Biomerieux Bact-Alert 3D User Manual

User Manual

[04]

95248

(01/2010)

EC REP

bioMérieux, Inc.
Box 15969
Durham, North Carolina 27704-0969 / USA
Tel. [phone]

bioMérieux
au capital de 12 029 370 €
673 620 399 RCS LYON
69280 Marcy l’Etoile / France
tél. [phone] / fax [phone]
http://www.biomerieux.com

®

SA

Algeria

bioMérieux Algérie EURL

Algéria Business Center
Les Pins Maritimes - Mohammadia
Alger
tel. [phone]
fax [phone]

Argentina

bioMérieux Argentina

Av. Congreso 1745
C1428BUE
Capital Federal Buenos Aires
tel. [phone]
fax [phone]

Australia

bioMérieux Australia P/L

Unit 25 - Parkview Business Centre
1, Maitland Place
Baulkham Hills NSW 2153
tel. [phone]
fax [phone]

Austria

bioMérieux Austria GmbH

Eduard-Kittenberger-Gasse 97
Top 3
A-1230 Wien
tel. [phone]
fax [phone]

Belgium

bioMérieux Benelux s.a./n.v.

Media Square
18–19 Place des Carabiniers
Bruxelles 1030
tel. [phone]
fax [phone]

Brazil

bioMérieux Brasil SA

Estrada Do Mapuá
491 Taquara - Jacarepaguá
CEP 22710 261
Rio de Janeiro RJ
tel. [phone]
fax [phone]

Canada

bioMérieux Canada, Inc.

7815, Henri-Bourassa West
Saint Laurent, QC
H4S 1P7
tel. [phone]
fax [phone]

Chile

bioMérieux Chile S.A.

Seminario 131
Providencia
Santiago
tel. [phone]
fax [phone]

China

bioMérieux China Limited

Room 1601-02B & 10
Est Ocean Centre
nº 24A Jiang Guo Men Nei Street
100004 Beijing
tel. [phone]
fax [phone]

bioMérieux China Limited

Room 2605, South Tower,
World Trade Center
371-375 Huan Shi Dong East Road
510095 Guangzhou
tel. [phone]
fax [phone]

Colombia

bioMérieux Colombia Ltda

Avenida 15 No. 100-43
Piso 2
Bogotá, D.C.
tel. [phone]
fax [phone]

(57) 1 520 0831

Czech Republic

bioMérieux CZ s.r.o.

Business Park Kosice
Jinonická 80
158 00 Praha 5
tel. [phone]

(420) 2 57 290 232

fax [phone]

Denmark

bioMérieux Danmark Aps

Smedeholm 13C
2730 Herlev
tel. [phone]
fax [phone]

Finland

bioMérieux Suomi Oy

Konalantie 47 C
FI-00390 Helsinki
tel. [phone]
fax [phone]

France

bioMérieux SA

69280 Marcy l’Etoile
tel. (33) (0)4 78 87 20 00
fax (33) (0)4 78 87 20 90
http://www.biomerieux.com

Germany

bioMérieux Deutschland GmbH

Weberstrasse 8
D 72622 Nürtingen
tel. [phone]
fax [phone]

Greece

bioMérieux Hellas S.A.

Papanikoli 70
15232 Halandri
Athens
tel. [phone]
fax [phone]

Hungary

bioMérieux Hungária Kft.

Fóto út. 56 (5. emelet)
H-1047 Budapest
tel. [phone]
fax [phone]

India

bioMérieux India Pvt. Ltd

A-32, Mohan Co-Operative Ind. Estate
New Delhi 110 024
tel. [phone]
fax [phone]

Indonesia
Representation Office

bioMérieux Indonesia

Enseval Building
Kawasan Industri Pulo Gadung ­JI. Pulo - Lentut No. 10
Jakarta Timur 13920
tel. [phone]
fax [phone]

Italy

bioMérieux Italia S.p.A.

Via Fiume Bianco, 56
00144 Roma
tel. [phone]
fax [phone]

Ivory Coast

bioMérieux Afrique Occidentale

08 BP 2634
Avenue Joseph Blohorn
Abidjan 08
tel. [phone] 41 40
fax [phone]

Japan

Sysmex bioMérieux, Ltd.

Osaki Central Tower 8F
1-2-2 Osaki Shinagawa-ku
Tokyo 141-0032
tel. [phone]
fax [phone]

Korea

bioMérieux Korea Co., Ltd.

1st & 2nd Floor, Yoosung Building
# 830-67 Yeoksam-dong,
Kangnam-gu
Séoul 135-080
tel. [phone]
fax [phone]

Mexico

bioMérieux México SA de CV

Chihuahua 88, col. Progreso
México 01080, D.F.
tel. [phone]
fax [phone]

Netherlands (The)

bioMérieux Benelux BV

Boseind 15
P.O. Box 23
5280 AA Boxtel
tel. [phone]
fax [phone]

i Manual Name

702358-4EN1 REV nn/nnnn

New Zealand

bioMérieux New Zealand Ltd.

C/- Logical Freight Solutions
12C Rennie Drive, Airport Oaks
Auckland
tel. [phone]
fax [phone]

Norway

bioMérieux Norge AS

Økernveien 145
N-0513, Oslo
tel. [phone]
fax [phone]

Philippines (The)
Representation Office

bioMérieux Philippines

11th Floor, Pearlbank Centre
146 Valero Street, Salcedo Village
1227 Makati City
tel. [phone]
fax [phone]

Poland

bioMérieux Polska Sp. Z.o.o.

Ul. Zeromskiego 17
01-882 Warsaw
tel. [phone]
fax [phone]

Portugal

bioMérieux Portugal, Lda.

Av. 25 de Abril de 1974, nº 23-3º
2795-197 LINDA-A-VELHA
tel. [phone]
fax [phone]

Russia

o.o.o. bioMérieux

Derbenevskaya ul. 20, str. 11
115 114 Moscow
tel. [phone]
fax [phone]

Singapore

bioMérieux Singaporete. Ltd.

11 Biopolis Way, Helios, Block 11
#10-03 Singapore 138667
tel. [phone]
fax [phone]

South Africa

bioMérieux South Africa Pty

7 Malibongwe Drive
Randburg 2125
tel. [phone]
fax [phone]

Spain

bioMérieux España S.A.

Manual Tovar, 45–47
28034 Madrid
tel. [phone]
fax [phone]

Sweden

bioMérieux Sverige AB

Hantverksvägen 15
436 33 Askim
tel. [phone]
fax [phone]

Switzerland

bioMérieux Suisse s.a.

51, avenue Blanc
Case postale 2150
1211 Genève 2
tel. [phone]
fax [phone]

Taiwan
Representation Office

bioMérieux China Limited
Taiwan Branch

RM 608, No. 6-3 Ching Cheng Street
Taipei 105
tel. [phone]
fax [phone]

Thailand

bioMérieux Thailand Ltd

3195/9 Vibulthani Tower, 4th Floor
Rama IV Road, Klongton, Klongtoey
Bangkok 10110
tel. [phone]
fax [phone]

Turkey

bioMérieux Diagnostik A.S.

ğirmen Sok. Nida Plaza Kat:6

De
34742 Kozyata
tel. [phone]
fax [phone]

United Kingdom

bioMérieux UK Ltd

Grafton Way, Basingstoke
Hampshire RG22 6HY
tel. [phone]
fax [phone]

USA

bioMérieux, Inc.

100 Rodolphe Street
Durham NC 27712
tel. [phone]

Vietnam
Representation Office

bioMérieux Vietnam

Room 4A, 4th Floor
Green House Building
62A Pham Ngoc Thach Street, Ward 6
District 3
Ho Chi Minh City
tel. [phone]
fax [phone]

ği-Istanbul

Manual Name ii
702358-4EN1 REV nn/nnnn

This product and its documentation complies with the In Vitro Diagnostic
Medical Device Directive 98/79/EC.

Liability Disclaimer

bioMérieux, Inc. makes no express or implied warranty regarding this
manual, its quality, performance, or appropriate use regarding any type of
specific procedure.

Furthermore, this manual may be modified by bioMérieux without notice and
without implying any obligation or liability on the part of the company.

Intellectual Property

bioMérieux, the blue logo, BacT/ALERT, BacT/LINK and MB/BacT are used,
pending, and/or registered trademarks of bioMérieux in the USA and other
countries.

CLSI is a registered trademark of Clinical and Laboratory Standards Institute,
Inc.

PSC and Quickscan are registered trademarks of PSC, Inc.

Zip is a registered trademark of Iomega Corporation.

© 2010 bioMérieux, Inc. All rights reserved.

No part of this publication may be reproduced, transmitted, transcribed,
stored in a retrieval system, or translated into any language (human or
computer) in any form, or by any means whatsoever, without the prior
express written permission of bioMérieux, Inc.

Warranty

bioMérieux, Inc., (“Seller”) warrants the BacT/ALERT® instrument (the
“Instrument”) to the original purchaser for a period of one (1) year after date
of installation against defects in material and workmanship and defects
arising from failure to conform to specifications applicable on the date of
installation. Seller further agrees to correct, either by repair, or, at its election,
by replacement, any such defect found on examination to have occurred,
under normal use and service, during such one-year period, provided Seller
is promptly notified in writing upon discovery of such defect.

Seller shall not be liable under this Warranty for any defect arising from abuse
of the system, failure to operate and maintain the system in accordance with
the documentation included with the Instrument, including repair service,
alteration or modification of the system by any person other than service
personnel of bioMérieux, Inc., or use of modified, changed, or previously
used disposables.

The warranty of Seller set forth above and the obligations and liabilities
of Seller thereunder are exclusive and in lieu of all other remedies or
warranties, express or implied, arising by law or otherwise, with respect
to the system delivered hereunder (including without limitation any
obligation of Seller with respect to merchantability, fitness for particular
purpose and non-infringement). In no event shall Seller be liable for
incidental or consequential damages, however arising and whether or
not occasioned by Seller’s negligence.

This Warranty shall not be extended or altered except by written instrument
signed by Seller.

All of the product elements in the Seller’s Instrument and the total Instrument
are warranted to be new or equivalent to new for the full product warranty
period of one year. Disposables and replacement items with a normal life
expectancy of less than one (1) year, such as batteries and bulbs, are
excluded from this warranty.

STANDARD SYMBOLS

The following table presents symbols that may appear in the instructions for
use or on the instrument, package inserts, or packaging.

CE-Marking of Conformity

Consult Instructions for Use

Use by

Manufacturer

Date of manufacture

Contains sufficient for <n> tests

Keep dry

Fragile, handle with care

Caution, consult accompanying documents

Biological risks

Electric shock warning

Radiation warning

Potential pinch-point warning

Laser

Temperature limitation

Upper limit of temperature

Lower limit of temperature

In Vitro Diagnostic Medical Device

Standard Symbols

Batch code

Authorized Representative in the European Community

Catalog number

Serial Number

Do not reuse

Recyclable

Separate collection for waste electrical and electronic
equipment

Standard Symbols

Very toxic

Corrosive

Sodium azide

Irritant

Positive control

Negative control

Keep away from sunlight

Protect from light

This way up

Do not stack

Humidity limitation

Fuse

Direct current

Alternating current

Both direct and alternating current

Three-phase alternating current

Earth (ground) terminal

Protective conductor terminal

Frame or chassis terminal

Equipotentiality

ON (supply)

Standard Symbols

OFF (supply)

ON (only for a component of the system equipment)

OFF (only for a component of the system equipment)

Equipment protected throughout by double insulation or
reinforced insulation (Equivalent to Class II of IEC 536)

Potential tip over/crush hazard

TABLE OF CONTENTS

Standard Symbols......................................................................................................vi

List of Figures ..........................................................................................................xiii

List of Tables ...........................................................................................................xvii

H

OW TO USE THIS MANUAL........................................................................................ 1-1

Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Specimen/Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Purpose of the BacT/ALERT

Additional Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Purpose of This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Manual Organization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Chapter Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Finding Topics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Typographic and Usage Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Name and Titles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Press . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Procedural Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Select. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

User Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

Warnings, Cautions, and Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

®

3D System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

S

YSTEM OVERVIEW ..................................................................................................... 2-1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Hardware Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Software Configuration Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

21 CFR Part 11 and HIPAA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Theory Of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Principle of Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Electrical Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Electrical Grounding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Electrical and Electronic Recycling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Fuse Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

®

BacT/ALERT

3D Hardware. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Mycobacteria Drawers (Clinical Use). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Controller Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

Operator Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9

Barcode Reader Aperture. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

BacT/ALERT® 3D User Manual i
95248

Table of Contents

Backup Drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10

Keyboard Drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10

Quick Reference Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10

Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10

Accessing the Controller Module Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11

Printer Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13

Audible Alarm Speaker. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

External Speaker Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

Power Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

Display Switch Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

CPU 1 Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

CPU 2 Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

Module Ports (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

Monitor Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

Modem Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

LIS Port (Diagnostic Port). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

COMM Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15

Controller Module Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Electrical Power Services Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15

Power Consumed in Watts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15

Heat Dissipated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15

Sound Emission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15

Instrument Dimensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15

Controller Module Environmental Requirements . . . . . . . . . . . . . . . . . . . 2-15

Operating Temperature Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15

Storage Temperature Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15

Operating Humidity Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15

Storage Humidity Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15

Maximum Operating and Storage Altitude . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-16

Pollution degree 2 in accordance with IEC 664 . . . . . . . . . . . . . . . . . . . . . . . .2-16

Overvoltage Category II per IEC 664 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-16

Combination Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16

Operator Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17

Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17

Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18

UPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18

Backup Drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18

Drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18

Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18

Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18

Cell Indicator Lamp/Cell Indicator Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18

Cell Flag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18

Thermometer (Not Shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19

Drawer Indicator Light — Yellow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19

Drawer Indicator Light — Green. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19

Printer Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19

External Speaker Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19

Power Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19

ii BacT/ALERT® 3D User Manual

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Table of Contents

Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19

Display Switch Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20

CPU 1 Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-20

CPU 2 Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-20

Module Port (3). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-20

Modem Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-20

LIS Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20

Barcode Scanner Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-20

Keyboard Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20

Monitor Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-20

COMM Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20

Combination Module Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20

Electrical Power Services Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-20

Power Consumed in Watts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-21

Heat Dissipated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-21

Combination Module Dimensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-21

Sound Emission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-21

Combination Module Environmental Requirements. . . . . . . . . . . . . . . . . 2-21

Operating Temperature Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21

Storage Temperature Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-21

Operating Humidity Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-21

Storage Humidity Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-21

Maximum Operating and Storage Altitude . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21

Pollution degree 2 in accordance with IEC 664 (Clinical Use) . . . . . . . . . . . . .2-21

Overvoltage Category II per IEC 664 (Clinical Use) . . . . . . . . . . . . . . . . . . . . .2-21

Incubation Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22

Drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-22

Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-22

Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-22

Cell Indicator Lamp/Cell Indicator Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-23

Cell Flag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-23

Drawer Indicator Light — Yellow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-23

Drawer Indicator Light — Green. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-23

