Biomerieux Bact-Alert 3D - User Manual
User Manual
95248
(01/2010)
bioMérieux, Inc.
Box 15969
Durham, North Carolina 27704-0969 / USA
Tel. (1) 800-682-2666
EC
[04]
REP
bioMérieux® SA
au capital de 12 029 370 €
673 620 399 RCS LYON
69280 Marcy l’Etoile / France
tél. 33 (0)4 78 87 20 00 / fax 33 (0)4 78 87 20 90
http://www.biomerieux.com
Algeria
bioMérieux Algérie EURL
Algéria Business Center
Les Pins Maritimes - Mohammadia
Alger
tel. (213) 21 89 14 81
fax (213) 21 89 14 82
Argentina
bioMérieux Argentina
Av. Congreso 1745
C1428BUE
Capital Federal Buenos Aires
tel. (54) 11 5555 6800
fax (54) 11 5555 6888
Australia
bioMérieux Australia P/L
Unit 25 - Parkview Business Centre
1, Maitland Place
Baulkham Hills NSW 2153
tel. (61) 2 8852 4700
fax (61) 2 8852 4777
Austria
bioMérieux Austria GmbH
Eduard-Kittenberger-Gasse 97
Top 3
A-1230 Wien
tel. (43) 186 50 650
fax (43) 186 50 661
Belgium
bioMérieux Benelux s.a./n.v.
Media Square
18–19 Place des Carabiniers
Bruxelles 1030
tel. (32) 2 743 01 70
fax (32) 2 733 55 97
Brazil
bioMérieux Brasil SA
Estrada Do Mapuá
491 Taquara - Jacarepaguá
CEP 22710 261
Rio de Janeiro RJ
tel. (55) 21 2444 1400
fax (55) 21 2445 6025
Canada
bioMérieux Canada, Inc.
7815, Henri-Bourassa West
Saint Laurent, QC
H4S 1P7
tel. (1) 514 336 7321
fax (1) 514 807 0015
Chile
bioMérieux Chile S.A.
Seminario 131
Providencia
Santiago
tel. (56) 2634 20 92
fax (56) 2634 20 93
i
China
bioMérieux China Limited
Room 1601-02B & 10
Est Ocean Centre
nº 24A Jiang Guo Men Nei Street
100004 Beijing
tel. (86) 10 6515 6963
fax (86) 10 6515 6993
bioMérieux China Limited
Room 2605, South Tower,
World Trade Center
371-375 Huan Shi Dong East Road
510095 Guangzhou
tel. (86) 20 8762 7010
fax (86) 20 8762 7015
Colombia
bioMérieux Colombia Ltda
Avenida 15 No. 100-43
Piso 2
Bogotá, D.C.
tel. (57) 1 520 0080
fax (57) 1 520 0088
(57) 1 520 0831
Czech Republic
bioMérieux CZ s.r.o.
Business Park Kosice
Jinonická 80
158 00 Praha 5
tel. (420) 2 57 290 623
(420) 2 57 290 232
fax (420) 2 57 290 964
Denmark
bioMérieux Danmark Aps
Smedeholm 13C
2730 Herlev
tel. (45) 70 10 84 00
fax (45) 70 10 84 01
Finland
bioMérieux Suomi Oy
Konalantie 47 C
FI-00390 Helsinki
tel. (358) 9 8545 6000
fax (358) 9 8545 6045
Hungary
bioMérieux Hungária Kft.
Fóto út. 56 (5. emelet)
H-1047 Budapest
tel. (36) 1 231 3050
fax (36) 1 231 3059
India
bioMérieux India Pvt. Ltd
A-32, Mohan Co-Operative Ind. Estate
New Delhi 110 024
tel. (91) 11 42 09 88 00
fax (91) 11 24 64 88 30
Indonesia
Representation Office
bioMérieux Indonesia
Enseval Building
Kawasan Industri Pulo Gadung JI. Pulo - Lentut No. 10
Jakarta Timur 13920
tel. (62) 21 461 51 11
fax (62) 21 460 41 07
Italy
bioMérieux Italia S.p.A.
Via Fiume Bianco, 56
00144 Roma
tel. (39) 06 523 081
fax (39) 06 523 08240
Ivory Coast
bioMérieux Afrique Occidentale
08 BP 2634
Avenue Joseph Blohorn
Abidjan 08
tel. (225) 22 40 93 93/22 40 41 40
fax (225) 22 40 93 94
Japan
Sysmex bioMérieux, Ltd.
Osaki Central Tower 8F
1-2-2 Osaki Shinagawa-ku
Tokyo 141-0032
tel. (81) 3 6834 2666
fax (81) 3 6834 2667
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
Korea
bioMérieux Korea Co., Ltd.
1st & 2nd Floor, Yoosung Building
# 830-67 Yeoksam-dong,
Kangnam-gu
Séoul 135-080
tel. (82) 2 2188 4700
fax (82) 2 547 6263
Germany
bioMérieux Deutschland GmbH
Weberstrasse 8
D 72622 Nürtingen
tel. (49) 7022 30070
fax (49) 7022 36110
Mexico
bioMérieux México SA de CV
Chihuahua 88, col. Progreso
México 01080, D.F.
tel. (52) 55 5481 9550
fax (52) 55 5616 2245
Greece
bioMérieux Hellas S.A.
Papanikoli 70
15232 Halandri
Athens
tel. (30) 2 10 81 72 400
fax (30) 2 10 68 00 880
Netherlands (The)
bioMérieux Benelux BV
Boseind 15
P.O. Box 23
5280 AA Boxtel
tel. (31) 411 65 48 88
fax (31) 411 65 48 73
Manual Name
702358-4EN1 REV nn/nnnn
New Zealand
bioMérieux New Zealand Ltd.
C/- Logical Freight Solutions
12C Rennie Drive, Airport Oaks
Auckland
tel. (64) 9 918 6354
fax (64) 9 918 6355
Norway
bioMérieux Norge AS
Økernveien 145
N-0513, Oslo
tel. (47) 23 37 55 50
fax (47) 23 37 55 51
Philippines (The)
Representation Office
bioMérieux Philippines
11th Floor, Pearlbank Centre
146 Valero Street, Salcedo Village
1227 Makati City
tel. (632) 817 7741
fax (632) 812 0896
Poland
bioMérieux Polska Sp. Z.o.o.
Ul. Zeromskiego 17
01-882 Warsaw
tel. (48) 22 569 85 00
fax (48) 22 569 85 54
Portugal
bioMérieux Portugal, Lda.
Av. 25 de Abril de 1974, nº 23-3º
2795-197 LINDA-A-VELHA
tel. (351) 21 415 23 50
fax (351) 21 418 32 67
Russia
o.o.o. bioMérieux
Derbenevskaya ul. 20, str. 11
115 114 Moscow
tel. (7) 495 221 10 79
fax (7) 495 221 10 79
Manual Name
702358-4EN1 REV nn/nnnn
Singapore
bioMérieux Singaporete. Ltd.
11 Biopolis Way, Helios, Block 11
#10-03 Singapore 138667
tel. (65) 6513 9554
fax (65) 6478 9501
South Africa
bioMérieux South Africa Pty
7 Malibongwe Drive
Randburg 2125
tel. (27) 11 801 91 10
fax (27) 11 791 24 19
Spain
bioMérieux España S.A.
Manual Tovar, 45–47
28034 Madrid
tel. (34) 91 358 11 42
fax (34) 91 358 06 29
Sweden
bioMérieux Sverige AB
Hantverksvägen 15
436 33 Askim
tel. (46) 31 68 84 90
fax (46) 31 68 48 48
Switzerland
bioMérieux Suisse s.a.
51, avenue Blanc
Case postale 2150
1211 Genève 2
tel. (41) 22 906 57 60
fax (41) 22 906 57 42
Taiwan
Representation Office
bioMérieux China Limited
Taiwan Branch
RM 608, No. 6-3 Ching Cheng Street
Taipei 105
tel. (886) 2 2545 2250
fax (886) 2 2545 0959
Thailand
bioMérieux Thailand Ltd
3195/9 Vibulthani Tower, 4th Floor
Rama IV Road, Klongton, Klongtoey
Bangkok 10110
tel. (66) 2 661 56 44
fax (66) 2 661 56 45
Turkey
bioMérieux Diagnostik A.S.
Değirmen Sok. Nida Plaza Kat:6
34742 Kozyataği-Istanbul
tel. (90) 216 444 00 83
fax (90) 216 373 16 63
United Kingdom
bioMérieux UK Ltd
Grafton Way, Basingstoke
Hampshire RG22 6HY
tel. (44) 1256 461881
fax (44) 1256 816863
USA
bioMérieux, Inc.
100 Rodolphe Street
Durham NC 27712
tel. (1) 919 620 2000
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. (84) 88 209 906
fax (84) 88 209 905
ii
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
TABLE OF CONTENTS
Standard Symbols......................................................................................................vi
List of Figures ..........................................................................................................xiii
List of Tables ...........................................................................................................xvii
HOW 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Press . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Procedural Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Select . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
User Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1-7
1-7
1-7
1-7
1-8
1-8
Warnings, Cautions, and Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
SYSTEM OVERVIEW ..................................................................................................... 2-1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Hardware Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Software Configuration Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
21 CFR Part 11 and HIPAA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Theory Of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2-2
2-2
2-3
2-4
Principle of Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
Electrical Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electrical Grounding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electrical and Electronic Recycling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fuse Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2-4
2-6
2-7
2-7
BacT/ALERT® 3D Hardware. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Mycobacteria Drawers (Clinical Use). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Controller Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Operator Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
Barcode Reader Aperture. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
BacT/ALERT® 3D User Manual
95248
i
Table of Contents
Backup Drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10
Keyboard Drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10
Quick Reference Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10
Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10
Accessing the Controller Module Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Printer Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13
Audible Alarm Speaker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
External Speaker Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
Power Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
Display Switch Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
CPU 1 Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
CPU 2 Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
Module Ports (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
Monitor Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
Modem Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
LIS Port (Diagnostic Port) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
COMM Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
Controller Module Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
Electrical Power Services Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
Power Consumed in Watts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
Heat Dissipated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
Sound Emission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
Instrument Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
Controller Module Environmental Requirements . . . . . . . . . . . . . . . . . . . 2-15
Operating Temperature Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
Storage Temperature Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
Operating Humidity Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
Storage Humidity Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
Maximum Operating and Storage Altitude . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-16
Pollution degree 2 in accordance with IEC 664 . . . . . . . . . . . . . . . . . . . . . . . .2-16
Overvoltage Category II per IEC 664 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-16
Combination Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
Operator Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17
Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17
Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
UPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
Backup Drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
Drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
Cell Indicator Lamp/Cell Indicator Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
Cell Flag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
Thermometer (Not Shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19
Drawer Indicator Light — Yellow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19
Drawer Indicator Light — Green . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19
Printer Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19
External Speaker Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19
Power Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19
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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
BacT/ALERT® 3D Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27
Operator Panel Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27
Common Screen Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28
Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-28
Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-28
Common System Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-28
Scroll Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-29
Slidebar Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-29
Anchor Display/Scroll Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-29
Text Entry Field. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-30
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
EDITING 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
EDITING 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
SOFTWARE 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
Shutdown Method 2
Shutdown Method 3
Shutdown Method 4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-11
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-11
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-12
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .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
SYSTEM 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 PART 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
MYCOBACTERIAL 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
INTERNATIONAL CHARACTER ENTRY ............................................................................A-1
International Character Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-2
Clinical Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
INDUSTRY Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Entering International Characters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-4
BOTTLE QUALITY CONTROL.........................................................................................B-1
BacT/ALERT® Culture Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-2
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-2
Flip Cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stopper/Seal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bottle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Volume Designations (Clinical Use) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Volume Designations (INDUSTRY Use). . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Limitations of the Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Clinical Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
INDUSTRY Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
B-3
B-3
B-3
B-3
B-3
B-3
B-4
B-4
B-4
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) . . . . . . . . . . . . . . . . . . . . . . .
Blood (or Sample) Volume too High . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Large Bottle Loading and Unloading Events . . . . . . . . . . . . . . . . . . . . . . . . . .
Temperature Changes in the Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Anonymous Bottle Loading of BacT/ALERT® FA and PF Bottles . . . . . . . . . .
Bottle Not Completely Loaded into the Cell . . . . . . . . . . . . . . . . . . . . . . . . . . .
C-2
C-2
C-3
C-3
C-4
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
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 ........................................................................................2-9
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
xiv
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 CO2 ...................................................... 11-8
xvi
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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HOW TO USE THIS MANUAL
1
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
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How To Use This Manual
Intended Audience
Intended Audience
The BacT/ALERT® 3D system and this manual are intended for laboratory
use by trained, professional, clinical and INDUSTRY users.
Most material in the manual applies to both sets of users. If any information in
the manual is intended for clinical use only or industry use only, it is marked
Clinical Use or INDUSTRY Use.
Specimen/Sample
In this manual, you will find references to both “specimen” and “sample.”
“Specimen” refers to Clinical Use, and “sample” refers to INDUSTRY Use.
Purpose of the BacT/ALERT® 3D System
The BacT/ALERT® 3D Microbial Detection System is a totally automated test
system capable of incubating, agitating, and continuously monitoring aerobic
and anaerobic media inoculated with:
• patient specimens suspected of having bacteremia, fungemia, and/or
mycobacteremia (Clinical Use),
or
• samples to be monitored for bacterial or fungal contamination (INDUSTRY
Use).
CAUTION: bioMérieux shall not be liable as to any defect arising
from abuse of the instrument, failure to operate and maintain the
instrument in accordance with the User Manual, operation of the
instrument by a person who has not been trained in its operation
by bioMérieux, repair, service, alteration or modification of the
instrument by any person other than service personnel of
bioMérieux, or modification, change or reuse of the disposables
supplied by bioMérieux for use in the instrument.
CAUTION: This BacT/ALERT® 3D User Manual is only intended
for use with B.30 Software or higher. The software version B.30
(or higher) is displayed at the bottom of the instrument icon on
the Main screen.
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Additional Supplies
How To Use This Manual
CAUTION: All figures depicting operator screens are examples
only. Actual screens may differ to the extent they are affected by
the actual data entered by the operator, or actual data
transmitted to the instrument over the DBMS or LIS interface, or
actual data generated by the instrument.
CAUTION: Regarding section "Entering Report Labels," the user
is solely responsible for the choice of customized report label
text and for validating that the intended label text appears in all
associated reports. bioMérieux shall not be liable for any
consequences resulting from misinterpretation of customized
report labels.
CAUTION: (INDUSTRY Use) The BacT/ALERT® system is
marketed for use in the detection of microorganisms in blood
and other normally sterile body fluids, and in the detection of
microorganisms in other sample matrices and for additional
specific indications for use, as specified in the package inserts,
user manuals, and labeling of the specific components of the
BacT/ALERT® system. Customers who use the
BacT/ALERT® system in testing of sample types or for
indications other than those described in the applicable package
inserts and user manuals do so at their own risk. Performance
characteristics for the BacT/ALERT® system for any use outside
the labeling, package insert, or user manual have not been
established.
Additional Supplies
Contact bioMérieux or your local vendor for laboratory supplies and
accessories.
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Purpose of This Manual
Purpose of This Manual
This manual focuses on the BacT/ALERT® 3D software application and how
you use it in your workflow. It contains step-by-step procedures for using your
BacT/ALERT® 3D system.
By using these procedures, you can perform all the functions required to
operate your system, including:
• accessing the BacT/ALERT® 3D software
• system monitoring
• entering data (where applicable)
• loading and unloading bottles
• viewing and printing data (printing with the BacT/ALERT® 3D Signature is
performed at the data management computer)
• LIS interaction with the BacT/ALERT® 3D 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.
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 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 hardware and software
configurations available. Also, the operator panel screens are listed along
with a description of common screen elements.
Chapter 3, Basic Functions (Clinical Use) — Introduces you to the Main
screen and shows you how to perform basic functions (ex. enter data, view
faults, view the Cell Status screen, load/unload bottles, etc.). This chapter
also introduces you to the Setup screen and the associated function buttons.
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Manual Organization
How To Use This Manual
Chapter 4, Basic Functions (INDUSTRY Use) — Introduces you to the
Main screen and shows you how to perform basic functions (ex. enter data,
view faults, view the Cell Status screen, load/unload bottles, etc.). This
chapter also introduces you to the Setup screen and the associated function
buttons.
Chapter 5, Editing Test Data (Clinical Use) — Explains how to access
bottle data for loaded and unloaded bottles using the Edit Bottle Detail
screen. This chapter shows you how to view and edit bottle data.
Chapter 6, Editing Test Data (INDUSTRY Use) — Explains how to access
bottle data for loaded and unloaded bottles using the Edit Bottle Detail
screen. This chapter shows you how to view and edit bottle data.
Chapter 7, Software Configuration — Explains how to configure the
software for your specific needs. This chapter shows you how to set the
maximum test time, set the audible alarms, change the system password,
initiate a manual backup, configure report screens, and view and print
calibration data.
Chapter 8, System Maintenance — This chapter provides you with
procedures on how to perform maintenance on the BacT/ALERT® 3D
hardware and software.
Chapter 9, System Troubleshooting — Describes the different types of
instrument fault, instrument status and operator error codes, as well as bottle
and user output device problems, you may encounter when using the
instrument. Cause(s) and solutions(s) for each type of fault/error/problem are
also listed.
Chapter 10, 21 CFR Part 11 Mode — This chapter explains how to log in
and out of the instrument while in 21 CFR Part 11 mode, as well as
instructions for configuring users (ex. adding or deleting a user, or clearing a
user password). This chapter also describes the events recorded in the audit
trail and how to retrieve the audit trail.
Chapter 11, Mycobacterial Testing (Clinical Use) — This chapter provides
you with a complete description of the of the BacT/ALERT® 3D instrument
when it is configured for Mycobacterial (MB) functions.
Appendix A, International Character Entry — Explains how to enter
international characters on the BacT/ALERT® 3D instrument.
Appendix B, Bottle Quality Control — This chapter provides you with a
description of the BacT/ALERT® 3D culture bottle along with a quality control
procedure.
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Chapter Organization
Glossary — An alphabetized list of frequently used terms along with a
definition for each term.
Chapter Organization
All chapters include the following:
• About This Chapter — Brief description of the chapter’s content and
purpose.
• Chapter Contents — A table of contents for the chapter.
• Descriptions and/or Procedures — Chapters contain descriptions and
procedures appropriate to their subject matter. See the Manual
Organization section in this chapter for more information.
• Background Information, where applicable and useful.
Finding Topics
This manual uses several methods to help you find information and keep your
bearings.
Table of Contents — Located at the front of the manual. It contains the titles
of all chapters/appendices and their sections, and the page number of each
title and section.
List of Figures — Located at the front of the manual. It contains a list of all
figures in the manual and the page number of each figure.
List of Tables — Located at the front of the manual. It contains a list of all
tables in the manual and the page number of each table.
Chapter Contents — Located at the front of each chapter. It lists all sections
in the chapter and their page numbers.
Page Headers — Located at the top of each page. There are two parts to a
header: the chapter title and the primary section title.
Page Footers — Located at the bottom of each page. There are three parts
to a footer: the manual’s title, the chapter’s part number, and the page
number.
Index — Located at the back of the manual. It contains topical entries and
their page numbers.
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Typographic and Usage Conventions
How To Use This Manual
Typographic and Usage Conventions
Name and Titles
Button, icon and field names are in Proper Case, bold.
Example: Press the Select Maximum Test Time button.
The names of windows and screens are in Proper Case, but are not bolded.
Example: The Set Maximum Test Time screen...
Press
This manual uses the word “press” to refer to pressing a button on the
Controller Module Operator Panel.
Example: Press the Load Bottles button.
We also use the word “press” to refer to pressing a key on the keyboard in
order to initiate action in the firmware.
Keyboard entries are in Proper Case and bolded (ex. Ctrl). If two keys are to
be pressed simultaneously, they will be separated with a plus sign (ex. press
Ctrl + Alt + Delete).
Procedural Steps
Steps in procedures are sequentially numbered. A bullet list in a step
indicates options.
Sections that contain procedures are denoted by the Procedure icon in the
margin.
Figure 1-1: Procedure Icon
References
References to chapter and section titles in this manual are in Proper Case.
Example: See Chapter 7, Software Configuration.
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How To Use This Manual
Warnings, Cautions, and Information
References to other manuals are in Proper Case and italic.
Example: See the BacT/ALERT® 3D Service Manual.
Select
The word “select” is generally used for selecting user interface navigation.
Example: Select the appropriate bottle type from the Media Type scroll
button.
User Input
Instructions for user input begin with the word “type” or “enter.” This manual
uses bold for literal user input and italic for placeholders.
Example of a Literal User Input: Enter the Software Exit Password
24313124.
In this example, you are to type exactly what you see on the page (24313124
in this example).
Example of a Placeholder: Enter your password before you...
In this example, you are to type your assigned password.
Warnings, Cautions, and Information
This manual uses different types of symbols to alert you to important
information. Symbols and their associated information are labeled in text
where they occur and set off from surrounding paragraphs, as shown in the
following examples.
WARNING
Warning is a statement that alerts the user to the possibility of
injury, death, or other serious adverse reactions associated
with the use or misuse of a device.
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Warnings, Cautions, and Information
How To Use This Manual
CAUTION: Caution is a statement that alerts the user to the
possibility of a problem with the device associated with its use
or misuse. Such problems include device malfunction, device
failure, damage to the device, or damage to other property.
Where applicable, a caution statement may include a precaution
that should be taken to avoid the hazard.
IMPORTANT:
Note:
Important relates to content presented in this manual. It is used to
reinforce the importance of your understanding or remembering
something.
Note supplies additional information about a topic.
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Warnings, Cautions, and Information
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SYSTEM OVERVIEW
2
About This Chapter
This chapter gives you a complete description of the different
BacT/ALERT® 3D hardware and software configurations available. Also, the
operator panel screens are listed along with a description of common screen
elements.
Note:
Information in this chapter that is intended for clinical use only or industry use
only is marked Clinical Use or INDUSTRY Use.
Chapter Contents
Introduction • 2-2
Hardware Configuration • 2-2
Software Configuration Options • 2-2
21 CFR Part 11 and HIPAA • 2-3
Theory Of Operation • 2-4
Electrical Warnings • 2-4
Electrical Grounding • 2-6
Electrical and Electronic Recycling • 2-7
Fuse Replacement • 2-7
BacT/ALERT® 3D Hardware • 2-8
Mycobacteria Drawers (Clinical Use) • 2-8
Controller Module • 2-9
Controller Module Specifications • 2-15
Controller Module Environmental Requirements • 2-15
Combination Module • 2-16
Combination Module Specifications • 2-20
Combination Module Environmental Requirements • 2-21
Incubation Module • 2-22
Incubation Module Specifications • 2-25
Incubation Module Environmental Requirements • 2-25
Instrument Installation and Setup (Clinical Use) • 2-26
Instrument Installation and Setup (INDUSTRY Use) • 2-26
BacT/ALERT® 3D Software • 2-27
Operator Panel Screens • 2-27
Common Screen Elements • 2-28
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System Overview
Introduction
Introduction
The BacT/ALERT® 3D is the next generation of BacT/ALERT®
instrumentation with comparable sensitivity and specificity to the
BacT/ALERT® Classic systems. The system is non-invasive. A touchactivated operator panel allows for a text-free user interface to direct rapid
loading and unloading of individual test samples.
Once placed in the unit, handling of a specimen/sample bottle is not required
until a result is obtained. Immediately upon detection, positive results are
indicated visually on the unit's monitor and, if desired, by an audible beep. If
no microbial growth is present after a specified time, a specimen/sample is
determined to be negative. The system will also indicate the negative
samples that are ready for removal when prompted. Because the system
handles bottles individually, testing of new specimens/samples may begin at
any time. The system also utilizes barcode technology to assist in specimen/
sample and data tracking.
The disposable culture bottles contain a liquid emulsion sensor that is
monitored continuously using solid-state photodetectors. In addition, the
bottles contain media and atmosphere which promote the recovery of a wide
variety of microorganisms without venting.
Hardware Configuration
The BacT/ALERT® 3D utilizes a flexible modular design in one of two
hardware configurations.
• A Controller Module that directs 1 to 6 Incubation Modules (each with 240
cells for bottle monitoring).
• A Combination Module that either stands alone (120 cells for bottle
monitoring), or directs up to 3 Incubation Modules.
Software Configuration Options
Both the Controller and Combination Modules supervise the reading of the
sensors and contain decision-making algorithms to determine which
specimens/samples are positive or negative. Both modules can be arranged
in one of three BacT/ALERT® 3D software configurations:
• BacT/ALERT® 3D Select configuration — The BacT/ALERT® 3D
Controller or Combination Module is not connected to either a bioMérieux
data management computer or a Laboratory Information System (LIS).
Limited data management is available through the system.
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Introduction
System Overview
• BacT/ALERT® 3D SelectLink configuration — The BacT/ALERT® 3D
Controller or Combination module is connected directly to an LIS. Limited
data management is available through the system.
• BacT/ALERT® 3D Signature configuration — The BacT/ALERT® 3D
Controller or Combination Module is connected directly to a bioMérieux
data management computer. Data generated by the BacT/ALERT® 3D is
managed by extensive data management software produced by
bioMérieux. This data management software provides a high level of
flexibility. Data can easily be stored for a definable length of time, edited,
queried, sorted, and reported. Predefined queries and reports are
available, or they can be customized by the user. A detailed description of
the data management software is found in the appropriate data
management system operator manual.
The software configuration is listed at the top of all screens (except for the
Edit Cell Contents or View Cell Contents screen). The background color will
also indicate the configuration unless there is an error condition or a loaded
positive bottle (see Main Screen Introduction in Chapter 3, Clinical Use, and
Main Screen Introduction in Chapter 4, INDUSTRY Use):
• Blue — BacT/ALERT® 3D Select configuration
• Green — BacT/ALERT® 3D SelectLink configuration
• Gray — BacT/ALERT® 3D Signature configuration
21 CFR Part 11 and HIPAA
The BacT/ALERT® 3D Version B.30 or higher product release provides
compatibility with 21 CFR Part 11 and Health Insurance and Portability and
Accountability Act (HIPAA) requirements.
When installed, the BacT/ALERT® 3D instrument can be configured to
operate in 21 CFR Part 11 mode. If 21 CFR Part 11 mode is enabled, you will
need to enter a user name and password to access all functions available to
the user. See Log In/Out of System — 21 CFR Part 11 Mode in Chapter 10.
To meet HIPAA requirements, a password is required to view and print test
data. These functions include access to the Print, Report Label Entry,
Report Configuration, Calibration Report, and Calibration History
buttons. These buttons are accessed via a Report Selection screen (see
Figure 3-11 for Clinical Use or Figure 4-11 for INDUSTRY Use). See the
topic, Configuring Report Screens in Chapter 7 for further information.
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Introduction
Theory Of Operation
Principle of Detection
If microorganisms are present in the test sample, carbon dioxide is produced
as the microorganisms metabolize the substrates in the culture medium.
When growth of the microorganisms produces CO2, the color of the sensor in
the bottom of each culture bottle changes from dark to light.
A light-emitting diode (LED) projects light onto the sensor. The light reflected
is measured by a photodetector. As more CO2 is generated, more light is
reflected. This information is compared to the initial sensor reading. If there is
a high initial CO2 content, an unusually high rate of CO2 production, and/or a
sustained production of CO2, the sample is determined to be positive.
Mycobacterial growth in the BacT/ALERT® MP Bottles may also be
determined positive by the delta or a slow sustained change of CO2
production (Clinical Use).
If the CO2 level does not change significantly after a specified number of days
at optimal conditions, the sample is determined to be negative.
CAUTION: Unloading or manipulating the bottles when not
indicated by the system may interfere with critical bottle
readings.
Electrical Warnings
The BacT/ALERT® 3D has been designed and tested in accordance with the
standards listed below and has been supplied in a safe condition. A CB
Certification and Construction File have been established for the apparatus.
• UL 61010-1 (2nd Edition, 2001), Safety Requirements for Electrical
Equipment for Measurement, Control, and Laboratory Use; Part 1: General
Requirements
• IEC 61010-1 (2nd Edition, 2001), Safety Requirements for Electrical
Equipment for Measurement, Control and Laboratory Use
• IEC 61010-2-081 (1st Edition, 2001), Safety Requirements for Electrical
Equipment for Measurement, Control, and Laboratory Use –
Part 2-081: Particular requirements for automatic and semi-automatic
laboratory equipment for analysis and other purposes
• CAN/CSA-C22.2 No. 1010.1-92, Safety Requirements for Electrical
Equipment for Measurement, Control and Laboratory Use
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WARNING
The user must adhere to the following warnings to ensure safe
operation and to maintain the apparatus in a safe condition:
• Ensure that the BacT/ALERT® 3D instrument is configured for
the correct voltage at the instrument’s power entry port
before turning on.
• Intentional interruption of the protective conductor inside or
outside the apparatus, or disconnection of the protective
ground terminal, is prohibited.
• Disconnect the apparatus from all voltage sources before it is
opened for any adjustment, replacement, maintenance, or
repair.
• Do not perform any adjustments, maintenance, or repairs of
the opened apparatus while under voltage. If this is
unavoidable, maintenance must be carried out only by a
skilled person who is aware of the hazard involved.
• Whenever it is likely that the BacT/ALERT® 3D module has
been impaired, it should be rendered inoperative and
secured against any unintended operation by disconnecting
the power cord. If the presence of moisture is evident, turn
off the machine at the breaker before removing the power
cord and fuse.
• Do not forcibly remove the Zip® disk from the instrument.
Forcibly removing the Zip® disk may cause damage to the
Zip® disk or Zip® drive and may cause the system to lock up.
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Introduction
WARNING
Contact your local bioMérieux Representative if any of the
following conditions occur:
• System shows visible damage.
• System fails to perform intended measurements.
• System has been subjected to storage under unfavorable
conditions (ex. above 90% humidity, extreme temperatures,
dusty environment, prolonged storage).
• System has been subjected to severe transport stresses.
Electrical Grounding
An electrical ground is required for this instrument. Before installing the
instrument, ensure that a grounded wall receptacle is available for each
module, which is factory equipped with a power supply cord that has the
appropriate grounding plug. It must be plugged into a mating grounding type
wall receptacle in accordance with the National Electrical Code and
applicable local codes and ordinances for this type of installation (see
Figure 2-1)..
WARNING
Do not remove the power cord’s ground prong under any
circumstances.
WARNING
Do not insert any object, other than a Zip® disk, into the Zip®
drive under any circumstances.
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1
2
Figure 2-1: Electrical Grounding Requirements
1 — US Standard
2 — 220 Volt - European
Electrical and Electronic Recycling
WARNING
This statement only applies to European countries with regard
to the waste electrical and electronic equipment European
directive:
You can play an important role in contributing to reuse,
recycling and other forms of recovery of waste electrical and
electronic equipment. Sorting this type of waste significantly
reduces potential negative effects on the environment and
human health as a result of the presence of hazardous
substances in electrical and electronic equipment.
At the end of the life cycle of this product, do not dispose of the
product as unsorted municipal waste, even if it is
decontaminated. It is imperative that you contact bioMérieux to
assure for its appropriate disposal.
Fuse Replacement
There are no user-serviceable fuses in the BacT/ALERT® 3D system.
Contact your local bioMérieux Instrument Service Representative.
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BacT/ALERT® 3D Hardware
Each BacT/ALERT® 3D system includes either a Controller Module with at
least one Incubation Module or a Combination Module. Each Controller
Module can direct up to six Incubation Modules. Each Combination Module
contains two incubation drawers in a right or left-handed configuration and
can direct up to three additional Incubation Modules.
Incubation Modules are available in right and left-handed configurations. A
right-handed Incubation Module is designed for placement on the right side of
the Controller or Combination Module and allows bottle access from the left
of an open drawer. Incubation Modules contain four drawers, each with the
capacity to hold up to 60 culture bottles. An Incubation Module can be
configured so one or more drawers are empty, allowing a 60, 120, 180, or
240-bottle capacity.
Mycobacteria Drawers (Clinical Use)
Mycobacteria (MB) and non-MB drawers can co-exist in the same Incubation
Module. MB drawers may be provided directly by bioMérieux or may be
converted from a non-MB configuration in the field. This is accomplished by
disengaging the agitation mechanism so the three racks within each drawer
remain immobile.
Each MB drawer handle has a red MB label also displaying the Incubation
Module number and letter corresponding to that drawer. The MB drawer
faces on the Instrument icon of the Main screen are also labeled.
Note:
2-8
The BacT/ALERT® 3D software must also be configured to activate the MB
status of each drawer.
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Controller Module
1
2
3
4
5
Figure 2-2: Instrument Front View
1 — Operator Panel
2 — Barcode Reader
3 — Backup Drive (Located in Barcode Reader Aperture)
4 — Barcode Reader Strip
5 — Keyboard Drawer
Operator Panel
Displays bottle and system information. Includes a touchscreen overlay so
that the operator may input selections and data by touching the screen.
Barcode Reader Aperture
Houses a removable Barcode Reader that is used to scan bottle barcode
labels to identify bottles and accession/sample barcodes when loading or
unloading. The reader can be removed, if desired.
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Figure 2-3: Removing the Barcode Reader Through the Barcode Reader Aperture
Backup Drive
Used for system backups and software upgrades. May be either a Zip® Drive
or a USB Port, depending on system configuration. Located in the Barcode
Reader Aperture.
Keyboard Drawer
Houses a pullout working surface, Quick Reference Card, and keyboard.
Quick Reference Card
Describes specific error codes. Located in the keyboard drawer beneath the
Barcode Reader Aperture. Located at the bottom of the Controller Module.
Keyboard
Provides an alternate means of input. Serves as a backup input device
should the Touchscreen or Barcode Reader fail.
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Accessing the Controller Module Keyboard
There are two different designs of keyboard drawers, Design A and Design B
(see Figure 2-4).
To access the keyboard in a drawer of Design A:
1)
Pull the keyboard drawer on the bottom of the Controller Module face out
as far as it will go. A cover is exposed which includes a pocket for the
Reference Card.
2)
Grasp the sides of the exposed cover nearest the face of the Controller
Module.
3)
Press the metal latches on each side of the drawer to extend fully.
4)
Extend the drawer fully, and swivel the cover up.
5)
Remove the keyboard, close the cover, and rest the keyboard on the
working surface.
To access the keyboard in a drawer of Design B:
1)
Pull the keyboard drawer on the bottom of the Controller Module face out
as far as it will go. A cover is exposed which includes a pocket for the
Reference Card.
2)
Grasp the sides of the exposed cover nearest you.
3)
Press the metal latches on each side of the drawer to extend fully.
4)
Swivel the cover up from the front to expose the keyboard.
5)
Remove the keyboard, close the cover, and rest the keyboard on the
working surface.
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Design A
1
Design B
2
Figure 2-4: Accessing the Keyboard and Reference Card
1 — Notch for cord
2 — Press latch on each side to close
When keyboard entry is complete, the keyboard may be returned to its
original position beneath the cover plate. Close the drawer by depressing
both latches on each side of the drawer while pushing it closed.
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1
2
3
14
4
5
13
12
11
6
10
9
8
7
Figure 2-5: Back View Controller Module
1 — Power Switch
8 — Monitor Port
2 — Power Connector
9 — Modem Port
3 — Display Switch Assembly
10 — LIS Port (Diagnostic Port)
4 — CPU 1 Port
11 — Printer Port
5 — CPU 2 Port
12 — Comm Port
6 — Module Ports (6)
13 — External Speaker Port
7 — Fans
14 — Audible Alarm Speaker
Printer Port
Interface port (parallel) for producing hard copy reports when the instrument
is not in the BacT/ALERT® Signature configuration.
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Audible Alarm Speaker
Specified by the user to flag instrument failures, operator errors, and positive
bottle results.
External Speaker Port
Port for connecting external speakers that are available for order as a
separate kit.
Power Connector
Connector for alternating current (AC) power cord.
Power Switch
Turns the AC Power to the instrument On and Off.
Display Switch Assembly
Used to select the internal or external display device.
CPU 1 Port
Used to connect the bioMérieux data management computer to the Controller
Module (or Combination Module) or to connect two Controller Modules
together.
CPU 2 Port
Used to connect two Controller Modules (or Combination Modules) together.
Module Ports (6)
Connects an Incubation Module to the Controller Module.
Monitor Port
Used to connect an external monitor, if necessary.
Modem Port
Used to connect an external modem to the Controller Module. Allows remote
diagnosis of instrument problems. The external modem box should be in the
“OFF” position when not in use by a bioMérieux Representative.
LIS Port (Diagnostic Port)
Used to connect the Controller Module to a Laboratory Information System
(LIS). See Figure 2-5, Back View Controller Module, on page 2-13.
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COMM Port
Reserved for future use.
Controller Module Specifications
Electrical Power Services Requirements
• 100/120 Volts (50-60 Hz)
• 220/240 Volts (50-60 Hz)
Power Consumed in Watts
• @115 Volts (72 Watts typical)
• @230 Volts (72 Watts typical)
Heat Dissipated
• 245 BTU/Hr. 2840 maximum
Sound Emission
• 46.4 dB
Instrument Dimensions
• Width — 14 inches (35.6 cm)
• Height — 36 inches (91.4 cm)
• Depth — 24.3 inches (61.7 cm)
• Weight — 91 pounds (57.2 Kg)
Controller Module Environmental Requirements
Operating Temperature Range
• 10°C to 30°C (50°F to 86°F)
Storage Temperature Range
• –17°C to 57°C (0°F to 135°F)
Operating Humidity Range
• 10% to 90% relative humidity, non-condensing.
Storage Humidity Range
• 10% to 90% relative humidity, non-condensing.
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Maximum Operating and Storage Altitude
• 6562 feet (2000 meters)
Pollution degree 2 in accordance with IEC 664
Overvoltage Category II per IEC 664
Combination Module
4
5
6
2
3
7
8
1
Figure 2-6: Front View Combination Module
1 — Keyboard
2 — Printer
3 — Barcode Reader
4 — Operator Panel
5 — Combination Module
6 — Backup Drive
7 — UPS
8 — Modem
2-16
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14 13 12
1
2
11
3
4
10
9
5 67 8
Figure 2-7: Back View Combination Module
1 — CPU 1 and CPU 2 Ports
9 — Printer Port
2 — Power Switch
10 — COMM Port
3 — Power Connector
11 — Fan
4 — UPS Port
12 — External Speaker Port
5 — Module 2 – 5 Ports
13 — Keyboard Port
6 — Display Switch Assembly
14 — Barcode Reader Port
7 — Modem Port
15 — LIS Port
8 — Monitor Port
Operator Panel
Provides a way of displaying information. Includes a touchscreen overlay so
that the operator may input selections and data by touching the screen.
Barcode Reader
The Barcode Reader is external to the Combination Module. The Barcode
Reader, used to scan bottle barcode labels to identify bottles and accession/
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System Overview
sample barcodes when loading or unloading, is on a stand separate from the
Combination Module.
Keyboard
The keyboard is external to the Combination Module. It provides an alternate
means of input. Serves as a backup input device should the Touchscreen or
Barcode Reader fail.
UPS
The UPS is external to the Combination Module.
Backup Drive
The Backup Drive allows system backups to be made to either a Zip® disk or
USB Flash Drive.
Drawer
Labeled A or B in the Combination Module. Each drawer contains 3 racks for
a drawer capacity of 60 culture bottles.
Rack
Each rack contains 20 cells.
Cell
Cells are designated with a number from 1 to 60. Each cell holds and
monitors one culture bottle.
Cell Indicator Lamp/Cell Indicator Light
Located next to each cell in the rack.
• Illuminates to indicate which cells are available for loading after the
operator selects the Load Bottles function.
• Illuminates to indicate which cells should be unloaded when the
operator selects one of the Unload Bottles functions.
• Blinks slowly or rapidly to indicate whether a bottle load or unload was
performed correctly or incorrectly, respectively.
Cell Flag
Secures bottles in cells and aids in cell diagnostics and bottle loading and
unloading determinations.
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1
Figure 2-8: Cell Flag (Clip Removed)
1 — Clip
Thermometer (Not Shown)
Located in back of drawer.
Drawer Indicator Light — Yellow
• Illuminates when the drawer is open and turns off when the drawer is
closed.
• Flashes if the drawer remains open too long or if an error condition is
associated with the drawer.
Drawer Indicator Light — Green
• Illuminates if the drawer or its cells are involved in an operation the
user has selected.
• Flashes in conjunction with the yellow indicator if a drawer is left open
too long.
Printer Port
Interface port (parallel) for producing hard copy reports when the instrument
is not in BacT/ALERT® 3D Signature configuration.
External Speaker Port
Port for connecting external speakers. External speakers are available for
order as a separate kit.
Power Connector
Connector for Alternating Current (AC) power cord.
Power Switch
Turns the AC power to the Combination Module on and off.
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Display Switch Assembly
Used to select the internal or external display device.
CPU 1 Port
Used to connect the bioMérieux data management computer to the
Combination Module or to connect to a Controller Module.
CPU 2 Port
Used to connect to a Controller Module (or Combination Module).
Module Port (3)
Connects an Incubation Module to the Combination Module.
Modem Port
Used to connect an external modem to the Combination Module. Allows
remote diagnosis of instrument problems. The external modem box should be
in the “OFF” position when not in use by a bioMérieux Representative.
LIS Port
Used to connect the Combination Module to a Laboratory Information System
(LIS).
Barcode Scanner Port
Used to connect the barcode scanner.
Keyboard Port
Used to connect the keyboard.
Monitor Port
Used to connect an external monitor, if necessary.
COMM Port
Reserved for future use.
Combination Module Specifications
Electrical Power Services Requirements
• 100/120 Volts (50/60 Hz)
• 220/240 Volts (50/60 Hz)
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Power Consumed in Watts
• @115 Volts — 256 Watts (idle), 640 Watts typical
• @230 Volts — 265 Watts (idle), 640 Watts typical
Heat Dissipated
• 904 BTU/Hr. 2840 maximum
Combination Module Dimensions
• Width — 19.5 inches (49.6 cm)
• Height — 30.8 inches (78.1 cm)
• Depth — 24.5 inches (62.2 cm)
• Unloaded Weight — 200 pounds (90.7 Kg)
• Loaded Weight — 216.5 (98.2Kg)
Sound Emission
• 55.5 dB
Combination Module Environmental Requirements
Operating Temperature Range
• 10°C to 30°C (50°F to 86°F)
Storage Temperature Range
• –17°C to 57°C (0°F to 135°F)
Operating Humidity Range
• 10% to 90% relative humidity, non-condensing.
Storage Humidity Range
• 10% to 90% relative humidity, non-condensing.
Maximum Operating and Storage Altitude
• 6562 feet (2000 meters)
Pollution degree 2 in accordance with IEC 664 (Clinical Use)
Overvoltage Category II per IEC 664 (Clinical Use)
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Incubation Module
6
5
4
1
2
3
Figure 2-9: Front View Incubation Module (Right-Handed Configuration)
1 — Green Indicator Lamp
2 — Yellow Indicator Lamp
3 — Drawer Label
4 — Digital Thermometer (located on the inner front panel of drawer B
in right-hand module and drawer A of left-hand module)
5 — Drawer
6 — Drawer Release Latch
Drawer
Labeled A, B, C, or D in each Incubation Module. Contains 3 racks for a
drawer capacity of 60 culture bottles.
Rack
Each rack contains 20 cells.
Cell
Designated with a number from 1 to 60. Each cell holds and monitors one
culture bottle.
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Cell Indicator Lamp/Cell Indicator Light
Located next to each cell in the rack.
• Illuminates to indicate which cells are available for loading after the
operator selects the Load Bottles function.
• Illuminates to indicate which cells should be unloaded when the
operator selects one of the Unload Bottles functions.
• Blinks slowly or rapidly to indicate whether a bottle load or unload was
performed correctly or incorrectly respectively.
Cell Flag
Secures bottles in cells and aids in cell diagnostics and bottle loading and
unloading determinations (see Figure 2-8, Cell Flag (Clip Removed), on
page 2-19).
Drawer Indicator Light — Yellow
• Illuminates when the drawer is open and turns off when the drawer is
closed.
• Flashes if the drawer remains open too long or if an error condition is
associated with the drawer.
Drawer Indicator Light — Green
• Illuminates if the drawer or its cells are involved in an operation the
user has selected.
• Flashes in conjunction with the yellow indicator if a drawer is left open
too long.
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1
2
3
Figure 2-10: Back View Incubation Module
1 — Power Switch
2 — Power Connector
3 — Controller Module Port
Controller Module Port
Connects the Controller Module to an Incubation Module.
Power Connector
Connector for AC power cord.
Power Switch
Turns the AC power of the Incubation Module On and Off.
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Incubation Module Specifications
Electrical Power Services Requirements
• 100/120 Volts (50/60Hz)
• 220/240 Volts (50-60 Hz)
Power Consumed in Watts
• @115 Volts — 256 Watts (idle), 640 Watts typical
• @230 Volts — 265 Watts (idle) 640 Watts typical
Heat Dissipated
• 904 BTU/Hr. 2840 maximum
Instrument Dimensions
• Width — 19.5 inches (49.6 cm)
• Height — 36 inches (91.4 cm)
• Depth — 24.3 inches (61.7 cm)
• Unloaded Weight — 262 pounds (118.8 Kg)
• Loaded Weight — 307 (133.8 Kg)
Sound Emission
54.7 dB
Incubation Module Environmental Requirements
Operating Temperature Range
• 10°C to 30°C (50°F to 86°F)
Storage Temperature Range
• –17°C to 57°C (0°F to 135°F)
Operating Humidity Range
• 10% to 90% relative humidity, non-condensing.
Storage Humidity Range
• 10% to 90% relative humidity, non-condensing.
Maximum Operating and Storage Altitude
• 6562 feet (2000 meters)
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Instrument Installation and Setup (Clinical Use)
CAUTION: Initial installation and setup of the BacT/ALERT® 3D
Microbial Detection System, or of any added Incubation
Module(s) is to be performed only by a bioMérieux Service
Representative.
WARNING
Clinical Use: The BacT/ALERT® 3D has been designed to
minimize risks associated with MB testing. However, to further
reduce the risks of accidental exposure to infectious agents,
additional precautions should be taken. It is strongly
recommended that the instrument be placed in a laboratory
used for the routine culture of M. tuberculosis. For activities
involving the propagation and manipulation of M. tuberculosis
or Mycobacterium species grown in culture, Biosafety Level 3
Practice, Containment Equipment, and Facilities are required
as recommended by CDC and NIH guidelines.
