Biomerieux Bact-Alert 3D-60 User Manual

User Manual

[03]

95269

(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, 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 a registered trademarks of PSC, Inc.

Zip is a registered trademark of Iomega Corporation.

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.

© 2010 bioMérieux, Inc. All rights reserved.

Warranty

Seller, bioMérieux, Inc., warrants the BacT/ALERT® 3D 60 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 (1) 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 Seller; 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 consequential
damages, 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 ............................................................................................................ix

List of Tables ............................................................................................................xiii

H

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

About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

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

Purpose of the BacT/ALERT

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

Purpose of This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

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

Chapter Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

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

Typographic and Usage Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Name and Titles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Click . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

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

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

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

Select. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

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

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

®

3D 60 System. . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

S

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

About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Principle of Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

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

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

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

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

®

BacT/ALERT

BacT/ALERT® 3D 60 User Manual i
95269

3D 60 Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Table of Contents

Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9

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

Mouse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9

Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9

UPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9

Backup Drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9

UPS Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10

UPS Serial Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10

Monitor Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10

Mouse Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11

Keyboard Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11

Printer Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11

External Speaker Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11

Power Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11

Power Entry Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11

Modem Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11

LIS Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11

Comm Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11

Instrument Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Electrical Power Services Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11

Power Consumed in Watts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

Heat Dissipated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

Sound Emission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

Instrument Dimensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

Instrument Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . 2-12

Operating Temperature Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

Storage Temperature Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

Operating Humidity Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

Storage Humidity Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

Maximum Operating and Storage Altitude . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

Pollution Degree 2 in accordance with IEC 664 . . . . . . . . . . . . . . . . . . . . . . . .2-12

Overvoltage Category II per IEC 664 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

Instrument Installation and Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13

BacT/ALERT

®

3D 60 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13

Monitor Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13

Common Screen Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Icon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

Common System Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

Scroll Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15

Slidebar Switch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15

Anchor Display/Scroll Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15

Text Entry Field. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-16

SYSTEM INSTALLATION ................................................................................................ 3-1

About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

ii BacT/ALERT® 3D 60 User Manual

95269

Table of Contents

Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Verifying Site Requirements Are Met. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Verifying Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Setting the AC Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Choosing Instrument Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Making Instrument Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Powering Up the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Configuring the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Setting the Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Checking for Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Functional Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Modem Functional Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Barcode Reader Functional Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

®

UPS Functional Test (BacT/ALERT

3D 60 Only, APC UPS 650) . . . . . 3-12

Installing the Optional Restraint . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

B

ASIC FUNCTIONS....................................................................................................... 4-1

About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

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

Monitoring the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Main Screen Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

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

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

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

Viewing Faults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

Viewing the Cell Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

Understanding the View Cell Status Screen Display . . . . . . . . . . . . . . . . . . . . .4-6

Text/Data Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8

Common Text Fields and Field Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8

Using the Barcode Scanner to Enter Data. . . . . . . . . . . . . . . . . . . . . . . . . 4-8

Manually Entering Text into a Data Entry Field (Keyboard). . . . . . . . . . . . 4-9

Loading Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

Loading Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

Changing the Maximum Test Time (Individual Bottles) . . . . . . . . . . . . . . 4-13

Handling Anonymous Bottles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14

Unloading Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14

Unloading Bottles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15

Handling Unconfirmed Positive Bottles (False Positives) . . . . . . . . . . . . 4-17

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EDITING TEST DATA .................................................................................................... 5-1

Accessing the Setup Screen Function Buttons . . . . . . . . . . . . . . . . . . . . . . . . 4-18

Accessing the Setup Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18

Inactivity Timeout for all Setup Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-19

Setup Screen Function Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

Viewing and Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21

Viewing Bottle Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21

Viewing/Printing Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21

Viewing/Printing Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21

Using the Print Screen Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21

Viewing and Printing Test Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22

Viewing and Printing Bottle Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29

Display Bottle Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31

Sending/Requesting LIS Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36

Sending Results to the LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36

Requesting Information from the LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36