Controller Module Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24

Power Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-24

Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-24

Incubation Module Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25

Electrical Power Services Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-25

Power Consumed in Watts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-25

Heat Dissipated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-25

Instrument Dimensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-25

Sound Emission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-25

Incubation Module Environmental Requirements . . . . . . . . . . . . . . . . . . 2-25

Operating Temperature Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25

Storage Temperature Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-25

Operating Humidity Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-25

Storage Humidity Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-25

Maximum Operating and Storage Altitude . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25

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BASIC FUNCTIONS (CLINICAL USE).............................................................................. 3-1

Instrument Installation and Setup (Clinical Use) . . . . . . . . . . . . . . . . . . . . 2-26

Instrument Installation and Setup (INDUSTRY Use) . . . . . . . . . . . . . . . . 2-26

BacT/ALERT® 3D Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-27

Operator Panel Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27

Common Screen Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28

Icon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-28

Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-28

Common System Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-28

Scroll Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-29

Slidebar Switch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-29

Anchor Display/Scroll Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-29

Text Entry Field. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-30

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Monitoring the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Main Screen Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Background Color. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4

Instrument Icon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4

Bottle Count Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5

Viewing Faults. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Viewing the Cell Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Understanding the View Cell Status Screen Display . . . . . . . . . . . . . . . . . . . . .3-8

Text/Data Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Common Text Fields and Field Limit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Using the Barcode Scanner to Enter Data . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Manually Entering Text into a Data Entry Field (Keyboard) . . . . . . . . . . . 3-10

Loading Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

Loading Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

Changing the Maximum Test Time — Individual Bottles . . . . . . . . . . . . . 3-15

Handling Anonymous Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16

Unloading Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16

Unloading Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17

Handling Unconfirmed Positive Bottles (False Positives) . . . . . . . . . . . . . 3-19

Accessing the Setup Screen Function Buttons . . . . . . . . . . . . . . . . . . . . . . . . 3-20

Accessing the Setup Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20

Inactivity Timeout for all Setup Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-21

Setup Screen Function Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21

Viewing and Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23

Viewing Bottle Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23

Viewing/Printing Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23

Viewing/Printing Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23

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Using the Print Screen Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24

Viewing, Printing, and Exporting Test Data . . . . . . . . . . . . . . . . . . . . . . . 3-24

Viewing and Printing Bottle Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31

Display Bottle Readings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-34

Sending/Requesting LIS Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-39

Sending Results to the LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-39

Requesting Information from the LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-39

BASIC FUNCTIONS (INDUSTRY USE) ......................................................................... 4-1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Monitoring the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Main Screen Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Background Color. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4

Instrument Icon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4

Bottle Count Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5

Viewing Faults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

Viewing the Cell Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

Understanding the View Cell Status Screen Display . . . . . . . . . . . . . . . . . . . . .4-8

Text/Data Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

Common Text Fields and Field Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

Using the Barcode Scanner to Enter Data. . . . . . . . . . . . . . . . . . . . . . . . 4-10

Manually Entering Text into a Data Entry Field (Keyboard). . . . . . . . . . . 4-10

Loading Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Loading Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Changing the Maximum Test Time — Individual Bottles. . . . . . . . . . . . . 4-14

Handling Anonymous Bottles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15

Unloading Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16

Unloading Bottles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16

Handling Unconfirmed Positive Bottles (False Positives) . . . . . . . . . . . . 4-19

Accessing the Setup Screen Function Buttons. . . . . . . . . . . . . . . . . . . . . . . . 4-20

Accessing the Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20

Inactivity Timeout for all Setup Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21

Setup Screen Function Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21

Viewing and Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

Viewing Bottle Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-23

Viewing/Printing Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-23

Viewing/Printing Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-23

Using the Print Screen Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-24

Viewing, Printing, and Exporting Test Data . . . . . . . . . . . . . . . . . . . . . . . 4-24

Viewing and Printing Bottle Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31

Display Bottle Readings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34

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E

Sending/Requesting LIS Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39

Sending Results to the LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39

Requesting Information from the LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39

DITING TEST DATA (CLINICAL USE) ........................................................................... 5-1

Viewing/Editing Bottle Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Selecting Bottles Using the Edit Cell Contents Button . . . . . . . . . . . . . . . . 5-3

Selecting Bottles Using the Select Bottle to Edit/Graph Button . . . . . . . . . 5-4

Editing Bottle Details Using the Edit Bottle Detail Screen. . . . . . . . . . . . . . 5-5

Edit Bottle ID Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6

View Accession Number Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6

View Hospital ID Field. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6

View Patient First Name Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6

View Patient Last Name Field. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6

Edit Load Status Slidebar Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-7

Edit Maximum Test Time Scroll Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-7

Edit Bottle Type Scroll Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-7

View Cell Location Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8

View First Loaded Time Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8

View Last Unloaded Time Icon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8

View Time of Last Bottle Reading Icon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8

View Test Time Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8

View Test Result Icon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9

Edit Test Result Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9

Graph Bottle Readings Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-10

View Algorithm/Polynomial Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-10

View How Determined/Positivity Index Icon . . . . . . . . . . . . . . . . . . . . . . . . . . .5-11

Editing Data Relationships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-12

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Initiating the Edit Data Relationships Function . . . . . . . . . . . . . . . . . . . . . 5-12

Editing Bottle ID to Accession Number Relationships. . . . . . . . . . . . . . . . 5-14

Attaching Bottle IDs without an Accession Number to an Accession Number .5-14

Moving a Bottle ID Association from one Accession Number to Another . . . . .5-15

Editing Accession Number to Hospital ID Relationships. . . . . . . . . . . . . . 5-16

Attaching Accession Numbers without a Hospital ID to a Hospital ID . . . . . . .5-16

Moving an Accession Number Association from one Hospital ID to Another . .5-17

Editing Hospital ID to Patient Name Relationships . . . . . . . . . . . . . . . . . . 5-17

E

DITING TEST DATA (INDUSTRY USE)....................................................................... 6-1

Viewing/Editing Bottle Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Selecting Bottles Using the Edit Cell Contents Button . . . . . . . . . . . . . . . . 6-3

Selecting Bottles Using the Select Bottle to Edit/Graph Button . . . . . . . . . 6-4

Editing Bottle Details Using the Edit Bottle Detail Screen. . . . . . . . . . . . . . 6-5

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Edit Bottle ID Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6

View Sample ID Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6

View User Defined 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6

View User Defined 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6

View User Defined 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6

Edit Load Status Slidebar Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-7

Edit Maximum Test Time Scroll Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Edit Bottle Type Scroll Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-7

View Cell Location Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-8

View First Loaded Time Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-8

View Last Unloaded Time Icon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-8

View Time of Last Bottle Reading Icon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

View Test Time Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-8

View Test Result Icon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-9

Edit Test Result Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-9

Graph Bottle Readings Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-10

View Algorithm/Polynomial Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-10

View How Determined/Positivity Index Icon . . . . . . . . . . . . . . . . . . . . . . . . . . .6-11

Editing Data Relationships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12

Initiating the Edit Data Relationships Function . . . . . . . . . . . . . . . . . . . . 6-12

Editing Bottle ID to Sample ID Relationships. . . . . . . . . . . . . . . . . . . . . . 6-14

Attaching Bottle IDs without a Sample ID to a Sample ID . . . . . . . . . . . . . . . .6-14

Moving a Bottle ID Association from one Sample ID to Another . . . . . . . . . . .6-15

Editing Sample ID to User Defined 3 Relationships . . . . . . . . . . . . . . . . 6-16

Attaching Sample IDs without a User Defined 3 to a User Defined 3. . . . . . . .6-16

Moving a Sample ID Association from One User Defined 3 to Another . . . . . .6-17

Editing User Defined 3 to User Defined 1/User Defined 2

Relationships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17

S

OFTWARE CONFIGURATION........................................................................................ 7-1

Setting the Maximum Test Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Setting the Audible Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Priority of Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Terminating an Instrument Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Changing the System Password. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Initiating Manual Backup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7

Configuring Report Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

Entering Report Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10

Configuring Report Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13

Load Report Configuration Screen (Clinical Use). . . . . . . . . . . . . . . . . . . . . . .7-16

Status Report Configuration Screen (Clinical Use) . . . . . . . . . . . . . . . . . . . . .7-17

Unload Report Configuration Screen (Clinical Use) . . . . . . . . . . . . . . . . . . . . .7-18

Load Report Configuration Screen (INDUSTRY Use) . . . . . . . . . . . . . . . . . . . 7-19

Status Report Configuration Screen (INDUSTRY Use) . . . . . . . . . . . . . . . . . . 7-20

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SYSTEM MAINTENANCE ............................................................................................... 8-1

Unload Report Configuration Screen (INDUSTRY Use). . . . . . . . . . . . . . . . . .7-21

Viewing and Printing Calibration Data . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-21

Viewing and Printing Calibration History. . . . . . . . . . . . . . . . . . . . . . . . . . 7-25

Hardware Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Preventative Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Safety Precautions and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

General Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3

Spill Cleanup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3

Disinfection Procedure for Spills Onto the Instrument (Clinical Use) . . . . . . . . .8-4

Disinfection Procedure for Spills Onto the Instrument (INDUSTRY Use). . . . . .8-5

Disinfection Procedure for Spills Within the Instrument . . . . . . . . . . . . . . . . . . .8-5

Using the Keyboard in Place of the Operator Panel . . . . . . . . . . . . . . . . . . 8-8

UPS On/Off Button Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9

Controller Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-9

Combination Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-10

Controller/Combination Module Reboot/Shutdown (BacT/ALERT® 3D

Select and SelectLink) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10

Shutdown Method 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-11

Shutdown Method 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-11

Shutdown Method 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-12

Shutdown Method 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-13

Controller or Combination Module Startup . . . . . . . . . . . . . . . . . . . . . . . . 8-13

®

Full System Shutdown (BacT/ALERT

3D Signature) . . . . . . . . . . . . . . . 8-13

Full System Startup (BacT/ALERT® 3D Signature) . . . . . . . . . . . . . . . . . 8-14

Set Up an External Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14

Restore Internal Monitor Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14

Software Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-15

Restarting an Incubation Module or the Combination Module Drawers . . 8-15

Setting and Formatting the System Date and Time . . . . . . . . . . . . . . . . . 8-17

Enabling and Disabling Modules, Drawers, Racks, and Cells . . . . . . . . . 8-18

Relocating Bottles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-21

Adjusting an Incubation or Combination Module’s Temperature . . . . . . . 8-21

Checking an Incubation or Combination Module’s Temperature . . . . . . . . . . .8-21

Setting the Optimal Temperature for an Incubation or Combination Module . .8-24

Calibrating an Incubation or Combination Module’s Temperature . . . . . . . . . .8-25

Calibrating an Instrument Cell. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-25

Locating a Cell Which Failed Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-26

Viewing a Cell’s Readings and/or Calibrating a Cell. . . . . . . . . . . . . . . . . . . . .8-26

Viewing Incubation Module Information . . . . . . . . . . . . . . . . . . . . . . . . . . 8-29

S

YSTEM TROUBLESHOOTING ....................................................................................... 9-1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

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Fault Codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

Instrument Fault Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

Instrument Status Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-24

Operator Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-27

Bottle Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-39

User Output Device Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-39

21 CFR P

ART 11 MODE ........................................................................................... 10-1

Log In/Out of System — 21 CFR Part 11 Mode . . . . . . . . . . . . . . . . . . . . . . . 10-2

Logging In for the First Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2

Logging In . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5

Inactivity Timeout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7

Login Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7

Change Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8

Change Password Errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9

Logging Out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12

Configuring Users — 21 CFR Part 11 Mode. . . . . . . . . . . . . . . . . . . . . . . . . 10-12

Adding a User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-13

Deleting a User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15

Deleting More Than One User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-16

Clearing a User Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-16

Clearing More Than One User Password. . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17

Audit Trail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-18

Accessing the Audit Trail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-20

M

YCOBACTERIAL TESTING (CLINICAL USE)................................................................ 11-1

System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2

BacT/ALERT® 3D Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3

Circulation Fan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-3

Rocker Clamp. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-3

Installation Procedures and Special Requirements . . . . . . . . . . . . . . . . . . . . .11-4

Barcodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-4

Load Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

Unload Positives and Negatives. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-5

Set Maximum Test Time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

Positive Detection Algorithm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

Bottle Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-5

System Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

MB Drawer Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-6

Limitations of the Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-7

Service and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-7

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I

NTERNATIONAL CHARACTER ENTRY ............................................................................A-1

B

Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7

Principle of Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-7

Safety Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8

General Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-9

Spill Cleanup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-9

Disinfection Procedure for Spills Within/Onto the Instrument . . . . . . . . . . . . . .11-9

Remove Drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-10

Device Comparison for Recovery of Mycobacteria. . . . . . . . . . . . . . . . . 11-10

International Character Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-2

Clinical Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

INDUSTRY Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

Entering International Characters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-4

OTTLE QUALITY CONTROL.........................................................................................B-1

BacT/ALERT

®

Culture Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-2

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-2

Flip Cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3

Stopper/Seal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3

Bottle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3

Volume Designations (Clinical Use) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3

Volume Designations (INDUSTRY Use). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3

Barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3

Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4

Limitations of the Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4

Clinical Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4

INDUSTRY Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4

Quality Control of Growth Performance . . . . . . . . . . . . . . . . . . . . . . . . . . .B-4

Blood Culture Bottles (SA, SN, FA, FN, and PF) . . . . . . . . . . . . . . . . . . . . . . . B-5

Mycobacteria Culture Bottles (MB and MP) . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5

Culture Bottles (iAST, iNST, and iLYM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5

BEST PRACTICES ........................................................................................................C-1

Best Practices for Preventing False Positives . . . . . . . . . . . . . . . . . . . . . . . . . .C-2

Preventing False Positives — User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-2

High Amount of White Blood Cells (Clinical Use) . . . . . . . . . . . . . . . . . . . . . . . C-2

Blood (or Sample) Volume too High . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2

Large Bottle Loading and Unloading Events . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

Temperature Changes in the Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

Anonymous Bottle Loading of BacT/ALERT

Bottle Not Completely Loaded into the Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . C-4

®

FA and PF Bottles . . . . . . . . . . C-4

Preventing False Positives — Instrument . . . . . . . . . . . . . . . . . . . . . . . . . .C-5

Cell Noise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5

High Initial Value Readings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-7

False Positive MP Process Bottles Flagged by Delta Algorithm (Clinical Use) C-7

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GLOSSARY....................................................................................................GLOSSARY-1

I

NDEX .................................................................................................................. INDEX-1

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LIST OF FIGURES

Figure 1-1: Procedure Icon ...................................................................................................1-7

Figure 2-1: Electrical Grounding Requirements ...................................................................2-7

Figure 2-2: Instrument Front View ........................................................................................2-9

Figure 2-3: Removing the Barcode Reader Through the Barcode Reader Aperture .........2-10

Figure 2-4: Accessing the Keyboard and Reference Card .................................................2-12

Figure 2-5: Back View Controller Module ...........................................................................2-13

Figure 2-6: Front View Combination Module ......................................................................2-16

Figure 2-7: Back View Combination Module ......................................................................2-17

Figure 2-8: Cell Flag (Clip Removed) .................................................................................2-19