At a minimum, the instrument should be placed in a contained environment
with controlled access which has a tuberculosis exposure control plan. The
locations should have surfaces which can be easily decontaminated using an
appropriate topical disinfectant. The instrument must not be placed in an
open corridor or hallway that is accessible to the general public or the patient
population.
If it is necessary to move or store the BacT/ALERT® 3D System or one of its
modules, contact bioMérieux Service for assistance.
Instrument Installation and Setup (INDUSTRY Use)
CAUTION: Initial installation and setup of the BacT/ALERT® 3D
Microbial Detection System, or of any added Incubation
Module(s), is to be performed only by your local bioMérieux
Representative.
If it is necessary to move or store the BacT/ALERT® 3D System or one of its
modules, contact your local bioMérieux Representative for assistance.
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BacT/ALERT® 3D Software
Operator Panel Screens
The Main screen is normally visible on the Operator Panel, but other screens
may be displayed to perform a variety of functions. Each screen has a screen
ID number in the upper left-hand corner to cross-reference it to the following
descriptions and instructions in this Manual. When selected, the Setup
screen replaces the Main screen.
Screen ID Numbers
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
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1.0 Main screen
1.1 View Cell Status screen
1.2 Change Maximum Test Time screen
1.3 User Login screen (21 CFR Part 11 mode only)
2.0 Setup screen
2.1 Set Date/Time screen
2.2 Enable/Disable Module, Drawer, Rack, or Cell screen
2.3 Calibrate Module Temperature screen
2.4 Calibrate Cell screen
2.4.1 Cell Calibration Report Screen
2.7 Set Maximum Test Time screen
2.8 Set Audible Alarm Options screen
2.9 Change Password screen
2.11 Select Bottle to Edit/Graph screen
2.11.1 Edit Bottle Detail screen
2.11.1.1 Edit Test Result
2.11.2 Graph Bottle Readings screen
2.11.2.1 Bottle Readings screen
2.12 Edit Cell Contents screen (2.11.1, 2.11.1.1, 2.11.2 and 2.11.2.1 can
also be accessed from this screen)
2.13 View Incubation Module Information screen
2.14 Report Label Entry screen *
2.15 Report Configuration screen *
2.15.1 Report screen *
2.16 Backup Management screen
2.17 Edit Data Relationships screens
2.19 Viewing and Printing Calibration data screen
2.20 Bottle Type Customization screen
2.21 Report Selection screen*
2.21.1 Calibration History screen
2.23 User Configuration screen (21 CFR Part 11 mode only)
2.23.1 Add User screen (21 CFR Part 11 mode only)
2.23.2 Delete User screen (21 CFR Part 11 mode only)
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• 2.23.3 Change User Password screen (21 CFR Part 11 mode only)
* Screen's availability dependent upon BacT/ALERT® 3D software
configuration.
Common Screen Elements
Icon
• Graphic symbols used instead of text to convey information and
concepts in the Operator Panel.
Button
• Appear as rectangular shapes which can be pressed to input choices
or activate functions.
• Button function is indicated by icon displayed on button face.
• If a button is gray, then it is disabled and its associated function is
unavailable.
1
2
Figure 2-11: Button Examples
1 — Enabled Button
2 — Disabled Button
Common System Buttons
Table 2-1: Common System Buttons
Check button – Accept changes, save data or
entries on that particular screen.
Cancel button – Discard changes or entries on
that particular screen to keep the original
values.
Previous Screen Button – Return to the
previous screen.
Next Screen Button – Move to the next
available screen.
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Scroll Button
• Used for numeric entry and symbolic or media type selection.
• Consists of two small buttons and an area between them to display
the current value.
• Touching the top or bottom button of the scroll button displays the
next higher or lower value.
• Adjacent scroll buttons provide entry for multi-digit values.
Figure 2-12: Scroll Button
Slidebar Switch
• Turns a function On or Off. The specific function is represented by a
separate icon next to the slidebar.
• Touching the right half of the icon moves the slidebar to the right,
indicating an On selection (1).
• Touching the left half of the icon moves the slidebar to the left,
indicating an Off selection (0).
Figure 2-13: Slidebar Switch
Anchor Display/Scroll Buttons
• Anchor Display top or bottom buttons — Control whether the display
stays anchored on the first or last line of the diagnostic output.
• Line scroll up or down buttons — Move the display area one line at a
time (up or down). This function can also be performed by pressing the
↑ or ↓ key on the keyboard.
• Page scroll up or down buttons — Move the display area one page (up
or down). This function can also be performed by pressing the Page
Up or Page Down key on the keyboard.
• Home/End scroll buttons — Position the display area to the first or last
line of the diagnostic output. This function can also be performed by
pressing the Home or End key on the keyboard.
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System Overview
1
3
5
7
2
4
6
8
Figure 2-14: Anchor Display/Scroll Buttons
1 — Anchor Display Top Button
2 — Anchor Display Bottom Button
3 — Line Scroll Up Button
4 — Line Scroll Down Button
5 — Page Scroll Up Button
6 — Page Scroll Down Button
7 — Home Scroll Button
8 — End Scroll Button
Text Entry Field
A text entry field appears as a rectangular box that allows the user to enter
text either manually via the keyboard or by scanning a barcode (see Text/
Data Entry in Chapter 3). The Bottle ID field on the Main screen is an
example of a text field (see Figure 3-1, Main Screen).
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BASIC FUNCTIONS (CLINICAL USE)
3
About This Chapter
This chapter introduces you to the Main screen and provides you with
procedures on how to perform daily basic functions for clinical use.
Chapter Contents
Introduction • 3-2
Monitoring the System • 3-3
Main Screen Introduction • 3-3
Viewing Faults • 3-6
Viewing the Cell Status Screen • 3-7
Text/Data Entry • 3-9
Common Text Fields and Field Limit • 3-9
Using the Barcode Scanner to Enter Data • 3-10
Manually Entering Text into a Data Entry Field (Keyboard) • 3-10
Loading Bottles • 3-11
Loading Bottles • 3-11
Changing the Maximum Test Time — Individual Bottles • 3-15
Handling Anonymous Bottles • 3-16
Unloading Bottles • 3-16
Unloading Bottles • 3-17
Handling Unconfirmed Positive Bottles (False Positives) • 3-19
Accessing the Setup Screen Function Buttons • 3-20
Accessing the Setup Screen • 3-20
Setup Screen Function Buttons • 3-21
Viewing and Printing • 3-23
Introduction • 3-23
Viewing, Printing, and Exporting Test Data • 3-24
Viewing and Printing Bottle Graphs • 3-31
Display Bottle Readings • 3-34
Sending/Requesting LIS Information • 3-39
Sending Results to the LIS • 3-39
Requesting Information from the LIS • 3-39
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Introduction
Introduction
The basic functions are those tasks that may be performed during daily
workflow. They include:
• Monitoring system
• Entering data (where applicable)
• Loading and unloading bottles
• Viewing and printing data (printing with the BacT/ALERT® 3D Signature is
performed at the data management computer.)
• LIS interaction with the BacT/ALERT® 3D SelectLink
• Accessing the Setup screen
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Monitoring the System
Main Screen Introduction
The BacT/ALERT® 3D system can be monitored from the Main screen (see
Figure 3-1).
10
1
9
2
3
8
4
5
6
7
Figure 3-1: Main Screen
1 — Screen ID Number
2 — Bottle Count Table
3 — Unload Buttons
4 — Manual Send Test Results button (SelectLink only)
5 — Manual Request Test Orders button (SelectLink only)
6 — Logout button (21 CFR Part 11 mode only)
7 — Load Bottles button
8 — Instrument Icon
9 — Current Date/Time
10 — Software Configuration
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CAUTION: If the current date/time displayed at the top of the
screen does not advance, contact bioMérieux Customer Service
immediately.
Background Color
The default background color is determined by the software configuration
(see Software Configuration Options in Chapter 2). The following conditions
will override default background colors:
• A yellow screen indicates that the instrument has detected a positive bottle.
• A red screen indicates that an instrument fault has occurred. Touching the
screen or pressing any key on the keyboard returns a red screen to yellow
or the configuration default color depending on whether positive bottles are
present. The fault code will remain on the screen until the error is cleared.
Instrument Icon
The following information is indicated on the Instrument icon:
• System ID numbers are assigned to both the Controller/Combination
Module and Incubation Modules.
• Combination Module has 2 System ID numbers.
• The programmed optimal temperature (ºC) is displayed for each Incubation
Module.
• Software version number for the BacT/ALERT® 3D Controller/Combination
Module.
• Disabled or uninstalled components appear diagonally striped in gray on
the screen.
• An entire rack will appear diagonally striped if only one of its cells is
disabled.
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1
4
5
2
3
Figure 3-2: Combination Module with an Additional Incubation Module
1 — Combination Module Instrument Icon
2 — Combination Module ID
3 — Software Version
4 — Incubation Module ID
5 — Optimal Temp (ºC)
1
2
4
3
5
Figure 3-3: Controller Module with One Incubation Module
1 — Controller Module Instrument Icon
2 — Optimal Temp (ºC)
3 — Disabled Rack or Cell
4 — Controller ID
5 — Software Version
Bottle Count Table
Located just above the Instrument icon are the Unload buttons and a bottle
count table indicating the number of bottles of each type currently loaded in
the instrument.
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Monitoring the System
3
5
7
9
4
6
8
10
1
2
Figure 3-4: Bottle Count Table/Unload Buttons
1 — Total number of mycobacteria (MB) bottles loaded in the system.
2 — Total number of blood or sterile fluid culture (BC) bottles loaded in
the system.
3 — Total number of identified bottles with a positive test status.
4 — Unload Positive Identified Bottles Button
5 — Total number of bottles (identified and anonymous) with a
negative test status.
6 — Unload Negative Bottles Button
7 — Total number of anonymous bottles with a positive test status.
8 — Unload Positive Anonymous Bottles Button
9 — Total number of anonymous bottles with a negative-to-date or
negative test status.
10 — Unload Anonymous Negative or Negative-to-Date Bottles Button
Viewing Faults
Instrument faults are reported using a numeric code within a red diamond
shape. Fault codes are displayed on the Instrument icon where the fault
condition exists.
Note:
Only high priority codes are displayed on the Instrument icon.
1)
If the code appears on the Controller Module or the top half of the
Combination Module, then move to Step 4. If the fault code appears on
an Incubation Module or bottom half of the Combination Module, then
continue to Step 2.
2)
Touch the Incubation or Combination Module on the Instrument icon
that contains the fault code.
3)
The View Cell Status screen appears (see Viewing the Cell Status
Screen on page 3-7 and Figure 3-5).
• Drawer faults appear at the top of the screen.
• Rack faults appear at the left end of the rack display.
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• Cell faults appear in the cell display.
4)
For a complete list and description of Instrument Fault Codes, see the
topic, Instrument Fault Codes in Chapter 9.
Viewing the Cell Status Screen
The View Cell Status screen is continuously updated with changes that occur
while the screen is active, such as the loading/unloading of bottles, new test
results, and the error status of the drawer, as indicated by fault codes
appearing or disappearing. To view the cell status screen:
1)
Display the View Cell Status screen by touching the appropriate
Incubation Module on the Instrument icon (see Figure 3-1, Main Screen,
on page 3-3).
9
11 10
1
2
8
3
7
4
6
5
Figure 3-5: View Cell Status Screen
1 — Incubation Module
Indicator
6 — Drawer Selection Button
2 — Cell Fault Code
8 — Cell
3 — Rack Fault Code
9 — Restart Incubation Module
Button
4 — Previous Screen Button
5 — Incubation Module
Selection Button
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7 — Rack
10 — Drawer Fault Code
11 — Drawer Indicator
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Monitoring the System
2)
Note:
If necessary, use the Incubation Module Selection and Drawer Selection
buttons to display the desired drawer.
If a drawer is not installed, it is not displayed.
3)
Press the Previous Screen button to return to the Main screen.
Understanding the View Cell Status Screen Display
For each cell, the cell identification number appears at the top of the circle.
A hollow circle indicates an empty cell, and a solid circle indicates a loaded
cell. The color of the solid circle indicates the bottle status or a cell that is
pending quality control check.
• Black — negative-to-date bottle
• Green — negative bottle
• Yellow — positive bottle
• White — cell is pending quality control check
Loaded cells also contain symbols to indicate the bottle's status:
Note:
+
Positive
–
Negative
*
Negative-to-date
~+
Critical determination in progress. (Represents
a bottle that is presently undergoing a critical
determination as to whether it will turn positive
or remain negative or negative-to-date.)
Bottles with a critical determination in progress status will be temporarily
removed from the bottle count table on the Main screen.
Cells loaded with an anonymous bottle contain a ?. If a loaded cell contains
no ?, then the bottle is identified.
Disabled racks and cells are indicated by gray diagonal stripes within their
borders. Disabled drawers are indicated by gray diagonal stripes within the
drawer indicator (see Enabling and Disabling Modules, Drawers, Racks, and
Cells in Chapter 8).
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1
2
Figure 3-6: Disabled Cell and Drawer
1 — Disabled Cell
2 — Disabled Drawer
Note:
If a drawer is disabled, its racks and cells are disabled and turn gray.
Text/Data Entry
Common Text Fields and Field Limit
Bottle ID field
Patient First Name field — may contain up to
20 characters
Patient Last Name field — may contain up to
31 characters
Accession Number field — may contain up to
16 characters
Hospital ID field — may contain up to 22
characters
Note:
The field length and initial character type (alpha, numeric, or other) can be
configured for the Accession Number field. The initial character type can be
configured for the Bottle ID field. To configure these fields, contact your local
bioMérieux Representative.
Note:
The Hospital ID, Patient First Name, and Patient Last Name fields do not
display with the BacT/ALERT® 3D Signature configuration.
Note:
All fields except the Bottle ID field may be hidden or disabled regardless of
software configuration. To hide or disable a field, contact your local
bioMérieux Representative.
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Note:
Text/Data Entry
To change the order of the patient fields, contact your local bioMérieux
Representative.
Using the Barcode Scanner to Enter Data
To scan a bottle or accession barcode:
1)
Before scanning the barcode, touch the desired field to place focus on
that field. The field should turn white indicating focus.
2)
Rotate the bottle so the bottle ID or accession number barcode is on top.
3)
Place the bottle over the barcode strip located in the Barcode Reader
Aperture below the Control Panel of the Controller Module (see
Figure 2-2, Instrument Front View) or at the base of the barcode reader
stand with the Combination Module (see Figure 2-6, Front View
Combination Module).
4)
There will be two short beeps when the bottle ID is successfully scanned
into the Bottle ID field.
5)
If the Accession Number field is enabled, there will be three short
beeps when the accession number is successfully scanned into the
Accession Number field.
If an Operator Error occurs, a series of beeps will alert the operator to view
the Operator Panel.
If the barcode is not read:
Note:
1)
Verify the appropriate field has focus.
2)
Move the bottle away from the barcode strip and initiate another scan.
The Hospital ID field is a keyboard-entry field only.
Manually Entering Text into a Data Entry Field (Keyboard)
Field text, where applicable, can be entered using the keyboard (see
Figure 2-4, Accessing the Keyboard and Reference Card). If a barcode label
cannot be scanned successfully, the bottle ID or accession number can also
be entered using the keyboard.
See Appendix A for International character entry instructions.
Note:
3-10
Before entering text into a field, touch the desired field to place focus on that
field. The field should turn white indicating focus.
1)
Using the keyboard, enter the desired text.
2)
Press the Tab key to move focus to the next field.
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Note:
If desired, change the cursor location using the keyboard keys. Keys that
provide cursor positioning and editing functions are as follows:
LEFT ARROW
Moves cursor left one position
RIGHT
ARROW
Moves cursor right one position
HOME
Moves cursor to the start of the text field
END
Moves cursor to one position past end of text
DELETE
Deletes the character at the current cursor position
BACKSPACE
Deletes the character at the current cursor position
and moves the cursor left one position
Note:
Entering text does not over-write existing text located to the right of the
insertion point.
Note:
Entered text defaults to all-uppercase. To change the default, contact your
local bioMérieux Representative.
Loading Bottles
CAUTION: In order to preserve test data integrity, handle only
one bottle at a time. Completely load a bottle according to this
procedure before proceeding to the next bottle.
Loading Bottles
1)
From the Main screen (see Figure 3-1, Main Screen, on page 3-3), press
the Load Bottles button (
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Loading Bottles
The Load Mode screen appears.
1
2
3
4
5
7
6
8
Figure 3-7: Main Screen — Load Mode
1 — Load Bottles Icon
5 — Patient First Name Field*
2 — Change Maximum Test
Time Button
6 — Accession Number Field
3 — Bottle Type Scroll Button
8 — Hospital ID Field*
7 — Patient Last Name Field*
4 — Bottle ID Field
*Available with Select and SelectLink only.
The number of available cells appears at the bottom of each drawer on
the Instrument icon.
Green indicators on Incubation or Combination Module drawers
illuminate drawers that contain available cells.
CAUTION: Inspect each bottle and sensor before loading:
If the sensor is yellow, treat the bottle as a positive culture. If the
bottle is cracked, do not load the bottle.
2)
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Verify the Bottle ID field appears white, then scan or manually enter the
bottle ID (see Text/Data Entry on page 3-9).
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If the field is left blank when a bottle is loaded, then the bottle is
considered anonymously loaded (see Handling Anonymous Bottles on
page 3-16).
3)
Verify the correct bottle type is displayed on the Bottle Type scroll
button.
If the Bottle ID field contains data from a generic label, the bottle type
can be manually entered using the Bottle Type scroll button before
inserting the bottle to ensure proper testing of the bottle. The instrument
will also beep continuously to alert the operator that the bottle type needs
to be manually entered. The audible alert can be disabled by calling
bioMérieux for assistance. See Figure 3-7, Main Screen — Load Mode,
on page 3-12.
CAUTION: For best results, manually enter the bottle type when
“GENERIC” is the displayed bottle type. Otherwise, observe the
following:
When a bottle is loaded with a generic or anonymous bottle type,
care must be taken to load BacT/ALERT® MP bottles into
drawers labeled MB. The maximum test time assigned to a
generic bottle loaded into an MB drawer is the same time
assigned to the BacT/ALERT® MP media type in the Set
Maximum Test Time screen (see Setting the Maximum Test
Time in Chapter 7).
All non-MB bottles must be loaded into drawers labeled BC and
the maximum test time is set to the time specified for the
Unknown bottle type.
BacT/ALERT® MB Bottles should never be loaded with a Generic
media type or loaded anonymously. BacT/ALERT® MB must be
displayed on the Bottle Type scroll button before loading a
BacT/ALERT® MB bottle.
4)
If the Accession Number field is enabled and blank, then continue to
Step 5. If the Accession Number field is disabled, then go to Step 7.
5)
Verify the Accession Number field appears white, then scan or
manually enter the accession number.
6)
If the fields are displayed and enabled, then manually enter the following
in the order listed: Hospital ID, Patient First Name, and Patient Last
Name.
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Loading Bottles
• To change the order of the Patient First Name and Patient Last
Name fields, contact your local bioMérieux Representative.
• Entries to the Patient First Name and Patient Last Name fields
cannot be made without the Hospital ID entry.
Note:
The Hospital ID field is a keyboard-entry only field.
7)
The default maximum test time is displayed above the Change Maximum
Test Time button. The scanned bottle's maximum test time can be
adjusted if desired. See Changing the Maximum Test Time — Individual
Bottles on page 3-15.
8)
If all drawers are closed, slowly open a drawer with an illuminated
indicator. Available cells will have an illuminated cell indicator light.
9)
Insert the bottle, sensor first, into a cell with an illuminated cell indicator
light.
WARNING
An erroneous test result (ex. false negative or false positive)
could occur if a bottle is not fully seated into a cell. When
inserting a bottle, ensure the bottle is fully seated into the cell.
See Appendix C, Best Practices for additional information on
preventing false positives.
10) The cell indicator light blinks slowly to acknowledge the bottle is loaded.
11) Verify that all text fields clear before proceeding.
12) Repeat Step 2 through Step 11 for each remaining bottle. Limit the bottle
load time to two minutes in one area to control entry of room temperature
bottles into racks. Close the drawer to allow temperature to equilibrate
before loading in that area again. Load bottles into different drawers (ex.,
If you have four incubators, use the drawers in all four incubators). See
Appendix C, Best Practices for loading bottles.
CAUTION: If a large number of bottles are loaded into the
Incubation Module at the same time and in the same areas, a
large heat mass loss within the racks may occur. This heat loss
may trigger the acceleration or rate algorithms to erroneously
flag positive.
13) When all bottles are loaded, ensure that all drawers are completely
closed, then press the Check button.
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If no operator or bottle loading activity has been recorded in a period of
two minutes, the instrument will terminate the Load Bottle operation.
Operator activity includes:
• pressing keys on the keyboard
• scanning barcodes
• touching the Operator Panel
• loading or unloading bottles
14) If applicable, enter the patient and accession data associated with the
loaded bottles into the bioMérieux data management computer.
Changing the Maximum Test Time — Individual Bottles
1)
From the Load screen, press the Change Maximum Test Time button
(
) after scanning the bottle barcode.
The Change Maximum Test Time screen overlays and disables the Load
screen.
2
1
Figure 3-8: Change Maximum Test Time Screen
1 — Bottle ID Field
2 — Max Test Time Scroll Buttons
2)
Verify the bottle ID matches that of the bottle for which you wish to
change the maximum test time.
3)
Adjust the maximum test time in days using the Max Test Time scroll
buttons.
4)
Press the Check button to accept the changes, or the Cancel button to
retain the original setting.
The system returns to the Load Mode screen.
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Unloading Bottles
Note:
Changing the maximum test time of an individual bottle during loading does
not affect any other bottles of the same type.
Note:
The maximum test time of an individual bottle can also be changed from the
Edit Bottle Detail screen after loading (see Viewing/Editing Bottle Data in
Chapter 5).
Handling Anonymous Bottles
Bottles loaded into the Incubation Module without accessing the Load Bottles
function on the Main screen are referred to as Anonymous bottles because
they are not associated with a bottle ID.
CAUTION: BacT/ALERT® MB (Mycobacteria Blood) Bottles
should never be loaded anonymously. Appropriate testing of
anonymous bottles occurs only when BacT/ALERT® MP bottles
are loaded into drawers labeled MB and non-MB bottles are
loaded into drawers labeled BC.
The maximum test time of anonymous bottles loaded into MB
drawers is the same time specified for the BacT/ALERT® MP
media type on the Set Maximum Test Time screen.
Anonymous bottles loaded into BC drawers are assigned the
standard default algorithm.
Anonymous bottles should be removed and identified as specified in
Unloading Bottles on page 3-16, or identified using the Edit Bottle Detail
screen (see Editing Bottle Details Using the Edit Bottle Detail Screen in
Chapter 5).
Unloading Bottles
The BacT/ALERT® 3D signals which type of bottles are ready for unloading
by enabling the appropriate Unload button.
CAUTION: In order to preserve test data integrity, handle only
one bottle at a time. It is important to complete the procedure for
each bottle before proceeding to the next bottle.
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Unloading Bottles
1)
Generate an Unload report (see Viewing, Printing, and Exporting Test
Data on page 3-24).
2)
From the Main screen (see Figure 3-1, Main Screen, on page 3-3), press
the appropriate Unload button.
• The Unload Mode screen appears (see Figure 3-9).
• Green indicators illuminate on drawers containing bottles of the
selected unload type.
1
2
3
4
5
6
7
8
Figure 3-9: Main Screen — Unload Mode
1 — Unload Bottles Icon
5 — Patient First Name Field
2 — Unload Buttons
6 — Accession Number Field
3 — Bottle Type Scroll Button
7 — Patient Last Name Field
4 — Bottle ID Field
8 — Hospital ID Field
3)
Open the indicated drawer. When the indicated drawer is open, cell
indicator lights light up next to all bottles in the selected category.
4)
Remove one of the bottles indicated. Wait for the cell light to blink slowly
to acknowledge the removal of the bottle.
5)
If the bottle was identified when loaded:
• The bottle ID and bottle type will appear on the Unload Mode screen;
however, the accession number, hospital ID, patient first name, and
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Unloading Bottles
patient last name will appear in disabled text fields, if information is
available.
a. It is not necessary to re-scan the bottle ID; however, doing so will
verify that bottle's identity.
b. If fields are blank or need editing, then use the Edit Data
Relationships function (see Editing Data Relationships in Chapter 5).
6)
Go to Step 8.
7)
If the bottle was anonymously loaded (the Bottle ID field is blank), scan
or manually enter the bottle ID.
a. Identify the bottle by entering the bottle ID, bottle type, accession
number, hospital ID, and patient first and last name as performed in
the procedure, Loading Bottles on page 3-11.
• Scanning the bottle ID successfully results in two short beeps.
• Scanning the accession number successfully results in three short
beeps.
• When identifying anonymous bottles, information entered in the Bottle
ID, Bottle Type, Accession Number, Hospital ID, Patient First
Name, and Patient Last Name fields, and with the Bottle Type scroll
button, is associated with the unloaded bottle once the next bottle is
unloaded or the Check button is pressed.
b. If the bottle is to be reloaded, immediately return the bottle to the cell
with the slowly blinking cell indicator light before unloading another
bottle.
WARNING
Bottles with a critical determination in progress will be
temporarily removed from the bottle count table on the Main
screen.
c. Do not reload the bottle if its status is negative, positive, or if it is
necessary to use the bottle label to enter information into the
bioMérieux data management computer.
CAUTION: Reloading bottles anonymously that were previously
loaded will result in duplicate bottle records.
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8)
Repeat Step 3 through Step 5 for the remaining bottles to be unloaded.
Limit the bottle unload time to no more than two minutes in one area.
Close the drawer to allow temperature to equilibrate before unloading
from the area again. See Appendix C, Best Practices for unloading
bottles and preventing false positives.
CAUTION: If a large number of bottles are unloaded from the
Incubation Module at the same time and in the same areas, a
large heat mass loss within the racks may occur. This heat loss
may trigger the acceleration or rate algorithms to erroneously
flag positive.
9)
When finished unloading bottles, ensure that all drawers are completely
closed.
10) Press the Check button on the Unload Mode screen.
11) Verify that the bottles listed on the Unload report were unloaded.
12) Where applicable, enter patient and accession data associated with the
unloaded bottles into the bioMérieux data management computer.
13) Reload any previously Anonymous negative-to-date bottles.
If no operator or bottle loading activity has been recorded in a period of
two minutes, the instrument will terminate the Unload Bottle operation.
Operator activity includes:
•
•
•
•
pressing keys on the keyboard
scanning barcodes
touching the Operator Panel
loading or unloading bottles
Handling Unconfirmed Positive Bottles (False Positives)
If a smear of a positive bottle reveals no microorganisms, the bottle should be
subcultured and reloaded into the instrument via the Load Bottles function
(see Loading Bottles on page 3-11).
Note:
If a bottle is reloaded into the instrument, its status will revert to negative-todate once a reading has been taken (maximum time – 10 minutes).
If growth appears on the subculture, edit the bottle's status to Positive on the
Edit Test Result screen which is accessed from the Edit Bottle Detail screen
(see Edit Test Result Button in Chapter 5), and unload the now positive
bottle.
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Accessing the Setup Screen Function Buttons
Note:
Results that have been manually changed to negative or positive via the Edit
Bottle Detail screen (see Editing Bottle Details Using the Edit Bottle Detail
Screen in Chapter 5), will be marked on the report with a stick figure ( ).
Note:
If a bottle is positive (set manually, or positive by any other reason) and then
is manually changed to negative-to-date, the stick figure ( ) will not appear.
Accessing the Setup Screen Function Buttons
To view and print data, print graphs, and perform all of the editing,
configuration, and maintenance functions of the system, you must first
access the Setup screen function buttons.
Accessing the Setup Screen
1)
From the Main screen (see Figure 3-1, Main Screen, on page 3-3), press
the Next Screen button (
).
The Setup screen appears.
1
4
3
2
Figure 3-10: Setup Screen
1 — Password Entry Keypad
2 — Function Buttons
3 — Key Symbol Button
4 — Padlock Icon
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Accessing the Setup Screen Function Buttons
2)
Basic Functions (Clinical Use)
Enter a valid password using the 1 – 4 buttons. Until a valid password is
entered and accepted, the Padlock icon will appear in the closed
position.
Note:
Acceptable passwords consist of any combination of the numbers 1 to 4 and
have a maximum length of eight characters.
Note:
Instruments are shipped with a password of 1234. For information on
changing the default password, see Changing the System Password in
Chapter 7.
3)
Press the Key Symbol button to accept the password.
4)
After a valid password is accepted, the Padlock icon changes to the full
open position and the function buttons become enabled.
Note:
To correct an error made while entering a password, press the Key Symbol
button and re-enter the password.
Note:
If more than 8 characters are entered, the Password Entry buttons will
become inactive and turn gray. Press the Key Symbol button and re-enter
the password.
Inactivity Timeout for all Setup Screens
While you are in the Setup screen (see Figure 3-10, Setup Screen) or one of
its sub-menus, an inactivity timeout will occur (within a period of time
configured by your bioMérieux Service Representative) if you do not perform
one of the following actions:
• press a screen or keyboard button
• scan a barcode
• load or unload a bottle
If an inactivity timeout occurs, the instrument display reverts from the
currently displayed screen to the Main screen. Any pending function is
cancelled as if the Cancel button on each successive screen was pressed.
Note:
If a timeout occurs, it is possible that partially entered information will be lost.
Note:
The inactivity timeout feature is disabled while a red operator error is
displayed on the screen.
Setup Screen Function Buttons
Set Date/Time button (see Setting and Formatting the System Date and Time in Chapter 8)
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Accessing the Setup Screen Function Buttons
Enable/Disable Module, Drawer, Rack, or Cell button (see Enabling and Disabling
Modules, Drawers, Racks, and Cells in Chapter 8)
Calibrate Module Temperature button (see Adjusting an Incubation or Combination
Module’s Temperature in Chapter 8)
Set Maximum Test Time button (see Setting the Maximum Test Time in Chapter 7)
Set Audible Alarm Options button (see Setting the Audible Alarms in Chapter 7)
Change Password button (see Changing the System Password in Chapter 7)
Select Bottle to Edit/Graph button (see Selecting Bottles Using the Select Bottle to Edit/
Graph Button in Chapter 5)
Edit Cell Contents button (see Selecting Bottles Using the Edit Cell Contents Button in
Chapter 5)
Calibrate Cell button (see Calibrating an Instrument Cell in Chapter 8)
View Incubation Module Information button (see Viewing Incubation Module
Information in Chapter 8)
Backup Management button (see Initiating Manual Backup in Chapter 7)
Edit Data Relationships button (see Initiating the Edit Data Relationships Function in
Chapter 5)
Report button — Select and SelectLink only (see Viewing, Printing, and Exporting Test
Data on page 3-24)
Configure Users button — Button only appears in 21 CFR Part 11 mode (see Configuring
Users — 21 CFR Part 11 Mode in Chapter 10)
Bottle Processing/Customization button (For use only with instruction from bioMérieux)
3-22
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Viewing and Printing
Introduction
Viewing Bottle Data
The following bottle information can be viewed by accessing the Edit Bottle
Detail screen as described in Editing Test Data (see Viewing/Editing Bottle
Data in Chapter 5):
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Bottle ID
Accession number
Hospital ID (where applicable)
Patient first and last name (where applicable)
Cell ID
Maximum test time
Bottle type
Date/time loaded
Date/time unloaded
Date/time of last bottle reading
Test time
Test result
Algorithm type
How determined/positivity index
Viewing/Printing Reports
With a BacT/ALERT® 3D Signature configuration, reports are viewed and
printed at the data management computer.
With the BacT/ALERT® 3D Select or SelectLink configurations, reports are
viewed and printed by using the Report button as described in the topic,
Viewing, Printing, and Exporting Test Data on page 3-24.
Viewing/Printing Graphs
Bottle Graphs can be viewed and printed on the BacT/ALERT® 3D Select
and SelectLink configurations as described in the topic, Viewing and Printing
Bottle Graphs on page 3-31. For the Signature configuration, graphics can be
viewed as described in the topic, Viewing and Printing Bottle Graphs on page
3-31, or at the data management computer. Since the BacT/ALERT® 3D
Signature configuration is not connected to a printer, you must use the data
management computer to print a graph.
Note:
The print feature can be made unavailable regardless of software
configuration. When the feature is unavailable, the Print buttons do not
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Viewing and Printing
display. To make the print feature unavailable, contact your local bioMérieux
Representative.
Using the Print Screen Function
You can print the current screen on the instrument by pressing Ctrl + P on
the keyboard.
Note:
Select and SelectLink configurations only.
Viewing, Printing, and Exporting Test Data
Note:
If you have a BacT/ALERT® 3D Signature configuration, you must use the
data management computer to view and print reports.
1)
From the Setup screen (see Figure 3-10, Setup Screen, on page 3-20),
press the Report button (
Note:
).
The Report button is not available with the BacT/ALERT® 3D Signature
configuration.
The Report Selection screen appears.
1
2
3
4
5
Figure 3-11: Report Selection Screen
1 — Display Report 1 Button
4 — Previous Screen Button
2 — Display Report 2 Button
5 — Check Button
3 — Display Report 3 Button
3-24
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2)
Press the Display Report 1, 2, or 3 button that is configured for the
information desired.
The Report screen will display. There are three default report
configurations:
• Display Report 1 button — Generates the Load Report screen with
1st Load Time as the primary sort, and Accession Number as the
secondary sort. Report has section breaks based on 1st Load Time.
• Display Report 2 button — Generates the Status Report screen with
Accession Number as the primary sort, and Bottle Type as the
secondary sort. Report has section breaks based on Accession
Number.
• Display Report 3 button — Generates the Unload Report screen with
Loaded as the primary sort, and Test Result as the secondary sort.
Report has section breaks based on Loaded and Test Result.
See Configuring Report Contents in Chapter 7 for examples of the Load,
Status, and Unload Report Configuration screens.
Note:
Data from the last 1,920 bottles are displayed each time a Report screen is
accessed. The report screens come configured with default settings, but the
report configurations can be changed to display different data and to sort the
data differently (see Configuring Report Contents in Chapter 7).
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21
20
19
18
1
2
17
3
16
4
5
15
6
14
7
8
9
10
11
12
13
Figure 3-12: Sample Report Screen
1 — Section Scroll Up Button
11 — Line Scroll Down Button
2 — Relative Record Scroll
Indicator
12 — Page Scroll Down Button
3 — Relative Record Scroll Bar
14 — Gap Detection Indicator
4 — Find Text Button
15 — Report Data Lines
5 — Save Button
16 — Stick Figure
6 — Print Current Section
Button
17 — Current Section Line
7 — Print Report Button
8 — Cancel Print Button
9 — Previous Screen Button
10 — Section Scroll Down
Button
3-26
13 — End Scroll Button
18 — Home Scroll Button
19 — Page Scroll Up Button
20 — Report Title
21 — Line Scroll Up Button
Note:
Results that have been manually changed to negative or positive (see Editing
Bottle Details Using the Edit Bottle Detail Screen in Chapter 5) will be marked
on the report with a stick figure ( ).
Note:
If a bottle is positive (set manually, or positive by any other reason) and then
is manually changed to negative-to-date, the stick figure ( ) will not appear.
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Note:
Bottles with an Instrument Fault Code 80 will be marked on the report with a
Gap Detection indicator (!) next to the result. If a negative bottle has an
Instrument Fault Code 80 while it is being unloaded, the Gap Detection
indicator will remain on the report (see Instrument Fault Codes in Chapter 9).
Note:
The Current Group Line will always display the group that is associated with
the first displayed data record. It is always highlighted for easy reference. If
there are no section breaks in the displayed report, this line will become the
first line of data records displayed and reference highlighting will not occur.
3)
Note:
The Group scroll buttons are disabled if there are no section breaks in the
displayed report or if there are no available sections in the indicated direction.
4)
Note:
To scroll up to the oldest data line (the first data record in the report),
press the Home scroll button or press the Home key on the keyboard.
The Home scroll button is disabled if there are no report data lines in the
indicated direction.
7)
Note:
To scroll up or down a data page, press the appropriate Page scroll
button or press the appropriate Page Up or Page Down key on the
keyboard.
The Page scroll buttons are disabled if there are no data lines in the indicated
direction.
6)
Note:
To scroll up or down a data line, press the appropriate Line scroll button
or press the appropriate ↑ or ↓ key on the keyboard.
The Line scroll buttons are disabled if there are no data lines in the indicated
direction.
5)
Note:
To scroll up or down a group, press the appropriate Group scroll button.
To scroll down to the newest data line (the last data record in the report),
press the End scroll button or press the End key on the keyboard.
The End scroll button is disabled if there are no report data lines in the
indicated direction.
8)
To move to a relative record position, press the Relative Record scroll
bar above/below the Relative Record Indicator.
Note:
The Relative Record Indicator is sized proportionally to the amount of records
in the report.
Note:
The Relative Record scroll bar is disabled if the Relative Record Indicator is
the same size as the scroll bar and all the data records in the report are
displayed.
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9)
Viewing and Printing
To print the report, press the appropriate Print button:
• Pressing the Print Report button prints all records in the database
(with a maximum of 1,920 records).
• Pressing the Print Current Group button prints the Current Group
Line and all data records associated with the group.
Note:
The Print buttons are only available if a printer is configured for the system.
To configure a printer for the system, contact your local bioMérieux
Representative.
10) While the report is printing:
• All Print and Save buttons are disabled.
• The operator may, however, view and scroll through the displayed
report, search for text in the displayed report, or exit the Report screen
and perform other operations.
• The Cancel Print button becomes available.
11) Press the Cancel Print button to stop sending data to the printer and to
empty the queue of any data waiting to be sent to the printer.
Note:
Once the cancellation has been completed, the Print and Save buttons will
become enabled, and the Cancel Print button will be disabled.
12) To specify a text string and initiate a search of the report data for the
specified text, press the Find Text button. The Find Text screen will
appear.
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1
Figure 3-13: Find Text Screen
1 — Find Text Field
Use the keyboard to enter the text you wish to seek, and press the
Check button to return to the Report screen. Pressing the Cancel button
will cancel the search request and return to the Report screen.
Note:
The search will be performed upon returning to the report screen starting
from the top of the report. The record that contains the first occurrence of the
text will be scrolled to the first line of data displayed and the text itself will be
highlighted for reference.
If no occurrence of the specified text is found, the data displayed will not
change and no reference highlighting will occur.
13) To find the next instance of the specified text, press the F3 key on the
keyboard.
Note:
If no new instance of the text is found the data displayed, and the highlighted
text will remain the same.
14) To save the displayed report to a text file, press the Save button.
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Viewing and Printing
The Save To File screen appears.
1
Figure 3-14: Save to File Screen
1 — File Name Field
Note:
The default file name and path will appear automatically in the File Name
field. Use the keyboard to change the name of the file.
Note:
All reports are saved to the pathname, D:\REPORTS, either using the default
file name or a specified file name. All reports are automatically given an
extension of .TXT.
15) Place the backup media in the backup drive.
Note:
Backup media can either be a Zip® disk or a USB flash drive.
16) Press the Check button to initiate the save and return to the Report
screen. Pressing the Cancel button will cancel the save request and
return to the Report screen.
Note:
The Print buttons will be disabled while the save is taking place. Once the
save has completed, the Print buttons will be enabled.
WARNING
Do not insert any object, other than a Zip® disk, into the Zip®
drive under any circumstances.
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CAUTION: Do not forcibly remove the Zip® disk from the
instrument. Forcibly removing the Zip® disk may cause damage
to the Zip® disk or Zip® drive and may cause the system to lock
up.
17) Press the Previous Screen button to return to the screen from which the
Report screen was accessed.
Viewing and Printing Bottle Graphs
Note:
If you have a BacT/ALERT® 3D Signature configuration, you must use the
data management computer to print a bottle graph since the
BacT/ALERT® 3D Signature configuration is not connected to a printer.
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons on page 3-20).
2)
Press the Select Bottle to Edit/Graph button (
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The Select Bottle to Edit/Graph screen overlays and disables the Setup
screen.
9
1
8
2
7
3
4
5
6
Figure 3-15: Select Bottle to Edit/Graph Screen
1 — Incubation Module Scroll
Button
6 — Check Button
2 — Cell Scroll Buttons
7 — Graph Bottle Readings
Button
3 — Setup Screen (Disabled)
8 — Drawer Scroll Button
4 — Previous Screen Button
9 — Bottle ID Field
5 — Cancel Button
3)
Note:
Only the last 1,920 bottles loaded can be retrieved. Any other entry in the
Bottle ID field is invalid and will cause an Operator Error 940 (see Operator
Error Codes in Chapter 9).
4)
3-32
If you know the bottle ID of the bottle whose readings you wish to graph,
then enter the bottle ID in the Bottle ID field (see Text/Data Entry on
page 3-9) and go to Step 5. If you know the cell location but not bottle ID,
then continue to Step 4.
Adjust the Incubation Module (1–6), Drawer (A–D), and Cell (1–60)
scroll buttons to select the cell location of the bottle whose readings you
wish to graph. The cell location defaults to Module 1, Drawer A, Cell 1
(1A01).
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Note:
Only cell locations with currently loaded bottles can be used to view bottle
graphs. To view graphs of recently unloaded bottles (the most recent 1,920
bottles loaded), you must use the Bottle ID field.
5)
Press the Graph Bottle Readings button (
).
The Graph Bottle Readings screen appears (see Figure 3-16).
11
9
10
1
8
7
3
2
4
5
6
Figure 3-16: Graph Bottle Readings Screen
1 — Name Field*
7 — Bottle Readings Range
2 — Previous Screen Button
8 — Days Tested Range
3 — Adjust Y Scale Button
9 — Hospital ID Field*
4 — Adjust X Scale Button
10 — Accession Number Field
5 — Bottle Readings Button
11 — Bottle ID Field
6 — Print Graph Button
* Available in Select and
SelectLink only.
You can also access the Graph Bottle Readings screen via the Edit
Bottle Detail screen (see Editing Bottle Details Using the Edit Bottle
Detail Screen in Chapter 5). The screen ID number is the same
regardless of how it is accessed.
• The Y axis range defaults to 0 – 5000, and the X axis range defaults to
0 – maximum test time of the bottle in days.
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• If the bottle was determined positive, then a dot and the time to
detection (days) are displayed at the point where it was determined
positive.
6)
To adjust the Y or X axis, click the appropriate Adjust Scale button.
When one of these buttons is clicked, the axis re-scales so that the
maximum endpoint of the scale is just higher then the maximum value of
the range. Adjusting the scale may mean increasing or decreasing the
range of the scale.
When one of the Adjust Scale buttons is clicked, the arrow on the button
changes directions. To return to the original scale, click the Adjust Scale
button(s) a second time.
7)
Press the Print Graph button, if available, to print the graph as it
appears on the screen.
Note:
The Print Graph button is only available if a printer is configured for the
system. The Print Graph button is disabled while a print is in progress.
Note:
To configure a printer for the system, contact your local bioMérieux
Representative.
8)
When done, press the Previous Screen button to return to the Select
Bottle to Edit/Graph screen.
Display Bottle Readings
The Bottle Readings screen displays the exact values of the bottle readings
for an individual bottle, along with the date and time each reading was taken.
Note:
The polynomial is applied to the bottle readings. The readings are not the raw
readings.
If there are bottle readings available for you to view, the Bottle Readings
button on the Graph Bottle Readings screen turns blue (see Figure 3-16). If
there are no readings available, the button is gray.
1)
From the Graph Bottle Readings screen (see Figure 3-16), press the
Bottle Readings button (
3-34
).
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The Bottle Readings screen appears.
15
14
13
12
1
11
2
3
4
5
6
7
8
9
10
Figure 3-17: Bottle Readings Screen
1 — Bottle Cell Location
9 — Page Scroll Down Button
2 — Find Text Button
10 — End Scroll Button
3 — Save Button
4 — Print Button
11 — Bottle Reading (Date/
Time/Reading)
5 — Cancel Print Button
12 — Home Scroll Button
6 — Previous Screen Button
13 — Page Scroll Up Button
7 — Anchor Display Bottom
Button
14 — Line Scroll Up Button
8 — Line Scroll Down Button
2)
Note:
To scroll up or down a data line, press the appropriate Line scroll button
or press the appropriate ↑ or ↓ key on the keyboard.
The Line scroll buttons are disabled if there are no data lines in the indicated
direction.
3)
Note:
15 — Anchor Display Top
Button
To scroll up or down a data page, press the appropriate Page scroll
button or press the appropriate Page key on the keyboard.
The Page scroll buttons are disabled if there are no data lines in the indicated
direction.
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4)
Note:
To scroll down to the newest data line (the last data record in the report),
press the End scroll button or press the End key on the keyboard.
The End scroll button is disabled if there are no report data lines in the
indicated direction.
6)
Note:
To scroll up to the oldest data line (the first data record in the report),
press the Home scroll button or press the Home key on the keyboard.
The Home scroll button is disabled if there are no report data lines in the
indicated direction.
5)
Note:
Viewing and Printing
To print the bottle readings, press the Print button.
The Print buttons are only available if a printer is configured for the system.
To configure a printer for the system, contact your local bioMérieux
Representative.
7)
While the report is printing:
• All Print and Save buttons are disabled.
• The operator may, however, view and scroll through the displayed list,
search for text in the displayed list, or exit the Bottle Readings screen
and perform other operations.
• The Cancel Print button becomes available.
8)
Note:
Once the cancellation has been completed the Print and Save buttons will
become enabled, and the Cancel Print button will be disabled.
9)
3-36
Press the Cancel Print button to stop sending data to the printer and to
empty the queue of any data waiting to be sent to the printer.
To specify a text string and initiate a search of the report data for the
specified text, press the Find Text button.
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The Find Text screen appears.
1
Figure 3-18: Find Text Screen
1 — Find Text Field
Use the keyboard to enter the text you wish to seek, and press the
Check button to return to the Bottle Readings screen. Pressing the
Cancel button will cancel the search request and return to the Bottle
Readings screen.
