AST carrier (see Figure 4-6), which
should then be placed in the AST tube rack (see Figure 4-7). The AST tube rack holds up to 55 tubes,
which can include eleven 5-tube AST sets or five 8-tube sets with three 5-tube sets, etc.
Maintaining the proper order of tubes in the AST carrier is essential to performing the test properly.
The order of tubes in the AST carrier ALWAYS follows this general guideline:
• Growth Control tube to the far left of the barcode; followed by STR, INH, RIF, EMB, or PZA
tubes as you move from left to right.
• If you are using both drug concentrations of STR, INH, and/or EMB, the lower concentration
tube precedes the higher, left to right. Refer to Figure 2-2 for all AST Set configurations.
AST SIRE or PZA drugs should be reconstituted, and tube sets should be prepared according to the BD
BACTEC MGIT 960 SIRE Kit Package Insert or the BD BACTEC MGIT 960 PZA Kit Package Insert, respec-
tively.
When setting up the AST tube sets, you must use the correct size tube carrier for the AST set you are
testing. The number of tubes in the set is encoded in the carrier's barcode. Using a carrier of the
incorrect size will cause the instrument to interpret the absence of a tube as an error condition,
which invalidates the results for the entire AST set.

WARNINGS
MAKE SURE THAT ALL CAPS ARE SCREWED ON THE TUBES SECURELY BEFORE
PLACING THEM IN THE AST CARRIER.
IT IS STRONGLY RECOMMENDED THAT YOU PREPARE THE AST SPECIMENS WITH
THE TUBES IN THE TUBE RACK. IF A CAP IS NOT SECURE AND THE AST SET
CARRIER IS LIFTED, THE AFFECTED TUBE WILL BE CAPTURED BY THE TUBE RACK.
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 VIRUSES AND
HUMAN IMMUNODEFICIENCY VIRUS, MAY BE PRESENT IN CLINICAL
SPECIMENS. “STANDARD PRECAUTIONS”1,3 - 5 AND INSTITUTIONAL GUIDE-
LINES SHOULD BE FOLLOWED IN HANDLING ALL ITEMS CONTAMINATED WITH
BLOOD AND 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 PREPARATION OR HANDLING, USE THE ESTABLISHED PROCE-
DURE IN YOUR FACILITY FOR DEALING WITH MYCOBACTERIAL SPILLS. AN
INOCULATED LEAKING OR BROKEN TUBE MAY PRODUCE AN AEROSOL OF
MYCOBACTERIA; APPROPRIATE HANDLING SHOULD BE OBSERVED.
1 - 5 Ibid.

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 4 – Operation

Figure 4-6 – AST Carrier (5-tube set)

Figure 4-7 – AST Tube Rack

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BD BACTEC MGIT Instrument User’s Manual

4.6.2 Entering New AST Sets

1 Take the AST tube sets to the instrument using the AST Tube Rack. Open the desired drawer.
Press the “tube entry” soft key.

2 Scan the AST carrier's barcode label. The carrier barcode indicates that what you are entering
is an AST set, how many tubes are in the set, and the set’s sequence number.
3 If Accession Barcoding is enabled, an Isolate Number is assigned to the set. To change the
isolate number, press the “isolate number” soft key. Use the UP ARROW key to increase or
the DOWN ARROW key to decrease the isolate number.

Also when Accession Barcoding is enabled, the instrument expects an accession barcode to
be scanned after the AST carrier barcode. Scan the accession barcode if it is available. If it is
not available, press the “accession barcode not available” soft key. (Note that if you do, you
cannot assign an isolate number.)

4 The display shows the default carrier set. Check that the AST set definition is displayed cor-
rectly for the AST set currently being entered. If the displayed definition is correct, go to
Step 6. If the AST set being entered is not the default set, go to Step 5 to change the AST set
definition.

Check also that the order of tubes in the AST carrier matches that displayed for the AST set
definition selected for the current set.
5 To change the AST set definition, press the “change AST set definition” soft key. Use the UP
ARROW or DOWN ARROW key to scroll through the available definitions for the scanned car-
rier size. (As you scroll, the default set is indicated by a check mark in the main body of the
display.) Press the “OK” soft key to select the highlighted set.

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 4 – Operation

Figure 4-8 – AST Set Login Display

At the top of the Main Body of the display, the Growth Control tube sta-
tion assignment is shown; below that, all AST set tube station assign-
ments are shown. This is the order in which you must place tubes in the
carrier in order for accurate results to be reported at AST test completion.

6 The assigned stations of the tubes in the set are shown in the main body of the display. In
addition, the station LEDs of all the assigned stations for the set illuminate GREEN. Carefully
insert the tube set into the indicated stations, making sure that the Growth Control tube is
located in the leftmost indicated station. Make sure that all the tubes and the carriers are
fully seated in the drawer.

NOTES

• Use of an incorrect AST set definition will cause inaccurate results.

• Make sure you place the drug tubes in the exact order indicated on
the LCD display.

• Make sure you place the AST set in the stations indicated by GREEN
indicators, with the Growth Control tube leftmost of the tubes in the
set. Unlike standard tubes that are undergoing routine testing, where
error and anonymous tubes can be resolved or identified, the results for
AST sets that encounter error status are discarded.

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BD BACTEC MGIT Instrument User’s Manual

7 Repeat Steps 2 - 6 for each of the AST sets you want to enter.
When you are done entering the current batch of AST sets, close the drawer and wait a moment
while the drawer performs a “quick scan” of drawer contents. If you have misplaced any AST sets,
the quick scan can detect this and put the affected set into error status. If you wait until the quick
scan is complete, you can correct any station errors before the AST set begins testing.

4.6.3 Removing Completed AST Sets

When AST sets complete testing, the “Completed AST Sets” field in the AST Summary region of the
display shows the quantity of completed AST sets. In addition, the Positive Tube/Completed AST Set
Indicator for the drawer illuminates.

Completed AST Sets field

1 Open the desired drawer. Press the “remove completed AST sets” soft key.

2 If the set location is present, the first completed AST set stations illuminate with FLASHING
GREEN indicators. Remove the carrier and scan its barcode label. The LEDs at this station
extinguish. Repeat to remove additional AST sets. Place completed AST sets in the AST tube
rack.
3 If the set location is NOT present, you can clear the set by pressing the “clear set/clear sta-
tion” soft keys.

4.6.4 Anonymous Sets

The most common anonymous tube/set situation occurs when tubes are placed in the instrument
without being scanned through the Tube Entry function. These anonymous tubes are detected by
the instrument at the next test cycle. If this occurs with an AST set, when the “identify anonymous”
soft key is pressed, the first anonymous tube is lit.
To identify/clear anonymous AST sets:
1 Open the drawer with anonymous tubes.
2 Press the “identify anonymous” soft key.
3 If you identify an anonymous set and clear the station/set, what you identified will not
appear on an Unloaded AST Report because the instrument has no recall that the anony-
mous stations were filled with a set.
4 The first anonymous station is shown in the main body of the display, and the ORANGE sta-
tion indicator at this station illuminates.

Scan the carrier barcode, not the individual tube barcode. This is the only way the instru-
ment can know that it is an AST set that is anonymous.

(If just the tube whose station is lit is scanned, the instrument believes it is an anonymous
growth and detection tube, and shows you the station into which to place the tube by light-

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 4 – Operation

ing the green station indicator. If this occurs, simply leave the tube out of that station, allow
the station to go into error, then clear the error through the Resolve Errors function.)
5 After you scan the carrier barcode, the instrument lights the stations where the set resides
(orange indicators) and offers you the option of clearing the AST set, or each tube in the set
individually. Press the desired soft key.
If the station is Anonymous Empty with a Hard Error, the “clear station” button will not
appear.
Please note that if you select to clear the AST set, the anonymous station will then clear (not
the AST set) since the tube(s) were never scanned. To remove the AST set, you must do so
through the completed AST sets workflow (Section 4.6.3).

6 The confirmation Step asks you to press “OK” to proceed to clear the stations, or “cancel” to
cancel the operation.

7 After you clear the set, you must use Tube Entry to reenter the set as a new AST set, as
described in Section 4.6.2 – Entering New AST Sets. AST Set Re-entry can only be done if the
initial set entry was not longer than 8 hours ago.