Figure 2-9: Front View Incubation Module (Right-Handed Configuration) ..........................2-22

Figure 2-10: Back View Incubation Module ..........................................................................2-24

Figure 2-11: Button Examples ..............................................................................................2-28

Figure 2-12: Scroll Button .....................................................................................................2-29

Figure 2-13: Slidebar Switch ................................................................................................2-29

Figure 2-14: Anchor Display/Scroll Buttons ..........................................................................2-30

Figure 3-1: Main Screen .......................................................................................................3-3

Figure 3-2: Combination Module with an Additional Incubation Module ...............................3-5

Figure 3-3: Controller Module with One Incubation Module .................................................3-5

Figure 3-4: Bottle Count Table/Unload Buttons ....................................................................3-6

Figure 3-5: View Cell Status Screen ....................................................................................3-7

Figure 3-6: Disabled Cell and Drawer ..................................................................................3-9

Figure 3-7: Main Screen — Load Mode .............................................................................3-12

Figure 3-8: Change Maximum Test Time Screen ...............................................................3-15

Figure 3-9: Main Screen — Unload Mode ..........................................................................3-17

Figure 3-10: Setup Screen ...................................................................................................3-20

Figure 3-11: Report Selection Screen ..................................................................................3-24

Figure 3-12: Sample Report Screen .....................................................................................3-26

Figure 3-13: Find Text Screen ..............................................................................................3-29

Figure 3-14: Save to File Screen ..........................................................................................3-30

Figure 3-15: Select Bottle to Edit/Graph Screen ..................................................................3-32

Figure 3-16: Graph Bottle Readings Screen ........................................................................3-33

Figure 3-17: Bottle Readings Screen ...................................................................................3-35

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Figure 3-18: Find Text Screen ............................................................................................. 3-37

Figure 3-19: Save to File Screen ......................................................................................... 3-38

Figure 4-1: Main Screen ...................................................................................................... 4-3

Figure 4-2: Combination Module with an Additional Incubation Module .............................. 4-5

Figure 4-3: Controller Module with One Incubation Module ................................................ 4-5

Figure 4-4: Bottle Count Table/Unload Buttons ................................................................... 4-6

Figure 4-5: View Cell Status Screen .................................................................................... 4-7

Figure 4-6: Disabled Cell and Drawer ................................................................................. 4-9

Figure 4-7: Main Screen — Load Mode ............................................................................ 4-12

Figure 4-8: Change Maximum Test Time Screen .............................................................. 4-15

Figure 4-9: Main Screen — Unload Mode ......................................................................... 4-17

Figure 4-10: Setup Screen .................................................................................................. 4-20

Figure 4-11: Report Selection Screen ................................................................................. 4-24

Figure 4-12: Sample Report Screen .................................................................................... 4-26

Figure 4-13: Find Text Screen ............................................................................................. 4-29

Figure 4-14: Save to File Screen ......................................................................................... 4-30

Figure 4-15: Select Bottle to Edit/Graph Screen ................................................................. 4-32

Figure 4-16: Graph Bottle Readings Screen ....................................................................... 4-33

Figure 4-17: Bottle Readings Screen .................................................................................. 4-35

Figure 4-18: Find Text Screen ............................................................................................. 4-37

Figure 4-19: Save to File Screen ......................................................................................... 4-38

Figure 5-1: Edit Cell Contents Screen ................................................................................. 5-3

Figure 5-2: Select Bottle to Edit/Graph Screen ................................................................... 5-4

Figure 5-3: Edit Bottle Detail Screen ................................................................................... 5-5

Figure 5-4: Edit Test Result Screen .................................................................................... 5-9

Figure 5-5: Edit Data Relationships Screen ...................................................................... 5-13

Figure 5-6: Edit Bottle ID to Accession Number Relationships Screen ............................. 5-14

Figure 5-7: Edit Accession Number to Hospital ID Relationships Screen ......................... 5-16

Figure 5-8: Edit Hospital ID to Patient Name Relationships Screen .................................. 5-18

Figure 6-1: Edit Cell Contents Screen ................................................................................. 6-3

Figure 6-2: Select Bottle to Edit/Graph Screen ................................................................... 6-4

Figure 6-3: Edit Bottle Detail Screen ................................................................................... 6-5

Figure 6-4: Edit Test Result Screen .................................................................................... 6-9

Figure 6-5: Edit Data Relationships Screen ...................................................................... 6-13

xiv BacT/ALERT® 3D User Manual

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Figure 6-6: Edit Bottle ID to Sample ID Relationships Screen ...........................................6-14

Figure 6-7: Edit Sample ID to User Defined 3 Relationships Screen .................................6-16

Figure 6-8: Edit User Defined 3 to User Defined 1/User Defined 2

Relationships Screen .......................................................................................6-18

Figure 7-1: Set Maximum Test Time Screen ........................................................................7-2

Figure 7-2: Setting the Audible Alarm Options Screen .........................................................7-4

Figure 7-3: Change Password Screen .................................................................................7-6

Figure 7-4: Padlock Icon (Full Open position) ......................................................................7-6

Figure 7-5: Padlock Icon (Half Open Position) .....................................................................7-7

Figure 7-6: Padlock Icon (Closed Position) ..........................................................................7-7

Figure 7-7: Backup Management Screen .............................................................................7-8

Figure 7-8: Backup In Progress Icon ....................................................................................7-9

Figure 7-9: Report Selection Screen ..................................................................................7-10

Figure 7-10: Report Label Entry Screen ...............................................................................7-11

Figure 7-11: Report Selection Screen ..................................................................................7-14

Figure 7-12: Load Report Configuration Screen (Clinical Use) ............................................7-16

Figure 7-13: Status Report Configuration Screen (Clinical Use) ..........................................7-17

Figure 7-14: Unload Report Configuration Screen (Clinical Use) .........................................7-18

Figure 7-15: Load Report Configuration Screen (INDUSTRY Use) .....................................7-19

Figure 7-16: Status Report Configuration Screen (INDUSTRY Use) ...................................7-20

Figure 7-17: Unload Report Configuration Screen (INDUSTRY Use) ..................................7-21

Figure 7-18: Report Selection Screen ..................................................................................7-22

Figure 7-19: Cell Calibration Report .....................................................................................7-23

Figure 7-20: Calibration Report ............................................................................................7-24

Figure 7-21: Report Selection Screen ..................................................................................7-25

Figure 7-22: Calibration History Screen ...............................................................................7-26

Figure 8-1: Front Access UPS Orientation .........................................................................8-10

Figure 8-2: Exit Software Button ........................................................................................8-12

Figure 8-3: View Cell Status Screen ..................................................................................8-16

Figure 8-4: Set Date/Time Screen ......................................................................................8-17

Figure 8-5: Enable/Disable Module, Drawer, Rack, or Cell Screen ....................................8-19

Figure 8-6: Reference Thermometer (Drawer B — Right-hand Configuration) ..................8-22

Figure 8-7: Digital Thermometer (Drawer A — Left-hand Configuration) ...........................8-22

Figure 8-8: Calibrate Module Temperature Screen ............................................................8-23

Figure 8-9: Calibrate Cell Screen .......................................................................................8-27

BacT/ALERT® 3D User Manual xv
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Figure 8-10: View Incubation Module Information Screen ................................................... 8-30

Figure 9-1: Instrument Icon with Fault Codes ...................................................................... 9-3

Figure 9-2: Instrument Status Code 710 ........................................................................... 9-24

Figure 9-3: Operator Error Code 911 ................................................................................ 9-27

Figure 9-4: QuickScan

®

6000 Reset Barcode ................................................................... 9-40

Figure 9-5: Honeywell Reset Barcode ............................................................................... 9-40

Figure 9-6: Red Informational Warning Screen ................................................................. 9-42

Figure 10-1: Main Screen While Logged Out — 21 CFR Part 11 Mode .............................. 10-2

Figure 10-2: User Login Screen .......................................................................................... 10-3

Figure 10-3: User Login Screen with Change Password Fields .......................................... 10-4

Figure 10-4: Main Screen While Logged In — 21 CFR Part 11 Mode ................................. 10-5

Figure 10-5: User Login Screen .......................................................................................... 10-6

Figure 10-6: User Login Screen with Wrong Password Alert .............................................. 10-8

Figure 10-7: User Login Screen with Change Password Fields .......................................... 10-9

Figure 10-8: User Login Screen with Change Password Error .......................................... 10-10

Figure 10-9: User Login Screen with Wrong Password Alert ............................................ 10-11

Figure 10-10:User Configuration Screen ............................................................................ 10-13

Figure 10-11:Add User Screen ........................................................................................... 10-14

Figure 10-12:Delete User Screen ....................................................................................... 10-15

Figure 10-13:Clear Password Screen ................................................................................ 10-17

Figure 11-1: Instrument Icon for MB-Configured System .................................................... 11-3

Figure 11-2: Bottle Count Table and Unload Buttons .......................................................... 11-6

Figure 11-3: Metabolic Pathway for Mycobacterial CO

Figure B-1: Typical BacT/ALERT

®

Culture Bottle ................................................................B-2

...................................................... 11-8

2

Figure C-1: Example Cell Graph ..........................................................................................C-4

Figure C-2: Cell Graph Example — Electronics ...................................................................C-5

Figure C-3: Cell Graph Example — Reverts to Normal ........................................................C-6

Figure C-4: Cell Graph Example — Cyclic ...........................................................................C-6

Figure C-5: Cell Graph Example — High Initial Value Reading ...........................................C-7

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LIST OF TABLES

Table 2-1: Common System Buttons ................................................................................2-28

Table 5-1: Bottle Specific Algorithms ................................................................................5-10

Table 5-2: Status Determination Codes ............................................................................5-11

Table 6-1: Bottle Specific Algorithms ................................................................................6-10

Table 6-2: Status Determination Codes ............................................................................6-11

Table 7-1: Report Field Descriptions .................................................................................7-12

Table 10-1: Audit Trail Events ...........................................................................................10-18

Table 11-1: Device Comparison for Recovery of Mycobacteria ........................................11-10

Table A-1: International Character Table ........................................................................... A-2

Table C-1: Bottle Volumes ..................................................................................................C-2

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xviii BacT/ALERT® 3D User Manual

95248

HOW TO USE THIS MANUAL

About This Chapter

This chapter gives you important information about the BacT/ALERT® 3D
system and how to use this manual. It is recommended that you read this
chapter first.

1

IMPORTANT: Read this manual carefully before you attempt to operate the

BacT/ALERT

®

3D system.

Chapter Contents

Intended Audience • 1-2

Specimen/Sample • 1-2

Purpose of the BacT/ALERT
Additional Supplies • 1-3
Purpose of This Manual • 1-4
Manual Organization • 1-4
Chapter Organization • 1-6
Finding Topics • 1-6
Typographic and Usage Conventions • 1-7

Name and Titles • 1-7
Press • 1-7
Procedural Steps • 1-7
References • 1-7
Select • 1-8
User Input • 1-8

Warnings, Cautions, and Information • 1-8

®

3D System • 1-2

BacT/ALERT® 3D User Manual 1-1
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How To Use This Manual Intended Audience

Intended Audience

The BacT/ALERT® 3D system and this manual are intended for laboratory
use by trained, professional, clinical and INDUSTRY users.

Most material in the manual applies to both sets of users. If any information in
the manual is intended for clinical use only or industry use only, it is marked
Clinical Use or INDUSTRY Use.

Specimen/Sample

In this manual, you will find references to both “specimen” and “sample.”
“Specimen” refers to Clinical Use, and “sample” refers to INDUSTRY Use.

Purpose of the BacT/ALERT® 3D System

The BacT/ALERT® 3D Microbial Detection System is a totally automated test
system capable of incubating, agitating, and continuously monitoring aerobic
and anaerobic media inoculated with:

• patient specimens suspected of having bacteremia, fungemia, and/or
mycobacteremia (Clinical Use),

or

• samples to be monitored for bacterial or fungal contamination (INDUSTRY
Use).

CAUTION: bioMérieux shall not be liable as to any defect arising
from abuse of the instrument, failure to operate and maintain the
instrument in accordance with the User Manual, operation of the
instrument by a person who has not been trained in its operation
by bioMérieux, repair, service, alteration or modification of the
instrument by any person other than service personnel of
bioMérieux, or modification, change or reuse of the disposables
supplied by bioMérieux for use in the instrument.

CAUTION: This BacT/ALERT® 3D User Manual is only intended
for use with B.30 Software or higher. The software version B.30
(or higher) is displayed at the bottom of the instrument icon on
the Main screen.

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Additional Supplies How To Use This Manual

CAUTION: All figures depicting operator screens are examples
only. Actual screens may differ to the extent they are affected by
the actual data entered by the operator, or actual data
transmitted to the instrument over the DBMS or LIS interface, or
actual data generated by the instrument.

CAUTION: Regarding section "Entering Report Labels," the user
is solely responsible for the choice of customized report label
text and for validating that the intended label text appears in all
associated reports. bioMérieux shall not be liable for any

consequences resulting from misinterpretation of customized
report labels.

CAUTION: (INDUSTRY Use) The BacT/ALERT® system is
marketed for use in the detection of microorganisms in blood
and other normally sterile body fluids, and in the detection of
microorganisms in other sample matrices and for additional
specific indications for use, as specified in the package inserts,
user manuals, and labeling of the specific components of the
BacT/ALERT
BacT/ALERT

®

system. Customers who use the

®

system in testing of sample types or for
indications other than those described in the applicable package
inserts and user manuals do so at their own risk. Performance
characteristics for the BacT/ALERT

®

system for any use outside
the labeling, package insert, or user manual have not been
established.

Additional Supplies

Contact bioMérieux or your local vendor for laboratory supplies and
accessories.

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How To Use This Manual Purpose of This Manual

Purpose of This Manual

This manual focuses on the BacT/ALERT® 3D software application and how
you use it in your workflow. It contains step-by-step procedures for using your
BacT/ALERT

By using these procedures, you can perform all the functions required to
operate your system, including:

• accessing the BacT/ALERT

• system monitoring

• entering data (where applicable)

• loading and unloading bottles

• viewing and printing data (printing with the BacT/ALERT® 3D Signature is
performed at the data management computer)

• LIS interaction with the BacT/ALERT

• accessing the Setup screen

Note: Screens and figures are intended for illustrative purposes only and are not to

be construed as representations of actual test data, results, or components.
Screens and components are not shown to scale.

®

3D system.

®

3D software

®

3D SelectLink

Manual Organization

This manual is organized by chapters. Chapters are organized according to
the order of menu commands in the software application.

Chapter 1, How To Use This Manual — Provides an introduction to the
BacT/ALERT
that you read this chapter first.

Chapter 2, System Overview — This chapter gives you a complete

description of the different BacT/ALERT
configurations available. Also, the operator panel screens are listed along
with a description of common screen elements.