Note:
The search will be performed upon returning to the report screen starting
from the top of the report. The record that contains the first occurrence of the
text will be scrolled to the first line of data displayed and the text itself will be
highlighted for reference.
If no occurrence of the specified text is found, the data displayed will not
change and no reference highlighting will occur.
10) To find the next instance of the specified text, press the F3 key on the
keyboard.
Note:
If no new instance of the text is found, the data displayed, and the highlighted
text will remain the same.
11) To save the bottle readings to a text file, press the Save button.
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The Save To File screen appears.
1
Figure 3-19: Save to File Screen
1 — File Name Field
Note:
The default file name and path will appear automatically in the File Name
field. Use the keyboard to change the name of the file.
Note:
All reports are saved to the pathname, D:\REPORTS, either using the default
file name or a specified file name. All reports are automatically given an
extension of .TXT.
12) Place the backup media in the backup drive.
Note:
Backup media can either be a Zip® disk or a USB flash drive.
13) Press the Check button to initiate the save and return to the Bottle
Readings screen. Pressing the Cancel button will cancel the save
request and return to the Bottle Readings screen.
Note:
The Print buttons will be disabled while the save is taking place. Once the
save has completed, the Print buttons will be enabled.
WARNING
Do not insert any object, other than a Zip® disk, into the Zip®
drive under any circumstances.
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CAUTION: Do not forcibly remove the Zip® disk from the
instrument. Forcibly removing the Zip® disk may cause damage
to the Zip® disk or Zip® drive and may cause the system to lock
up.
14) Press the Previous Screen button to return to the screen from which the
Bottle Readings screen was accessed.
15) When done, press the Previous Screen button to return to the Graph
Bottle Readings screen.
Sending/Requesting LIS Information
Results can be manually sent to, and demographics can be manually
requested from, an LIS when the BacT/ALERT® 3D SelectLink configuration
is used.
Note:
Data is transmitted according to the BacT/LINK® protocol. For more
information, contact your local bioMérieux Representative.
Note:
The system can be configured to perform these functions automatically. To
adjust these settings, contact your local bioMérieux Representative.
Note:
The arrows on the Manual Send Test Results and Manual Request Test
Orders buttons also serve as an indicator of automatic data transfer.
Sending Results to the LIS
1)
From the Main screen (see Figure 3-1, Main Screen, on page 3-3), press
the Manual Send Test Results button (
).
The arrow on the button face will blink during the transfer.
Note:
Only accessions with one or more bottles that have had a status change to
positive, or that have reached maximum test time with a negative status and
have been unloaded, since the last transfer will be sent.
Requesting Information from the LIS
1)
From the Main screen (see Figure 3-1, Main Screen, on page 3-3), press
the Manual Request Test Orders button (
).
The arrow on the button face will blink during the transfer.
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BASIC FUNCTIONS (INDUSTRY USE)
4
About This Chapter
This chapter introduces you to the Main screen and provides you with
procedures on how to perform daily basic functions for INDUSTRY use.
Chapter Contents
Introduction • 4-2
Monitoring the System • 4-3
Main Screen Introduction • 4-3
Viewing Faults • 4-6
Viewing the Cell Status Screen • 4-7
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
Setup Screen Function Buttons • 4-21
Viewing and Printing • 4-23
Introduction • 4-23
Viewing, Printing, and Exporting Test Data • 4-24
Viewing and Printing Bottle Graphs • 4-31
Display Bottle Readings • 4-34
Sending/Requesting LIS Information • 4-39
Sending Results to the LIS • 4-39
Requesting Information from the LIS • 4-39
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Introduction
Introduction
The basic functions are those tasks that may be performed during daily
workflow. They include:
• Monitoring system
• Entering data (where applicable)
• Loading and unloading bottles
• Viewing and printing data (printing with the BacT/ALERT® 3D Signature is
performed at the data management computer.)
• LIS interaction with the BacT/ALERT® 3D SelectLink
• Accessing the Setup screen
4-2
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Monitoring the System
Main Screen Introduction
The BacT/ALERT® 3D system can be monitored from the Main screen (see
Figure 4-1).
10
1
9
2
3
8
4
5
6
7
Figure 4-1: Main Screen
1 — Screen ID Number
2 — Bottle Count Table
3 — Unload Buttons
4 — Manual Send Test Results Button (SelectLink only)
5 — Manual Request Test Orders Button (SelectLink only)
6 — Logout Button (21 CFR Part 11 Mode only)
7 — Load Bottles Button
8 — Instrument Icon
9 — Current Date/Time
10 — Software Configuration
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CAUTION: If the current date/time displayed at the top of the
screen does not advance, contact bioMérieux Customer Service
immediately.
Background Color
The default background color is determined by the software configuration
(see Software Configuration Options in Chapter 2). The following conditions
will override default background colors:
• A yellow screen indicates that the instrument has detected a positive bottle.
• A red screen indicates that an instrument fault has occurred. Touching the
screen or pressing any key on the keyboard returns a red screen to yellow
or the configuration default color depending on whether positive bottles are
present. The fault code will remain on the screen until the error is cleared.
Instrument Icon
The following information is indicated on the Instrument icon:
• System ID numbers are assigned to both the Controller/Combination
Module and Incubation Modules.
• Combination Module has 2 System ID numbers.
• The programmed optimal temperature (ºC) is displayed for each Incubation
Module.
• Software version number for the BacT/ALERT® 3D Controller/Combination
Module.
• Disabled or uninstalled components appear diagonally striped in gray on
the screen.
• An entire rack will appear diagonally striped if only one of its cells is
disabled.
4-4
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1
4
5
2
3
Figure 4-2: Combination Module with an Additional Incubation Module
1 — Combination Module Instrument Icon
2 — Combination Module ID
3 — Software Version
4 — Incubation Module ID
5 — Optimal Temp (ºC)
1
2
4
3
5
Figure 4-3: Controller Module with One Incubation Module
1 — Controller Module Instrument Icon
2 — Optimal Temp (ºC)
3 — Disabled Rack or Cell
4 — Controller ID
5 — Software Version
Bottle Count Table
Located just above the Instrument icon are the Unload buttons and a bottle
count table indicating the number of bottles of each type currently loaded in
the instrument.
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Monitoring the System
3
5
7
9
4
6
8
10
1
2
Figure 4-4: Bottle Count Table/Unload Buttons
1 — Total number of mycobacteria (MB) bottles loaded in the system
(reserved for other applications).
2 — Total number of bottles loaded in the system. BC refers to bottle
count.
3 — Total number of identified bottles with a positive test status.
4 — Unload Positive Identified Bottles Button
5 — Total number of bottles (identified and anonymous) with a
negative test status.
6 — Unload Negative Bottles Button
7 — Total number of anonymous bottles with a positive test status.
8 — Unload Positive Anonymous Bottles Button
9 — Total number of anonymous bottles with a negative-to-date or
negative test status.
10 — Unload Anonymous Negative or Negative-to-Date Bottles Button
Viewing Faults
Instrument faults are reported using a numeric code within a red diamond
shape. Fault codes are displayed on the Instrument icon where the fault
condition exists.
Note:
Only high priority codes are displayed on the Instrument icon.
1)
If the code appears on the Controller Module or the top half of the
Combination Module, then move to Step 4. If the fault code appears on
an Incubation Module or bottom half of the Combination Module, then
continue to Step 2.
2)
Touch the Incubation or Combination Module on the Instrument icon
that contains the fault code.
3)
The View Cell Status screen appears (see Viewing the Cell Status
Screen on page 4-7 and Figure 4-5).
• Drawer faults appear at the top of the screen.
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Monitoring the System
Basic Functions (INDUSTRY Use)
• Rack faults appear at the left end of the rack display.
• Cell faults appear in the cell display.
4)
For a complete list and description of Instrument Fault Codes, see the
topic, Instrument Fault Codes in Chapter 9.
Viewing the Cell Status Screen
The View Cell Status screen is continuously updated with changes that occur
while the screen is active, such as the loading/unloading of bottles, new test
results, and the error status of the drawer, as indicated by fault codes
appearing or disappearing. To view the cell status screen:
1)
Display the View Cell Status screen by touching the appropriate
Incubation Module on the Instrument icon (see Figure 4-1, Main Screen,
on page 4-3).
9
11 10
1
2
8
3
7
4
6
5
Figure 4-5: View Cell Status Screen
1 — Incubation Module
Indicator
6 — Drawer Selection Button
2 — Cell Fault Code
8 — Cell
3 — Rack Fault Code
9 — Restart Incubation Module
Button
4 — Previous Screen Button
5 — Incubation Module
Selection Button
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7 — Rack
10 — Drawer Fault Code
11 — Drawer Indicator
4-7
Basic Functions (INDUSTRY Use)
2)
Note:
Monitoring the System
If necessary, use the Incubation Module Selection and Drawer Selection
buttons to display the desired drawer.
If a drawer is not installed, it is not displayed.
3)
Press the Previous Screen button to return to the Main screen.
Understanding the View Cell Status Screen Display
For each cell, the cell identification number appears at the top of the circle.
A hollow circle indicates an empty cell, and a solid circle indicates a loaded
cell. The color of the solid circle indicates the bottle status or a cell that is
pending quality control check.
• Black — negative-to-date bottle
• Green — negative bottle
• Yellow — positive bottle
• White — cell is pending quality control check
Loaded cells also contain symbols to indicate the bottle's status:
Note:
+
Positive
–
Negative
*
Negative-to-date
~+
Critical determination in progress. (Represents
a bottle that is presently undergoing a critical
determination as to whether it will turn positive
or remain negative or negative-to-date.)
Bottles with a critical determination in progress status will be temporarily
removed from the bottle count table on the Main screen.
Cells loaded with an anonymous bottle contain a ?. If a loaded cell contains
no ?, then the bottle is identified.
Disabled racks and cells are indicated by gray diagonal stripes within their
borders. Disabled drawers are indicated by gray diagonal stripes within the
drawer indicator (see Enabling and Disabling Modules, Drawers, Racks, and
Cells in Chapter 8).
4-8
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1
2
Figure 4-6: Disabled Cell and Drawer
1 — Disabled Cell
2 — Disabled Drawer
Note:
If a drawer is disabled, its racks and cells are disabled and turn gray.
Text/Data Entry
Common Text Fields and Field Limits
Bottle ID field
User Defined 1 field — may contain up to 20
characters
User Defined 2 field — may contain up to 31
characters
Sample ID # field — may contain up to 16
characters
User Defined 3 field — may contain up to 22
characters
Note:
The field length and initial character type (alpha, numeric, or other) can be
configured for the Sample ID field. The initial character type can be
configured for the Bottle ID field. To configure these fields, contact your local
bioMérieux Representative.
Note:
The User Defined 1, User Defined 2, and User Defined 3 fields do not
display with the BacT/ALERT® 3D Signature configuration.
Note:
All fields except the Bottle ID field may be hidden or disabled regardless of
software configuration. To hide or disable a field, contact your local
bioMérieux Representative.
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Text/Data Entry
Using the Barcode Scanner to Enter Data
To scan a bottle or sample barcode:
1)
Before scanning the barcode, touch the desired field to place focus on
that field. The field should turn white indicating focus.
2)
Rotate the bottle so the bottle ID or sample ID barcode is on top.
3)
Place the bottle over the barcode strip located in the Barcode Reader
Aperture below the Control Panel of the Controller Module (see
(Figure 2-2, Instrument Front View) or at the base of the barcode reader
stand with the Combination Module (see Figure 2-6, Front View
Combination Module).
4)
There will be two short beeps when the bottle ID is successfully scanned
into the Bottle ID field.
5)
If the Sample ID field is enabled, there will be three short beeps when
the Sample ID is successfully scanned into the sample ID field.
If an Operator Error occurs, a series of beeps will alert the operator to view
the Operator Panel.
If the barcode is not read:
Note:
1)
Verify the appropriate field has focus.
2)
Move the bottle away from the barcode strip and initiate another scan.
The User Defined 3 field is a keyboard-entry field only.
Manually Entering Text into a Data Entry Field (Keyboard)
Field text, where applicable, can be entered using the keyboard (see
Figure 2-4, Accessing the Keyboard and Reference Card). If a barcode label
cannot be scanned successfully, the bottle ID or sample ID can also be
entered using the keyboard.
See Appendix A for International character entry instructions.
Note:
4-10
Before entering text into a field, touch the desired field to place focus on that
field. The field should turn white indicating focus.
1)
Using the keyboard, enter the desired text.
2)
Press the Tab key to move focus to the next field.
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Loading Bottles
Basic Functions (INDUSTRY Use)
Note:
If desired, change the cursor location using the keyboard keys. Keys that
provide cursor positioning and editing functions are as follows:
LEFT ARROW
Moves cursor left one position
RIGHT
ARROW
Moves cursor right one position
HOME
Moves cursor to the start of the text field
END
Moves cursor to one position past end of text
DELETE
Deletes the character at the current cursor position
BACKSPACE
Deletes the character at the current cursor position
and moves the cursor left one position
Note:
Entering text does not over-write existing text located to the right of the
insertion point.
Note:
Entered text defaults to all-uppercase. To change the default, contact your
local bioMérieux Representative.
Loading Bottles
CAUTION: In order to preserve test data integrity, handle only
one bottle at a time. Completely load a bottle according to this
procedure before proceeding to the next bottle.
Loading Bottles
1)
From the Main screen (see Figure 4-1, Main Screen, on page 4-3), press
the Load Bottles button (
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Basic Functions (INDUSTRY Use)
Loading Bottles
The Load Mode screen appears.
1
2
3
4
5
7
6
8
Figure 4-7: Main Screen — Load Mode
1 — Load Bottles Icon
5 — User Defined 1*
2 — Change Maximum Test
Time Button
6 — Sample ID Field
3 — Bottle Type Scroll Button
8 — User Defined 3*
7 — User Defined 2*
4 — Bottle ID Field
*Available with Select and SelectLink only.
The number of available cells appears at the bottom of each drawer on
the Instrument icon.
Green indicators on Incubation or Combination Module drawers
illuminate drawers that contain available cells.
CAUTION: Inspect each bottle and sensor before loading:
If the sensor is yellow, treat the bottle as a positive culture. If the
bottle is cracked, do not load the bottle.
2)
4-12
Verify the Bottle ID field appears white, then scan or manually enter the
bottle ID (see Text/Data Entry on page 4-9).
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Loading Bottles
Basic Functions (INDUSTRY Use)
If the field is left blank when a bottle is loaded, then the bottle is
considered anonymously loaded (see Handling Anonymous Bottles on
page 4-15).
3)
Verify the correct bottle type is displayed on the Bottle Type scroll
button.
If the Bottle ID field contains data from a generic label, the bottle type
can be manually entered using the Bottle Type scroll button before
inserting the bottle to ensure proper testing of the bottle. The instrument
will also beep continuously to alert the operator that the bottle type needs
to be manually entered. The audible alert can be disabled by calling
bioMérieux for assistance. See Figure 4-7, Main Screen — Load Mode,
on page 4-12.
4)
If the Sample ID field is enabled and blank, then continue to Step 5. If
the Sample ID field is disabled, then go to Step 7.
5)
Verify the Sample ID field appears white, then scan or manually enter
the sample ID.
6)
If the fields are displayed and enabled, then manually enter the following
in the order listed: User Defined 3, User Defined 1, and User Defined 2.
• Entries to the User Defined 1 and User Defined 2 fields cannot be
made without a User Defined 3 entry.
Note:
The User Defined 3 field is a keyboard-entry only field.
7)
The default maximum test time is displayed above the Change Maximum
Test Time button. The scanned bottle's maximum test time can be
adjusted if desired. See Changing the Maximum Test Time — Individual
Bottles on page 4-14.
8)
If all drawers are closed, slowly open a drawer with an illuminated
indicator. Available cells will have an illuminated cell indicator light.
9)
Insert the bottle, sensor first, into a cell with an illuminated cell indicator
light.
WARNING
An erroneous test result (ex. false negative or false positive)
could occur if a bottle is not fully seated into a cell. When
inserting a bottle, ensure the bottle is fully seated into the cell.
See Appendix C, Best Practices for additional information on
preventing false positives
10) The cell indicator light blinks slowly to acknowledge the bottle is loaded.
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Loading Bottles
11) Verify that all text fields clear before proceeding.
12) Repeat Step 2 through Step 11 for each remaining bottle. Limit the bottle
load time to two minutes in one area to control entry of room temperature
bottles into racks. Close the drawer to allow temperature to equilibrate
before loading in that area again. Load bottles into different drawers (ex.
If you have four incubators, use the drawers in all four incubators). See
Appendix C, Best Practices for loading bottles.
CAUTION: If a large number of bottles are loaded into the
Incubation Module at the same time and in the same areas, a
large heat mass loss within the racks may occur. This heat loss
may trigger the acceleration or rate algorithms to erroneously
flag positive.
13) When all bottles are loaded, ensure that all drawers are completely
closed, then press the Check button.
If no operator or bottle loading activity has been recorded in a period of
two minutes, the instrument will terminate the Load Bottle operation.
Operator activity includes:
• pressing keys on the keyboard
• scanning barcodes
• touching the Operator Panel
• loading or unloading bottles
14) If applicable, enter User Defined 3 and sample data associated with the
loaded bottles into the bioMérieux data management computer.
Changing the Maximum Test Time — Individual Bottles
1)
From the Load screen, press the Change Maximum Test Time button
(
4-14
) after scanning the bottle barcode.
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Basic Functions (INDUSTRY Use)
The Change Maximum Test Time screen overlays and disables the Load
screen.
2
1
Figure 4-8: Change Maximum Test Time Screen
1 — Bottle ID Field
2 — Max Test Time Scroll Buttons
2)
Verify the bottle ID matches that of the bottle for which you wish to
change the maximum test time.
3)
Adjust the maximum test time in days using the Max Test Time scroll
buttons.
4)
Press the Check button to accept the changes, or the Cancel button to
retain the original setting.
The system returns to the Load Mode screen.
Note:
Changing the maximum test time of an individual bottle during loading does
not affect any other bottles of the same type.
Note:
The maximum test time of an individual bottle can also be changed from the
Edit Bottle Detail screen after loading (see Viewing/Editing Bottle Data in
Chapter 6).
Handling Anonymous Bottles
Bottles loaded into the Incubation Module without accessing the Load Bottles
function on the Main screen are referred to as Anonymous bottles because
they are not associated with a bottle ID.
• Anonymous bottles should be removed and identified as specified in
Unloading Bottles on page 4-16 or identified using the Edit Bottle
Detail screen (see Editing Bottle Details Using the Edit Bottle Detail
Screen in Chapter 6).
• Anonymous bottles are assigned the standard default algorithm.
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Basic Functions (INDUSTRY Use)
Unloading Bottles
Unloading Bottles
The BacT/ALERT® 3D signals which type of bottles are ready for unloading
by enabling the appropriate Unload button.
CAUTION: In order to preserve test data integrity, handle only
one bottle at a time. It is important to complete the procedure for
each bottle before proceeding to the next bottle.
Unloading Bottles
1)
Generate an Unload report (see Viewing, Printing, and Exporting Test
Data on page 4-24).
2)
From the Main screen (see Figure 4-1, Main Screen, on page 4-3), press
the appropriate Unload button.
• The Unload Mode screen appears (see Figure 4-9).
• Green indicators illuminate on drawers containing bottles of the
selected unload type.
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Unloading Bottles
Basic Functions (INDUSTRY Use)
1
2
3
4
5
7
6
8
Figure 4-9: Main Screen — Unload Mode
1 — Unload Bottles Icon
5 — User Defined 1
2 — Unload Buttons
6 — Sample ID Field
3 — Bottle Type Scroll Button
7 — User Defined 2
4 — Bottle ID Field
8 — User Defined 3
The User Defined 3, User Defined 1, and User Defined 2 fields are
unavailable with the BacT/ALERT® 3D Signature configuration.
The fields may manually be made unavailable or disabled regardless of
software configuration. To make the field(s) unavailable, contact your
local bioMérieux Representative.
3)
Open the indicated drawer. When the indicated drawer is open, cell
indicator lights light up next to all bottles in the selected category.
4)
Remove one of the bottles indicated. Wait for the cell light to blink slowly
to acknowledge the removal of the bottle.
5)
If the bottle was identified when loaded:
• The bottle ID and bottle type will appear on the Unload Mode screen;
however, the sample ID, User Defined 3, User Defined 1, and User
Defined 2 will appear in disabled text fields, if information is available.
a. It is not necessary to re-scan the bottle ID; however, doing so will
verify that bottle's identity.
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Basic Functions (INDUSTRY Use)
Unloading Bottles
b. If fields are blank or need editing, then use the Edit Data
Relationships function (see Editing Data Relationships in Chapter 6).
6)
Go to Step 8.
7)
If the bottle was anonymously loaded (the Bottle ID field is blank), scan
or manually enter the bottle ID.
a. Identify the bottle by entering the bottle ID, bottle type, sample ID,
User Defined 3, User Defined 1, and User Defined 2.
• The User Defined 1 and User Defined 2 entries cannot be made
without a User Defined 3 entry.
Scanning the bottle ID successfully results in two short beeps.
Scanning the sample ID successfully results in three short beeps.
When identifying anonymous bottles, information entered in the Bottle
ID, Bottle Type, Sample ID, User Defined 3, User Defined 1, and User
Defined 2 fields, and with the Bottle Type scroll button, is associated
with the unloaded bottle once the next bottle is unloaded or the Check
button is pressed.
b. If the bottle is to be reloaded, immediately return the bottle to the cell
with the slowly blinking cell indicator light before unloading another
bottle.
WARNING
Bottles with a critical determination in progress will be
temporarily removed from the bottle count table on the Main
screen.
c. Do not reload the bottle if its status is negative, positive, or if it is
necessary to use the bottle label to enter information into the
bioMérieux data management computer.
CAUTION: Reloading bottles anonymously that were previously
loaded will result in duplicate bottle records.
8)
4-18
Repeat Step 3 through Step 5 for the remaining bottles to be unloaded.
Limit the bottle unload time to no more than 2 minutes in one area. Close
the drawer to allow temperature to equilibrate before unloading from the
area again. See Appendix C, Best Practices for unloading bottles and
preventing false positives.
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Unloading Bottles
Basic Functions (INDUSTRY Use)
CAUTION: If a large number of bottles are unloaded from the
Incubation Module at the same time and in the same areas, a
large heat mass loss within the racks may occur. This heat loss
may trigger the acceleration or rate algorithms to erroneously
flag positive.
9)
When finished unloading bottles, ensure that all drawers are completely
closed.
10) Press the Check button on the Unload Mode screen.
11) Verify that the bottles listed on the Unload report were unloaded.
12) Where applicable, enter User Defined 3 and sample data associated with
the unloaded bottles into the bioMérieux data management computer.
13) Reload any previously Anonymous negative-to-date bottles.
If no operator or bottle loading activity has been recorded in a period of
two minutes, the instrument will terminate the Unload Bottle operation.
Operator activity includes:
•
•
•
•
pressing keys on the keyboard
scanning barcodes
touching the Operator Panel
loading or unloading bottles
Handling Unconfirmed Positive Bottles (False Positives)
If a smear of a positive bottle reveals no microorganisms, the bottle should be
subcultured and reloaded into the instrument via the Load Bottles function
(see Loading Bottles on page 4-11).
Note:
If a bottle is reloaded into the instrument, its status will revert to negative-todate once a reading has been taken (maximum time – 10 minutes).
If growth appears on the subculture, edit the bottle's status to Positive on the
Edit Test Result screen which is accessed from the Edit Bottle Detail screen
(see Edit Test Result Button in Chapter 6), and unload the now positive
bottle.
Note:
Results that have been manually changed to negative or positive via the Edit
Bottle Detail screen (see Editing Bottle Details Using the Edit Bottle Detail
Screen in Chapter 6), will be marked on the report with a stick figure ( ).
Note:
If a bottle is positive (set manually, or positive by any other reason) and then
is manually changed to negative-to-date, the stick figure ( ) will not appear.
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Basic Functions (INDUSTRY Use)
Accessing the Setup Screen Function Buttons
Accessing the Setup Screen Function Buttons
To view and print data, print graphs, and perform all of the editing,
configuration, and maintenance functions of the system, you must first
access the Setup screen function buttons.
Accessing the Setup Screen
1)
From the Main screen (see Figure 4-1, Main Screen, on page 4-3), press
the Next Screen button (
).
The Setup screen appears.
1
4
3
2
Figure 4-10: Setup Screen
1 — Password Entry Keypad
2 — Function Buttons
3 — Key Symbol Button
4 — Padlock Icon
2)
Note:
4-20
Enter a valid password using the 1 – 4 buttons. Until a valid password is
entered and accepted, the Padlock icon will appear in the closed
position.
Acceptable passwords consist of any combination of the numbers 1 to 4 and
have a maximum length of eight characters.
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Accessing the Setup Screen Function Buttons
Note:
Basic Functions (INDUSTRY Use)
Instruments are shipped with a password of 1234. For information on
changing the default password, see Changing the System Password in
Chapter 7.
3)
Press the Key Symbol button to accept the password.
4)
After a valid password is accepted, the Padlock icon changes to the full
open position and the function buttons become enabled.
Note:
To correct an error made while entering a password, press the Key Symbol
button and re-enter the password.
Note:
If more than 8 characters are entered, the Password Entry buttons will
become inactive and turn gray. Press the Key Symbol button and re-enter
the password.
Inactivity Timeout for all Setup Screens
While you are in the Setup screen (see Figure 4-10, Setup Screen) or one of
its sub-menus, an inactivity timeout will occur (within a period of time
configured by your bioMérieux Service Representative) if you do not perform
one of the following actions:
• press a screen or keyboard button
• scan a barcode
• load or unload a bottle
If an inactivity timeout occurs, the instrument display reverts from the
currently displayed screen to the Main screen. Any pending function is
cancelled as if the Cancel button on each successive screen was pressed.
Note:
If a timeout occurs, it is possible that partially entered information will be lost.
Note:
The inactivity timeout feature is disabled while a red operator error is
displayed on the screen.
Setup Screen Function Buttons
Set Date/Time button (see Setting and Formatting the System Date and Time in Chapter 8)
Enable/Disable Module, Drawer, Rack, or Cell button (see Enabling and Disabling
Modules, Drawers, Racks, and Cells in Chapter 8)
Calibrate Module Temperature button (see Adjusting an Incubation or Combination
Module’s Temperature in Chapter 8)
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Basic Functions (INDUSTRY Use)
Accessing the Setup Screen Function Buttons
Set Maximum Test Time button (see Setting the Maximum Test Time in Chapter 7)
Set Audible Alarm Options button (see Setting the Audible Alarms in Chapter 7)
Change Password button (see Changing the System Password in Chapter 7)
Select Bottle to Edit/Graph button (see Selecting Bottles Using the Select Bottle to Edit/
Graph Button in Chapter 6)
Edit Cell Contents button (see Selecting Bottles Using the Edit Cell Contents Button in
Chapter 6)
Calibrate Cell button (see Calibrating an Instrument Cell in Chapter 8)
View Incubation Module Information button (see Viewing Incubation Module
Information in Chapter 8)
Backup Management button (see Initiating Manual Backup in Chapter 7)
Edit Data Relationships button (see Initiating the Edit Data Relationships Function in
Chapter 6)
Report button — Select and SelectLink only (see Viewing, Printing, and Exporting Test
Data on page 4-24)
Configure Users button — Button only appears in 21 CFR Part 11 mode (see Configuring
Users — 21 CFR Part 11 Mode in Chapter 10)
Bottle Processing/Customization button (For use only with instruction from bioMérieux)
4-22
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Viewing and Printing
Basic Functions (INDUSTRY Use)
Viewing and Printing
Introduction
Viewing Bottle Data
The following bottle information can be viewed by accessing the Edit Bottle
Detail screen as described in Editing Test Data (see Viewing/Editing Bottle
Data in Chapter 6):
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Bottle ID
Sample ID
User Defined 3 (where applicable)
User Defined 1 (where applicable)
User Defined 2 (where applicable)
Cell ID
Maximum test time
Bottle type
Date/time loaded
Date/time unloaded
Date/time of last bottle reading
Test time
Test result
Algorithm type
How determined/positivity index
Viewing/Printing Reports
With a BacT/ALERT® 3D Signature configuration, reports are viewed and
printed at the data management computer.
With the BacT/ALERT® 3D Select or SelectLink configurations, reports are
viewed and printed by using the Report button as described in the topic,
Viewing, Printing, and Exporting Test Data on page 4-24.
Viewing/Printing Graphs
Bottle Graphs can be viewed and printed on the BacT/ALERT® 3D Select
and SelectLink configurations as described in the topic, Viewing and Printing
Bottle Graphs on page 4-31. For the Signature configuration, graphics can be
viewed as described in the topic, Viewing and Printing Bottle Graphs on
page 4-31, or at the data management computer. Since the BacT/ALERT®
3D Signature configuration is not connected to a printer, you must use the
data management computer to print a graph.
Note:
The print feature can be made unavailable regardless of software
configuration. When the feature is unavailable, the Print buttons do not
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Basic Functions (INDUSTRY Use)
Viewing and Printing
display. To make the print feature unavailable, contact your local bioMérieux
Representative.
Using the Print Screen Function
You can print the current screen on the instrument by pressing Ctrl + P on
the keyboard.
Note:
Select and SelectLink configurations only.
Viewing, Printing, and Exporting Test Data
Note:
If you have a BacT/ALERT® 3D Signature configuration, you must use the
data management computer to view and print reports.
1)
From the Setup screen (see Figure 4-10, Setup Screen, on page 4-20),
press the Report button (
Note:
).
The Report button is not available with the BacT/ALERT® 3D Signature
configuration.
The Report Selection screen appears.
1
2
3
4
5
Figure 4-11: Report Selection Screen
1 — Display Report 1 Button
4 — Previous Screen Button
2 — Display Report 2 Button
5 — Check Button
3 — Display Report 3 Button
4-24
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Viewing and Printing
Basic Functions (INDUSTRY Use)
2)
Press the Display Report 1, 2, or 3 button that is configured for the
information desired.
The Report screen will display. There are three default report
configurations:
• Display Report 1 button — Generates the Load Report screen with
1st Load Time as the primary sort, and Sample ID as the secondary
sort. Report has section breaks based on 1st Load Time.
• Display Report 2 button — Generates the Status Report screen with
Sample ID as the primary sort, and Bottle Type as the secondary
sort. Report has section breaks based on Sample ID.
• Display Report 3 button — Generates the Unload Report screen with
Loaded as the primary sort, and Test Result as the secondary sort.
Report has section breaks based on Loaded and Test Result.
See Configuring Report Contents in Chapter 7 for examples of the Load,
Status and Unload Report Configuration screens.
Note:
Data from the last 1,920 bottles are displayed each time a Report screen is
accessed. The report screens come configured with default settings, but the
report configurations can be changed to display different data and to sort the
data differently (see Configuring Report Contents in Chapter 7).
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Basic Functions (INDUSTRY Use)
Viewing and Printing
21
20
19
1
2
18
3
17
4
16
5
15
6
14
7
8
9
10
11
12
13
Figure 4-12: Sample Report Screen
1 — Section Scroll Up Button
11 — Line Scroll Down Button
2 — Relative Record Scroll
Indicator
12 — Page Scroll Down Button
3 — Relative Record Scroll Bar
14 — Gap Detection Indicator
4 — Find Text Button
15 — Report Data Lines
5 — Save Button
16 — Stick Figure
6 — Print Current Section
Button
17 — Current Section Line
7 — Print Report Button
8 — Cancel Print Button
9 — Previous Screen Button
10 — Section Scroll Down
Button
4-26
13 — End Scroll Button
18 — Home Scroll Button
19 — Page Scroll Up Button
20 — Report Title
21 — Line Scroll Up Button
Note:
Results that have been manually changed to negative or positive (see Editing
Bottle Details Using the Edit Bottle Detail Screen in Chapter 6) will be marked
on the report with a stick figure ( ).
Note:
If a bottle is positive (set manually, or positive by any other reason) and then
is manually changed to negative-to-date, the stick figure ( ) will not appear.
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Note:
Bottles with an Instrument Fault Code 80 will be marked on the report with a
Gap Detection indicator (!) next to the result. If a negative bottle has an
Instrument Fault Code 80 while it is being unloaded, the Gap Detection
indicator will remain on the report (see Instrument Fault Codes in Chapter 9).
Note:
The Current Group Line will always display the group that is associated with
the first displayed data record. It is always highlighted for easy reference. If
there are no section breaks in the displayed report, this line will become the
first line of data records displayed and reference highlighting will not occur.
3)
Note:
The Group scroll buttons are disabled if there are no section breaks in the
displayed report or if there are no available sections in the indicated direction.
4)
Note:
To scroll up to the oldest data line (the first data record in the report),
press the Home scroll button or press the Home key on the keyboard.
The Home scroll button is disabled if there are no report data lines in the
indicated direction.
7)
Note:
To scroll up or down a data page, press the appropriate Page scroll
button or press the appropriate Page Up or Page Down key on the
keyboard.
The Page scroll buttons are disabled if there are no data lines in the indicated
direction.
6)
Note:
To scroll up or down a data line, press the appropriate Line scroll button
or press the appropriate ↑ or ↓ key on the keyboard.
The Line scroll buttons are disabled if there are no data lines in the indicated
direction.
5)
Note:
To scroll up or down a group, press the appropriate Group scroll button.
To scroll down to the newest data line (the last data record in the report),
press the End scroll button or press the End key on the keyboard.
The End scroll button is disabled if there are no report data lines in the
indicated direction.
8)
To move to a relative record position, press the Relative Record scroll
bar above/below the Relative Record Indicator.
Note:
The Relative Record Indicator is sized proportionally to the amount of records
in the report.
Note:
The Relative Record scroll bar is disabled if the Relative Record Indicator is
the same size as the scroll bar and all the data records in the report are
displayed.
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9)
Viewing and Printing
To print the report, press the appropriate Print button:
• Pressing the Print Report button prints all records in the database
(with a maximum of 1,920 records).
• Pressing the Print Current Group button prints the Current Group
Line and all data records associated with the group.
Note:
The Print buttons are only available if a printer is configured for the system.
To configure a printer for the system, contact your local bioMérieux
Representative.
10) While the report is printing:
• All Print and Save buttons are disabled.
• The operator may, however, view and scroll through the displayed
report, search for text in the displayed report, or exit the Report screen
and perform other operations.
• The Cancel Print button becomes available.
11) Press the Cancel Print button to stop sending data to the printer and to
empty the queue of any data waiting to be sent to the printer.
Note:
Once the cancellation has been completed, the Print and Save buttons will
become enabled, and the Cancel Print button will be disabled.
12) To specify a text string and initiate a search of the report data for the
specified text, press the Find Text button. The Find Text screen will
appear.
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1
Figure 4-13: Find Text Screen
1 — Find Text Field
Use the keyboard to enter the text you wish to seek, and press the
Check button to return to the Report screen. Pressing the Cancel button
will cancel the search request and return to the Report screen.
Note:
The search will be performed upon returning to the report screen starting
from the top of the report. The record that contains the first occurrence of the
text will be scrolled to the first line of data displayed and the text itself will be
highlighted for reference.
If no occurrence of the specified text is found, the data displayed will not
change and no reference highlighting will occur.
13) To find the next instance of the specified text, press the F3 key on the
keyboard.
Note:
If no new instance of the text is found the data displayed, and the highlighted
text will remain the same.
14) To save the displayed report to a text file, press the Save button.
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Viewing and Printing
The Save To File screen appears.
1
Figure 4-14: Save to File Screen
1 — File Name Field
Note:
The default file name and path will appear automatically in the File Name
field. Use the keyboard to change the name of the file.
Note:
All reports are saved to the pathname, D:\REPORTS, either using the default
file name or a specified file name. All reports are automatically given an
extension of .TXT.
15) Place the backup media in the backup drive.
Note:
Backup media can either be a Zip® disk or a USB flash drive.
16) Press the Check button to initiate the save and return to the Report
screen. Pressing the Cancel button will cancel the save request and
return to the Report screen.
Note:
The Print buttons will be disabled while the save is taking place. Once the
save has completed, the Print buttons will be enabled.
WARNING
Do not insert any object, other than a Zip® disk, into the Zip®
drive under any circumstances.
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CAUTION: Do not forcibly remove the Zip® disk from the
instrument. Forcibly removing the Zip® disk may cause damage
to the Zip® disk or Zip® drive and may cause the system to lock
up.
17) Press the Previous Screen button to return to the screen from which the
Report screen was accessed.
Viewing and Printing Bottle Graphs
Note:
If you have a BacT/ALERT® 3D Signature configuration, you must use the
data management computer to print a bottle graph since the
BacT/ALERT® 3D Signature configuration is not connected to a printer.
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons on page 4-20).
2)
Press the Select Bottle to Edit/Graph button (
).
The Select Bottle to Edit/Graph screen overlays and disables the Setup
screen.
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Viewing and Printing
9
1
8
2
7
3
4
5
6
Figure 4-15: Select Bottle to Edit/Graph Screen
1 — Incubation Module Scroll
Button
6 — Check Button
2 — Cell Scroll Buttons
7 — Graph Bottle Readings
Button
3 — Setup Screen (Disabled)
8 — Drawer Scroll Button
4 — Previous Screen Button
9 — Bottle ID Field
5 — Cancel Button
3)
Note:
Only the last 1,920 bottles loaded can be retrieved. Any other entry in the
Bottle ID field is invalid and will cause an Operator Error 940 (see Operator
Error Codes in Chapter 9).
4)
Note:
4-32
If you know the bottle ID of the bottle whose readings you wish to graph,
then enter the bottle ID in the Bottle ID field (see Text/Data Entry on
page 4-9) and go to Step 5. If you know the cell location but not bottle ID,
then continue to Step 4.
Adjust the Incubation Module (1–6), Drawer (A–D), and Cell (1–60)
scroll buttons to select the cell location of the bottle whose readings you
wish to graph. The cell location defaults to Module 1, Drawer A, Cell 1
(1A01).
Only cell locations with currently loaded bottles can be used to view bottle
graphs. To view graphs of recently unloaded bottles (the most recent 1,920
bottles loaded), you must use the Bottle ID field.
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5)
Press the Graph Bottle Readings button (
).
The Graph Bottle Readings screen appears (see Figure 4-16).
11
9
10
1
8
7
2
3
4
5
6
Figure 4-16: Graph Bottle Readings Screen
1 — User Defined 1/User
Defined 2*
7 — Bottle Readings Range
2 — Previous Screen Button
9 — User Defined 3*
3 — Adjust Y Scale Button
10 — Sample ID Field
4 — Adjust X Scale Button
11 — Bottle ID Field
5— Bottle Readings Button
* Available in Select and
SelectLink only.
6 — Print Graph Button
8 — Days Tested Range
You can also access the Graph Bottle Readings screen via the Edit
Bottle Detail screen (see Editing Bottle Details Using the Edit Bottle
Detail Screen in Chapter 6). The screen ID number is the same
regardless of how it is accessed.
• The Y axis range defaults to 0 – 5000, and the X axis range defaults to
0 – maximum test time of the bottle in days.
• If the bottle was determined positive, then a dot and the time to
detection (days) are displayed at the point where it was determined
positive.
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6)
Viewing and Printing
To adjust the Y or X axis, click the appropriate Adjust Scale button.
When one of these buttons is clicked, the axis re-scales so that the
maximum endpoint of the scale is just higher then the maximum value of
the range. Adjusting the scale may mean increasing or decreasing the
range of the scale.
When one of the Adjust Scale buttons is clicked, the arrow on the button
changes directions. To return to the original scale, click the Adjust Scale
button(s) a second time.
7)
Press the Print Graph button, if available, to print the graph as it
appears on the screen.
Note:
The Print Graph button is only available if a printer is configured for the
system. The Print Graph button is disabled while a print is in progress.
Note:
To configure a printer for the system, contact your local bioMérieux
Representative.
8)
When done, press the Previous Screen button to return to the Select
Bottle to Edit/Graph screen.
Display Bottle Readings
The Bottle Readings screen displays the exact values of the bottle readings
for an individual bottle, along with the date and time each reading was taken.
Note:
The polynomial is applied to the bottle readings. The readings are not the raw
readings.
If there are bottle readings available for you to view, the Bottle Readings
button on the Graph Bottle Readings screen turns blue (see Figure 4-16). If
there are no readings available, the button is gray.
1)
From the Graph Bottle Readings screen (see Figure 4-16), press the
Bottle Readings button (
).
The Bottle Readings screen appears.
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15
14
13
12
1
11
2
3
4
5
6
7
8
9
10
Figure 4-17: Bottle Readings Screen
1 — Bottle Cell Location
9 — Page Scroll Down Button
2 — Find Text Button
10 — End Scroll Button
3 — Save Button
4 — Print Button
11 — Bottle Reading (Date/
Time/Reading)
5 — Cancel Print Button
12 — Home Scroll Button
6 — Previous Screen Button
13 — Page Scroll Up Button
7 — Anchor Display Bottom
Button
14 — Line Scroll Up Button
8 — Line Scroll Down Button
2)
Note:
To scroll up or down a data line, press the appropriate Line scroll button
or press the appropriate ↑ or ↓ key on the keyboard.
The Line scroll buttons are disabled if there are no data lines in the indicated
direction.
3)
Note:
15 — Anchor Display Top
Button
To scroll up or down a data page, press the appropriate Page scroll
button or press the appropriate Page key on the keyboard.
The Page scroll buttons are disabled if there are no data lines in the indicated
direction.
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4)
Note:
To scroll down to the newest data line (the last data record in the report),
press the End scroll button or press the End key on the keyboard.
The End scroll button is disabled if there are no report data lines in the
indicated direction.
6)
Note:
To scroll up to the oldest data line (the first data record in the report),
press the Home scroll button or press the Home key on the keyboard.
The Home scroll button is disabled if there are no report data lines in the
indicated direction.
5)
Note:
Viewing and Printing
To print the bottle readings, press the Print button.
The Print buttons are only available if a printer is configured for the system.
To configure a printer for the system, contact your local bioMérieux
Representative.
7)
While the report is printing:
• All Print and Save buttons are disabled.
• The operator may, however, view and scroll through the displayed list,
search for text in the displayed list, or exit the Bottle Readings screen
and perform other operations.
• The Cancel Print button becomes available.
8)
Note:
Once the cancellation has been completed the Print and Save buttons will
become enabled, and the Cancel Print button will be disabled.
9)
4-36
Press the Cancel Print button to stop sending data to the printer and to
empty the queue of any data waiting to be sent to the printer.
To specify a text string and initiate a search of the report data for the
specified text, press the Find Text button.
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The Find Text screen appears.
1
Figure 4-18: Find Text Screen
1 — Find Text Field
Use the keyboard to enter the text you wish to seek, and press the
Check button to return to the Bottle Readings screen. Pressing the
Cancel button will cancel the search request and return to the Bottle
Readings screen.
Note:
The search will be performed upon returning to the report screen starting
from the top of the report. The record that contains the first occurrence of the
text will be scrolled to the first line of data displayed and the text itself will be
highlighted for reference.
If no occurrence of the specified text is found, the data displayed will not
change and no reference highlighting will occur.
10) To find the next instance of the specified text, press the F3 key on the
keyboard.
Note:
If no new instance of the text is found, the data displayed, and the highlighted
text will remain the same.
11) To save the bottle readings to a text file, press the Save button.
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Viewing and Printing
The Save To File screen appears.
1
Figure 4-19: Save to File Screen
1 — File Name Field
Note:
The default file name and path will appear automatically in the File Name
field. Use the keyboard to change the name of the file.
Note:
All reports are saved to the pathname, D:\REPORTS, either using the default
file name or a specified file name. All reports are automatically given an
extension of .TXT.
12) Place the backup media in the backup drive.
Note:
Backup media can either be a Zip® disk or a USB flash drive.
13) Press the Check button to initiate the save and return to the Bottle
Readings screen. Pressing the Cancel button will cancel the save
request and return to the Bottle Readings screen.
Note:
The Print buttons will be disabled while the save is taking place. Once the
save has completed, the Print buttons will be enabled.
WARNING
Do not insert any object, other than a Zip® disk, into the Zip®
drive under any circumstances.
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CAUTION: Do not forcibly remove the Zip® disk from the
instrument. Forcibly removing the Zip® disk may cause damage
to the Zip® disk or Zip® drive and may cause the system to lock
up.
14) Press the Previous Screen button to return to the screen from which the
Bottle Readings screen was accessed.
15) When done, press the Previous Screen button to return to the Graph
Bottle Readings screen.
Sending/Requesting LIS Information
Results can be manually sent to, and demographics can be manually
requested from, an LIS when the BacT/ALERT® 3D SelectLink configuration
is used.
Note:
Data is transmitted according to the BacT/LINK® protocol. For more
information, contact your local bioMérieux Representative.
Note:
The system can be configured to perform these functions automatically. To
adjust these settings, contact your local bioMérieux Representative.
Note:
The arrows on the Manual Send Test Results and Manual Request Test
Orders buttons also serve as an indicator of automatic data transfer.
Sending Results to the LIS
1)
From the Main screen (see Figure 4-1, Main Screen, on page 4-3), press
the Manual Send Test Results button (
).
The arrow on the button face will blink during the transfer.
Note:
Only accessions with one or more bottles that have had a status change to
positive, or that have reached maximum test time with a negative status and
have been unloaded, since the last transfer will be sent.
Requesting Information from the LIS
1)
From the Main screen (see Figure 4-1, Main Screen, on page 4-3), press
the Manual Request Test Orders button (
).
The arrow on the button face will blink during the transfer.
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EDITING TEST DATA (CLINICAL USE)
5
About This Chapter
This chapter provides you with procedures for viewing and editing bottle data
for Clinical Use.
Chapter Contents
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
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
Editing Accession Number to Hospital ID Relationships • 5-16
Editing Hospital ID to Patient Name Relationships • 5-17
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Viewing/Editing Bottle Data
Viewing/Editing Bottle Data
Introduction
By accessing the Edit Bottle Detail screen of both currently loaded and
recently unloaded bottles, you can perform the following bottle editing
functions:
• Identifying an anonymous bottle
• Editing a bottle ID
• Editing the maximum test time of a currently loaded bottle
• Editing a bottle type
• Manually changing a bottle's test result
• Unloading a bottle from a faulty rack
Note:
The bottle record must be one of the 1,920 bottle records stored in the
database.
