Biomerieux Bact-Alert 3D-60 User Manual

User Manual

95269

(01/2010)

			bioMérieux, Inc.
			Box 15969
			Durham, North Carolina 27704-0969 / USA
			Tel. [phone]
			bioMérieux® SA
	EC	REP
			au capital de 12 029 370 €
			673 620 399 RCS LYON
			69280 Marcy l’Etoile / France
			tél. [phone] / fax [phone]
[03]			http://www.biomerieux.com

	Algeria	China	Hungary
	bioMérieux Algérie EURL	bioMérieux China Limited	bioMérieux Hungária Kft.
	Algéria Business Center	Room 1601-02B & 10	Fóto út. 56 (5. emelet)
	Les Pins Maritimes - Mohammadia	Est Ocean Centre	H-1047 Budapest
	Alger	nº 24A Jiang Guo Men Nei Street	tel. [phone]
	tel. [phone]	100004 Beijing	fax [phone]
	fax [phone]	tel. [phone]	India
	Argentina	fax [phone]
			bioMérieux India Pvt. Ltd
	bioMérieux Argentina	bioMérieux China Limited	A-32, Mohan Co-Operative Ind. Estate
	Av. Congreso 1745	Room 2605, South Tower,	New Delhi 110 024
	C1428BUE	World Trade Center	tel. [phone]
	Capital Federal Buenos Aires	371-375 Huan Shi Dong East Road	fax [phone]
	tel. [phone]	510095 Guangzhou	Indonesia
	fax [phone]	tel. [phone]
			Representation Office
	Australia	fax [phone]
			bioMérieux Indonesia
		Colombia
	bioMérieux Australia P/L		Enseval Building
	Unit 25 - Parkview Business Centre	bioMérieux Colombia Ltda	Kawasan Industri Pulo Gadung -
	1, Maitland Place	Avenida 15 No. 100-43	JI. Pulo - Lentut No. 10
	Baulkham Hills NSW 2153	Piso 2	Jakarta Timur 13920
	tel. [phone]	Bogotá, D.C.	tel. [phone]
	fax [phone]	tel. [phone]	fax [phone]
	Austria	fax [phone]	Italy
		(57) 1 520 0831
	bioMérieux Austria GmbH		bioMérieux Italia S.p.A.
		Czech Republic
	Eduard-Kittenberger-Gasse 97		Via Fiume Bianco, 56
	Top 3	bioMérieux CZ s.r.o.	00144 Roma
	A-1230 Wien	Business Park Kosice	tel. [phone]
	tel. [phone]	Jinonická 80	fax [phone]
	fax [phone]	158 00 Praha 5	Ivory Coast
	Belgium	tel. [phone]
			bioMérieux Afrique Occidentale
		(420) 2 57 290 232
	bioMérieux Benelux s.a./n.v.		08 BP 2634
		fax [phone]
	Media Square		Avenue Joseph Blohorn
		Denmark
	18–19 Place des Carabiniers		Abidjan 08
	Bruxelles 1030	bioMérieux Danmark Aps	tel. [phone] 41 40
	tel. [phone]	Smedeholm 13C	fax [phone]
	fax [phone]	2730 Herlev	Japan
	Brazil	tel. [phone]
			Sysmex bioMérieux, Ltd.
		fax [phone]
	bioMérieux Brasil SA		Osaki Central Tower 8F
		Finland
	Estrada Do Mapuá		1-2-2 Osaki Shinagawa-ku
	491 Taquara - Jacarepaguá	bioMérieux Suomi Oy	Tokyo 141-0032
	CEP 22710 261	Konalantie 47 C	tel. [phone]
	Rio de Janeiro RJ	FI-00390 Helsinki	fax [phone]
	tel. [phone]	tel. [phone]	Korea
	fax [phone]	fax [phone]
			bioMérieux Korea Co., Ltd.
	Canada	France
			1st & 2nd Floor, Yoosung Building
	bioMérieux Canada, Inc.	bioMérieux SA	# 830-67 Yeoksam-dong,
	7815, Henri-Bourassa West	69280 Marcy l’Etoile	Kangnam-gu
	Saint Laurent, QC	tel. (33) (0)4 78 87 20 00	Séoul 135-080
	H4S 1P7	fax (33) (0)4 78 87 20 90	tel. [phone]
	tel. [phone]	http://www.biomerieux.com	fax [phone]
	fax [phone]	Germany	Mexico
	Chile
		bioMérieux Deutschland GmbH	bioMérieux México SA de CV
	bioMérieux Chile S.A.	Weberstrasse 8	Chihuahua 88, col. Progreso
	Seminario 131	D 72622 Nürtingen	México 01080, D.F.
	Providencia	tel. [phone]	tel. [phone]
	Santiago	fax [phone]	fax [phone]
	tel. [phone]	Greece	Netherlands (The)
	fax [phone]
		bioMérieux Hellas S.A.	bioMérieux Benelux BV
		Papanikoli 70	Boseind 15
		15232 Halandri	P.O. Box 23
		Athens	5280 AA Boxtel
		tel. [phone]	tel. [phone]
		fax [phone]	fax [phone]

