Vitek XL User manual

Vitek XL User manual
Instrument User Manual
510731-10EN1 (06/2008)
24262
bioMérieux, Inc.
Box 15969
Durham, North Carolina 27704-0969 / USA
Tel. (1) 800-682-2666
EC
[04]
REP
bioMérieux® SA
au capital de 12 029 370 €
673 620 399 RCS LYON
69280 Marcy l’Etoile / France
tél. 33 (0)4 78 87 20 00 / fax 33 (0)4 78 87 20 90
http://www.biomerieux.com
Argentina
bioMérieux Argentina
Av. Congreso 1745
C1428BUE
Capital Federal Buenos Aires
tel. (54) 11 5555 6800
fax (54) 11 5555 6888
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
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
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
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 2455 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
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
i
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
France
bioMérieux SA
69280 Marcy l’Etoile
tel. (33) 0(4) 78 87 20 00
fax (33) 0(4) 78 87 20 90
http://www.biomerieux.com
Germany
bioMérieux Deutschland GmbH
Weberstrasse 8
D 72622 Nürtingen
tel. (49) 7022 30070
fax (49) 7022 36110
Greece
bioMérieux Hellas S.A.
Papanikoli 70
15232 Halandri
Athens
tel. (30) 210 81 72 400
fax (30) 210 68 00 880
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
Abidjan 08
tel. (225) 22 40 93 93/22 40 41 40
fax (225) 22 40 93 94
Japan
Sysmex bioMérieux, Ltd.
Seizan Bldg.
12-28 Kita-Aoyama 2-chome
Minato-ku, Tokyo 107-0061
tel. (81) 3 5411 87 11
fax (81) 3 5411 87 10
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
Mexico
bioMérieux México SA de CV
Chihuahua 88, col. Progreso
México 01080, D.F.
tel. (52) 55 5481 9550
fax (52) 55 5616 2245
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
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
Manual Name
702358-4EN1 REV nn/nnnn
Norway
bioMérieux Norge AS
Økernveien 145
N-0513, Oslo
tel. (47) 23 37 55 50
fax (47) 23 37 55 51
Spain
bioMérieux España S.A.
Manual Tovar, 45–47
28034 Madrid
tel. (34) 91 358 11 42
fax (34) 91 358 06 29
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
Sweden
bioMérieux Sverige AB
Hantverksvägen 15
436 33 Askim
tel. (46) 31 68 84 90
fax (46) 31 68 48 48
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
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
Regent House Bldg, 16th Floor
183 Rajdamri Road, Lumpini,
Pathumwan
Bangkok 10330
tel. (66) 2 651 98 00
fax (66) 2 651 98 01
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
ii
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, bioLIAISON and VITEK are used,
pending and/or registered trademarks belonging to bioMérieux
SA or one of its subsidiaries.
© 2008 by bioMérieux, Inc. All rights reserved.
No part of this publication may be reproduced, transmitted,
transcribed, stored in a retrieval system, or translated into any
language (human or computer) in any form, or by any means
whatsoever, without the prior express written permission of
bioMérieux, Inc.
Patent Information
Product covered by one or more of U.S. Patent Numbers
D377,455; 5,670,375; 5,674,454; 5,697,409; 5,736,102;
5,762,873; 5,762,874; 5,798,084; 5,798,085; 5,853,666;
5,853,667; 5,856,193; 5,869,006; 5,881,781; 5,888,455;
5,891,396; 5,897,835; 5,925,884; 5,955,736; 5,965,090;
6,024,921; 6,086,824; 6,136,270; 6,156,565; D414,272;
D437,797; 5,609,828; 5,746,980; 5,804,437; 5,869,005;
5,932,177; 5,951,952; 6,267,929; 6,309,890; 6,340,573;
D397,611; D393,592; and Foreign Counterparts.
Warranty
Seller, bioMérieux, Inc., warrants the VITEK® 2 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
Manual Name
702357-3EN1 REV nn/nnnn
i
Standard Symbols
Electric shock warning
Radiation warning
Potential pinch-point warning
Laser
Temperature limitation
Upper limit of temperature
Lower limit of temperature
In Vitro Diagnostic Medical Device
Batch code
Authorized Representative in the European Community
Catalog number
Serial Number
Do not reuse
Recyclable
ii
Manual Name
702357-3EN1 REV nn/nnnn
Standard Symbols
Separate collection for waste electrical and electronic
equipment
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
Manual Name
702357-3EN1 REV nn/nnnn
iii
Standard Symbols
Fuse
Direct current
Alternating current
Both direct and alternating current
Three-phase alternating current
Earth (ground) terminal
Protective conductor terminal
Frame or chassis terminal
Equipotentiality
ON (supply)
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)
iv
Manual Name
702357-3EN1 REV nn/nnnn
GENERAL WARNINGS
IMPORTANT:
The user is advised to read and understand all instructions in this
manual to be able to derive the best performance from the VITEK® 2
instrument and the Smart Carrier Station.
IMPORTANT:
The configuration that you have purchased is adapted to the legislation
and standards of the different countries it will be sent to. For this
reason, it may differ from the one presented in this document. However,
this will have no effect on the performance of your VITEK® 2 instrument
or the Smart Carrier Station. For further information on peripherals
(computer, printer, monitor, etc.) please refer to the relevant
manufacturers’ instruction manuals.
IMPORTANT:
If either the VITEK® 2 instrument or the Smart Carrier Station does not
respond properly to keyboard inputs after an inadvertent electrostatic
discharge or electrical fast transient, turn the power off, then back on
using the power switch and resume normal operations.
VITEK® 2 Instrument User Manual
510731-10EN1
i
General Warnings
General Warnings
BIOHAZARD WARNING
This instrument may be involved with hazardous organism
suspensions. This user manual does not purport to address all
of the safety matters associated with the instrument’s use. It is
the responsibility of the user of this instrument to establish and
follow appropriate safety and health practices and to determine
the applicability of regulatory limitations prior to use.
BIOHAZARD WARNING
All organism suspensions should be considered as potentially
infectious. Qualified laboratory personnel should use
acceptable procedures for biohazardous material.
LASER WARNING
All access doors and covers must remain closed when
processing cards to avoid exposure to laser light.
AMBIENT LIGHT/DIRECT SUNLIGHT WARNING
The transmittance optics are sensitive to ambient light. Ensure
all access doors are closed when cards are processing in the
instrument. Do not place the instrument in direct sunlight.
Strong light shining onto the front of the instrument can cause
the optics to read incorrectly.
ii
VITEK® 2 Instrument User Manual
510731-10EN1
General Warnings
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.
VITEK® 2 Instrument User Manual
510731-10EN1
iii
General Warnings
Laser Caution
A laser caution label appears on the VITEK® 2 and VITEK® 2 XL at the
following locations:
VITEK® 2
VITEK® 2 XL
• on the front access door
• on the left front access door
• on the inside panel behind the
front access door
• above the center front sliding door
• behind the waste collection door
• behind the right side waste
collection door
The label appears as shown here:
CAUTION
Laser light when open.
DO NOT STARE INTO BEAM.
530520-2
iv
VITEK® 2 Instrument User Manual
510731-10EN1
TABLE OF CONTENTS
General Warnings ........................................................................................................i
General Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Laser Caution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
List of Tables ............................................................................................................xiii
List of Figures ...........................................................................................................xv
How To Use This Manual ........................................................................................ 1-1
Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
How to Find Topics and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Typographic and Usage Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Graphical User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Click . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Names and Titles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
Press . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
Select . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
Screen Text . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
User Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
Warnings, Cautions, and Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Smart Carrier Station .............................................................................................. 2-1
Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Unpacking Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Unpacking Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Installation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Preparations for Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Smart Carrier Station Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
SCS Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
SCS Base Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
System Physical and Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Setup Bar Codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
SCS Configuration .................................................................................................. 3-1
Configuration Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
VITEK® 2 Instrument User Manual
510731-10EN1
v
Table of Contents
When to Configure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Accessing Configuration Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
SCS Main Configuration Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Cassette ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Setting Cassette ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
Setup Technologist ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Setting Setup Technologist ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
Bench Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Setting Bench Name. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
SCS Workflow Configuration Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
AST Dilution Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Setting AST Dilution Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
Erase Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Setting Cassette Erase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
Begin Data Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Setting Begin Data Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
SCS Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Setting SCS Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7
Audible Feedback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Setting Audible Feedback. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8
Host Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Changing Host Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8
Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Setting SCS Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8
SCS Firmware Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
VITEK® 2 Instrument ............................................................................................... 4-1
External Instrument Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Controls, Access Doors and Connections . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Turning on the VITEK® 2 Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Startup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Instrument Hardware Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Smart Carrier Station (SCS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Cassettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Cassette Load and Unload Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Boats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Bar Code Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Button Memory Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Dispenser/Pipettor Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Dispenser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11
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Pipettor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12
Displacement Pump Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13
Filler Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sealer Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Test Card Incubation and Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Optics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4-13
4-14
4-14
4-15
4-16
Transmittance Optics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16
Card Ejection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Waste Collection Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
User Interface System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
Keypad and Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
Configuring the VITEK® 2 Instrument ................................................................... 5-1
Configuration Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Configuration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Setting Configuration Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cassette Names . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Instrument Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Schedule Instrument QC Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cassette Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dilution Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bar Code Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Audible Alarm Enable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Audible Alarm Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Visual Alarm Enable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Audible Feedback Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Screen Contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Waste Tray Warning Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5-2
5-2
5-3
5-3
5-4
5-5
5-5
5-6
5-6
5-6
5-7
5-7
5-7
5-8
Using the Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Defining Character Sets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Setting Time for QC Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Using Option Boxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Setting a Range Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Processing VITEK® 2 Test Cards........................................................................... 6-1
Instrument Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Displaying the Status Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Instrument Status Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Non Standard Card Reading Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Card Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cassette Name Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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6-3
6-4
6-4
6-5
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Dilution Mode Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Status Screen Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Monitoring Pipette Tips and Saline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
VITEK® 2 Menu System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Frequently Used Keys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
About the Smart Carrier Station (SCS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
Advantages of Using SCS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
Cassette Edit Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Understanding the Slot Indicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
SCS Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Option Boxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14
Organism ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-14
Gram Positive Susceptibility Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-14
Offline Test Result Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-14
ANC Identification Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-15
Offline Test Result Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-15
Gram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-15
Morphology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-15
Aerotolerance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-15
Modifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-16
Selecting an Entry Using an Option Box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-16
Bar Code Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Processing Test Cards Using the Smart Carrier Station . . . . . . . . . . . . . . . . . 6-16
Configuration Options for Smart Carrier Workflow . . . . . . . . . . . . . . . . . . 6-16
Smart Carrier Workflow. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Entering Test Information With SCS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Correct Positioning of AST Cards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-18
Loading a Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
Using the Cassette Load Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-19
Loading a Cassette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-20
Monitoring Card Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-20
Tracking Cassettes and Cards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-21
Processing Test Cards in Cassette Only Mode . . . . . . . . . . . . . . . . . . . . . . . . 6-21
Configuration Options in Cassette Only Mode . . . . . . . . . . . . . . . . . . . . . 6-21
Cassette Only Mode Workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21
Cassette Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22
Printing a Cassette Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-22
Using the Cassette Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-22
Correct Positioning of Susceptibility Test Cards. . . . . . . . . . . . . . . . . . . . . . . .6-24
Using the Cassette Setup Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-24
Loading a Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25
Using the Cassette Load Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-26
Loading a Cassette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-26
Monitoring Test Card Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-27
Entering Data for a Cassette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27
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Tracking Cassettes and Cards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-27
Batch Loads (Smart Carrier or Cassette Only Mode) . . . . . . . . . . . . . . . . . . . 6-28
Selecting Batch Loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28
Before You Begin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-28
Starting a Batch Load . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28
Unloading the Cassette and Removing Waste . . . . . . . . . . . . . . . . . . . . . . . . 6-30
Unloading a Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-30
Removing Ejected Test Cards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31
Removing the Waste Collection Tray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-32
Replacing the Waste Collection Tray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-32
Maintaining the VITEK® 2 Instrument.................................................................... 7-1
Maintaining Disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Monitoring the Disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Interpreting the Graphs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3
Using the Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4
Expiration of Disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4
The Dispenser/Pipettor Accessory Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Installing an Accessory Kit, Part A: Saline and Tubing . . . . . . . . . . . . . . . 7-4
Installing an Accessory Kit, Part B: Pipette Tips . . . . . . . . . . . . . . . . . . . . 7-8
Cleaning the Carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
Removing the Carousel for Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
Carousel Cleaning Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
Replacing the Carousel After Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
Cleaning the Cassettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19
Replacing the Button Memory Module. . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20
Cleaning the Boats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-21
Removing Boats for Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-21
Cleaning the Boats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-23
Replacing Boats after Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-23
Cleaning the Instrument Interior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-24
Shutting Down the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cleaning the Test Card Collection Tray . . . . . . . . . . . . . . . . . . . . . . . . . .
Cleaning Optics (Normal Maintenance) . . . . . . . . . . . . . . . . . . . . . . . . . .
Cleaning the Base Pan, Vacuum Seal and Vacuum Chamber . . . . . . . .