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 3).
2)
Access the Edit Bottle Detail screen for a specific bottle. There are two
methods you can use to access the Edit Bottle Detail screen:
• Select loaded bottles using the Edit Cell Contents button (
).
See Selecting Bottles Using the Edit Cell Contents Button on page 5-3.
or
• Select loaded and recently unloaded bottles using the Select Bottle to
Edit/Graph button (
). See Selecting Bottles Using the Select
Bottle to Edit/Graph Button on page 5-4.
5-2
3)
Edit the bottle details as necessary (see Editing Bottle Details Using the
Edit Bottle Detail Screen on page 5-5).
4)
Press the Check button to save the changes and exit the screen or press
the Cancel button to restore the information originally displayed and exit
the screen.
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Editing Test Data (Clinical Use)
Selecting Bottles Using the Edit Cell Contents Button
Note:
This function can only be used for currently loaded bottles. To view
information of recently unloaded bottles, select the bottle from the Select
Bottle to Edit/Graph screen (see Selecting Bottles Using the Select Bottle to
Edit/Graph Button on page 5-4).
1)
From the Setup screen (see Figure 3-10, Setup Screen), press the Edit
Cell Contents button.
The Edit Cell Contents screen appears.
7
5
6
1
4
2
3
Figure 5-1: Edit Cell Contents Screen
1 — Cell
2 — Previous Screen Button
3 — Incubation Module Selection Button
4 — Drawer Selection Button
5 — Restart Incubation Module Button
6 — Drawer Indicator
7 — Incubation Module Indicator
Note:
The Edit Cell Contents screen displays the same information as the View Cell
Status screen (see Understanding the View Cell Status Screen Display in
Chapter 3) and is continuously updated.
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Viewing/Editing Bottle Data
2)
Select the desired drawer and Incubation Module using the Incubation
Module Selection and Drawer Selection buttons.
3)
Touch the appropriate Cell icon.
The Edit Bottle Detail screen appears (see Editing Bottle Details Using
the Edit Bottle Detail Screen on page 5-5).
Selecting Bottles Using the Select Bottle to Edit/Graph Button
1)
From the Setup screen (see Figure 3-10, Setup Screen), press the
Select Bottle to Edit/Graph button.
The Select Bottle to Edit/Graph screen overlays and disables the Setup
screen.
6
1
5
2
4
3
Figure 5-2: Select Bottle to Edit/Graph Screen
1 — Incubation Module Scroll Button
2 — Cell Scroll Buttons
3 — Setup Screen (Disabled)
4 — Graph Bottle Readings Button
5 — Drawer Scroll Button
6 — Bottle ID Field
2)
5-4
If the bottle ID is known, enter the bottle ID in the Bottle ID field (see
Text/Data Entry in Chapter 3) and proceed to Step 4.
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Note:
Editing Test Data (Clinical Use)
Only the last 1,920 bottles loaded can be retrieved. Any other entry in the
Bottle ID field is invalid and will cause an Operator Error 940 (see Operator
Error Codes in Chapter 9).
3)
Note:
If the cell location (but not bottle ID) is known, adjust the Incubation
Module (1–6), Drawer (A–D), and Cell (1–60) scroll buttons to select the
appropriate bottle location.
Only cell locations with currently loaded bottles can be used to view/edit
bottle data. To view data of recently unloaded bottles, you must use the
Bottle ID field.
4)
Press the Check button.
The Edit Bottle Detail screen appears (see Editing Bottle Details Using
the Edit Bottle Detail Screen on page 5-5).
Editing Bottle Details Using the Edit Bottle Detail Screen
Note:
The bottle record can be edited before and after the bottle has been unloaded
from the system.
If a bottle has not already been selected, you can select a bottle to edit using
either the Edit Cell Contents or the Select Bottle to Edit/Graph button as
described in Selecting Bottles Using the Edit Cell Contents Button on page
5-3, and Selecting Bottles Using the Select Bottle to Edit/Graph Button on
page 5-4.
Figure 5-3: Edit Bottle Detail Screen
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Viewing/Editing Bottle Data
The screen ID is determined by the method in which the Edit Bottle Detail
screen was accessed. The screen behaves in the same way regardless
of how it is accessed.
• The screen ID is 2.11.1 if you access it from the Select Bottle to Edit/
Graph screen.
• The screen ID is 2.12.1 if you access it from the Edit Cell Contents
screen.
Edit Bottle ID Field
A blank Bottle ID field indicates the bottle is currently anonymous. To assign
a bottle ID to an anonymous bottle or edit the bottle ID of an identified bottle:
1)
Touch the Bottle ID field (the field turns white).
2)
Manually enter the bottle ID using the keyboard or scan the barcode (see
Text/Data Entry in Chapter 3).
3)
Press the Check button.
View Accession Number Field
Disabled field that displays the accession number associated with the
displayed bottle record.
View Hospital ID Field
Disabled field that displays the hospital ID associated with the displayed
bottle record.
View Patient First Name Field
Disabled field that displays the patient first name associated with the
displayed bottle record.
View Patient Last Name Field
Disabled field that displays the patient last name associated with the
displayed bottle record.
Note:
5-6
The View Accession Number, View Hospital ID, View Patient First Name,
and View Patient Last Name fields are “view-only” fields.
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Editing Test Data (Clinical Use)
Note:
The Hospital ID, Patient First Name, and Patient Last Name fields are not
available with the BacT/ALERT® 3D Signature configuration.
Note:
The fields may be hidden regardless of BacT/ALERT® 3D configuration. To
make the field(s) unavailable, contact your local bioMérieux Representative.
Edit Load Status Slidebar Switch
It is possible to change the load status of an identified bottle in a faulty rack
from loaded to unloaded. However, it is not possible to change a bottle's load
status from unloaded to loaded.
Slidebar interpretation:
• 0 = unloaded
• 1 = loaded
Note:
The slidebar is disabled if the associated rack is functioning properly.
Edit Maximum Test Time Scroll Buttons
Displays the incubation period for the selected bottle after which the bottle's
status will change from negative-to-date to negative.
Note:
The maximum test time of a bottle can be edited in days and tenths of a day
at any time.
Edit Bottle Type Scroll Button
Displays the media type of the selected bottle. Use the scroll buttons to select
the appropriate bottle type.
Note:
Anonymous bottles loaded into a BC type drawer are assigned to the
UNKNOWN bottle type.
Note:
The Bottle ID, Load Status, Maximum Test Time, and Bottle Type fields
can be edited concurrently or one at a time. Press the Check button to save
changes.
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Viewing/Editing Bottle Data
View Cell Location Icon
Displays the location of the selected bottle. The location is either the current
location or the last cell location, depending on whether the bottle is still
loaded.
Cell ID consists of the following three components in order:
• Incubation Module #
• Drawer letter
• Cell #
View First Loaded Time Icon
Displays the date and time the selected bottle was first loaded into the
system. The number of days since the bottle was first loaded appears in
parenthesis below the date and time.
View Last Unloaded Time Icon
Displays the date and time the selected bottle was last unloaded from the
system. The number of days since the bottle was unloaded appears in
parenthesis below the date and time. No time will be displayed if the bottle
has never been unloaded.
View Time of Last Bottle Reading Icon
Displays the date and time of the last bottle reading that was successfully
processed by the detection algorithm. The number of days since the last
bottle reading was processed appears in parenthesis below the date and time
of the last bottle reading.
View Test Time Icon
Displays the date and time the last test result changed. The number of days
that have passed between load and last determination appears in
parenthesis below the date and time. The date and time will not be displayed
if the bottle's status has not changed from negative-to-date.
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Editing Test Data (Clinical Use)
View Test Result Icon
Displays the test status of the selected bottle. Test status is displayed inside
the bottle icon:
+
Positive (yellow bottle)
-
Negative (green bottle)
*
Negative-to-date (gray bottle)
~+
Critical determination in progress (gray bottle)
Edit Test Result Button
You can use the Edit Test Result button to change the status of the
displayed bottle:
1)
Press the Edit Test Result button.
The Edit Test Result screen overlays and disables the Edit Bottle Detail
screen.
1
2
3
Figure 5-4: Edit Test Result Screen
1 — Positive Status Checkbox
2 — Negative Status Checkbox
3 — Negative-To-Date Status Checkbox
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Viewing/Editing Bottle Data
2)
Touch the checkbox that corresponds to the desired status to insert an
X.
3)
Press the Check button to accept the change and return to the Edit
Bottle Detail screen, or press the Cancel button to keep the current
status and return to the Edit Bottle Detail screen.
Note:
Results that have been manually changed to negative or positive via the Edit
Bottle Detail screen (see Editing Bottle Details Using the Edit Bottle Detail
Screen on page 5-5) will be marked on the report with a stick figure ( ).
Note:
If a bottle is positive (set manually, or positive by any other reason) and then
is manually changed to negative-to-date, the stick figure ( ) will not appear.
Graph Bottle Readings Button
Displays the bottle graph on the Graph Bottle Readings screen (see Viewing
and Printing Bottle Graphs in Chapter 3).
View Algorithm/Polynomial Icon
The number above the slash represents the type of bottle specific algorithm
used for the data analysis of the selected bottle.
Table 5-1: Bottle Specific Algorithms
Algorithm No.
Bottle Type
11
SA Plastic, SN Plastic
12
FA Plastic
13
MP Plastic
15
PF Plastic
17
MB Glass
The number below the slash represents the type of polynomial. There are two
types of polynomials:
• Polynomial 1 — LES Glass
• Polynomial 2 — LES Plastic
5-10
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View How Determined/Positivity Index Icon
The number above the slash displays a numerical code representing how the
selected bottle's status was determined.
Table 5-2: Status Determination Codes
Status
Determination
Code
How Status Determined
1
Rate
2
Acceleration
3
Initial value
4
Maximum test time exceeded
5
Delta
6
Test in progress
7
Manual (changed at Database Management System)
8
Manual (changed at BacT/ALERT® 3D)
9
Algorithm change (see Fault Code 74)
10
Manual (changed by LIS)
11
Wrong controller module (see Fault Code 79)
20–23
Corrupted bottle record
200–204
Detection of invalid data
205
Missing readings
The number below the slash is the Positivity Index. An index less than 1
indicates a negative or negative-to-date bottle. An index greater than or equal
to 1 indicates a positive bottle.
Note:
The number displayed on the lower right of the Edit Bottle Detail screen (not
associated with an icon) is a bottle sequence number, which may be utilized
by your bioMérieux Representative.
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Editing Test Data (Clinical Use)
Editing Data Relationships
Editing Data Relationships
Introduction
Bottle information (Bottle ID, Accession Number, Hospital ID, Patient First
Name, Patient Last Name) is typically associated to a bottle when a bottle is
loaded. If necessary, however, these values can later be changed by editing
the data relationships. This is initiated by pressing the Edit Data
Relationships button on the Setup screen.
The following sections will cover:
• Initiating the Edit Data Relationships function (see Initiating the Edit
Data Relationships Function on page 5-12).
• Editing Bottle ID to Accession Number relationships (see Editing Bottle
ID to Accession Number Relationships on page 5-14).
• Editing Accession Number to Hospital ID relationships (see Editing
Accession Number to Hospital ID Relationships on page 5-16).
• Editing Hospital ID to Patient Name relationships (see Editing Hospital
ID to Patient Name Relationships on page 5-17).
Initiating the Edit Data Relationships Function
5-12
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 3).
2)
Press the Edit Data Relationships button (
).
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The Edit Data Relationships screen appears.
1
2
3
Figure 5-5: Edit Data Relationships Screen
1 — Edit Bottle ID to Accession Number Relationships Button
2 — Edit Accession Number to Hospital ID Relationships Button
3 — Edit Hospital ID to Patient Name Relationships Button
Note:
The Edit Data Relationships screen is not available with the
BacT/ALERT® 3D Signature configuration. Pressing the Edit Data
Relationships button will display the Edit Bottle ID to Accession Number
screen (see Editing Bottle ID to Accession Number Relationships on
page 5-14).
Note:
The availability of the buttons also depends on the availability of the fields.
Example: If the Patient First Name and Patient Last Name fields are not
displayed on the system, then the Edit Hospital ID to Name Relationships
button is not available.
3)
To edit a Bottle ID to accession number relationship, press the
corresponding button and see Editing Bottle ID to Accession Number
Relationships on page 5-14.
4)
To edit an Accession Number to Hospital ID relationship, press the
corresponding button and see Editing Accession Number to Hospital ID
Relationships on page 5-16.
5)
To edit a Hospital ID to patient name relationship, press the
corresponding button and see Editing Hospital ID to Patient Name
Relationships on page 5-17.
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Editing Data Relationships
Editing Bottle ID to Accession Number Relationships
1
2
6
3
4
5
Figure 5-6: Edit Bottle ID to Accession Number Relationships Screen
1 — Accession Number Field
2 — Hospital ID Field
3 — Patient Last Name Field
4 — Bottle ID Scroll Box
5 — Data Transfer Buttons
6 — Accession Number Selection Buttons
Note:
The Accession Number Selection button will only appear if the system is
set to allow reuse of accession numbers. By default, the BacT/ALERT® 3D is
set to regard accession numbers as always unique. If you desire to re-use
accession numbers, contact your local bioMérieux Representative.
Note:
When the Edit Bottle ID to Accession Number Relationships screen is first
accessed, the Accession Number field is blank and all bottle IDs not
associated with an Accession Number are displayed in both Bottle ID scroll
boxes.
Attaching Bottle IDs without an Accession Number to an Accession Number
5-14
1)
Access the Edit Bottle ID to Accession Number Relationships screen
(see Initiating the Edit Data Relationships Function on page 5-12).
2)
Enter the accession number in the left Accession Number field that you
wish to associate to the bottle(s).
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If the entered accession number is associated with more than one
hospital ID, use the Accession Number Selection button to scroll
through each instance as indicated in the Hospital ID and Patient Last
Name fields.
Note:
3)
Touch the bottle ID(s) in the right Bottle ID scroll box to be associated
with the accession number. The selected bottle ID(s) highlight.
4)
Press the top Data Transfer button to move the Bottle ID(s) to the left
Bottle ID scroll box.
5)
Press the Check button to accept the changes, or press the Cancel
button to restore all relationships originally displayed.
6)
When done, press the Previous Screen button to return to the Edit Data
Relationships screen.
If you accessed the Edit Bottle ID to Accession Number Relationships screen
directly from the Setup screen, the Previous Screen button will return to the
Setup screen.
Moving a Bottle ID Association from one Accession Number to Another
1)
Access the Edit Bottle ID to Accession Number Relationships screen
(see Initiating the Edit Data Relationships Function on page 5-12).
2)
Enter the accession number in the left Accession Number field to which
the bottle(s) is currently associated.
If the entered accession number is associated with more than one
Hospital ID, the Accession Number Selection button can be used to
scroll through each instance as indicated in the Hospital ID and Patient
Last Name fields.
3)
Enter the accession number in the right Accession Number field that
you wish to associate to the bottle(s).
If the entered accession number is associated with more than one
hospital ID, the Accession Number Selection button can be used to
scroll through each instance as indicated in the Hospital ID and Patient
Last Name fields.
4)
Touch the bottle ID(s) in the left Bottle ID scroll box that are to be
transferred. The selected bottle ID(s) highlight.
5)
Press the bottom Data Transfer button to move the bottle ID(s) to the
right Bottle ID scroll box.
6)
Press the Check button to accept the changes, or press the Cancel
button to restore all relationships originally displayed.
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7)
Note:
When done, press the Previous Screen button to return to the Edit Data
Relationships screen.
If you accessed the Edit Bottle ID to Accession Number Relationships screen
directly from the Setup screen, the Previous Screen button will return to the
Setup screen.
Editing Accession Number to Hospital ID Relationships
1
2
3
5
4
Figure 5-7: Edit Accession Number to Hospital ID Relationships Screen
1 — Hospital ID Field
2 — Patient Last Name Field
3 — Accession Number Scroll Box
4 — Bottle ID List Box
5 — Data Transfer Buttons
Note:
When the Edit Accession Number to Hospital ID Relationships screen is first
accessed, the Hospital ID field is blank and all accession number(s) not
associated with a hospital ID are displayed in both Accession Number scroll
boxes.
Attaching Accession Numbers without a Hospital ID to a Hospital ID
1)
5-16
Access the Edit Accession Number to Hospital ID Relationships screen
(see Initiating the Edit Data Relationships Function on page 5-12).
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2)
Enter the hospital ID in the left Hospital ID field that you wish to
associate to the accession number(s).
3)
Touch the accession number(s) in the right Accession Number scroll
box that are to be associated to the hospital ID.
The selected accession number(s) highlight. The bottle IDs associated
with the accession number that was touched last appears in the Bottle
ID list box.
4)
Press the top Data Transfer button to move the accession number(s) to
the left Accession Number scroll box.
5)
Press the Check button to accept the changes, or press the Cancel
button to restore all original relationships.
6)
When done, press the Previous Screen button to return to the Edit Data
Relationships screen.
Moving an Accession Number Association from one Hospital ID to Another
1)
Access the Edit Accession Number to Hospital ID Relationships screen
(see Initiating the Edit Data Relationships Function on page 5-12).
2)
Enter the hospital ID in the left Hospital ID field that the accession
number(s) is currently associated.
3)
Enter the hospital ID in the right Hospital ID field with which you wish to
associate to the accession number(s).
4)
Touch the accession number(s) in the left Accession Number scroll box
that are to be transferred.
The selected accession number(s) highlight. The bottle IDs associated
with the accession number that was touched last appears in the Bottle
ID list box.
5)
Press the bottom Data Transfer button to move the accession
number(s) to the right Accession Number scroll box.
6)
Press the Check button to accept the changes, or press the Cancel
button to restore all relationships originally displayed.
7)
When done, press the Previous Screen button to return to the Edit Data
Relationships screen.
Editing Hospital ID to Patient Name Relationships
1)
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Access the Edit Hospital ID to Patient Name Relationships screen (see
Initiating the Edit Data Relationships Function on page 5-12).
5-17
Editing Test Data (Clinical Use)
Editing Data Relationships
1
4
2
3
Figure 5-8: Edit Hospital ID to Patient Name Relationships Screen
1 — Hospital ID Field
2 — Patient First Name Field
3 — Patient Last Name Field
4 — Previous Screen Button
Note:
5-18
2)
Enter the hospital ID in the Hospital ID field for which you want to add/
edit the patient name association.
3)
Enter the correct patient name into the Patient First Name and Patient
Last Name fields.
4)
Press the Check button to accept the changes, or press the Cancel
button to restore all relationships originally displayed.
5)
When done, press the Previous Screen button to return to the Edit Data
Relationships screen.
The Patient First Name and Patient Last Name fields will remain
unavailable until a known hospital ID is entered.
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EDITING TEST DATA (INDUSTRY USE)
6
About This Chapter
This chapter provides you with procedures for viewing and editing bottle data
for INDUSTRY Use.
Chapter Contents
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
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
Editing Sample ID to User Defined 3 Relationships • 6-16
Editing User Defined 3 to User Defined 1/User Defined 2
Relationships • 6-17
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Viewing/Editing Bottle Data
Viewing/Editing Bottle Data
Introduction
By accessing the Edit Bottle Detail screen of both currently loaded and
recently unloaded bottles, you can perform the following bottle editing
functions:
• Identifying an anonymous bottle
• Editing a bottle ID
• Editing the maximum test time of a currently loaded bottle
• Editing a bottle type
• Manually changing a bottle's test result
• Unloading a bottle from a faulty rack
Note:
The bottle record must be one of the 1,920 bottle records stored in the
database.
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 4).
2)
Access the Edit Bottle Detail screen for a specific bottle. There are two
methods you can use to access the Edit Bottle Detail screen:
• Select loaded bottles using the Edit Cell Contents button (
See Selecting Bottles Using the Edit Cell Contents Button on
page 6-3.
).
or
• Select loaded and recently unloaded bottles using the Select Bottle to
Edit/Graph button (
). See Selecting Bottles Using the Select
Bottle to Edit/Graph Button on page 6-4.
6-2
3)
Edit the bottle details as necessary (see Editing Bottle Details Using the
Edit Bottle Detail Screen on page 6-5).
4)
Press the Check button to save the changes and exit the screen or press
the Cancel button to restore the information originally displayed and exit
the screen.
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Selecting Bottles Using the Edit Cell Contents Button
Note:
This function can only be used for currently loaded bottles. To view
information of recently unloaded bottles, select the bottle from the Select
Bottle to Edit/Graph screen (see Selecting Bottles Using the Select Bottle to
Edit/Graph Button on page 6-4).
1)
From the Setup screen (See Figure 4-10, Setup Screen), press the Edit
Cell Contents button.
The Edit Cell Contents screen appears.
7
5
6
1
4
2
3
Figure 6-1: Edit Cell Contents Screen
1 — Cell
2 — Previous Screen Button
3 — Incubation Module Selection Button
4 — Drawer Selection Button
5 — Restart Incubation Module Button
6 — Drawer Indicator
7 — Incubation Module Indicator
Note:
The Edit Cell Contents screen displays the same information as the View Cell
Status screen (see Understanding the View Cell Status Screen Display in
Chapter 4) and is continuously updated.
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Viewing/Editing Bottle Data
2)
Select the desired drawer and Incubation Module using the Incubation
Module Selection and Drawer Selection buttons.
3)
Touch the appropriate Cell icon.
The Edit Bottle Detail screen appears (see Editing Bottle Details Using
the Edit Bottle Detail Screen on page 6-5).
Selecting Bottles Using the Select Bottle to Edit/Graph Button
1)
From the Setup screen (see Figure 4-10, Setup Screen), press the
Select Bottle to Edit/Graph button.
The Select Bottle to Edit/Graph screen overlays and disables the Setup
screen.
6
1
5
2
4
3
Figure 6-2: Select Bottle to Edit/Graph Screen
1 — Incubation Module Scroll Button
2 — Cell Scroll Buttons
3 — Setup Screen (Disabled)
4 — Graph Bottle Readings Button
5 — Drawer Scroll Button
6 — Bottle ID Field
2)
6-4
If the bottle ID is known, enter the bottle ID in the Bottle ID field (see
Text/Data Entry in Chapter 4) and proceed to Step 4.
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Note:
Editing Test Data (INDUSTRY Use)
Only the last 1,920 bottles loaded can be retrieved. Any other entry in the
Bottle ID field is invalid and will cause an Operator Error 940 (see Operator
Error Codes in Chapter 9).
3)
Note:
If the cell location (but not bottle ID) is known, adjust the Incubation
Module (1–6), Drawer (A–D), and Cell (1–60) scroll buttons to select the
appropriate bottle location.
Only cell locations with currently loaded bottles can be used to view/edit
bottle data. To view data of recently unloaded bottles, you must use the
Bottle ID field.
4)
Press the Check button.
The Edit Bottle Detail screen appears (see Editing Bottle Details Using
the Edit Bottle Detail Screen on page 6-5).
Editing Bottle Details Using the Edit Bottle Detail Screen
Note:
The bottle record can be edited before and after the bottle has been unloaded
from the system.
If a bottle has not already been selected, you can select a bottle to edit using
either the Edit Cell Contents or the Select Bottle to Edit/Graph button as
described in see Selecting Bottles Using the Edit Cell Contents Button on
page 6-3, and Selecting Bottles Using the Select Bottle to Edit/Graph
Button on page 6-4.
Figure 6-3: Edit Bottle Detail Screen
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Viewing/Editing Bottle Data
The screen ID is determined by the method in which the Edit Bottle Detail
screen was accessed. The screen behaves in the same way regardless
of how it is accessed.
• The screen ID will be 2.11.1 if you access it from the Select Bottle to
Edit/Graph screen.
• The screen ID will be 2.12.1 if you access it from the Edit Cell
Contents screen.
Edit Bottle ID Field
A blank Bottle ID field indicates the bottle is currently anonymous. To assign
a bottle ID to an anonymous bottle or edit the bottle ID of an identified bottle:
1)
Touch the Bottle ID field (the field turns white).
2)
Manually enter the bottle ID using the keyboard or scan the barcode (see
Text/Data Entry in Chapter 4).
3)
Press the Check button.
View Sample ID Field
Disabled field that displays the Sample ID associated with the displayed
bottle record.
View User Defined 1
Disabled field that displays the User Defined 1 associated with the displayed
bottle record.
View User Defined 2
Disabled field that displays the User Defined 2 associated with the displayed
bottle record.
View User Defined 3
Disabled field that displays the User Defined 3 associated with the displayed
bottle record.
Note:
6-6
The View Sample ID, View User Defined 1, View User Defined 2, and View
User Defined 3 fields are “view-only” fields.
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Note:
The User Defined 1, User Defined 2, and User Defined 3 fields are not
available with the BacT/ALERT® 3D Signature configuration.
Note:
The fields may be hidden regardless of BacT/ALERT® 3D configuration. To
make the field(s) unavailable, contact your local bioMérieux Representative.
Edit Load Status Slidebar Switch
It is possible to change the load status of an identified bottle in a faulty rack
from loaded to unloaded. However, it is not possible to change a bottle's load
status from unloaded to loaded.
Slidebar interpretation:
• 0 = unloaded
• 1 = loaded
Note:
The slidebar is disabled if the associated rack is functioning properly.
Edit Maximum Test Time Scroll Buttons
Displays the incubation period for the selected bottle after which the bottle's
status will change from negative-to-date to negative.
Note:
The maximum test time of a bottle can be edited in days and tenths of a day
at any time.
Edit Bottle Type Scroll Button
Displays the media type of the selected bottle. Use the scroll buttons to select
the appropriate bottle type.
Note:
Anonymous bottles are assigned to the UNKNOWN bottle type.
Note:
The Bottle ID, Load Status, Maximum Test Time, and Bottle Type fields
can be edited concurrently or one at a time. Press the Check button to save
changes.
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Viewing/Editing Bottle Data
View Cell Location Icon
Displays the location of the selected bottle. The location is either the current
location or the last cell location, depending on whether the bottle is still
loaded.
Cell ID consists of the following three components in order:
• Incubation Module #
• Drawer letter
• Cell #
View First Loaded Time Icon
Displays the date and time the selected bottle was first loaded into the
system. The number of days since the bottle was first loaded appears in
parenthesis below the date and time.
View Last Unloaded Time Icon
Displays the date and time the selected bottle was last unloaded from the
system. The number of days since the bottle was unloaded appears in
parenthesis below the date and time. No time will be displayed if the bottle
has never been unloaded.
View Time of Last Bottle Reading Icon
Displays the date and time of the last bottle reading that was successfully
processed by the detection algorithm. The number of days since the last
bottle reading was processed appears in parenthesis below the date and time
of the last bottle reading.
View Test Time Icon
Displays the date and time the last test result changed. The number of days
that have passed between load and last determination appears in
parenthesis below the date and time. The date and time will not be displayed
if the bottle's status has not changed from negative-to-date.
6-8
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View Test Result Icon
Displays the test status of the selected bottle. Test status displayed inside the
bottle icon:
+
Positive (yellow bottle)
-
Negative (green bottle)
*
Negative-to-date (gray bottle)
~+
Critical determination in progress (gray bottle)
Edit Test Result Button
You can use the Edit Test Result button to change the status of the
displayed bottle:
1)
Press the Edit Test Result button.
The Edit Test Result screen overlays and disables the Edit Bottle Detail
screen.
1
2
3
Figure 6-4: Edit Test Result Screen
1 — Positive Status Checkbox
2 — Negative Status Checkbox
3 — Negative-To-Date Status Checkbox
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Viewing/Editing Bottle Data
2)
Touch the checkbox that corresponds to the desired status to insert an
X.
3)
Press the Check button to accept the change and return to the Edit
Bottle Detail screen, or press the Cancel button to keep the current
status and return to the Edit Bottle Detail screen.
Note:
Results that have been manually changed to negative or positive via the Edit
Bottle Detail screen (see Editing Bottle Details Using the Edit Bottle Detail
Screen on page 6-5) will be marked on the report with a stick figure ( ).
Note:
If a bottle is positive (set manually, or positive by any other reason) and then
is manually changed to negative-to-date, the stick figure ( ) will not appear.
Graph Bottle Readings Button
Displays the bottle graph on the Graph Bottle Readings screen (see Viewing
and Printing Bottle Graphs in Chapter 4).
View Algorithm/Polynomial Icon
The number above the slash represents the type of bottle specific algorithm
used for the data analysis of the selected bottle.
Table 6-1: Bottle Specific Algorithms
Algorithm No.
Bottle Type
11
iAST, iNST, iLYM, iFN, BPA, BPN
12
iFA
15
iPF
The number below the slash represents the type of polynomial. Polynomial 2
(LES Plastic) is used for the INDUSTRY bottle.
6-10
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View How Determined/Positivity Index Icon
The number above the slash displays a numerical code representing how the
selected bottle's status was determined.
Table 6-2: Status Determination Codes
Status
Determination
Code
How Status Determined
1
Rate
2
Acceleration
3
Initial value
4
Maximum test time exceeded
5
Delta
6
Test in progress
7
Manual (changed at Database Management System)
8
Manual (changed at BacT/ALERT® 3D)
9
Algorithm change (see Fault Code 74)
10
Manual (changed by LIS)
11
Wrong controller module (see Fault Code 79)
20–23
Corrupted bottle record
200–204
Detection of invalid data
205
Missing readings
The number below the slash is the Positivity Index. An index less than 1
indicates a negative or negative-to-date bottle. An index greater than or equal
to 1 indicates a positive bottle.
Note:
The number displayed on the lower right of the Edit Bottle Detail screen (not
associated with an icon) is a bottle sequence number, which may be utilized
by your bioMérieux Representative.
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Editing Test Data (INDUSTRY Use)
Editing Data Relationships
Editing Data Relationships
Introduction
Bottle information (Bottle ID, Sample ID, User Defined 3, User Defined 2,
User Defined 1) is typically associated to a bottle when a bottle is loaded. If
necessary, however, these values can later be changed by editing the data
relationships. This is initiated by pressing the Edit Data Relationships
button on the Setup screen.
The following sections will cover:
• Initiating the Edit Data Relationships function (see Initiating the Edit
Data Relationships Function on page 6-12).
• Editing Bottle ID to Sample relationships (see Editing Bottle ID to
Sample ID Relationships on page 6-14).
• Editing Sample ID to User Defined 3 relationships (see Editing Sample
ID to User Defined 3 Relationships on page 6-16).
• Editing User Defined 3 to User Defined 1/User Defined 2 relationships
(see Editing User Defined 3 to User Defined 1/User Defined 2
Relationships on page 6-17).
Initiating the Edit Data Relationships Function
6-12
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 4).
2)
Press the Edit Data Relationships button (
).
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Editing Test Data (INDUSTRY Use)
The Edit Data Relationships screen appears.
1
2
3
Figure 6-5: Edit Data Relationships Screen
1 — Edit Bottle ID to Sample ID Relationships Button
2 — Edit Sample ID to User Defined 3 Relationships Button
3 — Edit User Defined 3 to User Defined 1/User Defined 2
Relationships Button
Note:
The Edit Data Relationships screen is not available with the
BacT/ALERT® 3D Signature configuration. Pressing the Edit Data
Relationships button will display the Edit Bottle ID to Sample ID screen (see
Editing Bottle ID to Sample ID Relationships on page 6-14).
Note:
The availability of the buttons also depends on the availability of the fields.
Example: If the User Defined 1 and User Defined 2 fields are not displayed
on the system, then the Edit User Defined 3 to User Defined 1/User
Defined 2 fields are not available.
3)
To edit a Bottle ID to Sample ID relationship, press the corresponding
button and see Editing Bottle ID to Sample ID Relationships on
page 6-14.
4)
To edit a Sample ID to User Defined 3 relationship, press the
corresponding button and see Editing Sample ID to User Defined 3
Relationships on page 6-16.
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5)
Editing Data Relationships
To edit a User Defined 3 to User Defined 1/User Defined 2 relationship,
press the corresponding button and see Editing User Defined 3 to User
Defined 1/User Defined 2 Relationships on page 6-17.
Editing Bottle ID to Sample ID Relationships
1
2
3
6
4
5
Figure 6-6: Edit Bottle ID to Sample ID Relationships Screen
1 — Sample ID Field
2 — User Defined 3
3 — User Defined 2
4 — Bottle ID Scroll Box
5 — Data Transfer Buttons
6 — Sample ID Selection Buttons
Note:
The Sample ID Selection button will only appear if the system is set to allow
reuse of Sample IDs. By default, the BacT/ALERT® 3D is set to regard
Sample IDs as always unique. If you desire to re-use sample IDs, contact
your local bioMérieux Representative.
Note:
When the Edit Bottle ID to Sample ID Relationships screen is first accessed,
the Sample ID field is blank and all bottle IDs not associated with a Sample
ID are displayed in both Bottle ID scroll boxes.
Attaching Bottle IDs without a Sample ID to a Sample ID
1)
6-14
Access the Edit Bottle ID to Sample ID Relationships screen (see
Initiating the Edit Data Relationships Function on page 6-12).
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2)
Enter the sample ID in the left Sample ID field that you wish to associate
to the bottle(s).
If the entered Sample ID is associated with more than one User Defined
3, use the Sample ID Selection button to scroll through each instance
as indicated in the User Defined 3 and User Defined 2 fields.
Note:
3)
Touch the bottle ID(s) in the right Bottle ID scroll box to be associated
with the Sample ID. The selected bottle ID(s) highlight.
4)
Press the top Data Transfer button to move the Bottle ID(s) to the left
Bottle ID scroll box.
5)
Press the Check button to accept the changes, or press the Cancel
button to restore all relationships originally displayed.
6)
When done, press the Previous Screen button to return to the Edit Data
Relationships screen.
If you accessed the Edit Bottle ID to Sample ID Relationships screen directly
from the Setup screen, the Previous Screen button will return to the Setup
screen.
Moving a Bottle ID Association from one Sample ID to Another
1)
Access the Edit Bottle ID to Sample ID Relationships screen (see
Initiating the Edit Data Relationships Function on page 6-12).
2)
Enter the sample ID in the left Sample ID field to which the bottle(s) is
currently associated.
If the entered sample ID is associated with more than one User Defined
3, the Sample ID Selection button can be used to scroll through each
instance as indicated in the User Defined 3 and User Defined 2 fields.
3)
Enter the sample ID in the right Sample ID field that you wish to
associate to the bottle(s).
If the entered sample ID is associated with more than one User Defined
3, the Sample ID Selection button can be used to scroll through each
instance as indicated in the User Defined 3 and User Defined 2 fields.
4)
Touch the bottle ID(s) in the left Bottle ID scroll box that are to be
transferred. The selected bottle ID(s) highlight.
5)
Press the bottom Data Transfer button to move the bottle ID(s) to the
right Bottle ID scroll box.
6)
Press the Check button to accept the changes, or press the Cancel
button to restore all relationships originally displayed.
7)
When done, press the Previous Screen button to return to the Edit Data
Relationships screen.
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Editing Test Data (INDUSTRY Use)
Note:
Editing Data Relationships
If you accessed the Edit Bottle ID to Sample ID Relationships screen directly
from the Setup screen, the Previous Screen button will return to the Setup
screen.
Editing Sample ID to User Defined 3 Relationships
1
2
3
4
6
5
Figure 6-7: Edit Sample ID to User Defined 3 Relationships Screen
1 — User Defined 3 Field
2 — User Defined 1 Field
3 — User Defined 2 Field
4 — Sample ID Scroll Box
5 — Bottle ID List Box
6 — Data Transfer Buttons
Note:
When the Edit Sample ID to User Defined 3 Relationships screen is first
accessed, the User Defined 3 is blank and all Sample ID(s) not associated
with a User Defined 3 are displayed in both Sample ID scroll boxes.
Attaching Sample IDs without a User Defined 3 to a User Defined 3
6-16
1)
Access the Edit Sample ID to User Defined 3 Relationships screen (see
Initiating the Edit Data Relationships Function on page 6-12).
2)
Enter the User Defined 3 in the left User Defined 3 that you wish to
associate to the Sample ID(s).
3)
Touch the sample ID(s) in the right Sample ID scroll box that are to be
associated to the User Defined 3.
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Editing Test Data (INDUSTRY Use)
The selected sample ID(s) highlight. The bottle IDs associated with the
Sample ID that was touched last appears in the Bottle ID list box.
4)
Press the top Data Transfer button to move the sample ID(s) to the left
Sample ID scroll box.
5)
Press the Check button to accept the changes, or press the Cancel
button to restore all original relationships.
6)
When done, press the Previous Screen button to return to the Edit Data
Relationships screen.
Moving a Sample ID Association from One User Defined 3 to Another
1)
Access the Edit Sample ID to User Defined 3 Relationships screen (see
Initiating the Edit Data Relationships Function on page 6-12).
2)
Enter the User Defined 3 in the left User Defined 3 that the sample ID(s)
is currently associated.
3)
Enter the User Defined 3 in the right User Defined 3 with which you wish
to associate to the sample ID(s).
4)
Touch the sample ID(s) in the left Sample ID scroll box that are to be
transferred.
The selected sample ID(s) highlight. The bottle IDs associated with the
sample ID that was touched last appears in the Bottle ID list box.
5)
Press the bottom Data Transfer button to move the sample ID(s) to the
right Sample ID scroll box.
6)
Press the Check button to accept the changes, or press the Cancel
button to restore all relationships originally displayed.
7)
When done, press the Previous Screen button to return to the Edit Data
Relationships screen.
Editing User Defined 3 to User Defined 1/User Defined 2
Relationships
1)
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Access the Edit User Defined 3 to User Defined 1/User Defined 2
Relationships screen (see Initiating the Edit Data Relationships
Function on page 6-12).
6-17
Editing Test Data (INDUSTRY Use)
Editing Data Relationships
1
4
2
3
Figure 6-8: Edit User Defined 3 to User Defined 1/User Defined 2 Relationships Screen
1 — User Defined 3
2 — User Defined 1
3 — Previous Screen Button
4 — User Defined 2
6-18
2)
Enter the User Defined 3 in the User Defined 3 for which you want to
add/edit the User Defined 1/User Defined 2 association.
3)
Enter the correct User Defined 1/User Defined 2 into the User Defined 1
and User Defined 2 fields.
4)
Press the Check button to accept the changes, or press the Cancel
button to restore all relationships originally displayed.
5)
When done, press the Previous Screen button to return to the Edit Data
Relationships screen.
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SOFTWARE CONFIGURATION
7
About This Chapter
This chapter provides you with procedures on how to configure the software.
Note:
Information in this chapter that is intended for clinical use only or industry use
only is marked Clinical Use or INDUSTRY Use.
Chapter Contents
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
Viewing and Printing Calibration Data • 7-21
Viewing and Printing Calibration History • 7-25
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Setting the Maximum Test Time
Setting the Maximum Test Time
Perform the following procedure to set a universal maximum test time (or time
that a negative-to-date bottle will be tested before being called final negative)
for each media type. The result is that each time a bottle is loaded, its
maximum test time will default to the maximum test time configured for its
media type.
Note:
The maximum test time can be changed for an individual bottle while loading,
if desired, or can be changed after a bottle is loaded in the Edit Bottle Detail
screen. For Clinical Use, see Changing the Maximum Test Time — Individual
Bottles in Chapter 3. For INDUSTRY Use, see Changing the Maximum Test
Time — Individual Bottles in Chapter 4.
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 3 for Clinical Use, or in
Chapter 4 for INDUSTRY Use).
2)
Press the Set Maximum Test Time button (
).
The Set Maximum Test Time screen overlays and disables the Setup
screen.
1
3
2
4
Figure 7-1: Set Maximum Test Time Screen
1 — Media Type Scroll Button
2 — Previous Screen Button
3 — Incubation Period Scroll
Buttons
4 — Check Button
7-2
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Setting the Audible Alarms
Note:
Software Configuration
3)
Select the appropriate bottle type from the Media Type scroll button.
4)
Set the incubation period in days and tenths of a day using the
Incubation Period scroll buttons.
The minimum test time that can be specified is 0.1 day.
5)
Note:
Press the Check button to save the maximum test time settings, or press
the Cancel button to return the system to the previous maximum test
time settings.
Changing the maximum test time has no affect on bottles currently loaded.
The new maximum test time will be attributed to bottles loaded after the
setting is changed.
6)
Press the Previous Screen button to return to the Setup screen.
Note:
Generic or anonymous bottles in a BC drawer will be assigned the unknown
maximum test time.
Note:
Clinical Use: Generic or anonymous bottles in the MB drawer will use the
maximum test time assigned to the BacT/ALERT® MP bottle.
Setting the Audible Alarms
You can enable/disable the following audible alarms:
• Positive Bottle Alarm – A repeated sequence of brief beeps followed
by a pause. This sequence of beeps are repeated every 60 seconds
until the bottle is removed.
• Instrument Fault Alarm – An ongoing, continuous sequence of brief
beeps. Once the condition is acknowledged (see Terminating an
Instrument Alarm on page 7-5), the alarm will sound again in 30
minutes if the error condition still exists.
Note:
The default setting for the fault reminder period is 30 minutes. If you require a
different time period, contact your local bioMérieux Representative.
• Operator Error Alarm – Two brief beeps to alert the operator to look
at the Operator Panel where an error code or picture is displayed. For
resolution of a specific error code, see Operator Error Codes in
Chapter 9.
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Software Configuration
Note:
Setting the Audible Alarms
Operator error alarms do not repeat.
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 3 for Clinical Use, or in
Chapter 4 for INDUSTRY Use.).
2)
Press the Set Audible Alarm Options button (
).
The Set Audible Alarm Options screen overlays and disables the Setup
screen.
3
1
2
Figure 7-2: Setting the Audible Alarm Options Screen
1 — Positive Bottle Alarm Slidebar Switch
2 — Operator Error Alarm Slidebar Switch
3 — Instrument Fault Alarm Slidebar Switch
3)
4)
Enable and/or disable alarms by adjusting the slidebar switches to the
desired settings:
• 0 — disabled
• 1 — enabled
Press the Check button to save any changes, or press the Cancel
button to return the system to the original settings.
The system returns to the Setup screen.
7-4
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Changing the System Password
Note:
Software Configuration
In addition to the Instrument Audible Alarms, the bar code reader is also
programmed to provide an audible alarm in three instances. These are:
• Bar code is scanned with entry to Bottle ID field
• Accession bar code is scanned with entry to Accession Number field
• Any Operator errors related to scanning, loading or unloading
The bar code reader alarms are not disabled by setting the Operator Error
Alarm slide bar to the zero setting.
Priority of Alarms
The audible alarms which will sound correspond to the most critical condition
according to the priorities listed (highest to lowest) below:
1)
Instrument fault
2)
Positive bottles
3)
Operator errors
Terminating an Instrument Alarm
To terminate an alarm, perform one of the following:
• Acknowledge the condition causing the alarm by touching any area of any
screen of the Operator Panel or by pressing any key on the keyboard.
• Disable the alarm.
Note:
To remove or adjust your error alarm delay cycle, contact your local
bioMérieux Representative.
Changing the System Password
Perform the following procedure to change the system password that is used
to enable the Setup screen function buttons.
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 3 for Clinical Use, or in
Chapter 4 for INDUSTRY Use).
2)
Press the Change Password button (
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Software Configuration
Changing the System Password
The Change Password screen overlays and disables the Setup screen.
4
1
2
3
Figure 7-3: Change Password Screen
1 — Password Entry Keypad
2 — Previous Screen Button
3 — Check Button
4 — Padlock Icon
3)
Note:
Enter a valid password using the Password Entry Keypad buttons.
Acceptable passwords consist of any combination of the numbers 1 to 4 and
have a maximum length of eight characters.
4)
The Padlock icon changes to a full open position after the Key Symbol
button is pressed. If the Padlock icon does not open, then repeat Step 3.
Figure 7-4: Padlock Icon (Full Open position)
7-6
5)
Enter the new password using the Password Entry Keypad buttons.
6)
Press the Key Symbol button.
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The Padlock icon changes to a half open position.
Figure 7-5: Padlock Icon (Half Open Position)
7)
Re-enter the new password to verify.
8)
Press the Key Symbol button. If the same password is entered both
times, then the Padlock icon closes. If the new password was not
verified correctly, the Padlock icon will open completely. The user must
then start over with Step 5 to change the password.
Figure 7-6: Padlock Icon (Closed Position)
9)
Press the Check button to accept the new password, or press the
Cancel button to retain the old password.
10) Press the Previous Screen button to return to the Setup screen.
Note:
Record the new password in a secure location. This password will be needed
to access all function buttons on the Setup screen.
Initiating Manual Backup
Perform the following procedure to initiate an immediate backup of the
system to a Zip® disk or USB flash drive. The backup procedure, though
lengthy, does not prohibit you from simultaneously performing any other
functions on the system.
Note:
If you have a 250 MB Zip® Drive, use only 250 MB Zip® disks for backups.
Note:
If you have a 750 MB Zip® Drive, you may use either 250 or 750 MB Zip®
disks for backups.
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IMPORTANT:
Initiating Manual Backup
If you have a USB Port, use only USB Flash Drives provided by
bioMérieux for backups.
1)
Access the Setup screen and enter a valid password see (Accessing the
Setup Screen Function Buttons in Chapter 3 for Clinical Use, or in
Chapter 4 for INDUSTRY Use).
2)
Press the Backup Management button (
).
The Backup Management screen overlays and disables the Setup
screen.
1
4
2
3
Figure 7-7: Backup Management Screen
1 — Automatic Backup Time Scroll Buttons
2 — Previous Screen Button
3 — Check Button
4 — Manual Backup Button
Note:
The Automatic Backup Time scroll buttons are disabled by default. If you
wish to set an automatic backup time, contact your local bioMérieux
Representative.
3)
To initiate an immediate backup, press the Manual Backup button.
The system returns to the Setup screen.
Note:
7-8
If a manual backup is initiated without a Zip® disk inserted in the drive or USB
flash drive inserted in the USB port, then an Instrument Status Code 810 will
display (see Instrument Status Codes in Chapter 9).
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Configuring Report Screens
Software Configuration
Note:
While the system is being backed up, the Backup In Progress icon will
appear in the upper left corner of the Backup Management and Main screens.