4.6.5 Error AST Sets

Anonymous Stations Created by Misplacement
Another way that anonymous tubes are inadvertently created is when an AST set is not placed in
the stations assigned by the Tube Entry function. If the set is misplaced to the left or right of the
assigned stations, then often one error station (where a tube should have been present but was
not) and one anonymous station (where a tube should not have been present but was) results.
When the carrier is scanned in this situation, the E33 error indicates that the set is known to the
instrument but is in the wrong location.
• Place the set in the green locations.
• Clear the anonymous stations as described in Section 4.6.4, Steps 4 - 6.
• Remove completed set per Step 3 in Section 4.6.3.
AST Set Errors
• AST set errors may be caused by not achieving the appropriate inoculum in a test set. The
instrument uses algorithms to determine if the Growth Control tube, used to assess the AST
set, is at the appropriate inoculum level.

If the instrument does not detect the appropriate level of growth in the Growth Control
tube by day 13 of testing, the AST set may be under-inoculated (see Section 7
Troubleshooting, error code E92 - subcode 00000200).
• If the instrument detects significant growth in the Growth Control or any set tube prior to
day 4, the AST set may be either over-inoculated or contaminated (see Section 7

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BD BACTEC MGIT Instrument User’s Manual

Troubleshooting, error code E92 - sub-code 00000400).

4.6.6 AST Results

Results of AST tube testing are only available on the Unloaded AST Set Report (Section 5.5.6). Two
values are reported for normally completed AST tubes:
 Status – R for Resistant
S for Susceptible
C for Growth Control
D for completed sets that go into Error
X for tubes that encounter any type of Error condition
 Growth Unit (G/U) – a numeric value used by the instrument to determine the growth of the
isolate.

4.7 Positive and Negative Specimens

With the BD BACTEC MGIT Instrument, tubes are typically incubated and tested for 42 days before
they are removed from the instrument. Clinical performance of the BD BACTEC MGIT Instrument 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 con-
taminants, the tube may be re-entered into the instrument. The instrument allows re-entry of instru-
ment 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
tube is treated as a newly entered tube (new Start of Protocol date and previous readings are dis-
carded).

4.7.1 Notification of Positive Tubes

The instrument 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

• Until the condition is acknowledged, the audible alert sounds (if enabled)

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 4 – Operation

4.7.2 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.
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. Remove one
of the positive tubes and scan the positive tube’s barcode label. The LEDs at this station
extinguish.

Figure 4-9 – Remove Positive Tubes Display

5 Repeat Steps 3 – 4 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.
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. Tubes should remain at room tempera-
ture while they are out of the instrument.

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BD BACTEC MGIT Instrument User’s Manual

4.7.3 Returning Positive Tubes to the Instrument for Further Testing

The instrument 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. The tubes 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 drawer. 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 identi-
fied) 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 pro-
tocol setting back to the setting established within your laboratory (recommended 42 – 56
days) before entering any additional tubes.

4.7.4 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 – Operation

4.7.5 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 instrument 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 data-
base.
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.

Figure 4-10 – Remove Negative Tubes Display (single tube removal)

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BD BACTEC MGIT Instrument User’s Manual

5 To remove all negative tubes (batch removal), press the “remove negatives – batch” soft
key. Remove all the tubes in the indicated stations. The barcode scanner turns off, so you
cannot scan 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.
Once identified, they are treated as newly entered tubes.

Figure 4-11 – Remove Negative Tubes Display (batch tube removal)

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 - Operation

4.8 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 with-
out 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 instrument 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 dis-
play similar to the following appears (showing the same station as is flashing):

Figure 4-12 – Remove Ongoing Tubes Display

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.

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BD BACTEC MGIT Instrument User’s Manual

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 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 num-
ber.
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
BD 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 Sec-
tion 13 – Supplemental Procedures, for information on reading tubes manually.)

4.9 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 or a tube
that was placed in a station without being scanned). 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
instrument 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 instrument.
The Identify Anonymous function enables you to locate anonymous tubes in the instrument and
assign them to stations, or to clear empty stations with missing tubes (typically caused by removing
a tube without scanning it out via one of the vial removal activities).
To identify anonymous tubes while using the AST feature, refer to Section 4.6.4.
To identify anonymous tubes – Accession Barcoding Disabled:
These instructions should be used to identify anonymous BD 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 sta-
tion 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.

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 4 – Operation

Figure 4-13 – Identify Anonymous Tubes Display

4 Scan the tube’s barcode label. The scanned sequence number is now assigned to this sta-
tion. In addition, the station LEDs of the assigned station illuminate GREEN.

Return the tube to this station.

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.
6 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 BD 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 sta-
tion 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.

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BD BACTEC MGIT Instrument User’s Manual

4 Scan the tube’s barcode sequence 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 acces-
sion barcode label, or press the “accession barcode not 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. Return the tube to this station.
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.
8 For anonymous tubes in other drawers, repeat the procedure from Step 1 – 6.

4.10 Resolving Station Errors

As you perform activities at the BD BACTEC MGIT 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 illumi-
nating. Generally, the more serious the condition, the more ways the instrument notifies you of the
problem.

CAUTION

When the instrument 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 30s, are
reported in the system alert log. These errors cause the system alert icon to appear on the Main Sta-
tus 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.

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 4 – Operation

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 instrument into an alert condition (though
they are reported in the system alert log). These errors can frequently be cleared by simply perform-
ing 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 4-14. Specific suggestions for resolving error stations are provided
in Section 7.2 – Error Messages, under error code E12.
All the “E” type error codes are discussed in detail in Section 7.2 – Error Messages. The audible tones
are discussed in Section 3.8 – Audible Tones and Alarms.

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Open drawer and
press “resolve

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station errors”
soft key

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BD BACTEC MGIT Instrument User’s Manual

Print Date: 13-May-2015 14:18:14 GMT Daylight Time

(First error station is shown)

Press UP ARROW or
Will the DOWN ARROW to resolve
Can the tube

Doc Part: EN
Is the tube tube be
NO NO

Doc Type: ZLU

in the be returned YES next station error. When
returned
station? now? tube is ready to be
later?
returned, repeat
procedure from first

Usage: Production Usage

YES NO
YES

Figure 4-14 – How to Resolve Error Stations

Version: E
Revision: 14
Scan the tube
barcode and
Press “force station
return tube
available” soft key

Status: Released EFFECTIVE

to station

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 4 – Operation

4.11 Printing Reports

The following reports can be selected for printing at the instrument:
• Unloaded Positives – a list of all positive tubes removed from the instrument 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 instrument 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 instrument
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
• Unloaded AST sets – a list of all AST sets removed from the instrument since the last time the
report was printed and confirmed
If connected to the BD EpiCenter™ system, additional reports are available for printing. Refer to BD
EpiCenter Help for additional information.
To print a report:
1 From the Main Status screen, press the “print reports” soft key.

2 The Reports menu appears.

Figure 4-15 – Reports Menu

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BD BACTEC MGIT Instrument User’s Manual

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

Unloaded Unloaded Unloaded Instrument Unloaded AST

QC Report
Positive Tubes Negative Tubes Ongoing Tubes Inventory Sets

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.

4.12 LIS Communications

The LIS Communications feature provides a method for the BD BACTEC MGIT Instrument to upload
information to a compatible Laboratory Information System (LIS). LIS Communications can be con-
figured to upload test results, tube entry and removal, and isolate and specimen (accession) records
(numbers) 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 BD repre-
sentative. The LIS Vendor Interface Specification (available upon request) provides complete details
on the BD BACTEC MGIT Instrument 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. Consum-
able 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).

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 4 – Operation

A list of setup parameters is presented below:

Option Selections Purpose

LIS Communications Enable or Disable Enable instrument to communicate with LIS

Select whether instrument sends data to LIS

Upload Results Solicited or Unsolicited
automatically or only on request

Select whether instrument uploads tube

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

Select whether instrument uploads results for

Orphan Results Enable or Disable
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 BD representative and your LIS vendor.