7-25
7-25
7-26
7-28
Cleaning the Drip Pan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-29
Removing the Drip Pan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cleaning the Drip Pan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Replacing the Drip Pan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Turning the Instrument On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7-30
7-30
7-31
7-31
Cleaning the SCS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-32
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Troubleshooting the VITEK® 2 Instrument ........................................................... 8-1
Error Handling System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Error Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Types of Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Status Screen Error Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Instrument Halted Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Reviewing an Instrument Halted Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-6
Resolving a Transport Halted Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-6
Message Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Reviewing a Message Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-9
Error Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Reviewing an Error Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-10
Cassette Load Processing Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Types of Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Workflow Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
Bar Code Read Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
Resolving Bar Code Read Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-11
SCS and Bar Code Reader Conflict . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13
Resolving SCS and Bar Code Reader Conflicts. . . . . . . . . . . . . . . . . . . . . . . .8-13
Inoculum Errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14
Resolving an Inoculum Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-15
Card Capacity Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16
Resolving a Card Capacity Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-16
Disposables Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-17
How to Resolve a Disposables Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-17
Working Without the Bar Code Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-17
Entering Bar Codes Manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-17
Disabling the Bar Code Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-17
Entering Bar Codes Manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-18
Instrument Diagnostics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18
Instrument Diagnostics Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18
Diagnostic Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19
Checking the Instrument Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-19
Dispenser/Pipettor Diagnostic Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-20
Dispenser/Pipettor Volumetric Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-21
Cleaning Optics (Cards Processing) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-23
Optical Diagnostic Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-26
Boat Transport Positions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-26
Power Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-28
Displaying Version Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-28
Using Error Message and Recovery Table . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-29
Restarting the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-29
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Table of Contents
Appendix A: Hardware Specifications ..................................................................A-1
VITEK® 2 Instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mass . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Optical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
A-1
A-1
A-2
A-3
A-3
Transmittance Optics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
General Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dispenser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pipettor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vacuum (Filler) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sealer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Incubator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
A-4
A-4
A-4
A-4
A-4
A-4
Glossary ...................................................................................................... Glossary-1
Index .................................................................................................................. Index-1
Notes ................................................................................................................ Notes-1
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Table of Contents
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LIST OF TABLES
Table 2-1:
Physical Characteristics .....................................................................................2-9
Table 2-2:
Electrical Requirements .....................................................................................2-9
Table 2-3:
Environmental Requirements .............................................................................2-9
Table 2-4:
Bar Code Scanner Model References .............................................................2-11
Table 3-1:
SCS Configuration Options ................................................................................3-2
Table 4-1:
Components Involved in the Test Card Processing Cycle .................................4-5
Table 4-2:
Indicator Light States .........................................................................................4-7
Table 5-1:
Configuration Options that Affect Instrument Operation ....................................5-2
Table 5-2:
Configuration Options that Affect Only Physical Parameters .............................5-2
Table 5-3:
Types of Interfaces for Configuration Options ...................................................5-8
Table 6-1:
Optical Configurations ........................................................................................6-5
Table 6-2:
Summary of SCS Functions .............................................................................6-13
Table 6-3:
Processing Test Cards (Using the Smart Carrier) ............................................6-17
Table 6-4:
Data Entry Methods (Smart Carrier Mode) ......................................................6-18
Table 6-5:
Cassette Load Parameters (Smart Carrier Mode) ...........................................6-19
Table 6-6:
Card Identity Components (Smart Carrier Mode) ............................................6-21
Table 6-7:
Processing Test Cards (Cassette Only Mode) .................................................6-22
Table 6-8:
Cassette Load Parameters (Cassette Only Mode) ..........................................6-25
Table 6-9:
Card Identity Components (Cassette Only Mode) ...........................................6-27
Table 8-1:
Dispenser/Pipettor Volumetric Test .................................................................8-22
Table 8-2:
Error Message and Recovery Table ................................................................8-30
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List of Tables
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LIST OF FIGURES
Figure 2-1:
Smart Carrier Station .........................................................................................2-2
Figure 2-2:
SCS – Cable Connections .................................................................................2-4
Figure 2-3:
Initial SCS Screen ..............................................................................................2-6
Figure 2-4:
The Smart Carrier Station ..................................................................................2-7
Figure 2-5:
The SCS Keyboard ............................................................................................2-8
Figure 2-6:
SCS Firmware Update Screen .........................................................................2-10
Figure 2-7:
Bar Codes for Bar Code Scanner – A ..............................................................2-13
Figure 2-8:
Bar Codes for Bar Code Scanner – B ..............................................................2-14
Figure 2-9:
Bar Codes for Bar Code Scanner – C ..............................................................2-15
Figure 2-10: Bar Codes for Bar Code Scanner – D ..............................................................2-16
Figure 3-1:
SCS Main Configuration Screen ........................................................................3-3
Figure 3-2:
SCS Workflow Configuration Screen .................................................................3-5
Figure 3-3:
SCS Utilities Screen ...........................................................................................3-7
Figure 3-4:
SCS Firmware Update Screen ...........................................................................3-9
Figure 4-1:
The VITEK® 2 60 Instrument .............................................................................4-2
Figure 4-2:
VITEK® 2 XL Instrument ....................................................................................4-2
Figure 4-3:
Cassette Components .......................................................................................4-6
Figure 4-4:
The Cassette Load/Unload Station ....................................................................4-7
Figure 4-5:
Boat Components ..............................................................................................4-9
Figure 4-6:
Dispenser System ............................................................................................4-11
Figure 4-7:
Disposable Pipettes .........................................................................................4-12
Figure 4-8:
Carousel Placement .........................................................................................4-15
Figure 4-9:
Carousel Reader Head ....................................................................................4-15
Figure 4-10: Optics ...............................................................................................................4-16
Figure 4-11: Waste Collection Station ..................................................................................4-17
Figure 4-12: The VITEK® 2 Keypad and Screen ..................................................................4-18
Figure 5-1:
The Instrument QC Status Screen .....................................................................5-4
Figure 5-2:
VITEK® 2 Main Menu .........................................................................................5-9
Figure 5-3:
Cassette Names Configuration Screen ..............................................................5-9
Figure 5-4:
Character Selection Screen .............................................................................5-10
Figure 5-5:
Schedule QC Status Screen ............................................................................5-11
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List of Figures
Figure 5-6:
Option Box Screen .......................................................................................... 5-12
Figure 5-7:
Range Value Screen ....................................................................................... 5-12
Figure 6-1:
VITEK® 2 Status Screen in Cassette Only Mode .............................................. 6-3
Figure 6-2:
VITEK® 2 Status Screen in Non Standard Card Reading Mode ....................... 6-4
Figure 6-3:
Pipette Tips Status ............................................................................................ 6-7
Figure 6-4:
VITEK® 2 Main Menu ........................................................................................ 6-7
Figure 6-5:
Detailed Structure of the VITEK® 2 Menu System ............................................ 6-8
Figure 6-6:
Previous Screen Key ......................................................................................... 6-9
Figure 6-7:
Fields of the Cassette Edit Screen .................................................................. 6-11
Figure 6-8:
Organism ID Options ....................................................................................... 6-14
Figure 6-9:
Offline Tests Option Box ................................................................................. 6-15
Figure 6-10: Offline Test Result Screen .............................................................................. 6-15
Figure 6-11: Correct Orientation of Cassettes ..................................................................... 6-20
Figure 6-12: Cassette Worksheet ........................................................................................ 6-23
Figure 6-13: Cassette Setup Screen ................................................................................... 6-24
Figure 6-14: Correct Orientation of Cassette ....................................................................... 6-26
Figure 6-15: Batch Load Screen .......................................................................................... 6-29
Figure 6-16: Smart Carrier Mode Batch Load Screen ......................................................... 6-29
Figure 6-17: Cassette Only Mode Batch Load Screen ........................................................ 6-30
Figure 6-18: The Waste Collection Station .......................................................................... 6-32
Figure 7-1:
VITEK® 2 Status Screen ................................................................................... 7-3
Figure 7-2:
Location of Saline Dispensing Chamber ........................................................... 7-5
Figure 7-3:
Cannula and Tubing Assembly ......................................................................... 7-6
Figure 7-4:
Saline Dispensing Chamber .............................................................................. 7-6
Figure 7-5:
Saline Fill Line ................................................................................................... 7-7
Figure 7-6:
Location of Pipettor Tip Container ..................................................................... 7-8
Figure 7-7:
Pipette Tip Replacement ................................................................................... 7-9
Figure 7-8:
VITEK® 2 XL Carousel Cleaning Screen ........................................................ 7-11
Figure 7-9:
VITEK® 2 XL Preparing for Section Removal Screen ..................................... 7-11
Figure 7-10: Machined Incubator Access Cover ................................................................. 7-12
Figure 7-11: Molded Incubator Access Cover ..................................................................... 7-13
Figure 7-12: Carousel Cleaning Prompt .............................................................................. 7-13
Figure 7-13: Removing a Carousel Section ......................................................................... 7-14
Figure 7-14: Machined Incubator Access Cover ................................................................. 7-16
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List of Figures
Figure 7-15: Molded Incubator Access Cover ......................................................................7-16
Figure 7-16: Carousel Cleaning Replace Section Now Screen ............................................7-17
Figure 7-17: Orientation of the Carousel ..............................................................................7-17
Figure 7-18: Removing the Button Memory Module .............................................................7-20
Figure 7-19: Metal Contacts on Cassette .............................................................................7-20
Figure 7-20: Replacing the Button Memory Module .............................................................7-21
Figure 7-21: Boat Cleaning Prompt ......................................................................................7-22
Figure 7-22: Positioning of Boat ...........................................................................................7-24
Figure 7-23: Optics ...............................................................................................................7-27
Figure 7-24: Opening the Optics ..........................................................................................7-27
Figure 7-25: Vacuum Seal ....................................................................................................7-29
Figure 7-26: Drip Pan Handle ...............................................................................................7-30
Figure 7-27: SCS Base Unit Metal Contacts ........................................................................7-32
Figure 8-1:
VITEK® 2 Error Handling System ......................................................................8-3
Figure 8-2:
Instrument Halted Status Screen .......................................................................8-5
Figure 8-3:
Transport Halted Screen (VITEK® 2) .................................................................8-7
Figure 8-4:
Transport Halted Screen (VITEK® 2 XL) ............................................................8-7
Figure 8-5:
VITEK® 2 Status Screen ....................................................................................8-8
Figure 8-6:
Message Queue .................................................................................................8-9
Figure 8-7:
Bar Code Error Message .................................................................................8-12
Figure 8-8:
Resolving Bar Code Errors ..............................................................................8-12
Figure 8-9:
Card Type Error Message ................................................................................8-14
Figure 8-10: Inoculum Source Error Message .....................................................................8-15
Figure 8-11: Card Capacity Warning Message ....................................................................8-16
Figure 8-12: Bar Code Reader Screen .................................................................................8-18
Figure 8-13: Temperature Diagnostics Screen (VITEK® 2 XL) ............................................8-19
Figure 8-14: Temperature Diagnostics Screen (VITEK® 2) ..................................................8-20
Figure 8-15: Optics ...............................................................................................................8-24
Figure 8-16: Opening the Optics ..........................................................................................8-25
Figure 8-17: Boat Transport Positions ..................................................................................8-27
Figure 8-18: Version Information Screen .............................................................................8-29
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List of Figures
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HOW TO USE T HIS MANUAL
1
Introduction
This chapter gives you important information about how to use this manual.
bioMérieux recommends that you read this chapter first.
IMPORTANT:
Read this manual carefully before you attempt to operate the VITEK® 2
system.
Chapter Contents
Organization • 1-2
Printed Documentation • 1-2
Intended Use • 1-2
How to Find Topics and Procedures • 1-3
Typographic and Usage Conventions • 1-3
References • 1-3
Graphical User Interface • 1-3
Warnings, Cautions, and Information • 1-5
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1-1
Organization
How To Use This Manual
Organization
The manual is separated into four basic parts:
• Part 1, which includes Chapter 2 and Chapter 3, covers the Smart Carrier
Station. Chapter 2 describes the hardware and Chapter 3 provides the
procedures you use to configure this station for your laboratory workflow.
• Part 2, which includes Chapter 4 and Chapter 5, covers the VITEK® 2
Instrument. Chapter 4 describes the hardware and Chapter 5 shows you
how to configure the instrument’s user interface.
• Part 3, including only Chapter 6, is the primary part of the manual. It
describes all of the procedures you need to follow to process VITEK® 2 test
cards. The chapter contains two subparts, one each to describe test card
processing with, and without, a Smart Carrier Station.
• Part 4, consisting of Chapter 7 and Chapter 8, provides troubleshooting
and maintenance procedures for the VITEK® 2 instrument.
Documentation
The documentation for the VITEK® 2 system consists of this manual and
VITEK® 2 Systems Product Information. This division allows for the possibility
that the computer workstation may be in a different location than the VITEK®
2 instrument and Smart Carrier Station.
• This manual covers the VITEK® 2 instrument and the Smart Carrier
Station, including both the hardware and the programmed user interfaces.
• The VITEK® 2 Systems Product Information contains information about the
test cards, including culture techniques, analytical techniques, and
performance characteristics.
Intended Use
The VITEK® 2 and Smart Carrier Station (SCS) have applications as in vitro
diagnostic medical devices.
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How To Use This Manual
How to Find Topics and Procedures
How to Find Topics and Procedures
There are four tools to help you find a topic or procedure in the manual.
• General Table of Contents. This table is located in the front of the manual
and includes the entire document. You can use this table to locate major
headings throughout the manual. The table also includes a List of Tables
and a List of Figures.
• Chapter Table of Contents. Each of the succeeding chapters begin with
their own tables of contents. They contain the same information as the
general table for the manual, but have the advantage of addressing only
what is in that chapter.
• Page Headers. Each page in the manual has a header, which can serve as
a visual aid to help you find a topic. The inside portion of the header, the
side closest to the binding, always shows the chapter title. The outside
portion of the header shows the title of the current section.
• Index. Found at the end of the manual, the Index is the most useful device
for finding individual topics throughout the manual.
Typographic and Usage Conventions
References
References to chapter and section titles in this manual are in Proper Case.
Example: See Chapter 5, Configuring the VITEK® 2 Instrument.
References to other manuals are in Proper Case and italic font.
Example: See the VITEK® 2 Systems Product Information.
Graphical User Interface
Click
The term “click” refers to moving a mouse pointer to choose or select a
command, window, button or option, then pressing the left, or primary, mouse
button to initiate action in the software.
Example: Click OK
Commands
Menu, keyboard and button commands are in proper case, bold.
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1-3
Typographic and Usage Conventions
How To Use This Manual
Example: File > Quit menu command
Names and Titles
The names and titles of menus, dialog boxes, fields, icons and toolbar
buttons are in proper case, bold.
Example: Setup menu
The names of windows are in proper case, but are not bold.
Example: Configuration window
Press
The term “press” refers to holding down a key on the keyboard in order to
initiate action in the software.
Example: Press Enter
Select
The word “select” is generally used for selecting menus, menu commands
and GUI navigation.
Example: Select File > Quit
Screen Text
Text that appears on the screen will be shown in a monotype font.
Example: Saline Test in Progress
User Input
Instructions for user input begin with the word “type” or “enter.” These
instructions use bold for literal user input and italic for placeholders.
Example of literal user input: Login as micb, and password micb
In this example, type exactly what you see on the page (micb in this
example).
Example of a placeholder: Enter your password before you...
In this example, type your assigned password.
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How To Use This Manual
Typographic and Usage Conventions
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:
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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Typographic and Usage Conventions
1-6
How To Use This Manual
VITEK® 2 Instrument User Manual
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SMART CARRIER STATION
2
Introduction
Use this chapter to familiarize yourself with the Smart Carrier hardware. It
includes an overview of each part of the unit.
Chapter Contents
Purpose • 2-2
Unpacking Instructions • 2-2
Unpacking Procedure • 2-3
Installation Procedure • 2-4
Preparations for Operation • 2-5
Smart Carrier Station Overview • 2-6
SCS Keyboard • 2-8
SCS Base Unit • 2-9
System Physical and Electrical Requirements • 2-9
Setup Bar Codes • 2-10
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2-1
Purpose
Smart Carrier Station
Purpose
The purpose of this chapter is to aid in the safe handling, setup, configuration
and operation of the Smart Carrier Station.
Unpacking Instructions
Figure 2-1 shows a Smart Carrier Station (SCS).
4
1
3
2
5
Figure 2-1: Smart Carrier Station
1 — Display Screen
2 — Power Supply
3 — Base Unit
4 — Bar Code Scanner
5 — Keyboard
2-2
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Smart Carrier Station
Unpacking Instructions
Inspect the shipping container for external damage. If it has been damaged,
inspect the SCS itself for damage. If the SCS has been damaged, file a claim
with the shipper and notify bioMérieux, Inc.
Check the packing list included with the VITEK® 2 System and verify that all
required items are included in the shipment.