Chapter 3, Basic Functions (Clinical Use) — Introduces you to the Main

screen and shows you how to perform basic functions (ex. enter data, view
faults, view the Cell Status screen, load/unload bottles, etc.). This chapter
also introduces you to the Setup screen and the associated function buttons.

1-4 BacT/ALERT® 3D User Manual

®

3D system and how to use this manual. It is recommended

®

3D hardware and software

95248

Manual Organization How To Use This Manual

Chapter 4, Basic Functions (INDUSTRY Use) — Introduces you to the

Main screen and shows you how to perform basic functions (ex. enter data,
view faults, view the Cell Status screen, load/unload bottles, etc.). This
chapter also introduces you to the Setup screen and the associated function
buttons.

Chapter 5, Editing Test Data (Clinical Use) — Explains how to access

bottle data for loaded and unloaded bottles using the Edit Bottle Detail
screen. This chapter shows you how to view and edit bottle data.

Chapter 6, Editing Test Data (INDUSTRY Use) — Explains how to access

bottle data for loaded and unloaded bottles using the Edit Bottle Detail
screen. This chapter shows you how to view and edit bottle data.

Chapter 7, Software Configuration — Explains how to configure the

software for your specific needs. This chapter shows you how to set the
maximum test time, set the audible alarms, change the system password,
initiate a manual backup, configure report screens, and view and print
calibration data.

Chapter 8, System Maintenance — This chapter provides you with

procedures on how to perform maintenance on the BacT/ALERT

®

3D

hardware and software.

Chapter 9, System Troubleshooting — Describes the different types of

instrument fault, instrument status and operator error codes, as well as bottle
and user output device problems, you may encounter when using the
instrument. Cause(s) and solutions(s) for each type of fault/error/problem are
also listed.

Chapter 10, 21 CFR Part 11 Mode — This chapter explains how to log in

and out of the instrument while in 21 CFR Part 11 mode, as well as
instructions for configuring users (ex. adding or deleting a user, or clearing a
user password). This chapter also describes the events recorded in the audit
trail and how to retrieve the audit trail.

Chapter 11, Mycobacterial Testing (Clinical Use) — This chapter provides

you with a complete description of the of the BacT/ALERT

®

3D instrument

when it is configured for Mycobacterial (MB) functions.

Appendix A, International Character Entry — Explains how to enter

international characters on the BacT/ALERT

®

3D instrument.

Appendix B, Bottle Quality Control — This chapter provides you with a

description of the BacT/ALERT® 3D culture bottle along with a quality control
procedure.

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How To Use This Manual Chapter Organization

Glossary — An alphabetized list of frequently used terms along with a

definition for each term.

Chapter Organization

All chapters include the following:

• About This Chapter — Brief description of the chapter’s content and
purpose.

• Chapter Contents — A table of contents for the chapter.

• Descriptions and/or Procedures — Chapters contain descriptions and
procedures appropriate to their subject matter. See the Manual
Organization section in this chapter for more information.

• Background Information, where applicable and useful.

Finding Topics

This manual uses several methods to help you find information and keep your
bearings.

Table of Contents — Located at the front of the manual. It contains the titles
of all chapters/appendices and their sections, and the page number of each
title and section.

List of Figures — Located at the front of the manual. It contains a list of all
figures in the manual and the page number of each figure.

List of Tables — Located at the front of the manual. It contains a list of all
tables in the manual and the page number of each table.

Chapter Contents — Located at the front of each chapter. It lists all sections
in the chapter and their page numbers.

Page Headers — Located at the top of each page. There are two parts to a
header: the chapter title and the primary section title.

Page Footers — Located at the bottom of each page. There are three parts
to a footer: the manual’s title, the chapter’s part number, and the page
number.

Index — Located at the back of the manual. It contains topical entries and
their page numbers.

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Typographic and Usage Conventions How To Use This Manual

Typographic and Usage Conventions

Name and Titles

Button, icon and field names are in Proper Case, bold.

Example: Press the Select Maximum Test Time button.

The names of windows and screens are in Proper Case, but are not bolded.

Example: The Set Maximum Test Time screen...

Press

This manual uses the word “press” to refer to pressing a button on the
Controller Module Operator Panel.

Example: Press the Load Bottles button.

We also use the word “press” to refer to pressing a key on the keyboard in
order to initiate action in the firmware.

Keyboard entries are in Proper Case and bolded (ex. Ctrl). If two keys are to
be pressed simultaneously, they will be separated with a plus sign (ex. press

Ctrl + Alt + Delete).

Procedural Steps

Steps in procedures are sequentially numbered. A bullet list in a step
indicates options.

Sections that contain procedures are denoted by the Procedure icon in the
margin.

Figure 1-1: Procedure Icon

References

References to chapter and section titles in this manual are in Proper Case.

Example: See Chapter 7, Software Configuration.

BacT/ALERT® 3D User Manual 1-7
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How To Use This Manual Warnings, Cautions, and Information

References to other manuals are in Proper Case and italic.

Example: See the BacT/ALERT® 3D Service Manual.

Select

The word “select” is generally used for selecting user interface navigation.

Example: Select the appropriate bottle type from the Media Type scroll
button.

User Input

Instructions for user input begin with the word “type” or “enter.” This manual
uses bold for literal user input and italic for placeholders.

Example of a Literal User Input: Enter the Software Exit Password

24313124.

In this example, you are to type exactly what you see on the page (24313124
in this example).

Example of a Placeholder: Enter your password before you...

In this example, you are to type your assigned password.

Warnings, Cautions, and Information

This manual uses different types of symbols to alert you to important
information. Symbols and their associated information are labeled in text
where they occur and set off from surrounding paragraphs, as shown in the
following examples.

WARNING

Warning is a statement that alerts the user to the possibility of
injury, death, or other serious adverse reactions associated
with the use or misuse of a device.

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Warnings, Cautions, and Information How To Use This Manual

CAUTION: Caution is a statement that alerts the user to the
possibility of a problem with the device associated with its use
or misuse. Such problems include device malfunction, device
failure, damage to the device, or damage to other property.
Where applicable, a caution statement may include a precaution
that should be taken to avoid the hazard.

IMPORTANT: Important relates to content presented in this manual. It is used to

reinforce the importance of your understanding or remembering
something.

Note: Note supplies additional information about a topic.

BacT/ALERT® 3D User Manual 1-9
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How To Use This Manual Warnings, Cautions, and Information

1-10 BacT/ALERT® 3D User Manual

95248

SYSTEM OVERVIEW

About This Chapter

2

This chapter gives you a complete description of the different
BacT/ALERT
operator panel screens are listed along with a description of common screen
elements.

Note: Information in this chapter that is intended for clinical use only or industry use

only is marked Clinical Use or INDUSTRY Use.

Chapter Contents

Introduction • 2-2

Hardware Configuration • 2-2
Software Configuration Options • 2-2
21 CFR Part 11 and HIPAA • 2-3
Theory Of Operation • 2-4
Electrical Warnings • 2-4
Electrical Grounding • 2-6
Electrical and Electronic Recycling • 2-7
Fuse Replacement • 2-7

BacT/ALERT

Mycobacteria Drawers (Clinical Use) • 2-8
Controller Module • 2-9
Controller Module Specifications • 2-15
Controller Module Environmental Requirements • 2-15
Combination Module • 2-16
Combination Module Specifications • 2-20
Combination Module Environmental Requirements • 2-21
Incubation Module • 2-22
Incubation Module Specifications • 2-25
Incubation Module Environmental Requirements • 2-25
Instrument Installation and Setup (Clinical Use) • 2-26
Instrument Installation and Setup (INDUSTRY Use) • 2-26

BacT/ALERT

Operator Panel Screens • 2-27
Common Screen Elements • 2-28

®

®

®

3D hardware and software configurations available. Also, the

3D Hardware • 2-8

3D Software • 2-27

BacT/ALERT® 3D User Manual 2-1
95248

System Overview Introduction

Introduction

The BacT/ALERT® 3D is the next generation of BacT/ALERT®
instrumentation with comparable sensitivity and specificity to the
BacT/ALERT
activated operator panel allows for a text-free user interface to direct rapid
loading and unloading of individual test samples.

Once placed in the unit, handling of a specimen/sample bottle is not required
until a result is obtained. Immediately upon detection, positive results are
indicated visually on the unit's monitor and, if desired, by an audible beep. If
no microbial growth is present after a specified time, a specimen/sample is
determined to be negative. The system will also indicate the negative
samples that are ready for removal when prompted. Because the system
handles bottles individually, testing of new specimens/samples may begin at
any time. The system also utilizes barcode technology to assist in specimen/
sample and data tracking.

The disposable culture bottles contain a liquid emulsion sensor that is
monitored continuously using solid-state photodetectors. In addition, the
bottles contain media and atmosphere which promote the recovery of a wide
variety of microorganisms without venting.

®

Classic systems. The system is non-invasive. A touch-

Hardware Configuration

The BacT/ALERT® 3D utilizes a flexible modular design in one of two
hardware configurations.

• A Controller Module that directs 1 to 6 Incubation Modules (each with 240
cells for bottle monitoring).

• A Combination Module that either stands alone (120 cells for bottle
monitoring), or directs up to 3 Incubation Modules.

Software Configuration Options

Both the Controller and Combination Modules supervise the reading of the
sensors and contain decision-making algorithms to determine which
specimens/samples are positive or negative. Both modules can be arranged
in one of three BacT/ALERT

®

• BacT/ALERT
Controller or Combination Module is not connected to either a bioMérieux
data management computer or a Laboratory Information System (LIS).
Limited data management is available through the system.

2-2 BacT/ALERT® 3D User Manual

3D Select configuration — The BacT/ALERT® 3D

®

3D software configurations:

95248

Introduction System Overview

• BacT/ALERT® 3D SelectLink configuration — The BacT/ALERT® 3D
Controller or Combination module is connected directly to an LIS. Limited
data management is available through the system.

• BacT/ALERT

®

3D Signature configuration — The BacT/ALERT® 3D

Controller or Combination Module is connected directly to a bioMérieux
data management computer. Data generated by the BacT/ALERT

®

3D is
managed by extensive data management software produced by
bioMérieux. This data management software provides a high level of
flexibility. Data can easily be stored for a definable length of time, edited,
queried, sorted, and reported. Predefined queries and reports are
available, or they can be customized by the user. A detailed description of
the data management software is found in the appropriate data
management system operator manual.

The software configuration is listed at the top of all screens (except for the
Edit Cell Contents or View Cell Contents screen). The background color will
also indicate the configuration unless there is an error condition or a loaded
positive bottle (see Main Screen Introduction in Chapter 3, Clinical Use, and

Main Screen Introduction in Chapter 4, INDUSTRY Use):

• Blue — BacT/ALERT

• Green — BacT/ALERT® 3D SelectLink configuration

• Gray — BacT/ALERT® 3D Signature configuration

21 CFR Part 11 and HIPAA

The BacT/ALERT® 3D Version B.30 or higher product release provides
compatibility with 21 CFR Part 11 and Health Insurance and Portability and
Accountability Act (HIPAA) requirements.

When installed, the BacT/ALERT
operate in 21 CFR Part 11 mode. If 21 CFR Part 11 mode is enabled, you will
need to enter a user name and password to access all functions available to
the user. See Log In/Out of System — 21 CFR Part 11 Mode in Chapter 10.

To meet HIPAA requirements, a password is required to view and print test
data. These functions include access to the Print, Report Label Entry,
Report Configuration, Calibration Report, and Calibration History
buttons. These buttons are accessed via a Report Selection screen (see

Figure 3-11 for Clinical Use or Figure 4-11 for INDUSTRY Use). See the

topic, Configuring Report Screens in Chapter 7 for further information.

®

3D Select configuration

®

3D instrument can be configured to

BacT/ALERT® 3D User Manual 2-3
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System Overview Introduction

Theory Of Operation

Principle of Detection

If microorganisms are present in the test sample, carbon dioxide is produced
as the microorganisms metabolize the substrates in the culture medium.
When growth of the microorganisms produces CO
the bottom of each culture bottle changes from dark to light.

A light-emitting diode (LED) projects light onto the sensor. The light reflected
is measured by a photodetector. As more CO
reflected. This information is compared to the initial sensor reading. If there is
a high initial CO
sustained production of CO

content, an unusually high rate of CO2 production, and/or a

2

, the sample is determined to be positive.

2

Mycobacterial growth in the BacT/ALERT® MP Bottles may also be
determined positive by the delta or a slow sustained change of CO
production (Clinical Use).

If the CO2 level does not change significantly after a specified number of days
at optimal conditions, the sample is determined to be negative.

, the color of the sensor in

2

is generated, more light is

2

2

CAUTION: Unloading or manipulating the bottles when not
indicated by the system may interfere with critical bottle
readings.

Electrical Warnings

The BacT/ALERT®3D has been designed and tested in accordance with the
standards listed below and has been supplied in a safe condition. A CB
Certification and Construction File have been established for the apparatus.

• UL 61010-1 (2nd Edition, 2001), Safety Requirements for Electrical

Equipment for Measurement, Control, and Laboratory Use; Part 1: General
Requirements

• IEC 61010-1 (2nd Edition, 2001), Safety Requirements for Electrical

Equipment for Measurement, Control and Laboratory Use

• IEC 61010-2-081 (1st Edition, 2001), Safety Requirements for Electrical

Equipment for Measurement, Control, and Laboratory Use –
Part 2-081: Particular requirements for automatic and semi-automatic
laboratory equipment for analysis and other purposes

• CAN/CSA-C22.2 No. 1010.1-92, Safety Requirements for Electrical

Equipment for Measurement, Control and Laboratory Use

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Introduction System Overview

WARNING

The user must adhere to the following warnings to ensure safe
operation and to maintain the apparatus in a safe condition:

• Ensure that the BacT/ALERT

®

3D instrument is configured for
the correct voltage at the instrument’s power entry port
before turning on.

• Intentional interruption of the protective conductor inside or
outside the apparatus, or disconnection of the protective
ground terminal, is prohibited.

• Disconnect the apparatus from all voltage sources before it is
opened for any adjustment, replacement, maintenance, or
repair.

• Do not perform any adjustments, maintenance, or repairs of
the opened apparatus while under voltage. If this is
unavoidable, maintenance must be carried out only by a
skilled person who is aware of the hazard involved.

• Whenever it is likely that the BacT/ALERT

®

3D module has
been impaired, it should be rendered inoperative and
secured against any unintended operation by disconnecting
the power cord. If the presence of moisture is evident, turn
off the machine at the breaker before removing the power
cord and fuse.

• Do not forcibly remove the Zip
Forcibly removing the Zip

®

Zip

disk or Zip® drive and may cause the system to lock up.

®

disk from the instrument.

®

disk may cause damage to the

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System Overview Introduction

WARNING

Contact your local bioMérieux Representative if any of the
following conditions occur:

• System shows visible damage.

• System fails to perform intended measurements.

• System has been subjected to storage under unfavorable
conditions (ex. above 90% humidity, extreme temperatures,
dusty environment, prolonged storage).