About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6

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

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

View Cell Location Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-7

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8

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

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

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

View How Determined/Positivity Index Icon . . . . . . . . . . . . . . . . . . . . . . . . . . .5-10

Editing Data Relationships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-11

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

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

Editing Bottle ID to Accession Number Relationships . . . . . . . . . . . . . . . 5-13

Attaching Bottle IDs Without an Accession Number to an Accession Number 5-14

Moving a Bottle ID Association from one Accession Number to Another . . . . .5-14

Editing Accession Number to Hospital ID Relationships . . . . . . . . . . . . . 5-15

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

Moving an Accession Number Association from one Hospital ID to Another . .5-16

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

S

OFTWARE CONFIGURATION........................................................................................ 6-1

About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Setting the Maximum Test Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Setting the Audible Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Priority of Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

Terminating an Instrument Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

Changing the System Password. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

Initiating Manual Backup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Configuring Report Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

Entering Report Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

Configuring Report Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13

Load Report Configuration Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-16

Status Report Configuration Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-17

Unload Report Configuration Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-18

Viewing and Printing Calibration Data . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19

Viewing and Printing Calibration History . . . . . . . . . . . . . . . . . . . . . . . . . 6-22

SYSTEM MAINTENANCE ............................................................................................... 7-1

About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Hardware Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Preventative Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Safety Precautions and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Spill Cleanup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3

Disinfection Procedure for Spills Onto the Instrument . . . . . . . . . . . . . . . . . . . .7-3

Disinfection Procedure for Spills Within the Instrument . . . . . . . . . . . . . . . . . . . 7-4

Using the Keyboard in Place of the Mouse . . . . . . . . . . . . . . . . . . . . . . . . 7-6

UPS On/Off Button Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7

Instrument Reboot/Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7

Shutdown Method 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

Shutdown Method 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

Shutdown Method 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

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S

Shutdown Method 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-9

Instrument Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

Software Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

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

Restarting the Incubation Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10

Setting and Formatting the System Date and Time . . . . . . . . . . . . . . . . . 7-11

Enabling and Disabling Racks and Cells . . . . . . . . . . . . . . . . . . . . . . . . . 7-13

Relocating Bottles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-14

Adjusting an Instrument’s Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15

Checking an Instrument's Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15

Setting the Optimal Temperature for an Instrument . . . . . . . . . . . . . . . . . . . . .7-17

Calibrating an Instrument's Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-17

Calibrating an Instrument Cell. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18

Locating a Cell Which Failed Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-18

Viewing a Cell's Readings and/or Calibrating a Cell. . . . . . . . . . . . . . . . . . . . .7-19

Viewing Incubation Chamber Information . . . . . . . . . . . . . . . . . . . . . . . . . 7-22

YSTEM TROUBLESHOOTING .......................................................................................8-1

About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Fault Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3

Instrument Fault Codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

Instrument Status Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16

Operator Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18

Bottle Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-29

User Output Device Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-29

21 CFR P

ART 11 MODE..............................................................................................9-1

About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1

Log In/Out of System — 21 CFR Part 11 Mode. . . . . . . . . . . . . . . . . . . . . . . . . 9-2

Logging In for the First Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

Logging In . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

Inactivity Timeout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7

Login Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7

Change Password. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8

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

Logging Out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12

Configuring Users — 21 CFR Part 11 Mode . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12

Adding a User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13

Deleting a User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-15

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Deleting More Than One User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-16

Clearing a User Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16

Clearing More Than One User Password. . . . . . . . . . . . . . . . . . . . . . . . .9-17

Audit Trail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-18

Accessing the Audit Trail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-20

M

YCOBACTERIAL TESTING......................................................................................... 10-1

About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2

BacT/ALERT

Circulation Fan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-3

Installation Procedures and Special Requirements . . . . . . . . . . . . . . . . . . . . .10-3

®

3D 60 Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3

BacT/ALERT® 3D 60 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4

Barcodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-4

Set Maximum Test Time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4

Positive Detection Algorithm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4