Note:
The packaging materials and shipping container should be retained for future
transportation needs, if necessary.
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 electric 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 it’s proper disposal.
Unpacking Procedure
To remove the SCS from its shipping container:
1)
Open the shipping carton and remove the unit from the carton.
2)
Carefully remove the unit from the packing material. Be sure to remove
all parts and literature from the carton.
3)
Remove the remaining packing materials from the SCS and store with
the shipping container.
WARNING
An electric shock hazard could exist if the enclosure of the SCS
or its external power supply is damaged exposing electrical
components.
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2-3
Unpacking Instructions
Smart Carrier Station
Installation Procedure
After completing the unpacking procedure, the SCS is ready to be placed in
its permanent location. The SCS is intended for use on any normal, flat bench
top, commonly found in a microbiology lab, away from direct sunlight. Some
cables must be connected to the unit. Figure 2-2 shows the cable
connections on the back of the unit.
1
2
3
4
5
Figure 2-2: SCS – Cable Connections
The back panel of the base unit, shown in Figure 2-2, contains the on/off
switch, the power cord receptacle, and the connector ports for various cables.
1 — On/Off Switch
2 — DC Power Receptacle
3 — Receptacle for the Bar Code Scanner
4 — Circular Connector for the SCS Keyboard
5 — Service/Update Cable Connector
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Smart Carrier Station
Preparations for Operation
Preparations for Operation
Place the SCS in its permanent location.
WARNING
Do not place the SCS in a location where it could be exposed to
direct sunlight during operation.
Position the instrument to meet the minimum clearance of 5 cm (2 in.) on all
sides and 30.5 cm (12 in.) above the instrument to provide adequate space
for placing cassettes onto the unit.
Use this procedure to begin using the SCS. The unit should be located on a
bench top with room next to it for test cards and specimens. Use Figure 2-2 of
the SCS to locate and identify the various parts referred to in the procedure.
WARNING
An electric shock hazard could exist if the SCS or its external
power supply is immersed in water.
1)
Connect the SCS keyboard to its receptacle (4, Figure 2-2) on the back
of the base unit.
2)
Connect the bar code scanner to its receptacle (3) on the back of the
base unit.
3)
Connect the external power supply cord to the back of the SCS (2) and
the main cord to an AC power outlet.
4)
Push the On/Off switch (1) to turn the unit on. The computer takes a few
moments to go through its startup routine.
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2-5
Smart Carrier Station Overview
Smart Carrier Station
Figure 2-3: Initial SCS Screen
5)
Note:
When the SCS is ready to be used, the screen shown in Figure 2-3 will
be displayed. If there is no display, switch the power OFF and restart at
Step 2.
If you have not yet customized your configuration settings, the Configuration
screen is displayed. For information on changing the settings, see Chapter 3
in this Manual.
Smart Carrier Station Overview
The Smart Carrier Station (SCS) is a small computer dedicated to collecting
information about test cards and specimens, and for transferring that
information to the VITEK® 2 instrument. The SCS, shown in Figure 2-4, has
five main components.
2-6
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Smart Carrier Station
Smart Carrier Station Overview
3
2
1
5
4
Figure 2-4: The Smart Carrier Station
1 — SCS Base Unit. The SCS base contains the microprocessor. There are
connection ports on the back of the base for the keyboard and the bar code
scanner. The top of the base is specifically shaped to accept a cassette.
Metal contacts on the base connect the unit’s computer to a button memory
chip on the cassette. Ensure that the cassette is fully seated in order to make
an electrical connection to the cassette memory. This memory chip stores the
information you entered to be transferred to the workstation.
2 — SCS Display Screen. The display for the SCS is a liquid crystal display
(LCD). Use the display to view and confirm the information you are entering
for the test cards and specimens.
3 — SCS Bar Code Scanner. The SCS is equipped with a bar code scanner
that allows you to enter data with a simple bar code scan rather than
repeated typing. You can scan most data fields. The data appears
automatically on the display. The scanner can be hand-held or used while
mounted in its holder.
4 — SCS Keyboard. The SCS keyboard has a standard set of alphanumeric
keys, plus several specially designed keys for SCS functions. The SCS
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2-7
SCS Keyboard
Smart Carrier Station
keyboard is smaller than a standard size keyboard, so it can be stored under
the Base Unit.
5 — External Power Supply. The SCS is powered by an external DC power
supply. This power supply accepts 120 VAC to 240 VAC mains power via a
detachable two conductor power cord.
SCS Keyboard
The SCS keyboard has a standard set of alphabetic and numeric keys. It also
has several keys that are uniquely designed for use on the SCS.
Figure 2-5: The SCS Keyboard
Help. Displays context-sensitive help screens and data field option boxes.
Previous Slot/ Next Slot. This key has two functions. When you press the
arrow on the left, the display changes to the Previous Slot. When you press
the arrow on the right, the display changes to the Next Slot.
Shift. Changes case of letter entered on keyboard.
Shift Lock. When Shift Lock is selected, the light next to the shift lock key
goes on and the keypad stays in the upper case mode. Press Shift Lock
again to cancel upper case mode.
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Smart Carrier Station
SCS Base Unit
SCS Base Unit
The base unit for the SCS contains the electronic components that make its
data entry and storage functions possible. The power switch and cable
connectors are located on the back panel of the base unit.
The base unit is actually a small computer with its own processing unit,
memory, and software program. However, the program in this computer is
limited to the task of entering and storing data for a cassette.
System Physical and Electrical Requirements
These physical specifications do not include the bar code scanner or the
external power supply.
Table 2-1: Physical Characteristics
Height:
27.6 cm (10.9 in.)
Width:
30.5 cm (12.0 in.)
Depth:
23.2 cm (9.1 in.)
Table 2-2: Electrical Requirements
Input Voltages/
Currents:
100/120 VAC +/- 10% (auto range) at 0.22 amp nominal
200/240 VAC +/- 10% (auto range) at 0.11 amp nominal
50/60 Hz
Power:
27 watt (nominal)
Heat:
92 BTU/Hr (nominal)
Power Cord:
Detachable 2 wire with an IEC 320 C7 appliance connector
Table 2-3: Environmental Requirements
Indoor Usage
Do not install in direct sunlight.
Pollution Degree 2 in accordance with IEC 664
Over voltage Category II per IEC 664
Ambient Room
Temperature:
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15 ºC to 30 ºC
2-9
Setup Bar Codes
Smart Carrier Station
Table 2-3: Environmental Requirements (Continued)
Shipment and
Storage
Temperature:
–20 ºC to +50 ºC
Humidity:
20% to 80% (Non-Condensing)
Minimum
installation
altitude:
–100m
Maximum
installation
altitude:
2000m
WARNING
Do not operate the SCS in an environment above 30 °C (86 °F)
Setup Bar Codes
The bar code scanner is programmed at the factory. Use these setup bar
codes in the event that the Bar Code Scanner loses its settings.
1)
Press F4 to access the Configuration screen.
2)
Press Next or Previous Screen until the Firmware Update screen
displays.
1
Figure 2-6: SCS Firmware Update Screen
2-10
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Smart Carrier Station
Setup Bar Codes
IMPORTANT:
3)
Review the last two digits of the serial number (1, Figure 2-6) to
determine which generation of SCS is in use.
4)
Press F2 to exit the Configuration screen.
5)
Refer to Table 2-4 and print the applicable bar code figure to use to
program the bar code scanner.
Print the applicable bar code figure using a laser printer.
6)
Align the scanner several inches away from the first bar code illustrated
in the applicable figure.
7)
Pull the trigger on the scanner and align the red beam over the bar code.
When the scanner emits a two-toned beep, release the trigger.
8)
Align the scanner several inches away from the next bar code illustrated
in the applicable figure.
9)
Pull the trigger on the scanner and align the red beam over the bar code.
When the scanner emits a two-toned beep, release the trigger.
10) Repeat Step 8 and Step 9 until all bar codes in the figure have been
scanned.
Note:
The bar codes are numbered in the order they should be scanned.
The scanner is now programmed.
For more information on the configuration and operation of the Smart Carrier
Station and Bar Code Scanner (including configuration for 'stand' and 'hand
held' modes) refer to the instructions provided with the scanner stand
(included with the Smart Carrier Station) and Chapter 3, SCS Configuration.
Table 2-4: Bar Code Scanner Model References
SCS Common
Name
1st Generation
or G1
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510731-10EN1
SCS Part
Number(s)
530001-1
530001-2
Bar Code
Reader
Bar Code
Reference
Figure
Model 3400
(Scanner ID
Number 722106)
P/N 531130-1
(Discontinued)
Figure 2-7
Model 3800
(Scanner ID
Number IT3800)
(Programmed to
XT Mode)
P/N 514144-1
Figure 2-9
2-11
Setup Bar Codes
Smart Carrier Station
Table 2-4: Bar Code Scanner Model References (Continued)
SCS Common
Name
2nd Generation
or G2
3rd Generation
or G3
2-12
SCS Part
Number(s)
530001-3
530001-4
27203
27204
27209
Bar Code
Reader
Bar Code
Reference
Figure
Model 3400
(Scanner ID
Number 722106)
P/N 531130-1
(Discontinued)
Figure 2-8
Model 3800
(Scanner ID
Number IT3800)
(Programmed to
AT Mode)
P/N 514144-2
Figure 2-10
Model 3800 –
Black
Figure 2-10
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510731-10EN1
Smart Carrier Station
1
2
3
4
5
6
Setup Bar Codes
Factory Default
7
Exit PGM mode
8
Enter Program Mode
9
Good Read Delay
PC-XT Format
Enter Program Mode
Set Inter char delay
10
High
11
Exit PGM mode
Code 0 (3-27)
Code 2 (3-27)
Figure 2-7: Bar Codes for Bar Code Scanner – A
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510731-10EN1
2-13
Setup Bar Codes
1
2
3
4
5
6
Smart Carrier Station
Factory Default
7
Exit PGM mode
8
Enter Program Mode
9
Good Read Delay
PC-AT Format
Enter Program Mode
Set Inter char delay
10
High
11
Exit PGM mode
Code 0 (3-27)
Code 2 (3-27)
Figure 2-8: Bar Codes for Bar Code Scanner – B
2-14
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510731-10EN1
Smart Carrier Station
Setup Bar Codes
Factory Defaults
~
0
1
D
E
F
A
L
T
.
1
IBM/XT Interface
~
0
1
P A P
CR Suffix
_
X
T
;
V S U F C R
.
2
Intercharacter Delay 10ms (02)
~
0
Good Read Medium Delay
1 D L Y C H R 0
2
;
G R D D L Y 2
.
3
4
Figure 2-9: Bar Codes for Bar Code Scanner – C
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2-15
Setup Bar Codes
Smart Carrier Station
Factory Defaults (AT Interface)
~ 0 1 D E F A L T
.
1
CR Suffix
Intercharacter Delay 10ms
~ 0 1 V S U F C R ; D L Y C H R 0 2 .
2
3
Figure 2-10: Bar Codes for Bar Code Scanner – D
2-16
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510731-10EN1
SCS CONFIGURATION
3
Introduction
Configuration options allow you to operate the Smart Carrier Station in a
number of different ways. This chapter explains not only how to set these
options, but also how each option affects the data stored in the button
memory of a cassette.
Chapter Contents
Configuration Overview • 3-2
When to Configure • 3-2
Accessing Configuration Screens • 3-3
SCS Main Configuration Options • 3-3
Cassette ID • 3-3
Setup Technologist ID • 3-4
Bench Name • 3-4
SCS Workflow Configuration Options • 3-5
AST Dilution Mode • 3-5
Erase Cassette • 3-6
Begin Data Entry • 3-6
SCS Utilities • 3-7
Language • 3-7
Audible Feedback • 3-8
Host Type • 3-8
Time and Date • 3-8
SCS Firmware Update • 3-9
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3-1
Configuration Overview
SCS Configuration
Configuration Overview
When to Configure
Set SCS configuration options before you insert a cassette and enter
information for the test cards. When first turned on, the Configuration Screen
is displayed if you have not customized your settings.
Note:
One exception to this is the Firmware Update screen. You do not need to
use that screen until you receive instructions from bioMérieux to do so.
There are eleven configuration options on the SCS:
Table 3-1: SCS Configuration Options
Configuration Screen Name
Smart Carrier Station Configuration
Workflow Configuration
Utilities
Firmware Update
Option
Reference
Cassette ID
page 3-3
*Setup Technologist ID
page 3-4
*Bench Name
page 3-4
AST Dilution Mode
page 3-5
Erase Cassette
page 3-6
Begin Data Entry
page 3-6
Language
page 3-7
Audible Settings
page 3-8
Host Type
page 3-8
Time and Date
page 3-8
Firmware Updates
page 3-9
*This field will be displayed and available only if the Host Type field is set to “PC”.
The options are divided among four screens:
• Smart Carrier Station Configuration – Includes the Cassette ID, Setup
Technologist ID, and Bench Name options.
• Workflow Configuration – Includes the AST Dilution Mode option, the
option for automatically erasing the cassette memory, and an option for
determining the start point of the Cassette Edit screen.
• Utilities – Includes the Language, Audible Feedback Settings, Host Type,
and Time and Date options.
3-2
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SCS Configuration
SCS Main Configuration Options
• Firmware Updates – Displays the current firmware version and includes
options for uploading new software for the SCS.
Accessing Configuration Screens
Access the SCS Configuration screen by pressing F4, followed by the
Previous or Next Slot key to switch to the other screens.
SCS Main Configuration Options
Figure 3-1: SCS Main Configuration Screen
Cassette ID
When test information is entered into a Smart Carrier Station, the Cassette ID
is also saved to identify the cards that were processed in that cassette. This
is especially useful in laboratories with multiple Smart Carrier stations.
The Cassette ID consists of one to three alphanumeric characters. An SCS
name may reflect something about the use of the station. If, for example, a
particular individual is assigned to an SCS, that individual’s initials can be
used for the SCS name. The Cassette ID becomes a part of each test card’s
address that appears on the workstation’s card directory.
Note:
The Cassette ID field cannot be blank. If you do not enter a custom value in
the Cassette ID field, the default Cassette ID of “SCS” will be used.
Note:
Single digit numerals are reserved for use with the VITEK® 2 PC Virtual
Cassette workflow and are not allowed for use as a Cassette ID by the SCS.
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3-3
SCS Main Configuration Options
SCS Configuration
Setting Cassette ID
1)
Press F4 to access the Configuration screen.
2)
In the Cassette ID field, type up to three characters and press Enter.
3)
Press F2 to exit the SCS Configuration screen.
or
Press Next or Previous Screen to access other configuration screens.
Setup Technologist ID
The Setup Technologist ID field allows you to enter your name at the SCS
and transfers that information to the workstation. This field will be displayed
and available only if the Host Type field is set to “PC”.
Setting Setup Technologist ID
1)
Press F4 to access the Configuration screen.
2)
Press the Down Arrow key to move the cursor to the Setup
Technologist ID field.
3)
In the Setup Technologist ID field, type up to thirty-five characters and
press Enter.