NOTE

If the BD BACTEC MGIT Instrument is connected to a LIS, it cannot be

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

4.13 Use with the BD EpiCenter™ System

For comprehensive operating instructions for the BD EpiCenter system, refer to the built-in Help.
Please note the following regarding use of the BD BACTEC MGIT Instrument with the BD EpiCenter
system:
• The BD BACTEC MGIT Instrument obtains its date and time settings from the BD EpiCenter
system. If you need to correct the system date or time, perform the correction at the BD
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 BD 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
BD EpiCenter system. This occurs only after new installations and only for tubes currently in
the instrument(s).
• The state of the link with the BD 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.

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BD BACTEC MGIT Instrument User’s Manual

• If the BD BACTEC MGIT Instrument is connected to a LIS, it cannot be connected to the BD

EpiCenter system. However, if the BD BACTEC MGIT Instrument is connected to BD
EpiCenter, then a LIS connection can be established via BD EpiCenter.

4.14 Power Failures

The information in the BD BACTEC MGIT Instrument is stored in non-volatile RAM. Data in NVRAM is
maintained by a long-life battery. When a power failure is detected, the BD BACTEC MGIT software
records the time of the failure and performs an orderly shutdown of the instrument. No BD 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). BD BBL MGIT 7 mL tube testing resumes when power is restored.
For AST sets that are in the instrument during a power failure, refer to the recommendations in Sec-
tion 7 – Troubleshooting, error code E92 for recommendations on how to proceed.
If power is lost to the BD BACTEC MGIT Instrument for more than 24 hours, it is strongly recom-
mended that all BD BBL MGIT 7 mL tubes in the instrument be removed and incubated offline at 37
°C. These tubes must be read manually throughout the remainder of the eight week protocol
according to the supplemental procedure in Section 13.
You may, at your option, connect the instrument to an Uninterruptible Power Supply (UPS). Use of a
UPS may help prevent interruptions to testing.

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 5 – Reference
5.1 General
This section presents reference material on the BD BACTEC MGIT Instrument user interface. The fol-
lowing information is presented:
• Software menu tree
• Display types and regions
• Icon charts
• Reports

5.2 Software Menu Tree

The following is a hierarchical list of all displays/functions in the instrument. 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 Alarm 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)
Set AST Default Sets (Section 2.4.2)
LIS Communications Enable/Disable/Setup (Section 2.4.2)

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BD BACTEC MGIT Instrument User’s Manual

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 4.11)
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 and Inventory AST Set Reports (Section 5.5.4)
QC Report (Section 5.5.5)
Unloaded AST Set Report (Section 5.5.6)
Review System Alert List (Section 3.3.4, 7.2)
Temperature Display (Section 6.2.1)
Main Activity Screen (Door Open)
Tube / AST Set Entry (Section 4.6)
Remove Positive Tubes (Section 4.7)
Remove Negative Tubes (Section 4.7)
Identify Anonymous Tubes (Section 4.9)
Resolve Station Errors (Section 4.10)
Remove Ongoing Tubes (Section 4.8)
Remove Completed AST Sets (Section 4.6.3)

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 instru-
ment level activities. These icons are as follows:

The “configuration” icon, where you can access instrument setup

parameters

The “maintenance” icon, where you can perform instrument indicator

lamp verifications, block and unblock stations, write data to a floppy disk
or USB flash drive, and update instrument software

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 5 – Reference

The “configuration” icon, where you can access instrument setup

parameters

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, instrument and station status information is always in view at the top of the screen. The
following information is presented (see Figure 5-1):
• Instrument number
• Current date
• Current time
• LIS or network indicator (if 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 (or 320) because tubes can have multiple
statuses)

For the BD BACTEC MGIT 960, drawers A, B, and C are shown in the Summary region. For the
BD BACTEC MGIT 320, only drawer A is shown.
• When the AST feature is enabled, an additional window appears, just below the Summary
Region. This window adds two counters for AST sets. The top counter shows the number of
Ongoing AST sets in each of the drawers. The bottom counter shows the number of
Completed AST sets in each drawer. These are the only two statuses that are shown on the
display for AST sets. Final AST results (Susceptible or Resistant) are only printed on the
Unloaded AST Sets Report. This is the only way AST results can be viewed. The Unloaded AST
Sets Report is discussed in Section 5.5.6 – Unloaded AST Set Report.
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 shown and described above.

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BD BACTEC MGIT Instrument User’s Manual

Last Station Assigned in the Tube Entry

Current Date Drawer and Status

Instrument
Number
Current
Time
Summary
LIS/
Network
Enabled

AST
Summary
Main Body

|--------------------------------- Soft Key Assignments--------------------------------|

Figure 5-1 – Main Status Screen (for BD BACTEC MGIT 320 instrument with AST and Network
enabled)

5.3.2 Main Activity Screen

The Main Activity screen (Figure 5-2) is displayed when an instrument drawer 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 BD 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.

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 5 – Reference

The “tube entry” icon, which allows you to enter new BD BBL MGIT 7 mL
tubes for testing.

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 instrument 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.

The “remove AST sets” icon. This icon appears only when AST is enabled
and there are completed AST sets in the instrument. It allows you to remove
these completed AST sets.

In addition, instrument 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 or network indicator (if 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 (or 320) because tubes can have multiple
statuses)

For the BD BACTEC MGIT 960, drawers A, B, and C are shown in the Summary region. For the
BD BACTEC MGIT 320, only drawer A is shown.

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BD BACTEC MGIT Instrument User’s Manual

• When the AST feature is enabled, an additional window appears, just below the Summary
Region. This window adds two counters for AST sets. The top counter shows the number of
Ongoing AST sets in each of the drawers. The bottom counter shows the number of
Completed AST sets in each drawer. These are the only two statuses that are shown on the
display for AST sets. Final AST results (Susceptible or Resistant) are only printed on the
Unloaded AST Sets Report. This is the only way AST results can be viewed. The Unloaded AST
Sets Report is discussed in Section 5.5.6 – Unloaded AST Set Report.
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 shown and described above.

Last Station Assigned in the Tube Entry

Current Date Drawer and Status

Instrument
Number
Current
Time
Summary

AST
Summary
Main Body

|--------------------------------- Soft Key Assignments--------------------------------|

Figure 5-2 – Main Activity Screen

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 5 – Reference

5.4 Icon Charts

The following charts show all the icons that appear in the instrument. The icons are arranged in
groups relating to where they appear during instrument 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 AST sets (ongoing)

Completed AST sets

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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BD BACTEC MGIT Instrument User’s Manual

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 instrument number (BD

Set audible alert volume
BACTEC MGIT 960)

Set instrument number (BD

Set report language
BACTEC MGIT 320)

English language Spanish language

French language Italian language

German language Polish language

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 5 – Reference

Configuration Icons

Icon Meaning Icon Meaning

Accession barcoding
Japanese language
enable/disable

Set default AST sets AST carrier (2 tubes, 3, 4, etc.)

AST set position 1 AST set position 2

AST set position 3, etc. LIS enable/disable

Alert/Error Notification Icons

Icon Meaning Icon Meaning

System alert Activity error or instrument full

Problem with floppy disk Floppy disk full, insert another

inserted or no disk is inserted one

Insert floppy disk Power was removed at this time

Problem with USB flash drive

Power was restored
inserted or USB flash drive is full

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BD BACTEC MGIT Instrument User’s Manual

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 floppy disk

Update software with floppy Update software with USB flash

disk drive

Copy data to USB flash drive Replace single calibrator tube

Replace all calibrators in drawer

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 current operation/level

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 5 – Reference

Action/Navigation Icons

Force station available Scroll up or increase value

Force AST stations available 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

Unloaded AST Set Report

Activity Icons

Icon Meaning Icon Meaning

Tube entry Barcode scanner is ready

Scan tube sequence # barcode Scan tube accession barcode

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BD BACTEC MGIT Instrument User’s Manual

Activity Icons

Icon Meaning Icon Meaning

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

Remove completed AST set Change AST set definition

AST operations AST set entry

Default AST set is shown Isolate number

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 5 – Reference

5.5 Reports
Six instrument reports are available for printing. The reports are as follows:
• Unloaded Positives (Section 5.5.1) – a list of all positive tubes removed from the instrument
since the last time the report was printed and confirmed (up to a maximum of 500 unloaded
tubes)
• Unloaded Negatives (Section 5.5.2) – a list of all negative tubes removed from the
instrument since the last time the report was printed and confirmed (up to a maximum of
500 unloaded tubes)
• Unloaded Ongoings (Section 5.5.3) – a list of all ongoing (in protocol) tubes removed from
the instrument since the last time the report was printed and confirmed (up to a maximum
of 500 unloaded tubes)
• Instrument Inventory (Section 5.5.4) – a list of all current station assignments (excluding
Available stations), either for the whole instrument or for individual drawers

and

Inventory AST Set – a list of all AST sets and their station assignments (if AST is enabled)
• Quality Control (Section 5.5.5) – 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
• Unloaded AST Set (Section 5.5.6) – a list of all AST sets removed from the instrument since
the last time the report was printed and confirmed
Each of the reports is discussed in greater detail in the sections that follow.
If connected to the BD EpiCenter system, additional reports are available for printing. Refer to BD
EpiCenter Help for additional information.