• System has been subjected to severe transport stresses.

Electrical Grounding

An electrical ground is required for this instrument. Before installing the
instrument, ensure that a grounded wall receptacle is available for each
module, which is factory equipped with a power supply cord that has the
appropriate grounding plug. It must be plugged into a mating grounding type
wall receptacle in accordance with the National Electrical Code and
applicable local codes and ordinances for this type of installation (see

Figure 2-1)..

WARNING

Do not remove the power cord’s ground prong under any
circumstances.

WARNING

Do not insert any object, other than a Zip® disk, into the Zip®
drive under any circumstances.

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Introduction System Overview

1 2

Figure 2-1: Electrical Grounding Requirements

1 — US Standard
2 — 220 Volt - European

Electrical and Electronic Recycling

WARNING

This statement only applies to European countries with regard
to the waste electrical and electronic equipment European
directive:

You can play an important role in contributing to reuse,
recycling and other forms of recovery of waste electrical and
electronic equipment. Sorting this type of waste significantly
reduces potential negative effects on the environment and
human health as a result of the presence of hazardous
substances in electrical and electronic equipment.

At the end of the life cycle of this product, do not dispose of the
product as unsorted municipal waste, even if it is
decontaminated. It is imperative that you contact bioMérieux to
assure for its appropriate disposal.

Fuse Replacement

There are no user-serviceable fuses in the BacT/ALERT® 3D system.
Contact your local bioMérieux Instrument Service Representative.

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System Overview BacT/ALERT® 3D Hardware

BacT/ALERT® 3D Hardware

Each BacT/ALERT® 3D system includes either a Controller Module with at
least one Incubation Module or a Combination Module. Each Controller
Module can direct up to six Incubation Modules. Each Combination Module
contains two incubation drawers in a right or left-handed configuration and
can direct up to three additional Incubation Modules.

Incubation Modules are available in right and left-handed configurations. A
right-handed Incubation Module is designed for placement on the right side of
the Controller or Combination Module and allows bottle access from the left
of an open drawer. Incubation Modules contain four drawers, each with the
capacity to hold up to 60 culture bottles. An Incubation Module can be
configured so one or more drawers are empty, allowing a 60, 120, 180, or
240-bottle capacity.

Mycobacteria Drawers (Clinical Use)

Mycobacteria (MB) and non-MB drawers can co-exist in the same Incubation
Module. MB drawers may be provided directly by bioMérieux or may be
converted from a non-MB configuration in the field. This is accomplished by
disengaging the agitation mechanism so the three racks within each drawer
remain immobile.

Each MB drawer handle has a red MB label also displaying the Incubation
Module number and letter corresponding to that drawer. The MB drawer
faces on the Instrument icon of the Main screen are also labeled.

Note: The BacT/ALERT

status of each drawer.

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®

3D software must also be configured to activate the MB

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BacT/ALERT® 3D Hardware System Overview

Controller Module

1

2

3

4

1 — Operator Panel
2 — Barcode Reader
3 — Backup Drive (Located in Barcode Reader Aperture)
4 — Barcode Reader Strip
5 — Keyboard Drawer

Operator Panel

Displays bottle and system information. Includes a touchscreen overlay so
that the operator may input selections and data by touching the screen.

Barcode Reader Aperture

Houses a removable Barcode Reader that is used to scan bottle barcode
labels to identify bottles and accession/sample barcodes when loading or
unloading. The reader can be removed, if desired.

5

Figure 2-2: Instrument Front View

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System Overview BacT/ALERT® 3D Hardware

Figure 2-3: Removing the Barcode Reader Through the Barcode Reader Aperture

Backup Drive

Used for system backups and software upgrades. May be either a Zip® Drive
or a USB Port, depending on system configuration. Located in the Barcode
Reader Aperture.

Keyboard Drawer

Houses a pullout working surface, Quick Reference Card, and keyboard.

Quick Reference Card

Describes specific error codes. Located in the keyboard drawer beneath the
Barcode Reader Aperture. Located at the bottom of the Controller Module.

Keyboard

Provides an alternate means of input. Serves as a backup input device
should the Touchscreen or Barcode Reader fail.

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Accessing the Controller Module Keyboard

There are two different designs of keyboard drawers, Design A and Design B
(see Figure 2-4).

To access the keyboard in a drawer of Design A:

1) Pull the keyboard drawer on the bottom of the Controller Module face out
as far as it will go. A cover is exposed which includes a pocket for the
Reference Card.

2) Grasp the sides of the exposed cover nearest the face of the Controller
Module.

3) Press the metal latches on each side of the drawer to extend fully.

4) Extend the drawer fully, and swivel the cover up.

5) Remove the keyboard, close the cover, and rest the keyboard on the

working surface.

To access the keyboard in a drawer of Design B:

1) Pull the keyboard drawer on the bottom of the Controller Module face out
as far as it will go. A cover is exposed which includes a pocket for the
Reference Card.

2) Grasp the sides of the exposed cover nearest you.

3) Press the metal latches on each side of the drawer to extend fully.

4) Swivel the cover up from the front to expose the keyboard.

5) Remove the keyboard, close the cover, and rest the keyboard on the

working surface.

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System Overview BacT/ALERT® 3D Hardware

Design A Design B

1

2

Figure 2-4: Accessing the Keyboard and Reference Card

1 — Notch for cord
2 — Press latch on each side to close

When keyboard entry is complete, the keyboard may be returned to its
original position beneath the cover plate. Close the drawer by depressing
both latches on each side of the drawer while pushing it closed.

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BacT/ALERT® 3D Hardware System Overview

1
2

3

4

5

6

Figure 2-5: Back View Controller Module

1 — Power Switch
2 — Power Connector
3 — Display Switch Assembly
4 — CPU 1 Port
5 — CPU 2 Port
6 — Module Ports (6)
7 — Fans

14

13
12
11

10

9
8

7

8 — Monitor Port
9 — Modem Port
10 — LIS Port (Diagnostic Port)
11 — Printer Port
12 — Comm Port
13 — External Speaker Port
14 — Audible Alarm Speaker

Printer Port

Interface port (parallel) for producing hard copy reports when the instrument
is not in the BacT/ALERT

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®

Signature configuration.

System Overview BacT/ALERT® 3D Hardware

Audible Alarm Speaker

Specified by the user to flag instrument failures, operator errors, and positive
bottle results.

External Speaker Port

Port for connecting external speakers that are available for order as a
separate kit.

Power Connector

Connector for alternating current (AC) power cord.

Power Switch

Turns the AC Power to the instrument On and Off.

Display Switch Assembly

Used to select the internal or external display device.

CPU 1 Port

Used to connect the bioMérieux data management computer to the Controller
Module (or Combination Module) or to connect two Controller Modules
together.

CPU 2 Port

Used to connect two Controller Modules (or Combination Modules) together.

Module Ports (6)

Connects an Incubation Module to the Controller Module.

Monitor Port

Used to connect an external monitor, if necessary.

Modem Port

Used to connect an external modem to the Controller Module. Allows remote
diagnosis of instrument problems. The external modem box should be in the
“OFF” position when not in use by a bioMérieux Representative.

LIS Port (Diagnostic Port)

Used to connect the Controller Module to a Laboratory Information System
(LIS). See Figure 2-5, Back View Controller Module, on page 2-13.

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BacT/ALERT® 3D Hardware System Overview

COMM Port

Reserved for future use.

Controller Module Specifications

Electrical Power Services Requirements

• 100/120 Volts (50-60 Hz)

• 220/240 Volts (50-60 Hz)

Power Consumed in Watts

• @115 Volts (72 Watts typical)

• @230 Volts (72 Watts typical)

Heat Dissipated

• 245 BTU/Hr. 2840 maximum

Sound Emission

• 46.4 dB

Instrument Dimensions

• Width — 14 inches (35.6 cm)

• Height — 36 inches (91.4 cm)

• Depth — 24.3 inches (61.7 cm)

• Weight — 91 pounds (57.2 Kg)

Controller Module Environmental Requirements

Operating Temperature Range

• 10°C to 30°C (50°F to 86°F)

Storage Temperature Range

• –17°C to 57°C (0°F to 135°F)

Operating Humidity Range

• 10% to 90% relative humidity, non-condensing.

Storage Humidity Range

• 10% to 90% relative humidity, non-condensing.

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System Overview BacT/ALERT® 3D Hardware

Maximum Operating and Storage Altitude

• 6562 feet (2000 meters)

Pollution degree 2 in accordance with IEC 664

Overvoltage Category II per IEC 664

Combination Module

4

23

1

Figure 2-6: Front View Combination Module

1 — Keyboard
2 — Printer
3 — Barcode Reader
4 — Operator Panel
5 — Combination Module
6 — Backup Drive
7 — UPS
8 — Modem

5

6

7

8

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14

13

15

12

1

2

11

3
4

10
9

7

6

5

8

Figure 2-7: Back View Combination Module

1 — CPU 1 and CPU 2 Ports
2 — Power Switch
3 — Power Connector
4 — UPS Port
5 — Module 2 – 5 Ports
6 — Display Switch Assembly
7 — Modem Port

9 — Printer Port
10 — COMM Port
11 — Fan
12 — External Speaker Port
13 — Keyboard Port
14 — Barcode Reader Port
15 — LIS Port

8 — Monitor Port

Operator Panel

Provides a way of displaying information. Includes a touchscreen overlay so
that the operator may input selections and data by touching the screen.

Barcode Reader

The Barcode Reader is external to the Combination Module. The Barcode
Reader, used to scan bottle barcode labels to identify bottles and accession/

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System Overview BacT/ALERT® 3D Hardware

sample barcodes when loading or unloading, is on a stand separate from the
Combination Module.

Keyboard

The keyboard is external to the Combination Module. It provides an alternate
means of input. Serves as a backup input device should the Touchscreen or
Barcode Reader fail.

UPS

The UPS is external to the Combination Module.

Backup Drive

The Backup Drive allows system backups to be made to either a Zip® disk or
USB Flash Drive.

Drawer

Labeled A or B in the Combination Module. Each drawer contains 3 racks for
a drawer capacity of 60 culture bottles.

Rack

Each rack contains 20 cells.

Cell

Cells are designated with a number from 1 to 60. Each cell holds and
monitors one culture bottle.

Cell Indicator Lamp/Cell Indicator Light

Located next to each cell in the rack.

• Illuminates to indicate which cells are available for loading after the

operator selects the Load Bottles function.

• Illuminates to indicate which cells should be unloaded when the

operator selects one of the Unload Bottles functions.

• Blinks slowly or rapidly to indicate whether a bottle load or unload was

performed correctly or incorrectly, respectively.

Cell Flag

Secures bottles in cells and aids in cell diagnostics and bottle loading and
unloading determinations.

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BacT/ALERT® 3D Hardware System Overview

1

Figure 2-8: Cell Flag (Clip Removed)

1 — Clip

Thermometer (Not Shown)

Located in back of drawer.

Drawer Indicator Light — Yellow

• Illuminates when the drawer is open and turns off when the drawer is

closed.

• Flashes if the drawer remains open too long or if an error condition is

associated with the drawer.

Drawer Indicator Light — Green

• Illuminates if the drawer or its cells are involved in an operation the

user has selected.

• Flashes in conjunction with the yellow indicator if a drawer is left open

too long.

Printer Port

Interface port (parallel) for producing hard copy reports when the instrument
is not in BacT/ALERT

®

3D Signature configuration.

External Speaker Port

Port for connecting external speakers. External speakers are available for
order as a separate kit.

Power Connector

Connector for Alternating Current (AC) power cord.

Power Switch

Turns the AC power to the Combination Module on and off.

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System Overview BacT/ALERT® 3D Hardware

Display Switch Assembly

Used to select the internal or external display device.

CPU 1 Port

Used to connect the bioMérieux data management computer to the
Combination Module or to connect to a Controller Module.

CPU 2 Port

Used to connect to a Controller Module (or Combination Module).

Module Port (3)

Connects an Incubation Module to the Combination Module.

Modem Port

Used to connect an external modem to the Combination Module. Allows
remote diagnosis of instrument problems. The external modem box should be
in the “OFF” position when not in use by a bioMérieux Representative.

LIS Port

Used to connect the Combination Module to a Laboratory Information System
(LIS).

Barcode Scanner Port

Used to connect the barcode scanner.

Keyboard Port

Used to connect the keyboard.

Monitor Port

Used to connect an external monitor, if necessary.

COMM Port

Reserved for future use.

Combination Module Specifications

Electrical Power Services Requirements

• 100/120 Volts (50/60 Hz)

• 220/240 Volts (50/60 Hz)

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BacT/ALERT® 3D Hardware System Overview

Power Consumed in Watts

• @115 Volts — 256 Watts (idle), 640 Watts typical

• @230 Volts — 265 Watts (idle), 640 Watts typical

Heat Dissipated

• 904 BTU/Hr. 2840 maximum

Combination Module Dimensions

• Width — 19.5 inches (49.6 cm)

• Height — 30.8 inches (78.1 cm)

• Depth — 24.5 inches (62.2 cm)

• Unloaded Weight — 200 pounds (90.7 Kg)

• Loaded Weight — 216.5 (98.2Kg)

Sound Emission

• 55.5 dB

Combination Module Environmental Requirements

Operating Temperature Range

• 10°C to 30°C (50°F to 86°F)

Storage Temperature Range

• –17°C to 57°C (0°F to 135°F)

Operating Humidity Range

• 10% to 90% relative humidity, non-condensing.

Storage Humidity Range

• 10% to 90% relative humidity, non-condensing.

Maximum Operating and Storage Altitude

• 6562 feet (2000 meters)

Pollution degree 2 in accordance with IEC 664 (Clinical Use)

Overvoltage Category II per IEC 664 (Clinical Use)

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System Overview BacT/ALERT® 3D Hardware

Incubation Module

6

5

4

1

2

Drawer

Rack

Cell

3

Figure 2-9: Front View Incubation Module (Right-Handed Configuration)

1 — Green Indicator Lamp
2 — Yellow Indicator Lamp
3 — Drawer Label
4 — Digital Thermometer (located on the inner front panel of drawer B

in right-hand module and drawer A of left-hand module)
5 — Drawer
6 — Drawer Release Latch

Labeled A, B, C, or D in each Incubation Module. Contains 3 racks for a
drawer capacity of 60 culture bottles.

Each rack contains 20 cells.

Designated with a number from 1 to 60. Each cell holds and monitors one
culture bottle.

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BacT/ALERT® 3D Hardware System Overview

Cell Indicator Lamp/Cell Indicator Light

Located next to each cell in the rack.

• Illuminates to indicate which cells are available for loading after the
operator selects the Load Bottles function.

• Illuminates to indicate which cells should be unloaded when the
operator selects one of the Unload Bottles functions.

• Blinks slowly or rapidly to indicate whether a bottle load or unload was
performed correctly or incorrectly respectively.

Cell Flag

Secures bottles in cells and aids in cell diagnostics and bottle loading and
unloading determinations (see Figure 2-8, Cell Flag (Clip Removed), on

page 2-19).