4)
Press F2 to exit the SCS Configuration screen.
or
Press Next or Previous Screen to access other configuration screens.
Bench Name
The Bench Name field allows you to enter an alphanumeric name that tags a
bench (or Sample Area) where a given cassette was set up. This field will be
displayed and available only if the Host Type field is set to “PC”.
Setting Bench Name
1)
Press F4 to access the Configuration screen.
2)
Press the Down Arrow key to move the cursor to the Bench Name field.
3)
In the Bench Name field, type up to thirty characters and press Enter.
4)
Press F2 to exit the SCS Configuration screen.
or
Press Next or Previous Screen to access other configuration screens.
3-4
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SCS Configuration
SCS Workflow Configuration Options
SCS Workflow Configuration Options
Figure 3-2: SCS Workflow Configuration Screen
AST Dilution Mode
An AST, or Antimicrobial Susceptibility Test, uses an inoculum that is
specifically diluted according to the type of test card being used. These
inocula can be prepared manually by the technologist, or prepared
automatically by VITEK® 2 at the Dispenser/Pipettor station.
The AST Dilution mode setting is transferred to the VITEK® 2 instrument
using the cassette memory. If you set the AST Dilution Mode to automatic,
every AST in a cassette has its inoculum diluted by VITEK® 2. If the AST
Dilution Mode is set to pre-diluted, VITEK® 2 assumes that the AST dilutions
have already been performed.
Setting AST Dilution Mode
1)
Press F4 to access the Configuration screen.
2)
Press Next or Previous Screen to access the Workflow Configuration
screen.
3)
Press 1 to set the dilution mode to Automatic (default).
or
Press 2 to set the dilution mode to Pre-diluted (manual).
4)
Press F2 to exit the SCS Configuration screen.
or
Press Next or Previous Screen to access other configuration screens.
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3-5
SCS Workflow Configuration Options
SCS Configuration
Erase Cassette
The Cassette Erase function gives you the option of automatically erasing
cassettes that have been processed by the VITEK® 2 instrument.
Setting Cassette Erase
1)
Press F4 to access the Configuration screen.
2)
Press Next or Previous Screen to access the Workflow Configuration
screen.
There are two settings available, Automatic (default) and Verify First.
• Select Automatic to automatically erase cassettes that have been
processed.
• Select Verify First to display and review data before it is erased.
3)
Note:
Press 1 or 2 to select Automatic or Verify First as indicated on the
screen.
If you select Verify First, when you place a cassette that has been processed
by the instrument on the Smart Carrier Station, the following message
displays:
Cassette has been processed
4)
Press F1 to erase, or press any other key to display processed
information.
5)
Press F2 to exit the screen.
Begin Data Entry
The Begin Data Entry function allows you to customize the workflow
associated with the Cassette Edit screen.
Setting Begin Data Entry
1)
Press F4 to access the Configuration screen.
2)
Press Next or Previous Screen to access the Workflow Configuration
screen.
The possible settings are Cassette ID and Accession/Lab ID. (Accession
ID is the same as Lab ID.)
•Select Cassette ID to begin data entry in the Cassette ID field of the
Cassette Edit screen (default).
•Select Accession ID to begin data entry in the Accession ID field of
the Cassette Edit screen.
3)
3-6
Press 1 or 2 to select your preferred workflow as indicated on the screen.
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510731-10EN1
SCS Configuration
SCS Utilities
4)
Press F2 to exit the Workflow Configuration screen.
or
Press Next or Previous Screen to access other configuration screens.
SCS Utilities
Figure 3-3: SCS Utilities Screen
Language
The SCS interface is programmed in limited languages. English is the default
language setting.
By setting this configuration option, you can work on the SCS in the language
of your choice.
Setting SCS Language
1)
Press F4 to access the Configuration screen.
2)
Press the Down Arrow key to move the cursor to the Language Choice
field.
3)
In the Language field, press Help to display an option box with the
available languages.
4)
Press the Up or Down Arrow key to select a language, then press
Enter.
5)
Press F2 to exit the SCS Configuration screen.
or
Press Next or Previous Screen to access other configuration screens.
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3-7
SCS Utilities
SCS Configuration
Audible Feedback
The SCS custom keyboard does not have an audible click when you press a
key. This option enables an audible click from the instrument every time you
press a key on the SCS keyboard.
Setting Audible Feedback
1)
Press F4 to access the Configuration screen.
2)
Press the Down Arrow key to move the cursor to the Enable Audible
Feedback field.
3)
In the Audible Feedback field, press 0 to turn the Audible Feedback off.
or
Press 1 to turn the Audible Feedback on (default).
4)
Press F2 to exit the SCS Configuration screen.
or
Press Next or Previous Screen to access other configuration screens.
Host Type
This field allows you to configure the instrument to communicate with either a
PC workstation or an AIX workstation.
Changing Host Type
1)
Press F4 to access the Configuration screen.
2)
Press the Down Arrow key to move the cursor to the Host Type field.
3)
In the Host Type field, press 1 to select the PC workstation option
(default).
or
Press 2 to select the AIX workstation option.
4)
Press F2 to exit the SCS Configuration screen.
or
Press Next or Previous Screen to access other configuration screens.
Time and Date
The SCS tracks the time of day and the calendar date.
Setting SCS Time and Date
1)
3-8
Press F4 to access the Configuration screen.
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SCS Configuration
SCS Firmware Update
2)
Press the Down Arrow key to move the cursor to the Time field.
3)
In the Hour field, enter the current hour, using a 24-hour format (for
example, 9 PM = 2100). Press Enter to accept the new value.
4)
Enter the current minutes. Press Enter to accept the new value.
5)
Enter the current day. Press Enter to accept the new value.
6)
Enter the current month. Press Enter to accept the new value.
7)
Enter the current, four-digit year. Press Enter to accept the new value.
8)
Press F2 to exit the SCS Configuration screen.
or
Press Next or Previous Screen to access other configuration screens.
SCS Firmware Update
You receive periodic program updates, or update media, along with
installation instructions for these updates, from bioMérieux. When you
perform an update, all the necessary SCS files are included in the product
release.
Figure 3-4: SCS Firmware Update Screen
The SCS firmware can be updated to enhance its functions. These updates
are performed by connecting the SCS to the workstation using a cable.
There are two Firmware Update options:
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3-9
SCS Firmware Update
SCS Configuration
Receive Firmware Update – This field allows you to request a complete
firmware update from the workstation.
Request Specific File – This field allows you to request a specific file from
the workstation. If the use of this field is neccessary, the appropriate
procedure will be included in the instructions that were provided with the
update media.
3-10
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VITEK® 2 INSTRUMENT
4
Introduction
This chapter describes the hardware systems in the VITEK® 2 instrument.
External Instrument Components on page 4-2 points out the controls and
connections found on the instrument’s exterior, and the doors by which you
gain access to its interior. Instrument Hardware Components on page 4-5
describes the work stations and components in the instrument.
Chapter Contents
External Instrument Components • 4-2
Controls, Access Doors and Connections • 4-3
Connections • 4-4
Turning on the VITEK® 2 Instrument • 4-4
Startup Procedure • 4-4
Instrument Hardware Components • 4-5
Smart Carrier Station (SCS) • 4-5
Cassettes • 4-6
Cassette Load and Unload Station • 4-7
Boats • 4-8
Bar Code Reader • 4-9
Button Memory Reader • 4-10
Dispenser/Pipettor Station • 4-11
Filler Station • 4-13
Sealer Station • 4-14
Test Card Incubation and Reading • 4-14
Carousel • 4-15
Optics • 4-16
Card Ejection • 4-16
Waste Collection Station • 4-17
User Interface System • 4-18
Keypad and Screen • 4-18
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4-1
VITEK® 2 Instrument
External Instrument Components
External Instrument Components
The following images contain a front and a left side view of the VITEK® 2 and
VITEK® 2 XL instrument. Use the diagram to locate and familiarize yourself
with the external controls and the access doors to the interior of the
instrument.
9
5
1
4
11
2
12
3
13
8
Figure 4-1: The VITEK® 2 60 Instrument
9
6
7
4
1
4
11
2
12
10
3
13
8
Figure 4-2: VITEK® 2 XL Instrument
4-2
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VITEK® 2 Instrument
External Instrument Components
Controls, Access Doors and Connections
CAUTION: All access doors should remain closed when
processing cards.
LASER WARNING
All access doors and covers must remain closed when
processing cards to avoid exposure to laser light.
1 — User Interface Screen and Keypad. This screen and keypad comprise
the User Interface system. See page 4-18 for detailed information.
2 — Front Access Door. Provides access to the diluter, pipette tip container,
and a portion of the test card transport system. The door opens from the right
side.
3 — Cassette Load/Unload Door. Provides access to the Cassette Load/
Unload station. The door slides up to open. A locking mechanism prevents
opening of this door at inappropriate times.
4 — Waste Collection Door. Provides access to the Waste Collection
Station where ejected test cards are removed from the instrument. The door
is held in place magnetically and lowers from the top.
5 — Top-Right Access Door. Provides access to the optics and the
carousel. The door lifts from the front and stays in the open position.
Note:
The top-right access door cannot be opened unless the Waste Collection
door (4, Figure 4-1 and Figure 4-2) is opened first.
Note:
This door is secured by two screws, and requires a flathead screwdriver to
open.
6 — Top Access Door Section A. VITEK® 2 XL only. Provides access to the
optics and carousel for Section A.
7 — Top Access Door Section B. VITEK® 2 XL only. Provides access to the
optics and carousel for Section B.
8 — Bottom Access Door. Provides access to the drip pan. The door is held
in place magnetically and must be pulled down to open.
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4-3
Turning on the VITEK® 2 Instrument
VITEK® 2 Instrument
9 — Saline Access Door. Provides access to the sterile saline bag. The door
lifts from the front and stays in the open position.
10 — Center Front Sliding Door. VITEK® 2 XL only. The Cassette load/
unload door (3) must be opened before this door can be opened.
Connections
11 — UPS Connection. This cable connector port connects VITEK® 2 to an
uninterruptable power supply (UPS). The connection allows the UPS to notify
the VITEK® 2 instrument of a power loss so the VITEK® 2 can start
appropriate procedures.
12 — Workstation Connection. This connector port accepts the cable that
connects the VITEK® 2 instrument to the workstation computer.
13 — AC Power Switch and Cord Receptacle. This switch supplies power
to the VITEK® 2 instrument. The cord receptacle accepts the power cord that
is connected to the electricity source.
Turning on the VITEK® 2 Instrument
Note:
Refer to the environmental and electrical specifications for the VITEK® 2
instrument in Appendix A before starting the instrument.
Startup Procedure
1)
Make sure the VITEK® 2 instrument has been connected to an
appropriate power supply using the power cord supplied with the
instrument.
2)
Press the AC power switch to the ON position (13, Figure 4-2).
The instrument goes through an initialization sequence that includes several
self tests. During this time, VITEK® 2 is also bringing the carousel area up to
its specified temperature for test card incubation.
After a few minutes, the VITEK® 2 Status screen appears. The Status field at
the top of the screen should show a status of Warming or OK. The Warming
status means that the carousel temperature is not yet within its specified
range. This can take several minutes.
VITEK® 2 is ready to begin processing cards when the Status field shows
OK. (For more information about the Status field, see the topic Instrument
Status Field in Chapter 6).
4-4
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VITEK® 2 Instrument
Instrument Hardware Components
Instrument Hardware Components
The VITEK® 2 instrument is an integrated system, combining the tasks of
sample preparation, test card inoculation, and test card incubation and
reading.
The parts and functions of the VITEK® 2 instrument can best be described by
following a test card through the phases of a typical processing cycle.
Table 4-1 summarizes this cycle, and shows you where you can find more
details about a particular component of the VITEK® 2 instrument.
Table 4-1: Components Involved in the Test Card Processing Cycle
Component
Processing Phase
Information
Cassettes
Test card transport
page 4-6
Cassette Load and Unload Station
Test card transport
page 4-7
Boats
Test card transport
page 4-8
Bar Code Reader
Sample preparation
page 4-9
Button Memory Reader
Sample preparation
page 4-10
Dispenser/Pipettor Station
Sample preparation
page 4-11
Filler Station
Sample preparation
page 4-13
Sealer Station
Sample preparation
page 4-14
Test Card Incubation and Reading
Test card analysis
page 4-14
Carousel
Test card analysis
page 4-15
Optics
Test car analysis
page 4-16
Card Ejection
Test card transport
page 4-16
Waste Collection Station
Test card transport
page 4-17
User Interface System
All process phases
page 4-18
Smart Carrier Station (SCS)
The SCS is not a part of the VITEK® 2 instrument, but it is the station where
the entire process begins. For complete details on the SCS, see Chapter 2.
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510731-10EN1
4-5
VITEK® 2 Instrument
Instrument Hardware Components
Cassettes
BIOHAZARD WARNING
The boat should be considered as potentially contaminated
and should be handled appropriately. Qualified laboratory
personnel should take the usual precautions necessary for
infectious agents.
The cassette is the main component of the test card transport system. It can
hold up to 15 test cards with their inoculum test tubes. In systems using the
Smart Carrier Station, the button memory chip on the cassette is used to
store and transport data from the Smart Carrier Station to VITEK® 2.
1
3
3
5
2
4
Figure 4-3: Cassette Components
1 — Test Card Slots. The top portion of a cassette is divided into 15 test
card slots that can hold various combinations of VITEK® 2 test cards.
2 — Test Tube Holders. The front portion of a cassette has 15 wells that
hold test tubes for inoculum.
3 — Test Tube Release. Test tubes are held securely in the cassette by a
retaining bar. A release lever is provided for easy disposal of used test tubes.
4-6
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VITEK® 2 Instrument
Instrument Hardware Components
4 — Button Memory. For systems using a Smart Carrier Station, each
cassette is fitted with a special memory chip, called the button memory.
When a cassette is on a Smart Carrier Station, the button memory stores the
information that you enter for each test card. This information is read by a
station in VITEK® 2, which marks the memory chip as being read, allowing
the cassette to be reused.
5 — Cassette Base. The base of a cassette is specially shaped to:
• Fit snugly onto the base unit of the Smart Carrier Station. When properly
fitted on the base unit, the contacts for the button memory are touching the
contacts that protrude from the base unit.
• Fit into a boat. The shape of the cassette base matches the well on the top
of a boat. This ensures that the two units move as one through VITEK® 2.
The shape also ensures that the cassette can only be put into a boat in the
proper orientation
Cassette Load and Unload Station
Load and unload cassettes from VITEK® 2 using this station. The station
consists of the cassette load door (1, Figure 4-4) and a green indicator
light (2). The door has a locking mechanism.
1
2
Figure 4-4: The Cassette Load/Unload Station
Table 4-2: Indicator Light States
Light
Status
On
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Error Condition and Resolution
The cassette load door is unlocked. You may open the door to
load cassettes.
