User Manual - Frank`s Hospital Workshop
User Manual
95269
(01/2010)
bioMérieux, Inc.
Box 15969
Durham, North Carolina 27704-0969 / USA
Tel. (1) 800-682-2666
EC
[03]
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, and MB/BacT are used, pending,
and/or registered trademarks of bioMérieux in the USA and other countries.
CLSI is a registered trademark of Clinical and Laboratory Standards Institute,
Inc.
PSC and Quickscan are a registered trademarks of PSC, Inc.
Zip is a registered trademark of Iomega Corporation.
No part of this publication may be reproduced, transmitted, transcribed,
stored in a retrieval system, or translated into any language (human or
computer) in any form, or by any means whatsoever, without the prior
express written permission of bioMérieux, Inc.
© 2010 bioMérieux, Inc. All rights reserved.
Warranty
Seller, bioMérieux, Inc., warrants the BacT/ALERT® 3D 60 instrument (the
“instrument”) to the original purchaser for a period of one (1) year after date of
installation against defects in material and workmanship and defects arising
from failure to conform to specifications applicable on the date of installation.
Seller further agrees to correct, either by repair, or, at its election, by
replacement, any such defect found on examination to have occurred, under
normal use and service, during such one (1) year period, provided Seller is
promptly notified in writing upon discovery of such defect.
Seller shall not be liable under this Warranty for any defect arising from abuse
of the system, failure to operate and maintain the system in accordance with
the documentation included with the Instrument, including repair service,
alteration or modification of the system by any person other than service
personnel of bioMérieux, Inc., or Seller; or use of modified, changed, or
previously used disposables.
The Warranty of Seller set forth above and the obligations and liabilities of
Seller thereunder are exclusive and in lieu of all other remedies or warranties,
express or implied, arising by law or otherwise, with respect to the system
delivered hereunder (including without limitation any obligation of Seller with
respect to merchantability, fitness for particular purpose, and consequential
damages, and whether or not occasioned by Seller’s negligence).
This Warranty shall not be extended or altered except by written instrument
signed by Seller.
All of the product elements in the Seller’s Instrument and the total instrument
are warranted to be new or equivalent to new for the full product warranty
period of one year. Disposables and replacement items with a normal life
expectancy of less than one (1) year, such as batteries and bulbs, are
excluded from this warranty.
STANDARD SYMBOLS
The following table presents symbols that may appear in the instructions for
use or on the instrument, package inserts, or packaging.
CE-Marking of Conformity
Consult Instructions for Use
Use by
Manufacturer
Date of manufacture
Contains sufficient for <n> tests
Keep dry
Fragile, handle with care
Caution, consult accompanying documents
Biological risks
Electric shock warning
Standard Symbols
Radiation warning
Potential pinch-point warning
Laser
Temperature limitation
Upper limit of temperature
Lower limit of temperature
In Vitro Diagnostic Medical Device
Batch code
Authorized Representative in the European Community
Catalog number
Serial Number
Do not reuse
Recyclable
Separate collection for waste electrical and electronic
equipment
Standard Symbols
Very toxic
Corrosive
Sodium azide
Irritant
Positive control
Negative control
Keep away from sunlight
Protect from light
This way up
Do not stack
Humidity limitation
Fuse
Direct current
Standard Symbols
Alternating current
Both direct and alternating current
Three-phase alternating current
Earth (ground) terminal
Protective conductor terminal
Frame or chassis terminal
Equipotentiality
ON (supply)
OFF (supply)
ON (only for a component of the system equipment)
OFF (only for a component of the system equipment)
Equipment protected throughout by double insulation or
reinforced insulation (Equivalent to Class II of IEC 536)
Potential tip over/crush hazard
TABLE OF CONTENTS
Standard Symbols......................................................................................................vi
List of Figures ............................................................................................................ix
List of Tables ............................................................................................................xiii
HOW TO USE THIS MANUAL ........................................................................................ 1-1
About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Purpose of the BacT/ALERT® 3D 60 System . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Additional Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Purpose of This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Manual Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Chapter Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Finding Topics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Typographic and Usage Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Name and Titles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Click . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Press . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Procedural Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Select . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
User Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1-6
1-6
1-7
1-7
1-7
1-7
1-8
Warnings, Cautions, and Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
SYSTEM OVERVIEW ..................................................................................................... 2-1
About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Hardware Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Software Configuration Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
21 CFR Part 11 and HIPAA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Theory Of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2-2
2-2
2-3
2-3
Principle of Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Electrical Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electrical Grounding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electrical and Electronic Recycling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fuse Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2-4
2-6
2-7
2-7
BacT/ALERT® 3D 60 Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
BacT/ALERT® 3D 60 User Manual
95269
i
Table of Contents
Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
Mouse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
UPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
Backup Drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
UPS Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10
UPS Serial Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10
Monitor Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10
Mouse Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Keyboard Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Printer Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
External Speaker Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Power Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Power Entry Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Modem Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
LIS Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Comm Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Instrument Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Electrical Power Services Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Power Consumed in Watts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
Heat Dissipated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
Sound Emission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
Instrument Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
Instrument Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Operating Temperature Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
Storage Temperature Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
Operating Humidity Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
Storage Humidity Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
Maximum Operating and Storage Altitude . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
Pollution Degree 2 in accordance with IEC 664 . . . . . . . . . . . . . . . . . . . . . . . .2-12
Overvoltage Category II per IEC 664 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
Instrument Installation and Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
BacT/ALERT® 3D 60 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Monitor Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Common Screen Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
Common System Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
Scroll Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
Slidebar Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
Anchor Display/Scroll Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
Text Entry Field. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-16
SYSTEM INSTALLATION ................................................................................................ 3-1
About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
ii
BacT/ALERT® 3D 60 User Manual
95269
Table of Contents
Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Verifying Site Requirements Are Met. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Verifying Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Setting the AC Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Choosing Instrument Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Making Instrument Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Powering Up the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Configuring the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Setting the Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Checking for Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Functional Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Modem Functional Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Barcode Reader Functional Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
UPS Functional Test (BacT/ALERT® 3D 60 Only, APC UPS 650) . . . . . 3-12
Installing the Optional Restraint . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
BASIC FUNCTIONS....................................................................................................... 4-1
About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Monitoring the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Main Screen Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Background Color. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
Instrument Icon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
Bottle Count Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
Viewing Faults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Viewing the Cell Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Understanding the View Cell Status Screen Display . . . . . . . . . . . . . . . . . . . . .4-6
Text/Data Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Common Text Fields and Field Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8
Using the Barcode Scanner to Enter Data. . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Manually Entering Text into a Data Entry Field (Keyboard). . . . . . . . . . . . 4-9
Loading Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Loading Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Changing the Maximum Test Time (Individual Bottles) . . . . . . . . . . . . . . 4-13
Handling Anonymous Bottles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Unloading Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Unloading Bottles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Handling Unconfirmed Positive Bottles (False Positives) . . . . . . . . . . . . 4-17
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Accessing the Setup Screen Function Buttons . . . . . . . . . . . . . . . . . . . . . . . . 4-18
Accessing the Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
Inactivity Timeout for all Setup Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-19
Setup Screen Function Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
Viewing and Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
Viewing Bottle Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21
Viewing/Printing Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21
Viewing/Printing Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21
Using the Print Screen Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21
Viewing and Printing Test Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
Viewing and Printing Bottle Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29
Display Bottle Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31
Sending/Requesting LIS Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36
Sending Results to the LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36
Requesting Information from the LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36
EDITING TEST DATA .................................................................................................... 5-1
About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Viewing/Editing Bottle Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Selecting Bottles Using the Edit Cell Contents Button . . . . . . . . . . . . . . . . 5-3
Selecting Bottles Using the Select Bottle to Edit/Graph Button . . . . . . . . . 5-4
Editing Bottle Details Using the Edit Bottle Detail Screen. . . . . . . . . . . . . . 5-5
Edit Bottle ID Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6
View Accession Number Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6
View Hospital ID Field. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6
View Patient First Name Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6
View Patient Last Name Field. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6
Edit Load Status Slidebar Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6
Edit Maximum Test Time Scroll Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-7
Edit Bottle Type Scroll Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-7
View Cell Location Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-7
View First Loaded Time Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8
View Last Unloaded Time Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8
View Time of Last Bottle Reading Icon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8
View Test Time Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8
View Test Result Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8
Edit Test Result Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9
Graph Bottle Readings Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-10
View Algorithm/Polynomial Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-10
View How Determined/Positivity Index Icon . . . . . . . . . . . . . . . . . . . . . . . . . . .5-10
Editing Data Relationships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
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Initiating the Edit Data Relationships Function . . . . . . . . . . . . . . . . . . . . 5-12
Editing Bottle ID to Accession Number Relationships . . . . . . . . . . . . . . . 5-13
Attaching Bottle IDs Without an Accession Number to an Accession Number 5-14
Moving a Bottle ID Association from one Accession Number to Another . . . . .5-14
Editing Accession Number to Hospital ID Relationships . . . . . . . . . . . . . 5-15
Attaching Accession Numbers Without a Hospital ID to a Hospital ID . . . . . . .5-16
Moving an Accession Number Association from one Hospital ID to Another . .5-16
Editing Hospital ID to Patient Name Relationships . . . . . . . . . . . . . . . . . 5-17
SOFTWARE CONFIGURATION........................................................................................ 6-1
About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Setting the Maximum Test Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Setting the Audible Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Priority of Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Terminating an Instrument Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Changing the System Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Initiating Manual Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Configuring Report Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
Entering Report Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
Configuring Report Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Load Report Configuration Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-16
Status Report Configuration Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-17
Unload Report Configuration Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-18
Viewing and Printing Calibration Data . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
Viewing and Printing Calibration History . . . . . . . . . . . . . . . . . . . . . . . . . 6-22
SYSTEM MAINTENANCE ............................................................................................... 7-1
About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Hardware Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Preventative Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Safety Precautions and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Spill Cleanup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3
Disinfection Procedure for Spills Onto the Instrument . . . . . . . . . . . . . . . . . . . .7-3
Disinfection Procedure for Spills Within the Instrument . . . . . . . . . . . . . . . . . . .7-4
Using the Keyboard in Place of the Mouse . . . . . . . . . . . . . . . . . . . . . . . . 7-6
UPS On/Off Button Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Instrument Reboot/Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Shutdown Method 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-8
Shutdown Method 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-8
Shutdown Method 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-9
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Shutdown Method 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-9
Instrument Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Software Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Restarting the Incubation Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
Setting and Formatting the System Date and Time . . . . . . . . . . . . . . . . . 7-11
Enabling and Disabling Racks and Cells . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
Relocating Bottles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-14
Adjusting an Instrument’s Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
Checking an Instrument's Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15
Setting the Optimal Temperature for an Instrument . . . . . . . . . . . . . . . . . . . . .7-17
Calibrating an Instrument's Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-17
Calibrating an Instrument Cell. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18
Locating a Cell Which Failed Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-18
Viewing a Cell's Readings and/or Calibrating a Cell. . . . . . . . . . . . . . . . . . . . .7-19
Viewing Incubation Chamber Information . . . . . . . . . . . . . . . . . . . . . . . . . 7-22
SYSTEM TROUBLESHOOTING ....................................................................................... 8-1
About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Fault Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Instrument Fault Codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Instrument Status Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16
Operator Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18
Bottle Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-29
User Output Device Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-29
21 CFR PART 11 MODE.............................................................................................. 9-1
About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Log In/Out of System — 21 CFR Part 11 Mode . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Logging In for the First Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Logging In . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Inactivity Timeout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Login Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Change Password. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
Change Password Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Logging Out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12
Configuring Users — 21 CFR Part 11 Mode . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12
Adding a User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Deleting a User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-15
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Deleting More Than One User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-16
Clearing a User Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16
Clearing More Than One User Password. . . . . . . . . . . . . . . . . . . . . . . . .9-17
Audit Trail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-18
Accessing the Audit Trail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-20
MYCOBACTERIAL TESTING......................................................................................... 10-1
About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
BacT/ALERT® 3D 60 Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Circulation Fan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-3
Installation Procedures and Special Requirements . . . . . . . . . . . . . . . . . . . . .10-3
BacT/ALERT® 3D 60 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Barcodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-4
Set Maximum Test Time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-4
Positive Detection Algorithm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-4
Bottle Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-4
System Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
MB Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5
Limitations of the Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5
Service and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-6
Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
Principle of Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-6
Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7
General Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-8
Spill Cleanup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-8
Disinfection Procedure for Spills Within/Onto the Instrument . . . . . . . . . . . . . .10-8
UNPACKING INSTRUCTIONS..........................................................................................A-1
BacT/ALERT® 3D 60 Unpacking Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
PART CHECKLIST ........................................................................................................B-1
BacT/ALERT® 3D 60 Part Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Optional Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Recommended Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
INSTALLATION CHECKLIST ...........................................................................................C-1
BacT/ALERT® 3D 60 Installation Checklist. . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
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Table of Contents
INTERNATIONAL CHARACTER ENTRY ............................................................................D-1
About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-1
Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-1
International Character Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-2
Entering International Characters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-3
BOTTLE QUALITY CONTROL.........................................................................................E-1
About This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-1
Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-1
BacT/ALERT® Culture Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-2
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-2
Flip Cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stopper/Seal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bottle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Volume Designations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Limitations of the Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
E-3
E-3
E-3
E-3
E-3
E-3
E-4
Quality Control of Growth Performance . . . . . . . . . . . . . . . . . . . . . . . . . . .E-4
Blood Culture Bottles (SA, SN, FA, FN, and PF) . . . . . . . . . . . . . . . . . . . . . . . E-4
Mycobacteria Culture Bottles (MB and MP) . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5
GLOSSARY ................................................................................................... GLOSSARY-1
INDEX .................................................................................................................. INDEX-1
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LIST OF FIGURES
Figure 1-1:
Procedure Icon ...................................................................................................1-7
Figure 2-1:
Electrical Grounding Requirements ...................................................................2-7
Figure 2-2:
Instrument Front View ........................................................................................2-8
Figure 2-3:
Instrument Rear View ......................................................................................2-10
Figure 2-4:
Button Examples ..............................................................................................2-14
Figure 2-5:
Scroll Button .....................................................................................................2-15
Figure 2-6:
Slidebar Switch ................................................................................................2-15
Figure 2-7:
Anchor Display/Scroll Buttons ..........................................................................2-16
Figure 3-1:
Power Entry Module with Fuse Holder Removed ..............................................3-3
Figure 3-2:
PEM with 115 VAC Version ...............................................................................3-4
Figure 3-3:
PEM with 230 VAC Version ...............................................................................3-5
Figure 3-4:
Additional Fuse Holder Views ............................................................................3-6
Figure 3-5:
Installation and Setup Diagram — Port and Power Connections .......................3-9
Figure 3-6:
Modem Configuration and Dip Switch Settings ................................................3-11
Figure 3-7:
Countertop/Surface Mounting Diagram ...........................................................3-13
Figure 3-8:
Mounting Surface Diagram ..............................................................................3-13
Figure 3-9:
Mounting Surface (Drilling) Template ...............................................................3-14
Figure 4-1:
Main Screen .......................................................................................................4-3
Figure 4-2:
Instrument Icons ................................................................................................4-4
Figure 4-3:
Bottle Count Table/Unload Buttons ....................................................................4-5
Figure 4-4:
View Cell Status Screen ....................................................................................4-6
Figure 4-5:
Disabled Cell ......................................................................................................4-7
Figure 4-6:
Main Screen — Load Mode .............................................................................4-10
Figure 4-7:
Change Maximum Test Time Screen ...............................................................4-13
Figure 4-8:
Main Screen — Unload Mode ..........................................................................4-15
Figure 4-9:
Setup Screen ...................................................................................................4-18
Figure 4-10: Report Selection Screen ..................................................................................4-22
Figure 4-11: Sample Report Screen .....................................................................................4-24
Figure 4-12: Find Text Screen ..............................................................................................4-27
Figure 4-13: Save to File Screen ..........................................................................................4-28
Figure 4-14: Select Bottle to Edit/Graph Screen ..................................................................4-29
Figure 4-15: Graph Bottle Readings Screen ........................................................................4-30
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Figure 4-16: Bottle Readings Screen .................................................................................. 4-32
Figure 4-17: Find Text Screen ............................................................................................. 4-34
Figure 4-18: Save to File Screen ......................................................................................... 4-35
Figure 5-1:
Edit Cell Contents Screen ................................................................................. 5-3
Figure 5-2:
Select Bottle to Edit/Graph Screen ................................................................... 5-4
Figure 5-3:
Edit Bottle Detail Screen ................................................................................... 5-5
Figure 5-4:
Edit Test Result Screen .................................................................................... 5-9
Figure 5-5:
Edit Data Relationships Screen ...................................................................... 5-12
Figure 5-6:
Edit Bottle ID to Accession Number Relationships Screen ............................. 5-13
Figure 5-7:
Edit Accession Number to Hospital ID Relationships Screen ......................... 5-15
Figure 5-8:
Edit Hospital ID to Patient Name Relationships Screen .................................. 5-17
Figure 6-1:
Set Maximum Test Time Screen ....................................................................... 6-2
Figure 6-2:
Set Audible Alarm Options Screen .................................................................... 6-4
Figure 6-3:
Change Password Screen ................................................................................ 6-6
Figure 6-4:
Padlock Icon (Full Open Position) ..................................................................... 6-6
Figure 6-5:
Padlock Icon (Half Open Position) .................................................................... 6-7
Figure 6-6:
Padlock Icon (Closed Position) ......................................................................... 6-7
Figure 6-7:
Backup Management Screen ............................................................................ 6-8
Figure 6-8:
Backup in Progress Icon ................................................................................... 6-8
Figure 6-9:
Report Selection Screen ................................................................................. 6-10
Figure 6-10: Report Label Entry Screen .............................................................................. 6-11
Figure 6-11: Report Selection Screen ................................................................................. 6-14
Figure 6-12: Load Report Configuration Screen .................................................................. 6-16
Figure 6-13: Status Report Configuration Screen ............................................................... 6-17
Figure 6-14: Unload Report Configuration Screen .............................................................. 6-18
Figure 6-15: Report Selection Screen ................................................................................. 6-19
Figure 6-16: Cell Calibration Report Screen ........................................................................ 6-20
Figure 6-17: View Window ................................................................................................... 6-21
Figure 6-18: Report Selection Screen ................................................................................. 6-22
Figure 6-19: Calibration History Screen .............................................................................. 6-23
x
Figure 7-1:
View Cell Status Screen .................................................................................. 7-11
Figure 7-2:
Set Date/Time Screen ..................................................................................... 7-12
Figure 7-3:
Enable/Disable Rack or Cell Screen ............................................................... 7-13
Figure 7-4:
Reference Thermometer ................................................................................. 7-15
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Figure 7-5:
Calibrate Instrument Temperature Screen .......................................................7-16
Figure 7-6:
Calibrate Cell Screen .......................................................................................7-19
Figure 7-7:
View Incubation Chamber Information Screen ................................................7-23
Figure 8-1:
Instrument Icon with Fault Codes ......................................................................8-3
Figure 8-2:
Instrument Status Code 710 ............................................................................8-16
Figure 8-3:
Operator Error Code 911 .................................................................................8-18
Figure 8-4:
QuickScan® 6000 Reset Barcode ....................................................................8-30
Figure 8-5:
Honeywell Reset Barcode ................................................................................8-30
Figure 8-6:
Informational Warning Screen .........................................................................8-31
Figure 9-1:
Main Screen While Logged Out —21 CFR Part 11 Mode ..................................9-2
Figure 9-2:
User Login Screen .............................................................................................9-3
Figure 9-3:
User Login Screen with Change Password Fields .............................................9-4
Figure 9-4:
Main Screen While Logged In — 21 CFR Part 11 Mode ...................................9-5
Figure 9-5:
User Login Screen .............................................................................................9-6
Figure 9-6:
User Login Screen with Wrong Password Alert .................................................9-8
Figure 9-7:
User Login Screen with Change Password Fields .............................................9-9
Figure 9-8:
User Login Screen with Change Password Error .............................................9-10
Figure 9-9:
User Login Screen with Wrong Password Alert ...............................................9-11
Figure 9-10: User Configuration Screen ...............................................................................9-13
Figure 9-11: Add User Screen ..............................................................................................9-14
Figure 9-12: Delete User Screen ..........................................................................................9-15
Figure 9-13: Clear Password Screen ...................................................................................9-17
Figure 10-1: Instrument Icon for MB-Configured System .....................................................10-3
Figure 10-2: Bottle Count Table and Unload Buttons ...........................................................10-4
Figure 10-3: Metabolic Pathway for Mycobacterial CO2 ......................................................10-7
Figure E-1:
Typical BacT/ALERT® Culture Bottle ................................................................ E-2
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LIST OF TABLES
Table 2-1:
Common System Buttons ................................................................................2-14
Table 3-1:
Facility Power Rating and Conversion Chart .....................................................3-4
Table 3-2:
Restraint Hardware ..........................................................................................3-12
Table 3-3:
Table of Equivalent Dimensions (Inches to Centimeters) ................................3-14
Table 5-1:
Bottle Specific Algorithms ................................................................................5-10
Table 5-2:
Status Determination Codes ............................................................................5-10
Table 6-1:
Report Field Descriptions .................................................................................6-12
Table 9-1:
Audit Trail Events .............................................................................................9-18
Table D-1:
International Character Table ........................................................................... D-2
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HOW TO USE THIS MANUAL
1
About This Chapter
This chapter gives you important information about the
BacT/ALERT® 3D 60 system and how to use this manual. We recommend
that you read this chapter first.