The icon will disappear every 5 seconds for half a second.
Figure 7-8: Backup In Progress Icon
Note:
If you attempt to perform a function (for example, load or unload a bottle)
while a manual backup is taking place, you may encounter a brief screen
grayout. This is a safety feature that prevents database corruption by allowing
the software to close and exit files prior to giving you access.
WARNING
Do not insert any object, other than a Zip® disk, into the Zip®
drive under any circumstances.
CAUTION: Do not forcibly remove the Zip® disk from the
instrument. Forcibly removing the Zip® disk may cause damage
to the Zip® disk or Zip® drive and may cause the system to lock
up.
Configuring Report Screens
Introduction
Report screens are accessed by pressing the appropriate Display Report
Screen button from the Report Selection screen (see Viewing and Printing in
Chapter 3 for Clinical Use, or Chapter 4 for INDUSTRY Use). The following
procedures show you how to configure these report screens.
Note:
The report function is available with the BacT/ALERT® 3D Select and
SelectLink configurations.
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Software Configuration
Configuring Report Screens
Entering Report Labels
The following procedure describes how you can select labels to use as
column headings for all reportable fields on system reports.
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 3 for Clinical Use, or in
Chapter 4 for INDUSTRY Use).
2)
From the Setup screen, press the Report button (
).
The Report Selection screen appears.
1
2
3
Figure 7-9: Report Selection Screen
1 — Report Label Entry Button
3 — Check Button
2 — Cancel Button
3)
7-10
Press the Report Label Entry button (
).
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Software Configuration
The Report Label Entry screen appears.
1
2
Figure 7-10: Report Label Entry Screen
1 — Cancel Button
2 — Check Button
Note:
The above default report labels are assigned at installation and can be
modified or changed.
4)
Access the keyboard (see Accessing the Controller Module Keyboard in
Chapter 2).
5)
Touch the field where you will enter the new label.
The field turns white.
6)
Enter the new label. Labels may contain up to 15 characters; however,
labels will be truncated on the reports if the column widths do not allow
room for the entire label (see Configuring Report Contents on
page 7-13).
7)
After you have made all of the desired label changes, verify that all labels
are unique and there are no empty label fields.
8)
Press the Check button to accept the label changes, or press the
Cancel button to retain the previous labels.
The system returns to the Setup screen.
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Configuring Report Screens
Note:
Operator Error 960 displays if the Check button is pressed with duplicate
Report Label entries present (see Operator Error Codes in Chapter 9).
Note:
Operator Error 961 displays if the Check button is pressed with blank Report
Label fields present.
CAUTION: The user is solely responsible for the choice of
customized report label text and for validating that the intended
label text appears in all associates reports. bioMérieux shall not
be liable for any consequences resulting from misinterpretation
of customized report labels.
Table 7-1: Report Field Descriptions
Field
Description
Displays the maximum number of days a bottle will be tested to the
tenth of a day (ex. XX.X).
Displays the bottle type with no abbreviation.
Displays 1 for bottle loaded or 0 for bottle not loaded.
Displays cell location. Example: 1A01.
Displays the date the bottle was loaded in one of the following formats,
depending on Set Date/Time screen setting:
MM/DD/YY or DD/MM/YY.
Displays the date the bottle was unloaded in one of the following
formats, depending on Set Date/Time screen setting:
MM/DD/YY or DD/MM/YY.
Displays the Date and Time of the last successful bottle reading in one
of the following formats, depending on Set Date/Time screen setting:
MM/DD/YY HH:MM or DD/MM/YY HH:MM.
The time is always displayed in 24 hour format regardless of the Set
Date/Time screen setting.
Displays the time in days since the bottle has been loaded for
negative-to-date bottles, or the time it took to make the result
determination for positive and negative bottles. The time is displayed in
hundredths of days (ex. XX.XX).
Displays the bottle test result as + for positive, - for negative, or * for
negative to date.
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Table 7-1: Report Field Descriptions (Continued)
Field
Description
Displays the bottle ID.
Clinical Use: Displays the accession number or other kind of data
entered by the user.
INDUSTRY Use: Referred to in this manual as Sample ID.
Clinical Use: Displays the hospital ID or other kind of data entered by
the user.
INDUSTRY Use: Referred to in this manual as User Defined 3.
Clinical Use: Displays the patient’s first name or other kind of data
entered by the user.
INDUSTRY Use: Referred to in this manual as User Defined 1.
Clinical Use: Displays the patient’s last name or other kind of data
entered by the user.
INDUSTRY Use: Referred to in this manual as User Defined 2.
Configuring Report Contents
Perform the following procedure to configure the Report screens to show the
desired information (see Figure 3-12, Sample Report Screen for Clinical Use,
or Figure 4-12, Sample Report Screen for INDUSTRY Use).
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 3 for Clinical Use, or in
Chapter 4 for INDUSTRY Use).
2)
From the Setup screen, press the Report button (
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Software Configuration
Configuring Report Screens
The Report Selection screen appears.
1
2
3
Figure 7-11: Report Selection Screen
1 — Report Configuration Button
2 — Cancel Button
3 — Check Button
3)
Press the Report Configuration button (
).
The Report Configuration screen displays.
Clinical Use: See Figure 7-12, Figure 7-13, and Figure 7-14 for
examples of the Load, Status, and Unload Report Configuration screens,
respectively.
INDUSTRY Use: See Figure 7-15, Figure 7-16, and Figure 7-17 for
examples of the Load, Status, and Unload Report Configuration screens,
respectively.
Note:
7-14
4)
Press the Edit Report button that corresponds to the report you wish to
reconfigure.
5)
Adjust the Column Selection scroll buttons so that the desired fields are
reported in the desired order. The scroll buttons correspond to the report
columns from left to right.
Each Column Selection scroll button contains all reportable fields plus a
blank selection so that the column can be left blank.
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Software Configuration
6)
Note:
The 70 to the left of the selection boxes denotes the total available width, and
the number to the right of the equals sign denotes the available width left (ex.
the total minus the sum of the Column Width selection boxes).
7)
Note:
Note:
Adjust the column widths by touching the Column Width selection box
under the column to be altered and enter the new width. Make certain the
column widths do not exceed the total available.
Adjust the Primary/Secondary Sort scroll buttons, if desired, to sort the
report.
Each Primary/Secondary Sort scroll button both contain all reportable fields
plus a blank selection if a sort is not to be performed.
8)
Select the order of any sorts with the Sort Order Selection button. If the
arrow is pointed upward, there will be an ascending sort and if the arrow
is pointed downward, there will be a descending sort.
9)
Touch the Section Break checkbox(es) to set a section break.
You can select a sort for a field that is not chosen as one of the report
columns. If a section break is also chosen for that sort, then the field’s data
will display in the section break line. This, in effect, allows you to report two
extra data fields.
10) Press the Preview Report button to view the report configuration (see
Figure 3-12, Sample Report Screen for Clinical Use, or Figure 4-12,
Sample Report Screen for INDUSTRY Use).
11) Press the Previous Screen button to return to the Report Configuration
screen.
12) Make any adjustments to the report configuration desired.
13) Press the Check button to accept the changes to the report
configuration, or press the Cancel button to retain the original
configuration.
14) Press the Previous Screen button to return to the Setup screen.
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Software Configuration
Configuring Report Screens
Load Report Configuration Screen (Clinical Use)
1
2
3
11
4
12
5
6
7
8
9
10
Figure 7-12: Load Report Configuration Screen (Clinical Use)
1 — Report Title
2 — Column Selection Scroll Buttons
3 — Column Width Selection Boxes
4 — Edit Report Buttons
5 — Preview Report Button
6 — Previous Screen Button
7 — Cancel Button
8 — Check Button
9 — Section Break Checkboxes
10 — Sort Order Buttons
11 — Primary Sort Scroll Button
12 — Secondary Sort Scroll Button
7-16
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Status Report Configuration Screen (Clinical Use)
1
2
3
11
4
12
5
6
7
8
9
10
Figure 7-13: Status Report Configuration Screen (Clinical Use)
1 — Report Title
2 — Column Selection Scroll Buttons
3 — Column Width Selection Boxes
4 — Edit Report Buttons
5 — Preview Report Button
6 — Previous Screen Button
7 — Cancel Button
8 — Check Button
9 — Section Break Checkboxes
10 — Sort Order Buttons
11 — Primary Sort Scroll Button
12 — Secondary Sort Scroll Button
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Software Configuration
Configuring Report Screens
Unload Report Configuration Screen (Clinical Use)
1
2
3
11
4
12
5
6
7
8
9
10
Figure 7-14: Unload Report Configuration Screen (Clinical Use)
1 — Report Title
2 — Column Selection Scroll Buttons
3 — Column Width Selection Boxes
4 — Edit Report Buttons
5 — Preview Report Button
6 — Previous Screen Button
7 — Cancel Button
8 — Check Button
9 — Section Break Checkboxes
10 — Sort Order Buttons
11 — Primary Sort Scroll Button
12 — Secondary Sort Scroll Button
7-18
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Load Report Configuration Screen (INDUSTRY Use)
1
2
3
11
4
12
5
6
7
8
9
10
Figure 7-15: Load Report Configuration Screen (INDUSTRY Use)
1 — Report Title
2 — Column Selection Scroll Buttons
3 — Column Width Selection Boxes
4 — Edit Report Buttons
5 — Preview Report Button
6 — Previous Screen Button
7 — Cancel Button
8 — Check Button
9 — Section Break Checkboxes
10 —Sort Order Buttons
11 — Primary Sort Scroll Button
12 — Secondary Sort Scroll Button
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Software Configuration
Configuring Report Screens
Status Report Configuration Screen (INDUSTRY Use)
1
2
3
11
4
5
12
6
7
8
9
10
Figure 7-16: Status Report Configuration Screen (INDUSTRY Use)
1 — Report Title
2 — Column Selection Scroll Buttons
3 — Column Width Selection Boxes
4 — Edit Report Buttons
5 — Preview Report Button
6 — Previous Screen Button
7 — Cancel Button
8 — Check Button
9 — Section Break Checkboxes
10 — Sort Order Buttons
11 — Primary Sort Scroll Button
12 — Secondary Sort Scroll Button
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Unload Report Configuration Screen (INDUSTRY Use)
1
2
3
11
4
12
5
6
7
8
9
10
Figure 7-17: Unload Report Configuration Screen (INDUSTRY Use)
1 — Report Title
2 — Column Selection Scroll Buttons
3 — Column Width Selection Boxes
4 — Edit Report Buttons
5 — Preview Report Button
6 — Previous Screen Button
7 — Cancel Button
8 — Check Button
9 — Section Break Checkboxes
10 — Sort Order Buttons
11 — Primary Sort Scroll Button
12 — Secondary Sort Scroll Button
Viewing and Printing Calibration Data
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 3 for Clinical Use, or in
Chapter 4 for INDUSTRY Use).
2)
From the Setup screen, press the Report button (
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Software Configuration
Configuring Report Screens
The Report Selection screen appears.
1
Figure 7-18: Report Selection Screen
1 — Calibration Report Button
3)
7-22
Press the Calibration Report button (
).
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The Cell Calibration Report screen appears.
1
6
5
2
3
4
Figure 7-19: Cell Calibration Report
1 — Report Header
2 — Print Button
3 — Cancel Print Button
4 — Scroll Down Buttons
5 — View Window
6 — Scroll Up Buttons
Note:
4)
Enter a report title in the Report Header field (a maximum of 64
alphanumeric characters).
5)
To scroll up a line, page, or home, press the appropriate Scroll Up
buttons.
6)
To scroll down a line, page, or end, press the appropriate Scroll Down
buttons.
The Scroll Up/Down buttons are disabled if there are no available lines/
pages in the indicated direction.
7)
Note:
To print the report, press the Print button.
The Print buttons are only available if a printer is configured for the system.
To configure a printer for the system, contact your local bioMérieux
Representative.
8)
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When the report begins printing:
7-23
Software Configuration
Configuring Report Screens
• The Print button is disabled while a report is printing. You may,
however, view and scroll through the displayed report.
• The Exit button is disabled while a report is printing.
• The Cancel Print button (
) is enabled. Press the Cancel
Print button to stop the printing as soon as the print queue empties.
9)
Press the Previous Screen button to return to the Report Selection
screen.
The report content is displayed in the View window and contains the
following features:
• The ID of each installed rack.
• The number of cells out of calibration for the rack just identified.
• The ID of the cells that are out of calibration for the rack just identified.
1
4
2
3
Figure 7-20: Calibration Report
1 — Rack ID
2 — Number of Cells out of Calibration for this Rack
3 — Incubation Module Separator Line
4 — IDs of Cells out of Calibration
Note:
7-24
Always print a calibration report prior to calibrating any cells. Then print a
report after calibrating the cells. In this manner, you will have a record
showing corrective action was taken.
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Configuring Report Screens
Software Configuration
Viewing and Printing Calibration History
The Calibration History screen shows you when cells went in and out of
calibration.
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 3 for Clinical Use, or in
Chapter 4 for INDUSTRY Use).
2)
From the Setup screen, press the Report button (
).
The Report Selection screen appears.
1
Figure 7-21: Report Selection Screen
1 — Calibration History Button
3)
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Press the Calibration History button (
).
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Software Configuration
Configuring Report Screens
The Calibration History screen appears.
1
2
9
3
8
4
5
7
6
Figure 7-22: Calibration History Screen
1 — Screen ID
2 — Report Header
3 — Date, Time, Cell Location, and Cell Status
4 — Print Button
5 — Cancel Print Button
6 — Previous Screen Button
7 — Scroll Down Buttons
8 — View Window
9 — Scroll Up Buttons
The report content is displayed in the View window and contains the
following information:
• The date and time event occurred (in or out of calibration)
• Cell Location
• Cell Status: 0 = when cell falls out of calibration/1 = when cell goes
back in calibration
If the cell is manually calibrated, (calibrated) is displayed to the right of
the 1. Or, if in 21 CFR Part 11 mode, the user name is displayed.
Note:
7-26
There is nothing displayed to the right of the 1 or 0 if the cell falls out of
calibration, or drifts back into calibration.
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Software Configuration
Note:
The last 10,000 calibration events are saved in the calibration history. When
the maximum number of events is reached, the oldest events are overwritten.
4)
Enter a report title in the Report Header field (a maximum of 65
alphanumeric characters).
This title appears at the top of the report when printed.
Note:
5)
To scroll up a line, page, or home, press the appropriate Scroll Up
buttons.
6)
To scroll down a line, page, or end, press the appropriate Scroll Down
buttons.
The Scroll Up/Down buttons are disabled if there are no available lines/
pages in the indicated direction.
7)
Note:
To print the report, press the Print button.
The print buttons are only available if a printer is configured for the system.
To configure a printer for the system, contact your local bioMérieux
Representative.
8)
When the report begins printing:
• The Print button is disabled while a report is printing. You may,
however, view and scroll through the displayed report.
• The Exit button is disabled while a report is printing.
• The Cancel Print button (
) is enabled. Press the Cancel
Print button to stop the printing as soon as the print queue empties.
9)
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Press the Previous Screen button to return to the Report Selection
screen.
7-27
Software Configuration
7-28
Configuring Report Screens
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SYSTEM MAINTENANCE
8
About This Chapter
This chapter provides you with procedures on how to perform hardware and
software maintenance on the BacT/ALERT® 3D instrument.
Note:
Information in this chapter that is intended for clinical use only or industry use
only is marked Clinical Use or INDUSTRY Use.
Chapter Contents
Hardware Maintenance • 8-2
Preventative Maintenance • 8-2
Safety Precautions and Procedures • 8-2
Using the Keyboard in Place of the Operator Panel • 8-8
UPS On/Off Button Location • 8-9
Controller/Combination Module Reboot/Shutdown (BacT/ALERT® 3D Select and
SelectLink) • 8-10
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
Adjusting an Incubation or Combination Module’s Temperature • 8-21
Calibrating an Instrument Cell • 8-25
Viewing Incubation Module Information • 8-29
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Hardware Maintenance
Preventative Maintenance
Routine BacT/ALERT® 3D preventive maintenance is included in
bioMérieux's regular service program. There is no additional requirement for
customer performed preventive maintenance. Contact your local bioMérieux
Representative to schedule periodic service.
Safety Precautions and Procedures
The design of the BacT/ALERT® 3D provides several features in the interest
of operator and laboratory safety.
• All glass bioMérieux BacT/ALERT® media bottles are manufactured
with a polyethylene safety sleeve to limit the effects of damage to a
bottle.
• All bioMérieux BacT/ALERT® media bottles are non-venting (except
iAST and iLYM — Industry Use) to minimize the risk of needle sticks.
• Each bottle cell within the BacT/ALERT® 3D Incubation and
Combination Modules is sealed to help contain and minimize effects of
liquid leakage.
• A drip tray is incorporated at the bottom of each drawer, beneath the
opening end of the racks, to minimize the effect of any spillage of
liquid.
• The circulating fans within the Incubation and Combination Modules
turn off whenever any drawer is open, minimizing airflow and the
potential for aerosols.
• To reduce the chance for binding a heavily overlabeled bottle,
Incubation and Combination Module cells are gently tapered and
fabricated from a pliable polymer.
• Electrical voltages within each Incubation or Combination Module
drawer are low (approximately 5 volts or less) to minimize potential
electrical hazards.
• Should the optimal temperature in an Incubation Module be set to a
point outside the range 35–37°C, a yellow Operator alert will appear
on the Calibrate Module Temperature screen of the Controller or
Combination Module.
8-2
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• Any mention of bleach refers to the standard 5.25% sodium
hypochlorite. A 10% bleach solution would indicate a 1:10 dilution of
the standard 5.25% sodium hypochlorite.
WARNING
Clinical Use: Pathogenic microorganisms including Hepatitis B
virus and Human Immunodeficiency Virus (HIV) may be present
in specimens. Universal Precautions and Local Laboratory
guidelines should be followed in handling all items
contaminated with blood or body fluids. If an inoculated bottle
is found to be leaking or is accidentally broken during
collection or transport, use the established procedures in your
facility for dealing with biohazardous material. As a minimum,
Universal Precautions should be employed. Bottles should be
discarded in an appropriate manner.
General Precautions
The following precautions should be observed during maintenance and
repair, even in situations where a spill is neither observed nor suspected. Any
parts removed or tools used should be cleaned using a 10% bleach solution
before removal from the laboratory. Anything that cannot be disinfected
should be sealed in a plastic bag, labeled as biohazardous and handled
accordingly. In addition, the laboratory’s safety precautions should always be
observed.
Spill Cleanup
• Where appropriate, follow your laboratory's spill clean up procedures.
WARNING
Clinical Use: For spills that might involve M. tuberculosis,
proper protective equipment should be worn, including
suitable respirator, gloves, eye protection, and a lab coat. In
some cases, coveralls or shoe covers should be worn to avoid
contaminating street clothing.
1)
Clinical Use: Gently cover the spill area with a paper towel. Apply a 10%
bleach solution or other EPA registered tuberculocidal disinfectant. Apply
a 10% bleach solution.
or
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INDUSTRY Use: Gently cover the spill area with a paper towel. Apply a
10% bleach solution.
2)
Using the bleach solution, wet down all surfaces with which the spill may
have come in contact.
3)
Allow all surfaces adequate contact time with the bleach solution
(15–30 minutes) before cleanup.
4)
All materials used in the clean up should be treated as biohazardous
waste.
Disinfection Procedure for Spills Onto the Instrument (Clinical Use)
Any blood or test specimen spilled on an instrument should be removed
immediately using the following procedure.
WARNING
Protective gloves should always be worn when handling blood,
blood components, or blood-contaminated material.
WARNING
Handle specimens and inoculated culture bottles as though
capable of transmitting infectious agents. All inoculated
bottles, specimen collection needles, and blood drawing
devices should be autoclaved before they are discarded.
8-4
1)
Clean the spill from the instrument following your institution's
recommended procedure for decontamination or the procedure
described in the latest revision of Clinical and Laboratory Standards
Institute (CLSI) guideline ”Protection of Laboratory Workers from
Instrument Biohazards and Infectious Disease Transmitted by Blood,
Body fluids, and Tissue” CLSI Document M29-A.
2)
After decontamination, wipe with damp (water only) towel and thoroughly
dry.
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Disinfection Procedure for Spills Onto the Instrument (INDUSTRY Use)
Any test sample spilled on an instrument should be removed immediately
using the following procedure.
1)
Clean the spill from the instrument following your laboratory’s
recommended procedure for decontamination.
2)
After decontamination, wipe with damp (water only) towel and thoroughly
dry.
Disinfection Procedure for Spills Within the Instrument
Note:
This procedure applies to both Clinical Use and INDUSTRY Use.
Any test specimen/sample spilled in an instrument should be removed
immediately and the affected areas decontaminated using the following
procedure.
WARNING
Clinical Use: If a spill is detected that might involve
M. tuberculosis, only persons wearing protective clothing and
suitable respiratory protection should remain in the room.
Note:
1)
Visually inspect the extent of the leakage or spill. Determine if one or
more racks, or the drawer itself is contaminated.
2)
Remove the leaking bottle if possible.
If a bottle becomes lodged in the cell, contact bioMérieux Customer Service.
Do not try to dislodge bottle by pulling on the rack.
3)
Unload positive and negative bottles in affected rack(s) (see Unloading
Bottles in Chapter 3, for Clinical Use, or see Unloading Bottles in
Chapter 4 for INDUSTRY Use).
4)
Relocate remaining bottles in affected rack(s) using the following
procedure.
a. From the Main screen, press Ctrl + F10 to enter a special Bottles
Relocation mode that allows bottles to be relocated.
The cell indicator lights will illuminate in the following pattern:
• Cells with bottles are lit continuously.
• Cells available for reloading are unlit.
b. Pull bottles out one at a time and reload one at a time into any
available cell.
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Note:
Hardware Maintenance
When relocating bottles using Ctrl + F10, you must unload one bottle from a
cell and reload it into the destination cell BEFORE unloading another bottle.
This procedure must be done one bottle at a time.
c. If the Bottle ID field for a loaded bottle is blank, be sure to identify the
anonymous bottle by scanning the barcode as it is unloaded (see
Handling Anonymous Bottles in Chapter 3 for Clinical Use, or see
Handling Anonymous Bottles in Chapter 4 for INDUSTRY Use).
d. When all bottles are unloaded, press the Check button on the Main
screen.
CAUTION: When unloading multiple bottles using Ctrl + F10, the
bottles must be reloaded before 1 hour has passed using the
normal Load Bottles icon to avoid a subculture event.
8-6
Note:
Clinical Use: Bottles affected by the spill should not be reloaded until they
have been decontaminated. Decontaminate the bottles following your
institution's recommended procedure for decontamination or the procedure
described in the latest revision of CLSI guideline “Protection of Laboratory
Workers from Instrument Biohazards and Infectious Disease Transmitted by
Blood, Body Fluids, and Tissue” CLSI Document M29-A. Press the Load
Bottles button to reload the decontaminated bottles.
Note:
INDUSTRY Use: Bottles affected by the spill should not be reloaded until they
have been cleaned. Clean the bottles following your laboratory’s
recommended procedure. Press the Load Bottles button to reload the
cleaned bottles.
5)
Disable the affected cells, rack(s), or drawer (see Enabling and Disabling
Modules, Drawers, Racks, and Cells on page 8-18).
6)
If an affected cell contains a large amount of liquid, carefully aspirate it
using a pipette or similar device, and dispose of it in an appropriate
biohazardous waste container.
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7)
If the spill is confined to one or a few cells of one drawer rack, the
affected cells may be cleaned and disinfected with a 10% bleach
solution, using the following procedure:
CAUTION: Do not expose the cell or rack to the bleach solution
for an extended period. 10% bleach is the ONLY disinfectant that
has been validated for use with the cells. DO NOT use a different
disinfectant or a bleach solution stronger than 10% or damage
to cell components may occur.
a. Insert absorbent material, such as gauze, into the cell to remove any
remaining fluid. Carefully remove and discard the gauze in a
biohazardous waste container.
b. Wipe out the interior of the cell with gauze soaked with 10% bleach
solution and discard in a biohazardous waste container.
c. Insert several layers of gauze saturated with a 10% bleach solution
into the cell and let sit for 15 to 30 minutes to decontaminate. The
gauze should be soaked to the point of saturation but not so wet that
liquid drips out of the cell.
d. Remove and discard the gauze in a biohazardous waste container.
e. Wipe the interior of the cell with gauze soaked in distilled water to
rinse.
f. Allow the cell to air dry.
g. Calibrate the cell. If the cell passes calibration, enable the cell (see
Enabling and Disabling Modules, Drawers, Racks, and Cells on
page 8-18).
8)
Clinical Use: If the cell fails calibration or there is visible blood stain
residue still present in the cell, particularly on the bottom, clean as
follows:
or
INDUSTRY Use: If the cell fails calibration or there is visible residue still
present in the cell, particularly on the bottom, clean as follows:
a. Insert absorbent material, such as gauze, into the cell to remove any
remaining fluid. Carefully remove and discard the gauze in a
biohazardous waste container.
b. Rinse with 10% bleach solution, then distilled water and let air dry.
c. Calibrate the cell. If the cell still cannot be calibrated, disable the cell
and insert an orange cell plug to indicate the cell should not be used.
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9)
For more extensive spills, it may be necessary to remove one or more
racks or an entire drawer. To gain access to the bottom drip tray and
internal drawer surfaces, remove all three racks, or remove a drawer.
Note:
If removing a rack or drawer is necessary, contact your local bioMérieux
Representative.
Note:
Clinical Use: Decontaminate bottles, cells, racks, and drawers following your
institution's recommended procedure for decontamination or the procedure
described in the latest revision of CLSI guideline “Protection of Laboratory
Workers from Instrument Biohazards and Infectious Disease Transmitted by
Blood, Body Fluids, and Tissue” CLSI Document M29-A.
Note:
INDUSTRY Use: Clean bottles, cells, racks, and drawers following your
laboratory’s recommended procedure for cleaning.
Using the Keyboard in Place of the Operator Panel
Normally, the Operator Panel is used to make selections and enter data. The
keyboard provides an alternate method as follows (see Accessing the
Controller Module Keyboard in Chapter 2).
• Items on a screen may be selected using the Tab key. The selected item is
identified by a contrasting color outlining the item.
• Pressing the Enter key initiates the function for the selected item.
• For menus that require entry of a numeric password, you can use the
numeric keys in place of touching the screen. Use the 1 to 4 keys to enter
the password value. Use the 5 key in place of pressing the Key Symbol
button.
• Scroll buttons are selected using the Tab key. Once you select the desired
scroll button, use the > or < keys to select the Up or Down scroll arrow.
Function keys can be used to invoke the following functions.
Alt + F5
8-8
Clears Instrument Fault Code 80 faults for all cells at the same
time. This function only works while the Setup screen is displayed
and after a password is entered.
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Ctrl + F1
Activates a special unload mode. This identifies bottles that are
loaded in cells that are non-operational. The green drawer indicator
is lit in drawers containing non-operational cells. When the drawer
is opened, the cell indicator lights will light for those bottles in nonoperational cells. Cells with rapidly flashing cell indicator lights are
disabled or unusable.
In this mode, the Controller or Combination Module automatically
activates the Unload Bottles function. Bottles can be removed from
the indicated cells one at a time and moved to usable cells whose
cell indicator light will be off. This function only works while the
Main screen is displayed.
Ctrl + F2
Activates a special unload mode. This identifies cells out of
calibration. All such cells are identified whether they are loaded or
not. The green drawer indicator is lit on drawers containing out-ofcalibration cells. When the drawer is opened, the cell indicator
lights will light for cells out of calibration. This function only works
while the Main screen is displayed.
Ctrl + F3
Activates a special unload mode. This identifies bottles which have
an Instrument Fault Code 80. When the drawer is opened, the cell
indicator lights will light for those bottles with the 80 instrument
fault. In this mode, the instrument automatically activates the
Unload Bottles function. This function only works while the Main
screen is displayed.
Ctrl + F10
Activates a special bottle relocation mode. This identifies all
currently loaded bottles regardless of their test status. The green
drawer indicator is lit on drawers with loaded bottles. When the
drawer is opened, the cell indicator lights will light for the loaded
cells. Cells available for reloading are unlit. This function only works
while the Main screen is displayed.
UPS On/Off Button Location
Controller Module
There are two Controller Module UPS configurations: Front and Rear Access.
Use the following steps to identify the relevant configuration.
1)
Remove the upper Pop-off Access Panel from the front of the Controller
Module.
2)
If configured for Front Access, the UPS On/Off button will be visible
inside the instrument (see Figure 8-1). Immediate access to the UPS On/
Off button is available; otherwise, continue with Step 3.
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1
2
3
Figure 8-1: Front Access UPS Orientation
1 — UPS On/Off Button
2 — Lower Attachments for Pop-Off Access Panel
3 — Operator Panel
3)
If the UPS On/Off button is not visible, the instrument is configured for
Rear Access.
4)
Carefully move the Controller Module to gain access to the rear of the
instrument. Locate and remove the UPS On/Off Access Plug (see
Figure 2-5, Back View Controller Module). The UPS On/Off button is
approximately ½ inch into the instrument through the Access opening.
Combination Module
The UPS for the Combination Module is external. The UPS On/Off button is
located at the front of the UPS (Figure 2-6, Front View Combination Module).
Controller/Combination Module Reboot/Shutdown (BacT/ALERT® 3D
Select and SelectLink)
The following situations require the Controller or Combination Module to be
turned off or rebooted.
• Anticipated power outage.
• Moving a system to a new location.
• Fixing an unresponsive Operator Panel or keyboard.
8-10
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Note:
Before rebooting the Controller or Combination Module, always perform a
system backup (see Initiating Manual Backup in Chapter 7). Do not proceed
with the reboot until the Backup in Progress icon no longer displays.
Note:
Contact your local bioMérieux Customer Service Representative prior to
rebooting to clear an error condition.
Perform in sequence as many of Methods 1 — 4 as are required to power
down or reboot the system.
CAUTION: Contact your local bioMérieux Customer Service prior
to using Method 4.
Shutdown Method 1
1)
Access the Controller or Combination Module keyboard (see Accessing
the Controller Module Keyboard in Chapter 2).
2)
Press each key in the order listed: Esc Y E S.
3)
Wait for the software to exit to a black screen with a C:\ > prompt.
To reboot the program, press each keyboard key in the order listed
keeping each key depressed and then simultaneously releasing all three
keys: Ctrl + Alt + Delete.
or
Alternately, to turn Off the power for the Controller or Combination
Module and the UPS, see Method 4.
Shutdown Method 2
1)
Note:
Press the Right Arrow button to advance to the Setup screen.
If the Operator Panel is unresponsive, proceed to Method 4.
2)
Enter the Software Exit Password: 24313124.
3)
The password entered is accepted by pressing the Key Symbol button
at the right end of the row of Password Entry buttons.
4)
After the Software Exit Password is correctly entered, the Padlock icon
changes to the full open position. The Exit Software button will become
visible and will be the only active button on the Setup screen.
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1
Figure 8-2: Exit Software Button
1 — Exit Software Button
5)
Press the Exit Software button.
6)
Wait for the C:\> prompt to appear on a black screen.
To reboot the BacT/ALERT® 3D, press each keyboard key in the order
listed, keeping each key depressed. Then simultaneously release all
three keys: Ctrl + Alt + Delete.
or
Alternately, to turn Off the power for the Controller or Combination
Module and the UPS, see Method 4.
Shutdown Method 3
Note:
1)
Access the Controller or Combination Module keyboard (see Accessing
the Controller Module Keyboard in Chapter 2).
2)
Press each keyboard key in the order listed, keeping each key
depressed and then simultaneously releasing all four keys: Ctrl + Alt +
Shift + 2.
If keyboard is unresponsive, proceed to Method 4.
3)
8-12
Wait for the C:\ > prompt to appear on a black screen.
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To reboot the program, press each keyboard key in the order listed
keeping each key depressed and then simultaneously releasing all three
keys: Ctrl + Alt + Delete.
or
Alternately, to turn Off the power for the Controller or Combination
Module and the UPS, see Method 4.
Shutdown Method 4
CAUTION: Contact your local bioMérieux Customer Service
Representative prior to using Method 4.
1)
Turn Off the Controller or Combination Module Power Switch. This
switch is located in the upper left corner facing the back of the module.
2)
Press the UPS On/Off button once to turn Off the power to the UPS (see
UPS On/Off Button Location on page 8-9).
Controller or Combination Module Startup
1)
Turn On the Controller or Combination Module Power Switch. This
switch is located in the upper left corner facing the back of the module.
2)
Press the UPS On/Off button once to turn On the power to the UPS (see
UPS On/Off Button Location on page 8-9).
Full System Shutdown (BacT/ALERT® 3D Signature)
If you have a BacT/ALERT® 3D Signature system and there is an anticipated
power outage, or if the entire system (including the bioMérieux data
management computer) must be moved, a full system shutdown is required.
Use the following steps to perform a full system shutdown.
1)
If applicable, exit bioMérieux data management computer application.
2)
If applicable, turn Off the power to the bioMérieux data management
system computer and other hardware.
3)
Exit software on the Controller or Combination Module (see Controller/
Combination Module Reboot/Shutdown (BacT/ALERT® 3D Select and
SelectLink) on page 8-10).
4)
Turn Off the power of the Controller or Combination Module (see
Controller/Combination Module Reboot/Shutdown (BacT/ALERT® 3D
Select and SelectLink) on page 8-10).
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5)
Turn Off power to the UPS (see UPS On/Off Button Location on
page 8-9).
6)
Turn Off the power of the Incubation Module(s).
Full System Startup (BacT/ALERT® 3D Signature)
Use the following steps to restart the BacT/ALERT® 3D Signature system
after performing the Full System Shutdown.
1)
If applicable, turn On the power to all of the bioMérieux data
management system hardware.
2)
Turn On the power to the UPS (see UPS On/Off Button Location on
page 8-9).
3)
Turn On the power for the Controller or Combination Module.
4)
Turn On the power for the Incubation Module(s).
Set Up an External Monitor
Use the following steps to set up an external monitor for use with the
BacT/ALERT® 3D.
Note:
IMPORTANT:
Only newer versions of the CPU will support an external monitor.
1)
Connect the external monitor to the MONITOR port on the rear panel of
the instrument.
2)
Set the display switch assembly to the EXTERNAL position.
3)
Reboot the system. For Select and SelectLink configurations, see
Controller/Combination Module Reboot/Shutdown (BacT/ALERT® 3D
Select and SelectLink) in Chapter 8. For Signature configuration, see
Full System Shutdown (BacT/ALERT® 3D Signature), and Full System
Startup (BacT/ALERT® 3D Signature) in Chapter 8.
Changes to the display switch assembly settings do not become
effective until after the system has been rebooted.
4)
Verify that the external monitor is working correctly.
Restore Internal Monitor Settings
Use the following steps to restore the internal monitor settings for the
BacT/ALERT® 3D.
8-14
1)
Disconnect the external monitor from the MONITOR port on the rear
panel of the instrument.
2)
Set the display switch assembly to the INTERNAL position.
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3)
IMPORTANT:
Reboot the system. For Select and SelectLink configurations, see
Controller/Combination Module Reboot/Shutdown (BacT/ALERT® 3D
Select and SelectLink) in Chapter 8. For Signature configuration, see
Full System Shutdown (BacT/ALERT® 3D Signature), and Full System
Startup (BacT/ALERT® 3D Signature) in Chapter 8.
Changes to the display switch assembly settings do not become
effective until after the system has been rebooted.
4)
Verify that the internal monitor is working correctly.
Software Maintenance
The following procedures describe maintenance procedures that are
performed using the software. These procedures are available regardless of
software configuration, but should not need to be performed on a daily basis.
The functions described are:
• Restarting an Incubation Module or the Combination Module drawers (see
Restarting an Incubation Module or the Combination Module Drawers on
page 8-15).
• Setting the date/time and selecting date/time formats (see Setting and
Formatting the System Date and Time on page 8-17).
• Enabling and disabling modules, drawers, racks, and cells (see Enabling
and Disabling Modules, Drawers, Racks, and Cells on page 8-18).
• Checking the temperature, setting the optimal temperature, and calibrating
the temperature of the Incubation or Combination Modules (see Adjusting
an Incubation or Combination Module’s Temperature on page 8-21).
• Calibrating and viewing readings of cells (see Calibrating an Instrument
Cell on page 8-25).
• Viewing Incubation Module information (see Viewing Incubation Module
Information on page 8-29).
Restarting an Incubation Module or the Combination Module Drawers
Perform the following to restart an Incubation Module or the drawers of a
Combination Module without using the power switch in the case of a
communication problem.
1)
Touch the Instrument icon on the Main screen (see Figure 3-1, Main
Screen for Clinical Use, or Figure 4-1, Main Screen for INDUSTRY Use).
The View Cell Status screen appears.
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1
2
3
Figure 8-3: View Cell Status Screen
1 — Restart Incubation Module Button
2 — Incubation Module Selection Button
3 — Drawer Selection Button
Note:
8-16
2)
Press the Incubation Module Selection button, if necessary, to display
a drawer from the affected Incubation or Combination Module.
3)
Press the Restart Incubation Module button.
It is normal for Instrument Status Code 710 to display briefly.
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Setting and Formatting the System Date and Time
Note:
The date and time are set at installation, but the system does not adjust
automatically for daylight savings time.
CAUTION: DO NOT change the date without first contacting your
local bioMérieux Customer Service Representative.
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 3 for Clinical Use, or in
Chapter 4 for INDUSTRY Use).
2)
From the Setup screen, press the Set Date/Time button (
).
The Set Date/Time screen overlays and disables the Setup screen.
5
1
2
3
4
Figure 8-4: Set Date/Time Screen
1 — Set Time Scroll Buttons
2 — Set Date Scroll Buttons
3 — Setup Screen (Disabled)
4 — Date Format Slidebar Switch
5 — Time Format Scroll Button
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Note:
Note:
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3)
Adjust the time using the Set Time scroll buttons. The scroll buttons to
the left of the colon determine the hour, and the scroll buttons to the right
of the colon determine the minutes.
4)
Adjust the time format using the Time Format scroll button. When the
scroll button is set to AM or PM, a 12-hour format is employed. If H is
selected, the 24-hour format will apply.
5)
Adjust the date using the Set Date scroll buttons. The two scroll bars
used to enter the month have [1–12] displayed below them, and the two
scroll bars used to enter the day have [1–31] displayed below them. The
order of these will depend on the date format selection.
6)
Adjust the date format using the Date Format slidebar switch. The left
option is MM/DD/YY and the right option is DD/MM/YY.
The date format selected applies to the current date/time display at the top of
each screen, to all fields that display a date and/or time, and to reports where
available.
7)
Press the Check button to accept the changes, or press the Cancel
button to retain the original settings.
8)
The system returns to the Setup screen.
With BacT/ALERT® 3D Signature systems, changes to date and time in the
bioMérieux data management computer will be reflected in the
BacT/ALERT® 3D. Changes made at the BacT/ALERT® 3D do not affect the
data management computer.
Enabling and Disabling Modules, Drawers, Racks, and Cells
1)
Before disabling an Incubation Module, drawer, rack, or cell, make
certain there are no bottles in the part to be disabled (see Relocating
Bottles on page 8-21).
2)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 3 for Clinical Use, or in
Chapter 4 for INDUSTRY Use).
3)
Press the Enable/Disable Module, Drawer, Rack, or Cell button
(
8-18
).
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The Enable/Disable Module, Drawer, Rack, or Cell screen overlays and
disables the Setup screen.
6
1
2
5
3
4
Figure 8-5: Enable/Disable Module, Drawer, Rack, or Cell Screen
1 — Incubation Module Scroll Button
2 — Enable/Disable Slidebar Switch
3 — Rack Scroll Button
4 — Setup Screen (Disabled)
5 — Cell Scroll Button
6 — Drawer Scroll Button
4)
To enable/disable an entire Incubation module or Combination Module
drawers:
a. Select the module desired (1–6) with the Incubation Module scroll
button.
b. Set the Enable/Disable slidebar switch below the Incubation Module
icon to enable (1) or disable (0).
c. Go to Step 8.
Note:
Disabling a module also disables the drawers, racks, and cells contained in
that module; however, disabling the module will not affect the slidebar
settings for those drawers, racks, and cells.
5)
To enable/disable an entire drawer:
a. Select the Incubation or Combination Module (1–6) that holds the
drawer with the Incubation Module scroll button.
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b. Select the Drawer desired (A–D) with the Drawer scroll button.
c. Set the Enable/Disable slidebar switch below the Drawer icon to
enable (1) or disable (0).
d. Go to Step 8.
Note:
If a drawer is disabled, then its racks and cells are disabled and turn gray;
however, disabling a drawer does not change the current setting of the
slidebars for the corresponding racks and cells.
6)
To enable/disable an entire rack:
a. Select the Incubation or Combination Module (1–6) that holds the rack
with the Incubation Module scroll button.
b. Select the drawer (A–D) that holds the rack with the Drawer scroll
button.
c. Select the rack desired (1–20, 21–40, or 41–60) with the Rack scroll
button.
d. Set the Enable/Disable slidebar switch below the Rack icon to
enable (1) or disable (0).
e. Go to Step 8.
Note:
If a rack is disabled, then the cells in that rack are disabled and turn gray;
however, disabling a rack does not change the current setting of each of the
slidebars for those cells.
7)
To enable/disable a cell:
a. Select the Incubation or Combination Module (1–6) that holds the cell
with the Incubation Module scroll button.
b. Select the Drawer (A–D) that holds the cell with the Drawer scroll
button.
c. Select the Rack (1–20, 21–40, or 41–60) that holds the cell with the
Rack scroll button.
d. Select the Cell desired (1–20) with the Cell scroll button.
e. Set the Enable/Disable slidebar switch below the Cell icon to enable
(1) or disable (0).
8-20
8)
Press the Check button to accept change(s), or the Cancel button to
return previous settings.
9)
Press the Previous Screen button to return to the Setup screen.
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Relocating Bottles
In certain situations (ex. before disabling a rack or drawer), it may be
necessary to move bottle(s) into another available cell, rack, or drawer.
CAUTION: When unloading multiple bottles using Ctrl + F10, the
bottles must be reloaded before 1 hour has passed using the
normal Load Bottles icon to avoid a subculture event.
1)
From the Main screen, press Ctrl + F10 to enter a special Bottles
Relocation mode. The cell indicator lights will illuminate in the following
pattern:
• Cells with bottles loaded are lit continuously.
• Cells available for reloading remain unlit.
2)
Note:
Pull bottles out one at a time and reload one at a time into any available
cell.
When relocating bottles using Ctrl + F10, you must unload one bottle from a
cell and reload it into the destination cell BEFORE unloading another bottle.
This procedure must be done one bottle at a time.
3)
If the Bottle ID field for a loaded bottle is blank, be sure to identify the
anonymous bottle by scanning the barcode as they are unloaded (see
Handling Anonymous Bottles in Chapter 3).
4)
When all bottles are relocated, press the Check button on the Main
screen (see Figure 3-1, Main Screen).
Adjusting an Incubation or Combination Module’s Temperature
The following procedures describe:
• How to check an Incubation or Combination Module's temperature.
• How to set an Incubation or Combination Module's optimal temperature
setting.
• How to calibrate an Incubation or Combination Module's temperature.
Checking an Incubation or Combination Module’s Temperature
Each Incubation and Combination Module includes either an NIST-traceable
reference thermometer, or a digital thermometer, in one of two different
configurations.
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The NIST-traceable reference thermometer (see Figure 8-6) is located in the
back of drawer B, if module is right-handed, or in the back of drawer A for lefthanded modules. This thermometer is the reference used to calibrate the
module temperature.
1
Figure 8-6: Reference Thermometer (Drawer B — Right-hand Configuration)
1 — Reference Thermometer
The digital thermometer (see Figure 8-7) is located on the inner front panel of
drawer B, if module is right-handed, or on the inner front panel of drawer A,
for left-handed modules. This thermometer is the reference used to calibrate
the module temperature.
1
Figure 8-7: Digital Thermometer (Drawer A — Left-hand Configuration)
1 — Digital Thermometer
8-22
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The thermometer should be periodically validated according to your current
protocol.
Before opening the drawer to take a reading with this thermometer, verify that
the module temperature is stable by doing the following.
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 3 for Clinical Use, or in
Chapter 4 for INDUSTRY Use).
2)
Press the Calibrate Module Temperature button (
).
The Calibrate Module Temperature screen overlays and disables the
Setup screen.
5
1
4
2
3
Figure 8-8: Calibrate Module Temperature Screen
1 — Incubation Module Scroll Button
2 — Internal Air Temp Indicator
3 — Setup Screen (Disabled)
4 — Actual Temp Scroll Buttons
5 — Optimal Temp Scroll Buttons
3)
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Select the desired Incubation or Combination Module (1–6) with the
Incubation Module Scroll button.
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4)
Observe the icon to the left of the Actual Temp scroll buttons.
Indicates the temperature is not stable. Do not
read the Reference Thermometer at this time.
Indicates the temperature is nearly stable. The
time underneath the hourglass is the number of
minutes: seconds remaining until stable
temperature is reached.
Indicates the temperature is stable. The
Reference Thermometer may be read.
5)
Once the temperature is stable, open the drawer containing the
Reference Thermometer and read the temperature.
6)
Close the drawer immediately after taking the reading.
Setting the Optimal Temperature for an Incubation or Combination Module
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 3 for Clinical Use, or in
Chapter 4 for INDUSTRY Use).
2)
Press the Calibrate Module Temperature button (
).
The Calibrate Module Temperature screen overlays and disables the
Setup screen (see Figure 8-8, Calibrate Module Temperature Screen).
Note:
3)
Select the desired Incubation or Combination Module (1–6) with the
Incubation Module scroll button.
4)
Enter the desired optimal temperature in degrees Celsius (°C) on the
Optimal Temp scroll buttons.
Clinical Use: The valid range of values for the optimal temperature of an
Incubation or Combination Module is 25.0°C to 45.0°C. However, the usual
test range encountered in clinical laboratories is 35°C to 37°C. If a
temperature is entered that is outside the range of 35°C to 37°C, a bright
yellow icon ( ) is displayed below the scroll button. The lowest
temperature the instrument can maintain is 7°C above ambient.