5.5.1 Unloaded Positives Report

The Unloaded Positives Report lists all the positive tubes removed from the instrument since the last
time the report was printed and confirmed (up to a maximum of 500 unloaded positive tubes).
When the report printing is confirmed, the records for these unloaded tubes are removed (deleted)
from the instrument. 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:

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BD BACTEC MGIT Instrument User’s Manual

Report Header
Title (Unloaded Positives Report)
Instrument number
Current date and time
Current drawer temperature(s)
Current instrument software version
Page number
Main Body of Report
Tube Position – in the form D/RCC, where D is the drawer letter (960: A, B, or C; 320: A
only), 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 (secondary
sort)
Sequence Number – the scanned tube barcode sequence number (tertiary sort)
Growth Unit – the final growth unit reading
Tube Status – + for positive, +T for threshold positive
TTD – the time to detection, in the form D(D);HH, where D(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 (primary sort)
Protocol Length – the number of days of the assigned testing protocol
Start of Protocol – the date and time of the first instrument test

Figure 5-3 – Sample Unloaded Positives Report (shown for BD BACTEC MGIT 960)

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 5 – Reference

5.5.2 Unloaded Negatives Report

The Unloaded Negatives Report lists all the negative tubes removed from the instrument since the
last time the report was printed and confirmed (up to a maximum of 500 unloaded negative tubes).
When the report printing is confirmed, the records for these unloaded tubes are removed (deleted)
from the instrument. 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 temperature(s)
Current instrument software version
Page number
Main Body of Report
Tube Position – in the form D/RCC, where D is the drawer letter (960: A, B, or C; 320: A
only), 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(D);HH, where D(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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BD BACTEC MGIT Instrument User’s Manual

Figure 5-4 – Sample Unloaded Negatives Report (shown for BD BACTEC MGIT 960)

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 5 – Reference

5.5.3 Unloaded Ongoings Report

The Unloaded Ongoings Report lists all the ongoing tubes removed from the instrument since the
last time the report was printed and confirmed (up to a maximum of 500 unloaded ongoing tubes).
When the report printing is confirmed, the records for these unloaded tubes are removed (deleted)
from the instrument. 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 temperature(s)
Current instrument software version
Page number
Main Body of Report
Tube Position – in the form D/RCC, where D is the drawer letter (960: A, B, or C; 320: A
only), 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(D);HH, where D(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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BD BACTEC MGIT Instrument User’s Manual

Figure 5-5 – Sample Unloaded Ongoings Report (shown for BD BACTEC MGIT 960)

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 5 – Reference

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 sta-
tions are not reported. A sample Instrument Inventory Report is shown in Figure 5-6.
When the AST feature is enabled, the Instrument Inventory Report is expanded to provide informa-
tion on AST sets in the instrument. First the Instrument Inventory Report prints information on all
the standard tubes in the instrument, then on all the AST sets. The AST portion of the report is
described below and shown in Figure 5-7.
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.

Instrument Inventory Report

The Instrument Inventory Report provides the following information:
Report Header
Title (Instrument Inventory Report)
Instrument number
Current date and time
Current drawer temperature(s)
Current instrument software version
Page number
Drawer (A for BD BACTEC MGIT 320; ABC for BD BACTEC MGIT 960)
Main Body of Report
Tube Position – in the form D/RCC, where D is the drawer letter (960: A, B, or C; 320: A
only), 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

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BD BACTEC MGIT Instrument User’s Manual

Figure 5-6 – Sample Instrument Inventory Report (shown for BD BACTEC MGIT 320)

TIP/TTD – the time in protocol or time to detection, in the form D(D);HH, where D(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 of the last test or when the tube
was 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
Inventory AST Set Report
The AST Instrument Inventory Report presents the following information:
Report Header
Title (Inventory AST Set Report)
Instrument number
Current date and time
Current drawer temperatures
Current instrument software version
Page number (numbering restarts at 1 for AST sets)
Drawer (A for BD BACTEC MGIT 320; ABC for BD BACTEC MGIT 960)

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 5 – Reference

Figure 5-7 – Sample Inventory AST Set Report (shown for BD BACTEC MGIT 960)

Main Body of Report

AST Set Information
Carrier Sequence Number
Time in Protocol (TIP) – in the form D(D);HH, where D(D) represents the number of
days and HH the number of hours from the start of protocol to the time the set was
removed from the instrument. If asterisks appear in this field, it indicates that the
value is not available.
Start of Protocol (SOP) – the date and time of the first instrument test
Access(ion) Number – the scanned accession barcode number, if one exists
Isolate Number (if one exists)
Tube Position – in the form D/RCC, where D is the drawer letter (960: A, B, or C; 320:
A only), 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.
Growth Unit (G/U) – a numeric value used by the instrument to determine the
growth of the isolate
Concentration – the concentration of the drug in the tube (if applicable)
Drug Name – Growth Control, Streptomycin, Isoniazid, Rifampin, Ethambutol, or Pyra-
zinamide

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BD BACTEC MGIT Instrument User’s Manual

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 5-8.

The Quality Control Report provides the following information:
Report Header
Title (Quality Control Report)
Instrument number
Current date and time
Current drawer temperature(s)
Current instrument 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 (960: A, B, or C; 320: A
only) 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 (typically indicates the last
reading was missed; if ? status recurs, contact your local BD representative)
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 (960: A, B, or C; 320: A only), 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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 5 – Reference

Figure 5-8 – Sample Quality Control Report (shown for BD BACTEC MGIT 960)

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BD BACTEC MGIT Instrument User’s Manual

5.5.6 Unloaded AST Set Report

The Unloaded AST Set Report lists all the AST sets removed from the instrument since the last time
the report was printed and confirmed. When the report printing is confirmed, the records for these
unloaded tubes are removed (deleted) from the instrument. This is why you are asked to confirm
that the report did successfully print. The instrument can store a minimum of four days of com-
pleted set information.
You can print the Unloaded AST Set Report by pressing the soft keys below the following icons:

to access report selection

to print the report

A sample Unloaded AST Set Report is shown in Figure 5-9.

The Unloaded AST Set Report provides the following information:
Report Header
Title (Unloaded AST Set Report)
Instrument number
Current date and time
Current drawer temperature(s)
Current instrument software version
Page number
Main Body of Report
AST Set Information
Carrier Sequence Number
Time in Protocol (TIP) – in the form D(D);HH, where D(D) represents the number of days
and HH the number of hours from the start of protocol to the time the set is marked as
Complete. If asterisks appear in this field, it indicates that the value is not available.
Start of Protocol (SOP) – the date and time of the first instrument test
Removed Date – the date on which the AST set was removed from the instrument
Accession Number – the scanned accession barcode number, if one exists
Isolate Number, if one exists

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 5 – Reference

Figure 5-9 – Sample Unloaded AST Set Report (shown for BD BACTEC MGIT 960)

Tube Information
Tube Positions – in the form D/RCC, where D is the drawer letter (960: A, B, or C; 320: A
only), 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.
Growth Unit (G/U) – a numeric value used by the instrument to determine the growth of
the isolate
Status – R for Resistant, S for Susceptible, C for Growth Control, D for completed sets
that go into Error, X for Error (includes error sub-code)
Concentration – the concentration of the drug in the tube (if applicable)
Drug Name – Growth Control, Streptomycin, Isoniazid, Rifampin, Ethambutol, or Pyra-
zinamide

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BD BACTEC MGIT Instrument User’s Manual

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 6 – Maintenance
6.1 General
The BD BACTEC MGIT 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 user 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 BD personnel only.