IMPORTANT:
Read this manual carefully before you attempt to operate the
BacT/ALERT® 3D 60 system.
Chapter Contents
Intended Audience • 1-2
Purpose of the BacT/ALERT® 3D 60 System • 1-2
Additional Supplies • 1-3
Purpose of This Manual • 1-3
Manual Organization • 1-4
Chapter Organization • 1-5
Finding Topics • 1-6
Typographic and Usage Conventions • 1-6
Name and Titles • 1-6
Click • 1-6
Press • 1-7
Procedural Steps • 1-7
References • 1-7
Select • 1-7
User Input • 1-8
Warnings, Cautions, and Information • 1-8
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How To Use This Manual
Intended Audience
Intended Audience
The BacT/ALERT® 3D 60 system and this manual are intended for laboratory
use by trained, professional users.
Purpose of the BacT/ALERT® 3D 60 System
The BacT/ALERT® 3D 60 Microbial Detection System is a totally automated
test system capable of incubating, agitating, and continuously monitoring
aerobic and anaerobic media inoculated with patient specimens suspected of
having bacteremia, fungemia, and/or mycobacteremia.
CAUTION: bioMérieux shall not be liable as to any defect arising
from abuse of the instrument, failure to operate and maintain the
instrument in accordance with the User Manual, operation of the
instrument by a person who has not been trained in its operation
by bioMérieux, repair, service, alteration or modification of the
instrument by any person other than service personnel of
bioMérieux, or modification, change or reuse of the disposables
supplied by bioMérieux for use in the instrument.
CAUTION: This BacT/ALERT® 3D User Manual is only intended
for use with B.30 Software or higher. The software version B.30
(or higher) is displayed at the bottom of the instrument icon on
the Main screen.
CAUTION: All figures depicting monitor screens are examples
only. Actual screens may differ to the extent they are affected by
the actual data entered by the user, or actual data transmitted to
the instrument over the LIS interface, or actual data generated
by the instrument.
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Additional Supplies
How To Use This Manual
CAUTION: Regarding section "Entering Report Labels," the user
is solely responsible for the choice of customized report label
text and for validating that the intended label text appears in all
associated reports. bioMérieux shall not be liable for any
consequences resulting from misinterpretation of customized
report labels.
Additional Supplies
Contact bioMérieux or your local vendor for laboratory supplies and
accessories.
Purpose of This Manual
This manual focuses on the BacT/ALERT® 3D 60 software application and
how you use it in your workflow. It contains step-by-step procedures for using
your BacT/ALERT® 3D 60 system.
By using these procedures, you can perform all the functions required to
operate your system, including:
• accessing the BacT/ALERT® 3D 60 software
• system monitoring
• entering order information (where applicable)
• loading and unloading bottles
• viewing and printing data
• LIS interaction with the BacT/ALERT® 3D 60 SelectLink
• accessing the Setup screen
Note:
Screens and figures are intended for illustrative purposes only and are not to
be construed as representations of actual test data, results, or components.
Screens and components are not shown to scale.
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How To Use This Manual
Manual Organization
Manual Organization
This manual is organized by chapters. Chapters are organized according to
the order of menu commands in the software application.
Chapter 1, How To Use This Manual — Provides an introduction to the
BacT/ALERT® 3D 60 system and how to use this manual. It is recommended
that you read this chapter first.
Chapter 2, System Overview — This chapter gives you a complete
description of the different BacT/ALERT® 3D 60 hardware and software
configurations available. Also, the monitor screens are listed along with a
description of common screen elements.
Chapter 3, System Installation — Provides detailed instructions on how to
install the instrument and perform functional tests.
Chapter 4, Basic Functions — Introduces you to the Main screen and
shows you how to perform basic functions (ex. enter data, view faults, view
the Cell Status screen, load/unload bottles, etc.). This chapter also introduces
you to the Setup screen and the associated function buttons.
Chapter 5, Editing Test Data — Explains how to access bottle data for
loaded and unloaded bottles using the Edit Bottle Detail screen. This chapter
shows you how to view and edit bottle data.
Chapter 6, Software Configuration — Explains how to configure the
software for your specific needs. This chapter shows you how to set the
maximum test time, set the audible alarms, change the system password,
initiate a manual backup, configure report screens, and view and print
calibration data.
Chapter 7, System Maintenance — This chapter provides you with
procedures on how to perform maintenance on the BacT/ALERT® 3D 60
hardware and software.
Chapter 8, System Troubleshooting — Describes the different types of
instrument fault, instrument status and operator error codes, as well as bottle
and user output device problems, you may encounter when using the
instrument. Cause(s) and solutions(s) for each type of fault/error/problem are
also listed.
Chapter 9, 21 CFR Part 11 Mode — This chapter explains how to log in and
out of the instrument while in 21 CFR Part 11 mode, as well as instructions for
configuring users (ex. adding or deleting a user, or clearing a user password).
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Chapter Organization
How To Use This Manual
This chapter also describes the events recorded in the audit trail and how to
retrieve the audit trail.
Chapter 10, Mycobacterial Testing — This chapter provides you with a
complete description of the of the BacT/ALERT® 3D 60 instrument when it is
configured for Mycobacterial (MB) functions.
Appendix A, BacT/ALERT® 3D 60 Unpacking Instructions — Contains a
diagram illustrating how to unpack the instrument.
Appendix B, BacT/ALERT® 3D 60 Part Checklist — To use when verifying
and inspecting kit contents.
Appendix C, BacT/ALERT® 3D 60 Installation Checklist — To use when
installing the instrument.
Appendix D, International Character Entry — Explains how to enter
international characters on the BacT/ALERT® 3D 60 instrument.
Appendix E, Bottle Quality Control — This chapter provides you with a
description of the BacT/ALERT® 3D 60 culture bottle along with a quality
control procedure.
Glossary — An alphabetized list of frequently used terms along with a
definition for each term.
Chapter Organization
All chapters include the following:
• About This Chapter — Brief description of the chapter’s content and
purpose.
• Chapter Contents — A table of contents for the chapter.
• Descriptions and/or Procedures — Chapters contain descriptions and
procedures appropriate to their subject matter. See the Manual
Organization section in this chapter for more information.
• Background Information, where applicable and useful.
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How To Use This Manual
Finding Topics
Finding Topics
This manual uses several methods to help you find information and keep your
bearings.
Table of Contents — Located at the front of the manual. It contains the titles
of all chapters/appendices and their sections, and the page number of each
title and section.
List of Figures — Located at the front of the manual. It contains a list of all
figures in the manual and the page number of each figure.
List of Tables — Located at the front of the manual. It contains a list of all
tables in the manual and the page number of each table.
Chapter Contents — Located at the front of each chapter. It lists all sections
in the chapter and their page numbers.
Page Headers — Located at the top of each page. There are two parts to a
header: the chapter title and the primary section title.
Page Footers — Located at the bottom of each page. There are three parts
to a footer: the manual’s title, the chapter’s part number, and the page
number.
Index — Located at the back of the manual. It contains topical entries and
their page numbers.
Typographic and Usage Conventions
Name and Titles
Button, icon and field names are in Proper Case, bold.
Example: Click the Select Maximum Test Time button.
The names of windows and screens are in Proper Case, but are not bolded.
Example: The Set Maximum Test Time screen...
Click
This manual uses the word “click” to refer to using a mouse to choose or
select a text entry field, button, or option.
Example: Click OK.
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Typographic and Usage Conventions
How To Use This Manual
See the Select section in this chapter for more information
Press
This manual uses 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.
References to other manuals are in Proper Case and italic.
Example: See the BacT/ALERT® 3D 60 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.
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How To Use This Manual
Warnings, Cautions, and Information
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.
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:
1-8
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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SYSTEM OVERVIEW
2
About This Chapter
This chapter gives you a complete description of the different
BacT/ALERT® 3D 60 hardware and software configurations available. Also,
the monitor screens are listed along with a description of common screen
elements.
Chapter Contents
Introduction • 2-2
Hardware Configuration • 2-2
Software Configuration Options • 2-2
21 CFR Part 11 and HIPAA • 2-3
Theory Of Operation • 2-3
Electrical Warnings • 2-4
Electrical Grounding • 2-6
Electrical and Electronic Recycling • 2-7
Fuse Replacement • 2-7
BacT/ALERT® 3D 60 Hardware • 2-8
Instrument • 2-8
Instrument Specifications • 2-11
Instrument Environmental Requirements • 2-12
Instrument Installation and Setup • 2-13
BacT/ALERT® 3D 60 Software • 2-13
Monitor Screens • 2-13
Common Screen Elements • 2-14
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Introduction
Introduction
The BacT/ALERT® 3D 60 is the next generation of BacT/ALERT®
instrumentation with comparable sensitivity and specificity to the
BacT/ALERT® 3D systems. The system is non-invasive. A monitor screen in
conjunction with a mouse 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 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 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 may begin at any time. The system
also utilizes barcode technology to assist in specimen 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 60 utilizes a stand-alone instrument that has 60 cells
for bottle monitoring.
Software Configuration Options
The instrument supervises the reading of the sensors and contains decisionmaking algorithms to determine which specimens are positive or negative.
The instrument can be arranged in one of two BacT/ALERT® 3D 60 software
configurations:
• BacT/ALERT® 3D Select configuration —The BacT/ALERT® 3D 60 is
not connected to a Laboratory Information System (LIS). Limited data
management is available through the system.
• BacT/ALERT® 3D SelectLink configuration — The BacT/ALERT® 3D 60
is connected directly to an LIS. Limited data management is available
through the system.
The software configuration is listed at the top of all screens (see Figure 4-1,
Main Screen) except for the Edit Cell Contents or View Cell Contents screen
(see Figure 5-1, Edit Cell Contents Screen). The background color will also
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indicate the configuration unless there is an error condition or a loaded
positive bottle (see Main Screen Introduction in Chapter 4):
• Blue — BacT/ALERT® 3D Select configuration
• Green — BacT/ALERT® 3D SelectLink configuration
21 CFR Part 11 and HIPAA
The BacT/ALERT® 3D 60 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 60 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 9).
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 4-10). See the topic, Configuring Report Screens in Chapter 6 for
further information.
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 blue-green to a lighter color.
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 CO2 level in the bottle. 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. If the CO2 level does not change significantly after a specified
number of days at optimal conditions, the sample is determined to be
negative.
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CAUTION: Unloading or manipulating the bottles when not
indicated by the system may interfere with critical bottle
readings.
Electrical Warnings
The BacT/ALERT® 3D 60 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 60 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.
• Ensure that only fuses with the required rated current and of
the specified type are used for replacement. The use of
makeshift fuses and the short-circuiting of fuse holders is
prohibited.
• Whenever it is likely that the BacT/ALERT® 3D 60 instrument
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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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 a grounded wall receptacle is available. 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
The only user-servicable fuses in the BacT/ALERT® 3D 60 system are
located in the Power Entry Module (see Setting the AC Power in Chapter 3).
For all other internal fuses, contact your local bioMérieux Instrument Service
Representative.
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System Overview
BacT/ALERT® 3D 60 Hardware
The BacT/ALERT® 3D 60 system includes a single instrument containing an
incubation chamber, monitor, keyboard, UPS, printer, barcode reader, and a
mouse. A door at the front of the instrument accesses the incubation
chamber.
The incubation chamber contains up to three racks, each with a capacity for
20 culture bottles. The incubation chamber may be configured for either
Mycobacteria (MB) or non-MB. Configuring the chamber for MB enables all
three racks within the chamber to remain immobile. It also causes the
Instrument icon on the Main screen to be labeled as MB.
Note:
The BacT/ALERT® 3D 60 software must also be configured to activate the
MB status.
Instrument
1
8
2
3
7
4
5
6
Figure 2-2: Instrument Front View
2-8
1 — Monitor
5 — Keyboard
2 — Incubation Chamber
6 — Mouse
3 — Printer
7 — UPS
4 — Barcode Reader
8 — Backup Drive
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Monitor
Displays bottle and system information.
Barcode Reader
A Barcode Reader is used to scan bottle barcode labels to identify bottles and
accession barcodes when loading or unloading.
Mouse
A mouse is used to move from one screen to another and to input data and
selections.
Keyboard
Provides an alternate means of input. Serves as a backup input device
should the barcode reader or mouse fail.
UPS
The UPS (Uninterruptible Power Supply) is external to the
BacT/ALERT® 3D 60.
Backup Drive
The Backup Drive allows system backups to be made to either a Zip® disk or
USB flash drive, depending on system configuration.
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System Overview
1
2
3
12
11
4
5
6
7
8
9
10
Figure 2-3: Instrument Rear View
1 — Communications Panel
7 — Monitor Port
2 — Printer Port
8 — Keyboard Port
3 — Mouse Ports
9 — External Speaker Port
4 — LIS Port
10 — Power Entry Module
5 — Modem Port
11 — UPS Port
6 — Serial UPS Port
12 — Barcode Reader Port
UPS Port
Used to connect an external UPS to the instrument. Located on the
Communications Panel.
UPS Serial Port
Reserved for future use. Located on the Communications Panel.
Monitor Port
Port for connecting the monitor to the instrument. Located on the
Communications Panel.
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Mouse Ports
Used for connecting the mouse to the instrument. Located on the
Communications Panel.
Keyboard Port
Port for connecting the keyboard to the instrument. Located on the
Communications Panel.
Printer Port
Interface port (parallel) for connecting the printer to the instrument to produce
hard copy reports. Located on the Communications Panel.
External Speaker Port
Port for connecting external speakers to the instrument. Available for order as
a separate kit. Located on the Communications Panel.
Power Connector
Connector for alternating current (AC) power cord.
Power Entry Module
Turns the AC Power to the instrument On and Off.
Modem Port
Used to connect an external modem to the instrument allowing 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 Instrument to a Laboratory Information System (LIS).
Located on the Communications Panel.
Comm Port
Reserved for future use. Located on the Connection Panel.
Instrument Specifications
Electrical Power Services Requirements
• 100/120 Volts @ 50/60Hz
• 220/240 Volts @ 50/60 Hz
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Power Consumed in Watts
• 115 Volts (380W max. — 255W Typical)
• 230 Volts (380W max. — 255W Typical)
Heat Dissipated
• 1300 BTU/Hr max. -- 870 BTU/Hr Typical
Sound Emission
• 50.8 dB
Instrument Dimensions
• Width — 22.75 in. (57.8 cm)
• Height — 24 in. (61 cm)
• Depth — 19.5 in. (49.5 cm)
• Weight (Unloaded) — 90 lbs. (41 Kg)
• Weight (Loaded) — 98 lbs. (45 Kg)
Instrument 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
Overvoltage Category II per IEC 664
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System Overview
Instrument Installation and Setup
For information on the Installation and Setup of the BacT/ALERT® 3D 60
instrument, see Chapter 3, System Installation.
BacT/ALERT® 3D 60 Software
Monitor Screens
The Main screen is normally visible on the Monitor, but other screens may be
displayed to perform a variety of functions. Each screen has a screen ID
number in the upper left-hand corner to cross-reference it to the following
descriptions and instructions in this Manual. When selected, the Setup
screen replaces the Main screen.
Screen ID Numbers
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
1.0 Main screen
1.1 View Cell Status screen
1.2 Change Maximum Test Time screen
1.3 User Login screen (21 CFR Part 11 mode only)
2.0 Setup screen
2.1 Set Date/Time screen
2.2 Enable/Disable Rack or Cell screen
2.3 Calibrate 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 Chamber 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
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System Overview
•
•
•
•
•
•
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)
2.23.3 Change User Password screen (21 CFR Part 11 mode only)
Common Screen Elements
Icon
Graphic symbols used instead of text to convey information and concepts in
the Monitor.
Button
• Appear as rectangular shapes which can be clicked 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 2-4: 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.
• Clicking 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 2-5: Scroll Button
Slidebar Switch
• Turns a function On or Off. The specific function is represented by a
separate icon next to the slidebar.
• Clicking the right half of the icon moves the slidebar to the right,
indicating an On selection (1).