Note:
8-24
INDUSTRY Use: The valid range of values for the optimal temperature of an
Incubation or Combination Module is 25.0°C to 45.0°C. The lowest
temperature the instrument can maintain is 7°C above ambient.
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5)
Press the Check button to initiate the temperature adjustment, or press
the Cancel button to retain the previous setting.
6)
Press the Previous Screen button to return to the Setup screen.
7)
After the temperature becomes stable (see Checking an Incubation or
Combination Module’s Temperature on page 8-21), calibrate the
Incubation module.
Calibrating an Incubation or Combination Module’s Temperature
Note:
Temperature calibration is required: Anytime the optimal (setpoint)
temperature is changed; or anytime the periodic check of the Reference
Thermometer reveals that the temperature is more than 0.5°C above or
below the module's setpoint.
1)
Check the Incubation or Combination Module's temperature (see
Checking an Incubation or Combination Module’s Temperature on
page 8-21).
2)
Enter the temperature from the thermometer in degrees Celsius (°C) on
the Actual Temp scroll buttons (see Figure 8-8, Calibrate Module
Temperature Screen).
3)
Press the Check button to initiate the calibration, or press the Cancel
button to retain the previous calibration.
4)
Press the Previous Screen button to return to the Setup screen.
5)
Check the temperature when stable to verify the calibration was
successful.
Calibrating an Instrument Cell
The following procedures describe how to:
• locate a cell which failed calibration
• view a cell's readings
• calibrate a cell
Note:
It is not necessary to perform routine cell calibration. If a cell fails its
automatic internal diagnostic check, Instrument Fault Code 60 appears in the
Instrument icon on the Main screen.
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CAUTION: A cell which has failed the automatic internal
diagnostic check no longer records bottle readings and will not
be indicated as available when loading bottles. The cell must be
calibrated or disabled.
CAUTION: Do not invoke the Calibrate Cell screen unless the
cell to be calibrated is empty.
Locating a Cell Which Failed Calibration
Note:
1)
View the Main screen to locate the Instrument Fault Code 60 in the
Instrument icon.
2)
Locate the cell with the fault (see Viewing Faults in Chapter 3 for Clinical
Use, or in Chapter 4 for INDUSTRY Use).
If the cell cannot be calibrated immediately, disable the cell (see Enabling
and Disabling Modules, Drawers, Racks, and Cells on page 8-18).
CAUTION: To prevent anonymous loading into the disabled cell,
place an orange cell plug into the cell.
Viewing a Cell’s Readings and/or Calibrating a Cell
8-26
1)
If calibrating, print out the Cell Calibration Report (see Viewing and
Printing Calibration Data in Chapter 7).
2)
If the cell to be calibrated contains a bottle, then relocate it (see
Relocating Bottles on page 8-21).
3)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 3 for Clinical Use, or in
Chapter 4 for INDUSTRY Use).
4)
From the Setup screen, press the Calibrate Cell button (
).
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The Calibrate Cell screen overlays and disables the Setup screen.
6
1
2
5
3
4
Figure 8-9: Calibrate Cell Screen
1 — Incubation Module Scroll Button
2 — Cell Scroll Buttons
3 — Cell Reading Indicator
4 — Setup Screen (Disabled)
5 — Calibration Staircase Icon
6 — Drawer Scroll Button
5)
Select a particular cell to be calibrated:
• Choose the appropriate Incubation or Combination Module (1–6) with
the Incubation Module scroll button.
• Choose the appropriate drawer (A–D) with the Drawer scroll button.
• Choose the appropriate cell (1–60) with the Cell scroll buttons.
The first screen displays an X at the base of the Staircase icon. This
prompts the user to verify the cell is empty and the drawer is closed.
Note:
The Module, Drawer, and the Cell scroll buttons will be grayed-out and
inactive until calibration of the cell is complete.
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To view a cell’s reading:
6)
Note:
The cell's readings can now be read below the Cell scroll buttons. The
first set of numbers represents the uncalibrated reading and the number
to the right of the arrow represents the calibrated readings.
If an Incubation module is not configured properly or is not responding,
asterisks will replace the digits on the screen.
If you would like to calibrate a cell, proceed to next step.
7)
Press the Check button.
The cell light of the cell selected for calibration is now illuminated and #1
appears above the first step of the Calibration Staircase icon.
8)
Insert Standard Number One into the selected cell without touching the
ends of the calibration standard as calibration could be affected. (A
single ring around the end of the reflectance standard identifies Standard
#1).
9)
Press the Check button.
A #2 appears above the second step of the Calibration Staircase icon.
10) Insert Standard Number Two into the selected cell. (Two rings around
the end of the reflectance standard identifies Standard #2).
11) Press the Check button.
A #3 appears above the third step of the Calibration Staircase icon.
12) Insert Standard Number Three into the selected cell. (Three rings around
the end of the reflectance standard identifies Standard #3).
13) Press the Check button.
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A #4 appears above the fourth step of the Calibration Staircase icon.
14) Insert Standard Number Four into the selected cell. (Four rings around
the end of the reflectance standard identifies Standard #4).
15) Press the Check button.
16) If a check mark appears at the top of the Calibration Staircase icon,
then the calibration of the cell was successful. Remove Standard
Number Four and press the Check button to save the new calibration
values.
17) If Instrument Fault Code 60 appears at the top of the Calibration
Staircase icon, then the calibration of the cell is unsuccessful. Press the
Cancel button and follow Step 4 through Step 14 to recalibrate the cell.
Note:
The cell is not automatically enabled after calibration is completed
successfully. If the cell was previously disabled, it must be enabled (see
Enabling and Disabling Modules, Drawers, Racks, and Cells on page 8-18).
18) Press the Previous Screen button to return to the Setup screen.
Note:
The calibration process can be canceled and any new calibration values
discarded by pressing the Cancel button at any step during the calibration
process.
19) Print out the Cell Calibration Report (see Viewing and Printing
Calibration Data in Chapter 7).
Viewing Incubation Module Information
This procedure describes how to locate the following information:
• Serial Numbers
• Hardware Revisions
• Software Revisions
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You may be requested to retrieve this information during the course of
troubleshooting by bioMérieux Instrument Services Personnel.
1)
Access the Setup screen and enter a valid password to access the
function buttons (see Accessing the Setup Screen Function Buttons in
Chapter 3 for Clinical Use, or in Chapter 4 for INDUSTRY Use).
2)
Press the View Incubation Module Information button (
).
The View Incubation Module Information screen replaces the Setup
screen.
1
2
3
4
Figure 8-10: View Incubation Module Information Screen
1 — Incubation Module
Indicator
2 — Incubation Module
Information
8-30
3 — Rack Information
4 — Incubation Module
Selection Button
3)
Select the appropriate Incubation module by pressing the Incubation
Module Selection button.
4)
Press the Previous Screen button to return to the Setup screen.
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SYSTEM TROUBLESHOOTING
9
About This Chapter
This chapter provides you with a description of the different types of
instrument fault, instrument status and operator error codes, as well as bottle
and user output device problems, that may be encountered when using the
instrument. Cause(s) and solutions(s) for each type of fault/error/problem are
also listed.
Note:
Information in this chapter that is intended for clinical use only or industry use
only is marked Clinical Use or INDUSTRY Use.
Note:
In this chapter, “accession number” refers to Clinical Use, and “sample ID”
refers to INDUSTRY Use.
Chapter Contents
Introduction • 9-2
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
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Introduction
Introduction
CAUTION: Failure to follow the procedures in this User Manual
or failure to attend to fault conditions reported by the instrument
within 1 hour may lead to invalid test results and the need to
subculture bottles.
The following codes are discussed in this chapter.
Note:
9-2
1
39
56
81
921
2
41
57
99
923
3
42
60
710
930
4
43
62
800
931
5
44
71
810
932
10
45
72
820
940
11
46
73
901
941
12
47
74
902
942
14
51
75
909
943
19
52
77
910
944
20
53
78
911
945
21
54
79
912
960
22
55
80
913
961
If the problem cannot be corrected using the solutions listed or a code is
displayed that does not appear in this list, contact your local bioMérieux
Representative.
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Fault Codes
Instrument Fault Codes
Instrument Fault Codes appear in the Instrument icon. A description of each
Instrument Fault Code is provided. The following is an example of an
Instrument icon with Instrument Fault Codes 4, 10, and 20. Fault codes are
displayed on the particular components where the errors are located.
Figure 9-1: Instrument Icon with Fault Codes
Note:
Locate specific bottles with fault by pressing the Incubation Module on the
Instrument icon on the Main screen to display the View Cell Status screen.
CAUTION: Fault codes referring to loss of incubator temperature
may adversely affect bottle testing and should be addressed
immediately.
#1
POWER FAULT IN INCUBATION MODULE
Cause: Power cable is missing or loose.
Solution: Secure both ends of power cable.
Cause: Incubation Module Power Switch is turned Off.
Solution: Turn on Power Switch (located in upper left corner
facing the back of the Incubation Module).
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Fault Codes
#2
COMMUNICATION LOST WITH INCUBATION MODULE
Cause: Communications cable between the Controller or
Combination Module and the Incubation Module is missing or
loose.
Solution: Secure both ends of the communications cable.
Restart the Incubation Module (see Restarting an Incubation
Module or the Combination Module Drawers in Chapter 8).
Cause: Possible hardware problem with the Controller Module
Board.
Solution: Call bioMérieux. DO NOT load bottles in the affected
Incubation Module(s) until the fault is corrected.
9-4
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#3
INCUBATION MODULE TEMPERATURE IS TOO HIGH
Background Information: The optimal temperature (setpoint)
and actual Incubation or Combination Module temperature are
not equilibrated. Two temperature sensors, one in the supply
side of the air plenum, and one in the cold air return, are used
to monitor the Incubation or Combination Module temperature.
This error will occur if there is a ± 2°C change from the setpoint
measured at the sensors for approximately 1 minute (5 or more
readings are taken every 10 seconds). Five or more readings
out of range are required to report this error. Common causes
for this error are: ambient room temperature is too high,
temperature calibration was not performed correctly, or
defective hardware (for example, module controller,
temperature sensors, or relay).
Cause: The Incubation or Combination Module optimal
temperature (setpoint) has been changed and has not yet
equilibrated at the new temperature.
Solution: Wait for the module temperature to equilibrate.
Cause: Operating temperature is not within specification for the
Incubation or Combination Module.
Solution: Perform the following procedure:
1.
Ensure the operating temperature is within the
specification (see Combination Module Environmental
Requirements or Incubation Module Environmental
Requirements in Chapter 2).
2.
Wait for the module temperature to equilibrate.
Cause: Bottle testing may be adversely affected due to one of
the following reasons:
• Hardware fault with the Controller or Combination
Module Board.
• Hardware fault with the Solid State Relays that
energize the heater.
• Faulty temperature sensors.
Solution: Contact bioMérieux immediately.
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Fault Codes
#4
INCUBATION MODULE TEMPERATURE IS TOO LOW
Background Information: The optimal temperature (setpoint)
and actual Incubation or Combination Module temperature are
not equilibrated. Two temperature sensors, one in the supply
side of the air plenum, and one in the cold air return, are used
to monitor the Incubation or Combination Module temperature.
This error will occur if there is a ± 2°C change from the setpoint
measured at the sensors for approximately 1 minute (5 or more
readings are taken every 10 seconds). Five or more readings
out of range are required to report this error. Common causes
for this error are drawer left open, setpoint changed and the
module has not yet equilibrated at the new temperature, drawer
switch misaligned, defective hardware (for example, module
controller, temperature sensors, relay, cutoff switch tripped, or
heater element).
Cause: The Incubation or Combination Module optimal
temperature (setpoint) has been changed and the module has
not yet equilibrated at the new temperature.
Solution: Wait until module temperature equilibrates.
Cause: One or more drawers have been left open or ajar for an
extended period.
Solution: Make sure all doors are tightly closed and allow the
module temperature 1 hour to equilibrate.
Cause: Bottle testing may be adversely affected due to one of
the following reasons:
• Hardware fault with the Controller or Combination
Module Board.
• Hardware fault with the Solid State Relays that
energize the heater.
• Faulty temperature sensors.
Solution: Call bioMérieux immediately.
#5
INCORRECT INCUBATION MODULE CONNECTION
Cause: Incubation Module communication cable may be
connected to wrong port.
Solution: Call bioMérieux.
Cause: Incubation Module ID switch may be incorrectly set.
Solution: Call bioMérieux. DO NOT load bottles into the
affected Incubation Module(s) until the fault is corrected.
9-6
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#10
CONTROLLER MODULE POWER FAULT
Cause: The Controller Module is not receiving AC power.
Solution:
1.
Ensure AC power source is adequate or connect to an
alternate power source.
2.
The Controller Module runs on UPS power for 1 minute. If
AC power is not restored during this time, the Instrument
and UPS turn Off. When AC power is restored the
Instrument will automatically reboot.
3.
If power is not restored within an hour, it may be
necessary to subculture bottles.
CAUTION – Do not load or unload bottles until
power is restored.
#11
INSUFFICIENT CHARGE IN UPS
Cause: The UPS battery is low.
Solution: Call bioMérieux.
#12
LIS COMMUNICATION FAULT
Cause: The LIS is not responding to the Controller Module.
Solution: Check the LIS. The fault automatically goes away
when communication with the LIS resumes.
Cause: The message from the Controller or Combination
Module is not reaching the LIS.
Solution: Check the cable connections between the Controller
or Combination Module and the LIS.
#14
SYSTEM AUTOMATICALLY REBOOTED
Cause: Unresponsive state detected in the software.
Solution: Call bioMérieux immediately. System performance
may be compromised.
#19
SOFTWARE EXCEPTION
Cause: A software exception has occurred.
Solution: Call bioMérieux immediately. System performance
may be compromised.
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Fault Codes
#20
DRAWER OPEN FOR TOO LONG
Cause: One or more drawers have been left open or ajar for an
extended period.
Solution: Make sure all doors are tightly closed.
Cause: Magnetic switches in the back of the drawer have failed
or become misaligned.
Solution: Call bioMérieux.
Cause: Fault in the drawer interface cable or printed board.
Solution: Call bioMérieux.
Cause: Fault in the Controller or Combination Module printed
circuit board.
Solution: Call bioMérieux.
#21
DRAWER AGITATION FAILURE
Cause: Mechanical failure in the agitation linkage.
Solution: Call bioMérieux.
Cause: Agitation motor either disconnected or inoperative.
Solution: Call bioMérieux.
Cause: Fault in rack #1 (for left facing drawer) or rack #3 (for
right facing drawer).
Solution: Call bioMérieux.
9-8
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#22
UNEXPECTED DRAWER AGITATION
Cause: Instrument not configured properly.
Solution: Relocate bottles in affected drawer using the
following procedure:
#39
1.
From the Main screen, press Ctrl + F10. Cells with bottles
are lit continuously.
2.
Pull bottles out one at a time.
3.
If the bottle is anonymous (the Bottle ID field is blank),
then enter the bottle ID (see Text/Data Entry in
Chapter 3). When all bottles are unloaded, press the
Check button on the Main screen.
4.
The removed bottles should be subcultured.
5.
Disable the drawer (see Enabling and Disabling Modules,
Drawers, Racks, and Cells in Chapter 8).
6.
Reload bottles via the Load Bottle function on the Main
screen.
7.
Call bioMérieux.
RACK TEMPERATURE FAULT
Background Information: The temperature in a specific rack
has changed beyond the setpoint (high or low). Two
temperature sensors, one at each end of the bottle rack, are
polled for the input signals. This fault code was added as an
early warning system requiring the user to observe the system
for temperature-related issues. This error will occur if there is a
± 4°C change from the setpoint measured at the bottle racks for
more than 60 minutes (six readings are taken every 10
minutes). Six or more readings out of range are required to
report this error. Typically, this error is seen after bottle loading
or unloading events. The change in thermal mass takes the
BacT/ALERT® 3D system several minutes to readjust. If the
temperature is high, bottle relocation is required and the
defective hardware is suspected (for example: temperature
sensor). If the temperature is low, ensure that the drawers are
closed and monitor the temperature for the next 30 to 40
minutes. If the fault code does not clear, bottle relocation is
required and defective hardware is suspected (for example,
module controller, temperature sensors, relay, cutoff switch
tripped, or heater element).
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System Troubleshooting
Fault Codes
Cause: One or more drawers have been left ajar for an
extended period or a system component may have failed.
Solution: Perform the following procedure:
1.
Check the incubation module temperature with an
independent thermometer. If the temperature is correct,
go to Step 4.
• If the temperature is high, the heater temperature
sensor may have failed. If temperature of incubator is
high, relocate bottles per Step 3.
• If the temperature is not high, go to Step 2.
2.
Make sure all drawers are tightly closed.
• If an open drawer is found, then close the drawer and
wait 30 minutes for the fault to disappear.
• If no open drawers are found, a system component
may have failed. If temperature of incubator is low,
relocate bottles as per Step 3.
3.
If temperature of incubator is incorrect, relocate all bottles
in affected incubator to a different incubator, using the
Bottle Relocation Procedure below.
4.
If incubator temperature is correct, recycle power to the
incubator.
If error will not clear after recycling power, relocate all bottles
from the rack(s) display Fault Code #39 to different racks that
are not displaying errors. Use the Bottle Relocation procedure
below.
9-10
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Fault Codes
System Troubleshooting
BOTTLE RELOCATION PROCEDURE
CAUTION – After Unloading multiple bottles
using Ctrl + F10, the bottles must be reloaded
before 1 hour has passed using the normal
Load Bottles icon to avoid a subculture event.
a)
Remove all positive bottles (anonymous and
identified) via the Unload Positive Bottle function on
the Main screen.
b)
From the Main screen, press Ctrl + F10. Cells with
bottles are lit continuously.
c)
Pull bottles out one at a time and immediately reload
one at a time in an incubator without the 39 fault.
Note - When relocating bottles using Ctrl + F10, you must
unload one bottle from a cell and reload it into the destination
cell BEFORE unloading another bottle. This procedure must be
done one bottle at a time.
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d)
If the bottle is anonymous (the Bottle ID field is
blank), then enter the bottle ID (see Text/Data
Entry in Chapter 3).
e)
When all bottles have been relocated, press the
Check button on the Main screen.
f)
Call bioMérieux.
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System Troubleshooting
Fault Codes
#41 47
RACK(S) X NOT RESPONDING
Cause: Incubation Module is disconnected. The number of the
Incubation Module is displayed in the Instrument icon on the
Main screen.
Solution:
1.
Reconnect each end of the communication cable.
2.
Ensure that the proper communications port of the
Controller or Combination Module (1–6) is connected to
the corresponding Incubation Module.
Cause: Faulty drawer interface cable or printed circuit board.
Solution: Relocate bottles manually (see Figure 5-3, Edit
Bottle Detail Screen for Clinical Use, or Figure 6-3, Edit Bottle
Detail Screen for INDUSTRY Use). The Edit Load Status
Slidebar switch will be bolded and available to manually unload
all affected bottles. Identify any anonymous bottles prior to
manually unloading. Reload bottles into functional cells with the
Load Bottles button on the Main Screen. Call bioMérieux.
Cause: Faulty rack controller or rack interface cable(s).
Solution: Relocate bottles manually (see Figure 5-3, Edit
Bottle Detail Screen for Clinical Use, or Figure 6-3, Edit Bottle
Detail Screen for INDUSTRY Use). The Edit Load Status
Slidebar switch will be bolded and available to manually unload
all affected bottles. Identify any anonymous bottles prior to
manually unloading. Reload bottles into functional cells with the
Load Bottles button on the Main Screen. Call bioMérieux.
#51 57
RACK HARDWARE FAILURE
Cause: Faulty rack printed circuit board.
Solution: From the Main screen, press Ctrl + F10 to enter a
special Bottle Relocation mode that allows bottles to be
relocated, then call bioMérieux. The quicker the bottles are
moved, the less likely they’ll need to be subcultured.
CAUTION – When Unloading multiple bottles
using Ctrl + F10, the bottles must be reloaded
before 1 hour has passed using the normal
Load Bottles icon to avoid a subculture event.
Note - When relocating bottles using Ctrl + F10, you must
unload one bottle from a cell and reload it into the destination
cell BEFORE unloading another bottle. This procedure must be
done one bottle at a time.
9-12
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System Troubleshooting
#60
CELL FAILED QC
Cause: A cell failed the automatic internal diagnostic check.
Solution: Perform the following procedure:
1.
Identify the cell that failed the QC using the View Cell
Status screen.
2.
Inspect the cell for debris and remove or clean, if
necessary.
3.
Calibrate (see Calibrating an Instrument Cell in Chapter 8).
4.
If calibration cannot be performed at this time, or if a cell
fails to calibrate, disable cell (see Enabling and Disabling
Modules, Drawers, Racks, and Cells in Chapter 8), and
insert an orange cell plug in the disabled cell.
Call bioMérieux if cell calibration is unsuccessful.
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System Troubleshooting
Fault Codes
#62
ERRONEOUS CELL LOAD STATUS REPORTED
Cause: A cell is out of calibration.
Solution: Use the View Cell Status screen (see Chapter 3,
Viewing Faults) to locate affected cells. Relocate bottle in
affected cells using the following procedure:
1.
From the Main screen, press Ctrl + F10 to enter a special
Bottle Relocation mode that allows bottles to be relocated.
The cell indicator lights will illuminate in the following
pattern:
CAUTION – After Unloading multiple bottles
using Ctrl + F10, the bottles must be reloaded
before 1 hour has passed using the normal
Load Bottles icon to avoid a subculture event.
• Cells with bottles are lit continuously.
• Cells available for reloading are unlit.
2.
Pull bottles out one at a time and reload one at a time into
any available cell.
Note - When relocating bottles using Ctrl + F10, you must
unload one bottle from a cell and reload it into the destination
cell BEFORE unloading another bottle. This procedure must be
done one bottle at a time.
3.
If the bottle is anonymous (the Bottle ID field is blank),
then enter the bottle ID (see Text/Data Entry in Chapter 3
for Clinical Use, or Text/Data Entry in Chapter 4 for
INDUSTRY Use). When all bottles are unloaded, press the
Check button on the Main screen.
4.
Attempt to calibrate the cell (see Calibrating an Instrument
Cell in Chapter 8).
5.
If the calibration fails, then disable the cell (see Enabling
and Disabling Modules, Drawers, Racks, and Cells in
Chapter 8).
• Insert an orange cell plug into the disabled cell.
• Call bioMérieux.
Note - Call bioMérieux if error occurs with numerous cells (it
could be a faulty rack controller.).
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Fault Codes
System Troubleshooting
#71
INVALID TIME STAMP
Cause: Hardware failure involving the real time clock.
CAUTION – Bottle readings are not processed
while the fault is present.
Solution: Call bioMérieux.
#72
INVALID CALCULATION DATA
Cause: Hardware failure involving the non-volatile random
access memory.
CAUTION – Bottles with fault are flagged
positive and bottle readings are not processed
while the fault is present.
Solution: Determine how long bottle readings have not been
processed by going to the Edit Bottle Detail screen and noting
the time of the last bottle reading (see Viewing/Editing Bottle
Data in Chapter 5 for Clinical Use, or Viewing/Editing Bottle
Data in Chapter 6 for INDUSTRY Use). If the time passed is
greater than 1 hour, bottles must be subcultured.
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1.
Unload the affected bottle via the Unload Positive Bottle
function on the Main screen.
2.
Subculture the bottle if necessary.
3.
Reload the bottle via the Load Bottle function on the Main
screen. The original first loaded date and time is
maintained.
4.
If the fault code persists, call bioMérieux.
9-15
System Troubleshooting
Fault Codes
#73
INVALID METHOD DATA
Cause: Important information used for bottle analysis has been
corrupted and therefore bottle readings are not being
processed. Bottles with fault are flagged positive 1 hour after
the fault code first appears. Bottle readings are not processed
while the fault is present.
Solution: Each bottle type uses the same method data.
Eventually, all bottles of the same type as the one with the fault
will also present the same fault code.
#74
1.
Reboot the system. For Select and SelectLink
configurations, see Controller/Combination Module
Reboot/Shutdown (BacT/ALERT® 3D Select and
SelectLink) in Chapter 8. For Signature configuration, see
Full System Shutdown (BacT/ALERT® 3D Signature) and
Full System Startup (BacT/ALERT® 3D Signature) in
Chapter 8.
2.
Call bioMérieux.
ALGORITHM CHANGE (CLINICAL USE)
Cause: An incorrect media type has been previously assigned
to a bottle, or an anonymous bottle has been placed in an
inappropriate drawer:
• An MB bottle has been placed anonymously into a nonMB drawer.
• A non-MB bottle has been placed anonymously into an
MB drawer.
• A BacT/ALERT® MB bottle has been loaded
anonymously in any drawer type.
Bottles with fault are flagged positive and bottle readings are
not processed while the fault is present.
Solution: Perform the following procedure:
9-16
1.
Press the Unload Positive Bottle button and unload the
affected bottle.
2.
Subculture the bottle.
3.
Reload the bottle via the Load Bottle function on the Main
screen. The original first loaded date and time are
maintained.
4.
If the fault code persists, call bioMérieux.
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Fault Codes
System Troubleshooting
#74
ALGORITHM CHANGE (INDUSTRY USE)
Cause: An incorrect media type has been previously assigned
to a bottle. Bottles with fault are flagged positive and bottle
readings are not processed while the fault is present.
Solution: Perform the following procedure:
#75
1.
Press the Unload Positive Bottle button and unload the
affected bottle.
2.
Subculture the bottle.
3.
Reload the bottle via the Load Bottle function on the Main
screen. The original first loaded date and time are
maintained.
4.
If the fault code persists, call bioMérieux.
BOTTLE DATA CORRUPTED
Cause: The data integrity check has found corrupted bottle
data. Bottles with fault are flagged positive and bottle readings
are not processed while the fault is present.
Solution: Perform the following procedure:
1.
Press the Unload Positive Bottle button and unload the
affected bottle.
2.
Subculture the bottle.
3.
Reload the bottle via the Load Bottle function on the Main
screen to begin testing of bottle.
• The original first loaded date and time is replaced with
the date and time the bottle is reloaded.
• The maximum test time is set to the default associated
with the bottle type.
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4.
If desired, the bottle's maximum test time may be
shortened so that the bottle will complete testing when
expected.
5.
If the fault code persists, call bioMérieux.
9-17
System Troubleshooting
Fault Codes
#77
READING POLYNOMIAL CHANGE
Cause: An incorrect bottle type has been previously assigned
to a bottle. Bottles with fault are flagged positive and bottle
readings are not processed while the fault is present.
Solution: Perform the following procedure:
#78
1.
Press the Unload Positive Bottle button and unload the
affected bottle.
2.
Subculture the bottle.
3.
Reload the bottle via the Load Bottle function on the Main
screen to restart testing. The original first loaded date and
time are maintained.
4.
If the fault code persists, call bioMérieux.
INCOMPLETE TEST DATA
Cause: This fault occurs when an identified bottle is reloaded
anonymously and later is identified and reloaded in the
instrument. The original bottle data cannot be merged with the
data collected when the bottle was anonymous and therefore
the test data is incomplete. Bottles with fault are flagged
positive and bottle readings are not processed while the fault is
present.
Solution: Perform the following procedure:
9-18
1.
Unload bottle with fault via the Unload Positive Bottle
function on the Main screen.
2.
Subculture the bottle.
3.
Reload the bottle via the Load Bottle function on the Main
screen to restart testing. The original first loaded date and
time are maintained.
4.
If the fault code persists, call bioMérieux.
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Fault Codes
System Troubleshooting
#79
BOTTLE RELOADED VIA WRONG CONTROLLER
(BACT/ALERT® 3D SIGNATURE SYSTEMS)
Cause: This fault occurs when a bottle is initially loaded in an
Incubation Module attached to a particular Controller Module
and then is reloaded into another Incubation Module attached
to a different Controller Module. Bottles with fault are flagged
positive.
Solution: Perform the following procedure:
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1.
Unload bottle with the fault via the Unload Positive Bottle
function on the Main screen.
2.
Subculture the bottle.
3.
Apply a generic bottle label to the bottle.
4.
Press the Load Bottle button on the Main screen.
5.
Scan the generic label.
6.
Select the correct bottle type.
7.
If desired, enter an Accession Number/Sample ID and
adjust the bottle’s maximum test time so the bottle will
complete testing when expected.
8.
Load the bottle. The date and time first loaded will reflect
this load.
9.
If the fault code persists, call bioMérieux.
9-19
System Troubleshooting
Fault Codes
#80
READING GAP DETECTED
Cause: This fault occurs when there is a gap in bottle readings
greater than 1 hour. This situation may occur when the power
to the Instrument or Incubation Module is lost for more than
1 hour. It may also occur if a negative-to-date bottle is
unloaded, then reloaded more than 1 hour later.
There are two procedures that can be followed when this fault
occurs. It is recommended that you print an Unload report
before clearing this fault to ensure that you have a record of all
bottles with an 80 fault.
Note - On the Load, Status and Unload reports, bottles with
Instrument Fault Code 80 will be marked on the report with a
Gap Detection indicator (!) next to the result. If a negative
bottle has an Instrument Fault Code 80 while it is unloaded, the
Gap Detection indicator will remain on the report (see Viewing,
Printing, and Exporting Test Data in Chapter 3 for Clinical Use,
or Viewing, Printing, and Exporting Test Data in Chapter 4 for
INDUSTRY Use).
Solution 1: This procedure instructs you to unload and
subculture each bottle to clear the 80 fault:
1.
From the Main screen, press Ctrl + F3 to enter a special
unload mode.
2.
Subculture the bottle.
3.
Reload the bottle via the Load Bottle function on the Main
screen to restart testing.
Solution 2: This procedure allows you to clear 80 faults for
each affected bottle without unloading.
WARNING – These bottles must have a terminal
subculture performed if their final status is
negative.
9-20
1.
From the Setup screen, enter the system password (see
Accessing the Setup Screen in Chapter 3 for Clinical Use,
or Accessing the Setup Screen in Chapter 4 for
INDUSTRY Use).
2.
Press Alt + F5 to clear all faults at the same time.
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System Troubleshooting
#81
BOTTLE LOADED IN CELL DURING QC
Cause: This fault occurs when a bottle is loaded in a cell that
has not completed the QC cycle. In this case, the fault is
displayed with no other fault on the View Cell Status screen.
The QC cycle for a cell is indicated by a white circle on the cell
status screen (see Figure 3-5, View Cell Status Screen for
Clinical Use, or Figure 4-5, View Cell Status Screen for
INDUSTRY Use). Bottle readings are taken while the fault is
present.
Solution: Perform the following procedure:
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1.
Remove the bottle from the cell that was just loaded.
2.
Reload the bottle into an available cell (one which has its
cell indicator light lit).
9-21
System Troubleshooting
Fault Codes
Cause: This fault occurs when a bottle is loaded in a cell that is
out of calibration (indicated by Fault Code 60). In this case,
Fault Codes 60 and 81 are both displayed on the View Cell
Status screen, alternating between the two faults (see
see Figure 3-5, View Cell Status Screen for Clinical Use, or
Figure 4-5, View Cell Status Screen for INDUSTRY Use). Bottle
readings are not taken while Fault Codes 60 and 81 are present
at the same time.
Solution 1: Perform the following procedure if this fault is
recognized within one hour of loading a bottle.
Note - To check the time the bottle was loaded, access the Edit
Bottle Detail screen (see Figure 5-3, Edit Bottle Detail Screen
for Clinical use, or Figure 6-3, Edit Bottle Detail Screen for
INDUSTRY Use).
1.
Remove the bottle from the cell that was just loaded.
2.
Reload the bottle into an available cell (one which has its
cell indicator light lit).
Solution 2: Perform the following procedure if this fault is
recognized more than one hour after loading a bottle, or the
time the bottle was loaded cannot be determined on the Edit
Bottle Detail screen.
1.
Access the View Cell Status screen (see Figure 3-5, View
Cell Status Screen for Clinical Use, or Figure 4-5, View
Cell Status Screen for INDUSTRY Use) to view the cell
error.
2.
If the cell displays Fault Code 81 and does not alternate
between Fault Codes 81 and 60, readings have been
taken on this bottle. Unload the bottle from the cell and
reload the bottle into a functional cell using the Load
Bottle function (see Figure 3-7, Main Screen — Load
Mode for Clinical use, or Figure 4-7, Main Screen — Load
Mode for INDUSTRY Use).
3.
If the cell displays an error code that alternates between
Fault Codes 81 and 60, then readings have not been
taken on this bottle. Unload the bottle and perform a
subculture. Reload the bottle into a functional cell using
the Load Bottle function (see Figure 3-7, Main Screen —
Load Mode for Clinical use, or Figure 4-7, Main Screen —
Load Mode for INDUSTRY Use).
WARNING – The bottle must be subcultured.
9-22
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Fault Codes
System Troubleshooting
#99
BOTTLE LOADED IN A NON-OPERATIONAL CELL
Cause: A bottle is currently loaded in either:
• A cell that has been disabled, or the rack in which the
cell is located is disabled.
• An enabled cell that is not taking bottle readings
because of one of the following faults: 51, 52, 54, 60, or
62.
Bottle readings are not processed in faulty cells.
Solution: Use the Edit Bottle Detail screen to determine when
the last bottle reading was successfully processed (see
Viewing/Editing Bottle Data in Chapter 5 for Clinical Use, or
Viewing/Editing Bottle Data in Chapter 6 for INDUSTRY Use). If
less than 1 hour has passed, it is only necessary to relocate the
bottles using the following procedure:
1.
From the Main screen, press Ctrl + F1. This mode
identifies cells containing bottles with 99, 51, 52, 54, 60, or
62 faults with a lit cell indicator light.
2.
Remove bottles from these cells one at a time, move them
to cells whose cell indicator lights are unlit. Bottles can be
moved to a different drawer (of the same configuration) as
necessary.
Note - If no bottle(s) are present in the indicated cell, call
bioMérieux Customer Support.
If more than an hour has passed, unload and subculture the
bottle in the faulty cells using the following procedure:
1.
From the Main screen, press Ctrl + F10.
2.
Remove a bottle to subculture and scan the bottle ID.
Repeat this step for the remaining bottles needing
subcultures.
3.
Press the Check button when done.
4.
After subculturing bottles, reload them via the Load Bottle
function on the Main screen.
Affected bottles that do not need to be subcultured should be
relocated. Relocate bottles.
Note - If no bottle(s) are present in the indicated cell, call
bioMérieux.
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System Troubleshooting
Fault Codes
Instrument Status Codes
Instrument Status Codes appear in a separate window on the Main screen
and are identified by a 98 in the top left corner. A description of each
Instrument Status Code is provided. The following is an example of an
Instrument Status Code 710.
Figure 9-2: Instrument Status Code 710
#710
INCUBATION MODULE TEMPORARILY UNAVAILABLE
WHILE POWER UP INITIALIZATION TAKES PLACE
Cause: Turning On the power of an Instrument or pressing the
Restart Incubation Module button invokes the Power Up
screen to appear on the operator panel. It is NOT possible to
perform any action when the Power Up screen is present.
Solution: No operator action is necessary. The Power Up
screen will disappear when the Incubation Module is ready. Do
NOT load bottles while the Power Up screen is present.
9-24
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Fault Codes
System Troubleshooting
#800
PRINTER FAULT
Cause: The Controller or Combination Module was unable to
print to the printer.
Solution: Check the following:
• The printer is powered on and connected to the
Instrument properly.
• The printer has paper.
• The paper is not jammed in the printer.
#810
BACKUP FAILED
Cause: The Controller or Combination Module was unable to
write backup data to the backup media, because the backup
media was either missing, defective, or removed while the
backup was still in progress.
Solution 1: Perform the following procedure if the backup
media is a Zip® drive:
1.
Verify that there is a Zip® disk in the Zip® drive and attempt
a manual backup (see Initiating Manual Backup in
Chapter 7).
2.
If this backup fails, insert a new Zip® disk and attempt a
manual backup.
3.
If this backup fails, call bioMérieux.
Solution 2: Perform the following procedure if the backup
media is a USB flash drive:
1.
Verify that there is a USB flash drive in the USB port and
attempt a manual backup (see Initiating Manual Backup in
Chapter 7).
2.
If this backup fails, remove the USB flash drive and verify
that it is an approved bioMérieux USB flash drive. If it is an
approved bioMérieux USB flash drive, re-insert and
attempt a manual backup.
or
If the USB flash drive is not an approved bioMérieux USB
flash drive, then insert a USB flash drive approved by
bioMérieux and attempt a manual backup.
3.
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If this backup fails, call bioMérieux.
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System Troubleshooting
Fault Codes
#820
BACKUP MEDIA MISSING OR BACKUP DRIVE FAULT
Cause: Backup media is not fully inserted into the drive.
Solution: Remove backup media and re-insert into the drive.
Cause: Backup media is corrupted.
Solution: Remove the backup media and replace with a
different backup media.
Cause: Backup drive failure.
Solution: Call bioMérieux.
Cause: Backup media is not an approved bioMérieux device.
Solution: Insert an approved bioMérieux device.
9-26
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Fault Codes
System Troubleshooting
Operator Error Codes
Operator Error Codes appear in a separate window on the Main screen and
are identified by a 99 in the top left corner. A description of each Operator
Error Code is provided. The following is an example of an Operator Error
Code 911.
Figure 9-3: Operator Error Code 911
#901
CORRUPTED BOTTLE RECORD HAS BEEN SELECTED
Cause: A corrupted bottle record has been selected for the Edit
Bottle Detail screen.
Solution: This error will automatically disappear.
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1.
Note the cell ID for the corrupted bottle record on the Edit
Bottle Detail screen.
2.
Go to the View Cell Status screen and check the cell for
Instrument Fault Code 75.
3.
If Instrument Fault 75 is present, then follow the procedure
provided to correct the problem (see Instrument Fault
Code #75 on page 9-17).
4.
If error persists, call bioMérieux.
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System Troubleshooting
Fault Codes
#902
REQUIRED DATA MISSING
Cause: Required data was not entered while loading bottles.
Solution:
#909
1.
Remove the bottle from the cell that was just loaded.
2.
Complete required fields (see Text/Data Entry in Chapter 3
for Clinical Use, or Text/Data Entry in Chapter 4 for
INDUSTRY Use).
3.
Reload bottle.
INVALID CELL LOAD — CELL QC IN PROCESS
Cause: This fault occurs when a bottle is loaded in a cell that
has not completed the QC cycle. The QC cycle for a cell is
indicated by a white circle on the cell status screen (see
Figure 3-5, View Cell Status Screen for Clinical Use, or see
Figure 4-5, View Cell Status Screen for INDUSTRY Use).
Note - The maximum time a cell may be disabled while
undergoing the QC cycle is 12 minutes.
Solution: Perform the following procedure:
1.
Remove the bottle from the cell that was just loaded.
The error will disappear.
9-28
2.
Scan the Bottle ID again and Accession Number (Clinical)
or Sample ID (INDUSTRY) (if needed).
3.
Reload the bottle into an available cell (one which has its
cell indicator light lit).
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Fault Codes
System Troubleshooting
#910
INVALID CELL LOAD
Cause: Indicates that a bottle was loaded in a cell belonging to
a wrong drawer type, or in a cell that is disabled or nonfunctional. This error also occurs if a bottle is loaded while an
Unload function is active.
Solution: Perform the following procedure:
1.
Remove the bottle from the cell that was just loaded. The
cell ID will be displayed in the error window on the
Controller or Combination Module.
2.
If in the Load function, re-scan the bottle ID and load the
bottle in a cell which has its cell indicator light lit.
Removing the indicated bottle also causes the Operator
Error screen to vanish.
DO NOT press the Check button on the Operator Error screen
except to intentionally ignore the error and leave the bottle
loaded.
Loading another bottle will clear the error and leave the original
bottle loaded in the non-functional cell.
#911
INVALID CELL UNLOAD
Cause: Indicates an incorrect bottle was unloaded from a nonindicated cell or that a bottle was unloaded while not in an
Unload function.
Solution: Replace the bottle into the cell from which it was just
unloaded. The cell ID will be displayed in the error window on
the Controller or Combination Module. The cell will also have a
rapidly flashing cell indicator light. Reloading the indicated
bottle also causes the Operator Error screen to vanish.
Press the Check button ONLY if the unload was intentional.
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System Troubleshooting
Fault Codes
#912
INVALID CELL RELOAD
Cause: When reloading a bottle, the bottle was placed in a
disabled or non-functional cell.
Solution: Perform the following procedure:
1.
Remove the bottle from the non-functional cell whose cell
indicator light will be flashing rapidly. The cell ID will also
be displayed in the error window on the Controller or
Combination Module.
2.
Reload the bottle into a functional cell. Moving the
indicated bottle to another cell causes the Operator Error
screen to vanish.
DO NOT press the Check button on the Operator Error screen
except to intentionally ignore the error and leave the bottle
loaded in the non-functional cell.
Ignoring the error leaves the original bottle in a non-functional
cell.
#913
BOTTLE ID JUST ENTERED MATCHES THAT OF A
CURRENTLY LOADED BOTTLE
Note - The bottle ID just entered is displayed at the top of the
Operator Error screen. The cell location of a bottle loaded with
the same ID is displayed below the bottle ID.
Cause: The bottle ID is incorrect for the bottle being loaded or
unloaded.
Solution: Rescan the bottle and press the Check button after it
turns red.
9-30
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System Troubleshooting
Cause: If the bottle ID is correct for the bottle being loaded or
unloaded, the bottle ID for the bottle in the cell location
indicated was incorrect.
Solution: Perform the following procedure:
1.
Record the cell location displayed in the Error Box.
2.
If the error occurred while loading, then do not load the
bottle at this time. Set the bottle aside and go to Step 4.
3.
If the error occurred while unloading an anonymous bottle,
return the bottle to its original cell location.
4.
Pull the bottle from the cell recorded in Step 1 and record
its bottle ID. (Ignore the Operator Error 911 that appears.
DO NOT press the Check button.)
5.
Return the above bottle to the cell from which it came (the
LED will be flashing).
6.
Go to the Edit Cell Contents screen and select the cell
recorded in Step 1 (see Selecting Bottles Using the Edit
Cell Contents Button in Chapter 5 for Clinical Use, or
Selecting Bottles Using the Edit Cell Contents Button in
Chapter 6 for INDUSTRY Use). The Edit Bottle Detail
screen appears.
7.
Enter the correct bottle ID (the one recorded in Step 4) in
the Bottle ID field.
8.
Press the Check button.
9.
If the error occurred while identifying an anonymous bottle,
identify the anonymous bottle.
or
If the error occurred while loading a bottle (see Step 2), reload the bottle from Step 2.
10. If the error persists, call bioMérieux.
#921
BARCODE SCAN NOT ALLOWED IN THIS MODE
Cause: Indicates a barcode label was scanned but current
screen does not accept barcodes. Frequently occurs if
appropriate function is not initiated, such as load or unload
bottles.
Solution: No action is required to correct this error. It
automatically resolves after 2 seconds.
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System Troubleshooting
Fault Codes
#923
INVALID BARCODE ENTRY
Cause: The scanned barcode cannot be accepted because it is
the wrong length, has the wrong starting character, or has an
invalid character.
• Unacceptable Bottle ID characters are ', “, \,*.
• Unacceptable Accession Number/Sample ID
characters are ‘, “, \, *, @.
Solution: Acknowledge error and re-scan bottle. If error
persists after re-scanning the barcode, attempt to enter the
Accession Number/Sample ID or bottle ID via the keyboard.
Ensure that barcode is entered into the correct field.
If error persists, use a Generic Bottle ID barcode.
#930
INCORRECT OR UNEXPECTED BARCODE LABEL
SCANNED WHILE UNLOADING A BOTTLE
Cause: A previously identified bottle is unloaded, but the wrong
label was scanned while unloading the bottle. The instrument
determines that it is not the same barcode currently associated
with the bottle and reports this error.
Note - Two bottle IDs are displayed in a box on the Operator
Error screen. At the top is the bottle ID of the bottle just
unloaded and scanned. The second bottle ID displayed was
assigned to the bottle when it was originally loaded or
identified.
Solution: If an error was made during the scanning of the
bottle, rescan the bottle and press the Check button after it
turns red.
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Fault Codes
System Troubleshooting
Cause: The correct barcode label is scanned after unloading
the bottle; apparently, the incorrect label was scanned when the
bottle was originally loaded.
Solution: Perform the following procedure:
#931
1.
If the unloaded bottle was scanned correctly, DO NOT
TOUCH the screen.
2.
Record the bottle ID and the cell ID, and return the bottle to
the cell from which it came.
3.
Go to the Select Bottle to Edit screen and use the scroll
buttons to enter the cell ID recorded.
4.
Press the Check button to display this bottle's information
on the Edit Bottle Detail screen. Edit the bottle ID to match
the bottle ID recorded and press the Check button.
5.
Return to the Unload function to unload the original bottle.
6.
If the error persists, call bioMérieux.
DETECTION ALGORITHM HAS BEEN CHANGED
Cause: An anonymous or identified bottle is unloaded and its
barcode is scanned. The instrument determines that the media
type associated with the barcode does not match the algorithm
used in analyzing the initial data.
Solution: Perform the following procedure:
1.
If the bottle has multiple labels, it may be that the wrong
label was scanned. Try re-scanning the bottle ID and if
correctly entered, press the Check button.
2.
If no changes are made and the Check button is pressed,
the bottle will be flagged positive and Instrument Fault
Code 74 or 77 will appear in the cell where the bottle was
loaded.
3.
Unload the bottle with the fault via the Positive Bottle
Unload function.
4.
Subculture the bottle and reload the bottle to restart
testing. See Instrument Fault Code #74 on page 9-16 for
Clinical Use (or INDUSTRY Use) or see Instrument Fault
Code #77 on page 9-18.
Note - Unload another bottle or press the Cancel button to
ignore the error.
WARNING – The bottle must be subcultured.
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System Troubleshooting
Fault Codes
Cause: An anonymous bottle is unloaded with a generic
barcode label. The operator uses the Bottle Type scroll button
to specify the media type. The error is reported while selecting
the bottle type.
Solution: Perform the following procedure:
1.
Note that the Operator Error screen also has a Bottle
Type scroll button. If an incorrect media type was entered,
correct it now and press the Check button.