	New Zealand	Singapore	Thailand
	bioMérieux New Zealand Ltd.	bioMérieux Singaporete. Ltd.	bioMérieux Thailand Ltd
	C/- Logical Freight Solutions	11 Biopolis Way, Helios, Block 11	3195/9 Vibulthani Tower, 4th Floor
	12C Rennie Drive, Airport Oaks	#10-03 Singapore 138667	Rama IV Road, Klongton, Klongtoey
	Auckland	tel. [phone]	Bangkok 10110
	tel. [phone]	fax [phone]	tel. [phone]
	fax [phone]	South Africa	fax [phone]
	Norway		Turkey
		bioMérieux South Africa Pty
	bioMérieux Norge AS	7 Malibongwe Drive	bioMérieux Diagnostik A.S.
	Økernveien 145	Randburg 2125	Değirmen Sok. Nida Plaza Kat:6
	N-0513, Oslo	tel. [phone]	34742 Kozyataği-Istanbul
	tel. [phone]	fax [phone]	tel. [phone]
	fax [phone]	Spain	fax [phone]
	Philippines (The)		United Kingdom
		bioMérieux España S.A.
	Representation Office	Manual Tovar, 45–47	bioMérieux UK Ltd
	bioMérieux Philippines	28034 Madrid	Grafton Way, Basingstoke
	11th Floor, Pearlbank Centre	tel. [phone]	Hampshire RG22 6HY
	146 Valero Street, Salcedo Village	fax [phone]	tel. [phone]
	1227 Makati City	Sweden	fax [phone]
	tel. [phone]		USA
		bioMérieux Sverige AB
	fax [phone]
		Hantverksvägen 15	bioMérieux, Inc.
	Poland
		436 33 Askim	100 Rodolphe Street
	bioMérieux Polska Sp. Z.o.o.	tel. [phone]	Durham NC 27712
	Ul. Zeromskiego 17	fax [phone]	tel. [phone]
	01-882 Warsaw	Switzerland	Vietnam
	tel. [phone]
		bioMérieux Suisse s.a.	Representation Office
	fax [phone]
		51, avenue Blanc	bioMérieux Vietnam
	Portugal
		Case postale 2150	Room 4A, 4th Floor
	bioMérieux Portugal, Lda.	1211 Genève 2	Green House Building
	Av. 25 de Abril de 1974, nº 23-3º	tel. [phone]	62A Pham Ngoc Thach Street, Ward 6
	2795-197 LINDA-A-VELHA	fax [phone]	District 3
	tel. [phone]	Taiwan	Ho Chi Minh City
	fax [phone]		tel. [phone]
		Representation Office
	Russia		fax [phone]
		bioMérieux China Limited
	o.o.o. bioMérieux	Taiwan Branch
	Derbenevskaya ul. 20, str. 11	RM 608, No. 6-3 Ching Cheng Street
	115 114 Moscow	Taipei 105
	tel. [phone]	tel. [phone]
	fax [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, 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

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

TABLE OF CONTENTS

Standard Symbols......................................................................................................	vi
List of Figures ............................................................................................................	ix
List of Tables ............................................................................................................	xiii
HOW TO USE THIS MANUAL........................................................................................	1-1

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

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

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

Purpose of the BacT/ALERT® 3D 60 System . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

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

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

BacT/ALERT® 3D 60 User Manual	i
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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

BASIC 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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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

EDITING TEST DATA ....................................................................................................

5-1

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

SOFTWARE 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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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

SYSTEM 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 PART 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

MYCOBACTERIAL 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® 3D 60 Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3

Circulation Fan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-3 Installation Procedures and Special Requirements . . . . . . . . . . . . . . . . . . . . .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
PART 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

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Table of Contents

INTERNATIONAL CHARACTER ENTRY............................................................................

D-1

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

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

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

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

BOTTLE 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
INDEX ..................................................................................................................	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

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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
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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	1

About This Chapter

This chapter gives you important information about the

BacT/ALERT® 3D 60 system and how to use this manual. We recommend that you read this chapter first.

IMPORTANT: Read this manual carefully before you attempt to operate the BacT/ALERT® 3D 60 system.

Chapter Contents

Intended Audience • 1-2

Purpose of the BacT/ALERT® 3D 60 System • 1-2

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

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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.

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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® 3D 60 instrument when it is configured for Mycobacterial (MB) functions.

Appendix A, BacT/ALERT® 3D 60 Unpacking Instructions — Contains a 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® 3D 60 instrument.

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

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.

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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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