• Clicking the left half of the icon moves the slidebar to the left, indicating
an Off selection (0).
Figure 2-6: 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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1
3
5
7
2
4
6
8
Figure 2-7: 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 4). The Bottle ID field on the Main screen is an
example of a text field.
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SYSTEM INSTALLATION
3
About This Chapter
This chapter provides you with detailed instructions on how to install the
instrument and perform functional testing.
Chapter Contents
Preparation • 3-2
Verifying Site Requirements Are Met • 3-2
Verifying Contents • 3-2
Installation • 3-3
Setting the AC Power • 3-3
Choosing Instrument Location • 3-6
Making Instrument Connections • 3-7
Powering Up the Instrument • 3-9
Configuring the Instrument • 3-10
Setting the Temperature • 3-10
Checking for Errors • 3-10
Functional Testing • 3-10
Modem Functional Test • 3-10
Barcode Reader Functional Test • 3-11
UPS Functional Test (BacT/ALERT® 3D 60 Only, APC UPS 650) • 3-12
Installing the Optional Restraint • 3-12
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Preparation
Preparation
Verifying Site Requirements Are Met
1)
Review the mandatory requirements below to ensure they are met:
• Lab environment temperature and humidity are within specified
tolerances.
• Temperature is between 10°C – 30°C
• Humidity is between 20% – 90%
• Unit is positioned away from direct sunlight and bright overhead lights.
• Telephone line for modem access is located within 25 feet.
• Floor or bench that is capable of supporting 126.0 lbs. (57.2 Kg) per
instrument installed.
• Unobstructed clearance of 4 inches behind and 12 inches above the
module.
• Verify that a dedicated AC circuit with proper voltage and current
ratings for the instrument and UPS are available and located within 8
feet (see Instrument Specifications in Chapter 2).
2)
Indicate that site requirements are met on the BacT/ALERT® 3D 60
Installation Checklist in Appendix C.
Verifying Contents
3-2
1)
Unpack the contents of the BacT/ALERT® 3D 60 using the
BacT/ALERT® 3D 60 Unpacking Instructions in Appendix A.
2)
Verify and Inspect contents of the BacT/ALERT® 3D 60 for shipping
damage using the BacT/ALERT® 3D 60 Part Checklist in Appendix B.
3)
Indicate that contents are verified on the BacT/ALERT® 3D 60
Installation Checklist in Appendix C.
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Installation
Setting the AC Power
WARNING
The BacT/ALERT® 3D 60 ships without a default voltage
setting. The procedure that follows describes how to insert the
fuse(s) for proper voltage setting. After installing proper
fuse(s), discard the remaining fuse(s).
Note:
The Power Entry Module (805-0017-02) is located in the rear and lower left
corner of the instrument.
Note:
When configured for 115 VAC, the PEM has one 6.3 Amp 250V time-delay
fuse (870-0008-25). In addition, a conversion clip is located across the
neutral line in the fuse holder.
Note:
When configured for 230 VAC, each PEM has two 5.0 Amp 250V time-delay
fuses (870-0008-24).
1)
Ensure the instrument is powered down.
2)
Ensure that the main power and interface cables are disconnected.
3)
Open the PEM cover using a small flat blade screwdriver.
4)
Slide out the fuse holder (see Figure 3-1).
1
Figure 3-1: Power Entry Module with Fuse Holder Removed
1 — Note the fuse orientation to the rear of the fuse holder.
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5)
Install the fuse(s) for the proper voltage rating. Determine the proper fuse
installation to use based on the Facility Power Ratings listed in
Table 3-1.
Table 3-1: Facility Power Rating and Conversion Chart
Facility Power Rating
Configuration
Fuse(s) to Use
110 Volts AC
115 VAC
One (1) 6.3A 250V Time-Delay Fuse
(Refer to Step a and Figure 3-2)
115 Volts AC
115 VAC
One (1) 6.3A 250V Time-Delay Fuse
(Refer to Step a and Figure 3-2)
125 Volts AC
115 VAC
One (1) 6.3A 250V Time-Delay Fuse
(Refer to Step a and Figure 3-2)
200 Volts AC
230 VAC
Two (2) 5.0A 250V Time-Delay fuses
(Refer to Step b and Figure 3-3)
220 Volts AC
230 VAC
Two (2) 5.0A 250V Time-Delay fuses
(Refer to Step b and Figure 3-3)
230 Volts AC
230 VAC
Two (2) 5.0A 250V Time-Delay fuses
(Refer to Step b and Figure 3-3)
240 Volts AC
230 VAC
Two (2) 5.0A 250V Time-Delay fuses
(Refer to Step b and Figure 3-3)
a. To configure the BacT/ALERT® 3D 60 for 115 VAC, refer to
Figure 3-2 to install a 6.3A 250V time-delay fuse.
1
2
Figure 3-2: PEM with 115 VAC Version
1 — Conversion Clip
3-4
2 — 6.3A 250V Time-Delay Fuse
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b. To configure the BacT/ALERT® 3D 60 for 230 VAC, see Figure 3-3 to
install the two 5.0A 250V time-delay fuses. Be sure to remove and
dispose of the conversion clip, if one is present.
1
Figure 3-3: PEM with 230 VAC Version
1 — 5.0A 250V Time-Delay Fuses (2 required)
CAUTION: Installation of the 115V conversion clip in the
230 VAC version (see Figure 3-3) COULD RESULT IN DAMAGE
to the unit. Ensure that the 115V conversion clip has been
removed if installing the 230 VAC version.
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Installation
1
2
Figure 3-4: Additional Fuse Holder Views
1 — Top/Bottom View
2 — Side View
6)
Reinstall the fuse holder.
7)
Close the PEM cover.
8)
Indicate that AC power is set on the BacT/ALERT® 3D 60 Installation
Checklist in Appendix C.
Choosing Instrument Location
WARNING
The BacT/ALERT® 3D 60 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 and 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.
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System Installation
If it is necessary to move or store the BacT/ALERT® 3D 60 System, contact
bioMérieux Service for assistance.
1)
Note:
Assemble and install the BacT/ALERT® 3D 60 Instrument in the
specified installation location.
If countertop or other permanent (bolted) installation is required, see
Installing the Optional Restraint on page 3-12.
2)
Indicate that location for instrument placement is chosen on the
BacT/ALERT® 3D 60 Installation Checklist in Appendix C.
Making Instrument Connections
The following steps describe the connections that need to be made prior to
powering up the BacT/ALERT® 3D 60. Figure 3-5 depicts the connections
described in the following steps:
1)
Note:
Connect the UPS battery per the instructions on the UPS. Place the UPS
near the instrument. Connect the UPS serial cable to the 9-pin connector
on the rear of the UPS and the other end to the UPS connector (not
Serial UPS) on the 3D 60 instrument Communications panel. UPS port
connection is shown in Figure 3-5.
The 9-Pin cable packed with the UPS should not be used and should be
discarded. Use the UPS Serial Cable (9-Pin) provided in the accessory kit.
2)
Connect the 3D 60 instrument’s main power cord into the properly rated
UPS AC receptacle labeled as Surge with Battery Backup.
3)
Plug the UPS main power cable into the properly rated AC wall outlet.
4)
Connect the external speaker cable (if external speakers are installed)
into the Ext Spkr jack on the Communications panel (not supplied —
optional). External speaker connection is shown in Figure 3-5.
5)
Plug in the external speaker’s AC power cord into the properly rated AC
wall outlet (not supplied — optional).
6)
Plug in the monitor’s15-pin cable into the Monitor port on the
Communications panel (not supplied — optional). Monitor port
connection is shown in Figure 3-5.
7)
Plug in the monitor main power cable to the properly rated UPS AC
receptacle labeled as Surge with Battery Backup.
8)
Connect the keyboard cable into the Keybrd port on the
Communications panel. Keyboard port connection is shown in
Figure 3-5.
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9)
Connect the printer’s parallel cable into the Printer port on the
Communications panel. Printer port connection is shown in Figure 3-5.
10) Plug in the printer’s main power cord into the UPS AC receptacle for
Surge Only (no Battery Backup).
11) Connect the modem’s communications interface cable to the Modem
port on the Communications panel. Modem port connection is shown in
Figure 3-5.
12) Connect the modem telephone cable to the Jack port on the modem (if
supplied and installed).
13) Plug in the modem’s power adapter into the modem. Plug in the main
power cord from the adapter into the properly rated AC wall outlet (if
supplied and installed).
14) Connect the barcode scanner’s communications cable into the Barcode
port on the Communications panel. Port connection is shown in
Figure 3-5.
15) Connect the mouse cable into the applicable Mouse port on the
Communications panel. Port connections are shown in Figure 3-5.
16) Indicate that all instrument connections are complete on the
BacT/ALERT® 3D 60 Installation Checklist in Appendix C.
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Installation
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10
Printer
Mouse
15
Barcode
Scanner
9
14
Communications Panel
LIS
Mouse
Modem Serial UPS
6
11
COMM
Printer
Keyboard
Monitor
Barcode
UPS
Ext Spkr
4
8
Speakers
UPS
5
Monitor
13
12
1
Keybrd
Modem
Surge outlets
with battery
backup.
7
3
Telephone
Line Jack
3D 60 Communications
Panel. See detailed view.
Rear
View
3D 60
2
Surge outlets
without battery
backup.
Figure 3-5: Installation and Setup Diagram — Port and Power Connections
Powering Up the Instrument
1)
Turn the UPS switch ON.
2)
Power up the instrument by turning on the Main Power switch on the rear
of the instrument.
3)
Power up the monitor, modem, and printer.
4)
Turn on the electric reference thermometer, if applicable, making sure
that it is set for Celsius.
5)
Indicate that the instrument is powered up on the BacT/ALERT® 3D 60
Installation Checklist in Appendix C.
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System Installation
Functional Testing
Configuring the Instrument
Note:
1)
Verify that the screen title Select or SelectLink is correctly displayed.
2)
Set up and verify maximum test times (see Setting the Maximum Test
Time in Chapter 6).
3)
Ensure that the lab supervisor is able to log onto the system with the
password 1234.
To change the password, see Changing the System Password in Chapter 6.
4)
Set the displayed date/time to reflect the current date and time in the lab
(see Setting and Formatting the System Date and Time in Chapter 7).
5)
Verify that each component is enabled by viewing the Main screen. Any
disabled component will be displayed by gray "hash marks" denoting the
disabled rack or individual cells within the rack. Use the Enable/Disable
Rack, and Cell screen to enable each, accordingly (see Enabling and
Disabling Racks and Cells in Chapter 7).
6)
Indicate that instrument configuration is completed on the
BacT/ALERT® 3D 60 Installation Checklist in Appendix C.
Setting the Temperature
1)
Set the instrument operating temperature. Once the temperature has
stabilized (4 hours), calibrate the actual instrument temperature (see
Adjusting an Instrument’s Temperature in Chapter 7).
2)
Indicate that the temperature is set on the BacT/ALERT® 3D 60
Installation Checklist in Appendix C.
Checking for Errors
1)
Ensure that no error codes are displayed on the Main screen.
2)
Indicate that there are no errors on the BacT/ALERT® 3D 60 Installation
Checklist in Appendix C.
Functional Testing
Modem Functional Test
3-10
1)
Set the modem’s DIP switches (see Figure 3-6).
2)
When modem and telephone connections are available, connect the
Modem Interface cable between the modem connector and the port
labeled Modem (located on the bulkhead on the rear of the instrument).
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Functional Testing
System Installation
Connect the telephone line (designated for modem access) into the Jack
port of the modem. See Figure 3-5 for the bulkhead modem connection
and Figure 3-6 for the 56K Fax Modem configuration diagrams.
3)
Note:
Power up the modem. Have bioMérieux Support Services dial into the
modem to verify the connection and modem’s functionality.
US Robotics computer and jack modem ports are labeled on the bottom of
the modem. (North America Only)
4)
Connect and configure the modems as shown in Figure 3-6. Set the
modem dip switch (see Figure 3-6).
6
2
4
5
7
3
1
1 2 3 4 56 7 8
Figure 3-6: Modem Configuration and Dip Switch Settings
1 — Dip Switch settings are on
the rear of the modem.
5 — Comp
2 — Telephone
7 — 957-0004-305 25-Pin to
9-Pin Cable
3 — Telephone Line
6 — Modem Port Connection
4 — Telco Modem
5)
Indicate that the Modem Functional Test is complete on the
BacT/ALERT® 3D 60 Installation Checklist in Appendix C.
Barcode Reader Functional Test
1)
From the Main screen (see Figure 4-1), click the Load Bottle button.
The Load Bottle screen appears.
2)
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Scan a bottle and verify that the scanned number matches the bottle.
3-11
System Installation
Installing the Optional Restraint
3)
Press the Done button to exit the Load Bottle mode and return to the
Main screen.
4)
Indicate that Barcode Reader Functional Test is complete on the
BacT/ALERT® 3D 60 Installation Checklist in Appendix C.
UPS Functional Test (BacT/ALERT® 3D 60 Only, APC UPS 650)
1)
Set the time to current local time.
2)
Disable the audible alarms using the system software (see Setting the
Audible Alarms in Chapter 6).
3)
Remove AC power from the UPS by removing the UPS AC power cord
from the wall outlet. Leave the UPS connected to the instrument and
leave the power switch set to ON.
4)
While waiting for 1 minute, verify that the UPS emits an audible alarm.
5)
Verify that the blue Abnormal Shutdown screen appears on the
instrument monitor screen.
6)
Verify that the instrument powers down.
7)
After the instrument powers off, restore power to the UPS.
8)
Verify that the instrument retains the correct time and has no visible
errors displayed on the monitor screen.
9)
Indicate that the UPS Functional Test is complete on the
BacT/ALERT® 3D 60 Installation Checklist in Appendix C.
Installing the Optional Restraint
The countertop mounting hardware consists of screws and flat washers used
to attach the instrument to a countertop (see Figure 3-7) or other surface of
variable thickness. For a list of required parts, see Table 3-2.
Table 3-2: Restraint Hardware
Item
3-12
Quantity
¼ in. x 20 x 5 in. Bolt
4 each
¼ in. Flat Washer
4 each
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System Installation
1
Figure 3-7: Countertop/Surface Mounting Diagram
1 – Threaded holes are accessible once the four rubber feet are
removed.
1)
Note:
Determine the desired location of the instrument on the countertop or
mounting surface.
Care should be taken to avoid braces or bulkheads within the counter which
could interfere with hardware installation and mounting. Drilling into these
braces may reduce the integrity of the counter’s strength.
2)
Determine the length of the bolts needed for mounting (see Figure 3-8).
Drill 3/8-in. holes in surface
Stationary Mounting Surface
¼ in. x 20
A + B = C (Calculated Length)
A = 2 ¾ in. (Equipment Interior Dimension)
B = Thickness of your mounting Surface
Figure 3-8: Mounting Surface Diagram
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For mounting surfaces up to 2 ¼ in. thick, use the 5-in. bolts supplied
with the instrument. For mounting surfaces or surfaces requiring longer
bolts, use Table 3-3 and Figure 3-8 to determine the required bolt length.
Table 3-3: Table of Equivalent Dimensions (Inches to Centimeters)
Equivalent Dimensions
½ in. = 1.3 cm
4 in. = 10.2 cm
2 ½ in. = 6.4 cm
5 in. = 12.7 cm
2 ¾ in. = 7 cm
13 in. = 33 cm
3 ½ in. = 8.9 cm
21 in. = 53 cm
3)
Transfer the dimensions from the Mounting Surface (Drilling) Template
(see Figure 3-9) to the actual mounting surface.
Rear clearance is
5 in. from hole, or
4 in. from
instrument.
Drill 3/8-in. holes (four places)
Top View
13 in.
Left side clearance: Allow 4 ½
in. from left side
of hole (or
3 ½ in. from
instrument.)
Front
21 in.
Note: Door will swing 3 ½ inches wide.
Figure 3-9: Mounting Surface (Drilling) Template
4)
Properly locate and drill four 3/8-in. diameter holes in the mounting
surface.
5)
Remove the rubber feet from the instrument.
• Position the instrument. Insert the bolts through ¼-in. flat washers,
through the mounting surface, and into the threaded inserts of the
instrument (see Figure 3-9).
6)
Note:
3-14
Lightly tighten the bolts.
Over-tightening the bolts may loosen the threaded inserts.
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Installing the Optional Restraint
7)
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System Installation
Indicate that the optional restraint is installed on the
BacT/ALERT® 3D 60 Installation Checklist in Appendix C.
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System Installation
3-16
Installing the Optional Restraint
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BASIC FUNCTIONS
4
About This Chapter
This chapter introduces you to the Main screen and provides you with
procedures on how to perform daily basic functions.
Chapter Contents
Introduction • 4-2
Monitoring the System • 4-2
Main Screen Introduction • 4-2
Viewing Faults • 4-5
Viewing the Cell Status Screen • 4-6
Text/Data Entry • 4-8
Using the Barcode Scanner to Enter Data • 4-8
Manually Entering Text into a Data Entry Field (Keyboard) • 4-9
Loading Bottles • 4-10
Loading Bottles • 4-10
Changing the Maximum Test Time (Individual Bottles) • 4-13
Handling Anonymous Bottles • 4-14
Unloading Bottles • 4-14
Unloading Bottles • 4-15
Handling Unconfirmed Positive Bottles (False Positives) • 4-17
Accessing the Setup Screen Function Buttons • 4-18
Accessing the Setup Screen • 4-18
Setup Screen Function Buttons • 4-19
Viewing and Printing • 4-21
Introduction • 4-21
Viewing and Printing Test Data • 4-22
Viewing and Printing Bottle Graphs • 4-29
Display Bottle Readings • 4-31
Sending/Requesting LIS Information • 4-36
Sending Results to the LIS • 4-36
Requesting Information from the LIS • 4-36
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4-1
Basic Functions
Introduction
Introduction
The basic functions are those tasks that may be performed during daily
workflow. They include:
• Monitoring the system
• Entering order information (where applicable)
• Loading and unloading bottles
• Viewing and printing data
• LIS interaction with the BacT/ALERT® 3D SelectLink
• Accessing the Setup screen
Monitoring the System
Main Screen Introduction
The BacT/ALERT® 3D 60 system can be monitored from the Main screen
(see Figure 4-1).
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Monitoring the System
Basic Functions
10
1
9
2
3
8
4
5
6
7
Figure 4-1: Main Screen
2 — Bottle Count Table
6 — Logout button (21 CFR
Part 11 mode only)
3 — Unload Buttons
7 — Load Bottles button
4 — Manual Send Test Results
button (SelectLink only)
8 — Instrument Icon
5 — Manual Request Test
Orders button (SelectLink
only)
10 — Software Configuration
1 — Screen ID Number
9 — Current Date/Time
CAUTION: If the current date/time displayed at the top of the
screen does not advance, call 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.