WARNING
ALL MAINTENANCE AND REPAIR OTHER THAN THE PROCEDURES
DESCRIBED IN SECTION 6.2 – ROUTINE MAINTENANCE MUST BE
PERFORMED BY QUALIFIED SERVICE PERSONNEL.

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 per-
formed:
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.

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BD BACTEC MGIT Instrument User’s Manual

3 Press the “maintenance” soft key:

Press the “test drawer indicators” soft key:

All three external indicator lamps on the drawer(s) should light, as well as the instrument
Alarm indicator. If any does not, contact BD to arrange replacement of the indicator.
Open drawer A. The soft key definitions now change to allow tests of station status LEDs.
The Maintenance – Test Indicators display appears:

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.

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 6 – Maintenance

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 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 (MGIT 960 only).
4 Three thermometers in special tubes are provided for temperature verification (QC) of instru-
ment incubation. (MGIT 320 instruments receive one thermometer.) 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 drawer(s) has/have
remained closed for a few hours. This will provide the most accurate readings of tube tem-
peratures.
Select the drawer to be verified and the station into which you want to place the tempera-
ture QC tube. To prevent the instrument from trying to test the temperature QC tube in this
station, you should block it from use. See Section 6.2.3.2 – Block 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 – Unblock Station) and to block the new station you select.
5 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 read-
ings for each of the drawers. If the readings are not within this range, refer to the instruc-
tions in Section 7 – Troubleshooting.

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BD BACTEC MGIT Instrument User’s Manual

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 6 – Maintenance

BD BACTEC MGIT Instrument Maintenance Log

(37.0 °C + 1/-2 °C)

Figure 6-1 – Instrument Maintenance Log

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BD BACTEC MGIT Instrument User’s Manual

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 unob-
structed; 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 – 6-4.
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. Be careful not to turn the
instrument off when removing the bezel.
2 For the BD BACTEC MGIT 960, to remove a filter, lift it up slightly, then pivot the bottom out-
ward. Lower the filter out of the filter housing. See Figure 6-2.
3 For the BD BACTEC MGIT 320, to remove a filter, slide the filter housing out of the instru-
ment (Figure 6-3 and 6-4).
4 Wash the filter in a mycobactericidal disinfectant. Place it on a paper towel and dry it thor-
oughly (if you are going to reuse it immediately).
5 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.
6 To replace the faceplate, 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. Be careful not to
turn the instrument off when replacing the bezel.

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 6 – Maintenance

Figure 6-2 – BD BACTEC MGIT 960 Air Filter Replacement

Figure 6-3 – BD BACTEC MGIT 320 Air Filter Replacement – Filter Location

Figure 6-4 – BD BACTEC MGIT 320 Air Filter Replacement – Filter Removal

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BD BACTEC MGIT Instrument User’s Manual

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. BD 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 6-5.
Calibrator tube replacement is a two-stage process: first you physically replace the actual calibrator
tubes, and second you inform the instrument software that you have replaced them. See Figures 6-6.
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 (see Figure 6-6). Then lift the cover off
(see Figure 6-7).
2 Remove the desired calibrator tube(s) and dispose of them in accordance with your institu-
tion’s policies and procedures.
3 Place the new calibrator tube(s) in the calibrator station(s) (see Figure 6-8).
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 display appears:

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 6 – Maintenance

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 instrument 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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BD BACTEC MGIT Instrument User’s Manual

BD BACTEC™ MGIT™ Instrument 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 6-5 – Calibration Log

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 6 – Maintenance

Lift 4 black
push-pull
fasteners

Figure 6-6 – Location of Calibrators

Remove Cover

Figure 6-7 – Calibrator Replacement (A)

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BD BACTEC MGIT Instrument User’s Manual

Remove calibrator vials

and replace with new ones

Figure 6-8 – Calibrator Replacement (B)

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.

WARNING
ONLY USE THE CLEANING METHOD DESCRIBED ABOVE AS OTHER
CLEANING AGENTS MAY CAUSE A HAZARD UPON CONTACT WITH THE
PARTS OR CONTENTS OF THE EQUIPMENT.

Figure 6-9 – Barcode Scanner Window

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 6 – Maintenance

6.2.3.2 Blocking a Station

Blocking a station designates the station as unavailable for testing. Some stations are blocked auto-
matically by the instrument (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.

4 Open the desired drawer. The “block station” soft key now appears in the soft key definition
area. (If there are already blocked stations in the instrument, the “unblock station” icon also
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 col-
umn 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.

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BD BACTEC MGIT Instrument User’s Manual

6 When the correct station number is displayed, press the “block station” soft key to block the
station. Repeat Step 5 if necessary 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 instrument (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.

2 Press the “maintenance” soft key:

3 Press the “maintenance” soft key again, until the maintenance display numbered 2/5 (block/
unblock stations) appears.

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 6 – Maintenance

4 Open the desired drawer.

5 The “unblock station” soft key shown below now appears in the soft key definition area.

6 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 col-
umn 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.
7 When the correct station number is displayed, press the “unblock station” soft key to
unblock the station. Repeat Step 5 if necessary to unblock additional stations.

8 Be sure to remove any bad station plugs you may have previously inserted for stations you
are unblocking.
9 When all the desired stations are unblocked, press the “exit” soft key.

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BD BACTEC MGIT Instrument User’s Manual

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 barcode.
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.

WARNING
ONLY USE THE CLEANING METHOD DESCRIBED ABOVE AS OTHER
CLEANING AGENTS MAY CAUSE A HAZARD UPON CONTACT WITH THE
PARTS OR CONTENTS OF THE EQUIPMENT.

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 BD.

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 6 – Maintenance

Documentation of decontamination must be presented to a BD representative upon request prior to

any service.

NOTE

If necessary, contact a BD representative to verify whether or not a

decontamination or cleaning method/agent could be hazardous.

6.2.3.6 Reuniting Separated Thermometer Liquid (Mercury and Non-Mercury)

If the liquid column in your temperature QC thermometer becomes separated, the techniques below
can be used to reunite it.

WARNING
HANDLE INSTRUMENTS WITH CARE. WEAR SAFETY GLASSES AND
GLOVES BEFORE PROCEEDING.

Unscrew the vial cap with the thermometer attached.

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 liquid and the separation to enter the
expansion chamber at the top of the thermometer. NOTE: Overfilling the expansion chamber
will break the thermometer. Remove the thermometer from the boiling water, and quickly
tap it on the surface of a large rubber stopper in the upright position allowing the gas
separating the column to rise above the column. Allow to cool slowly in the upright
position, and re-examine the thermometer before putting into service.
2 Should the separation occur in the lower portion of the column, cool the bulb in a mixture
of methanol and dry ice. Keep the thermometer in an upright position. Allow the liquid and
the separation to retreat into the bulb. As soon as the liquid enters the cone of the bulb
(upper portion), remove the thermometer from the mixture. Swing the thermometer (bulb
down) in a short arc to allow the gas separating the column to rise above the column. Allow
the thermometer to warm up slowly in the upright position and the liquid to re-enter the
capillary tube before touching the bulb. Re-examine the thermometer before putting into
service.

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BD BACTEC MGIT Instrument User’s Manual

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 7 – Troubleshooting
7.1 General
7.1.1 Instrument Service
If your BD BACTEC MGIT 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 instrument malfunction, contact your local BD representative (contact num-
bers are listed in Section 12).
This section discusses error messages, which appear when the instrument 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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BD BACTEC MGIT Instrument User’s Manual

7.2 Error/Alert Messages

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

When the instrument 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 instrument 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 sys-
tem 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.
AST Errors
The two major types of errors that can occur with the AST feature are Anonymous tubes and sta-
tion errors. Unlike individual BD BBL MGIT 7 mL tubes, anonymous and error AST sets cannot be
resolved. All such errors cause testing of the affected AST set to be terminated and the results to
be reported as Error (X).
Anonymous AST tubes appear in the Summary region of the display, and activate the “identify
anonymous” icon when the drawer is opened. However, when the “identify anonymous” soft
key is pressed, the only resolution is to force stations available, either all at once or individually.
All of the AST related errors that can occur trigger the E92 error code. The sub-code that appears
below the E92 code in the system alert list indicates the specific condition that caused the error.