Drawer Indicator Light — Yellow

• Illuminates when the drawer is open and turns off when the drawer is
closed.

• Flashes if the drawer remains open too long or if an error condition is
associated with the drawer.

Drawer Indicator Light — Green

• Illuminates if the drawer or its cells are involved in an operation the
user has selected.

• Flashes in conjunction with the yellow indicator if a drawer is left open
too long.

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System Overview BacT/ALERT® 3D Hardware

1
2

3

Figure 2-10: Back View Incubation Module

1 — Power Switch
2 — Power Connector
3 — Controller Module Port

Controller Module Port

Connects the Controller Module to an Incubation Module.

Power Connector

Connector for AC power cord.

Power Switch

Turns the AC power of the Incubation Module On and Off.

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Incubation Module Specifications

Electrical Power Services Requirements

• 100/120 Volts (50/60Hz)

• 220/240 Volts (50-60 Hz)

Power Consumed in Watts

• @115 Volts — 256 Watts (idle), 640 Watts typical

• @230 Volts — 265 Watts (idle) 640 Watts typical

Heat Dissipated

• 904 BTU/Hr. 2840 maximum

Instrument Dimensions

• Width — 19.5 inches (49.6 cm)

• Height — 36 inches (91.4 cm)

• Depth — 24.3 inches (61.7 cm)

• Unloaded Weight — 262 pounds (118.8 Kg)

• Loaded Weight — 307 (133.8 Kg)

Sound Emission

54.7 dB

Incubation Module Environmental Requirements

Operating Temperature Range

• 10°C to 30°C (50°F to 86°F)

Storage Temperature Range

• –17°C to 57°C (0°F to 135°F)

Operating Humidity Range

• 10% to 90% relative humidity, non-condensing.

Storage Humidity Range

• 10% to 90% relative humidity, non-condensing.

Maximum Operating and Storage Altitude

• 6562 feet (2000 meters)

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System Overview BacT/ALERT® 3D Hardware

Instrument Installation and Setup (Clinical Use)

CAUTION: Initial installation and setup of the BacT/ALERT® 3D
Microbial Detection System, or of any added Incubation
Module(s) is to be performed only by a bioMérieux Service
Representative.

WARNING

Clinical Use: The BacT/ALERT® 3D has been designed to
minimize risks associated with MB testing. However, to further
reduce the risks of accidental exposure to infectious agents,
additional precautions should be taken. It is strongly
recommended that the instrument be placed in a laboratory
used for the routine culture of M. tuberculosis. For activities
involving the propagation and manipulation of M. tuberculosis
or Mycobacterium species grown in culture, Biosafety Level 3
Practice, Containment Equipment, and Facilities are required
as recommended by CDC and NIH guidelines.

At a minimum, the instrument should be placed in a contained environment
with controlled access which has a tuberculosis exposure control plan. The
locations 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 the patient
population.

If it is necessary to move or store the BacT/ALERT
modules, contact bioMérieux Service for assistance.

®

3D System or one of its

Instrument Installation and Setup (INDUSTRY Use)

CAUTION: Initial installation and setup of the BacT/ALERT® 3D
Microbial Detection System, or of any added Incubation
Module(s), is to be performed only by your local bioMérieux
Representative.

If it is necessary to move or store the BacT/ALERT® 3D System or one of its
modules, contact your local bioMérieux Representative for assistance.

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BacT/ALERT® 3D Software System Overview

BacT/ALERT® 3D Software

Operator Panel Screens

The Main screen is normally visible on the Operator Panel, but other screens
may be displayed to perform a variety of functions. Each screen has a screen
ID number in the upper left-hand corner to cross-reference it to the following
descriptions and instructions in this Manual. When selected, the Setup
screen replaces the Main screen.

Screen ID Numbers

• 1.0 Main screen

• 1.1 View Cell Status screen

• 1.2 Change Maximum Test Time screen

• 1.3 User Login screen (21 CFR Part 11 mode only)

• 2.0 Setup screen

• 2.1 Set Date/Time screen

• 2.2 Enable/Disable Module, Drawer, Rack, or Cell screen

• 2.3 Calibrate Module Temperature screen

• 2.4 Calibrate Cell screen

• 2.4.1 Cell Calibration Report Screen

• 2.7 Set Maximum Test Time screen

• 2.8 Set Audible Alarm Options screen

• 2.9 Change Password screen

• 2.11 Select Bottle to Edit/Graph screen

• 2.11.1 Edit Bottle Detail screen

• 2.11.1.1 Edit Test Result

• 2.11.2 Graph Bottle Readings screen

• 2.11.2.1 Bottle Readings screen

• 2.12 Edit Cell Contents screen (2.11.1, 2.11.1.1, 2.11.2 and 2.11.2.1 can
also be accessed from this screen)

• 2.13 View Incubation Module Information screen

• 2.14 Report Label Entry screen *

• 2.15 Report Configuration screen *

• 2.15.1 Report screen *

• 2.16 Backup Management screen

• 2.17 Edit Data Relationships screens

• 2.19 Viewing and Printing Calibration data screen

• 2.20 Bottle Type Customization screen

• 2.21 Report Selection screen*

• 2.21.1 Calibration History screen

• 2.23 User Configuration screen (21 CFR Part 11 mode only)

• 2.23.1 Add User screen (21 CFR Part 11 mode only)

• 2.23.2 Delete User screen (21 CFR Part 11 mode only)

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System Overview BacT/ALERT® 3D Software

• 2.23.3 Change User Password screen (21 CFR Part 11 mode only)

* Screen's availability dependent upon BacT/ALERT® 3D software

configuration.

Common Screen Elements

Icon

• Graphic symbols used instead of text to convey information and
concepts in the Operator Panel.

Button

• Appear as rectangular shapes which can be pressed to input choices
or activate functions.

• Button function is indicated by icon displayed on button face.

• If a button is gray, then it is disabled and its associated function is
unavailable.

12

Figure 2-11: Button Examples

1 — Enabled Button
2 — Disabled Button

Common System Buttons

Table 2-1: Common System Buttons

Check button – Accept changes, save data or

entries on that particular screen.

Cancel button – Discard changes or entries on
that particular screen to keep the original
values.

Previous Screen Button – Return to the
previous screen.

Next Screen Button – Move to the next
available screen.

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BacT/ALERT® 3D Software System Overview

Scroll Button

• Used for numeric entry and symbolic or media type selection.

• Consists of two small buttons and an area between them to display
the current value.

• Touching the top or bottom button of the scroll button displays the
next higher or lower value.

• Adjacent scroll buttons provide entry for multi-digit values.

Figure 2-12: Scroll Button

Slidebar Switch

• Turns a function On or Off. The specific function is represented by a
separate icon next to the slidebar.

• Touching the right half of the icon moves the slidebar to the right,
indicating an On selection (1).

• Touching the left half of the icon moves the slidebar to the left,
indicating an Off selection (0).

Figure 2-13: Slidebar Switch

Anchor Display/Scroll Buttons

• Anchor Display top or bottom buttons — Control whether the display
stays anchored on the first or last line of the diagnostic output.

• Line scroll up or down buttons — Move the display area one line at a
time (up or down). This function can also be performed by pressing the
↑ or ↓ key on the keyboard.

• Page scroll up or down buttons — Move the display area one page (up
or down). This function can also be performed by pressing the Page
Up or Page Down key on the keyboard.

• Home/End scroll buttons — Position the display area to the first or last
line of the diagnostic output. This function can also be performed by
pressing the Home or End key on the keyboard.

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System Overview BacT/ALERT® 3D Software

1 — Anchor Display Top Button
2 — Anchor Display Bottom Button
3 — Line Scroll Up Button
4 — Line Scroll Down Button
5 — Page Scroll Up Button
6 — Page Scroll Down Button
7 — Home Scroll Button
8 — End Scroll Button

Text Entry Field

A text entry field appears as a rectangular box that allows the user to enter
text either manually via the keyboard or by scanning a barcode (see Text/

Data Entry in Chapter 3). The Bottle ID field on the Main screen is an

example of a text field (see Figure 3-1, Main Screen).

1

2

Figure 2-14: Anchor Display/Scroll Buttons

3

4

5

6

7

8

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BASIC FUNCTIONS (CLINICAL USE)

About This Chapter

This chapter introduces you to the Main screen and provides you with
procedures on how to perform daily basic functions for clinical use.

Chapter Contents

Introduction • 3-2
Monitoring the System • 3-3

Main Screen Introduction • 3-3
Viewing Faults • 3-6
Viewing the Cell Status Screen • 3-7

Text/Data Entry • 3-9

Common Text Fields and Field Limit • 3-9
Using the Barcode Scanner to Enter Data • 3-10
Manually Entering Text into a Data Entry Field (Keyboard) • 3-10

Loading Bottles • 3-11

Loading Bottles • 3-11
Changing the Maximum Test Time — Individual Bottles • 3-15
Handling Anonymous Bottles • 3-16

Unloading Bottles • 3-16

Unloading Bottles • 3-17
Handling Unconfirmed Positive Bottles (False Positives) • 3-19

Accessing the Setup Screen Function Buttons • 3-20

Accessing the Setup Screen • 3-20
Setup Screen Function Buttons • 3-21

Viewing and Printing • 3-23

Introduction • 3-23
Viewing, Printing, and Exporting Test Data • 3-24
Viewing and Printing Bottle Graphs • 3-31
Display Bottle Readings • 3-34

Sending/Requesting LIS Information • 3-39

Sending Results to the LIS • 3-39
Requesting Information from the LIS • 3-39

3

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Basic Functions (Clinical Use) Introduction

Introduction

The basic functions are those tasks that may be performed during daily
workflow. They include:

• Monitoring system

• Entering data (where applicable)

• Loading and unloading bottles

• Viewing and printing data (printing with the BacT/ALERT® 3D Signature is
performed at the data management computer.)

• LIS interaction with the BacT/ALERT

• Accessing the Setup screen

®

3D SelectLink

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Monitoring the System

Main Screen Introduction

The BacT/ALERT® 3D system can be monitored from the Main screen (see

Figure 3-1).

10

1

2

3

4

5

6

7

Figure 3-1: Main Screen

1 — Screen ID Number
2 — Bottle Count Table
3 — Unload Buttons
4 — Manual Send Test Results button (SelectLink only)
5 — Manual Request Test Orders button (SelectLink only)
6 — Logout button (21 CFR Part 11 mode only)
7 — Load Bottles button
8 — Instrument Icon
9 — Current Date/Time
10 — Software Configuration

9

8

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Basic Functions (Clinical Use) Monitoring the System

CAUTION: If the current date/time displayed at the top of the
screen does not advance, contact bioMérieux Customer Service
immediately.

Background Color

The default background color is determined by the software configuration
(see Software Configuration Options in Chapter 2). The following conditions
will override default background colors:

• A yellow screen indicates that the instrument has detected a positive bottle.

• A red screen indicates that an instrument fault has occurred. Touching the
screen or pressing any key on the keyboard returns a red screen to yellow
or the configuration default color depending on whether positive bottles are
present. The fault code will remain on the screen until the error is cleared.

Instrument Icon

The following information is indicated on the Instrument icon:

• System ID numbers are assigned to both the Controller/Combination
Module and Incubation Modules.

• Combination Module has 2 System ID numbers.

• The programmed optimal temperature (ºC) is displayed for each Incubation
Module.

• Software version number for the BacT/ALERT

®

3D Controller/Combination

Module.

• Disabled or uninstalled components appear diagonally striped in gray on
the screen.

• An entire rack will appear diagonally striped if only one of its cells is
disabled.

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1

2

4

5

3

Figure 3-2: Combination Module with an Additional Incubation Module

1 — Combination Module Instrument Icon
2 — Combination Module ID
3 — Software Version
4 — Incubation Module ID
5 — Optimal Temp (ºC)

1

1 — Controller Module Instrument Icon
2 — Optimal Temp (ºC)
3 — Disabled Rack or Cell
4 — Controller ID
5 — Software Version

Bottle Count Table

Located just above the Instrument icon are the Unload buttons and a bottle
count table indicating the number of bottles of each type currently loaded in
the instrument.

2

4

3

5

Figure 3-3: Controller Module with One Incubation Module

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Basic Functions (Clinical Use) Monitoring the System

3

57

1

2

468

Figure 3-4: Bottle Count Table/Unload Buttons

1 — Total number of mycobacteria (MB) bottles loaded in the system.
2 — Total number of blood or sterile fluid culture (BC) bottles loaded in

the system.
3 — Total number of identified bottles with a positive test status.
4 — Unload Positive Identified Bottles Button
5 — Total number of bottles (identified and anonymous) with a

negative test status.
6 — Unload Negative Bottles Button
7 — Total number of anonymous bottles with a positive test status.
8 — Unload Positive Anonymous Bottles Button
9 — Total number of anonymous bottles with a negative-to-date or

negative test status.
10 — Unload Anonymous Negative or Negative-to-Date Bottles Button

9

10

Viewing Faults

Instrument faults are reported using a numeric code within a red diamond
shape. Fault codes are displayed on the Instrument icon where the fault
condition exists.

Note: Only high priority codes are displayed on the Instrument icon.

1) If the code appears on the Controller Module or the top half of the

Combination Module, then move to Step 4. If the fault code appears on
an Incubation Module or bottom half of the Combination Module, then
continue to Step 2.

2) Touch the Incubation or Combination Module on the Instrument icon
that contains the fault code.

3) The View Cell Status screen appears (see Viewing the Cell Status

Screen on page 3-7 and Figure 3-5).

• Drawer faults appear at the top of the screen.

• Rack faults appear at the left end of the rack display.

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• Cell faults appear in the cell display.

4) For a complete list and description of Instrument Fault Codes, see the

topic, Instrument Fault Codes in Chapter 9.

Viewing the Cell Status Screen

The View Cell Status screen is continuously updated with changes that occur
while the screen is active, such as the loading/unloading of bottles, new test
results, and the error status of the drawer, as indicated by fault codes
appearing or disappearing. To view the cell status screen:

1) Display the View Cell Status screen by touching the appropriate

Incubation Module on the Instrument icon (see Figure 3-1, Main Screen,

on page 3-3).

1011

1

2

3

45

Figure 3-5: View Cell Status Screen

1 — Incubation Module

Indicator
2 — Cell Fault Code
3 — Rack Fault Code
4 — Previous Screen Button
5 — Incubation Module

Selection Button

9

8

7

6

6 — Drawer Selection Button
7 — Rack
8 — Cell
9 — Restart Incubation Module

Button
10 — Drawer Fault Code
11 — Drawer Indicator

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Basic Functions (Clinical Use) Monitoring the System

2) If necessary, use the Incubation Module Selection and Drawer Selection
buttons to display the desired drawer.

Note: If a drawer is not installed, it is not displayed.

3) Press the Previous Screen button to return to the Main screen.

Understanding the View Cell Status Screen Display

For each cell, the cell identification number appears at the top of the circle.