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Basic Functions
Monitoring the System
• A red screen indicates that an instrument fault has occurred. Clicking
anywhere on 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 corrected.
Instrument Icon
The following information is indicated on the Instrument icon:
• System ID numbers are assigned to both the Instrument and the
Incubation Chamber.
• The programmed optimal temperature (ºC) is displayed for the
Incubation Chamber.
• Software version number for the BacT/ALERT® 3D 60.
• Disabled or uninstalled components appear diagonally striped in gray
on the screen.
Note:
An entire rack will appear diagonally striped if only one of its cells is disabled.
5
4
3
1
2
Figure 4-2: Instrument Icons
1 — Incubation Chamber
4 — Controller ID
2 — Instrument
5 — Backup Drive
3 — Software Version
Bottle Count Table
Located just above the Instrument icon are the Unload buttons and a table
indicating the number of bottles of each type currently loaded in the
instrument.
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Monitoring the System
Basic Functions
3
5
7
9
4
6
8
10
1
2
Figure 4-3: 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 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 Instrument or the right side of the icon, then
move to Step 4. If the fault code appears on an Incubation Chamber or
left side of the icon, then continue to Step 2.
2)
Click the Incubation Chamber on the Instrument icon.
3)
The View Cell Status screen appears (see Figure 4-4, View Cell Status
Screen, on page 4-6).
• Door faults appear at the top of the screen.
• Rack faults appear at the left end of the rack display.
• Cell faults appear in the cell display.
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Basic Functions
Monitoring the System
4)
For a complete list and description of Instrument Fault Codes, see the
topic, Instrument Fault Codes in Chapter 8.
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 as indicated by fault codes appearing or
disappearing. To view the cell status screen:
1)
Display the View Cell Status screen by clicking the appropriate
Incubation Chamber on the left side of the Instrument icon (see
Figure 4-1, Main Screen).
1
6
2
5
3
4
Figure 4-4: View Cell Status Screen
1 — Door Fault Code
2 — Rack Fault Code
4 — Restart Incubation
Chamber Button
3 — Cell Fault Code
5 — Rack
6 — Cell Button
2)
Click 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.
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Monitoring the System
Basic Functions
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 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 (see
Figure 4-5) within their borders. (see Enabling and Disabling Racks and
Cells in Chapter 7).
Figure 4-5: Disabled Cell
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4-7
Basic Functions
Text/Data Entry
Text/Data Entry
Common Text Fields and Field Limits
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 fields may manually be made unavailable or disabled regardless of
software configuration. To make the field(s) unavailable or disabled, call your
local bioMérieux Representative.
Using the Barcode Scanner to Enter Data
To scan a bottle or accession barcode:
1)
Before scanning the barcode, click 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 at the base of the barcode
reader stand (see Figure 2-2, Instrument Front View).
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 Monitor.
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Text/Data Entry
Basic Functions
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. If a barcode
label cannot be scanned successfully, the bottle ID or accession number can
also be entered using the keyboard.
See Appendix D for International character entry instructions.
Note:
Note:
Before entering text into a field, touch the desired field to place focus on that
field. The field should turn white indicating focus.
1)
Using the keyboard, enter the desired text.
2)
Press the Tab key to move focus to the next field.
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.
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4-9
Basic Functions
Loading Bottles
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), click the Load Bottles button
(
).
The Load Mode screen appears.
1
2
9
3
4
5
6
7
8
Figure 4-6: Main Screen — Load Mode
1 — Load Bottles Icon
6 — Accession Number Field
2 — Change Maximum Test
Time Button
7 — Patient Last Name Field
3 — Bottle Type Scroll Button
9 — Cells Available for
Loading
4 — Bottle ID Field
8 — Hospital ID Field
5 — Patient First Name Field
The number of available cells appears at the bottom left hand side of the
Instrument icon.
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Loading Bottles
Basic Functions
CAUTION: Inspect each bottle and sensor before loading.
If the sensor is yellow, treat the bottle as positive. If the bottle is
cracked, do not load the bottle.
2)
Verify the Bottle ID field appears white, then scan or manually enter the
bottle ID (see Text/Data Entry on page 4-8).
If the field is left blank when a bottle is loaded, then the bottle is
considered anonymously loaded (see Handling Anonymous Bottles on
page 4-14).
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 4-6, Main Screen — Load
Mode, on page 4-10.
CAUTION: For best results, manually enter the bottle type when
"GENERIC" is the displayed bottle type. Otherwise, observe the
following:
The maximum test time assigned to a generic bottle loaded into
an incubation chamber configured for MB is the same time
assigned to the BacT/ALERT® MP media type in the Set
Maximum Test Type screen (see Setting the Maximum Test
Time in Chapter 6).
All non-MB bottles loaded into an Incubation Chamber for BC
have a maximum test time 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.
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Basic Functions
Loading Bottles
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.
• Entries to the Patient First Name and Patient Last Name fields
cannot be made without the Hospital ID entry.
• To change the order of the patient name fields, contact your
bioMérieux Representative.
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 4-13.
8)
Open the Incubation Chamber door. 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.
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 door to allow temperature to equilibrate
before loading in that area again.
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Loading Bottles
Basic Functions
CAUTION: If a large number of bottles are loaded into the
Incubation Chamber 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 the doors are completely closed,
then click 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
moving the mouse
loading or unloading bottles
Changing the Maximum Test Time (Individual Bottles)
1)
From the Load screen, click 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 4-7: Change Maximum Test Time Screen
1 — Bottle ID Field
2 — Max Test Time Scroll Buttons
2)
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Verify the bottle ID matches that of the bottle for which you wish to
change the maximum test time.
4-13
Basic Functions
Unloading Bottles
3)
Adjust the maximum test time in days using the Max Test Time scroll
buttons.
4)
Click 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 (see Viewing/Editing Bottle Data in Chapter 5) after
loading.
Handling Anonymous Bottles
Bottles loaded into the Incubation Chamber 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 an Incubation Chamber configured for MB.
The maximum test time of anonymous bottles loaded into the
MB Chamber is the same time specified for the BacT/ALERT®
MP media type on the Set Maximum Test Time screen.
Anonymous bottles loaded into the BC chamber are assigned
the standard default algorithm.
Anonymous bottles should be either removed and identified as specified in
Unloading Bottles on page 4-15 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 60 signals which type of bottles are ready for
unloading by enabling the appropriate Unload button.
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Unloading Bottles
Basic Functions
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 and Printing Test Data on
page 4-22).
2)
From the Main screen (see Figure 4-1), click the appropriate Unload
button.
The Unload Mode screen appears.
1
2
3
4
5
6
7
8
Figure 4-8: 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 door. When the door is open, the cell indicator lights will light
next to all bottles in the selected category.
4)
Remove one of the bottles indicated. Wait for the cell indicator light to
blink slowly to acknowledge the removal of the bottle.
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Basic Functions
Unloading Bottles
5)
If the bottle was identified when loaded:
a. The bottle ID and the bottle type will appear on the Unload Mode
screen; however, the accession number, hospital ID, patient first name
and patient last name will appear in disabled text fields, if information
is available.
b. It is not necessary to re-scan the bottle ID; however, doing so will
verify that bottle's identity.
c. If fields are blank or need editing, then use the Edit Data
Relationships function (see Editing Data Relationships in Chapter 5).
6)
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 (see Loading
Bottles on page 4-10).
• 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 is associated with the
unloaded bottle once the next bottle is unloaded or the Check
button is clicked.
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.
Note:
Do not reload the anonymous bottle if its status is negative or positive.
CAUTION: Reloading bottles anonymously that were previously
loaded will result in duplicate bottle records.
7)
4-16
Repeat Step 3 through Step 7 for the remaining bottles to be unloaded.
Limit the bottle unload time to no more than two minutes in one area.
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Close the door to allow temperature to equilibrate before unloading from
the area again.
CAUTION: If a large number of bottles are unloaded from the
Incubation Chamber 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.
8)
When finished unloading bottles, ensure that the door is completely
closed.
9)
Click the Check button on the Unload Mode screen.
10) Verify that the bottles to be unloaded are listed on the Unload report.
11) Reload any previously Anonymous Negative-to-Date bottles.
If no operator or bottle loading activity has been recorded in a period of 2
minutes, the instrument will terminate the Unload Bottle operation. Operator
activity includes:
•
•
•
•
pressing keys on the keyboard
scanning barcodes
moving the mouse
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 4-10).
Note:
If a bottle is reloaded into the instrument, its status will revert to negative-todate once a reading has been taken (maximum time – ten 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.
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.
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Basic Functions
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), click the Next Screen button
(
).
The Setup screen appears.
1
4
3
2
Figure 4-9: Setup Screen
1 — Password Entry Keypad
2 — Function Buttons
3 — Key Symbol Button
4 — Padlock Icon
2)
Note:
4-18
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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Note:
Basic Functions
Instruments are shipped with a password of 1234. For information on
changing the default password, see Changing the System Password in
Chapter 6.
3)
Click 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, click 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. Click the Key Symbol button and re-enter the
password.
Inactivity Timeout for all Setup Screens
While you are in the Setup screen (see Figure 4-9), 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 clicked.
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 7)
Enable/Disable Rack, or Cell button (see Enabling and Disabling Racks and
Cells in Chapter 7)
Calibrate Temperature button (see Checking an Instrument's Temperature in
Chapter 7)
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Basic Functions
Accessing the Setup Screen Function Buttons
Set Maximum Test Time button (see Setting the Maximum Test Time in
Chapter 6)
Set Audible Alarm Options button (see Setting the Audible Alarms in Chapter 6)
Change Password button (see Changing the System Password in Chapter 6)
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 Editing Bottle Details Using the Edit Bottle Detail
Screen in Chapter 5)
Calibrate Cell button (see Viewing a Cell's Readings and/or Calibrating a Cell in
Chapter 7)
View Incubation Chamber Information button (see Viewing Incubation
Chamber Information in Chapter 7)
Backup Management button (see Initiating Manual Backup in Chapter 6)
Edit Data Relationships button (see Initiating the Edit Data Relationships
Function in Chapter 5)
Report button (see Viewing and Printing Test Data in Chapter 4)
Configure Users button — Button only appears in 21 CFR Part 11 Mode (see
Configuring Users — 21 CFR Part 11 Mode in Chapter 9)
Bottle Processing/Customization button (For use only with instruction from
bioMérieux)
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Viewing and Printing
Basic Functions
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
Reports are viewed and printed by using the Report button as described in
the topic, Viewing and Printing Test Data on page 4-22.
Viewing/Printing Graphs
Bottle Graphs can be viewed on the BacT/ALERT® 3D 60 as described in the
topic, Viewing and Printing Bottle Graphs on page 4-29.
Note:
The print feature can be made unavailable. When the feature is unavailable,
the Print buttons do not display. To make the print feature unavailable, call
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.
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Basic Functions
Viewing and Printing
Viewing and Printing Test Data
1)
From the Setup screen (see Figure 4-9), click the Report button
(
).
The Report Selection screen appears.
1
2
3
4
5
Figure 4-10: Report Selection Screen
1 — Display Report 1 Button
2 — Display Report 2 Button
3 — Display Report 3 Button
4 — Previous Screen Button
5 — Check Button
2)
Click 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.
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• 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 6 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 6).
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Basic Functions
Viewing and Printing
21
20
19
18
1
2
17
3
16
4
5
15
6
14
7
8
9
10
11
12
13
Figure 4-11: 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
4-24
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 (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.
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
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Basic Functions
Instrument Fault Code 80 while it is being unloaded, the Gap Detection
indicator will remain on the report (see Instrument Fault Codes in Chapter 8).
Note:
The Current Section Line will always display the section 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 Section 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),
click the Home scroll button or click 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, click 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, click 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 section, click the appropriate Section scroll
button.
To scroll down to the newest data line (the last data record in the report),
click the End scroll button or click 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, click 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.
9)
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To print the report, click the appropriate Print button:
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Basic Functions
Viewing and Printing
• Clicking the Print Report button prints all records in the database
(with a maximum of 1,920 records).
• Clicking the Print Current Section button prints the Current Section
Line and all data records associated with the section.
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) Click 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, click the Find Text button.
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The Find Text screen appears.
1
Figure 4-12: Find Text Screen
1 — Find Text Field
Enter desired text and click the Check button. The report screen is
displayed. Clicking 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, click the Save button.
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Basic Functions
Viewing and Printing
The Save To File screen appears.
1
Figure 4-13: 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) Click the Check button to initiate the save and return to the report
screen. Clicking 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) Click the Previous Screen button to return to the screen from which the
Report screen was accessed.
Viewing and Printing Bottle Graphs
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons on page 4-18).
2)
Click the Select Bottle to Edit/Graph button (
).
The Select Bottle to Edit/Graph screen overlays and disables the Setup
screen.
7
1
2
3
4
5
6
Figure 4-14: Select Bottle to Edit/Graph Screen
1 — Cell Scroll Buttons
5 — Check Button
2 — Setup Screen (Disabled)
3 — Previous Screen Button
6 — Graph Bottle Readings
Button
4 — Cancel Button
7 — Bottle ID Field
3)
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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
4-29
Basic Functions
Viewing and Printing
page 4-8) and go to Step 5. If you know the cell location but not bottle ID,
then continue to Step 4.
Note:
Only the last 1,920 bottles loaded can be retrieved. Any other entry in the
Bottle ID field is invalid and will cause an Operator Error 940 (see Operator
Error Codes in Chapter 8).
4)
Note:
Adjust the Cell (1 – 60) scroll buttons to select the cell location of the
bottle whose readings you wish to graph. The cell location defaults to
Cell 1.
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)
Click the Graph Bottle Readings button (
).
The Graph Bottle Readings screen appears.
9
10
8
1
7
6
2
3
4
5
Figure 4-15: Graph Bottle Readings Screen
4-30
1 — Name Field
6 — Bottle Readings Range
2 — Adjust Y Scale Button
7 — Days Tested Range
3 — Adjust X Scale Button
8 — Hospital ID Field
4 — Bottle Readings Button
9 — Accession Number Field
5 — Print Graph Button
10 — Bottle ID Field
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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.
• If the bottle was determined positive, then a dot and the time to
detection 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)
Click 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, click 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 4-15). If
there are no readings available, the button is gray.
1)
From the Graph Bottle Readings screen (see Figure 4-15, Graph Bottle
Readings Screen, on page 4-30), click the Bottle Readings button
(
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).
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Basic Functions
Viewing and Printing
The Bottle Readings screen appears.
15
14
13
12
1
11
2
3
4
5
6
7
8
9
10
Figure 4-16: 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:
4-32
To scroll up or down a data line, click the appropriate Line scroll button
or click 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, click the appropriate Page scroll button
or click 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.
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4)
Note:
The Home scroll button is disabled if there are no report data lines in the
indicated direction.
5)
Note:
To scroll down to the newest data line (the last data record in the report),
click the End scroll button or click 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),
click the Home scroll button or click the Home key on the keyboard.
To print the bottle readings, click 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:
Click 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.
Once the cancellation has been completed the Print and Save buttons will
become enabled, and the Cancel Print button will be disabled.
9)
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To specify a text string and initiate a search of the report data for the
specified text, click the Find Text button.
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Basic Functions
Viewing and Printing
The Find Text screen appears.
1
Figure 4-17: Find Text Screen
1 — Find Text Field
Use the keyboard to enter the text you wish to seek, and click the Check
button to return to the Bottle Readings screen. Clicking 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, click the Save button.
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Viewing and Printing
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The Save To File screen appears.
1
Figure 4-18: 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) Click the Check button to initiate the save and return to the Bottle
Readings screen. Clicking 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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Basic Functions
Sending/Requesting LIS Information
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) Click the Previous Screen button to return to the screen from which the
Bottle Readings screen was accessed.
15) When done, click 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:
The system can be configured to perform these functions automatically. To
adjust these settings, call 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), click 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), click the Manual Request Test
Orders button (
).
The arrow on the button face will blink during the transfer.
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EDITING TEST DATA
5
About This Chapter
This chapter provides you with procedures for viewing and editing bottle data.
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 • 5-11
Introduction • 5-11
Initiating the Edit Data Relationships Function • 5-12
Editing Bottle ID to Accession Number Relationships • 5-13
Editing Accession Number to Hospital ID Relationships • 5-15
Editing Hospital ID to Patient Name Relationships • 5-17
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5-1
Editing Test Data
Viewing/Editing Bottle Data
Viewing/Editing Bottle Data
Introduction
By accessing the Edit Bottle Detail screen of both currently loaded and
recently unloaded bottles, the following bottle editing functions can be
performed:
• 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 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)
Click the Check button to save the changes and exit the screen or click
the Cancel button to restore the information originally displayed and exit
the screen.
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Editing Test Data
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 4-9), click the Edit Cell Contents
button.
The Edit Cell Contents screen appears.
1
2
3
Figure 5-1: Edit Cell Contents Screen
1 — Cell
2 — Rack
3 — Restart Incubation Chamber Button
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.
2)
Click the appropriate Cell icon.
The Edit Bottle Detail screen appears (see Editing Bottle Details Using
the Edit Bottle Detail Screen on page 5-5).
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Selecting Bottles Using the Select Bottle to Edit/Graph Button
1)
From the Setup screen (see Figure 4-9), click the Select Bottle to Edit/
Graph button.
The Select Bottle to Edit/Graph screen overlays and disables the Setup
screen.
4
1
3
2
Figure 5-2: Select Bottle to Edit/Graph Screen
1 — Cell Scroll Buttons
2 — Setup Screen (Disabled)
3 — Graph Bottle Readings Button
4 — Bottle ID Field
2)
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 8).
3)
Note:
5-4
If the bottle ID is known, then enter the bottle ID in the Bottle ID field
(see Text/Data Entry in Chapter 4) and proceed to Step 4.
If the cell location (but not bottle ID) is known, then adjust the 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.
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4)
Click 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, 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
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.
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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)
Click 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)
Click 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:
The View Accession Number, View Hospital ID, View Patient First Name
and View Patient Last Name fields are “view-only” fields.
Note:
The fields may also be made unavailable manually. To make the field(s)
unavailable, call 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.
5-6
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Editing Test Data
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 Incubation Chamber 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. Click the Check button to save
changes.
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 Chamber # (Always 1)
• Drawer letter (Always A)
• Cell #
Note:
In order to maintain consistency with the BacT/ALERT® 3D family, the cell ID
includes incubation module and Drawer IDs as well as cell IDs. Incubation
Module and Drawer IDs cannot be changed.
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Editing Test Data
Viewing/Editing Bottle Data
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 change from negative-to-date.