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 7 – Troubleshooting

Station errors cause testing of the affected AST set to be terminated and the results to be
reported as Error (X). Station errors can be instrument-related or inoculum-related. The last four
digits of the error sub-code are reported next to the affected station (if the error is station-
related) on the Unloaded AST Set Report. In many cases, you may correct the cause of the error
and re-enter the AST set as a new set for susceptibility testing only if the set’s Time in Protocol is
less than 8 hours.
To avoid station errors, always verify the correct placement of AST sets when they are entered in
the instrument; be sure tubes are fully seated when placing them into stations; make sure the
drawer's “quick scan” completes without error before you leave the area; and use the
“remove completed AST tubes” to scan the sets out of the station when you remove them.

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

E01 Positivity algorithms reset

The software algorithms that determine tube positivity have been reset. This message is informa-
tional.
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 sub-code 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 E02 might show sub-code 02202000,
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.

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BD BACTEC MGIT Instrument User’s Manual

CORRECTIVE ACTION(S)
 Check current temperature(s) on LCD display (accessible from Main Status screen) 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 and Setup).
 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)
• Instrument encountered a software error.
CORRECTIVE ACTION(S)
 Write data to disk (see Section 7.3) and call BD.

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 prob-
lem. If a number other than those in the chart appears, contact BD.
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 (see
Section 6.2.3.5 – Decontamination).
 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

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 7 – Troubleshooting

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.

E07 Power supplies high/low

POSSIBLE CAUSE(S)
• Problem detected in an instrument power supply.
CORRECTIVE ACTION(S)
 Contact your local BD representative for assistance. Do not reboot the instrument.

E08 Drawer voltage high/low

POSSIBLE CAUSE(S)
• Temporary electrical anomaly.
• Line voltage is outside of specification
• 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).
• Instrument 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 BD.

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BD BACTEC MGIT Instrument User’s Manual

E10 Database corruption

POSSIBLE CAUSE(S)
• Database checksum test failed.
CORRECTIVE ACTION(S)
 Write data to disk (see Section 7.3) and call BD.
 00000002, 00000008 – All tubes should be incubated offline and read manually according
to the procedure in Section 13.

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 4.10.

POSSIBLE CAUSE(S)
00000001, 00000002, 00000004, 00000008, 00000020
• Instrument 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.

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 7 – Troubleshooting

CORRECTIVE ACTION(S)
 If tube is in station, or was removed but you have now located it, use the “resolve station
errors” activity (Section 4.10) 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.
 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 BD BACTEC MGIT Instrument for more than 24 hours, it is strongly
recommended that all BD 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 Section 13.

MA0117(14) 7–7
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BD BACTEC MGIT Instrument User’s Manual

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 instrument 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 instrument 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 Section 13). 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
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 Section 13). 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 4.10 after the misplaced tubes have been tested manually.

7–8 MA0117(14)
Document: MA0117 Doc Type: ZLU Status: Released EFFECTIVE
Valid From: 12-May-2015 To: 31-Dec-9999 Doc Part: EN Revision: 14 Change #: 500000039342
Print Date: 13-May-2015 14:18:15 GMT Daylight Time Usage: Production Usage Version: E Classification: Restricted
 7 – Troubleshooting

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 instrument 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.

MA0117(14) 7–9
Document: MA0117 Doc Type: ZLU Status: Released EFFECTIVE
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Print Date: 13-May-2015 14:18:15 GMT Daylight Time Usage: Production Usage Version: E Classification: Restricted
BD BACTEC MGIT Instrument User’s Manual

E33 Moved tube with no error

POSSIBLE CAUSE(S)
• The instrument has detected a tube in a station that does not have a tube sequence number
assigned to it (i.e., an anonymous tube). When you are identifying anonymous tubes, the
instrument 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
barcode label and place the tube where the instrument 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 Section 13). 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 Section 13). Keep the tubes at
room temperature until the next test cycle, when the station errors are flagged.

7–10 MA0117(14)
Document: MA0117 Doc Type: ZLU Status: Released EFFECTIVE
Valid From: 12-May-2015 To: 31-Dec-9999 Doc Part: EN Revision: 14 Change #: 500000039342
Print Date: 13-May-2015 14:18:15 GMT Daylight Time Usage: Production Usage Version: E Classification: Restricted
 7 – Troubleshooting

 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 4.10 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 instrument 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 instrument expects you to
scan. The arrow pointing to the upper barcode indicates that the tube barcode sequence
number (preprinted on the BD BBL MGIT tube label) is expected:

MA0117(14) 7–11
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BD BACTEC MGIT Instrument User’s Manual

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

To prevent the error from occurring, always scan the type of barcode the instrument is
prompting you to scan.

E38 No floppy disk in the drive

POSSIBLE CAUSE(S)
• During the write data to disk function, the instrument 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 instrument 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 BD EpiCenter™ system.

POSSIBLE CAUSE(S)
• BD EpiCenter system is not running.
CORRECTIVE ACTION(S)
 Start BD EpiCenter system.
POSSIBLE CAUSE(S)
• Hardware problem between systems, such as disconnected cable between instrument and
BD 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 BD.

7–12 MA0117(14)
Document: MA0117 Doc Type: ZLU Status: Released EFFECTIVE
Valid From: 12-May-2015 To: 31-Dec-9999 Doc Part: EN Revision: 14 Change #: 500000039342
Print Date: 13-May-2015 14:18:15 GMT Daylight Time Usage: Production Usage Version: E Classification: Restricted
 7 – Troubleshooting

E43 LIS parameter changed: instrument 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)
• Instrument encountered a software error.
CORRECTIVE ACTION(S)
 Write data to disk (see Section 7.3) and call BD.

E92 AST set error

00000002, 00000004, 00000010, 00000040, 00000080

POSSIBLE CAUSE(S)
• Instrument cannot detect a tube in a station where one should be, or the readings or
temperature are out of tolerance. The tube may not be seated in the station completely, or
may have been pulled out of the instrument without being scanned out. Tube may be in a
row in which a calibrator tube failed.
00000200
POSSIBLE CAUSE(S)
• Error occurred after AST set completed.
CORRECTIVE ACTION(S)
 No corrective action required. Complete status and test results are maintained.

MA0117(14) 7–13
Document: MA0117 Doc Type: ZLU Status: Released EFFECTIVE
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BD BACTEC MGIT Instrument User’s Manual

POSSIBLE CAUSE(S)
• Instrument cannot detect sufficient indication of growth in the Growth Control tube, and
does not provide an interpretation of the AST set results. Too light inoculum or nonviable.
CORRECTIVE ACTION(S)
 Review inoculum preparation procedure and repeat test.
00000400
POSSIBLE CAUSE(S)
• Instrument detects indications of possible contaminated or overinoculated tube, and does
not provide an interpretation of the AST set results. The instrument cannot distinguish
between contaminated and overinoculated tubes. Overinoculated tube due to either the
initial cell suspension being too concentrated or the Growth Control tube inoculum not
being diluted properly.
CORRECTIVE ACTION(S)
 Review inoculum preparation procedure and repeat test.
 Inspect blood agar plate and AST tubes for contaminants. Repeat test with pure culture.
00001000, 00004000
POSSIBLE CAUSE(S)
• Instrument could not obtain sufficient readings to analyze AST set results, or more than
eight hours passed without test readings.
CORRECTIVE ACTION(S)
 Testing ceases. The entire set results are reported as Error (X). If an individual tube has
caused the error, it is shown on the Unloaded AST Report with the last 4 digits of the
appropriate sub-code in the Status field.

To clear the error condition, open the drawer and press the “remove completed AST set” soft
key. Then scan the carrier barcode or press the “force AST stations available” soft key. This
forces the set's protocol to be terminated and clears the error condition.

If the error occurs within 8 hours of the initial entry of the set, it may be reentered in
the instrument as a new set. If error occurs more than 8 hours after initial entry, all of
the AST tubes must be discarded. A new AST set must be reprepared, reentered, and
tested again.
00000800
POSSIBLE CAUSE(S)
• Detection algorithm has been reset.
CORRECTIVE ACTION(S)
 Message is informational. No action is required.
00002000
POSSIBLE CAUSE(S)
• Calibration failed in the row in which the AST set was located. Eight E05 errors precede the
occurrence of this error.