2.
See instructions above if no changes are made and the
Check button is pressed.
Note - Unload another bottle or press the Cancel button to
ignore the error.
WARNING – The bottle must be subcultured.
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Fault Codes
System Troubleshooting
#932
BOTTLE ID SCANNED MATCHES THAT OF A
PREVIOUSLY UNLOADED BOTTLE
Cause: An anonymous bottle is identified with a previously
unloaded bottle's ID.
Solution: If the bottle ID was entered incorrectly, enter the
correct bottle ID and press the Check button.
If the bottle ID was entered correctly, perform the following
procedure:
1.
Re-enter the bottle ID and press the Check button.
Note - The bottle readings for the previously unloaded bottle
will be lost and the Bottle ID, Accession Number/Sample ID,
First Loaded Time, Maximum Test Time, and Bottle Type will be
assigned to the newly identified bottle.
2.
Reload the bottle, if desired. Instrument Fault Code 78
appears and the bottle is flagged positive (see Instrument
Fault Code #78 on page 9-18).
CAUTION – Performing Step 1 and Step 2 result
in duplicate bottle ID’s that will be seen in
Editing Bottle ID to Accession Number
relationships and on the reports in the
BacT/ALERT® 3D Select and SelectLink
configurations.
3.
If the bottle is not reloaded (and another bottle is unloaded
or the Cancel button is pressed), the bottle’s anonymous
record will be lost.
If the bottle is returned to its cell without identifying the bottle,
the bottle will remain anonymous and Operator Error Code 932
will disappear.
#940
BOTTLE DETAIL NOT FOUND
Cause: Occurs only in the Select Bottle to Edit/Graph screen
when:
• An empty cell is selected.
• The bottle ID entered is not recognized as belonging to
a currently loaded or recently unloaded bottle.
Solution: This Operator Error Code will terminate
spontaneously after being briefly displayed. When the Select
Bottle to Edit/Graph screen is redisplayed, correct the previous
entry or press the Cancel button.
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System Troubleshooting
Fault Codes
Cause: This error may occur while in the Edit Cell Contents
screen when a loaded cell is selected, but no bottle record was
found.
Solution: Call bioMérieux.
#941
BOTTLE ID ENTERED MATCHES THAT OF A BOTTLE
THAT IS CURRENTLY LOADED IN A DIFFERENT CELL
Cause: When editing a bottle ID on the Edit Bottle Detail
screen, the bottle ID entered is the same as the bottle ID of a
bottle loaded in a different cell. Press the Cancel button to clear
the error.
Solution: If the bottle ID was entered incorrectly, enter the
correct bottle ID now and press the Check button.
If the bottle ID is correctly entered, perform the following
procedure.
1.
Press the Cancel button on the Edit Bottle Detail screen.
2.
Enter the same bottle ID (the one used on the previous
screen) and press the Check button to view information on
this bottle. Note the cell location on the Edit Bottle Detail
screen and remove the bottle currently in that cell to record
the actual bottle ID. Ignore the Operator Error 911 that
appears on the screen when the bottle is unloaded.
CAUTION – DO NOT press the Check button.
9-36
3.
Return the bottle to the same cell from which it was
removed.
4.
Correct the bottle ID and press the Check button. It is now
possible to edit or identify the original bottle ID.
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System Troubleshooting
#942
BOTTLE TYPE CHANGE REQUIRES DIFFERENT
ALGORITHM
Cause: In the Edit Bottle Detail screen, a bottle's media type
has been changed to a media type that requires different data
analysis.
Solution: If an error was made entering the new media,
perform the following procedure:
1.
Press the Cancel button and return to the Edit Bottle Detail
screen to correct the entry.
2.
Press the Check button on the Edit Bottle Detail screen to
save the changes.
If an error was not made, perform the following procedure:
#943
1.
Press the Check button to override the error. Note the cell
ID of the bottle.
2.
Press the Check button on the Edit Bottle Detail screen to
save changes.
3.
Go to the View Cell Status screen and check the cell for
Instrument Fault Code 74.
4.
If the fault is present, follow the procedure provided to
correct the problem. See Instrument Fault Code #74 on
page 9-16 for Clinical Use (or INDUSTRY Use).
IDENTIFIED BOTTLE CHANGED TO ANONYMOUS
Cause: The Bottle ID field has been cleared for an identified
bottle in the Edit Bottle Detail screen.
Solution: Press Cancel to return to the Edit Bottle Detail
Screen. Enter the correct bottle ID and press the Check button.
#944
MANUAL UNLOAD OF ANONYMOUS BOTTLE
Cause: An attempt was made to manually unload an
anonymous bottle from the Edit Bottle Detail screen.
Solution: Press the Cancel button to return to the Edit Bottle
Detail screen. Enter a bottle ID or change the Load Status
slidebar switch back to the load position (1).
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System Troubleshooting
Fault Codes
#945
BOTTLE ID ENTERED MATCHES THAT OF A
PREVIOUSLY UNLOADED BOTTLE
Cause: In the Edit Bottle Detail screen, a bottle has been given
the bottle ID of a previously unloaded bottle.
Solution: If the bottle ID was entered incorrectly, perform the
following procedure:
1.
Press the Cancel button on the error screen.
2.
Enter the correct bottle ID on the Edit Bottle Detail screen
and press the Check button.
If the Bottle ID was entered correctly, perform the following
procedure:
1.
Press the Check button on the error screen.
Note - The bottle readings for the previously unloaded bottle
will be lost and the Bottle ID, Accession Number/Sample ID,
First Loaded Time, Maximum Test Time, and Bottle Type will be
assigned to the newly identified bottle.
2.
#960
Press the Check button on the Edit Bottle Detail screen.
Instrument Fault Code 78 appears and the bottle is flagged
positive (see Instrument Fault Code #78 on page 9-18).
DUPLICATE ENTRIES
Cause: Two or more label entry fields on the Label Entry
screen contained the same entry when the Check button was
pressed.
Solution: Change one of the duplicate labels to a unique entry
and press the Check button.
#961
INVALID BLANK FIELD
Cause: One of the label entry fields on the Label Entry screen
was blank when the Check button was pressed.
Solution: Enter a label in the blank field and press the Check
button.
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Fault Codes
System Troubleshooting
Bottle Problems
ANONYMOUS BOTTLE INDICATED IN EMPTY CELL
Cause: The cell flag is stuck.
Solution: Verify that the flag is covering the bottom of the cell.
If not, try gently pressing on the flag spring to dislodge it
Cause: Flag is soiled.
Solution: Call bioMérieux.
Cell may need to be recalibrated. Calibrate cell (see Calibrating
an Instrument Cell in Chapter 8).
BOTTLE LODGED IN CELL
Cause: Too many labels applied to a bottle.
Solution: Call bioMérieux.
CAUTION – Do not twist the bottle.
Cause: The bottle label was wet when the bottle was loaded
and became stuck to the side of the cell.
Solution: Call bioMérieux.
User Output Device Problems
DRAWER INDICATOR(S) NEVER COME ON
Cause: Various.
Solution: Call bioMérieux.
CELL INDICATOR(S) NEVER COME ON
Cause: Various.
Solution: Call bioMérieux.
CONTROLLER OR COMBINATION MODULE ALARM NOT
SOUNDING
Cause: Alarm disabled.
Solution: Verify the alarm settings are correct (see Setting the
Audible Alarms in Chapter 7). If this does not correct the
problem, call bioMérieux.
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System Troubleshooting
Fault Codes
BARCODE SCANNER DOESN'T BEEP
Cause: Various.
Solution: Call bioMérieux.
BARCODE CANNOT BE SCANNED
Cause: Barcode scanning beam does not appear when a bottle
is placed over the bottle template label in the Barcode Reader
aperture.
Solution: Ensure the barcode scanner is fully depressed in the
cradle so the trigger is fully engaged.
Cause: The barcode gun needs cleaning.
Solution: Wipe the face of the gun with a soft cloth and water.
Cause: The connectors are improperly plugged in.
Solution: The keyboard beneath the barcode reader aperture
may be used to enter barcodes.
Cause: Scanner's Operational Parameters are no longer set.
Solution: Scan the applicable Reset Barcode (see Figure 9-4
or Figure 9-5) to reset the Operational Parameters.
Figure 9-4: QuickScan® 6000 Reset Barcode
Figure 9-5: Honeywell Reset Barcode
9-40
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Fault Codes
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KEYBOARD NOT RESPONDING
Cause: Various.
Solution: Reboot the system. For Select and SelectLink
configurations, see Controller/Combination Module Reboot/
Shutdown (BacT/ALERT® 3D Select and SelectLink) in
Chapter 8. For Signature configuration, see Full System
Shutdown (BacT/ALERT® 3D Signature) and Full System
Startup (BacT/ALERT® 3D Signature) in Chapter 8.
OPERATOR PANEL BLANK
Cause: Controller or Combination Module not receiving power.
Solution: Check the power switch and the power cord
connection.
OPERATOR PANEL UNRESPONSIVE
Cause: Various.
Solution: Reboot the system. For Select and SelectLink
configurations, see Controller/Combination Module Reboot/
Shutdown (BacT/ALERT® 3D Select and SelectLink) in
Chapter 8. For Signature configuration, see Full System
Shutdown (BacT/ALERT® 3D Signature), and Full System
Startup (BacT/ALERT® 3D Signature) in Chapter 8. Call
bioMérieux if the problem is not resolved.
Note - The keyboard may be used instead of the Operator
Panel to operate the instrument and to activate the load and
unload functions (see Using the Keyboard in Place of the
Operator Panel in Chapter 8).
OPERATOR PANEL — NO DISPLAY IMAGE
Cause: The monitor switch on the back of the Controller/
Combination Module is incorrectly set to EXTERNAL.
Solution: Check the monitor switch setting. If the monitor
switch is set to EXTERNAL, perform the following procedure:
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1.
Set the monitor switch to INTERNAL.
2.
Reboot the system. For Select and SelectLink
configurations, see Controller/Combination Module
Reboot/Shutdown (BacT/ALERT® 3D Select and
SelectLink) in Chapter 8. For Signature configuration, see
Full System Shutdown (BacT/ALERT® 3D Signature), and
Full System Startup (BacT/ALERT® 3D Signature) in
Chapter 8. Call bioMérieux if the problem is not resolved.
9-41
System Troubleshooting
Fault Codes
RED INFORMATIONAL WARNING SCREEN APPEARS
Cause: A red Informational Warning screen indicates that the
BIOS clock setting is incorrect.
Figure 9-6: Red Informational Warning Screen
Solution 1: If the software was exited and restarted, but the
system was not powered off, perform the following procedure:
1.
Press Y on the keyboard to start the system.
2.
Call your local bioMérieux representative immediately to
report the incorrect BIOS setting.
Solution 2: If the system was powered off and the Red
Information Warning screen (see Figure 9-6) appears when
powered on, perform the following procedure:
1.
Call your local bioMérieux representative immediately.
2.
If a representative is unavailable, press Y on the keyboard
to start the system.
All bottles will display Fault Code 72 and/or Fault Code 80
and need to be subcultured.
WARNING – These bottles must be subcultured.
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21 CFR PART 11 MODE
10
About This Chapter
This chapter provides you with instructions on how to log in and out of the
instrument while in 21 CFR Part 11 mode, as well as instructions for
configuring users (ex. adding or deleting a user, or clearing a user password).
This chapter also describes the events recorded in the audit trail and how to
access the audit trail.
Chapter Contents
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
Clearing a User Password • 10-16
Audit Trail • 10-18
Accessing the Audit Trail • 10-20
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21 CFR Part 11 Mode
Log In/Out of System — 21 CFR Part 11 Mode
Log In/Out of System — 21 CFR Part 11 Mode
When installed, the BacT/ALERT® 3D instrument can be configured to
operate in 21 CFR Part 11 mode. If 21 CFR Part 11 mode is enabled, you
need to enter a user name and password to access all functions available.
While logged out of the instrument in 21 CFR Part 11 mode, the following
Main screen is displayed (see Figure 10-1).
1
Figure 10-1: Main Screen While Logged Out — 21 CFR Part 11 Mode
1 — Login button
When logged out, you will have limited access to the instrument’s functions.
The following activities can be performed while logged out of the instrument:
•
•
•
•
view error status
view bottle count status
hear and clear audible alarm
view screen color changes when a bottle turns positive
Logging In for the First Time
When you log in to the instrument for the first time, the default password is
blank (see Adding a User on page 10-13).
10-2
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Log In/Out of System — 21 CFR Part 11 Mode
21 CFR Part 11 Mode
To log in to the instrument for the first time:
1)
From the Main screen while logged out (see Figure 10-1), press the
Login button (
).
The User Login screen appears.
1
4
2
5
6
3
Figure 10-2: User Login Screen
1 — User Name Field
2 — Password Field
3 — Previous Screen Button
4 — Check Button
5 — Cancel Button
6 — Change Password Button
2)
Touch the User Name field (field turns white) and enter your user name.
3)
From the User Login screen (see Figure 10-2, User Login Screen), press
the Change Password button (
).
The New Password and Confirm Password fields appear on the User
Login Screen (see Figure 10-3).
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21 CFR Part 11 Mode
Log In/Out of System — 21 CFR Part 11 Mode
4
1
5
2
3
Figure 10-3: User Login Screen with Change Password Fields
1 — New Password Field
2 — Confirm Password Field
3 — Previous Screen Button
4 — Check Button
5 — Change Password Button
10-4
4)
Enter your new password in the New Password field (password length
must be 6 to 24 characters).
5)
Re-enter your new password in the Confirm Password field.
6)
Press either the Check button or the Enter key to change your
password.
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Log In/Out of System — 21 CFR Part 11 Mode
21 CFR Part 11 Mode
The Main screen appears.
Figure 10-4: Main Screen While Logged In — 21 CFR Part 11 Mode
Note:
The Previous Screen button returns to the User Login screen (see
Figure 10-5, User Login Screen, on page 10-6) without logging in.
Logging In
When the instrument is configured for 21 CFR Part 11 mode, you will need to
log in to the instrument to have full access of all functions.
1)
From the Main screen while logged out (see Figure 10-1), press the
Login button (
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).
10-5
21 CFR Part 11 Mode
Log In/Out of System — 21 CFR Part 11 Mode
The User Login screen appears.
1
4
2
5
6
3
Figure 10-5: User Login Screen
1 — User Name Field
2 — Password Field
3 — Previous Screen Button
4 — Check Button
5 — Cancel Button
6 — Change Password Button
2)
Click in the User Name field (field turns white) and enter your user name.
3)
Press the Tab key on the keyboard to advance to the Password field (or
click in the Password field).
The Password field turns white.
4)
Enter your password in the Password field (password length must be 6
to 24 characters).
5)
Press the Check button or the Enter key to log in to the instrument.
The Main screen appears (see Figure 10-4, Main Screen While Logged In —
21 CFR Part 11 Mode, on page 10-5).
Note:
10-6
See Configuring Users — 21 CFR Part 11 Mode on page 10-12 for detailed
information on how to add and delete users, and clear user passwords.
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Log In/Out of System — 21 CFR Part 11 Mode
21 CFR Part 11 Mode
Inactivity Timeout
While you are logged in, an inactivity timeout will occur (within a period of
time configured by your bioMérieux Service Representative) if you do not
perform one of the following actions:
• press a screen or keyboard button
• scan a barcode
• load or unload a bottle
If an inactivity timeout occurs, the instrument display reverts back to the Login
screen (see Figure 10-1, Main Screen While Logged Out — 21 CFR Part 11
Mode, on page 10-2). Any pending function is cancelled as if the Cancel
button on each successive screen was pressed.
Note:
If a timeout occurs, it is possible that partially entered information will be lost.
Note:
The inactivity timeout feature is disabled while a red operator error is
displayed.
Login Errors
An alert displays on the User Login screen if you enter an unknown user
name or an incorrect password and press the Enter, Check, or Change
Password button (see Figure 10-6).
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21 CFR Part 11 Mode
Log In/Out of System — 21 CFR Part 11 Mode
4
1
3
2
Figure 10-6: User Login Screen with Wrong Password Alert
1 — Wrong Password Alert
2 — Previous Screen Button
3 — Change Password Button
4 — Cancel Button
Note:
A Wrong User Alert (
) appears to the right of the User Name field.
To clear the alert:
1)
Press the Cancel button to clear the alert and all of the fields.
2)
Re-enter your user name or password (see Logging In on page 10-5).
or
Press the Previous Screen button to return to the User Login screen
without logging in (see Figure 10-5, User Login Screen, on page 10-6).
Change Password
Once you have entered a valid user name and password, you can
change your password.
1)
From the User Login screen (see Figure 10-5, User Login Screen), press
the Change Password button (
10-8
).
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Log In/Out of System — 21 CFR Part 11 Mode
21 CFR Part 11 Mode
The New Password and Confirm Password fields appear on the User
Login Screen (see Figure 10-7).
4
1
5
2
3
Figure 10-7: User Login Screen with Change Password Fields
1 — New Password Field
2 — Confirm Password Field
3 — Previous Screen Button
4 — Check Button
5 — Change Password Button
Note:
2)
Enter your new password in the New Password field.
3)
Re-enter your new password in the Confirm Password field.
4)
Press either the Check button or the Enter key to change your
password.
The Previous Screen button returns to the User Login screen (see
Figure 10-5, User Login Screen, on page 10-6) without logging in.
Change Password Errors
If you enter an incorrect new password, a change password error appears on
the User Login screen (see Figure 10-8). If you enter a password with less
than 6 characters, a wrong password alert appears on the User Login screen
(see Figure 10-9).
Note:
If more than 24 characters are entered, the additional characters are ignored
and no error is displayed.
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21 CFR Part 11 Mode
Log In/Out of System — 21 CFR Part 11 Mode
1
6
2
3
7
4
5
Figure 10-8: User Login Screen with Change Password Error
1 — Change Password Error
2 — Password Field
3 — New Password Field
4 — Confirm Password Field
5 — Previous Screen Button
6 — Check Button
7 — Change Password Button
10-10
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Log In/Out of System — 21 CFR Part 11 Mode
21 CFR Part 11 Mode
1
6
2
3
7
4
5
Figure 10-9: User Login Screen with Wrong Password Alert
1 — Wrong Password Alert
2 — Password Field
3 — New Password Field
4 — Confirm Password Field
5 — Previous Screen Button
6 — Check Button
7 — Change Password Button
To clear the password error:
1)
Press the Password field.
The New Password and Confirm Password fields will clear.
Note:
2)
Enter your new password in the New Password field.
3)
Re-enter your new password in the Confirm Password field.
4)
Press the Check button or the Enter key to change your password.
The Previous Screen button returns to the User Login screen (see
Figure 10-5, User Login Screen, on page 10-6) without logging in.
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10-11
21 CFR Part 11 Mode
Configuring Users — 21 CFR Part 11 Mode
Logging Out
1)
From the Main screen (see Figure 10-4, Main Screen While Logged In —
21 CFR Part 11 Mode, on page 10-5), press the Logout button
(
) to log out of the instrument.
The Main screen (while logged out) appears (see Figure 10-1, Main
Screen While Logged Out — 21 CFR Part 11 Mode, on page 10-2).
Note:
If you do not log out, the system will automatically time out when it reaches
the inactivity timeout period (see Inactivity Timeout on page 10-7).
Configuring Users — 21 CFR Part 11 Mode
The User Configuration screen allows you to manage user accounts for up to
100 users. You can add users, delete users, and clear user passwords.
1)
Access the Setup Screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 4).
2)
From the Setup screen (see Figure 4-10, Setup Screen), press the
Configure Users button (
10-12
).
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Configuring Users — 21 CFR Part 11 Mode
21 CFR Part 11 Mode
The User Configuration screen appears.
1
2
5
3
6
4
Figure 10-10: User Configuration Screen
1 — Add User Button
2 — Clear Password Button
3 — Delete User Button
4 — Previous Screen Button
5 — User List
6 — Check Button
Note:
The Configure Users button is only active when the instrument is configured
for 21 CFR Part 11 mode.
Adding a User
To add a user to the User List:
1)
From the User Configuration screen (see Figure 10-10, User
Configuration Screen), press the Add User button (
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).
10-13
21 CFR Part 11 Mode
Configuring Users — 21 CFR Part 11 Mode
The Add User screen appears.
7
1
2
6
5
4
3
Figure 10-11: Add User Screen
1 — User Name Field
2 — Add User Button
3 — Previous Screen Button
4 — Check Button
5 — Scroll Down Button
6 — User List
7 — Scroll Up Button
Note:
Multiple users can be added without leaving this screen.
2)
Click in the User Name field (field turns white) and enter the user name.
The minimum user name length is 1 character and the maximum is 24
characters.
Note:
Do not use the asterisk (*) when adding a user name.
3)
Press the Add User button or the Enter key.
The new user is added to the User List.
4)
Note:
10-14
Press the Check or Previous Screen button to return to the User
Configuration screen.
When you log in to the instrument for the first time, the default password is
blank. See Logging In for the First Time on page 10-2, to set your password.
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Configuring Users — 21 CFR Part 11 Mode
21 CFR Part 11 Mode
Deleting a User
To delete a user from the User List:
1)
From the User Configuration screen (see Figure 10-10, User
Configuration Screen, on page 10-13), press the Delete User button
(
).
The Delete User screen appears.
6
1
5
4
3
2
Figure 10-12: Delete User Screen
1 — Delete User Button
2 — Previous Screen Button
3 — Check Button
4 — Scroll Down Button
5 — User List
6 — Scroll Up Button
2)
Press the Scroll Up or Scroll Down button to locate the user name to be
deleted.
3)
Click (or press) the user name to select.
4)
Press the Delete User button to delete the selected user from the User
List.
5)
Press the Check or Previous Screen button to return to the User
Configuration screen.
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21 CFR Part 11 Mode
Configuring Users — 21 CFR Part 11 Mode
Deleting More Than One User
To delete more than one user at a time:
1)
Note:
From the Delete User screen (see Figure 10-12), press the user names
to select.
If you select the wrong user name, press on the user name again to deselect.
2)
Press the Delete User button to delete the selected users from the User
List.
3)
Press the Check or Previous Screen button to return to the User
Configuration screen.
Clearing a User Password
In the event you may need to clear a user’s password (ex. a user forgets their
password), perform the following procedure.
1)
From the User Configuration screen (see Figure 10-10, User
Configuration Screen, on page 10-13), press the Clear Password button
(
).
The Clear Password screen appears.
10-16
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Configuring Users — 21 CFR Part 11 Mode
21 CFR Part 11 Mode
6
1
5
4
3
2
Figure 10-13: Clear Password Screen
1 — Clear Password Button
2 — Previous Screen Button
3 — Check Button
4 — Scroll Down Button
5 — User List
6 — Scroll Up Button
Note:
2)
Press the Scroll Up or Scroll Down button to locate the user name.
3)
Click (or press) the user name to select.
4)
Press the Clear Password button to clear the password for the selected
user.
5)
Press the Check or Previous Screen button to return to the User
Configuration screen.
When you clear a user password, the password is reset to the blank setting.
The user will then have to recreate a password (see Logging In for the First
Time on page 10-2).
Clearing More Than One User Password
To clear more than one user password at a time:
1)
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From the Clear Password screen (see Figure 10-13), press the user
name to select.
10-17
21 CFR Part 11 Mode
Note:
Audit Trail
If you select the wrong user name, press on the user name again to deselect.
2)
Press the Clear Password button to delete the passwords for the
selected users from the User List.
3)
Press the Check or Previous Screen button to return to the User
Configuration screen.
Audit Trail
One of the features of 21 CFR Part 11 mode is an audit trail that records
activities and other related information (ex. bottle events). Each audit trail
entry consists of an event, the time and date the event occurred. See
Table 10-1 for a list of events recorded in the audit trail.
Table 10-1: Audit Trail Events
Event
10-18
Event Parameters
User Log in
Time, Date, User ID
User Log out
Time, Date, User ID
Anonymous Bottle First
Loaded
Time, Date, User ID, Cell Location, Max Test
Time, Sequence Number
Identified Bottle First
Loaded
Time, Date, User ID, Cell Location, Bottle Type,
Max Test Time, Bottle ID, Accession Number,
Sequence Number
Bottle Identified
Time, Date, User ID, Cell Location, Bottle Type,
Max Test Time, Bottle ID, Accession Number,
Sequence Number
Bottle Moved
Time, Date, User ID, Original Cell, Destination
Cell, Sequence Number
Bottle Unloaded
Time, Date, User ID, Cell Location, Sequence
Number
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Table 10-1: Audit Trail Events (Continued)
Event
Bottle Record Changed
Event Parameters
Time, Date, User ID or LIS, Cell Location,
Action (Bottle Type Changed, Loaded Status
Changed, Max Test Time Per Bottle Changed,
Test Result Manually Changed, Bottle ID
Changed, Accession Number Changed),
Sequence Number, Bottle Type, Loaded Status,
Max Test Time, Test Result, How Determined,
Bottle ID, Accession Number
Note - The Bottle Type, Loaded Status,
Max Test Time, Test Result, How
Determined and Accession Number are
recorded in the Audit Trail when they
change.
Temperature Calibration
Time, Date, User ID, Module ID, New
Temperature Setpoint
Cell Calibration
Time, Date, User ID, Cell Location
Display Time Changed
Time, Date, User ID, Amount of Change relative
to UTC (Universal Coordinated Time)
Firmware Updated
Time, Date, Device, Firmware Revision
Note - User ID is not recorded.
Module, Drawer, Rack, or
Cell Enabled or Disabled
Time, Date, User ID, Location, Action (enable
or disable), Device
Note - This event is recorded only from
the Enable/Disable Module, Drawer, Rack,
or Cell screen (screen 2.2).
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Maximum Test Time for
Bottle Type Changed
Time, Date, User ID, Bottle Type, Max Test
Time
Positive Alarm Setting
Changed
Time, Date, User ID, Action (enable or disable)
Instrument Alarm Setting
Changed
Time, Date, User ID, Action (enable or disable)
Operation Error Alarm
Setting Changed
Time, Date, User ID, Action (enable or disable)
System Password
Changed
Time, Date, User ID
21 CFR Part 11 Mode
Changed
Time, Date, User ID, Action (enable or disable)
Note - User ID is recorded only for
disable.
10-19
21 CFR Part 11 Mode
Audit Trail
Table 10-1: Audit Trail Events (Continued)
Event
Event Parameters
User Account Changed
Time, Date, User ID, Action (user added, user
deleted, password changed or cleared)
Patient Name Changed
Time, Date, User ID, Hospital ID, First Name,
Last Name
Hospital ID Changed
Time Date, User ID, Accession Number,
Hospital ID
Cell Gap Detection Faults
Cleared
Time, Date, User ID, Number of bottles cleared
Note:
Some recorded events may occur while you are logged out and will not have
an associated User ID (ex., upgrading firmware). In these cases, the user is
listed as “Unknown”.
Note:
The audit trail is available on all BacT/ALERT® 3D software configurations,
regardless of 21 CFR Part 11 status.
Accessing the Audit Trail
The audit trail is available in English only and is not editable. The audit trail is
available as one of the Software Test screens.
To access the audit trail:
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 4).
2)
From the Setup screen, press Ctrl + D on the keyboard.
The Software Test screen appears.
3)
Press the 7 key on the keyboard.
The Audit trail appears in the Software Test screen window.
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MYCOBACTERIAL TESTING (CLINICAL USE)
11
About This Chapter
This chapter provides you with a complete description of the of the
BacT/ALERT® 3D instrument when it is configured for Mycobacterial (MB)
functions.
Chapter Contents
System Description • 11-2
Intended Use • 11-2
Overview • 11-2
BacT/ALERT® 3D Instrument • 11-3
System Startup • 11-6
General Information • 11-6
Theory of Operation • 11-7
Safety Features • 11-8
Device Comparison for Recovery of Mycobacteria • 11-10
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System Description
System Description
Intended Use
The Mycobacterial (MB) configuration of the BacT/ALERT® 3D instrument is
designed to grow and detect mycobacteria from patient samples.
Overview
The BacT/ALERT® 3D system uses no radioactive reagents, is non-invasive,
and offers walk-away automation for mycobacteria detection. No handling of
the bottle inoculated with specimen is required after it is placed in the
BacT/ALERT® 3D instrument. Positives are signaled immediately upon
detection. After a specified time, which can be determined by the operator,
negatives are signaled if no growth has been detected.
The BacT/ALERT® 3D instrument consists of a Controller Module that directs
the activity of one or more Incubation Modules. Each Incubation Module may
contain one or more MB Drawers for mycobacterial detection. Each drawer
can be converted by a service engineer to perform either an MB or non-MB
function. One important difference between the drawer configurations is that
MB Drawers do not agitate the bottles during incubation. MB Drawers are
clearly identified by a red label on the drawer handle. It is important to open
and close the door gently to minimize avoidable agitation when adding or
removing bottles.
The disposable Mycobacteria bottles contain bioMérieux’s patented
colorimetric sensor which is continuously monitored for positive sample
detection. Unloading or manipulating the bottles when not indicated by the
system may interfere with critical bottle readings. In addition, the bottles
contain broth and atmosphere which promote the recovery of a wide variety
of Mycobacterium species without venting. MB/BacT® Antimicrobial
Supplement and Reconstitution Fluid inhibit the growth of contaminating
organisms and enhance the recovery of mycobacteria.
The data generated by the BacT/ALERT® 3D are managed by extensive data
management software which provides a high level of flexibility. Mycobacterial
data can easily be stored, queried, sorted and reported. Predefined reports
and macros are available, or they may be customized by the user.
In the following pages, the elements of the MB configuration of the
BacT/ALERT® 3D will be described with special emphasis on how they differ
from the non-MB configuration described in the rest of this manual. While the
11-2
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function and use of MB configuration are similar to those of non-MB
configuration, there are important differences.
WARNING
Laboratory procedures involving mycobacteria require special
equipment and techniques to minimize biohazards. Specimen
preparation and positive sample handling must be done in a
biological safety cabinet.
BacT/ALERT® 3D Instrument
The instrument consists of a Controller Module and one or more Incubation
Modules. The instrument incubates and continuously monitors the status of
each mycobacterial culture bottle. The Incubation Modules consist of four
drawers each with a 60-bottle capacity. MB and non-MB drawers can coexist
in the same Incubation Module.
MB Drawers may be provided directly by bioMérieux or may be converted
from a non-MB configuration in the field.
Each MB Drawer handle has a red MB label also displaying the Incubation
Module number and letter corresponding to that drawer. The MB Drawer
faces on the Instrument icon of the Main screen are also labeled (see
Figure 11-1).
Figure 11-1: Instrument Icon for MB-Configured System
Circulation Fan
The circulation fan, normally running to distribute air within the
BacT/ALERT® 3D instrument, is turned off whenever a drawer in the
Incubation Module is opened.
Rocker Clamp
The BacT/ALERT® 3D drawer configured for MB has the agitation
mechanism disengaged so the three racks within each drawer remain
immobile.
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Mycobacterial Testing (Clinical Use)
Note:
System Description
The BacT/ALERT® 3D software must also be configured to activate the MB
status of each drawer (see MB Drawer Configuration on page 11-6).
Installation Procedures and Special Requirements
Initial installation and setup of the BacT/ALERT® 3D Microbial Detection
System, or of any added Incubation Module(s), are to be performed only by a
bioMérieux Service Representative.
If it is necessary to move or store the BacT/ALERT® 3D System or one of its
modules, contact bioMérieux Service for assistance.
The BacT/ALERT® 3D has been designed to minimize risks associated with
Mycobacterial testing. However, to further reduce the risks of accidental
exposure to infectious agents, additional precautions should be taken. It is
strongly recommended that the instrument be placed in a laboratory used for
the routine culture of M. tuberculosis. For activities involving the propagation
and manipulation of M. tuberculosis or Mycobacterium species grown in
culture, BioSafety Level 3 Practice, Containment Equipment, and Facilities
are required as recommended by CDC and NIH guidelines.
At a minimum, the instrument should be placed in a contained environment
with controlled access which has a tuberculosis exposure control plan.
The locations should have surfaces which can be easily decontaminated
using an appropriate topical disinfectant. The instrument must not be placed
in an open corridor or hallway that is accessible to the general public or the
patient population.
See Drawer Safety Closure Kit in Reagents & Accessories.
Barcodes
MP Process Bottle barcodes are encoded with the bottle type. MP Process
Bottle barcodes have an SM (plastic) prefix. When an MP Process Bottle
barcode is entered, the BacT/ALERT® 3D system will direct the user to load
the bottle into an MB Drawer. All MB Drawers are clearly marked with a red
label on the drawer handle.
MB Blood bottle barcodes are encoded with the bottle type. MB Blood bottle
barcodes have an !B (glass) prefix. When an MB Blood Bottle barcode is
11-4
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System Description
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entered, the BacT/ALERT® 3D system will direct the user to load the MB
Blood Bottle into any drawer containing cells available for loading.
WARNING
Do not use Generic barcodes to load BacT/ALERT® MB
Bottles.
Load Bottles
Cells are assigned based on the type of bottle. MP Process Bottles are
directed exclusively to MB Drawers.
Note:
Anonymously loaded MP Process Bottles must be placed in an MB drawer for
proper incubation and detection of positives.
Note:
MB Blood bottles must never be loaded anonymously.
Unload Positives and Negatives
If an instrument contains both MB and non-MB bottles, both bottle types will
be identified for unloading when any of the unload buttons is pressed. The
user then has an option of unloading all indicated bottles, all indicated bottles
of a certain type (ex. MB or non-MB), or a portion of the indicated bottles of
any type.
Set Maximum Test Time
The system default maximum test time is 42 days for Mycobacteria bottles.
Test times may be changed manually through the Set Maximum Test Time
screen (see Setting the Maximum Test Time in Chapter 7).
Positive Detection Algorithm
A special detection algorithm is used to detect growth of Mycobacterium
species. This algorithm is designed to detect growth at the earliest possible
time.
Bottle Status
The Main Screen on the monitor displays the status of positive or negative
Mycobacteria bottles separately from the status of other bottle types.
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Mycobacterial Testing (Clinical Use)
System Startup
Figure 11-2: Bottle Count Table and Unload Buttons
Located just above the Instrument icon on the Main screen are the Unload
buttons. Above each Unload button is a rectangular box containing the
number of bottles currently matching the unload criteria for that button.
The Bottle Count Table contains two rows. The top row displays the bottle
count for Mycobacteria culture bottles and is labeled MB. The bottom row
displays the bottle counts for non-mycobacterial culture bottles and is labeled
BC.
The leftmost box in each bottle count row contains the culture type label (ex.
BC, MB) and is not associated with an Unload button. The number displayed
within this box represents the total number of bottles (of any status) currently
loaded into the system.
The second leftmost box shows the total number of identified bottles with a
positive test status. It appears above the Positive Bottle icon.
The box third from the left shows the total number of identified and
anonymous bottles with a negative test status. It appears above the Negative
Bottle icon.
The box second from the right shows the total number of anonymous bottles
with a positive test, and is associated with the corresponding icon.
The total number of anonymous bottles with a negative-to-date or negative
test status appears rightmost, and is associated with the corresponding icon.
System Startup
General Information
MB Drawer Configuration
The BacT/ALERT® 3D drawer agitation mechanism can be disengaged at the
factory or by a service engineer on site, after which the three racks within the
drawer remain immobile. The BacT/ALERT® 3D Controller Module is also
configured by bioMérieux personnel to activate the MB status of each drawer.
11-6
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System Startup
Mycobacterial Testing (Clinical Use)
Limitations of the Test
Refer to the package insert enclosed with the MP Process Bottles for
additional information.
Service and Maintenance
Preventive maintenance and troubleshooting are performed as described in
Chapter 8, System Maintenance.
Additional procedures pertinent to Mycobacteria are referenced in Safety
Features on page 11-8.
Theory of Operation
The BacT/ALERT® 3D Mycobacterial Detection System utilizes a colorimetric
sensor and reflectance detector to determine the level of carbon dioxide
within the bottle. If microorganisms grow in the bottle, carbon dioxide is
produced which will change the color of the sensor on the bottom of the
bottle. The instrument monitors this color while incubating the sample and
determines if growth has occurred.
The MP Process Bottles contain a media which will, in combination with the
MB/BacT® Reconstitution Fluid, promote the growth of mycobacteria. If a
non-sterile sample is tested, the Reconstitution Fluid should be combined
with the MB/BacT® Antibiotic Supplement, which is then added to the
Process Bottle in accordance with the instructions in the package insert. The
addition of these antibiotics inhibits the growth of contaminating, nonmycobacterial microorganisms while permitting the growth, detection, and
recovery of mycobacteria.
Principle of Detection
Mycobacteria behave like most other aerobic bacteria with respect to
carbohydrate metabolism, energy production, and the biosynthesis of low
weight metabolites. They are able to assimilate a large range of
carbohydrates, lipids, and proteins. How mycobacteria assimilate and
organize these substrates is shown diagrammatically in Figure 11-3.
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11-7
Mycobacterial Testing (Clinical Use)
System Startup
Figure 11-3: Metabolic Pathway for Mycobacterial CO2
Glycerol was selected as the primary metabolic source in the MP Process
Bottle because of its unique metabolic pathway and its ability to maximize the
amount of CO2 generated by mycobacteria. Once ingested, glycerol is
converted to Acetyl-CoA and oxidized through the Krebs or Tricarboxcilic
Acid Cycle (TCA). CO2 and reduced electron carriers are the major metabolic
byproducts of this oxidation.
A solid-state sensor at the base of each MP Process Bottle detects CO2 as
an indicator of microbial growth. As the concentration of CO2 increases, the
sensor undergoes a color change from green to yellow.
Safety Features
The design of the BacT/ALERT® 3D provides several safety measures to
help mitigate hazards associated with mycobacteria and other organisms in
the interest of operator and laboratory safety. They are summarized as
follows.
• All glass bioMérieux BacT/ALERT® media bottles are manufactured with a
polymeric safety sleeve to help limit the effects of damage to a bottle.
Plastic bottles are made from a break-resistant material.
• Each bottle cell within the BacT/ALERT® 3D Incubation Module is sealed to
help contain and minimize effects of liquid spillage.
11-8
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• A drip tray is incorporated at the bottom of each drawer beneath the
opening end of the racks to minimize the effect of any spillage or liquid.
• The circulating fans within the Incubation Module turn off whenever any
Incubator Drawer is open to minimize airflow and the potential for aerosols.
• To reduce the chance of binding a heavily overlabeled bottle in a cell,
Incubation Module cells are gently tapered and fabricated from a compliant
polymer.
WARNING
Pathogenic Microorganisms including Hepatitis B virus and
Human Immunodeficiency Virus (HIV) may be present in
specimens. Universal Precautions and Local Laboratory
guidelines should be followed in handling all items
contaminated with blood or body fluids. If an inoculated tube is
found to be leaking or is accidentally broken during collection
or transport, use the established procedures in your facility for
dealing with Mycobacterial spills. As a minimum, Universal
Precautions should be employed. Tubes should be discarded
in an appropriate manner.
General Precautions
The following precautions should be observed during Maintenance and
Repair, even in situations where a spill is neither observed nor suspected. At
a minimum, disposable gloves, eye protection, and a laboratory coat should
be worn. Any parts removed or tools used should be decontaminated using a
10% bleach solution or other EPA registered tuberculocidal disinfectant
before removal from the laboratory. Anything which cannot be disinfected
should be sealed in a plastic bag, labeled as biohazardous, and handled
accordingly. In addition, the institution's safety precautions should always be
observed. Refer to Biosafety in Microbiological and Biomedical Laboratories.
HHS Publication No. CDC 93-8395. US Dept of Health and Human Services,
Public Health Service, Centers for Disease Control and Prevention, National
Institutes of Health, ed 3, 1993, pp 93-96.
Spill Cleanup
For specific spill cleanup procedures, see Safety Precautions and
Procedures in Chapter 8. (See also Spill Cleanup in Chapter 8.)
Disinfection Procedure for Spills Within/Onto the Instrument
If a spill is detected, only persons wearing protective clothing including
gloves, and a HEPA filter respirator should remain in the room. Any test
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Mycobacterial Testing (Clinical Use)
System Startup
specimen spilled in an instrument should be removed immediately using the
disinfection procedures in Chapter 8, System Maintenance.
Remove Drawer
If necessary, remove the Drawer according to the instructions packaged with
the Drawer Safety Closure Kit (Part Number 13228). The Drawer Safety
Closure Kit is stored beneath the top cover of the Controller Module.
Contact bioMérieux Instrument Service for replacement parts.
Device Comparison for Recovery of Mycobacteria
The following table shows device comparison of recovery of mycobacteria
based on concordance and discordance between the BacT/ALERT® 3D and
the MB/BacT systems.
Table 11-1: Device Comparison for Recovery of Mycobacteria
Test Results
MB/BacT
BacT3D
% of
Total
Positive
Positive
22
-
Negative
Negative
268
-
290
93.2%
Total Concordance
11-10
Number
Specimens
Positive
Negative
8
-
Negative
Positive
13
-
Total Discordance
21
6.8%
Total Specimens Tested
311
100.0%
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INTERNATIONAL CHARACTER ENTRY
A
About This Chapter
This chapter explains how to enter international characters on the
BacT/ALERT® 3D instrument.
Chapter Contents
International Character Entry • A-2
Entering International Characters • A-4
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International Character Entry
International Character Entry
You can enter International characters on the BacT/ALERT® 3D. Since the
keyboard does not contain the International characters, enter a base
character then use the Page Up or Page Down keys to toggle to the variant
character desired.
Each block in the table below lists a base character on the left and the
variants that can be accessed from that base character on the right.
Table A-1: International Character Table
Uppercase
Base Char
A
Lowercase
Base
Char
Variant
À
a
Variant
à
Á
á
Â
â
Ã
ã
Ä
ä
Å
å
Æ
æ
ª
E
È
e
É
é
Ê
ê
Ë
I
A-2
è
Ì
ë
i
ì
Í
í
Î
î
Ï
ï
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International Character Entry
Table A-1: International Character Table (Continued)
Uppercase
Base Char
O
Lowercase
Base
Char
Variant
Ò
o
Variant
ò
Ó
ó
Ô
ô
Õ
õ
Ö
ö
Ø
°
Ù
ø
Ú
ù
Û
ú
Ü
û
Ý
ü
Ñ
ý
Ç
ÿ
ß
ñ
µ
ç
Þ
-
Þ
-
International characters can be used in any of the following text fields on the
system:
Clinical Use
• Accession Number field
• Hospital ID field
• Patient First Name field
• Patient Last Name field
• Report Label fields
• Report Title field
INDUSTRY Use
• Sample ID field
• User Defined 3
• User Defined 1
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A-3
International Character Entry
• User Defined 2
• Report Label fields
• Report Title field
Entering International Characters
1)
Enter a base character from the table. See Manually Entering Text into a
Data Entry Field (Keyboard) in Chapter 3.
2)
Use the Page Up or Page Down key to scroll through the characters in
the block from the table.
Example: To enter an Å, perform one of the following:
• Press Shift + A then press Page Up six times.
or
• Press Shift + E, then press Page Down twice.
Note:
A-4
The entire International Character table can be scrolled through after entering
one base character. After scrolling through an entire block from the table, the
system scrolls to the base character in the next block. For example, if n is
entered and Page Up is pressed twice, then c will display.
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BOTTLE QUALITY CONTROL
B
About This Chapter
This chapter provides you with a description of the BacT/ALERT® 3D culture
bottle along with a quality control procedure.
Note:
Information in this chapter that is intended for clinical use only or industry use
only is marked Clinical Use or INDUSTRY Use.
Chapter Contents
BacT/ALERT® Culture Bottles • B-2
Introduction • B-2
Quality Control of Growth Performance • B-4
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BacT/ALERT® Culture Bottles
Bottle Quality Control
BacT/ALERT® Culture Bottles
Introduction
Disposable culture bottles to which samples are added for testing. Each
bottle contains a sensor that detects carbon dioxide (CO2) as an indicator of
microbial growth.
BacT/ALERT® culture bottles are ready for use. An expiration date is printed
on each bottle label. Do not use the media beyond the last day of the month
indicated. If the bottles are refrigerated, precipitates may form that will
disappear when the bottles are warmed to room temperature. Store protected
from light at room temperature (15–30°C). Bottles must be at room
temperature before use.
1
6
5
4
2
3
Figure B-1: Typical BacT/ALERT® Culture Bottle
B-2
1 — Flip Cap
4 — Volume Designations
2 — Culture Medium
5 — Barcode
3 — Sensor
6 — Stopper/Seal
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BacT/ALERT® Culture Bottles
Bottle Quality Control
Flip Cap
Plastic flip cap that ensures septum seal cleanliness, but not sterility.
Stopper/Seal
Butyl stopper secured with a color-coded aluminum seal. The stopper is not
sterile and should be disinfected prior to sample inoculation.
Bottle
See Figure B-1.
Volume Designations (Clinical Use)
Markings which indicate approximate volume in 5 mL increments for adult
bottles and 4 mL increments for pediatric bottles. These demarcations assist
in approximating the volume of sample added to a bottle.
Volume Designations (INDUSTRY Use)
Markings which indicate approximate volume in 5 mL increments. These
demarcations assist in approximating the volume of sample added to a bottle.
Barcode
The BacT/ALERT® 3D uses a barcode system to load bottle information.
Each BacT/ALERT® bottle has a barcode on its label. For convenience, a
portion of this barcode label may be peeled off and affixed to other records
(ex. requisition slips). When any other hospital or laboratory label is applied to
the bottle, ensure that at least one complete lengthwise portion of the
BacT/ALERT® barcode is left visible for proper scanning and that the bottle
can be easily removed from its cell.
Entering the barcode commands the BacT/ALERT® 3D system to apply the
proper algorithm to the bottle readings and to direct the bottle to the proper
drawer type:
• (Clinical Use) BacT/ALERT® MP Bottles will be directed to MB drawers
only.
• (Clinical Use) BacT/ALERT® MB Bottles will be directed to any drawer type
containing available cells.
• Non-MB bottles will be directed to non-MB drawers only.