View Test Result Icon
Displays the test status of the selected bottle. Test status is displayed inside
the bottle icon:
5-8
+
Positive (yellow bottle)
-
Negative (green bottle)
*
Negative-to-date (gray bottle)
~+
Critical determination in progress (gray bottle)
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Editing Test Data
Edit Test Result Button
You can use the Edit Test Result button to change the status of the
displayed bottle:
1)
Click 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
2)
Click the checkbox that corresponds to the desired status to insert an X.
3)
Click the Check button to accept the change and return to the Edit Bottle
Detail screen, or click the Cancel button to keep the current status and
return to the Edit Bottle Detail screen.
Note:
Results that have been manually changed 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.
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Viewing/Editing Bottle Data
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 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
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
5-10
How Status Determined
1
Rate
2
Acceleration
3
Initial value
4
Maximum test time exceeded
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Table 5-2: Status Determination Codes (Continued)
Status
Determination
Code
How Status Determined
5
Delta
6
Test in progress
7
Manual (changed at Database Management System)
8
Manual (changed at BacT/ALERT® 3D 60)
9
Algorithm change (see Fault Code 74)
10
Manual (changed by LIS)
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.
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 clicking 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 5-13).
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Editing Data Relationships
• Editing Accession Number to Hospital ID relationships (see Editing
Accession Number to Hospital ID Relationships on page 5-15).
• 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
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 4).
2)
Click the Edit Data Relationships button (
).
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 availability of the buttons also depends on the availability of the fields.
Example: If the Patient First Name and Patient Last Name fields are
unavailable on the system, then the Edit Hospital ID to Name
Relationships button is not available
3)
5-12
To edit a Bottle ID to accession number relationship, click the
corresponding button and see Editing Bottle ID to Accession Number
Relationships on page 5-13.
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4)
To edit an Accession Number to Hospital ID relationship, click the
corresponding button and see Editing Accession Number to Hospital ID
Relationships on page 5-15.
5)
To edit a Hospital ID to patient name relationship, click the
corresponding button and see Editing Hospital ID to Patient Name
Relationships on page 5-17.
Editing Bottle ID to Accession Number Relationships
1
2
3
6
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 60 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.
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Editing Test Data
Editing Data Relationships
Attaching Bottle IDs Without an Accession Number to an Accession Number
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).
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)
Click 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)
Click the top Data Transfer button to move the Bottle ID(s) to the left
Bottle ID scroll box.
5)
Click the Check button to accept the changes, or click the Cancel button
to restore all relationships originally displayed.
6)
When done, click the Previous Screen button to return to the Edit Data
Relationships screen.
If the Edit Bottle ID to Accession Number Relationships screen was accessed
directly from the Setup screen, then 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)
5-14
Click the bottle ID(s) in the left Bottle ID scroll box that are to be
transferred. The selected bottle ID(s) highlight.
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Note:
Editing Test Data
5)
Click the bottom Data Transfer button to move the bottle ID(s) to the
right Bottle ID scroll box.
6)
Click the Check button to accept the changes, or click the Cancel button
to restore all relationships originally displayed.
7)
When done, click the Previous Screen button to return to the Edit Data
Relationships screen.
If the Edit Bottle ID to Accession Number Relationships screen was accessed
directly from the Setup screen, then 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.
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Editing Test Data
Editing Data Relationships
Attaching Accession Numbers Without a Hospital ID to a Hospital ID
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 you wish to
associate to the accession number(s).
3)
Click 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 clicked last is displayed in the Bottle
ID list box.
Note:
4)
Click the top Data Transfer button to move the accession number(s) to
the left Accession Number scroll box.
5)
Click the Check button to accept the changes, or click the Cancel button
to restore all original relationships.
6)
When done, click the Previous Screen button to return to the Edit Data
Relationships screen.
If the Edit Accession Number to Hospital ID Relationships screen was
accessed directly from the Setup screen, then the Previous Screen button
will return to the Setup 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)
Click 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 clicked last is displayed in the Bottle
ID list box.
5-16
5)
Click the bottom Data Transfer button to move the accession number(s)
to the right Accession Number scroll box.
6)
Click the Check button to accept the changes, or click the Cancel button
to restore all relationships originally displayed.
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7)
Note:
When done, click the Previous Screen button to return to the Edit Data
Relationships screen.
If the Edit Accession Number to Hospital ID Relationships screen was
accessed directly from the Setup screen, then the Previous Screen button
will return to the Setup screen.
Editing Hospital ID to Patient Name Relationships
1)
Access the Edit Hospital ID to Patient Name Relationships screen (see
Initiating the Edit Data Relationships Function on page 5-12).
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 — Previous Screen Button
4 — Patient Last Name Field
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)
Click the Check button to accept the changes, or click the Cancel button
to restore all relationships originally displayed.
5)
When done, click the Previous Screen button to return to the Edit Data
Relationships screen.
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Editing Test Data
5-18
Editing Data Relationships
Note:
The Patient First Name and Patient Last Name fields will remain
unavailable until a known hospital ID is entered.
Note:
If the Edit Hospital ID to Patient Name Relationships screen was accessed
directly from the Setup screen, then the Previous Screen button will return to
the Setup screen.
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SOFTWARE CONFIGURATION
6
About This Chapter
This chapter provides you with procedures on how to configure the software.
Chapter Contents
Setting the Maximum Test Time • 6-2
Setting the Audible Alarms • 6-3
Priority of Alarms • 6-5
Terminating an Instrument Alarm • 6-5
Changing the System Password • 6-5
Initiating Manual Backup • 6-7
Configuring Report Screens • 6-9
Introduction • 6-9
Entering Report Labels • 6-9
Configuring Report Contents • 6-13
Viewing and Printing Calibration Data • 6-19
Viewing and Printing Calibration History • 6-22
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Software Configuration
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. 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 4).
2)
Click the Set Maximum Test Time button (
).
The Set Maximum Test Time screen overlays and disables the Setup
screen.
1
3
2
4
Figure 6-1: Set Maximum Test Time Screen
1 — Media Type Scroll Button
2 — Previous Screen Button
3 — Incubation Period Scroll Buttons
4 — Check Button
6-2
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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:
Click the Check button to save the maximum test time settings, or click
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)
Click the Previous Screen button to return to the Setup screen.
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 6-5), 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 Monitor where an error code or picture is displayed. For
resolution of a specific error code, see Operator Error Codes in
Chapter 8.
Note:
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 4).
2)
Click the Set Audible Alarm Options button (
).
The Set Audible Alarm Options screen overlays and disables the Setup
screen.
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Software Configuration
Setting the Audible Alarms
3
1
2
Figure 6-2: Set 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
Click the Check button to save any changes, or click the Cancel button
to return the system to the original settings.
The system returns to the Setup screen.
Note:
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.
6-4
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Changing the System Password
Software Configuration
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 clicking on any area
of any screen of the monitor 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 4).
2)
Click the Change Password button (
).
The Change Password screen overlays and disables the Setup screen.
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Software Configuration
Changing the System Password
4
1
2
3
Figure 6-3: 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 clicked. If the Padlock icon does not open, then repeat Step 3.
Figure 6-4: Padlock Icon (Full Open Position)
6-6
5)
Enter the new password using the Password Entry Keypad buttons.
6)
Click the Key Symbol button.
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Software Configuration
The Padlock icon changes to a half open position.
Figure 6-5: Padlock Icon (Half Open Position)
7)
Re-enter the new password to verify.
8)
Click 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 6-6: Padlock Icon (Closed Position)
9)
Click the Check button to accept the new password, or click the Cancel
button to retain the old password.
10) Click 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.
IMPORTANT:
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 4).
2)
Click the Backup Management button (
).
The Backup Management screen overlays and disables the Setup
screen.
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Software Configuration
Initiating Manual Backup
1
4
2
3
Figure 6-7: 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, click the Manual Backup button.
The system returns to the Setup screen.
Note:
If a manual backup is initiated without a Zip® disk inserted in the drive or a
USB flash drive inserted in the USB port, then an Instrument Status Code 810
will display (see Instrument Status Codes in Chapter 8).
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 6-8: Backup in Progress Icon
6-8
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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.
Note:
If you have a 250 MB Zip® Drive, only use 250 MB Zip® disks for backups.
Note:
If you have a 750 MB Zip® Drive, you may use either a 250 MB or 750 MB
Zip® disk for backups.
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 clicking the appropriate Display Report
Screen button from the Report Selection screen (see Viewing/Printing
Reports in Chapter 4 and Figure 4-10, Report Selection Screen). Perform the
following procedures to configure these report screens.
Entering Report Labels
The following procedure describes how to select labels to be used 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 4).
2)
From the Setup screen, click the Report button (
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Configuring Report Screens
The Report Selection screen appears.
1
2
3
Figure 6-9: Report Selection Screen
1 — Report Label Entry Button
2 — Cancel Button
3 — Check Button
3)
Click the Report Label Entry button (
).
The Report Label Entry screen appears.
6-10
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1
2
Figure 6-10: 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)
Click the field where you will enter the new label.
The field turns white.
5)
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 6-13).
6)
After all desired label changes have been made, verify that all labels are
unique and that no label fields are empty.
7)
Click the Check button to accept the label changes, or click the Cancel
button to retain the previous labels.
The system returns to the Setup screen.
Note:
Operator Error 960 displays if the Check button is clicked with duplicate
Report Label entries present (see Operator Error Codes in Chapter 8).
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Note:
Configuring Report Screens
Operator Error 961 displays if the Check button is clicked 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 6-1: 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 6-1: Report Field Descriptions (Continued)
Field
Description
Displays the bottle ID.
Displays the accession number or other kind of data entered by
the user.
Displays the hospital ID or other kind of data entered by the
user.
Displays the patient’s first name or other kind of data entered
by the user.
Displays the patient’s last name or other kind of data entered
by the user.
Configuring Report Contents
Perform the following procedure to configure the Report screens to show the
desired information (see Figure 4-11, Sample Report Screen).
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, click the Report button (
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Configuring Report Screens
The Report Selection screen appears.
1
2
3
Figure 6-11: Report Selection Screen
1 — Report Configuration Button
2 — Cancel Button
3 — Check Button
3)
Click the Report Configuration button (
).
The Report Configuration screen appears.
See Figure 6-12, Figure 6-13, and Figure 6-14 for examples of the Load,
Status, and Unload Report Configuration screens, respectively.
Note:
4)
Click 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.
6)
6-14
Adjust the column widths by clicking 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.
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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 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)
Click the Section Break checkbox(es) to set a section break.
A sort can be selected 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 fields data
will display in the section break line. This, in effect, allows the user to report
two extra data fields.
10) Click the Preview Report button to view the report configuration (see
Figure 4-11, Sample Report Screen in Chapter 4).
11) Click the Previous Screen button to return to the Report Configuration
screen.
12) Make any adjustments to the report configuration desired.
13) Click the Check button to accept the changes to the report configuration,
or click the Cancel button to retain the original configuration.
14) Click the Previous Screen button to return to the Setup screen.
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Load Report Configuration Screen
1
2
3
11
4
12
5
6
7
8
9
10
Figure 6-12: Load Report Configuration Screen
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
6-16
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Status Report Configuration Screen
1
2
3
11
4
12
5
6
7
8
9
10
Figure 6-13: Status Report Configuration Screen
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
1
2
3
11
4
12
5
6
7
8
9
10
Figure 6-14: Unload Report Configuration Screen
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
6-18
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Viewing and Printing Calibration Data
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, click the Report button (
).
The Report Selection screen appears.
1
Figure 6-15: Report Selection Screen
1 — Calibration Report Button
3)
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Click the Calibration Report button (
).
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Configuring Report Screens
The Cell Calibration Report screen appears.
1
6
5
2
3
4
Figure 6-16: Cell Calibration Report Screen
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, click the appropriate Scroll Up
buttons.
6)
To scroll down a line, page, or end, click 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:
6-20
To print the report, click 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.
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8)
When the report begins printing:
• The Print button is disabled while a report is printing. The operator
may, however, view and scroll through the displayed report.
• The Exit button is disabled while a report is printing.
• The Cancel Print button (
) replaces the Print button. Click
the Cancel Print button to stop the printing.
9)
Click 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
2
3
Figure 6-17: View Window
1 — Rack ID
2 — Number of Cells out of Calibration for this Rack
3 — ID of Cells out of Calibration
Note:
Always print a calibration report prior to calibrating any cells. Then print a
report after calibrating the cells. This will ensure that a record is obtained that
shows corrective action was taken.
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Software Configuration
Configuring Report Screens
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 4).
2)
From the Setup screen, click the Report button (
).
The Report Selection screen appears.
1
Figure 6-18: Report Selection Screen
1 — Calibration History Button
3)
6-22
Click the Calibration History button (
).
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The Calibration History screen appears.
1
7
2
6
3
4
5
Figure 6-19: Calibration History Screen
1 — Report Header
2 — Date, Time, Cell Location, and Cell Status
3 — Print Button
4 — Cancel Print Button
5 — Scroll Down Buttons
6 — View Window
7 — Scroll Up Buttons
The report content is displayed in the View window and contains the
following features:
• 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:
There is nothing displayed to the right of the 1 or 0 if the cell falls out of
calibration, or drifts back into calibration.
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.
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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, click the appropriate Scroll Up
buttons.
6)
To scroll down a line, page, or end, click 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, click 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. Click the Cancel Print
button to stop the printing as soon as the print queue empties.
9)
6-24
Click the Previous Screen button to return to the Report Selection
screen.
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SYSTEM MAINTENANCE
7
About This Chapter
This chapter provides you with procedures on how to perform hardware and
software maintenance on the BacT/ALERT® 3D 60 instrument.
Chapter Contents
Hardware Maintenance • 7-2
Preventative Maintenance • 7-2
Safety Precautions and Procedures • 7-2
Using the Keyboard in Place of the Mouse • 7-6
UPS On/Off Button Location • 7-7
Instrument Reboot/Shutdown • 7-7
Instrument Startup • 7-9
Software Maintenance • 7-9
Introduction • 7-9
Restarting the Incubation Chamber • 7-10
Setting and Formatting the System Date and Time • 7-11
Enabling and Disabling Racks and Cells • 7-13
Adjusting an Instrument’s Temperature • 7-15
Calibrating an Instrument Cell • 7-18
Viewing Incubation Chamber Information • 7-22
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Hardware Maintenance
Hardware Maintenance
Preventative Maintenance
Routine BacT/ALERT® 3D 60 preventive maintenance is determined by your
bioMérieux 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 60 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 to
minimize the risk of needle sticks.
• Each bottle cell within the BacT/ALERT® 3D 60 Instrument is sealed to
help contain and minimize effects of liquid leakage.
• The circulating fans within the Instrument turn off whenever the door is
open, minimizing airflow and the potential for aerosols.
• To reduce the chance for binding a heavily overlabeled bottle,
Instrument cells are gently tapered and fabricated from a pliable
polymer.
• Electrical voltages within the Incubation Chamber are low
(approximately 5 volts or less) to minimize potential electrical hazards.
• Should the optimal temperature in the Instrument be set to a point
outside the range 35–37°C, a yellow Operator alert will appear on the
Calibrate Temperature screen of the Instrument.
• 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
All spills should be treated as if capable of transmitting
disease.
7-2
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Spill Cleanup
Where appropriate, follow your institution's spill clean up procedures.
WARNING
For spills that might involve M. tuberculosis, proper protective
equipment should be worn, including HEPA filtered respirator,
gloves, eye protection, and a lab coat. In some cases, coveralls
or shoe covers should be worn to avoid contaminating street
clothing.
1)
Gently cover the spill area with a paper towel. Apply a 10% bleach
solution or other EPA registered tuberculocidal disinfectant.
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
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.
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 Within the Instrument
WARNING
If a spill is detected that might involve M. tuberculosis, only
persons wearing protective clothing and suitable respiratory
protection should remain in the room. Any test specimen
spilled in an instrument should be removed immediately and
the affected areas decontaminated using the following
procedure.
Note:
1)
Visually inspect the extent of the leakage or spill. Determine if the
instrument or any rack 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 4).
4)
Relocate the remaining bottles in the affected rack(s) using the following
procedure.
a. 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 are lit continuously.
• Cells available for reloading are unlit.
Note:
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 M-29A. Click the Load Bottles button to
reload the decontaminated bottles.
b. Relocate bottles one at a time into any available cell or unload
contaminated bottles.
Note:
7-4
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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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 4).
d. When all bottles are relocated or unloaded, click the Check button on
the Main screen.
CAUTION: When unloading multiple bottles using Ctrl + F10, the
bottles must be reloaded before one hour has passed using the
normal Load Bottles icon to avoid a subculture event.
5)
Disable the affected cell(s) or rack(s) (see Enabling and Disabling Racks
and Cells on page 7-13).
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.
7)
If the spill is confined to one or a few cells of one 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 15–30 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.
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g. Calibrate the cell. If the cell passes calibration, enable the cell (see
Enabling and Disabling Racks and Cells on page 7-13).
8)
If the cell fails calibration or there is visible blood 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.
9)
Note:
For more extensive spills, it may be necessary to remove one or more
racks. To gain access to internal instrument surfaces, remove all three
racks (contact your bioMérieux Representative).
Decontaminate bottles, cells, and racks, 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 M-29A.
Using the Keyboard in Place of the Mouse
Normally, the mouse and monitor are used to make selections and enter
data. The keyboard provides an alternate method as follows.
• 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, numeric keys can be
used in place of clicking on the screen. The 1 to 4 keys are used to enter
the password value. The 5 key is used in place of clicking the Key Symbol
button.
• Scroll buttons are selected using the Tab key. Once the desired scroll
button is selected, use the > or < keys to select the Up or Down scroll
arrow.
Function keys can be used to invoke the following functions:
Alt + F5
7-6
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. When the door is opened,
the cell indicator lights will light for those bottles in non-operational
cells. Cells with rapidly flashing cell indicator lights are disabled or
unusable.
In this mode, the Instrument automatically activates the Unload
Bottles function. Bottles can be removed from the indicated cells
one at a time and moved to unusable 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. When the door 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 door 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. When the
door 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
The UPS for the Instrument is external. The On/Off button is located at the
front of the UPS.
Instrument Reboot/Shutdown
The following situations require the Instrument to be turned off or rebooted.
• Anticipated power outage.
• Moving a system to a new location.
• Fixing an unresponsive mouse, monitor, or keyboard.
Note:
Before rebooting the Instrument, always perform a system backup (see
Initiating Manual Backup in Chapter 6). Do not proceed with the reboot until
the Backup in Progress icon no longer displays.
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Note:
Hardware Maintenance
Call 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)
On the keyboard, press each key in the order listed: Esc Y E S.