7–14 MA0117(14)
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 7 – Troubleshooting

CORRECTIVE ACTION(S)
 Testing ceases. Set results are reported as Error (X).

To clear the error condition, open the drawer and press the “remove completed AST set” soft
key. Then scan the carrier barcode or press the “force AST stations available” soft key. This
forces the set's protocol to be terminated and clears the error condition.

If the error occurs within 8 hours of the initial entry of the set, it may be reentered in
the instrument as a new set. If error occurs more than 8 hours after initial entry, all of
the AST tubes must be discarded. A new AST set must be set up again, reentered, and
tested.

7.3 Write Data to Disk Function

Under certain circumstances, BD will advise you to save (write) system data to a floppy disk or USB
flash drive. These circumstances include some error conditions and instrument malfunctions. In
some cases, with floppy disks, the data to be saved requires 2 or more floppy disks. 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 or USB flash drive in the medium port.
3 Press the “perform action” soft key.

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

5 Using a floppy disk and a second disk if required, the “swap disk” indicator appears. Remove
and label the first disk, and insert a second blank, formatted, write-enabled floppy disk in
the disk drive.

6 When the activity is complete, the instrument beeps three times. Remove the USB flash drive
or remove the floppy disk by pressing the disk eject button.

MA0117(14) 7–15
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BD BACTEC MGIT Instrument User’s Manual

7–16 MA0117(14)
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Print Date: 13-May-2015 14:18:15 GMT Daylight Time Usage: Production Usage Version: E Classification: Restricted
 8 – 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 BD BACTEC MGIT Instrument, rather than in
the strictly technical sense.

anonymous tube Anonymous tubes are those which have been placed in the instru-
ment 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 instrument.

applications The portion of the program which performs specific dedicated func-
tions such as controlling hardware devices.

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

the user and does not require operator interaction.

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

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.

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

program refers.

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BD BACTEC MGIT Instrument User’s Manual

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. Some-
times, 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 mag-
netic interference, such as computer monitors, power supplies, etc.

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.

flash or flash A type of computer memory.

memory

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 mag-
netic interference, such as computer monitors, power supplies, etc.

foreground task The currently active display or operation, with which the user is inter-
acting.

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.”

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 8 – Glossary and Abbreviations

HH Designation for the hour of the day in 24-hour military (or interna-
tional) 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 BD BACTEC MGIT Instrument
is the displays, icons, and soft keys through which you view informa-
tion and perform activities.

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.

MGIT™ Mycobacteria Growth Indicator Tube, a trademarked product of BD.

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 instrument software. These criteria relate to the mea-
surement of fluorescence in the tube sensor over one or more test
readings.

program A software utility.

prompt A message from the instrument 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 Posi-
tive 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 proto-
col, whichever comes first). During this re-entry window of time, the
tube is referred to as a “Pulled Positive.”

quick scan A fast scan of the drawer to determine which stations have tubes and
which do not.

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 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 BD BBL MGIT tube.

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BD BACTEC MGIT Instrument User’s Manual

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

BACTEC MGIT Instrument.

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

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

USB Universal Serial Bus (USB) is a standard type of connection for many
different kinds of devices. Generally, USB refers to the types of cables
and connectors used to connect many types of external devices, such
as printers, to computers. Another type of USB connection, the Flash
Drive, is a data storage device that includes flash memory with an
integrated Universal Serial Bus (USB) interface. USB flash drives are
typically removable and rewritable, and physically much smaller than
a floppy disk.

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.

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 9 – Limited Warranty
This warranty gives you specific legal rights. Additionally, you may have other rights that vary from
region to region.
The BD BACTEC MGIT Instrument is warranted to be free from defects in materials and workmanship
for a period of one year following delivery. BD’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.
BD will furnish new or remanufactured components upon its option. All replacements shall meet
new part specifications. Replaced components become the property of BD.
It is understood that the equipment covered by this Agreement has been installed in accordance
with the recommendations and instructions in the BD BACTEC MGIT Instrument User’s Manual.
Any damage to a BD BACTEC MGIT Instrument resulting from the insertion or removal of cables that
connect this instrument to systems other than those approved or supplied by BD 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 BD Diagnostic Sys-
tems be liable for indirect, incidental or consequential damages.

MA0117(14) 9–1
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BD BACTEC MGIT Instrument User’s Manual

9–2 MA0117(14)
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 10 – Replacement Parts
The following items may be ordered by contacting your local BD representative at the numbers in
Section 12.

Item Catalog Number

Instrument and General Parts

Barcode Labels (BD BBL MGIT tube, 500) 445874

Calibrator Kit (17 tubes) 445871

Filters, Air MGIT 960 (square) 444374

Filters, Air MGIT 960 (rectangular) 445888

Filters, Air MGIT 320 441674

Guide, Quick Reference 445885

Manual, BD BACTEC™ MGIT™ Instrument User’s (ea.) 445876

Plug, Bad Station (10) 445873

Thermometer, Temperature QC (ea.) 445872

AST

2-tube AST Set Carrier 445946

3-tube AST Set Carrier 445945

4-tube AST Set Carrier 445944

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BD BACTEC MGIT Instrument User’s Manual

Item Catalog Number

5-tube AST Set Carrier 445943

8-tube AST Set Carrier 445993

AST Transport Rack 445942

BD BACTEC MGIT INH 0.4 Kit (20 tests) 245126

BD BACTEC MGIT PZA Drug Kit (50 tests) 245128

BD BACTEC MGIT PZA Medium (25 tubes) 245115

BD BACTEC MGIT SIRE Kit (40 tests) 245123

BD BACTEC MGIT STR 4.0 Kit (20 tests) 245125

Barcode Labels (AST Set Carrier, 5) 445959

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 11 – Software Update Log
Whenever you receive a software update, please take a moment to log it below. This can assist you
and BD personnel in identifying software revision levels, potential software problems, etc.

Date Software Installed

Date Installed Notes
Received Version By

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BD BACTEC MGIT Instrument User’s Manual

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 12 – International Contacts

BD
BD de
Becton, Dickinson and Company
Mexico, S.A. de C.V.
2100 Derry Road West
Monte Pelvoux 111 • 9th Floor
Suite 100
Col. Lomas de Chapultepec
Mississauga, Ontario
11000 Mexico D.F.
Canada L6H 6R5
Voice: 52 5 237 1200 • Fax: 52 5 237 1287
Voice: (905) 855-5550, 800-268-5430

BD BD
Asia Pacific Division European Divisions
30 Tuas Avenue 2 11 Rue Aristide Bergès BP4
Singapore 639461 38800 Le Pont de Claix France
Voice: (65) 8610633 • Fax: (65) 8601590 Voice: 33 476 68 36 36 • Fax: 33 476 68 34 95

Nippon BD Co., Ltd.

Akasaka DS Building
5–26 Akasaka 8-chome BD
Minato-ku, Tokyo 107 7 Loveton Circle
Japan Sparks, Maryland 21152 USA
Voice: (81) 3 54138181 • Fax (81) 3 54138144 Voice: (410) 316-4000 •Fax: (410) 527-0244 or
410-316-4269
BD Toll-Free: Technical Services: 1-800-638-8663
Latin America Diagnostics Division Field Service: 1-800-544-7434
Rua Alexandre Dumas 1976 Customer Service: 1-800-675-0908
04717-004 Sao Paulo, S.P. Brazil
Voice: (55) 11 5459833 • Fax: (55) 11 2478644

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BD BACTEC MGIT Instrument User’s Manual

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 13 – Supplemental
Procedures
13.1 Reading BD BBL MGIT 7 mL Tubes Manually
A situation may arise where it is necessary to remove one or more ongoing negative BD 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. Use of Positive and Negative Control tubes is only for the interpretation of fluo-

NOTE

Once BD BBL MGIT 7 mL tubes have been removed from the BD BACTEC
MGIT Instrument for offline incubation, they must be read offline
throughout the eight week protocol. The tubes must not be returned to
the BD BACTEC MGIT Instrument.