Bottle Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-4

System Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5

General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5

MB Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5

Limitations of the Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5

Service and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-6

Theory of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6

Principle of Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-6

Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7

General Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-8

Spill Cleanup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-8

Disinfection Procedure for Spills Within/Onto the Instrument. . . . . . . . . . . . . .10-8

UNPACKING INSTRUCTIONS..........................................................................................A-1

BacT/ALERT® 3D 60 Unpacking Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . A-1

P

ART CHECKLIST ........................................................................................................B-1

BacT/ALERT

®

3D 60 Part Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

Optional Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

Recommended Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

INSTALLATION CHECKLIST ...........................................................................................C-1

BacT/ALERT® 3D 60 Installation Checklist. . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

BacT/ALERT® 3D 60 User Manual vii
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Table of Contents

INTERNATIONAL CHARACTER ENTRY ............................................................................D-1

B

About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-1

Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-1

International Character Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-2

Entering International Characters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-3

OTTLE QUALITY CONTROL.........................................................................................E-1

About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-1

Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-1

BacT/ALERT

®

Culture Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-2

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

Flip Cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3

Stopper/Seal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3

Bottle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3

Volume Designations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3

Barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3

Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3

Limitations of the Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4

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

Blood Culture Bottles (SA, SN, FA, FN, and PF) . . . . . . . . . . . . . . . . . . . . . . . E-4

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

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 ........................................................................................2-8

Figure 2-3: Instrument Rear View ......................................................................................2-10

Figure 2-4: Button Examples ..............................................................................................2-14

Figure 2-5: Scroll Button .....................................................................................................2-15

Figure 2-6: Slidebar Switch ................................................................................................2-15

Figure 2-7: Anchor Display/Scroll Buttons ..........................................................................2-16

Figure 3-1: Power Entry Module with Fuse Holder Removed ..............................................3-3

Figure 3-2: PEM with 115 VAC Version ...............................................................................3-4

Figure 3-3: PEM with 230 VAC Version ...............................................................................3-5

Figure 3-4: Additional Fuse Holder Views ............................................................................3-6

Figure 3-5: Installation and Setup Diagram — Port and Power Connections .......................3-9

Figure 3-6: Modem Configuration and Dip Switch Settings ................................................3-11

Figure 3-7: Countertop/Surface Mounting Diagram ...........................................................3-13

Figure 3-8: Mounting Surface Diagram ..............................................................................3-13

Figure 3-9: Mounting Surface (Drilling) Template ...............................................................3-14

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

Figure 4-2: Instrument Icons ................................................................................................4-4

Figure 4-3: Bottle Count Table/Unload Buttons ....................................................................4-5

Figure 4-4: View Cell Status Screen ....................................................................................4-6

Figure 4-5: Disabled Cell ......................................................................................................4-7

Figure 4-6: Main Screen — Load Mode .............................................................................4-10

Figure 4-7: Change Maximum Test Time Screen ...............................................................4-13

Figure 4-8: Main Screen — Unload Mode ..........................................................................4-15

Figure 4-9: Setup Screen ...................................................................................................4-18

Figure 4-10: Report Selection Screen ..................................................................................4-22

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

Figure 4-12: Find Text Screen ..............................................................................................4-27

Figure 4-13: Save to File Screen ..........................................................................................4-28

Figure 4-14: Select Bottle to Edit/Graph Screen ..................................................................4-29

Figure 4-15: Graph Bottle Readings Screen ........................................................................4-30

BacT/ALERT® 3D 60 User Manual ix
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Figure 4-16: Bottle Readings Screen .................................................................................. 4-32

Figure 4-17: Find Text Screen ............................................................................................. 4-34

Figure 4-18: Save to File Screen ......................................................................................... 4-35

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

Figure 5-6: Edit Bottle ID to Accession Number Relationships Screen ............................. 5-13

Figure 5-7: Edit Accession Number to Hospital ID Relationships Screen ......................... 5-15

