Biomerieux Bact-Alert 3D User Manual

User Manual

95248

(01/2010)

bioMérieux, Inc.

Box 15969

Durham, North Carolina 27704-0969 / USA

Tel. [phone]

bioMérieux

®

SA

au capital de 12 029 370 €

673 620 399 RCS LYON

69280 Marcy l’Etoile / France

tél. [phone] / fax [phone]

http://www.biomerieux.com

EC REP

[04]

i Manual Name

702358-4EN1 REV nn/nnnn

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]

Manual Name ii

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.

De

ğirmen Sok. Nida Plaza Kat:6

34742 Kozyata

ği-Istanbul

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]

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

Standard Symbols

Radiation warning

Potential pinch-point warning

Laser

Temperature limitation

Upper limit of temperature

Lower limit of temperature

In Vitro Diagnostic Medical Device

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

Standard Symbols

Alternating current

Both direct and alternating current

Three-phase alternating current

Earth (ground) terminal

Protective conductor terminal

Frame or chassis terminal

Equipotentiality

ON (supply)

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

BacT/ALERT

®

3D User Manual i

95248

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

®

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

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

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

Table of Contents

ii BacT/ALERT

®

3D User Manual

95248

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

Table of Contents

BacT/ALERT

®

3D User Manual iii

95248

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

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

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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

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

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

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

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

E

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

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

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

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

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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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

I

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

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

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

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

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

B

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

®

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

Bottle Not Completely Loaded into the Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . 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

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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

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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

2

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

Figure B-1: Typical BacT/ALERT

®

Culture Bottle ................................................................B-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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1

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.

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

®

3D System • 1-2

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

How To Use This Manual Intended Audience

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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.