Occasionally, a BacT/ALERT® barcode label may become unreadable to the
barcode scanner (ex. something spilled on the label, the label is covered or
torn). If this happens, generic barcode labels are available (contact your local
bioMérieux Representative). These labels begin with a G or a number and do
not contain bottle type information (ex. aerobic, anaerobic, etc.). Attach the
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generic BacT/ALERT® barcode label lengthwise on the bottle, not
horizontally around the bottle. Do not place the barcode label over the sensor
on the bottom of the bottle.
CAUTION: (Clinical Use) BacT/ALERT® MB Bottles must never
be loaded anonymously or with a Generic barcode.
Sensor
Colorimetric carbon dioxide sensor attached internally to the bottom of each
bottle.
Limitations of the Test
Refer to the package insert enclosed with the BacT/ALERT® culture bottles
for additional information.
Clinical Use
Many variables involved in blood culture testing cannot be practically
controlled to provide total confidence that results obtained are due solely to
proper or improper performance of any culture medium or detection system.
Note:
A Gram-stained smear from a negative bottle may sometimes contain a small
number of non-viable organisms that were derived from culture medium
components, staining reagents, immersion oil, or glass slides; therefore,
false-positive results are indicated.
INDUSTRY Use
Many variables involved in sample testing cannot be practically controlled to
provide total confidence that results obtained are due solely to proper or
improper performance of any culture medium or detection system.
Note:
A smear from a negative bottle may sometimes contain a small number of
non-viable organisms that were derived from culture medium components,
staining reagents, immersion oil, or glass slides; therefore, false positive
results are indicated.
Quality Control of Growth Performance
If desired, individual laboratories can perform routine quality control testing of
different lots of BacT/ALERT® blood culture bottles when used with the
BacT/ALERT® 3D System.
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Blood Culture Bottles (SA, SN, FA, FN, and PF)
Each case of BacT/ALERT® blood culture bottles (including BacT/ALERT®
SA, SN, FA, FN, and PF) is packaged with a Certificate of Conformance that
should be filed for inspection purposes. If additional QC is desired, bottles
should be seeded at approximately 400 CFU/bottle using SPS anticoagulated
fresh human blood with fresh growth of one or more of the organisms listed
on the Certificate of Conformance for each bottle type. The general
procedure is described below:
1)
Add 1–2 mL blood (Clinical Use) to the bottle(s).
2)
Using growth from solid media which is 18–24 hours old, prepare a
suspension in Tryptic Soy Broth (TSB) at 85–90% transmittance at 660
nm or a McFarland 0.5 density (108).
3)
Perform serial dilutions of this suspension as follows:
a. Dilute 1:100: Pipette 0.1 mL of suspension from Step 2 into 9.9 mL
TSB.
b. Dilute 1:100: Pipette 0.1 mL of suspension from Step 3a into 9.9 mL
TSB.
c. Dilute 1:10: Pipette 1.0 mL of dilution from Step 3b into 9.0 mL TSB
(density should then be approximately 103).
4)
Inoculate 0.4 mL of the final dilution from Step 3c into the desired adult
bottle. If using BacT/ALERT® PF, inoculate 0.2 mL of the final dilution
from Step 3c.
5)
As soon as possible, load the bottle(s). All aerobic organisms should be
positive within 48 hours and all anaerobic organisms within 72 hours.
Mycobacteria Culture Bottles (MB and MP)
Each case of BacT/ALERT® Mycobacteria culture bottles (including MP and
MB) is packaged with a Certificate of Conformance that should be filed for
inspection purposes. If additional QC is desired, refer to the instructions in the
package insert.
Culture Bottles (iAST, iNST, and iLYM)
At the time of release, each case of BacT/ALERT® culture bottles (including
iAST, iNST, and iLYM) is tested with a group of microorganisms that verify
the performance of the media. A Certificate of Conformance is issued by
bioMérieux that should be filed for inspection purposes. If additional QC is
desired, refer to the instructions in the package insert.
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BEST PRACTICES
C
About This Chapter
This chapter provides you with best practices for preventing false positives.
Note:
Information in this chapter that is intended for clinical use only or industry use
only is marked Clinical Use or INDUSTRY Use.
Chapter Contents
Best Practices for Preventing False Positives • C-2
Preventing False Positives — User • C-2
Preventing False Positives — Instrument • C-5
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Best Practices
Best Practices for Preventing False Positives
Best Practices for Preventing False Positives
Investigation into the causes of false positive rates for BacT/ALERT® 3D
systems have resulted in a list of Best Practices that, if performed, will reduce
the occurrence of false positives. In this appendix, false positives are divided
into two separate catergories: User and Instrument. Detailed descriptions of
conditions that may cause false positives are provided, along with Best
Practices and/or recommendations to prevent these conditions.
Preventing False Positives — User
This section describes conditions that may cause false positives that can be
prevented by the User.
High Amount of White Blood Cells (Clinical Use)
More than 105 leukocytes per mL of blood can be caused by hematological
disease, such as leukemia, or can be a reaction of the reticulo-endothelial
system to infections. These white blood cells can produce high amounts of
CO2. Bottles can be flagged positive by acceleration or rate algorithms.
Best Practice #1 — When no organisms are seen on the Gram stain, it is
appropriate to use the Load Bottles function to reload the bottle (see Loading
Bottles in Chapter 3 for Clinical Use, or Loading Bottles in Chapter 4 for
Industry Use). The status will default to Negative-to-Date and continue
incubation to detect growing organisms for the duration of the Maximum Test
Time. See Handling Unconfirmed Positive Bottles (False Positives) in
Chapter 3 (Clinical Use) or Chapter 4 (INDUSTRY Use).
Blood (or Sample) Volume too High
If the bottles are filled with more than 10 mL of blood, or turbid body fluid, they
can be flagged positive because of the CO2 produced by the blood cells. An
overfilled bottle may contain a blood cell content high enough to trigger
acceleration or rate algorithms.
Best Practice #2 — Do not fill the bottles with more than the volume
recommended in the package insert. See Table C-1 for recommended
volumes for each bottle type.
Table C-1: Bottle Volumes
Bottle Type
C-2
Recommended Volume
SA, SN, FA, FN
10 mL of sample
PF
Up to 4 mL of sample
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Best Practices
Table C-1: Bottle Volumes (Continued)
Bottle Type
Recommended Volume
BPA, BPN
4 mL of Leucocyte Reduced Apharesis Platelets
MP
0.5 mL of processed sample pellet
MB
3 to 5 mL of blood
iAST, iNST (INDUSTRY Use)
User validated and sample dependent
iLYM
(INDUSTRY Use)
Not more than 20 mL sample
CAUTION: Do not fill the bottles with more than the
recommended volume of sample.
Large Bottle Loading and Unloading Events
If large numbers of bottles are loaded into the BacT/ALERT® 3D, or unloaded
from the BacT/ALERT® 3D, at the same time and in the same areas, there
may be a very large heat loss within the racks. This may trigger the
acceleration or rate algorithms to erroneously flag positive.
Best Practice #3 — Limit the Loading time to 2 minutes in one area to control
the entry of room temperature bottles into the racks. Close the drawer to
allow the temperature to equilibrate before loading in that area again. Keep
the unload time to no more than 15 minutes. Close the drawer to allow the
temperature to equilibrate before unloading from that area again. You can
load bottles into different drawers. If you have four incubation modules, use
the drawers in all four incubation modules.
Temperature Changes in the Environment
The detection process of the BacT/ALERT® 3D is sensitive to temperature
changes. False positives can occur because of temperature changes. These
temperature changes can be caused by the following:
1)
Drawer of the BacT/ALERT® 3D open for more than 10 minutes for
extended workflow.
2)
Failure to close the drawer properly. Look for yellow drawer indicator
lights when leaving the room.
3)
Locating the instrument under an air conditioning or heating vent.
4)
Heating or cooling differences in the lab. For example, the lab
technicians on a different shift turn up or down the heat or air
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conditioning, there are open windows in the laboratory, or there are
drafts that are directed at the instrument.
5)
Loading too many bottles into a drawer in which bottles are already up to
temperature and incubating.
CAUTION: Bottles should never be refrigerated for transport
because some organisms are temperature sensitive.
Best Practice #4 — Ensure that temperature changes in the lab are
minimized, ensure that the drawers are properly closed when work is done,
and spread large bottle loads (unloads) across multiple drawers.
IMPORTANT:
Bottle reflectance and output of electronics varies with temperature.
Limiting temperature fluctuations reduces the false positive rate.
Anonymous Bottle Loading of BacT/ALERT ® FA and PF Bottles
When FA or PF bottles are loaded anonymously, the BacT/ALERT® 3D will
assign these bottles the default initial value threshold for the SA bottle of
3290. This default initial value threshold assignment is not changed, or recalculated, and because of the threshold differences between these bottle
types, false positives may occur.
Best Practice #5 — Avoid anonymous loading of the FA and PF bottles in a
BacT/ALERT® 3D instrument.
Bottle Not Completely Loaded into the Cell
False positives may occur when the bottle is not completely loaded into the
cell and is later pushed all the way into the cell. Figure C-1 an example of
how a cell graph appears when this occurs.
Figure C-1: Example Cell Graph
C-4
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Best Practice #6 — Always press the bottle all the way into the cell when
loading bottles.
Preventing False Positives — Instrument
This section describes causes of false positives that are due to the
instrument.
Cell Noise
Cells may exhibit electronic “noise” that is visible in the graph. There are
three main types instrument noise:
1)
The first type of noise is when cell graphs show irregular fluctuating
signals and sharp peaks and valleys, or large spikes in the graph.
Contact your bioMérieux representative to help determine if the power
supply is unstable, or if there are other electronics issues may be
isolated to specific locations and corrected. Determine if a first loaded
location is prevalent. Several bottles that were first loaded into a
particular cell, rack, or instrument may demonstrate cell noise causing
the algorithm(s) to be triggered. This is an infrequent, but typical, kind of
electro-mechanical failure mode for the BacT/ALERT® 3D.
Figure C-2: Cell Graph Example — Electronics
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2)
A second type of noise reverts to a normal graph when the bottle is
reloaded into another location (see Figure C-3). Contact your bioMérieux
representative if this occurs.
Figure C-3: Cell Graph Example — Reverts to Normal
3)
A third type of cell noise involves a characteristic signal pattern in
BacT/ALERT® 3D instruments that repeats (sometimes simultaneously
in multiple cells) and seems to “cycle” on a daily basis at particular times
(see Figure C-4). It may correlate to particular events such as
temperature, lighting, or facility power events. These cyclic “blips” trigger
a false positive event. Verify that there is a dedicated circuit for the
BacT/ALERT® 3D (for example, verify that there is not a centrifuge or a
refrigerator on the same circuit). Ensure there are no voltage drops at the
power outlet. Also follow Best Practice #4 to minimize temperature
fluctuations.
Figure C-4: Cell Graph Example — Cyclic
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High Initial Value Readings
Other false positives are due to high initial value readings in a cell that are
consistent in that cell, but normal when the positive bottle is unloaded and
reloaded into another cell (see Figure C-5). If this occurs, the cells should be
calibrated. If calibrating the cells does not correct the problem, disable and
plug the cell and contact your bioMérieux representative.
Figure C-5: Cell Graph Example — High Initial Value Reading
False Positive MP Process Bottles Flagged by Delta Algorithm (Clinical Use)
These false positives are specific to BacT/ALERT® MP Process bottles and
are triggered by the very sensitive “Delta” portion of the algorithm necessary
to detect mycobacteria that produce very small amounts of CO2. These false
positives may increase in number when calibration has drifted, or when cells
have been calibrated at a temperature lower or higher than what is
recommended, or if mycobacteria specimen processing is not consistent.
Perform cell calibration to unload MP Process bottles sequentially, and to
calibrate all cells as they are unloaded on a daily basis, until the process is
complete for all cells. Calibrate no more than three cells at a time to maintain
temperature and load MP Process bottles ONLY in Mycobacterial incubation
modules, if possible, to avoid temperature losses created by blood culture
loading events in drawers of a mixed blood/MB incubation module. Follow
Best Practice #4 to minimize temperature fluctuations.
IMPORTANT:
Bottle reflectance and output of electronics varies with temperature.
Limiting temperature fluctuations reduces the false positive rate.
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A standard method of processing mycobacteria specimens also helps to
prevent false positives. The most critical steps for mycobacteria specimen
processing are:
1)
Maintain a consistent sample size of 10 mL by adding saline to small
samples and splitting larger samples. This avoids too harsh or too little
decontamination when reagents are pre-measured in 10 mL aliquots.
2)
Decant liquid completely after centrifugation.
3)
Re-suspend the pellet in sterile 0.067M phosphate buffer, pH 6.8.
4)
Establish a processing method that consistently results in a sample with
a neutral pH.
5)
Use no more than the recommended 0.5 mL Mycobacterial Antibiotic
Supplement (MAS) per bottle.
These steps will help to minimize the BacT/ALERT® MP culture bottle false
positive rate while helping to maximize mycobacterium recovery rates. For
additional information, see the best practices for mycobacteria specimen
processing outlined in the Customer Training Manual: Mycobacterial Testing
with BacT/ALERT® Systems and Media, P/N 60-00467.
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GLOSSARY
Accession
(Clinical Use) A sample collected from a patient during a
single event.
Accession ID
(Clinical Use) Synonym for accession number.
Accession Number
(Clinical Use) A number that uniquely identifies the sample
or patient specimen.
Anonymous Bottle
A bottle that has been placed in an Incubation Module
without going through the formal bottle loading process.
Bottles loaded anonymously must eventually be identified
and assigned a bottle ID.
Audible Alarm
Specified by the user to flag positive bottle(s), instrument
failure, or an operator error.
Audit Trail
Record of activities and other related information (ex. bottle
events).
BacT/ALERT®
bioMérieux’s automated instrumentation to screen test
specimens (Clinical Use)/samples (INDUSTRY Use) for the
presence of microbes.
BacT/LINK®
BacT/LINK® is software for interfacing a BacT/ALERT®
system on an LIS.
Barcode Reader Aperture
Houses a removable Barcode Reader. Used to scan
accession numbers (Clinical Use)/Sample IDs (INDUSTRY
Use) or bottle barcode labels and to identify bottles when
loading or unloading.
Bottle Graph
A line graph that plots the microbial activity in a culture over
time.
Bottle ID
Usually a barcode that uniquely identifies a single culture
bottle.
Bottle Type
BacT/ALERT® bottle with a specific type of culture medium
(ex. BacT/ALERT® SA - Clinical Use, or BacT/ALERT®
iAST - INDUSTRY Use).
Cell
Holds and monitors each culture bottle. Each cell is
numbered from 1 through 60.
Cell Flag
Secures bottles in cells. Aids in cell diagnostics and with
bottle loading and unloading determinations.
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Glossary
Cell Indicator Light
Illuminates to show the location of positive, negative or
anonymous bottles as well as to show where new bottles
should be placed/removed. A cell indicator light is adjacent
to each cell.
Check Box
Textless YES/NO prompt. A check in the box equals YES
while no check equals NO.
CLSI
Clinical and Laboratory Standards Institute
Combination Module
Unit which contains the User Interface capability for the
BacT/ALERT® 3D bottle handling system and has two
incubation drawers built into the same module. The
Combination Module also controls up to three Incubation
Modules.
Controller Module
Unit which contains the User Interface capability for the
BacT/ALERT® 3D bottle handling system and controls up to
six Incubation Modules.
Controller Module
Communications Port
Connects the Controller Module to an Incubation Module.
CPU 1
Connector fitting used to connect the data management
system computer to the Controller Module or to connect two
Controller Modules together.
CPU 2
Connector fitting used to connect two Controller Modules
together.
Dimmed
BacT/ALERT® 3D disables (“dims” or “grays”) user interface
items (ex. menu items, buttons, text fields) that are
unavailable due to security restrictions or due to the current
context of the software. Disabled user interface items are
not selectable.
Disabled
Describes a user interface item (ex. button, text entry field)
that is not currently selectable by the user. Disabled user
interlace items are usually displayed in gray.
Drawer
In the Incubation Module, each drawer contains three racks
(60 cells in total) for a drawer capacity of 60 culture bottles.
The four drawers of each Incubation Module are labeled A,
B, C, or D. In the Controller Module, a drawer located below
the barcode reader aperture in the front of the unit affords
access to the Controller Keyboard and Quick Reference
Cards.
Drawer Indicator Light —
Yellow
Illuminates whenever that Incubation Module drawer is
open and turns off when the drawer is closed. Flashes if the
drawer remains open too long.
Glossary-2
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Drawer Indicator Light — Green
Illuminates if that Incubation Module drawer or its cells are
involved in the operation the user has selected. Flashes if
the drawer remains open too long.
Enabled
The opposite of disabled.
Field
Refers to an area on the screen where variable text is
displayed.
Generic Bottle ID
A Bottle ID that does not indicate one of the pre-defined
bottle types.
Grayed
See dimmed. Refers to user interface items that are not
selectable.
Hospital ID
(Clinical Use) Text string that uniquely identifies a patient.
Icons
System functions or buttons appearing on-screen in pictorial
form.
Incubation Module
Unit containing the four incubation drawers to hold and
incubate BacT/ALERT® bottles.
Indicator Light or Lamp
An identifier for a cell or drawer that lights up to indicate
location of a particular bottle or bottle-type. On drawers,
indicator lamps are adjacent to the drawer handle. Within
drawers, they are located on the racks adjacent to the
indicated cell.
Incubation Module
Communications Ports (6)
Each port connects an Incubation Module to the Controller
Module.
Keyboard
Provides a means of input for:
(Clinical Use) Bottle IDs, Accession Numbers, Hospital
IDs, and Names; or
(INDUSTRY Use) Bottle IDs, Sample IDs, User Defined 1,
User Defined 2 and User Defined 3 fields.
Also serves as a backup input device should the
Touchscreen or Barcode Reader fail.
Laboratory Information System
Name for a customer maintained computer (usually a
mainframe) that is used to collect information from
laboratory instruments. Abbreviated LIS.
LIS
Acronym for Laboratory Information System.
LIS Port (Diagnostic)
Connector fitting on the Controller Module and Combination
Module to connect to a Laboratory Information System.
Module
A component or subset of a system.
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Glossary
Monitor
A device upon which video images are displayed. In the
BacT/ALERT® 3D system, there is a monitor located on the
Controller Module and another as part of the bioMérieux
data management computer system.
Negative
Describes a culture bottle that has no evidence of microbial
activity.
Negative-to-date
Describes a culture bottle that is under test and negative so
far (pending).
NIST
National Institute of Standards and Technology.
Operator Panel
The Operator Touchscreen allowing user interface with all
instrument-related functions. Selections and other input can
be made by simply touching the Operator Panel.
Positive
Describes a culture bottle that has evidence of microbial
activity.
Power Connector
A fitting to attach the Alternating Current (AC) power cord.
Printer Port
Printer interface port (parallel) on the Controller Module or
Combination Module for producing hard copy reports and
graphs.
Prompt
A text entry field that appears on a screen. The primary
purpose for a prompt is for data entry. Read-only prompts
are not selectable and are dimmed. User entries into a
prompt are checked for validity according to the value range
internally assigned for that prompt.
Quick Reference Card
Outlines instructions for system operation and describes
specific error codes. Located in the drawer beneath the
barcode reader aperture.
Rack
Contains 20 cells, each of which can hold and monitor an
individual culture bottle. Racks gently rock to agitate bottles.
Reference Thermometer
See Thermometer.
Scroll Button
A Controller Module touchscreen button that allows
selection of numerical or symbolic values by pressing
arrows above or below a window which shows the selected
character. While an arrow is being pressed, the center
portion shows one character from among the available list
of choices.
Select
To choose a screen option with a pointing device.
Select Configuration
A BacT/ALERT® 3D configuration where the Controller
Module or Combination Module is connected to neither an
bioMérieux data management computer nor an LIS.
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Glossary
SelectLink Configuration
A BacT/ALERT® 3D configuration where the Controller
Module or Combination Module is connected directly to an
LIS.
Signature Configuration
A BacT/ALERT® 3D configuration where the Controller
Module is connected directly to an bioMérieux data
management computer.
Slidebar Switch
A rectangular Controller Module touchscreen device which
moves between ON and OFF (symbolized by 1 and 0,
respectively) when the corresponding end of the rectangle
is touched.
Thermometer
An independent, NIST-traceable temperature monitoring
device normally located in Drawer A or B of an Incubation
Module.
Toggle Button
A Controller Module screen button that becomes active
(appears to be pressed) after the corresponding screen
area is touched, and continues to be active until it is
touched again.
Unconfirmed Positive
Describes a bottle the system determined to be positive but
no confirmation is available by Gram stain or subculture.
Also referred to as a false positive.
UPS
Uninterruptible Power Supply (battery backup).
USB Flash Drive
Flash memory storage device integrated with a Universal
Serial Bus (USB).
User Interface
The methods by which a computer communicates with the
user.
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Glossary
Glossary-6
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INDEX
Numerics
INDUSTRY Use 6-14
attaching bottle IDs to an accession number
Clinical Use 5-14
21 CFR Part 11 Mode 10-1
accessing the audit trail 10-20
adding a user 10-13
audit trail 10-18
change password 10-8
change password errors 10-9
clearing a user password 10-16
clearing more than one user password 10-17
configuring users 10-12
deleting a user 10-15
deleting more than one user 10-16
inactivity timeout 10-7
log in/out of system 10-2
logging in 10-5
logging in for the first time 10-2
logging out 10-12
login errors 10-7
user list 10-13
wrong password alert 10-8
wrong user alert 10-8
A
accession
attaching to a hospital ID
Clinical Use 5-16
moving from one hospital ID to another
Clinical Use 5-17
add user screen (21 CFR Part 11 mode) 10-14
additional supplies 1-3
alarm
priority 7-5
setting 7-3
terminating an instrument 7-5
alerts (21 CFR Part 11 mode)
wrong password 10-8
wrong user 10-8
anchor display/scroll buttons 2-29
anonymous bottle indicated in empty cell 9-39
attaching accession numbers to a hospital ID
Clinical Use 5-16
attaching bottle IDs to a sample ID
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attaching sample IDs to a User Defined 3
INDUSTRY Use 6-16
audit trail
accessing 10-20
events 10-18
B
background color, monitor
Clinical Use 3-4
INDUSTRY Use 4-4
backup drive
USB port 2-9, 2-18
zip 2-9, 2-18
backups
initiating/scheduling 7-7
barcode cannot be scanned 9-40
barcode reader
description 2-9
doesn’t beep 9-40
location 2-9
barcode scanner
entering data
Clinical Use 3-10
INDUSTRY Use 4-10
basic functions
Clinical Use 3-1
INDUSTRY Use 4-1
best practices for bottle handling C-1, C-2
bottle
attaching ID to a sample ID
INDUSTRY Use 6-14
attaching ID to an accession
Clinical Use 5-14
broken See spills.
counts
Clinical Use 3-5
INDUSTRY Use 4-5
description B-2
diagram B-2
display readings
Index-1
Index
Clinical Use 3-34
INDUSTRY Use 4-34
loading procedure
Clinical Use 3-11
INDUSTRY Use 4-11
lodged in cell 9-39
moving from one accession number to another
Clinical Use 5-15
moving from one sample number to another
INDUSTRY Use 6-15
quality control B-1
relocation procedure 8-21
selecting
Clinical Use 5-3, 5-4
INDUSTRY Use 6-3, 6-4
unconfirmed positive handling
Clinical Use
INDUSTRY Use
unloading procedure
Clinical Use 3-16
INDUSTRY Use 4-16
viewing/printing graphs
Clinical Use 3-31
INDUSTRY Use 4-31
bottle handling
best practices C-1
bottle quality control B-1
bottle readings screen, diagram
Clinical Use 3-35
INDUSTRY Use 4-34
bottle type
entry tips
Clinical Use 3-13
INDUSTRY Use 4-13
scroll button
Clinical Use 3-17
INDUSTRY Use 4-17
button
accession number selection
Clinical Use 5-14
add user (21 CFR Part 11 mode) 10-13
adjust X scale
Clinical Use 3-33
INDUSTRY Use 4-33
adjust Y scale
Clinical Use 3-33
INDUSTRY Use 4-33
anchor display top or bottom 2-29
Index-2
anchor display/scroll 2-29
backup management 7-8
Clinical Use 3-22
INDUSTRY Use 4-22
bottle processing/customization
Clinical Use 3-22
INDUSTRY Use 4-22
bottle readings
Clinical Use 3-33
INDUSTRY Use 4-33
bottle type scroll
Clinical Use 3-17
INDUSTRY Use 4-17
calibrate cell 8-26
Clinical Use 3-22
INDUSTRY Use 4-22
calibrate module temperature 8-23, 8-24
Clinical Use 3-22
INDUSTRY Use 4-21
calibration history 7-25
calibration report 7-22
cancel 2-28
cell scroll
Clinical Use 3-32
INDUSTRY Use 4-32
change password 7-5
Clinical Use 3-22
INDUSTRY Use 4-22
change password (21 CFR Part 11 Mode) 10-4
change password (21 CFR Part 11 mode) 10-3,
10-8
check 2-28
clear password (21 CFR Part 11 mode) 10-13
column selection scroll 7-16, 7-17, 7-18, 7-19,
7-20, 7-21
configure users (21 CFR Part 11 mode) 10-12
Clinical Use 3-22
INDUSTRY Use 4-22
data transfer
Clinical Use 5-14
INDUSTRY Use 6-14
delete user (21 CFR Part 11 mode) 10-13, 10-15
description 2-28
display report 1 (load report screen)
Clinical Use 3-24
INDUSTRY Use 4-24
display report 2 (status report screen)
Clinical Use 3-24
INDUSTRY Use 4-24
display report 3 (unload report screen)
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Index
Clinical Use 3-24
INDUSTRY Use 4-24
drawer scroll
Clinical Use 3-32
INDUSTRY Use 4-32
edit
accession number to hospital ID relationships
Clinical Use 5-13
bottle ID to accession number relationships
Clinical Use 5-13
bottle ID to sample ID relationships
INDUSTRY Use 6-13
bottle type scroll
Clinical Use 5-7
INDUSTRY Use 6-7
cell contents
Clinical Use 3-22
INDUSTRY Use 4-22
data relationships
Clinical Use 3-22
INDUSTRY Use 4-22
hospital ID to patient name relationships
Clinical Use 5-13
maximum test time scroll
Clinical Use 5-7
INDUSTRY Use 6-7
sample ID to user defined 3 relationships
INDUSTRY Use 6-13
test result
Clinical Use 5-9
INDUSTRY Use 6-9
user defined 3 to user defined 1/2 relationships
INDUSTRY Use 6-13
edit data relationships
Clinical Use 5-12
INDUSTRY Use 6-12
enable/disable hardware
Clinical Use 3-22
INDUSTRY Use 4-21
enable/disable module, drawer, rack, or cell 8-18
enabled vs disabled 2-28
end scroll 2-29
exit software 8-12
graph bottle readings
Clinical Use 5-10
INDUSTRY Use 6-10
home scroll 2-29
incubation module scroll
Clinical Use 3-32
INDUSTRY Use 4-32
incubation period scroll 7-2
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line scroll up or down 2-29
login (21 CFR Part 11 Mode) 10-2
manual backup 7-8
manual request test orders
Clinical Use 3-39
INDUSTRY Use 4-39
manual send test results
Clinical Use 3-39
INDUSTRY Use 4-39
next screen 2-28
page scroll up or down 2-29
preview report 7-16, 7-19
previous screen 2-28
primary sort scroll 7-16, 7-17, 7-19, 7-20
print graph
Clinical Use 3-33
INDUSTRY Use 4-33
report 7-21, 7-25
Clinical Use 3-22
INDUSTRY Use 4-22
report configuration 7-14
report label entry 7-10
restart incubation module 8-16
sample ID selection
INDUSTRY Use 6-14
scroll 2-29
secondary sort scroll 7-16, 7-17, 7-18, 7-19, 7-
20, 7-21
select bottle to edit/graph
Clinical Use 3-22
INDUSTRY Use 4-22
set audible alarm options
Clinical Use 3-22
INDUSTRY Use 4-22
set date/time
Clinical Use 3-21
INDUSTRY Use 4-21
set maximum test time
Clinical Use 3-22
INDUSTRY Use 4-22
unload buttons
Clinical Use 3-3, 3-5
INDUSTRY Use 4-3, 4-5
view incubation module information
Clinical Use 3-22
INDUSTRY Use 4-22
Index-3
Index
C
calibrate cell screen, diagram 8-27
calibrate module temperature screen, diagram
8-23
calibration
incubation or combination module temperature 8-
25
instrument cell 8-25
locating cells which need 8-26
calibration data
printing 7-21
viewing 7-21
calibration history
printing 7-25
viewing 7-25
cancel button 2-28
carbon dioxide detection. See principle of
detection
cell
calibration procedure 8-25
description
combination module 2-18
incubation module 2-22
enable/disable 8-18
indicator light 2-18, 2-23
viewing readings 8-26
diagram
front view 2-16, 2-17
display switch assembly 2-17, 2-20
drawer 2-18
drawer restart procedure 8-15
environmental requirements 2-21
setting optimal temperature of 8-24
specifications 2-20
USB port 2-18
zip drive 2-18
configuring report contents 7-13
load report configuration screen
Clinical Use 7-16
INDUSTRY Use 7-19
section break checkboxes 7-16, 7-17, 7-19, 7-
20
status report configuration screen
Clinical Use 7-17
INDUSTRY Use 7-20
unload report configuration screen
Clinical Use 7-18
INDUSTRY Use 7-21
configuring report screens 7-9
Configuring Users (21 CFR Part 11 Mode)
user list 10-13
chapter organization 1-6
configuring Users (21 CFR Part 11 Mode) 1012, 10-13
add user screen 10-14
adding a user 10-13
clear password screen 10-16
clearing a user password 10-16
clearing more than one user password 10-17
delete user screen 10-15
deleting a user 10-15
deleting more than one user 10-16
check button 2-28
controller module
cell calibration report screen, diagram 7-23
cell flag 2-18, 2-23
cell reading indicator 8-27
changing maximum test time. See editing
maximum test time.
clear password screen (21 CFR Part 11 mode)
10-16
codes
(1-99) 9-3
(710-820) 9-24
(901-961) 9-27
status determination
Clinical Use 5-11
INDUSTRY Use 6-11
combination module
adjusting temperature 8-21
backup drive 2-16
Index-4
accessing the keyboard 2-11
backup drive 2-9
diagram
back view 2-12
front view 2-9
environmental requirements 2-15
shutdown/startup procedure 8-10
specifications 2-15
USB port 2-10
Zip® drive 2-10
conventions
typographic 1-7
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usage 1-7
D
Clinical Use 5-13
INDUSTRY Use 6-13
edit test result
data entry field
size limits
Clinical Use 3-9
INDUSTRY Use 4-9
delete user screen (21 CFR Part 11 mode) 1015
disinfection
spill cleanup 8-3
spills onto the instrument
Clinical Use 8-4
INDUSTRY Use 8-5
spills within the instrument 8-5
display bottle readings
Clinical Use 3-34
INDUSTRY Use 4-34
display switch assembly
combination module 2-17
drawer
combination module 2-18
controller module 2-10
enable/disable 8-18
incubation module 2-22
indicator light 2-19, 2-23
keyboard 2-10
drawers, mycobacteria (Clinical Use) 2-8
E
edit
load status
Clinical Use 5-7
INDUSTRY Use 6-7
edit bottle detail screen
fields
Clinical Use 5-5
INDUSTRY Use 6-5
edit bottle detail screen, diagram
Clinical Use 5-5
INDUSTRY Use 6-5
edit cell contents screen, diagram
Clinical Use 5-3
INDUSTRY Use 6-3
procedure
Clinical Use 5-9
INDUSTRY Use 6-9
edit test result screen, diagram
Clinical Use 5-9
INDUSTRY Use 6-9
editing
accession number to hospital ID relationship
procedure (Clinical Use) 5-16
screen (Clinical Use) 5-16
bottle ID to accession number relationship
procedure (Clinical Use) 5-14
screen (Clinical Use) 5-14
bottle ID to sample ID relationship
procedure (INDUSTRY Use) 6-14
screen (INDUSTRY Use) 6-14
hospital ID to patient name relationship
procedure (Clinical Use) 5-17
screen (Clinical Use) 5-17
maximum test time
Clinical Use 3-15
INDUSTRY Use 4-14
report content 7-13
report labels 7-10
sample ID to User Defined 3 relationship
procedure (INDUSTRY Use) 6-16
screen (INDUSTRY Use) 6-16
User Defined 3 to User Defined 1/2 relationship
procedure (INDUSTRY Use) 6-17
screen (INDUSTRY Use) 6-17
electrical and electronic recycling 2-7
electrical warnings 2-4
enable/disable hardware 8-18
enable/disable module, drawer, rack, or cell
screen, diagram 8-19
entering report labels 7-10
entering text into a data entry field
Clinical Use 3-10
INDUSTRY Use 4-10
environmental requirements
combination module 2-21
controller module 2-15
edit data relationships screen, diagram
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Index-5
Index
incubation module 2-25
electrical and electronic recycling 2-7
error codes, operator (901-961) 9-27
Health Insurance and Portability and
Accountability Act (HIPAA) requirements 2-3
errors
bottle problems 9-39
user output device problems 9-39
errors, nonsoftware 9-39
exporting
test data
Clinical Use 3-24
INDUSTRY Use 4-24
external monitor
setup 8-14
F
false positives
preventing C-2
false positives. See unconfirmed positives.
fault codes (1-99) 9-3
faults, viewing
Clinical Use 3-6
INDUSTRY Use 4-6
field, text entry 2-30
finding topics 1-6
full system shutdown (Signature only) 8-13
full system startup (Signature only) 8-14
function buttons
setup screen 3-21, 4-21
G
graph bottle readings screen, diagram
Clinical Use 3-33
INDUSTRY Use 4-33
graphs
Clinical Use 3-31
INDUSTRY Use 4-31
growth performance
quality control B-4
H
I
icon 2-28
backup in progress 7-9
calibration staircase 8-27
instrument
Clinical Use 3-4
INDUSTRY Use 4-4
instrument with fault codes 9-3
load bottles
Clinical Use 3-12
INDUSTRY Use 4-12
padlock 7-6
unload bottles
Clinical Use 3-17
INDUSTRY Use 4-17
view algorithm/polynomial
Clinical Use 5-10
INDUSTRY Use 6-10
view cell location
Clinical Use 5-8
INDUSTRY Use 6-8
view first loaded time
Clinical Use 5-8
INDUSTRY Use 6-8
view how determined/positivity index
Clinical Use 5-11
INDUSTRY Use 6-11
view last unloaded time
Clinical Use 5-8
INDUSTRY Use 6-8
view test result
Clinical Use 5-9
INDUSTRY Use 6-9
view test time
Clinical Use 5-8
INDUSTRY Use 6-8
view time of last bottle reading
Clinical Use 5-8
INDUSTRY Use 6-8
inactivity timeout (21 CFR Part 11 mode) 10-7
hardware
maintenance 8-2
overview 2-8
hazards and precautions
Index-6
incubation module
adjusting temperature 8-21
diagram
back view 2-23
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front view 2-22
environmental requirements 2-25
restart procedure 8-15
setting optimal temperature of 8-24
specifications 2-25
viewing information for 8-29
indicator light
cell 2-18, 2-23
drawer 2-19, 2-23
Installation
instrument
INDUSTRY Use 2-26
installation instructions
INDUSTRY Use 2-26
instrument fault codes 9-3
instrument icon
Clinical Use 3-4
INDUSTRY Use 4-4
instrument status codes 9-24
internal monitor
restore settings 8-14
international character
entering A-4
entry A-2
table A-2
Introduction
chapter organization 1-6
finding topics 1-6
K
keyboard
accessing the controller module 2-11
description (combination module) 2-18
drawer (controller module) 2-10
entering text into a data entry field
Clinical Use 3-10
INDUSTRY Use 4-10
using in place of the operator panel 8-8
L
Clinical Use 7-16
INDUSTRY Use 7-19
loading bottles
Clinical Use 3-11
INDUSTRY Use 4-11
locating a cell which failed calibration 8-26
log In/Out of System (21 CFR Part 11 Mode)
change password 10-8
change password button 10-3, 10-4
change password errors 10-9
confirm password field 10-4
inactivity timeout 10-7
logging in 10-5
logging in for the first time 10-2
logging out 10-12
login button 10-2
login errors 10-7
main screen while logged in 10-5
main screen while logged out 10-2
new password field 10-4
user login screen 10-3
log In/out of system (21 CFR Part 11 mode) 102
M
main screen
diagram
Clinical Use 3-3
INDUSTRY Use 4-3
diagram (load mode)
Clinical Use 3-12
INDUSTRY Use 4-12
diagram (unload mode)
Clinical Use 3-17
INDUSTRY Use 4-16
maintenance
hardware 8-2
preventative 8-2
software 8-15
system 8-1
Manual
light-emitting diode (LED) 2-4
LIS, sending and receiving information
Clinical Use 3-39
INDUSTRY Use 4-39
load report configuration screen, diagram
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standard symbols B-4, C-2, C-4
manual
standard symbols B-4, C-2, C-4
maximum test time
changing for an individual bottle
Clinical Use 3-15
Index-7
Index
INDUSTRY Use 4-14
setting defaults 7-2
screens 2-27
optimal temperature setting 8-24
mode, 21 CFR Part 11 10-1
module
P
enable/disable 8-18
password
monitor
changing 7-5
entry
Clinical Use 3-20
INDUSTRY Use 4-20
background color
Clinical Use 3-4
INDUSTRY Use 4-4
moving a bottle ID association from one
accession number to another
Clinical Use 5-15
power down procedure . See Controller Module,
reboot/shutdown procedure
power up procedure. See Controller Module,
startup procedure
moving a bottle ID association from one sample
number to another
INDUSTRY Use 6-15
preventative maintenance 8-2
safety precautions and procedures 8-2
moving a sample ID to User Defined 3
INDUSTRY Use 6-17
preventing false positives C-2
moving an accession number association from
one hospital ID to another
Clinical Use 5-17
printing
previous screen button 2-28
principle of detection 2-4
calibration data 7-21
calibration history 7-25
test data
Clinical Use 3-24
INDUSTRY Use 4-24
using the print screen function
Clinical Use 3-24
INDUSTRY Use 4-24
moving bottles. See relocating bottles.
mycobacteria drawers (Clinical Use) 2-8
mycobacterial testing
disinfection procedures
Clinical Use 8-4
INDUSTRY Use 8-5
installation procedures and special requirements
11-4
safety features 11-8
spill cleanup 8-3
system description 11-2
system startup 11-6
theory of operation 11-7
printing bottle graphs
Clinical Use 3-31
INDUSTRY Use 4-31
Q
quality control of growth performance B-4
blood culture bottles B-5
culture bottles B-5
mycobacteria culture bottles B-5
N
next screen button 2-28
nonsoftware errors 9-39
O
operator error codes 9-27
operator panel
description (combination module) 2-17
description (controller module) 2-9
quick reference card 2-10
R
rack
enable/disable 8-18
rebooting computer. See Controller Module,
reboot/shutdown procedure.
rebooting computer. See Controller Module,
Index-8
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Index
startup procedure.
recycling
electrical and electronic 2-7
reference card. See quick reference card.
relocating bottles 8-21
report configuration screen, diagram
load report
Clinical Use 7-16
INDUSTRY Use 7-19
status report
Clinical Use 7-17
INDUSTRY Use 7-20
unload report
Clinical Use 7-18
INDUSTRY Use 7-21
report field descriptions 7-12
report label entry screen, diagram 7-11
report selection screen, diagram 7-10, 7-22, 725
reports
configuring content 7-13
entering labels 7-10
reportable fields 7-12
requesting bottle demographics from LIS
Clinical Use 3-39
INDUSTRY Use 4-39
requirements
21 CFR Part 11 2-3
HIPAA 2-3
S
safety precautions and procedures 8-2
sample ID
attaching to a User Defined 3
INDUSTRY Use 6-16
moving from one User Defined 3 to another
INDUSTRY Use 6-17
samples
hazards and precautions 1-8, B-4, C-2, C-4
screen
add user (21 CFR Part 11 mode) 10-14
backup management 7-8
bottle readings
Clinical Use 3-35
INDUSTRY Use 4-34
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calibrate cell 8-27
calibrate module temperature 8-23
cell calibration report 7-23
change maximum test time (individual bottle)
Clinical Use 3-15
INDUSTRY Use 4-15
change password 7-6
clear password (21 CFR Part 11 mode) 10-16
colors determined by configuration 2-3
delete user (21 CFR Part 11 mode) 10-15
edit accession number to hospital ID relationships
(Clinical Use) 5-16
edit bottle detail
Clinical Use 5-5
INDUSTRY Use 6-5
edit bottle ID to accession number relationships
(Clinical Use) 5-14
edit bottle ID to accession number relationships
(INDUSTRY Use) 6-14
edit cell contents
Clinical Use 5-3
INDUSTRY Use 6-3
edit data relationships
Clinical Use 5-13
INDUSTRY Use 6-13
edit hospital ID to patient name relationships
(Clinical Use) 5-17
edit sample ID to User Defined 3 relationships
(INDUSTRY Use) 6-16
edit test result
Clinical Use 5-9
INDUSTRY Use 6-9
edit User Defined 3 to User Defined 1/2
relationships (INDUSTRY Use) 6-17
enable/disable module, drawer, rack, or cell 8-19
graph bottle readings
Clinical Use 3-33
INDUSTRY Use 4-33
load report configuration
Clinical Use 7-16
INDUSTRY Use 7-19
main
Clinical Use 3-3
INDUSTRY Use 4-3
main (load mode)
Clinical Use 3-12
INDUSTRY Use 4-12
main (unload mode)
Clinical Use 3-17
INDUSTRY Use 4-16
Index-9
Index
main screen while logged out (21 CFR Part 11
Mode) 10-2
mains screen while logged in (21 CFR Part 11
Mode) 10-5
report label entry 7-11
report selection 7-10, 7-14, 7-22, 7-25
select bottle to edit/graph
Clinical Use 3-32
INDUSTRY Use 4-31
set audible alarm options 7-4
set maximum test time 7-2
setup
Clinical Use 3-20
INDUSTRY Use 4-20
status report configuration
Clinical Use 7-17
INDUSTRY Use 7-20
unload report configuration
Clinical Use 7-18
INDUSTRY Use 7-21
user configuration (21 CFR Part 11 mode) 10-13
user login (21 CFR Part 11 mode) 10-3
view cell status
Clinical Use 3-7
INDUSTRY Use 4-7
view incubation module information 8-30
screen ID numbers 2-27
scroll button 2-29
select bottle to edit/graph screen, diagram
Clinical Use 3-32
INDUSTRY Use 4-31
selecting a bottle
via edit cell contents screen
Clinical Use 5-3
INDUSTRY Use 6-3
via select bottle to edit/graph screen
Clinical Use 5-4
INDUSTRY Use 6-4
sending test results to LIS
Clinical Use 3-39
INDUSTRY Use 4-39
set maximum test time screen, diagram 7-2
setting optimal temperatures 8-24
setting system date/time 8-17
setup instructions
INDUSTRY Use 2-26
setup screen
Index-10
accessing
Clinical Use 3-20
INDUSTRY Use 4-20
function buttons 3-21, 4-21
setup screen, diagram
Clinical Use 3-20
INDUSTRY Use 4-20
shutdown/startup procedure. See Controller
Module, shutdown/startup procedure.
shutting down the system (Signature only) 8-13
slidebar switch 2-29
edit load status
Clinical Use 5-7
INDUSTRY Use 6-7
software
configuration 7-1
configuration options 2-2
background color
Clinical Use 3-4
INDUSTRY Use 4-4
maintenance 8-15
software overview 2-27
specifications
combination module 2-20
controller module 2-15
incubation module 2-25
spills
cleanup 8-3
onto instrument
Clinical Use 8-4
INDUSTRY Use 8-5
within instrument 8-5
starting up the system (Signature only) 8-14
status codes, instrument (710-820) 9-24
status determination codes
Clinical Use 5-11
INDUSTRY Use 6-11
status report configuration, diagram
Clinical Use 7-17
INDUSTRY Use 7-20
system
maintenance 8-1
monitoring
Clinical Use 3-3
INDUSTRY Use 4-3
setting date/time 8-17
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Index
setup instructions
INDUSTRY Use 2-26
troubleshooting 9-1
U
unconfirmed positives
Clinical Use 3-19
INDUSTRY Use 4-19
system backup
USB flash drive 7-7
zip drive 7-7
unload report configuration, diagram
Clinical Use 7-18
INDUSTRY Use 7-21
system configuration
Select 2-2
SelectLink 2-3
Signature 2-3
unloading bottles
Clinical Use 3-16
INDUSTRY Use 4-16
system shutdown. See full system shutdown.
unresponsive operator panel 9-41
system startup. See full system startup.
UPS
orientation diagram 8-9
T
usage conventions 1-7
temperature
USB flash drive
adjusting incubation or combination module 8-21
setting optimal 8-24
system backup 7-8
USB port
test data
combination module 2-16
controller module 2-10
viewing, printing and exporting
Clinical Use 3-24
INDUSTRY Use 4-24
user configuration screen 10-13
user list (21 CFR Part 11 mode) 10-13
text entry field
description 2-30
size limits
Clinical Use 3-9
INDUSTRY Use 4-9
theory of operation 2-4
thermometer
location 2-19, 2-22
tips
backup 7-8
entering bottle type
Clinical Use 3-13
INDUSTRY Use 4-13
typographic conventions 1-7
name and titles 1-7
press 1-7
procedural steps 1-7
references 1-7
select 1-8
user input
literal use 1-8
placeholder 1-8
warnings and cautions 1-8
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user output device problems 9-39
V
view cell status screen
diagram
Clinical Use 3-7
INDUSTRY Use 4-7
view incubation module information screen,
diagram 8-30
viewing
bottle counts
Clinical Use 3-5
INDUSTRY Use 4-5
bottle data
Clinical Use 3-23
INDUSTRY Use 4-23
bottle graphs
Clinical Use 3-31
INDUSTRY Use 4-31
calibration data 7-21
calibration history 7-25
faults
Clinical Use 3-6
INDUSTRY Use 4-6
Index-11
Index
incubation module information 8-29
test data
Clinical Use 3-24
INDUSTRY Use 4-24
Z
Zip® drive
combination module 2-16
controller module 2-10
Index-12
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