A hollow circle indicates an empty cell, and a solid circle indicates a loaded
cell. The color of the solid circle indicates the bottle status or a cell that is
pending quality control check.

• Black — negative-to-date bottle

• Green — negative bottle

• Yellow — positive bottle

• White — cell is pending quality control check

Loaded cells also contain symbols to indicate the bottle's status:

+Positive
– Negative
* Negative-to-date
~ + Critical determination in progress. (Represents

a bottle that is presently undergoing a critical
determination as to whether it will turn positive
or remain negative or negative-to-date.)

Note: Bottles with a critical determination in progress status will be temporarily

removed from the bottle count table on the Main screen.

Cells loaded with an anonymous bottle contain a ?. If a loaded cell contains
no ?, then the bottle is identified.

Disabled racks and cells are indicated by gray diagonal stripes within their
borders. Disabled drawers are indicated by gray diagonal stripes within the
drawer indicator (see Enabling and Disabling Modules, Drawers, Racks, and

Cells in Chapter 8).

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Text/Data Entry Basic Functions (Clinical Use)

12

Figure 3-6: Disabled Cell and Drawer

1 — Disabled Cell
2 — Disabled Drawer

Note: If a drawer is disabled, its racks and cells are disabled and turn gray.

Text/Data Entry

Common Text Fields and Field Limit

Bottle ID field

Patient First Name field — may contain up to

20 characters

Patient Last Name field — may contain up to
31 characters

Accession Number field — may contain up to
16 characters

Hospital ID field — may contain up to 22
characters

Note: The field length and initial character type (alpha, numeric, or other) can be

configured for the Accession Number field. The initial character type can be
configured for the Bottle ID field. To configure these fields, contact your local
bioMérieux Representative.

Note: The Hospital ID, Patient First Name, and Patient Last Name fields do not

display with the BacT/ALERT

Note: All fields except the Bottle ID field may be hidden or disabled regardless of

software configuration. To hide or disable a field, contact your local
bioMérieux Representative.

®

3D Signature configuration.

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Basic Functions (Clinical Use) Text/Data Entry

Note: To change the order of the patient fields, contact your local bioMérieux

Representative.

Using the Barcode Scanner to Enter Data

To scan a bottle or accession barcode:

1) Before scanning the barcode, touch the desired field to place focus on
that field. The field should turn white indicating focus.

2) Rotate the bottle so the bottle ID or accession number barcode is on top.

3) Place the bottle over the barcode strip located in the Barcode Reader

Aperture below the Control Panel of the Controller Module (see

Figure 2-2, Instrument Front View) or at the base of the barcode reader

stand with the Combination Module (see Figure 2-6, Front View

Combination Module).

4) There will be two short beeps when the bottle ID is successfully scanned
into the Bottle ID field.

5) If the Accession Number field is enabled, there will be three short
beeps when the accession number is successfully scanned into the
Accession Number field.

If an Operator Error occurs, a series of beeps will alert the operator to view
the Operator Panel.

If the barcode is not read:

1) Verify the appropriate field has focus.

2) Move the bottle away from the barcode strip and initiate another scan.

Note: The Hospital ID field is a keyboard-entry field only.

Manually Entering Text into a Data Entry Field (Keyboard)

Field text, where applicable, can be entered using the keyboard (see

Figure 2-4, Accessing the Keyboard and Reference Card). If a barcode label

cannot be scanned successfully, the bottle ID or accession number can also
be entered using the keyboard.

See Appendix A for International character entry instructions.

Note: Before entering text into a field, touch the desired field to place focus on that

field. The field should turn white indicating focus.

1) Using the keyboard, enter the desired text.

2) Press the Tab key to move focus to the next field.

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Note: If desired, change the cursor location using the keyboard keys. Keys that

provide cursor positioning and editing functions are as follows:

LEFT ARROW Moves cursor left one position

Note: Entering text does not over-write existing text located to the right of the

insertion point.

Note: Entered text defaults to all-uppercase. To change the default, contact your

local bioMérieux Representative.

Loading Bottles

CAUTION: In order to preserve test data integrity, handle only
one bottle at a time. Completely load a bottle according to this
procedure before proceeding to the next bottle.

RIGHT
ARROW

HOME Moves cursor to the start of the text field

END Moves cursor to one position past end of text

DELETE Deletes the character at the current cursor position

BACKSPACE Deletes the character at the current cursor position

Moves cursor right one position

and moves the cursor left one position

Loading Bottles

1) From the Main screen (see Figure 3-1, Main Screen, on page 3-3), press

the Load Bottles button ( ).

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Basic Functions (Clinical Use) Loading Bottles

The Load Mode screen appears.

1

2

3

4

5

Figure 3-7: Main Screen — Load Mode

1 — Load Bottles Icon
2 — Change Maximum Test

Time Button

3 — Bottle Type Scroll Button

6

5 — Patient First Name Field*
6 — Accession Number Field
7 — Patient Last Name Field*
8 — Hospital ID Field*

7

8

4 — Bottle ID Field

*Available with Select and SelectLink only.

The number of available cells appears at the bottom of each drawer on
the Instrument icon.

Green indicators on Incubation or Combination Module drawers
illuminate drawers that contain available cells.

CAUTION: Inspect each bottle and sensor before loading:

If the sensor is yellow, treat the bottle as a positive culture. If the
bottle is cracked, do not load the bottle.

2) Verify the Bottle ID field appears white, then scan or manually enter the
bottle ID (see Text/Data Entry on page 3-9).

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If the field is left blank when a bottle is loaded, then the bottle is
considered anonymously loaded (see Handling Anonymous Bottles on

page 3-16).

3) Verify the correct bottle type is displayed on the Bottle Type scroll

button.

If the Bottle ID field contains data from a generic label, the bottle type
can be manually entered using the Bottle Type scroll button before
inserting the bottle to ensure proper testing of the bottle. The instrument
will also beep continuously to alert the operator that the bottle type needs
to be manually entered. The audible alert can be disabled by calling
bioMérieux for assistance. See Figure 3-7, Main Screen — Load Mode,

on page 3-12.

CAUTION: For best results, manually enter the bottle type when
“GENERIC” is the displayed bottle type. Otherwise, observe the
following:

When a bottle is loaded with a generic or anonymous bottle type,
care must be taken to load BacT/ALERT

®

MP bottles into
drawers labeled MB. The maximum test time assigned to a
generic bottle loaded into an MB drawer is the same time
assigned to the BacT/ALERT

®

MP media type in the Set
Maximum Test Time screen (see Setting the Maximum Test

Time in Chapter 7).

All non-MB bottles must be loaded into drawers labeled BC and
the maximum test time is set to the time specified for the
Unknown bottle type.

BacT/ALERT
media type or loaded anonymously. BacT/ALERT

®

MB Bottles should never be loaded with a Generic

®

MB must be
displayed on the Bottle Type scroll button before loading a
BacT/ALERT® MB bottle.

4) If the Accession Number field is enabled and blank, then continue to

Step 5. If the Accession Number field is disabled, then go to Step 7.

5) Verify the Accession Number field appears white, then scan or

manually enter the accession number.

6) If the fields are displayed and enabled, then manually enter the following

in the order listed: Hospital ID, Patient First Name, and Patient Last
Name.

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Basic Functions (Clinical Use) Loading Bottles

• To change the order of the Patient First Name and Patient Last

Name fields, contact your local bioMérieux Representative.

• Entries to the Patient First Name and Patient Last Name fields

cannot be made without the Hospital ID entry.

Note: The Hospital ID field is a keyboard-entry only field.

7) The default maximum test time is displayed above the Change Maximum

Test Time button. The scanned bottle's maximum test time can be
adjusted if desired. See Changing the Maximum Test Time — Individual

Bottles on page 3-15.

8) If all drawers are closed, slowly open a drawer with an illuminated
indicator. Available cells will have an illuminated cell indicator light.

9) Insert the bottle, sensor first, into a cell with an illuminated cell indicator
light.

WARNING

An erroneous test result (ex. false negative or false positive)
could occur if a bottle is not fully seated into a cell. When
inserting a bottle, ensure the bottle is fully seated into the cell.
See Appendix C, Best Practices for additional information on
preventing false positives.

10) The cell indicator light blinks slowly to acknowledge the bottle is loaded.

11) Verify that all text fields clear before proceeding.

12) Repeat Step 2 through Step 11 for each remaining bottle. Limit the bottle

load time to two minutes in one area to control entry of room temperature
bottles into racks. Close the drawer to allow temperature to equilibrate
before loading in that area again. Load bottles into different drawers (ex.,
If you have four incubators, use the drawers in all four incubators). See

Appendix C, Best Practices for loading bottles.

CAUTION: If a large number of bottles are loaded into the
Incubation Module at the same time and in the same areas, a
large heat mass loss within the racks may occur. This heat loss
may trigger the acceleration or rate algorithms to erroneously
flag positive.

13) When all bottles are loaded, ensure that all drawers are completely
closed, then press the Check button.

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If no operator or bottle loading activity has been recorded in a period of
two minutes, the instrument will terminate the Load Bottle operation.
Operator activity includes:

• pressing keys on the keyboard

• scanning barcodes

• touching the Operator Panel

• loading or unloading bottles

14) If applicable, enter the patient and accession data associated with the

loaded bottles into the bioMérieux data management computer.

Changing the Maximum Test Time — Individual Bottles

1) From the Load screen, press the Change Maximum Test Time button

( ) after scanning the bottle barcode.

The Change Maximum Test Time screen overlays and disables the Load
screen.

1

Figure 3-8: Change Maximum Test Time Screen

2

1 — Bottle ID Field
2 — Max Test Time Scroll Buttons

2) Verify the bottle ID matches that of the bottle for which you wish to

change the maximum test time.

3) Adjust the maximum test time in days using the Max Test Time scroll

buttons.

4) Press the Check button to accept the changes, or the Cancel button to

retain the original setting.

The system returns to the Load Mode screen.

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Basic Functions (Clinical Use) Unloading Bottles

Note: Changing the maximum test time of an individual bottle during loading does

not affect any other bottles of the same type.

Note: The maximum test time of an individual bottle can also be changed from the

Edit Bottle Detail screen after loading (see Viewing/Editing Bottle Data in

Chapter 5).

Handling Anonymous Bottles

Bottles loaded into the Incubation Module without accessing the Load Bottles
function on the Main screen are referred to as Anonymous bottles because
they are not associated with a bottle ID.

CAUTION: BacT/ALERT® MB (Mycobacteria Blood) Bottles
should never be loaded anonymously. Appropriate testing of
anonymous bottles occurs only when BacT/ALERT
are loaded into drawers labeled MB and non-MB bottles are
loaded into drawers labeled BC.

®

MP bottles

The maximum test time of anonymous bottles loaded into MB
drawers is the same time specified for the BacT/ALERT
media type on the Set Maximum Test Time screen.

Anonymous bottles loaded into BC drawers are assigned the
standard default algorithm.

Anonymous bottles should be removed and identified as specified in

Unloading Bottles on page 3-16, or identified using the Edit Bottle Detail

screen (see Editing Bottle Details Using the Edit Bottle Detail Screen in

Chapter 5).

Unloading Bottles

The BacT/ALERT® 3D signals which type of bottles are ready for unloading
by enabling the appropriate Unload button.

CAUTION: In order to preserve test data integrity, handle only
one bottle at a time. It is important to complete the procedure for
each bottle before proceeding to the next bottle.

®

MP

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Unloading Bottles

1) Generate an Unload report (see Viewing, Printing, and Exporting Test

Data on page 3-24).

2) From the Main screen (see Figure 3-1, Main Screen, on page 3-3), press

the appropriate Unload button.

• The Unload Mode screen appears (see Figure 3-9).

• Green indicators illuminate on drawers containing bottles of the
selected unload type.

1

2

3

4

5

Figure 3-9: Main Screen — Unload Mode

1 — Unload Bottles Icon
2 — Unload Buttons
3 — Bottle Type Scroll Button
4 — Bottle ID Field

6

7

8

5 — Patient First Name Field
6 — Accession Number Field
7 — Patient Last Name Field
8 — Hospital ID Field

3) Open the indicated drawer. When the indicated drawer is open, cell
indicator lights light up next to all bottles in the selected category.

4) Remove one of the bottles indicated. Wait for the cell light to blink slowly
to acknowledge the removal of the bottle.

5) If the bottle was identified when loaded:

• The bottle ID and bottle type will appear on the Unload Mode screen;

however, the accession number, hospital ID, patient first name, and

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Basic Functions (Clinical Use) Unloading Bottles

patient last name will appear in disabled text fields, if information is
available.

a. It is not necessary to re-scan the bottle ID; however, doing so will

verify that bottle's identity.

b. If fields are blank or need editing, then use the Edit Data

Relationships function (see Editing Data Relationships in Chapter 5).

6) Go to Step 8.

7) If the bottle was anonymously loaded (the Bottle ID field is blank), scan

or manually enter the bottle ID.

a. Identify the bottle by entering the bottle ID, bottle type, accession

number, hospital ID, and patient first and last name as performed in
the procedure, Loading Bottles on page 3-11.

• Scanning the bottle ID successfully results in two short beeps.

• Scanning the accession number successfully results in three short

beeps.

• When identifying anonymous bottles, information entered in the Bottle

ID, Bottle Type, Accession Number, Hospital ID, Patient First
Name, and Patient Last Name fields, and with the Bottle Type scroll

button, is associated with the unloaded bottle once the next bottle is
unloaded or the Check button is pressed.

b. If the bottle is to be reloaded, immediately return the bottle to the cell

with the slowly blinking cell indicator light before unloading another
bottle.

WARNING

Bottles with a critical determination in progress will be
temporarily removed from the bottle count table on the Main
screen.

c. Do not reload the bottle if its status is negative, positive, or if it is

necessary to use the bottle label to enter information into the
bioMérieux data management computer.

CAUTION: Reloading bottles anonymously that were previously
loaded will result in duplicate bottle records.

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8) Repeat Step 3 through Step 5 for the remaining bottles to be unloaded.
Limit the bottle unload time to no more than two minutes in one area.
Close the drawer to allow temperature to equilibrate before unloading
from the area again. See Appendix C, Best Practices for unloading
bottles and preventing false positives.

CAUTION: If a large number of bottles are unloaded from the
Incubation Module at the same time and in the same areas, a
large heat mass loss within the racks may occur. This heat loss
may trigger the acceleration or rate algorithms to erroneously
flag positive.

9) When finished unloading bottles, ensure that all drawers are completely
closed.

10) Press the Check button on the Unload Mode screen.

11) Verify that the bottles listed on the Unload report were unloaded.

12) Where applicable, enter patient and accession data associated with the

unloaded bottles into the bioMérieux data management computer.

13) Reload any previously Anonymous negative-to-date bottles.