2)
Wait for the software to exit to a black screen with a C:\ > prompt.
To reboot the BacT/ALERT® 3D 60, click 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 Instrument and the UPS, see
Method 4.
Shutdown Method 2
1)
Note:
Click the Right Arrow button to advance to the Setup screen.
If the system is unresponsive, proceed to Method 4.
2)
Enter the Software Exit Password 24313124.
3)
The password entered is accepted by clicking 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.
5)
Click the Exit Software button (
6)
Wait for the C:\> prompt to appear on a black screen.
).
To reboot the BacT/ALERT® 3D 60, click 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 Instrument and the UPS, see
Method 4.
7-8
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Shutdown Method 3
1)
Note:
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.
2)
Wait for the C:\> prompt to appear on a black screen.
To reboot the program, click 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 Instrument 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 Instrument Power Switch. This switch is located in the back,
just above the power cord entry.
2)
Click the UPS On/Off button once to turn Off the power to the UPS (see
UPS On/Off Button Location on page 7-7).
Instrument Startup
1)
Turn On the Instrument Power Switch. This switch is located in the lower
left corner facing the back of the Instrument.
2)
Click the UPS On/Off button once to turn On the power to the UPS (see
UPS On/Off Button Location on page 7-7).
Software Maintenance
Introduction
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:
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• Restarting the Incubation Chamber (see Restarting the Incubation
Chamber on page 7-10).
• Setting the date/time and selecting date/time formats (see Setting and
Formatting the System Date and Time on page 7-11).
• Enabling and disabling racks and cells (see Enabling and Disabling Racks
and Cells on page 7-13).
• Checking the temperature, setting the optimal temperature, and calibrating
the temperature of the Instrument (see Adjusting an Instrument’s
Temperature on page 7-15).
• Calibrating and viewing readings of cells (see Calibrating an Instrument
Cell on page 7-18).
• Viewing Incubation Chamber information (see Viewing Incubation
Chamber Information on page 7-22).
Restarting the Incubation Chamber
Perform the following to restart an Incubation Chamber without using the
power switch in the case of a communication problem.
1)
7-10
Click the Instrument icon on the Main screen (see Figure 4-1).
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The View Cell Status screen appears.
1
6
5
2
3
4
Figure 7-1: View Cell Status Screen
1 — Door Fault Code
2 — Rack Fault Code
3 — Cell Fault Code
4 — Restart Incubation Chamber Button
5 — Rack
6 — Cell
2)
Note:
Click the Restart Incubation Chamber button.
It is normal for instrument status code 710 to display briefly.
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.
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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, click the Set Date/Time button (
).
The Set Date/Time screen overlays and disables the Setup screen.
5
1
2
3
4
Figure 7-2: 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
7-12
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.
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6)
Note:
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)
Click the Check button to accept the changes, or click the Cancel button
to retain the original settings.
8)
The system returns to the Setup screen.
Enabling and Disabling Racks and Cells
1)
Before disabling a rack or cell, make certain there are no bottles in the
part to be disabled (see Relocating Bottles on page 7-14).
2)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 4).
3)
Click the Enable/Disable Rack or Cell button (
).
The Enable/Disable Rack or Cell screen overlays and disables the Setup
screen.
4
1
3
2
Figure 7-3: Enable/Disable Rack or Cell Screen
1 — Rack Scroll Button
2 — Setup Screen (Disabled)
3 — Enable/Disable Slidebar Switch
4 — Cell Scroll Button
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4)
To enable/disable an entire rack:
a. Select the Rack desired (1–20, 21–40, or 41–60) using the Rack
scroll button.
b. Set the Enable/Disable slidebar switch below the Rack icon to enable
(1) or disable (0).
c. Go to Step 6.
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.
5)
To enable/disable a cell:
a. Select the Rack (1–20, 21–40, or 41–60) that holds the cell using the
Rack scroll button.
b. Select the Cell desired (1–20) using the Cell scroll button.
c. Set the Enable/Disable slidebar switch below the Cell icon to enable
(1) or disable (0).
6)
Click the Check button to accept change(s), or the Cancel button to
return previous settings.
7)
Click the Previous Screen button to return to the Setup screen.
Relocating Bottles
In certain situations (ex. before disabling a rack), it may be necessary to
move bottle(s) into another available cell or rack.
CAUTION: When unloading multiple bottles using Ctrl + F10, the
bottles must be reloaded before one 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.
Note:
7-14
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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2)
Pull bottles out one at a time and reload one at a time into any available
cell.
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 4).
4)
When all bottles are relocated, click the Check button on the Main
screen (see Figure 4-1).
Adjusting an Instrument’s Temperature
The following procedures describe:
• How to check an Instrument’s temperature.
• How to set an Instrument’s optimal temperature setting.
• How to calibrate an Instrument’s temperature.
Checking an Instrument's Temperature
Each Instrument includes an NIST-traceable Reference Thermometer
located on the Rack Cable Cover (see Figure 7-4). This thermometer is the
reference used to calibrate the temperature.
1
1
Figure 7-4: Reference Thermometer
1 — Thermometer Location
Note:
The thermometer should be periodically validated according to your current
protocol.
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Before opening the door to take a reading with this thermometer, verify that
the 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 4).
2)
Click the Calibrate Instrument Temperature button (
).The
Calibrate Instrument Temperature screen overlays and disables the
Setup screen.
1
5
2
4
3
Figure 7-5: Calibrate Instrument Temperature Screen
1 — Internal Air Temp Indicator
2 — Time Remaining Until Stable Indicator
3 — Setup Screen (Disabled)
4 — Actual Temp Scroll Buttons
5 — Optimal Temp Scroll Buttons
3)
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.
7-16
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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.
4)
Read the temperature once the temperature is stable.
5)
Close the door immediately after taking the reading.
Setting the Optimal Temperature for an Instrument
1)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 4).
2)
Click the Calibrate Instrument Temperature button (
).
The Calibrate Instrument Temperature screen overlays and disables the
Setup screen (see Figure 7-5).
3)
Note:
Enter the desired optimal temperature in degrees Centigrade (°C) on the
Optimal Temp scroll buttons.
The valid range of values for the optimal temperature of an Instrument 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 5°C
above ambient.
4)
Click the Check button to initiate the temperature adjustment, or click the
Cancel button to retain the previous setting.
5)
Click the Previous Screen button to return to the Setup screen.
6)
Calibrate the Incubation Chamber after the temperature becomes stable
(see Checking an Instrument's Temperature on page 7-15).
Calibrating an Instrument's Temperature
Temperature calibration is required:
• Anytime the optimal (setpoint) temperature is changed.
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• Any time the periodic check of the Reference Thermometer reveals
that the temperature is more than 0.5°C above or below the setpoint.
1)
Check the Instrument's temperature (see Checking an Instrument's
Temperature on page 7-15).
2)
Enter the temperature from the Reference Thermometer in degrees
Centigrade (°C) on the Actual Temp scroll buttons (see Figure 7-5).
3)
Click the Check button to initiate the calibration, or click the Cancel
button to retain the previous calibration.
4)
Click 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.
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
7-18
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 4).
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If the cell cannot be calibrated immediately, disable the cell (see Enabling
and Disabling Racks and Cells on page 7-13).
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
1)
If calibrating, print out the Cell Calibration Report (see Viewing and
Printing Calibration Data in Chapter 6).
2)
If the cell to be calibrated contains a bottle, then relocate it (see
Relocating Bottles on page 7-14).
3)
Access the Setup screen and enter a valid password (see Accessing the
Setup Screen Function Buttons in Chapter 4).
4)
Click the Calibrate Cell button (
).
The Calibrate Cell screen overlays and disables the Setup screen.
1
4
2
3
Figure 7-6: Calibrate Cell Screen
1 — Cell Scroll Buttons
2 — Cell Reading Indicator
3 — Setup Screen (Disabled)
4 — Calibration Staircase Icon
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5)
Select a particular cell to be calibrated by choosing the appropriate cell
(1–60) with the Cell scroll buttons.
The first screen displays an X at the base of the Calibration Staircase
icon. This prompts the user to verify the cell is empty and the door is
closed.
Note:
The Cell scroll buttons will be grayed-out and inactive until calibration of the
cell is complete.
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 Chamber 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)
Click the Check button.
The cell indicator light of the cell selected for calibration is now
illuminated and #1 appears above the first step of the Calibration
Staircase icon.
7-20
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)
Click the Check button.
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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) Click 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) Click the Check button.
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) Click 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 click 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. Click the
Cancel button and follow Step 4 through Step 14 to recalibrate the cell.
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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 Racks and Cells on page 7-13).
18) Click the Previous Screen button to return to the Setup screen.
Note:
The calibration process can be canceled and any new calibration values
discarded by clicking 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 6).
Viewing Incubation Chamber Information
This procedure describes how to locate the following information:
• Serial Numbers
• Hardware Revisions
• Software Revisions
You may be requested to retrieve this information during the course of
troubleshooting by your local bioMérieux Representative.
7-22
1)
Arrow to the Setup screen and enter a valid password to access the
function buttons (see Accessing the Setup Screen Function Buttons in
Chapter 4).
2)
Click the View Incubation Chamber Information button (
).
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The View Incubation Chamber Information screen replaces the Setup
screen.
1
2
Figure 7-7: View Incubation Chamber Information Screen
1 — Incubation Chamber Information
2 — Rack Information
3)
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Click the Previous Screen button to return to the Setup screen.
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SYSTEM TROUBLESHOOTING
8
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.
Chapter Contents
Introduction • 8-2
Fault Codes • 8-3
Instrument Fault Codes • 8-3
Instrument Status Codes • 8-16
Operator Error Codes • 8-18
Bottle Problems • 8-29
User Output Device Problems • 8-29
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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 one hour may lead to invalid test results and the need to
subculture bottles.
The following codes are discussed in this chapter.
1
39
56
99
923
2
41
57
710
930
3
42
60
800
931
4
43
62
810
932
6
44
71
820
940
10
45
72
901
941
11
46
73
902
942
12
47
74
909
943
14
51
75
910
944
19
52
77
911
945
20
53
78
912
960
21
54
80
913
961
22
55
81
921
If the problem cannot be corrected using the solutions listed, or a code is
displayed that does not appear in this list, call 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 2, 10, and 20. Fault codes are
displayed on the particular components where the errors are located.
Figure 8-1: Instrument Icon with Fault Codes
Note:
Locate specific bottles with fault by clicking the Incubation Chamber 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 CHAMBER
Cause: Fuse has been blown.
Solution: Contact bioMérieux.
#2
COMMUNICATION LOST WITH INCUBATION CHAMBER
Cause: Internal cables may be loose, or hardware problem.
Solution: Contact bioMérieux.
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#3
INCUBATION CHAMBER TEMPERATURE IS TOO HIGH
Background Information: The optimal temperature (setpoint)
and actual Chamber 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 one 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
(ex. MOD SIG, temperature sensors, or relay).
Cause: The Instrument optimal temperature (setpoint) has
been changed and has not yet equilibrated at the new
temperature.
Solution: Wait for the chamber temperature to equilibrate.
Cause: Bottle testing may be adversely affected due to one of
the following reasons:
• Hardware fault with the ModSig Board.
• Hardware fault with the Solid State Relays that
energize the heater.
• Faulty temperature sensors.
Solution: Contact bioMérieux immediately.
#4
INCUBATION CHAMBER TEMPERATURE IS TOO LOW
Background Information: The optimal temperature (setpoint)
and actual Chamber 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 one 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 (ex. MOD SIG, temperature
sensors, relay, cutoff switch tripped, or heater element).
Cause: The Instrument optimal temperature (setpoint) has
been changed and the chamber has not yet equilibrated at the
new temperature.
Solution: Wait until Instrument temperature equilibrates.
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Cause: The door has been left open or ajar for an extended
period.
Solution: Make sure the door closes tightly and allow the
chamber temperature one hour to equilibrate.
Cause: Bottle testing may be adversely affected due to one of
the following reasons:
• Hardware fault with the ModSig Board.
• Hardware fault with the Solid State Relays that
energize the heater.
• Faulty temperature sensors.
Solution: Call bioMérieux immediately.
#6
AGITATION STEPPER MOTOR FAULT
Cause: Agitation Stepper Motor has reported a fault.
Solution: Call bioMérieux.
#10
INSTRUMENT POWER FAULT
Cause: The Instrument is not receiving AC power.
Solution:
1.
Ensure AC power source is adequate or connect to an
alternate power source.
2.
The Instrument 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 Instrument.
Solution: Check the LIS. The fault automatically goes away
when communication with the LIS resumes.
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Fault Codes
Cause: The message from the Instrument is not reaching the
LIS.
Solution: Check the cable connections between the Instrument
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.
#20
DOOR OPEN FOR TOO LONG
Cause: The door has been left open or ajar for an extended
period.
Solution: Make sure door is tightly closed.
Cause: Door sensors have failed or become misaligned.
Solution: Call bioMérieux.
Cause: Fault in the ModSig board.
Solution: Call bioMérieux.
#21
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 bottom rack.
Solution: Call bioMérieux.
#22
UNEXPECTED AGITATION
Cause: Instrument not configured properly.
Solution: Call bioMérieux.
8-6
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#39
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 (ex. MOD SIG,
temperature sensors, relay, cutoff switch tripped, or heater
element).
Cause: The door has been left ajar for an extended period or
there is a system failure.
Solution: Perform the following procedure:
#41 47
1.
Check the temperature in the Incubation Chamber.
2.
If the temperature is high, there is a system failure. Leave
the door open so the bottles will not overheat and call
bioMérieux.
3.
If the temperature is low, make sure the door is
completely closed and wait 30 minutes to see if the fault
goes away. If the fault does not go away, call bioMérieux.
RACK(S) X NOT RESPONDING
Cause: Faulty rack controller or rack interface cable(s).
Solution: Call bioMérieux.
#51 57
RACK HARDWARE FAILURE
Cause: Faulty Rack printed circuit board.
Solution: Call bioMérieux.
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Fault Codes
#60
CELL FAILED QC
Cause: A cell failed the automatic internal diagnostic check.
Solution: Perform the following procedure:
#62
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 7).
Get corrected Calibration Report, if necessary.
4.
If calibration cannot be performed at this time, or if a cell
fails to calibrate, disable cell, and insert an orange cell plug
in the disabled cell.
5.
Call bioMérieux if cell calibration is unsuccessful.
ERRONEOUS CELL LOAD STATUS REPORTED
Cause: A cell is out of calibration.
Solution: Use the View Cell Status screen (see Viewing
Faults in Chapter 4) 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:
• 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.
3.
If the bottle is anonymous (the Bottle ID field is blank),
then enter the bottle ID (see Text/Data Entry in Chapter 4).
When all bottles are unloaded, click the Check button on
the Main screen.
4.
Attempt to calibrate the cell (see Calibrating an Instrument
Cell in Chapter 7). Get corrected Calibration Report if
necessary.
5.
If the calibration fails, then disable the cell (see Enabling
and Disabling Racks and Cells in Chapter 7).
• 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).
8-8
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#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). If the time passed is greater than one hour,
bottles must be subcultured.
1.
#73
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.
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 one 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.
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1.
Reboot the system (see Instrument Reboot/Shutdown in
Chapter 7).
2.
Call bioMérieux.
8-9
System Troubleshooting
Fault Codes
#74
ALGORITHM CHANGE
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.
Click 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:
8-10
1.
Click 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.
4.
The original first loaded date and time is replaced with the
date and time the bottle is reloaded.
5.
The maximum test time is set to the default associated with
the bottle type.
6.
If desired, the bottle's maximum test time may be
shortened so that the bottle will complete testing when
expected.
7.
If the fault code persists, call bioMérieux.
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System Troubleshooting
#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.
Click 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:
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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.
8-11
System Troubleshooting
Fault Codes
#80
READING GAP DETECTED
Cause: This fault occurs when there is a gap in bottle readings
greater than one hour. This situation may occur when the
power to the Instrument is lost for more than one hour. It may
also occur if a negative-to-date bottle is unloaded, then
reloaded more than one 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
and Printing Test Data in Chapter 4).
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.
8-12
1.
From the Setup screen, enter the system password (see
Accessing the Setup Screen in Chapter 4).
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 4-4, View Cell Status Screen, on
page 4-6). 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).
8-13
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
Figure 4-4, View Cell Status Screen, on page 4-6). 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, on page 5-5).
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 4-4, View
Cell Status Screen, on page 4-6) 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 4-6, Main Screen — Load
Mode, on page 4-10).
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 4-6, Main Screen —
Load Mode, on page 4-10).
WARNING – The bottle must be subcultured.
8-14
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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). If less than one 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.
Note - If no bottle(s) are present in the indicated cell, call
bioMérieux.
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.
Click 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
Instrument Status Code 710.
Figure 8-2: Instrument Status Code 710
#710
INCUBATION CHAMBER TEMPORARILY UNAVAILABLE
WHILE POWER UP INITIALIZATION TAKES PLACE
Cause: Turning On the power of an Instrument or clicking the
Restart Incubation Chamber button invokes the Power Up
screen to appear on the monitor. 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 Chamber is ready.
Do NOT load bottles while the Power Up screen is present.
#800
PRINTER FAULT
Cause: The Instrument 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.
8-16
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System Troubleshooting
#810
BACKUP FAILED
Cause: The Instrument 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 6).
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 6).
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.
#820
If this backup fails, call bioMérieux.
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 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.
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System Troubleshooting
Fault Codes
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 Operator Error Code
911.
Figure 8-3: 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.
8-18
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 Fault 75 is present, then follow the procedure provided to
correct the problem (see Instrument Fault Code #75 on
page 8-10).
4.
If error persists, call bioMérieux.
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System Troubleshooting
#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 4).
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 4-4, View Cell Status Screen, on page 4-6).
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.
#910
2.
Scan the Bottle ID again and Accession Number (if
needed).
3.
Reload the bottle into an available cell (one which has its
cell indicator light lit).
INVALID CELL LOAD
Cause: Indicates that a bottle was loaded in a cell that is
disabled or non-functional. 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
Instrument.
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 CLICK 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.
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System Troubleshooting
Fault Codes
#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 Instrument. The cell will also have a rapidly flashing cell
indicator light. Reloading the indicated bottle also causes the
Operator Error screen to vanish.
Click the Check button ONLY if the unload was intentional.
#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 Instrument.
2.
Reload the bottle into a functional cell. Moving the
indicated bottle to another cell causes the Operator Error
screen to vanish.
DO NOT CLICK the Check button on the Operator Error screen
except to intentionally ignore the error and leave the bottle
loaded in the nonfunctional cell.
Ignoring the error leaves the original bottle in a nonfunctional
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 click the Check button after it
turns red.