Figure 5-8: Edit Hospital ID to Patient Name Relationships Screen .................................. 5-17

Figure 6-1: Set Maximum Test Time Screen ....................................................................... 6-2

Figure 6-2: Set Audible Alarm Options Screen .................................................................... 6-4

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

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

Figure 6-5: Padlock Icon (Half Open Position) .................................................................... 6-7

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

Figure 6-7: Backup Management Screen ............................................................................ 6-8

Figure 6-8: Backup in Progress Icon ................................................................................... 6-8

Figure 6-9: Report Selection Screen ................................................................................. 6-10

Figure 6-10: Report Label Entry Screen .............................................................................. 6-11

Figure 6-11: Report Selection Screen ................................................................................. 6-14

Figure 6-12: Load Report Configuration Screen .................................................................. 6-16

Figure 6-13: Status Report Configuration Screen ............................................................... 6-17

Figure 6-14: Unload Report Configuration Screen .............................................................. 6-18

Figure 6-15: Report Selection Screen ................................................................................. 6-19

Figure 6-16: Cell Calibration Report Screen ........................................................................ 6-20

Figure 6-17: View Window ................................................................................................... 6-21

Figure 6-18: Report Selection Screen ................................................................................. 6-22

Figure 6-19: Calibration History Screen .............................................................................. 6-23

Figure 7-1: View Cell Status Screen .................................................................................. 7-11

Figure 7-2: Set Date/Time Screen ..................................................................................... 7-12

Figure 7-3: Enable/Disable Rack or Cell Screen ............................................................... 7-13

Figure 7-4: Reference Thermometer ................................................................................. 7-15

x BacT/ALERT® 3D 60 User Manual

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Figure 7-5: Calibrate Instrument Temperature Screen .......................................................7-16

Figure 7-6: Calibrate Cell Screen .......................................................................................7-19

Figure 7-7: View Incubation Chamber Information Screen ................................................7-23

Figure 8-1: Instrument Icon with Fault Codes ......................................................................8-3

Figure 8-2: Instrument Status Code 710 ............................................................................8-16

Figure 8-3: Operator Error Code 911 .................................................................................8-18

Figure 8-4: QuickScan

®

6000 Reset Barcode ....................................................................8-30

Figure 8-5: Honeywell Reset Barcode ................................................................................8-30

Figure 8-6: Informational Warning Screen .........................................................................8-31

Figure 9-1: Main Screen While Logged Out —21 CFR Part 11 Mode ..................................9-2

Figure 9-2: User Login Screen .............................................................................................9-3

Figure 9-3: User Login Screen with Change Password Fields .............................................9-4

Figure 9-4: Main Screen While Logged In — 21 CFR Part 11 Mode ...................................9-5

Figure 9-5: User Login Screen .............................................................................................9-6

Figure 9-6: User Login Screen with Wrong Password Alert .................................................9-8

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

Figure 9-8: User Login Screen with Change Password Error .............................................9-10

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

Figure 9-10: User Configuration Screen ...............................................................................9-13

Figure 9-11: Add User Screen ..............................................................................................9-14

Figure 9-12: Delete User Screen ..........................................................................................9-15

Figure 9-13: Clear Password Screen ...................................................................................9-17

Figure 10-1: Instrument Icon for MB-Configured System .....................................................10-3

Figure 10-2: Bottle Count Table and Unload Buttons ...........................................................10-4

Figure 10-3: Metabolic Pathway for Mycobacterial CO2 ......................................................10-7

Figure E-1: Typical BacT/ALERT

®

Culture Bottle ................................................................ E-2

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LIST OF TABLES

Table 2-1: Common System Buttons ................................................................................2-14

Table 3-1: Facility Power Rating and Conversion Chart .....................................................3-4

Table 3-2: Restraint Hardware ..........................................................................................3-12

Table 3-3: Table of Equivalent Dimensions (Inches to Centimeters) ................................3-14

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

Table 5-2: Status Determination Codes ............................................................................5-10

Table 6-1: Report Field Descriptions .................................................................................6-12

Table 9-1: Audit Trail Events .............................................................................................9-18

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

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HOW TO USE THIS MANUAL

About This Chapter

1

This chapter gives you important information about the
BacT/ALERT
that you read this chapter first.