WARNING
TO AVOID EXPOSING YOUR EYES TO POTENTIALLY DAMAGING ULTRA-
VIOLET LIGHT, WEAR PROTECTIVE GLASSES WHEN OBSERVING FLUO-
RESCENCE.

rescence and is not intended as a control for the performance of the media. The procedure that fol-
lows is for the manual reading of tubes only, not for entry of controls into the instrument.

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BD BACTEC MGIT Instrument User’s Manual

13.1.1 Preparation of Interpretive Manual MGIT Positive Control Tube

1 Empty the broth from an uninoculated BD 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).
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. Discard the unused
portion.
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.

13.1.2 Preparation of Interpretive Manual MGIT Negative Control

Tube
An unopened, uninoculated BD BBL MGIT 7 mL tube is used as a negative control.

13.1.3 Reading Tubes Manually

A Positive Control and a Negative Control are important to correctly interpret 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 BD 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 BD 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 BD 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 BD 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 BD BBL MGIT 7 mL tubes cannot be
reused. If mycobacteria growth is suspected, follow the instructions given in the media
package insert.

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 13 - Supplemental Procedures

13.2 Reprocessing Contaminated BD BBL MGIT 7 mL

Tubes
In the event of the overgrowth of a BD 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 BD 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 BD 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.

MA0117(14) 13–3
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BD BACTEC MGIT Instrument User’s Manual

13–4 MA0117(14)
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 Notes

MA0117(14) Notes–1
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BD BACTEC MGIT Instrument User’s Manual

Notes–2 MA0117(14)
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 Index
A
alarm volume setup, 2-7
alarms, 3-10
alerts, 3-11, 7-2
anonymous tube
definition, 8-1
identifying, 4-25
arrow keys, 3-3

B
barcode scanner
how to scan, 3-6
overview, 1-4
Becton Dickinson
how to contact, 12-1
blocked station
definition, 8-1

C
calibration
calibrator replacement, 6-11–??
overview, 1-7
Calibrator, 6-12
cautions, 1-12
CLIA compliance, 2-12

D
database
save to disk, 7-15
date format setup, ??–2-7

MA0117(14) I–1
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BD BACTEC MGIT Instrument User’s Manual

decontamination, 6-17
displays
hierarchy, 5-1
types, 5-2–5-7
drawers
error station indicator, 3-8
negative tube indicator, 3-8
overview, 1-4
positive tube indicator, 3-8
release latch, 3-7

E
E01 error, 7-3
E02 error, 7-3
E04 error, 7-4
E05 error, 7-4
E06 error, 7-5
E07 error, 7-5
E08 error, 7-5
E09 error, 7-5
E10 error, 7-6
E11 error, 7-6
E12 error, 7-6
E13 error, 7-7
E30 error, 7-8
E31 error, 7-9
E32 error, 7-9
E33 error, 7-10
E34 error, 7-11
E35 error, 7-11
E37 error, 7-11
E38 error, 7-12
E39 error, 7-12
E45 error, 7-13
E50 error, 7-13
entering new tubes, 4-6–4-10
error messages, 7-2
error stations
indicator, 3-8
external ports, 1-6

F
floppy disk
eject button, 3-6
indicator, 3-5
overview, 1-4

H
how to
enter new tubes, 4-6–4-10
identify anonymous tubes, 4-23–4-25
print reports, 4-28–4-29
remove negatives, 4-20

I–2 MA0117(14)
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 Index

remove ongoing tubes, 4-22–4-23

remove positives, 4-18
resolve station errors, 4-25–4-27
return positives for further testing, 4-19
use the instrument (general), 4-2

I
icons, 5-8–5-14

K
keypad
alarm indicator, 3-4
arrow keys, 3-3
naming conventions, 1-9
overview, 1-5
SILENCE ALARM key, 3-4
soft(ware) keys, 3-3

L
LCD display
automatic dimming, 3-4
brightness dial, 3-6
display types, 5-2–5-7

M
maintenance, 6-17
"as needed", 6-13–6-19
air filter replacement, 6-6
barcode label replacement, 6-17
blocking stations, 6-14–6-16
calibrator replacement, 6-8–6-13
daily, 4-4–4-5, 6-1–6-3
decontamination, 6-17
log, 6-11
periodic, 6-6
scanner window, 6-14
thermometer mercury, 6-18
unblocking stations, 6-16–6-17
MGIT 320 Air Filter Replacement, 6-7, 6-8
MGIT 960 Air Filter Replacement, 6-7
MGIT tubes (BBL® MGIT™)
barcode replacement, 6-17
entering, 4-6–4-10
how to scan, 3-7
interpretive negative controls, 13-2
interpretive positive controls, 13-2
leakage or breakage, 6-17
media quality control, 4-3
negative indication, 3-8
positive indication, 3-8
reading manually, 13-1
reprocessing contaminated tubes, 13-3

MA0117(14) I–3
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BD BACTEC MGIT Instrument User’s Manual

status indicator, 3-10

N
negative tube indicator, 3-8
negatives
batch removal, 4-21
indication, 3-8
notification, 4-19
removing, 4-20

O
On/Off switch, 3-2

P
positive tube indicator, 3-8
positives
indication, 3-8
notification, 4-17
removing, 4-18
returning for further testing, 4-19
power failures, 4-1
power switch, 3-2
protocol setup, 2-6

R
replacement parts, 10-1
reports
Instrument Inventory, 5-22–5-23, ??–5-24, ??–5-29
printing, 4-28–4-29
Quality Control, 5-25–5-27
Unloaded Negatives, 5-18–5-19
Unloaded Ongoings, 5-20–5-21
Unloaded Positives, 5-16–5-17

S
save data to disk, 7-15
service
warning, 1-12, 6-1
setup, 2-4–??
soft keys
assignment area, 5-7
definition, 8-3
icons, 5-8–5-14
location, 3-3
software
display regions, 5-5–5-7
display types, 5-2–5-7
general operation, 4-2
icons, 5-8–5-14
installation, 2-12
menu tree, 5-1
overview, 1-6

I–4 MA0117(14)
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 Index

reports, 5-15
update log, 11-1
specifications
electrical, 2-3
environmental, 2-3
specimen
collection, 4-4
contamination, 13-3
preparation, 4-3–4-4
stations
blocking, 6-14–6-16
error indicator, 3-8
resolving errors, 4-27
status indicators, 3-10
unblocking, 6-16–6-17
system
alerts and errors, 7-2
Built-In-Test, 1-7
cabinet layout, 3-2
CLIA compliance, 2-12
daily maintenance, 6-1–6-3
decontamination, 6-17
external ports, 1-6
features, 1-2
installation, 2-1
maintenance log, 6-11
overview, 1-5, 1-6, 1-7
periodic maintenance, 6-6–??
photograph, 1-5
placement warnings, 2-2
power failures, 4-1
replacement parts, 10-1–??
service, 7-1
setup, 2-4–2-10
software installation, 2-12
software update log, 11-1
startup, 2-11
summary of cautions and warnings, 1-11–1-12
symbols used on the equipment, 1-9
warranty, 9-1

T
teal keys, 3-3
test protocol setup, 2-4

U
USB, 1-4, 1-6, 1-10, 2-12, 3-5, 5-2, 5-10, 5-11, 7-15

V
volume setup, 2-7

MA0117(14) I–5
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BD BACTEC MGIT Instrument User’s Manual

W
warnings, 1-12
warranty, 9-1
write data to disk, 7-15

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 Reader Comment Card
BD BACTEC™ MGIT™ Instrument User’s Manual (MA-0117)
After you have become familiar with your instrument and its documentation, please take a moment to evaluate the
manual. Your comments are a valuable tool for us to improve the usefulness of the manuals. NOTE: For any evaluation of
“average” or below, please add a specific comment on the blank lines at the end.
Thank you!

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Chapters
Table of Contents     
Introduction     
Installation     
Controls and Indicators     
Operation     
Reference     
Maintenance     
Troubleshooting     
Index     
Sections 8 – 13     
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     
Comments

Optional Name

Hospital

City, State

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 Fold Under & Tape

Fold Here

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NECESSARY IF
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PERMIT NO. 25 SPARKS, MD

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BD
Technical Writing, Mail Stop 634
7 Loveton Circle / P.O. Box 999
Sparks, MD 21152.9977

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