If no operator or bottle loading activity has been recorded in a period of
two minutes, the instrument will terminate the Unload Bottle operation.
Operator activity includes:

• pressing keys on the keyboard

• scanning barcodes

• touching the Operator Panel

• loading or unloading bottles

Handling Unconfirmed Positive Bottles (False Positives)

If a smear of a positive bottle reveals no microorganisms, the bottle should be
subcultured and reloaded into the instrument via the Load Bottles function
(see Loading Bottles on page 3-11).

Note: If a bottle is reloaded into the instrument, its status will revert to negative-to-

date once a reading has been taken (maximum time – 10 minutes).

If growth appears on the subculture, edit the bottle's status to Positive on the
Edit Test Result screen which is accessed from the Edit Bottle Detail screen
(see Edit Test Result Button in Chapter 5), and unload the now positive
bottle.

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Basic Functions (Clinical Use) Accessing the Setup Screen Function Buttons

Note: Results that have been manually changed to negative or positive via the Edit

Bottle Detail screen (see Editing Bottle Details Using the Edit Bottle Detail

Screen in Chapter 5), will be marked on the report with a stick figure ( ).

Note: If a bottle is positive (set manually, or positive by any other reason) and then

is manually changed to negative-to-date, the stick figure ( ) will not appear.

Accessing the Setup Screen Function Buttons

To view and print data, print graphs, and perform all of the editing,
configuration, and maintenance functions of the system, you must first
access the Setup screen function buttons.

Accessing the Setup Screen

1) From the Main screen (see Figure 3-1, Main Screen, on page 3-3), press

the Next Screen button ( ).

The Setup screen appears.

1

2

Figure 3-10: Setup Screen

1 — Password Entry Keypad
2 — Function Buttons
3 — Key Symbol Button
4 — Padlock Icon

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Accessing the Setup Screen Function Buttons Basic Functions (Clinical Use)

2) Enter a valid password using the 1 – 4 buttons. Until a valid password is
entered and accepted, the Padlock icon will appear in the closed
position.

Note: Acceptable passwords consist of any combination of the numbers 1 to 4 and

have a maximum length of eight characters.

Note: Instruments are shipped with a password of 1234. For information on

changing the default password, see Changing the System Password in

Chapter 7.

3) Press the Key Symbol button to accept the password.

4) After a valid password is accepted, the Padlock icon changes to the full

open position and the function buttons become enabled.

Note: To correct an error made while entering a password, press the Key Symbol

button and re-enter the password.

Note: If more than 8 characters are entered, the Password Entry buttons will

become inactive and turn gray. Press the Key Symbol button and re-enter
the password.

Inactivity Timeout for all Setup Screens

While you are in the Setup screen (see Figure 3-10, Setup Screen) or one of
its sub-menus, an inactivity timeout will occur (within a period of time
configured by your bioMérieux Service Representative) if you do not perform
one of the following actions:

• press a screen or keyboard button

• scan a barcode

• load or unload a bottle

If an inactivity timeout occurs, the instrument display reverts from the
currently displayed screen to the Main screen. Any pending function is
cancelled as if the Cancel button on each successive screen was pressed.

Note: If a timeout occurs, it is possible that partially entered information will be lost.

Note: The inactivity timeout feature is disabled while a red operator error is

displayed on the screen.

Setup Screen Function Buttons

Set Date/Time button (see Setting and Formatting the System Date and Time in Chapter 8)

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Basic Functions (Clinical Use) Accessing the Setup Screen Function Buttons

Enable/Disable Module, Drawer, Rack, or Cell button (see Enabling and Disabling

Modules, Drawers, Racks, and Cells in Chapter 8)

Calibrate Module Temperature button (see Adjusting an Incubation or Combination

Module’s Temperature in Chapter 8)

Set Maximum Test Time button (see Setting the Maximum Test Time in Chapter 7)

Set Audible Alarm Options button (see Setting the Audible Alarms in Chapter 7)

Change Password button (see Changing the System Password in Chapter 7)

Select Bottle to Edit/Graph button (see Selecting Bottles Using the Select Bottle to Edit/

Graph Button in Chapter 5)

Edit Cell Contents button (see Selecting Bottles Using the Edit Cell Contents Button in

Chapter 5)

Calibrate Cell button (see Calibrating an Instrument Cell in Chapter 8)

View Incubation Module Information button (see Viewing Incubation Module

Information in Chapter 8)

Backup Management button (see Initiating Manual Backup in Chapter 7)

Edit Data Relationships button (see Initiating the Edit Data Relationships Function in

Chapter 5)

Report button — Select and SelectLink only (see Viewing, Printing, and Exporting Test

Data on page 3-24)

Configure Users button — Button only appears in 21 CFR Part 11 mode (see Configuring

Users — 21 CFR Part 11 Mode in Chapter 10)

Bottle Processing/Customization button (For use only with instruction from bioMérieux)

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Viewing and Printing

Introduction

Viewing Bottle Data

The following bottle information can be viewed by accessing the Edit Bottle
Detail screen as described in Editing Test Data (see Viewing/Editing Bottle

Data in Chapter 5):

• Bottle ID

• Accession number

• Hospital ID (where applicable)

• Patient first and last name (where applicable)

•Cell ID

• Maximum test time

• Bottle type

• Date/time loaded

• Date/time unloaded

• Date/time of last bottle reading

•Test time

•Test result

• Algorithm type

• How determined/positivity index

Viewing/Printing Reports

With a BacT/ALERT® 3D Signature configuration, reports are viewed and
printed at the data management computer.

With the BacT/ALERT® 3D Select or SelectLink configurations, reports are
viewed and printed by using the Report button as described in the topic,

Viewing, Printing, and Exporting Test Data on page 3-24.

Viewing/Printing Graphs

Bottle Graphs can be viewed and printed on the BacT/ALERT® 3D Select
and SelectLink configurations as described in the topic, Viewing and Printing

Bottle Graphs on page 3-31. For the Signature configuration, graphics can be

viewed as described in the topic, Viewing and Printing Bottle Graphs on page

3-31, or at the data management computer. Since the BacT/ALERT

Signature configuration is not connected to a printer, you must use the data
management computer to print a graph.

Note: The print feature can be made unavailable regardless of software

configuration. When the feature is unavailable, the Print buttons do not

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®

3D

Basic Functions (Clinical Use) Viewing and Printing

display. To make the print feature unavailable, contact your local bioMérieux
Representative.

Using the Print Screen Function

You can print the current screen on the instrument by pressing Ctrl + P on
the keyboard.

Note: Select and SelectLink configurations only.

Viewing, Printing, and Exporting Test Data

Note: If you have a BacT/ALERT® 3D Signature configuration, you must use the

data management computer to view and print reports.

1) From the Setup screen (see Figure 3-10, Setup Screen, on page 3-20),

press the Report button ( ).

Note: The Report button is not available with the BacT/ALERT

configuration.

The Report Selection screen appears.

1

2

3

4

Figure 3-11: Report Selection Screen

1 — Display Report 1 Button
2 — Display Report 2 Button

4 — Previous Screen Button
5 — Check Button

3 — Display Report 3 Button

®

3D Signature

5

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2) Press the Display Report 1, 2, or 3 button that is configured for the
information desired.

The Report screen will display. There are three default report
configurations:

• Display Report 1 button — Generates the Load Report screen with

1st Load Time as the primary sort, and Accession Number as the
secondary sort. Report has section breaks based on 1st Load Time.

• Display Report 2 button — Generates the Status Report screen with

Accession Number as the primary sort, and Bottle Type as the
secondary sort. Report has section breaks based on Accession
Number.

• Display Report 3 button — Generates the Unload Report screen with

Loaded as the primary sort, and Test Result as the secondary sort.
Report has section breaks based on Loaded and Test Result.

See Configuring Report Contents in Chapter 7 for examples of the Load,
Status, and Unload Report Configuration screens.

Note: Data from the last 1,920 bottles are displayed each time a Report screen is

accessed. The report screens come configured with default settings, but the
report configurations can be changed to display different data and to sort the
data differently (see Configuring Report Contents in Chapter 7).

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21

20

19

1
2

3

4

5

6

7

8

9

10

Figure 3-12: Sample Report Screen

1 — Section Scroll Up Button
2 — Relative Record Scroll

Indicator
3 — Relative Record Scroll Bar
4 — Find Text Button
5 — Save Button
6 — Print Current Section

Button
7 — Print Report Button
8 — Cancel Print Button
9 — Previous Screen Button
10 — Section Scroll Down

Button

18

17

16

15

14

11 12 13

11 — Line Scroll Down Button
12 — Page Scroll Down Button
13 — End Scroll Button
14 — Gap Detection Indicator
15 — Report Data Lines
16 — Stick Figure
17 — Current Section Line
18 — Home Scroll Button
19 — Page Scroll Up Button
20 — Report Title
21 — Line Scroll Up Button

Note: Results that have been manually changed to negative or positive (see Editing

Bottle Details Using the Edit Bottle Detail Screen in Chapter 5) will be marked

on the report with a stick figure ( ).

Note: If a bottle is positive (set manually, or positive by any other reason) and then

is manually changed to negative-to-date, the stick figure ( ) will not appear.

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Note: Bottles with an Instrument Fault Code 80 will be marked on the report with a

Gap Detection indicator (!) next to the result. If a negative bottle has an

Instrument Fault Code 80 while it is being unloaded, the Gap Detection
indicator will remain on the report (see Instrument Fault Codes in Chapter 9).

Note: The Current Group Line will always display the group that is associated with

the first displayed data record. It is always highlighted for easy reference. If
there are no section breaks in the displayed report, this line will become the
first line of data records displayed and reference highlighting will not occur.

3) To scroll up or down a group, press the appropriate Group scroll button.

Note: The Group scroll buttons are disabled if there are no section breaks in the

displayed report or if there are no available sections in the indicated direction.

4) To scroll up or down a data line, press the appropriate Line scroll button

or press the appropriate ↑ or ↓ key on the keyboard.

Note: The Line scroll buttons are disabled if there are no data lines in the indicated

direction.

5) To scroll up or down a data page, press the appropriate Page scroll

button or press the appropriate Page Up or Page Down key on the
keyboard.

Note: The Page scroll buttons are disabled if there are no data lines in the indicated

direction.

6) To scroll up to the oldest data line (the first data record in the report),

press the Home scroll button or press the Home key on the keyboard.

Note: The Home scroll button is disabled if there are no report data lines in the

indicated direction.

7) To scroll down to the newest data line (the last data record in the report),

press the End scroll button or press the End key on the keyboard.

Note: The End scroll button is disabled if there are no report data lines in the

indicated direction.

8) To move to a relative record position, press the Relative Record scroll

bar above/below the Relative Record Indicator.

Note: The Relative Record Indicator is sized proportionally to the amount of records

in the report.

Note: The Relative Record scroll bar is disabled if the Relative Record Indicator is

the same size as the scroll bar and all the data records in the report are
displayed.

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9) To print the report, press the appropriate Print button:

• Pressing the Print Report button prints all records in the database
(with a maximum of 1,920 records).

• Pressing the Print Current Group button prints the Current Group
Line and all data records associated with the group.

Note: The Print buttons are only available if a printer is configured for the system.

To configure a printer for the system, contact your local bioMérieux
Representative.

10) While the report is printing:

• All Print and Save buttons are disabled.

• The operator may, however, view and scroll through the displayed
report, search for text in the displayed report, or exit the Report screen
and perform other operations.

•The Cancel Print button becomes available.

11) Press the Cancel Print button to stop sending data to the printer and to
empty the queue of any data waiting to be sent to the printer.

Note: Once the cancellation has been completed, the Print and Save buttons will

become enabled, and the Cancel Print button will be disabled.

12) To specify a text string and initiate a search of the report data for the

specified text, press the Find Text button. The Find Text screen will
appear.

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1

Figure 3-13: Find Text Screen

1 — Find Text Field

Use the keyboard to enter the text you wish to seek, and press the
Check button to return to the Report screen. Pressing the Cancel button
will cancel the search request and return to the Report screen.

Note: The search will be performed upon returning to the report screen starting

from the top of the report. The record that contains the first occurrence of the
text will be scrolled to the first line of data displayed and the text itself will be
highlighted for reference.

If no occurrence of the specified text is found, the data displayed will not
change and no reference highlighting will occur.

13) To find the next instance of the specified text, press the F3 key on the

keyboard.

Note: If no new instance of the text is found the data displayed, and the highlighted

text will remain the same.

14) To save the displayed report to a text file, press the Save button.

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The Save To File screen appears.

1

Figure 3-14: Save to File Screen

1 — File Name Field

Note: The default file name and path will appear automatically in the File Name

field. Use the keyboard to change the name of the file.

Note: All reports are saved to the pathname, D:\REPORTS, either using the default

file name or a specified file name. All reports are automatically given an
extension of .TXT.

15) Place the backup media in the backup drive.

Note: Backup media can either be a Zip

®

disk or a USB flash drive.

16) Press the Check button to initiate the save and return to the Report

screen. Pressing the Cancel button will cancel the save request and
return to the Report screen.

Note: The Print buttons will be disabled while the save is taking place. Once the

save has completed, the Print buttons will be enabled.

WARNING

Do not insert any object, other than a Zip® disk, into the Zip®
drive under any circumstances.

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CAUTION: Do not forcibly remove the Zip® disk from the
instrument. Forcibly removing the Zip
to the Zip

®

disk or Zip® drive and may cause the system to lock

up.

17) Press the Previous Screen button to return to the screen from which the

Report screen was accessed.

Viewing and Printing Bottle Graphs

Note: If you have a BacT/ALERT® 3D Signature configuration, you must use the

data management computer to print a bottle graph since the
BacT/ALERT

1) Access the Setup screen and enter a valid password (see Accessing the

Setup Screen Function Buttons on page 3-20).

2) Press the Select Bottle to Edit/Graph button ( ).

®

3D Signature configuration is not connected to a printer.

®

disk may cause damage

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The Select Bottle to Edit/Graph screen overlays and disables the Setup
screen.

9

1

8

2

7

3

4

Figure 3-15: Select Bottle to Edit/Graph Screen

5

1 — Incubation Module Scroll

Button
2 — Cell Scroll Buttons
3 — Setup Screen (Disabled)
4 — Previous Screen Button

6

6 — Check Button
7 — Graph Bottle Readings

Button
8 — Drawer Scroll Button
9 — Bottle ID Field

5 — Cancel Button

3) If you know the bottle ID of the bottle whose readings you wish to graph,
then enter the bottle ID in the Bottle ID field (see Text/Data Entry on

page 3-9) and go to Step 5. If you know the cell location but not bottle ID,

then continue to Step 4.

Note: Only the last 1,920 bottles loaded can be retrieved. Any other entry in the

Bottle ID field is invalid and will cause an Operator Error 940 (see Operator

Error Codes in Chapter 9).

4) Adjust the Incubation Module (1–6), Drawer (A–D), and Cell (1–60)

scroll buttons to select the cell location of the bottle whose readings you
wish to graph. The cell location defaults to Module 1, Drawer A, Cell 1
(1A01).

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