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

BacT/ALERT® 3D 60 system.

®

3D 60 system and how to use this manual. We recommend

Chapter Contents

Intended Audience • 1-2
Purpose of the BacT/ALERT
Additional Supplies • 1-3
Purpose of This Manual • 1-3
Manual Organization • 1-4
Chapter Organization • 1-5
Finding Topics • 1-6
Typographic and Usage Conventions • 1-6

Name and Titles • 1-6
Click • 1-6
Press • 1-7
Procedural Steps • 1-7
References • 1-7
Select • 1-7
User Input • 1-8

Warnings, Cautions, and Information • 1-8

®

3D 60 System • 1-2

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How To Use This Manual Intended Audience

Intended Audience

The BacT/ALERT® 3D 60 system and this manual are intended for laboratory
use by trained, professional users.

Purpose of the BacT/ALERT® 3D 60 System

The BacT/ALERT® 3D 60 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.

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.

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

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Additional Supplies How To Use This Manual

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.

Additional Supplies

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

Purpose of This Manual

This manual focuses on the BacT/ALERT® 3D 60 software application and
how you use it in your workflow. It contains step-by-step procedures for using
your BacT/ALERT

®

3D 60 system.

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

• accessing the BacT/ALERT® 3D 60 software

• system monitoring

• entering order information (where applicable)

• loading and unloading bottles

• viewing and printing data

• LIS interaction with the BacT/ALERT® 3D 60 SelectLink

• 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.

BacT/ALERT® 3D 60 User Manual 1-3
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How To Use This Manual Manual Organization

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

®

3D 60 system and how to use this manual. It is recommended

that you read this chapter first.

Chapter 2, System Overview — This chapter gives you a complete
description of the different BacT/ALERT

®

3D 60 hardware and software
configurations available. Also, the monitor screens are listed along with a
description of common screen elements.

Chapter 3, System Installation — Provides detailed instructions on how to
install the instrument and perform functional tests.

Chapter 4, Basic Functions — 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 — 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, 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 7, System Maintenance — This chapter provides you with
procedures on how to perform maintenance on the BacT/ALERT

®

3D 60

hardware and software.

Chapter 8, 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 9, 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).

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Chapter Organization How To Use This Manual

This chapter also describes the events recorded in the audit trail and how to
retrieve the audit trail.

Chapter 10, Mycobacterial Testing — This chapter provides you with a
complete description of the of the BacT/ALERT
configured for Mycobacterial (MB) functions.

Appendix A, BacT/ALERT

diagram illustrating how to unpack the instrument.

Appendix B, BacT/ALERT® 3D 60 Part Checklist — To use when verifying
and inspecting kit contents.

Appendix C, BacT/ALERT® 3D 60 Installation Checklist — To use when
installing the instrument.

Appendix D, International Character Entry — Explains how to enter
international characters on the BacT/ALERT

Appendix E, Bottle Quality Control — This chapter provides you with a
description of the BacT/ALERT® 3D 60 culture bottle along with a quality
control procedure.

Glossary — An alphabetized list of frequently used terms along with a
definition for each term.

Chapter Organization

®

3D 60 instrument when it is

®

3D 60 Unpacking Instructions — Contains a

®

3D 60 instrument.

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.

BacT/ALERT® 3D 60 User Manual 1-5
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How To Use This Manual Finding Topics

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.

Typographic and Usage Conventions

Name and Titles

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

Example: Click 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...

Click

This manual uses the word “click” to refer to using a mouse to choose or
select a text entry field, button, or option.

Example: Click OK.

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