4-7
VITEK® 2 Instrument
Instrument Hardware Components
Table 4-2: Indicator Light States (Continued)
Light
Status
Error Condition and Resolution
Off
The cassette load door is locked and cannot be opened.
Blinking
A boat with an empty cassette has arrived at the station. The
cassette load door is unlocked. Open the door and remove the
cassette. When you close the door, the blinking stops.
CAUTION: The VITEK® 2 test card transport system stops while
the cassette load door is open. Be sure to close the door after
loading or unloading a cassette.
BIOHAZARD WARNING
The boat should be considered as potentially contaminated
and should be handled appropriately. Qualified laboratory
personnel should take the usual precautions necessary for
infectious agents.
CAUTION: Do not move or remove a boat from the instrument
unless you are using the programmed function for this purpose.
Doing so can cause an instrument jam.
Boats
The VITEK® 2 instrument contains four plastic trays called boats. These
boats carry cassettes through the processing stations inside the VITEK® 2
instrument.
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4
5
1
2
3
Figure 4-5: Boat Components
A boat, shown in Figure 4-5, has particular features that support its three
major functions:
1— Test Card Transport. The top surface of a boat forms a specially shaped
well into which a cassette is placed. The shape of the well conforms to the
base of a cassette, providing it with a secure platform on which to ride. The
two pins in the well ensure that the cassette is placed into the boat only in the
proper orientation. An arrow is molded into the surface of the well to show the
proper orientation of the boat when placed in the instrument.
2 — Notched Base. The base of each boat is notched in several places.
These notches are used by the VITEK® 2 test card transport mechanisms
that move the boats through the module.
3 — Base Supports. Each boat stands on four low-friction feet, providing a
surface on which the boat can easily move.
4 — Spill Prevention. The well in the top of the boat catches any spills from
the cassette.
5 — Test Card Filling. Above the cassette well, there is a flat surface that
extends around the perimeter of the boat. This surface becomes the base of
the vacuum chamber when the boat reaches the Filler station.
Bar Code Reader
After a cassette is loaded onto a boat, the test card transport system moves
the boat past the bar code reader station. This station reads the information
encoded on the bar code label found on each VITEK® 2 test card. The
following information is included in the bar code:
Test Card Type — For example, a Gram Negative Susceptibility test card.
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Investigational Use Only (IUO) flag — This tells VITEK® 2 if an
experimental test card is being processed.
Test Card Expiration Date — This date is transferred to the workstation,
which prints it on the laboratory report.
Test Card Lot Information and Sequence Number — This includes the test
card’s lot number to provide manufacturing traceability. The sequence
number uniquely identifies a test card.
CAUTION: When handling VITEK® 2 test cards, make sure you
do not deface the bar code in any way.
LASER WARNING
All access doors and covers must remain closed when
processing cards to avoid exposure to laser light.
Button Memory Reader
The Button Memory Reader is a device that the VITEK® 2 instrument uses to
read the test card information stored by the Smart Carrier Station in the
memory chip on a cassette. VITEK® 2 uses this test card information in two
ways:
• The test card type entered at the SCS is compared to the test card type
that VITEK® 2 reads with its own bar code reader. This ensures that no
changes were made in the position of any test card in the cassette.
• The accession ID, test card type, and the other fields entered at the SCS
are sent to the computer. This information allows the software to link the
test card results from VITEK® 2 to patient demographic data and any
previous test results.
After the information is extracted from the button memory, VITEK® 2 marks
its contents as Read. When the cassette is put on the SCS again, a button
memory marked as Read is erased so the cassette can be used again.
CAUTION: The memory chip must be removed from the cassette
before cleaning the cassette.
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Dispenser/Pipettor Station
This station automatically prepares the organism dilution used for AST
(Antimicrobial Susceptibility Test) cards. VITEK® 2 provides a significant time
savings by ensuring that mated ID and AST cards are processed from the
same sample.
Dispenser
The dispenser system, shown in Figure 4-6, delivers 2.5 mL of sterile saline
into the test tube of each AST card in a cassette.
1
2
4
3
Figure 4-6: Dispenser System
Sterile Saline. The top of the VITEK® 2 instrument has a compartment
designed to hold a one-liter bag of sterile saline (1, Figure 4-6). This is
enough saline to process about 330 AST cards.
Dispenser Assembly. The dispenser assembly consists of a plastic
dispensing chamber and two sections of plastic tubing. One section of
tubing (2) leads from the dispensing chamber and is attached to the sterile
saline bag. The other section of tubing (3) also leads from the dispensing
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VITEK® 2 Instrument
Instrument Hardware Components
chamber but is attached to an air pump. It is fitted with a filter (4) to prevent
particulate contamination.
Electromechanical Components (not shown). The electromechanical
components control how the system works.
1)
When an AST card is detected, a valve opens to allow saline to travel
from its bag to the dispensing chamber.
2)
An optical sensor detects when the chamber is full (2.5 mL) and closes
the valve.
3)
The dispensing chamber rotates into position over the AST card’s test
tube.
4)
The air pump is activated, forcing the saline into the tube at a controlled
rate that minimizes splashing.
Pipettor
The pipettor station transfers a preset volume of an organism suspension
from its test tube into the test tube of its mated AST card.
1
2
Figure 4-7: Disposable Pipettes
1 — Disposable Pipette Tips. To prevent contamination, VITEK® 2 uses
single-use, disposable pipette tips.
2 — Container. The container holds up to 350 pipette tips. It has an internal
mechanism that ensures proper delivery of each pipette tip to the
displacement pump.
3 — Displacement Pump (not shown). The displacement pump withdraws
a specified volume of inoculum for dilution in the inoculum tube of an AST
card.
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Note:
The displacement pump is not normally visible as it is located directly behind
the interface screen and keypad.
Displacement Pump Operation
The displacement pump is part of a larger assembly that performs the
pipetting and transfer of the suspension when VITEK® 2 is in the Automatic
dilution mode. Here is how it works:
1)
The container drops a pipette tip into position.
2)
The displacement pump assembly extends a hollow metal tube into the
container, attaches a pipette tip to the tube, and withdraws the pipette tip
from the container. The instrument checks to ensure that a pipette tip is
attached.
3)
The pump assembly rotates so the pipette tip is over the ID suspension
test tube. The pipette tip is then lowered into the suspension. The
instrument checks to make sure there is fluid in the ID test tube.
4)
The pump draws the preprogrammed amount of suspension and
withdraws the pipette tip from the test tube.
5)
The cassette moves so that the susceptibility test tube is now under the
pipette tip.
6)
The pipette tip is lowered into the test tube and the pump dispenses the
suspension into the tube where it mixes with the saline from the
Dispenser.
7)
The pipette tip is removed from its attachment and left in the sample tube
for disposal.
Filler Station
At the Filler Station, all of the test cards in a cassette are inoculated with the
suspension contained in their corresponding test tubes.
The Filler Station uses a vacuum chamber and pump. When the boat carrying
a cassette reaches this station, the top of the vacuum chamber lowers onto
the boat, so the boat serves as the base of the vacuum chamber.
1)
The pump evacuates the air from the chamber. This forces the air inside
each test card to escape via the transfer tube and bubble up through the
suspension. The channels and wells inside of each test card are now at a
vacuum.
2)
After a short period, the vacuum is slowly released. The increasing air
pressure inside the chamber forces the suspension in each test tube
through the transfer tube and into the channels and wells of the test card.
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Instrument Hardware Components
VITEK® 2 Instrument
Various temperature and air pressure sensors in the system monitor the
inside of the vacuum chamber. VITEK® 2 ensures proper test card fills by
monitoring these parameters throughout the entire cycle and controlling the
rate at which the vacuum is drawn and released.
Note:
The seal on the vacuum chamber should be cleaned periodically. See the
maintenance schedules and procedures in Chapter 7 of this manual.
Sealer Station
CAUTION: The sealer station contains a wire that is heated
during the sealing operation. Do not reach into the instrument
during the sealing operation.
The Sealer station completes the functions inside VITEK® 2 that prepare the
test cards for incubation and reading. This is accomplished by heat-sealing
the transfer tube that delivered inoculum to the test card from its test tube.
This seals off the contents of the test card.
As the boat and cassette move through this station, a heated wire comes in
contact with each transfer tube. The plastic tube melts, causing most of it to
separate from the test card and drop into the test tube. The portion that
remains in the test card is sealed by the melting plastic.
Note:
The stub left from the transfer tube may be up to 0.1 inch (0.25 cm) long.
Test Card Incubation and Reading
Once test cards are sealed, they are ready to be incubated and read. The test
card transport system moves the boat and cassette into position for a
mechanism, called the Card Loader, to place each test card into a slot on a
carousel, where it remains throughout the reading cycle.
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Carousel
The Carousel, shown in Figure 4-8, has a capacity of 60 test cards. During
their time in the carousel, the test cards are incubated at an average
temperature of 35.5 °C.
Figure 4-8: Carousel Placement
As the carousel rotates, each test card moves into the reading position every
15 minutes. A mechanical device called the Reader Head, shown in
Figure 4-9, conveys the test card through the optics stations.
Figure 4-9: Carousel Reader Head
After the reading cycle, the test card returns to its slot in the carousel, where
it continues to incubate until its next read cycle.
Note:
The carousel is divided into four sections so it can be easily removed for
periodic cleaning. See Cleaning the Carousel on page 7-10.
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Instrument Hardware Components
Optics
The VITEK® 2 instrument performs its identification and susceptibility
analyses by continually monitoring the growth and activity of organisms
inside the wells of the test cards. The optics system performs this function.
Transmittance Optics
The transmittance optics (1, Figure 4-10) use visible light to directly measure
organism growth. These optics are based on an initial light reading of a well
before significant growth has begun. Light transmittance samplings of the
same well every 15 minutes measure organism growth by how much light is
prevented from going through the well.
1
Figure 4-10: Optics
The optics use light emitting diodes (LEDs) that produce light at the
appropriate wavelengths, and silicon photodetectors to capture the
transmitted light. The system is self-calibrating.
Note:
The optics should be cleaned periodically. See Cleaning Optics (Normal
Maintenance) on page 7-26.
Card Ejection
The card ejection function permanently removes test cards from the carousel
after their testing is completed. The mechanism that performs this function is
the same drive belt system that moves the test cards through the reader.
Instead of returning to the carousel, an ejected test card continues on to the
Waste Collection Station.
The amount of time that cards are held before being ejected automatically
from the carousel is set by an option in the System Configuration screen at
the workstation computer. Cards can also be ejected at any time using a
manual ejection function.
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CAUTION: Do NOT re-insert ejected test cards into the VITEK® 2
instrument.
WARNING
Make sure that all test card processing has been completed
before ejecting a test card.
Waste Collection Station
The card ejector removes test cards that have completed testing from the
reader. These test cards are collected in a tray at the Waste Collection
Station for removal from the VITEK® 2 instrument and disposal. The station,
shown in Figure 4-11, holds up to 60 test cards. The instrument counts test
cards as they fill the tray, and sends a message to the VITEK® 2 interface
screen when the station is full. A sensor in the station detects when the tray
has been emptied or if the tray is missing.
Figure 4-11: Waste Collection Station
Access the Waste Collection Station by opening the waste collection door on
the front of the VITEK® 2 instrument.
Note:
Keep the Waste Collection Station door closed except when test cards are
being removed from the station.
Note:
Empty the waste collection tray after loading a new cassette into the
instrument.
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VITEK® 2 Instrument
User Interface System
Note:
Periodically remove the waste collection tray for cleaning. See Cleaning the
Test Card Collection Tray on page 7-25.
User Interface System
Throughout the entire processing cycle for test cards, communication
between the user and the VITEK® 2 instrument is essential. The VITEK® 2
User Interface System provides the means of that communication.
Keypad and Screen
A keypad and screen are located on the front of the instrument. VITEK® 2
uses the screen to send messages about its operation, on-board
disposables, and possible problems. Use the keypad to respond to the
instrument instructions, to send commands to VITEK® 2, and to perform other
functions. Figure 4-12 identifies the components of the keypad and screen.
1
4
3
2
5
7
6
Figure 4-12: The VITEK® 2 Keypad and Screen
1 — Option Buttons. Use these buttons to select menu options or other
specified functions.
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User Interface System
2 — Help (?) Key. Press this key at any time to access the error/message
queue.
3 — Previous Screen Key. Use this key to:
•
•
•
•
Exit from a screen or function to its menu.
Return to a previous screen in a function.
Go from a sub-menu to its previous menu.
Go from the Main Menu to the Status screen.
4 — Undo Key. Use it to cancel the last action performed.
5 — Arrow Keys. Use these keys to:
• Scroll a screen or menu.
• Move the cursor on screen.
Note:
When Arrow keys are active, their icons appear on the display.
6 — Enter Key. Use this key to complete data entries, or when instructed to
do so on a screen.
7 — Numeric Keys. Use these keys to enter a number onto a screen.
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CONFIGURING THE VITEK® 2 INSTRUMENT
5
Introduction
Configuration options allow you to operate the VITEK® 2 instrument in a
number of different ways. This chapter explains not only how to set these
options, but how each option affects the operation of the instrument, and
therefore your laboratory workflow.
Certain configuration options affect only the physical interface and can be
changed to suit your preferences. For example, you can adjust the contrast
on the interface screen.
Other options affect how VITEK® 2 processes test cards, and therefore
should be carefully considered before setting or changing them.
Chapter Contents
Configuration Options • 5-2
Configuration Overview • 5-2
Setting Configuration Options • 5-2
Cassette Names • 5-3
Instrument Name • 5-3
Schedule Instrument QC Status • 5-4
Cassette Mode • 5-5
Dilution Mode • 5-5
Bar Code Reader • 5-6
Audible Alarm Enable • 5-6
Audible Alarm Volume • 5-6
Visual Alarm Enable • 5-7
Audible Feedback Volume • 5-7
Screen Contrast • 5-7
Waste Tray Warning Level • 5-8
Using the Interface • 5-8
Defining Character Sets • 5-9
Setting Time for QC Status • 5-10
Using Option Boxes • 5-11
Setting a Range Value • 5-12
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Configuring the VITEK® 2 Instrument
Configuration Options
Configuration Options
Configuration Overview
There are 12 configuration options in the VITEK® 2 user interface. They can
be divided into two groups, depending on whether or not the option affects
how the instrument operates. The group that affects instrument operation is
composed of the following options:
Table 5-1: Configuration Options that Affect Instrument Operation
Option
Reference
Cassette Names
page 5-3
Instrument Name
page 5-3
Schedule Instrument QC Status
page 5-4
Cassette Mode
page 5-5
Dilution Mode
page 5-5
Bar Code Reader
page 5-6
The group of options that affect only the physical parameters of the user
interface is composed of the following options:
Table 5-2: Configuration Options that Affect Only Physical Parameters
Option
Reference
Audible Alarm Enable
page 5-6
Audible Alarm Volume
page 5-6
Visual Alarm Enable
page 5-7
Audible Feedback Volume
page 5-7
Screen Contrast
page 5-7
Waste Tray Warning Level
page 5-8
Setting Configuration Options
Configuration options can be set or changed at almost any time. However,
you should follow this simple workflow to ensure that you set your options
correctly.