8-20
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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 click 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 2 (see Selecting Bottles Using the Edit
Cell Contents Button in Chapter 5). The Edit Bottle Detail
screen will display.
7.
Enter the correct bottle ID (the one recorded in Step 4) in
the Bottle ID field.
8.
Click 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 characters are ‘, “, \,
*, @.
Solution: Acknowledge error and rescan bottle. If error persists
after rescanning the barcode, attempt to enter the accession
number 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 click the Check button after it turns
red.
8-22
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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 click
anywhere on 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.
Click 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 click 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 rescanning the bottle ID and if
correctly entered, click the Check button.
2.
If no changes are made and the Check button is clicked,
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 8-10).
Note - Unload another bottle or click 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 click the Check button.
2.
See instructions above if no changes are made and the
Check button is clicked.
Note - Unload another bottle or click the Cancel button to
ignore the error.
WARNING – The bottle must be subcultured.
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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 click the Check button.
If the bottle ID was entered correctly, perform the following
procedure:
1.
Re-enter the bottle ID and click the Check button.
Note - The bottle readings for the previously unloaded bottle
will be lost and the bottle ID, Accession Number, 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 8-11).
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 clicked), 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 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 click 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. Click the Cancel button to clear
the error.
Solution: If the bottle ID was entered incorrectly, enter the
correct bottle ID now and click the Check button.
If the bottle ID is correctly entered, perform the following
procedure.
1.
Click the Cancel button on the Edit Bottle Detail screen.
2.
Enter the same bottle ID (the one used on the previous
screen) and click 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 Operational Error 911 that
appears on the screen when the bottle is unloaded.
CAUTION – DO NOT click the Check button.
8-26
3.
Return the bottle to the same cell from which it was
removed.
4.
Correct the bottle ID and click the Check button. It is now
possible to edit or identify the original bottle ID.
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#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.
Click the Cancel button and return to the Edit Bottle Detail
screen to correct the entry.
2.
Click 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.
Click the Check button to override the error. Note the cell
ID of the bottle.
2.
Click 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 8-10).
IDENTIFIED BOTTLE CHANGED TO ANONYMOUS
Cause: The Bottle ID field has been cleared for an identified
bottle in the Edit Bottle Detail screen.
Solution: Click Cancel to return to the Edit Bottle Detail
Screen. Enter the correct bottle ID and click 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: Click 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.
Click the Cancel button on the error screen.
2.
Enter the correct bottle ID on the Edit Bottle Detail screen
and click the Check button.
If the bottle ID was entered correctly, perform the following
procedure:
1.
Click 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, First Loaded
Time, Maximum Test Time, and Bottle Type will be assigned to
the newly identified bottle.
2.
960
Click 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 8-11).
DUPLICATE ENTRIES
Cause: Two or more label entry fields on the Label Entry
screen contained the same entry when the Check button was
clicked.
Solution: Change one of the duplicate labels to a unique entry
and click 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 clicked.
Solution: Enter a label in the blank field and click 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 clicking 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 7).
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
CELL INDICATOR LIGHT(S)
NEVER COME ON
Cause: Various.
Solution: Call bioMérieux.
INSTRUMENT ALARM NOT SOUNDING
Cause: Alarm disabled.
Solution: Verify the alarm settings are correct (see Setting the
Audible Alarms in Chapter 6). If this does not correct the
problem, call bioMérieux.
BARCODE SCANNER DOESN'T BEEP
Cause: Various.
Solution: Call bioMérieux.
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System Troubleshooting
Fault Codes
BARCODE CANNOT BE SCANNED
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: Perform the following procedure:
1.
Power down the Instrument (see Instrument Reboot/
Shutdown in Chapter 7).
2.
Make sure the barcode scanner is firmly connected at the
back of the Instrument (see Figure 2-3, Instrument Rear
View, on page 2-10).
3.
Restart the Instrument (see Instrument Reboot/
Shutdown in Chapter 7).
4.
Call bioMérieux if the problem is not resolved.
Note - The keyboard may also be used to enter the barcode
manually.
Cause: Scanner's Operational Parameters are no longer set.
Solution: Scan the applicable Reset Barcode (see Figure 8-4
or Figure 8-5) to reset the Operational Parameters.
Figure 8-4: QuickScan® 6000 Reset Barcode
Figure 8-5: Honeywell Reset Barcode
KEYBOARD NOT RESPONDING
Cause: Various.
Solution: Reboot the system (see Instrument Reboot/
Shutdown in Chapter 7).
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Fault Codes
System Troubleshooting
MONITOR BLANK
Cause: Instrument not receiving power.
Solution: Check the power switch and the power cord
connection.
SYSTEM UNRESPONSIVE
Cause: Various.
Solution: Reboot the system (see Instrument Reboot/
Shutdown in Chapter 7). Call bioMérieux if the problem is not
resolved.
Note - The keyboard may be used instead of the mouse to
operate the instrument and to activate the load and unload
functions (see Using the Keyboard in Place of the Mouse in
Chapter 7).
RED INFORMATIONAL WARNING SCREEN APPEARS
Cause: A red Informational Warning screen indicates that the
BIOS clock setting is incorrect.
Figure 8-6: 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 8-6) 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 – The bottles must be subcultured.
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Fault Codes
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21 CFR PART 11 MODE
9
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 • 9-2
Logging In for the First Time • 9-2
Logging In • 9-6
Inactivity Timeout • 9-7
Login Errors • 9-7
Change Password • 9-8
Change Password Errors • 9-9
Logging Out • 9-12
Configuring Users — 21 CFR Part 11 Mode • 9-12
Adding a User • 9-13
Deleting a User • 9-15
Clearing a User Password • 9-16
Audit Trail • 9-18
Accessing the Audit Trail • 9-20
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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 60 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 9-1).
1
Figure 9-1: 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 9-13).
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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 9-1), click the Login
button (
).
The User Login screen appears.
1
4
2
5
6
3
Figure 9-2: 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)
Click in the User Name field (field turns white) and enter your user name.
3)
From the User Login screen (see Figure 9-2, User Login Screen), click
the Change Password button (
).
The New Password and Confirm Password fields appear on the User
Login Screen (see Figure 9-3).
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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 9-3: 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
9-4
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)
Click 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 9-4: Main Screen While Logged In — 21 CFR Part 11 Mode
Note:
The Previous Screen button returns to the User Login screen (see
Figure 9-5, User Login Screen, on page 9-6) without logging in.
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21 CFR Part 11 Mode
Log In/Out of System — 21 CFR Part 11 Mode
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 9-1), click the Login
button (
).
The User Login screen appears.
1
4
2
5
6
3
Figure 9-5: 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.
9-6
4)
Enter your password in the Password field (password length must be 6
to 24 characters).
5)
Click the Check button or the Enter key to log in to the instrument.
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Log In/Out of System — 21 CFR Part 11 Mode
21 CFR Part 11 Mode
The Main screen appears (see Figure 9-4, Main Screen While Logged In —
21 CFR Part 11 Mode, on page 9-5).
Note:
See Configuring Users — 21 CFR Part 11 Mode on page 9-12 for detailed
information on how to add and delete users, and clear user passwords.
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 9-1, Main Screen While Logged Out —21 CFR Part 11
Mode, on page 9-2). Any pending function is cancelled as if the Cancel
button on each successive screen was clicked.
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 click the Enter, Check or Change
Password button (see Figure 9-6).
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21 CFR Part 11 Mode
Log In/Out of System — 21 CFR Part 11 Mode
4
1
3
2
Figure 9-6: 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)
Click 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 9-6).
or
Click the Previous Screen button to return to the User Login screen
without logging in (see Figure 9-5, User Login Screen, on page 9-6).
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 9-5, User Login Screen), click
the Change Password button (
9-8
).
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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 9-7).
4
1
5
2
3
Figure 9-7: 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)
Click either the Check button or the Enter key to change your password.
The Previous Screen button returns to the User Login screen (see
Figure 9-5, User Login Screen, on page 9-6) 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 9-8). If you enter a password with less
than 6 characters, a wrong password alert appears on the User Login screen
(see Figure 9-9).
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 9-8: 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
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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 9-9: 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)
Click in 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)
Click the Check button or the Enter key to change your password.
The Previous Screen button returns to the User Login screen (see
Figure 9-5, User Login Screen, on page 9-6) without logging in.
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9-11
21 CFR Part 11 Mode
Configuring Users — 21 CFR Part 11 Mode
Logging Out
1)
From the Main screen (see Figure 9-4, Main Screen While Logged In —
21 CFR Part 11 Mode, on page 9-5), click the Logout button (
to log out of the instrument.
)
The Main screen (while logged out) appears (see Figure 9-1, Main
Screen While Logged Out —21 CFR Part 11 Mode, on page 9-2).
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 9-7).
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 4-9, Setup Screen), click the
Configure Users button (
9-12
).
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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 9-10: 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 9-10, User
Configuration Screen), click the Add User button (
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).
9-13
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 9-11: 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)
Click the Add User button or the Enter key.
The new user is added to the User List.
4)
Note:
9-14
Click 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 9-2, 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 9-10, User
Configuration Screen, on page 9-13), click the Delete User button
(
).
The Delete User screen appears.
6
1
5
4
3
2
Figure 9-12: 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)
Click the Scroll Up or Scroll Down button to locate the user name to be
deleted.
3)
Click the user name to select.
4)
Click the Delete User button to delete the selected user from the User
List.
5)
Click 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 9-12), click on the user names
to select.
If you select the wrong user name, click on the user name again to deselect.
2)
Click the Delete User button to delete the selected users from the User
List.
3)
Click 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 9-10, User
Configuration Screen, on page 9-13), click the Clear Password button
(
9-16
).
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Configuring Users — 21 CFR Part 11 Mode
21 CFR Part 11 Mode
The Clear Password screen appears.
6
1
5
4
3
2
Figure 9-13: Clear Password Screen
Note:
1 — Clear Password Button
4 — Scroll Down Button
2 — Previous Screen Button
5 — User List
3 — Check Button
6 — Scroll Up Button
2)
Click the Scroll Up or Scroll Down button to locate the user name.
3)
Click the user name to select.
4)
Click the Clear Password button to clear the password for the selected
user.
5)
Click 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 9-2).
Clearing More Than One User Password
To clear more than one user password at a time:
1)
Note:
From the Clear Password screen (see Figure 9-13), click on the user
names to select.
If you select the wrong user name, click on the user name again to deselect.
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21 CFR Part 11 Mode
Audit Trail
2)
Click the Clear Password button to delete the passwords for the
selected users from the User List.
3)
Click 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 9-1 for a list of events recorded in the audit trail.
Table 9-1: Audit Trail Events
Event
9-18
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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Audit Trail
21 CFR Part 11 Mode
Table 9-1: 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, Chamber 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.
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 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)
Operator 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.
9-19
21 CFR Part 11 Mode
Audit Trail
Table 9-1: 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 60 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.
9-20
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MYCOBACTERIAL TESTING
10
About This Chapter
This chapter provides you with a complete description of the of the
BacT/ALERT® 3D 60 instrument when it is configured for Mycobacterial (MB)
functions.
Chapter Contents
System Description • 10-2
Intended Use • 10-2
Overview • 10-2
BacT/ALERT® 3D 60 Instrument • 10-3
BacT/ALERT® 3D 60 Software • 10-4
System Startup • 10-5
General Information • 10-5
Theory of Operation • 10-6
Safety Features • 10-7
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Mycobacterial Testing
System Description
System Description
Intended Use
The Mycobacterial (MB) configuration of the BacT/ALERT® 3D 60 instrument
is designed to grow and detect mycobacteria from patient samples.
Overview
The BacT/ALERT® 3D 60 system uses no radioactive reagents, is noninvasive, 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 60 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 60 instrument can be converted by a service engineer
to perform either MB or non-MB functions. One important difference between
the configurations is that MB configurations do not agitate the bottles during
incubation. It is important to open and close the door gently to minimize
avoidable agitation when adding or removing bottles.
The disposable mycobacteria bottles (MB and MP) 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.
In the following pages, the elements of the MB configuration of the
BacT/ALERT® 3D 60 will be described with special emphasis on how they
differ from the non-MB configuration described in the rest of this manual.
While the 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.
10-2
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System Description
Mycobacterial Testing
BacT/ALERT® 3D 60 Instrument
The instrument incubates and continuously monitors the status of each
mycobacterial culture bottle. The instrument consists of three racks each with
a capacity of 20 bottles. The instrument must be either MB or non-MB.
MB Instrument may be provided directly by bioMérieux or may be converted
from a non-MB configuration in the field.
An MB is displayed on the Instrument icon of the Main Screen (see
Figure 10-1).
Figure 10-1: Instrument Icon for MB-Configured System
Circulation Fan
The circulation fan, normally running to distribute air within the
BacT/ALERT® 3D 60 instrument, is turned off whenever the door is opened.
Note:
The BacT/ALERT® 3D 60 software must also be configured to activate the
MB processing (see MB Configuration on page 10-5).
Installation Procedures and Special Requirements
If it is necessary to move or store the BacT/ALERT® 3D 60 System, contact
your local bioMérieux Representative for assistance.
The BacT/ALERT® 3D 60 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.
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Mycobacterial Testing
System Description
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.
BacT/ALERT® 3D 60 Software
Barcodes
• Mycobacteria process bottle (MP) barcodes are encoded with the bottle
type and have an SM (plastic) prefix.
• Mycobacteria blood bottle (MB) barcodes are encoded with the bottle type
and have an !B (glass) prefix.
WARNING
Do not use Generic barcodes to load BacT/ALERT® MB Bottles.
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 6).
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.
Figure 10-2: Bottle Count Table and Unload Buttons
10-4
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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 status, 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
The installation of the BacT/ALERT® 3D 60 instrument is described in
Chapter 3, System Installation.
MB Configuration
The BacT/ALERT® 3D 60 agitation mechanism can be disengaged at the
factory or by a service engineer on site, after which the three racks remain
immobile. The BacT/ALERT® 3D 60 Instrument is also configured by
bioMérieux personnel to activate the MB status.
Limitations of the Test
Refer to the package insert enclosed with the Mycobacteria Process Bottles
(MP) for additional information.
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10-5
Mycobacterial Testing
System Startup
Service and Maintenance
Preventive maintenance and troubleshooting are performed as described in
Chapter 7, System Maintenance.
Additional procedures pertinent to Mycobacteria are referenced in this
chapter (see Safety Features on page 10-7).
Theory of Operation
The MB/BacT® 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 Mycobacteria Process Bottles (MP) 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, non-mycobacterial 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 10-3 below.
10-6
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Mycobacterial Testing
Figure 10-3: Metabolic Pathway for Mycobacterial CO2
Glycerol was selected as the primary metabolic source in the MP 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 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 60 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 60 Instrument is sealed to
help contain and minimize effects of liquid spillage.
• The circulating fans within the Instrument turn off whenever the door is
open to minimize airflow and the potential for aerosols.
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Mycobacterial Testing
System Startup
• To reduce the chance of binding a heavily overlabeled bottle in a cell,
Instrument 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 7. (See also Spill Cleanup in Chapter 7.)
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
specimen spilled in an instrument should be removed immediately using the
disinfection procedures (see Disinfection Procedure for Spills Onto the
Instrument in Chapter 7).
10-8
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A
UNPACKING INSTRUCTIONS
BacT/ALERT® 3D 60 Unpacking Instructions
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A-1
Unpacking Instructions
A-2
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B
PART CHECKLIST
BacT/ALERT® 3D 60 Part Checklist
SITE NAME ________________________________ SERIAL # _____________________
CITY, STATE _______________________________ SERVICE CALL #_______________
The following checklist can be used when verifying and inspecting kit contents (see Verifying
Contents in Chapter 3).
Contents
BacT/ALERT® 3D 60 Instrument
BacT/ALERT® 3D 60 User Manual Multi-language CD
2 ea. 5 amp fuse
1 ea. 6.3 amp fuse
1 ea. blank USB Flash Drive
Decontamination Procedure
Decontamination Certificate
Anonymous BTL Labeling Set – WARNING –
Rack - Bottle Carrier BTA
Mouse and Mouse Pad
Barcode Scanner and Manual
Scanner Stand
Keyboard
Power Cord
Printer
Parallel Printer cable
1/4" X20X5" bolt
1/4" flat washer
UPS
UPS Serial Cable
CRT Monitor
or
† Flat Panel Monitor
† Calibration Standards Kit
†
†
†
†
†
†
†
†
†
†
†
†
†
†
†
†
†
†
†
†
†
Optional Equipment
† Speaker Set -- For 110V BacT 3D 60
or
† Speaker Set -- For 220V BacT 3D 60
† Fax Modem – Domestic (Optional)- 120V
†
†
†
†
or
Fax Modem – International (Optional)
Serial Modem Cable (Optional)
UPS to Printer Power AC Adaptor
UPS to Printer AC Power Cable
Recommended Tools
† Small flat (plane blade) screwdriver
† Phillips screwdriver
This page may be copied for field use.
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BacT/ALERT® 3D 60 Part Checklist
B-2
Part Checklist
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C
INSTALLATION CHECKLIST
BacT/ALERT® 3D 60 Installation Checklist
SITE NAME ________________________________ SERIAL # _____________________
CITY, STATE _______________________________ SERVICE CALL #_______________
Preparation
Site Requirements are met (see page 3-2)
Unpack and Verify Contents (see page 3-2)
Pass
____
____
Initials
_____
_____
Installation
AC Power Configuration (see page 3-3)
Instrument Placement (see page 3-6)
Restraint Installation, if required (see page 3-12)
Instrument Connections made (see page 3-7)
Instrument powered up (see page 3-9)
Configure Instrument (see page 3-10)
Temperature Calibration (see page 3-10)
____
____
____
____
____
____
____
_____
_____
_____
_____
_____
_____
_____
Functional Testing
Modem Function Validation (see page 3-10)
Barcode Reader Validation (see page 3-11)
UPS Function Validation (see page 3-12)
Record Software Revision and Annotate Logbooks
____
____
____
____
_____
_____
_____
_____
The following table shows items that may be connected to the instrument as "shipped" or
"optionally installed" parts:
UPS
(Domestic or International)
_____
External Speaker Set (Domestic or
International)
_____
Monitor (Flat Panel or CRT)
_____
Keyboard
(Must be installed with the instrument)
_____
Printer
_____
Barcode Scanner
_____
Modem AC Adapter (Must be installed
with modem)
_____
Mouse
(Must be installed with the instrument)
_____
Modem (Domestic or International)
_____
Comments:
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
This page may be copied for field use.