1)
5-2
Read the descriptions contained in this chapter for each option.
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Configuration Options
2)
Evaluate the effect that an option has on your workflow and decide how
to set the option. This is especially important for the options in
Table 5-1.
3)
Set the options according to the choices made in Step 2, by following the
procedures in this chapter.
4)
Operate the system to validate the settings and evaluate the physical
parameter settings for the options in Table 5-2.
5)
Change any option as required.
Cassette Names
The Cassette Name option allows you to define up to 10 three-character
VITEK® 2 “users”, which can represent the technologists who process test
cards, sections of the laboratory from which test cards originate, or any
identification scheme you choose. On the VITEK® 2 workstation, you can
then filter the test card directory view by Cassette Name, in order to view
only the cards processed by a particular user.
The Cassette Name option is designed for workflows without a Smart Carrier
Station (SCS). The Cassette Name that you define replaces the cassette
name that would be read from the cassette’s button memory. You should use
this option if you do not have an SCS, or if you have a workflow that does not
require the use of an SCS.
Note:
If the VITEK® 2 instrument is in Smart Carrier mode, the Cassette Name
option cannot be accessed. If you attempt to use the option, the screen
displays the message:
This option is used with Cassette Only mode
For information on setting this option, see the procedure Using Option
Boxes on page 5-11.
Instrument Name
The Instrument Name option allows you to name a VITEK® 2 instrument
module. The name can contain up to 20 printable characters, including
spaces. The Instrument Name can be helpful in those laboratories with more
than one VITEK® 2 instrument to segregate, for example, specimen types or
technologists. The Instrument Name also displays on the Directory window
at the VITEK® 2 workstation.
The VITEK® 2 instrument names default to Instrument 1, Instrument 2, and
so on. You should use this option if you have more than one instrument
module. By assigning each instrument module a different name, you can view
test card directories by the instrument in which they are being processed.
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Configuring the VITEK® 2 Instrument
Configuration Options
For information on setting this option, see the procedure Defining
Character Sets on page 5-9.
Schedule Instrument QC Status
The QC Status is a report of the current incubator temperature and the status
of the optics systems. The report is sent to the VITEK® 2 workstation where it
is recorded with the date and time the report was taken.
The configuration option allows you to schedule up to three times of day
when a QC report is taken and recorded at the workstation.
The Instrument Quality Control Status includes two parameters:
• Carousel Incubator Temperature
• Optics Systems
The instrument continuously monitors these parameters so their status can
be determined at any time. The user interface provides a function, called
Display Instrument QC Status, to access this information.
1
2
3
4
Figure 5-1: The Instrument QC Status Screen
1 — This field displays the time and date that the previous QC status was
recorded. The field is blank if this function has never been used before.
2 — Temperature. For VITEK® 2, this field displays the current carousel
temperature in degrees Celsius. For the VITEK® 2 XL, the temperatures for
carousel A and B are displayed.
3 — Optical Systems. This field displays the status of the transmittance
optical system.
4 — Record. Press this button to transmit the QC status information to the
workstation. During the transfer the screen displays the message:
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Configuring the VITEK® 2 Instrument
Configuration Options
Recording QC Report
The instrument user interface contains a function with which you can
manually record a QC Status. You can set this option if you want the report
recorded automatically. For example, you can have the report recorded at the
same time every day.
For information on setting this option, see the procedure Setting Time for
QC Status on page 5-10.
Cassette Mode
The Cassette Mode tells the VITEK® 2 instrument whether or not you use a
Smart Carrier Station, and is critical to instrument operation. The option
enables or disables the instrument’s Button Memory Reader, a device that
reads information stored in the button memory.
The Cassette Mode option defaults to Smart Carrier, meaning that an SCS is
being used. Use this option to change the mode to Cassette Only if your
laboratory does not have an SCS.
For information on setting this option, see the procedure Using Option
Boxes on page 5-11.
Dilution Mode
The Dilution Mode option can be set to either Automatic or Pre-diluted. In
the Automatic mode, the Dispenser/Pipettor station in the VITEK® 2
instrument automatically prepares the inoculum for AST cards that have
matching ID cards. In the Pre-diluted mode, the Dispenser/Pipettor station is
disabled.
If you use an SCS, the operation of the Dispenser/Pipettor station is
determined by the information in the cassette’s button memory.
Note:
If the VITEK® 2 instrument is in Smart Carrier mode, the Dilution Mode option
cannot be accessed. If you attempt to use the option, the screen displays the
message:
This option is used with Cassette Only mode
However, if you are not using an SCS, this option must be set as follows:
• To Automatic if you want VITEK® 2 to prepare your AST card inocula.
• To Pre-diluted if you prepare AST card inocula manually.
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Configuring the VITEK® 2 Instrument
Configuration Options
Note:
If the instrument is in Cassette Only mode, you can use the Cassette Setup
function (Main Menu) to process individual cassettes in the dilution mode
opposite to the configuration setting.
BIOHAZARD WARNING
Biohazardous spills can occur inside the VITEK® 2 instrument
if the Dilution Mode option is not properly set. This is especially
true if pre-diluted samples are used with the mode set to
Automatic.
For information on setting this option, see the procedure Using Option
Boxes on page 5-11.
Bar Code Reader
The VITEK® 2 instrument has a bar code station that reads the bar code
labels on the test cards. If the reader becomes misaligned, or if some other
error occurs in the station, you may get repeated error messages about bad
bar codes.
Use this option to disable the bar code reader if there is a problem with the
station. Do NOT use this option unless you think there is a problem in the bar
code reader station.
For information on setting this option, see the procedure Using Option
Boxes on page 5-11.
Audible Alarm Enable
The instrument sounds an audible alarm to alert you to an error condition.
The alarm stops temporarily when you press any key on the instrument
keypad, sounding again if you do not access the message queue.
The Audible Alarm Enable option defaults to Enabled. The option to disable
the alarm is provided for cases where the instrument is located very near the
workstation. Since the workstation also sounds an alarm, disabling the
instrument’s alarm eliminates this redundancy.
For information on setting this option, see the procedure Using Option
Boxes on page 5-11.
Audible Alarm Volume
The volume of the audible alarm can be adjusted higher or lower to account
for laboratory conditions.
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Configuring the VITEK® 2 Instrument
Configuration Options
The default setting for the alarm volume is at the midpoint of its range. Use
this option to make the appropriate adjustments as required. The option
includes a test function so that you can hear the alarm while changing it.
For information on setting this option, see the procedure Setting a Range
Value on page 5-12.
Visual Alarm Enable
The instrument causes the interface screen display to blink to alert you to an
error condition. The blinking terminates when you press any key on the
instrument keypad.
Since the VITEK® 2 instrument and workstation each have an audible alarm,
the visible alarm may be unnecessary. If so, use this option to disable the
alarm.
CAUTION: Do not disable both the audible and visual alarms on
the instrument unless it is located very near the workstation.
Doing so makes it more difficult to know that an error condition
exists.
For information on setting this option, see the procedure Using Option
Boxes on page 5-11.
Audible Feedback Volume
The VITEK® 2 instrument interface uses a touch pad type of keypad. It
sounds an audible click when you press each key. The volume of the click
can be adjusted to account for laboratory conditions.
The default setting for the Audible Feedback volume is at the midpoint of its
range. Use this option to make the appropriate adjustments.
For information on setting this option, see the procedure Setting a Range
Value on page 5-12.
Screen Contrast
The VITEK® 2 user interface screen uses an LCD display. This option
controls the amount of background contrast on the display.
Viewing of a LCD screen can be enhanced by changing the contrast under
certain lighting conditions. Use this option to change the screen if conditions
require it.
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Configuring the VITEK® 2 Instrument
Using the Interface
For information on setting this option, see the procedure Setting a Range
Value on page 5-12.
Waste Tray Warning Level
The VITEK® 2 instrument displays a warning message when the Waste
Collection Tray reaches full capacity. Use this setting to adjust the amount of
advance warning the instrument will provide.
When the Waste Tray Warning Level is set to zero, the VITEK® 2 instrument
will issue the warning as soon as a card is loaded into the instrument that
would overfill the Waste Collection Tray when it is completed. As the value of
the Waste Tray Warning Level is increased, the instrument will allow that
number of cards to be loaded into the VITEK® 2 instrument above the
capacity of the waste tray before the warning is generated. If the Waste Tray
Warning Level is set to 60, the instrument will not issue any warnings, it will
only issue an Alarm when a card cannot be unloaded due to a full Waste
Collection Tray.
For information on setting this option, see the procedure Setting a Range
Value on page 5-12.
Using the Interface
There are 12 configuration options, but only four different procedures for
setting them, depending on the interface used. The four interfaces used and
the applicable configuration options are shown in Table 5-3.
Table 5-3: Types of Interfaces for Configuration Options
Type of Interface
5-8
Application Configuration Option
Reference
Character set
• Cassette Names
• Instrument Name
page 5-9
Set time
Schedule QC Status
page 5-10
Option box
• Cassette Mode
• Dilution Mode
• Bar Code Reader
• Audible Alarm
• Visible Alarm
page 5-11
Set range value
• Audible Alarm Volume
• Audible Feedback Volume
• Screen Contrast
• Waste Tray Warning Level
page 5-12
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Configuring the VITEK® 2 Instrument
Using the Interface
All of the configuration options for VITEK® 2 are on the Configuration menu.
You access this menu using the path:
Main Menu > Utilities > Configuration
The VITEK® 2 Main Menu looks like this:
Figure 5-2: VITEK® 2 Main Menu
Defining Character Sets
Use this procedure for the Cassette Names and Instrument Name
configuration options. Character sets can include any of the characters
provided on the character selection, plus the 10 digits from the keypad.
1)
Select the Cassette Names or Instrument Name configuration options
using the path:
Main Menu > Utilities > Configuration
2)
Choose Cassette Name or Instrument Name.
For the Cassette Names option, the following screen appears:
Figure 5-3: Cassette Names Configuration Screen
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Configuring the VITEK® 2 Instrument
Using the Interface
Note:
This screen does not appear for the Instrument Name option.
3)
Press a number key to select one of the ten cassette name positions,
and then press Enter.
The Character Selection screen appears:
Figure 5-4: Character Selection Screen
Note:
This screen is similar for both the Cassette Names and Instrument Name
options.
4)
Select a letter using the Arrow keys and then press the option button for
the character box.
If you make a mistake, press Backspace.
Setting Time for QC Status
The function allows you to set up to three times during the day at which an
instrument QC report is sent to the workstation.
Access this function using the path:
Main Menu > Utilities > Configuration > Schedule QC Status
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Configuring the VITEK® 2 Instrument
Using the Interface
The following screen appears:
Figure 5-5: Schedule QC Status Screen
The time fields operate on a 24-hour clock. Times A, B, or C are disabled
until you schedule the QC Status.
Note:
The Left or Right Arrow keys beneath Hours/Minutes allow you to toggle
between Hours and Minutes when setting the time.
To set the Hour for Time A:
1)
Press the Left Arrow key until Hours displays.
2)
Use the Up or Down Arrow keys to set the hour.
To set the Minutes for Time A:
1)
Press the Left Arrow key until Minutes displays.
2)
Use the Up or Down Arrow keys to set the minutes.
3)
To schedule another QC Status report, select Time B by pressing the
Next button.
4)
To exit the function press Enter.
Using Option Boxes
This procedure applies to the following configuration options:
•
•
•
•
•
Cassette Mode
Dilution Mode
Bar Code Reader
Audible Alarm Enable
Visual Alarm Enable
1)
Access one of the above configuration options using the following path:
Main Menu > Utilities > Configuration
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Configuring the VITEK® 2 Instrument
Using the Interface
2)
Press Up or Down Arrow to choose an option.
A screen similar to Figure 5-6 appears.
Figure 5-6: Option Box Screen
3)
To change the current setting, press the Up or Down Arrow keys.
Setting a Range Value
This procedure applies to the following configuration options:
•
•
•
•
1)
Audible Alarm Volume
Audible Feedback Volume
Screen Contrast
Waste Tray Warning Level
Access one of the above configuration options using the following path:
Main Menu > Utilities > Configuration
2)
Press Up or Down Arrow to choose an option in the range (see
Figure 5-7).
Figure 5-7: Range Value Screen
3)
Change the range value by pressing the Left or Right Arrow keys.
The bar graph and the numeric value change, and the actual parameter
changes in response to this action.
5-12
Note:
Do NOT set the screen contrast to either end of its available range. Doing so
may make the screen unusable.
Note:
For the Audible Alarm Volume parameter, a test button sounds the alarm.
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PROCESSING VITEK® 2 TEST CARDS
6
Introduction
This chapter contains the procedures you need to process VITEK® 2 test
cards. The chapter begins with three introductory sections that provide
reference information about the VITEK® 2 Status screen, the VITEK® 2 Menu
system, and the Smart Carrier Station interface.
The next two sections contain suggested workflows and the procedures for
working either with or without a Smart Carrier Station (SCS). The final section
deals with unloading test cards from the instrument.
Chapter Contents
Instrument Status Screen • 6-3
Displaying the Status Screen • 6-3
Instrument Status Field • 6-3
Non Standard Card Reading Mode • 6-4
Card Capacity • 6-4
Cassette Name Field • 6-5
Dilution Mode Indicator • 6-5
Status Screen Icons • 6-5
Monitoring Pipette Tips and Saline • 6-6
VITEK® 2 Menu System • 6-7
Frequently Used Keys • 6-9
About the Smart Carrier Station (SCS) • 6-9
Advantages of Using SCS • 6-9
Cassette Edit Screen • 6-11
Understanding the Slot Indicator • 6-12
SCS Functions • 6-13
Option Boxes • 6-14
Bar Code Scanner • 6-16
Processing Test Cards Using the Smart Carrier Station • 6-16
Configuration Options for Smart Carrier Workflow • 6-16
Smart Carrier Workflow • 6-17
Entering Test Information With SCS • 6-17
Loading a Cassette • 6-19
Processing Test Cards in Cassette Only Mode • 6-21
Configuration Options in Cassette Only Mode • 6-21
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Processing VITEK® 2 Test Cards
Cassette Only Mode Workflow • 6-21
Cassette Preparation • 6-22
Loading a Cassette • 6-25
Entering Data for a Cassette • 6-27
Batch Loads (Smart Carrier or Cassette Only Mode) • 6-28
Selecting Batch Loading • 6-28
Starting a Batch Load • 6-28
Unloading the Cassette and Removing Waste • 6-30
Unloading a Cassette • 6-30
Removing Ejected Test Cards • 6-31
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Instrument Status Screen
Instrument Status Screen
You use the Status screen more often than any other screen in the VITEK® 2
user interface. Since it is so basic to the workflow, the Status screen is very
easy to display and in many cases, the interface displays it automatically.
Displaying the Status Screen
There are three ways to display the Status screen:
• Automatically displays at the end of the instrument’s power up initialization
process.
• Automatically displays from the Main Menu whenever that menu is left
unattended for more than one minute.
• Displays from the Main Menu by pressing the Previous Screen key.
Instrument Status Field
The Status field appears at the top of the VITEK® 2 Status screen.
1
2
3
4
5
7
6
Figure 6-1: VITEK® 2 Status Screen in Cassette Only Mode
The Status field (1, Figure 6-1) displays one of the following:
• OK. This status means that all of the subsystems in the instrument are
working normally, and that the instrument is ready to accept test cards for
processing.
• Warming. This status is seen after the instrument is turned on. It means
that the incubation temperature in the Reader Station has not reached its
specified temperature. Test cards cannot be processed until this status
changes to OK.
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Processing VITEK® 2 Test Cards
Instrument Status Screen
• Messages. This status indicates that there is an error message in the
error/message queue that has not been viewed. Press the Help (?) key to
view the error/message queue.
• Errors. This status appears after the error/message queue is accessed if
the error condition has not been resolved. This status can be cleared only
by resolving the condition that generated the original message.
• Cleaning. This status indicates that either all four boats, or at least one
carousel section, have been removed for cleaning. Test card processing
cannot resume unless all carousel sections, or at least one boat, are
replaced.
Non Standard Card Reading Mode
A large X will be displayed over the Status screen when the instrument is
configured in a Non Standard Card Reading mode. Non Standard Card
Reading mode is for diagnostic troubleshooting by trained bioMeriéux Field
Service Engineers only. If the instrument is configured in a Non Standard
Card Reading Mode, do not process any cards and contact bioMeriéux
immediately.
Figure 6-2: VITEK® 2 Status Screen in Non Standard Card Reading Mode
Card Capacity
The MAX Available Slots field (2, Figure 6-1) indicates the number of
unoccupied slots in the instrument. You can load one or more cassettes
containing up to that number of test cards. If you load more than that number,
some of the test cards will not be processed unless additional slots become
available by the time the test cards reach the carousel.
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Instrument Status Screen
The number you see in the MAX Available Slots field depends on the
VITEK® 2 instrument you have and the optical configuration of the
instrument.
Table 6-1: Optical Configurations
Instrument/Max Available
VITEK® 2
Optical Configuration
• set of transmittance optics
MAX Available Slots: 60
VITEK® 2 XL
• ID transmittance optics (Section A)
MAX Available Slots: 120
• AST transmittance optics (Sections A & B)
Available ID Slots: 60
Cassette Name Field
When the instrument is in Cassette Only mode (3, Figure 6-1), this field
displays the name of the most recently used cassette. That cassette name is
applied to all cassettes unless you elect to change it. When the instrument is
in Smart Carrier mode, the field displays the name SCS.
Dilution Mode Indicator
The Dilution Mode Indicator field (4, Figure 6-1) displays when the instrument
is in Cassette Only mode. The field then tells you whether the instrument is
set to the Automatic or Pre-Diluted dilution mode. This field should be
checked before loading a cassette.
BIOHAZARD WARNING
Biohazardous spills can occur inside the VITEK® 2 instrument
if pre-diluted samples are used with the mode set to Automatic.
All organism suspensions should be considered as potentially
infectious. Qualified laboratory personnel should use
acceptable procedures for biohazardous material.
Status Screen Icons
The area on the Status screen just above the disposables graphs is reserved
for the Status screen (5, 7, Figure 6-1) icons.
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Processing VITEK® 2 Test Cards
Instrument Status Screen
•VITEK® 2 Instrument Icon. This icon represents
the VITEK® 2 instrument. It shows when one of the
access doors is open. These include the front
access door on the front of the instrument, and the
top access door.
•VITEK® 2 XL Instrument Icon. This icon
represents the VITEK® 2 XL instrument. It shows
when one of the access doors is open. These
include the Section A top access door, Section B
top access door, and the center front sliding door.
•Cassette Icon. An icon graphic of a cassette
appears while a cassette is processing through the
Bar Code Reader and Button Memory Reader
stations. Its presence reminds you to stay near the
instrument to ensure that the cassette does not
experience any load errors.
•Power Fail Icon. This icon indicates that the
instrument is being powered by the UPS battery
only. While the instrument is in this condition, no
new cassettes may be loaded. Cassette processing
continues for 20 minutes, or until the UPS battery
runs low, whichever comes first.
•Low Battery Icon. This icon indicates the UPS has
low batteries. All processing is halted immediately.
•Lost Communications Icon. This icon indicates
the instrument has lost communications with the
host computer. The amount of time after host
communications has been lost before an error is
generated is 1 hour.
Monitoring Pipette Tips and Saline
The VITEK® 2 instrument uses pipette tips and saline (6, Figure 6-1) for
automatic dilution of susceptibility inocula.
For each disposable, the Status screen displays a bar graph and number
similar to the one shown in Figure 6-3:
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Instrument Status Screen
Figure 6-3: Pipette Tips Status
As the disposables are used, the bar graphs begin to decrease. The graphs
are marked to show levels of ¼, ½, and ¾ capacity. The number associated
with the graph (156, in this example) decreases at the same time. When the
number goes under 40, the value changes to Low.
Note:
For pipette tips, the number refers to the number of available tips. For saline,
the number refers to the available number of aliquots.
CAUTION: The disposable monitors should be used as an
approximate indicator. Care should be used to prevent running
out of either disposable during test card processing.
VITEK® 2 Menu System
All of the functions used on the VITEK® 2 instrument are available through
the menu system. The system is composed of a Main Menu and a set of five
submenus.
Figure 6-4: VITEK® 2 Main Menu
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6-7
6-8
Cassette
Names
Instrument
Name
Boat Cleaning
Change Saline
Display Instrument
QC Status
Schedule
QC Status
Carousel Cleaning
Cleaning (Menu)
Change Pipette Tips
Maintenance (Menu)
Cassette
Mode
Dilution
Mode
Optics Cleaning
Shut Down
Cassette Setup
Optics
Audible
Alarm Enable
Audible Alarm
Volume
Card
Transport
Visual Alarm
Enable
Vacuum
Move
Boat
Waste Tray
Warning Level
Dispenser/
Pipettor
(Instrument) Diagnostics (Menu)
Utilities
(Menu)
Figure 6-5: Detailed Structure of the VITEK® 2 Menu System
Bar Code
Reader
Configuration (Menu)
Temperature
Batch Load
VITEK® 2
Main Menu
Screen
Contrast
Version
Info
Audible
Feedback
Message
Log
Resolve Bar
Code Errors
Instrument Status Screen
Processing VITEK® 2 Test Cards
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Processing VITEK® 2 Test Cards
About the Smart Carrier Station (SCS)
In Figure 6-5, the menu structure is shown with all of the function options
added. Bold lines show the menus and pathways between them.
This manual describes the pathway to a specific function by naming each
menu to access, with the menus separated by arrows. For example, the
pathway to the Change Saline function on the Maintenance menu would be
shown as follows:
Main Menu > Utilities > Maintenance > Change Saline
Frequently Used Keys
Option Buttons. There are five round buttons located along the right side of
the user interface screen. When a menu or function option appears on the
screen, you press the corresponding option button to access that menu or
function.
Previous Screen Key. This key has three actions, depending on what
displays on the screen.
Figure 6-6: Previous Screen Key
• If a function displays on the screen, press Previous Screen to return the
display to the menu from which the function was selected.
• If a menu displays on the screen, press Previous Screen to return the
display to the previous menu.
• If the Main Menu displays on the screen, press Previous Screen to return
the display to the Status screen.
About the Smart Carrier Station (SCS)
Advantages of Using SCS
The SCS is a labor-saving device that provides several advantages for your
laboratory workflow.
Bar Code Scanner. The bar code scanner allows you to utilize the bar codes
that are printed on the test cards and the SCS Job Aid Card. The Test Card
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6-9
About the Smart Carrier Station (SCS)
Processing VITEK® 2 Test Cards
Type, Organism, Offline Tests, and Modifier fields can be entered without
having to use the keyboard. If your laboratory uses bar codes for accession
number of specimens, these can also be entered using the scanner.
Cassette. The cassette helps you organize your work. Each cassette has 15
slots for test cards and 15 corresponding wells for specimen test tubes.
Information entry using the SCS bar code scanner or keyboard is organized
by slot, which allows you to create a simple workflow. For example, using the
bar code scanner, you could:
• Scan the accession ID, and place a specimen test tube in its well.
• Scan the test card, and place it in the corresponding slot.
• Scan the Job Aid Card for optional fields such as organism, offline tests, or
modifiers.
Matching ID and AST Cards. When the SCS computer sees an AST card, it
looks at the card in the previous slot. (For Gram negative AST cards, the
previous two slots are included.) If an ID card with the same accession
number is found, the cards are matched into a single group. Matched ID/AST
card groups provide two advantages:
In Automatic Dilution mode, the inoculum for the AST card is created
automatically in the VITEK® 2 instrument.
The organism identification called by the ID card is automatically applied to its
matching AST card. (Two Gram negative AST cards can be matched to a
Gram negative ID card; only one Gram positive AST card can be matched to
a Gram positive ID card.)
SCS Cassette ID. In larger laboratories, using multiple Smart Carriers, the
Cassette ID field provides an automatic trace between the test card and a
specific SCS. Each SCS is given a three-character name (Cassette ID). That
name is applied to every test card that is processed through the station.
When you look up a test card on the VITEK® 2 directory, the source of any
test card is instantly known. Smart Carriers can be named for the
technologists using them, for a laboratory location, or for the types of
specimens processed through them.
Safety. The cassette portion of the SCS provides a safe and convenient
method of transporting multiple test cards from the workbench to VITEK® 2.
Once a sample is placed in the cassette, the technologist never has to touch
it again.
Security. The SCS provides an extra measure of security for your test card/
specimen information. After a cassette is placed in VITEK® 2, a bar code
reader in the instrument reads the bar code on the test card, and compares
that information with the information it read from the cassette. Any
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About the Smart Carrier Station (SCS)
discrepancies in test card type or position in the cassette are reported to the
user so that corrective action can be taken.
Cassette Edit Screen
The Cassette Edit screen provides an interface for entering test information.
This screen is repeated for each cassette slot.
Figure 6-7: Fields of the Cassette Edit Screen
• Cassette ID. This field contains the cassettte identification string that will
identify the cassette that is being edited. The Cassette ID allows test
information to be searched on the workstation computer.
• Bench. (When Host Type is configured as PC). This field contains the
bench name that will be applied to the cassette that is being edited.
• Tech. (When Host Type is configured as PC). This field contains the Setup
Technologist ID that will be applied to the cassette that is being edited.
• Acc ID. This field allows the entry of an Accession ID to identify a specific
specimen. You may enter up to 20 alphanumeric characters or spaces.
Entry into this field is required before other test specific information can be
entered. This information is also referred to as a Lab ID.
• Isolate Number. Field that defaults to a value of 1 and is normally skipped
during data entry. To replace the default, move the cursor to this field using
the Up Arrow key.
• Test Card Type. This field is used to identify the type of test card that is to
be placed in the cassette slot.
• Organism ID. Field used for identifying an organism in an AST card.
• Offline Tests. Field that holds results of off-line tests performed for some
test cards.
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About the Smart Carrier Station (SCS)
Processing VITEK® 2 Test Cards
• Modifier. Field used for organism modifiers. Six generic entries, mod1 to
mod6, are preloaded. When this data reaches the workstation computer,
the generic entry is converted to one of the first six corresponding entries in
the Organism Modifier table of the bioLIAISON® database.
• Dilution Mode. The current dilution mode setting is displayed to allow
quick verification. Refer to Figure 3-2 for instructions on how to change this
setting.
• Slot Indicator. The slot indicator is the set of boxes at the bottom of the
Cassette Edit screen (see Figure 6-7). The information in the slot indicator
is read as follows:
1) A number corresponding to the currently displayed slot appears over
the appropriate box.
2) The row of boxes is filled in as data is entered.
3) These boxes are empty unless the user has entered data previously. A
box in the row is filled automatically when the user enters data into the
Card Type field. Indicators are:
• I+ = Gram positive ID
• I- = Gram negative ID
• IA = ANC ID
• IY = yeast ID
• IB = bacillus ID
• IH = haemophilus ID
• S+ = Gram positive susceptibility
• S- = Gram negative susceptibility
• SY = yeast susceptibility
• X = Indicates the position of the inoculum tube for a susceptibility
test without a preceding mated ID when in Automatic Dilution
mode. This slot must not contain a card.
Understanding the Slot Indicator
A shaded circle appears under a box when the SCS determines the test card
in the slot requires an organism suspension. A completely open circle
appears under a box when the test card in the slot requires an empty tube.
Empty tubes are used for AST cards when the SCS is set to Automatic
Dilution mode.
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About the Smart Carrier Station (SCS)
SCS Functions
Table 6-2 summarizes the functions that can be performed while entering
data, and the use of the special function keys.
Table 6-2: Summary of SCS Functions
Key
Name
Function(s)
How To Use It
Help (?)
Display context-sensitive help
screens and data field option
boxes.
Press Help (?).
Up/Down
or Left/
Right
Arrow key
Move between fields.
Press the Up/Down or Left/Right Arrow
keys.
Access the Isolate Number field.
Press the Left or Up Arrow keys to move
to the Isolate Number field.
Next or
Previous
Slot
Display an adjacent slot.
Press Next or Previous Slot.
F1
Copy data from a previous slot to
the current slot.
Press F1 to copy the appropriate data from
the previous slot.
F2
Exit a screen.
Press F2.
F3
Display the Summary screen.
1) Press F3 to display the first summary
screen.
2) Press Next or Previous Slot to display
the second summary screen.
F4
Display the Configuration screen.
Press F4.
F6
Display the Flex Panel Entry
screen.
Press F6.
F8
Erase the data in the current field.
Press F8.
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Processing VITEK® 2 Test Cards
About the Smart Carrier Station (SCS)
Table 6-2: Summary of SCS Functions (Continued)
Key
Name
Function(s)
F9
Erase the data for a slot.
Note: This function also erases
data in any successive linked slots.
F10
Erase all the data in the button
memory chip.
How To Use It
1) Press F9. A confirmation window
appears.
2) Press F1 to erase the data.
1) Press F10. A confirmation window
appears.
2) Press F1 to erase the button memory
chip.
Note:
The F7 key is currently unassigned.
Option Boxes
The Organism ID, Offline Test, and Modifier fields are restricted, that is,
they accept only certain data. When entering data manually via the keyboard,
option boxes provide access to the acceptable data entries.