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BacT/ALERT® 3D 60 Installation Checklist
C-2
Installation Checklist
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INTERNATIONAL CHARACTER ENTRY
D
About This Chapter
This chapter explains how to enter international characters on the
BacT/ALERT® 3D 60 instrument.
Chapter Contents
International Character Entry • D-2
Entering International Characters • D-3
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D-1
International Character Entry
International Character Entry
International Character Entry
You can enter International characters on the BacT/ALERT® 3D 60. 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 D-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
D-2
è
Ì
ë
i
ì
Í
í
Î
î
Ï
ï
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International Character Entry
International Character Entry
Table D-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:
• Accession Number field
• Hospital ID field
• Patient First Name field
• Patient Last Name field
• 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 4.
2)
Use the Page Up or Page Down key to scroll through the characters in
the block from the table.
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D-3
International Character Entry
International Character Entry
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:
D-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
E
About This Chapter
This chapter provides you with a description of the BacT/ALERT® 3D culture
bottle along with a quality control procedure.
Chapter Contents
BacT/ALERT® Culture Bottles • E-2
Introduction • E-2
Quality Control of Growth Performance • E-4
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E-1
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 E-1: Typical BacT/ALERT® Culture Bottle
1 — Flip Cap
2 — Culture Medium
3 — Sensor
4 — Volume Designations
5 — Barcode
6 — Stopper/Seal
E-2
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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.
Bottle
See Figure E-1.
Volume Designations
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.
Barcode
The BacT/ALERT® 3D 60 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 60 system to apply
the proper algorithm to the bottle readings.
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, type in the barcode or apply a generic barcode label
(contact your bioMérieux Representative). These labels begin with a "G" or a
number and do not contain bottle type information (ex. SA, SN, etc.). Attach
the 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: 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.
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E-3
BacT/ALERT® Culture Bottles
Bottle Quality Control
Limitations of the Test
Refer to the package insert enclosed with the BacT/ALERT® culture bottles
for additional information.
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.
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 60 System.
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 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)
E-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.
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BacT/ALERT® Culture Bottles
Bottle Quality Control
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.
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E-5
Bottle Quality Control
E-6
BacT/ALERT® Culture Bottles
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GLOSSARY
Accession
A sample collected from a patient during a single event.
Accession ID
Synonym for accession number.
Accession Number
A number that uniquely identifies the sample or patient
specimen.
Anonymous Bottle
A bottle that has been placed in an Incubation Chamber
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 for the presence of microbes.
Barcode Reader
Used to scan accession numbers 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).
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.
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
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Glossary-1
Glossary
Dimmed
BacT/ALERT® 3D 60 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.
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
Text string that uniquely identifies a patient.
Icons
System functions or buttons appearing on-screen in pictorial
form.
Indicator Light or Lamp
An identifier for a cell that lights up to indicate location of a
particular bottle or bottle-type. They are located on the
racks adjacent to the indicated cell.
Keyboard
Provides a means of input for Bottle IDs, Accession
Numbers, Hospital IDs, and Names. 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
Connector fitting on the Instrument to connect to a
Laboratory Information System.
Monitor
A device upon which video images are displayed.
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.
Glossary-2
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Glossary
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 Instrument 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.
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 button that allows selection of numerical or symbolic
values by clicking arrows above or below a window which
shows the selected character. While an arrow is being
clicked, 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 60 configuration where the Instrument
is connected to neither an bioMérieux data management
computer nor an LIS.
SelectLink Configuration
A BacT/ALERT® 3D 60 configuration where the Instrument
is connected directly to an LIS.
Slidebar Switch
A rectangular icon 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.
Toggle Button
A button that becomes active (appears to be clicked) after
the corresponding screen area is clicked, and continues to
be active until it is clicked 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).
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Glossary-3
Glossary
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.
Glossary-4
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INDEX
Numerics
21 CFR Part 11 Mode 9-1
accessing the audit trail 9-20
adding a user 9-13
audit trail 9-18
change password 9-8
change password errors 9-9
clearing a user password 9-16
clearing more than one user password 9-17
configuring users 9-12
deleting a user 9-15
deleting more than one user 9-16
inactivity timeout 9-7
log in/out of system 9-2
logging in 9-6
logging in for the first time 9-2
logging out 9-12
login errors 9-7
user list 9-13
wrong password alert 9-8
wrong user alert 9-8
A
accession
attaching to a hospital ID 5-16
moving from one hospital ID to another 5-16
add user screen (21 CFR Part 11 Mode) 9-14
additional supplies 1-3
alarm
priority 6-5
setting 6-3
terminating an instrument alarm 6-5
alarm not sounding 8-29
alerts (21 CFR Part 11 Mode)
wrong password 9-8
wrong user 9-8
anchor display/scroll buttons 2-15
anonymous bottle indicated in empty cell 8-29
attaching accession numbers to a
hospital ID 5-16
attaching bottle IDs to an accession
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number 5-14
audit trail
accessing 9-20
events 9-18
B
background color, monitor 4-3
backup(s)
initiating/scheduling 6-7
tips 6-8
barcode cannot be scanned 8-30
barcode reader
description 2-9
doesn’t beep 8-29
location 2-8
basic functions 4-1
blank monitor 8-31
bottle
attaching ID to an accession 5-14
description E-2
diagram E-2
loading procedure 4-10
lodged in cell 8-29
moving from one accession to another 5-14
quality control E-1
relocation procedure 7-14
selecting 5-3, 5-4
unconfirmed positive handling 4-17
unloading procedure 4-14
viewing/printing graphs 4-29
bottle counts 4-5
bottle quality control E-1
bottle type
entry tips 4-11
scroll button 4-10
button
accession number selection 5-13
add user (21 CFR Part 11 Mode) 9-13
adjust X scale 4-30
adjust Y scale 4-30
anchor display top or bottom 2-15
anchor display/scroll 2-15
backup management 4-20
Index-1
Index
bottle processing/customization 4-20
bottle readings 4-30
bottle type scroll 4-10
calibrate cell 4-20
calibrate instrument temperature 4-19
calibration history 6-22
calibration report 6-19
cancel 2-14
cell scroll 4-29
change password 4-20, 6-5
change password (21 CFR Part 11 mode) 9-3, 9-8
check 2-14
clear password (21 CFR Part 11 Mode) 9-13, 9-
print graph 4-30
report 4-20
report configuration 6-14
report label entry button 6-10
restart incubation chamber 7-11
scroll 2-15
secondary sort scroll 6-16, 6-17, 6-18
select bottle to edit/graph 4-20
set audible alarm options 4-20
set date/time 4-19
set maximum test time 4-20
unload buttons 4-3, 4-5
view incubation chamber information 4-20
16
column selection scroll 6-16, 6-17, 6-18
configure users 4-20
configure users (21 CFR Part 11 Mode) 9-12
data transfer 5-13
delete user (21 CFR Part 11 Mode) 9-13, 9-15
description 2-14
display report 1 (load report screen) 4-22
display report 2 (status report screen) 4-22
display report 3 (unload report screen) 4-22
edit
accession number to hospital ID
relationships 5-12
bottle ID to accession number relationships 5-12
bottle type scroll 5-7
cell contents 4-20
data relationships 4-20
hospital ID to patient name relationships 5-12
maximum test time scroll 5-7
report configuration 6-16, 6-17
test result 5-9
enable/disable hardware 4-19
enabled vs disabled 2-14
end scroll 2-15
exit software 7-8
graph bottle readings 5-10
home scroll 2-15
line scroll up or down 2-15
login (21 CFR Part 11 mode) 9-2
manual backup 6-8
manual request test orders 4-36
manual send test results 4-36
next screen 2-14
page scroll up or down 2-15
preview report 6-16, 6-17
previous screen 2-14
primary sort scroll 6-16, 6-17, 6-18
Index-2
C
calibrate cell screen, diagram 7-19
calibrate module temperature screen, diagram
7-16
calibration
instrument cell 7-18
instrument temperature 7-17
locating cells which need 7-18
calibration data
viewing and printing 6-19
calibration history
viewing and printing 6-22
cancel button 2-14
carbon dioxide detection. See principle of
detection
cell
calibration procedure 7-18
enable/disable 7-13
indicator light(s) never come on 8-29
reading indicator 7-19
viewing readings 7-19
cell calibration report screen, diagram 6-20
changing maximum test time. See editing
maximum test time.
chapter organization 1-5
check button 2-14
checklist
installation C-1
part B-1
clear password screen (21 CFR Part 11 Mode)
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Index
9-17
edit cell contents screen, diagram 5-3
codes
edit data relationships screen, diagram 5-12
(1-99) 8-3
(710-820) 8-16
(901-961) 8-18
edit test result
procedure 5-9
screen 5-9
configuring report contents
editing
load report configuration screen 6-16
section break checkboxes 6-16, 6-17
status report configuration screen 6-17
unload report configuration screen 6-18
accession number to hospital ID relationship
procedure 5-15
screen 5-15
bottle ID to accession number relationship
procedure 5-13
screen 5-13
hospital ID to patient name relationship
procedure 5-17
screen 5-17
maximum test time 4-13
report content 6-13
report labels 6-9
configuring report screens 6-9
configuring users (21 CFR Part 11 Mode) 9-12,
9-13
add user screen 9-14
adding a user 9-13
clear password screen 9-17
clearing a user password 9-16
clearing more than one user password 9-17
delete user screen 9-15
deleting a user 9-15
deleting more than one user 9-16
user list 9-13
electrical and electronic recycling 2-7
electrical warnings 2-4
enable/disable rack, or cell screen,
diagram 7-13
conventions
enabling/disabling hardware 7-13
typographic and usage 1-6
entering international characters D-3
D
entering report labels 6-9
entering text into a data entry field 4-9
data entry field, entering text 4-9
environmental requirements, instrument 2-12
delete user screen (21 CFR Part 11 Mode)
deleting more than one user 9-16
error codes (901-961) 8-18
errors
delete user screen (21 CFR part 11 Mode) 9-15
deleting a user 9-15
bottle problems 8-29
user output device problems 8-29
disinfection
spill cleanup 7-3
spills onto the instrument 7-3
spills within the instrument 7-4
display
bottle readings 4-31
errors, nonsoftware 8-29
F
false positives. See unconfirmed positives
fault codes (1-99) 8-3
faults, viewing 4-5
E
edit
load status 5-6
edit bottle detail screen
diagram 5-5
fields 5-5
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field, text entry 2-16
finding topics 1-6
full instrument shutdown 7-7
full instrument startup 7-9
function buttons
setup screen 4-18
Index-3
Index
G
viewing information for 7-22
gap detection indicator 4-24
graph bottle readings screen, diagram 4-30
indicator
gap detection 4-24
graphs, bottle 4-29
indicator light
cell 7-4, 7-14, 8-8
growth performance
Installation
quality control of blood culture bottles E-4
quality control of mycobacteria culture bottles E-5
growth performance, general E-4
hardware 3-3
instrument 2-13
system 3-1
installation
H
hardware
maintenance 7-2
overview 2-8
preventative maintenance 7-2
safety precautions and procedures 7-2
hazards and precautions
electrical and electronic recycling 2-7
health insurance and portability and
accountability act (HIPAA) requirements 2-3
checking for errors 3-10
choosing instrument location 3-6
configure the instrument 3-10
functional testing 3-10
instrument connections 3-7
optional restraint 3-12
power up the instrument 3-9
preparation 3-2
set the AC power 3-3
setting the temperature 3-10
verify contents 3-2
verifying site requirements 3-2
installation checklist C-1
I
icon 2-14
backup in progress 6-8
calibration staircase 7-19
instrument 4-4
instrument, with fault codes 8-3
load bottles 4-10
padlock 6-6
unload bottles 4-15
view algorithm/polynomial 5-10
view cell location 5-7
view first loaded time 5-8
view how determined/positivity index 5-10
view last unloaded time 5-8
view test result 5-8
view test time 5-8
view time of last bottle reading 5-8
inactivity timeout (21 CFR Part 11 mode) 9-7
incubation chamber
description 2-8
instrument icon 4-4
restarting 7-10
safety information 7-2
setting optimal temperature of 7-17
viewing faults 4-5
Index-4
installation instructions 2-13
instructions, unpacking A-1
instrument
diagram, back view 2-10
diagram, front view 2-8
location 3-6
reboot 7-7
shutdown 7-7
startup 7-9
instrument environmental requirements 2-12
instrument fault codes 8-3
instrument icon 4-4
instrument specifications 2-11
instrument status codes 8-16
international character
entering D-3
entry D-2
table D-2
introduction
chapter organization 1-5
finding topics 1-6
typographic and usage conventions 1-6
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Index
K
description 2-9
screens 2-13
keyboard
moving a bottle ID association from one
accession number to another 5-14
unresponsive 8-30
using in place of the mouse 7-6
moving an accession number association from
one hospital ID to another 5-16
L
moving bottles. See relocating bottles.
light-emitting diode (LED) 2-3
mycobacterial testing
disinfection procedure 7-3, 7-4
installation procedures and special requirements
LIS, sending and receiving information 4-36
load report configuration screen, diagram 6-16
10-3
loading bottles 4-10
safety features 10-7
system description 10-2
system startup 10-5
theory of operation 10-6
locating a cell which failed calibration 7-18
Log In/Out of System (21 CFR Part 11
Mode) 9-2
change password 9-8
change password button 9-3, 9-4
change password errors 9-9
confirm password field 9-4
inactivity timeout 9-7
logging in 9-6
logging in for the first time 9-2
logging out 9-12
login button 9-2
login errors 9-7
main screen while logged in 9-5
main screen while logged out 9-2
new password field 9-4
user login screen 9-3
N
next screen button 2-14
nonsoftware errors 8-29
O
operator error codes 8-18
optimal temperature setting 7-17
P
part checklist B-1
password
M
main screen
diagram 4-3
diagram (load mode) 4-10
diagram (unload mode) 4-15
maintenance
hardware 7-2
preventative 7-2
software 7-9
system 7-1
changing 6-5
entry 4-18
preventative maintenance 7-2
previous screen button 2-14
principle of detection 2-3
printing
bottle graphs 4-29
calibration data 6-19
calibration history 6-22
test data, report 4-22
using the print screen function 4-21
maximum test time
changing for an individual bottle 4-13
setting defaults 6-2
mode, 21 CFR Part 11 9-1
monitor
background color 4-3
blank 8-31
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Q
quality control of growth performance E-4
blood culture bottles E-4
mycobacteria culture bottles E-5
Index-5
Index
R
rack
enable/disable 7-13
rebooting the instrument 7-7
recycling
electrical and electronic 2-7
reference thermometer 7-15
relocating bottles 7-14
report configuration screen, diagram
load report 6-16
status report 6-17
unload report 6-18
report label entry screen, diagram 6-10
report selection screen, diagram 6-10, 6-14
reports
configuring content 6-13
entering labels 6-9
reportable fields 6-12
requesting bottle demographics from LIS 4-36
requirements
21 CFR Part 11 2-3
HIPAA 2-3
restarting the incubation chamber 7-10
S
edit bottle ID to accession number
relationships 5-13
edit cell contents 5-3
edit data relationships 5-12
edit hospital ID to patient name relationships 5-17
edit test result 5-9
enable/disable rack, or cell 7-13
graph bottle readings 4-30
load report configuration 6-16
main 4-3
main (load mode) 4-10
main (unload mode) 4-15
main screen while logged in (21 CFR Part 11
mode) 9-5
main screen while logged out (21 CFR Part 11
mode) 9-2
report label entry 6-10
report selection 6-10, 6-14
select bottle to edit/graph 4-29
set audible alarm options 6-3
set maximum test time 6-2
setup 4-18
status report configuration 6-17
unload report configuration 6-18
user configuration (21 CFR Part 11 Mode) 9-13
user login (21 CFR Part 11 mode) 9-3
view cell status 4-6
view incubation chamber information 7-23
screen ID numbers 2-13
safety precautions and procedures 7-2
samples
hazards and precautions 1-8
screen
add user screen (21 CFR Part 11 Mode) 9-14
backup management 6-7
bottle readings 4-32
calibrate cell 7-19
calibrate instrument temperature 7-16
calibration history 6-23
cell calibration report 6-20
change maximum test time (individual bottle) 4-13
change password 6-5
clear password (21 CFR Part 11 Mode) 9-17
colors determined by configuration 2-2
delete user screen (21CFR part 11 Mode) 9-15
edit accession number to hospital ID
relationships 5-15
edit bottle detail 5-5
Index-6
scroll button 2-15
select bottle to edit/graph screen, diagram 4-29
selecting a bottle
via edit cell contents screen 5-3
via select bottle to edit/graph screen 5-4
sending test results to LIS 4-36
set maximum test time screen, diagram 6-2
setting optimal temperatures 7-17
setting system date/time 7-11
setup instructions 2-13
setup screen
accessing 4-18
diagram 4-18
function buttons 4-18
shutting down the instrument 7-7
slidebar switch 2-15
edit load status 5-6
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Index
entering bottle type 4-11
software
configuration 6-1
configuration options 2-2
background color 4-3
maintenance 7-9
setting date/time 7-11
typographic and usage conventions 1-6
click 1-6
name and titles 1-6
press 1-7
procedural steps 1-7
references 1-7
select 1-7
user input 1-8
warnings, cautions, and information 1-8
software configuration
Select 2-2
SelectLink 2-2
software overview 2-13
typographic conventions 1-6
specifications, instrument 2-11
spills
cleanup 7-3
onto the instrument, disinfection 7-3
within the instrument, disinfection 7-4
U
unconfirmed positives 4-17
unloading bottles 4-14
starting up the instrument 7-9
unpacking instructions A-1
status codes (710-820) 8-16
unresponsive system 8-31
status report configuration screen, diagram 6-17
usage
system
conventions 1-6
maintenance 7-1
monitoring 4-2
setting date/time 7-11
setup instructions 2-13
troubleshooting 8-1
unresponsive 8-31
system backup
USB flash drive 6-7
zip drive 6-7
USB flash drive
system backup 6-7
user configuration screen 9-13
user list (21 CFR Part 11 Mode) 9-13
V
view cell status screen
diagram 4-6
view incubation chamber information screen,
diagram 7-23
T
temperature
viewing
calibration 7-17
checking 7-15
setting optimal 7-17
bottle counts 4-5
bottle data 4-21
bottle graphs 4-29
bottle readings 4-31
calibration data 6-19
calibration history 6-22
faults 4-5
incubation chamber information 7-22
test data 4-22
test data
viewing and printing 4-22
text entry field
description 2-16
size limits 4-8
theory of operation 2-3
thermometer
location 7-15
reference 7-15
tips
Z
zip drive
system backup 6-7
backup 6-8
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Index-7
Index
Index-8
BacT/ALERT® 3D 60 User Manual
95269
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