Organism ID
This field has several option boxes, depending on the AST card type you
enter in the Card Type field. For example:
Positive
Negative
Organism ID
> staaur
staneg
entspp
strpre
Organism ID
> esccol
promir
provul
pseaer
Figure 6-8: Organism ID Options
Gram Positive Susceptibility Card
Offline Test Result Screen
The contents of the option boxes for this field depend on the type of card you
enter in the Card Type field. For example, the option box for a Gram positive
susceptibility card would be similar to the following:
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About the Smart Carrier Station (SCS)
Offline Tests
>
blac
+ blac
Figure 6-9: Offline Tests Option Box
ANC Identification Card
Offline Test Result Screen
The Offline Test Result screen allows entry of values that are specific to
Anaerobic and Corynebacteria (ANC) tests. Use the Up and Down keys to
change fields.
Figure 6-10: Offline Test Result Screen
Gram
The Gram field provides an option box that allows the entry of Gram stain
information for the current test.
Allowed options are positive, negative, or variable.
Morphology
The Morphology field provides an option box that allows the entry of
morphology values associated with the current test.
Allowed options are cocci, bacilli, or coccobacilli.
Aerotolerance
The Aerotolerance provides an option box that allows the entry of
aerotolerance values associated with the current test. Allowed options are
aerobe, anaerobe, or facultative.
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Processing Test Cards Using the Smart Carrier Station
Processing VITEK® 2 Test Cards
Modifier
The option box for the Modifier field contains six default entries, mod 1 to
mod 6. When this data reaches the workstation computer, the entry is
matched to one of the first six entries in the Organism Modifier table of the
bioLIAISON® database.
Selecting an Entry Using an Option Box
1)
Use the Up or Down Arrow key to move the cursor into the correct field.
2)
Press the Help (?) key to access the option box for the field.
3)
Use the Up or Down Arrow key to move the selection pointer (>) to the
correct data entry.
4)
Press Enter to return to the data screen.
Bar Code Scanner
The bar code scanner reduces the time required for data input. If your
laboratory uses bar codes to identify patient specimens, these can be
scanned to enter the accession ID.
The required bar codes for the Organism, Offline Test, and Modifier fields
have been printed on the SCS Job Aid Card.
Bar code labels on every test card allow you to scan in the entry for the Card
Type field. Additional information from this bar code is also stored in the
cassette memory. This information helps VITEK® 2 properly identify and
process each test.
Processing Test Cards Using the Smart Carrier Station
Note:
If your system does not have an SCS, refer to the section Processing Test
Cards in Cassette Only Mode on page 6-21.
Configuration Options for Smart Carrier Workflow
Before using the SCS, make sure that the following options are properly set:
• On the Smart Carrier Station. All of the configuration options on the SCS
should be set. The most important of these is the Dilution Mode. Make sure
that it corresponds to how susceptibility inocula are processed for this
cassette. See AST Dilution Mode on page 3-5.
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Processing Test Cards Using the Smart Carrier Station
• On the VITEK® 2 Instrument. The most important configuration option for
using the SCS is the Cassette Mode. This option must be set to Smart
Carrier.
Smart Carrier Workflow
Table 6-3 provides a general workflow for using the SCS. This workflow
assumes that you have:
• selected the VITEK® 2 test cards to process
• decided whether to prepare susceptibility suspensions manually or
automatically using VITEK® 2
Note:
If you choose to prepare suspensions manually, suspension preparation
instructions can be found in the VITEK® Systems Product Information.
• prepared the inocula and have all material positioned by the SCS
Table 6-3: Processing Test Cards (Using the Smart Carrier)
Activity
1) Confirm configuration settings.
Reference Section(s)
• Configuration Options for Smart
Carrier Workflow on page 6-16.
• Cassette Edit Screen on
page 6-11.
2) Insert a cassette to display the Cassette Edit
screen.
• Step 1 on page 6-17.
3) Enter information for the first test card and
specimen in the first slot:
• Entering Test Information With
SCS on page 6-17.
• Using the SCS bar code scanner, or
• SCS Functions on page 6-13.
• Using the SCS keyboard
• Option Boxes on page 6-14.
4) Place the first test card and specimen test tube in
their appropriate slots.
N/A
5) Continue activities 3 and 4, filling the cassette slots sequentially.
Entering Test Information With SCS
The Cassette Edit screen is used to store information about specimens and
their test cards. You enter the information by positioning the cursor in a data
field for a particular test card slot. By default, the cursor is always in the
Accession ID field for slot 1 when the screen is first accessed. All fields are
empty unless previous data was entered for that slot.
1)
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Access the Cassette Edit screen.
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Processing VITEK® 2 Test Cards
Processing Test Cards Using the Smart Carrier Station
The SCS displays the Cassette Edit screen (see Figure 6-7)
automatically whenever a cassette is firmly seated on the SCS base unit.
2)
Select the correct slot.
• Make sure that the Cassette Edit screen is displaying the correct slot
(1–15). Use the Next Slot or Previous Slot keys.
• Make sure that the cursor (blinking bar) is in the correct field. Use the
Up or Down Arrow keys.
3)
Enter the data as shown in Table 6-4.
Table 6-4: Data Entry Methods (Smart Carrier Mode)
Field
Bar Code Method
Keyboard Method
Accession ID
Scan the bar code label on
the specimen.
Type the ID into the Accession/Lab ID
field.
Card Type
Scan the bar code label on
the card.
Type the 18-digit code from the bar code
label on the test card.
Organism ID
(AST card)
Scan an organism ID from
the SCS Job Aid Card.
Place the cursor in the Organism ID field
and press the Help (?) key. Select an
organism from the option box.
Offline Test
Scan a test from the SCS
Job Aid Card.
Place the cursor in the Offline Test field
and press the Help (?) key. Select a test
from the option box.
If the entered card type is ANC, an
Offline Test Result screen will be
displayed.
Modifier
Scan a modifier from the
SCS Job Aid Card.
Place the cursor in the Modifier field and
press the Help (?) key. Select a modifier
from the option box.
Note:
The SCS does not allow you to enter expired cards.
Note:
If you need to change any of the data you have entered, you must do so
before you remove the cassette from the SCS.
Correct Positioning of AST Cards
If you pre-dilute the inocula for the susceptibility tests, you can place the test
cards into any slots in the cassette, in any order you choose. However, when
VITEK® 2 is performing the dilution (Automatic Dilution mode), you must
follow these rules:
• The AST card must be placed in a slot immediately following the slot
containing the inoculum test tube.
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Processing VITEK® 2 Test Cards
Processing Test Cards Using the Smart Carrier Station
• A Gram negative inoculum can be used for either one or two susceptibility
tests. When diluting the inocula for two tests, the test cards must occupy
the two slots immediately following the slot containing the inoculum test
tube.
• The VITEK® 2 AST card type (e.g., AST-P515) MUST be entered in the
Card Type field on the Smart Carrier Station Cassette Edit screen. The
instrument is unable to prepare an AST dilution if the card type is not
entered.
These rules apply whether or not an ID card is used.
Loading a Cassette
BIOHAZARD WARNING
The cassette should be considered as potentially contaminated
and should be handled appropriately. Qualified laboratory
personnel should take the usual precautions necessary for
infectious agents.
After the information for a cassette has been entered at the SCS, the cassette
is ready to be loaded into the VITEK® 2 instrument. Before you load the
cassette, however, you should always check the Status screen. Look at the
parameters in Table 6-5 to make sure it is okay to load the cassette.
Table 6-5: Cassette Load Parameters (Smart Carrier Mode)
Parameter
What to Look For
Status
This field should read OK.
Available Slots
The value in this field should be greater than or equal to the
number of test cards you are loading.
Tips and Saline
The level of both disposables should be greater than or equal
to the number of test cards you are loading.
Note: This parameter may be ignored if you are operating in
the Pre-diluted mode.
Cassette Mode
This field should read SCS (Smart Carrier Station).
Using the Cassette Load Station
The Cassette Load Station is composed of the cassette load door and a
green indicator light. The indicator light tells you the status of the load station,
as shown in Table 4-2.
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6-19
Processing Test Cards Using the Smart Carrier Station
Processing VITEK® 2 Test Cards
Before you attempt to load a cassette, make sure the indicator light is on or is
blinking.
Loading a Cassette
1)
Open the Cassette Load Station by lifting the cassette load door up.
There should be an empty boat at the station, or one with a cassette that
contains waste.
CAUTION: Do not attempt to load a cassette if a boat is not at the
station. Damage to the cassette and the VITEK® 2 instrument is
possible.
2)
Place the cassette in the boat so that the specimen test tubes face the
front of the instrument.
Figure 6-11: Correct Orientation of Cassettes
Note:
The boat is shaped such that it will only accept a cassette in the proper
orientation.
CAUTION: To avoid possible processing errors, make sure that
all the test cards and test tubes are properly seated in the
cassette.
3)
Close the cassette load door.
The Cassette icon appears on the Status screen.
4)
Monitor the instrument until the Cassette icon disappears and the boat
moves forward to process cards.
Monitoring Card Processing
After a cassette is loaded, the test cards in it are scanned by the bar code
reader in VITEK® 2. This information is sent to the workstation so that you
can see a listing of the test cards in the Directory window. Additional
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Processing VITEK® 2 Test Cards
Processing Test Cards in Cassette Only Mode
information is provided once the test cards reach the Card Incubator and
Reader Station and are read for the first time.
Note:
The VITEK® 2 instrument should be attended during the first minute after a
cassette is loaded and the boat moves forward to process cards. This period
is denoted by the presence of the Cassette icon on the VITEK® 2 Status
screen. See Cassette Load Processing Errors on page 8-10 for additional
information.
Tracking Cassettes and Cards
The Cassette Name and Load Time, which appear in the VITEK® 2
Directory window at the workstation, help you identify each cassette in the
VITEK® 2 instrument. Table 6-6 shows how you can track each test card.
Table 6-6: Card Identity Components (Smart Carrier Mode)
Identifier
Example
Source
Cassette Name
RMT
The Smart Carrier Station into which the
cassette was scanned.
Slot position (1–15) of
the test card in the
cassette.
03
The actual test card position in the
cassette as read by the VITEK® 2 bar
code reader.
Load Time
Apr 03
08:35:40
The date and time the test card was read
by the VITEK® 2 bar code reader.
Processing Test Cards in Cassette Only Mode
Note:
If your system has a Smart Carrier Station, refer to the section Processing
Test Cards Using the Smart Carrier Station on page 6-16.
Configuration Options in Cassette Only Mode
On the VITEK® 2 instrument, set the:
• Cassette Mode to Cassette Only
• Dilution Mode to Automatic or Pre-Diluted, as appropriate
Note:
The procedure for these options appear in Chapter 5.
Cassette Only Mode Workflow
Table 6-7 provides a generalized workflow for working without a SCS. This
workflow assumes that you have:
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Processing VITEK® 2 Test Cards
Processing Test Cards in Cassette Only Mode
• selected the VITEK® 2 test cards to process
• decided whether to prepare susceptibility suspensions manually or
automatically using VITEK® 2
Note:
If you choose to prepare suspensions manually, suspension preparation
instructions can be found in the VITEK® 2 Systems Product Information.
Table 6-7: Processing Test Cards (Cassette Only Mode)
Activity
Reference(s)
1) Make sure that all configuration options are set correctly.
Configuration Options in Cassette Only
Mode on page 6-21.
2) Print a cassette worksheet at the workstation.
From the VITEK® 2 Directory, select:
Cassette>Print Worksheet.
3) Fill in the cassette worksheet with the test card and specimen
information for the cassette.
Using the Cassette Worksheet on
page 6-22.
4) Place the test cards and specimen test tubes in their appropriate
slots.
Correct Positioning of Susceptibility Test
Cards on page 6-24.
5) Access the Cassette Setup function on the VITEK® 2
instrument. Select or enter a cassette name and, if necessary,
change the dilution mode.
Using the Cassette Setup Function on
page 6-24.
6) Load the cassette onto the VITEK® 2 instrument.
Loading a Cassette on page 6-25.
7) Enter the information from the cassette worksheet into the
Cassette Edit window.
Monitoring Test Card Processing on
page 6-27.
Note: During the first minute of processing, a Cassette icon
appears on the VITEK® 2 Status screen. Wait until the boat moves
forward to process cards before accessing the Cassette Edit
window.
Cassette Preparation
Follow these procedures to set up the test cards and specimens for a
cassette.
Printing a Cassette Worksheet
Print cassette worksheets at the VITEK® 2 workstation. Refer to the topic
Generating Cassette Worksheets in the VITEK® 2 Software and AES User
Manual.
Using the Cassette Worksheet
The Cassette Worksheet (Figure 6-12) is designed to help you organize a set
of test cards and specimens for a cassette.
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Processing VITEK® 2 Test Cards
Processing Test Cards in Cassette Only Mode
Date: 07/26/2005 08:38:23
WSVT2-R04.02
4
Test Type
–––––––
bioMérieux
Cassette Report
1
Cassette ID:
2
Tests:
3
Instrument:
Page:
1
______________________
_____________
___________________________
Accession ID
Organism
Modifier
–––––––––––––– –––––– ––––––
Offline Tests
––––––––––
5
1 ____________
________________________ __________ __________
________________
2 ____________ ________________________ __________ __________
________________
3 ____________ ________________________ __________ __________
________________
4 ____________ ________________________ __________ __________
________________
5 ____________ ________________________ __________ __________
________________
6 ____________ ________________________ __________ __________
________________
7 ____________ ________________________ __________ __________
________________
8 ____________ ________________________ __________ __________
________________
9 ____________ ________________________ __________ __________
________________
10 ____________ ________________________ __________ __________
________________
11 ____________ ________________________ __________ __________
________________
12 ____________ ________________________ __________ __________
________________
13 ____________ ________________________ __________ __________
________________
14 ____________ ________________________ __________ __________
________________
15 ____________ ________________________ __________ __________
________________
Figure 6-12: Cassette Worksheet
1 — Cassette ID. Fill in the cassette name here.
2 — Tests. Fill in the number of test cards being placed in the cassette.
3 – Instrument Name. Fill in the name of the VITEK® 2 instrument into which
you placed the cassette.
4 – Fields. Use these fields to fill in the applicable information about the test
cards and specimens.
5 – Slot Numbers. The worksheet is preprinted with the 15 slot numbers.
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6-23
Processing VITEK® 2 Test Cards
Processing Test Cards in Cassette Only Mode
Correct Positioning of Susceptibility Test Cards
If you pre-dilute the inocula for the susceptibility tests, you can place the test
cards into any slots in the cassette, in any order you choose. However, when
VITEK® 2 is performing the dilution (Automatic Dilution mode), you must
follow these rules:
• The AST card must be placed in a slot immediately following the slot
containing the inoculum test tube.
• A Gram negative inoculum can be used for either one or two susceptibility
tests. When diluting the inocula for two tests, the test cards must occupy
the two slots immediately following the slot containing the inoculum test
tube.
These rules apply whether or not an ID card is used.
Using the Cassette Setup Function
Use the Cassette Setup function to define the cassette name to the
instrument, and, if necessary, to change the Dilution Mode setting for a
cassette.
1)
Note:
Access the Cassette Setup function on the Main Menu.
If the VITEK® 2 instrument is in Smart Carrier mode, the Cassette Setup
function cannot be accessed. If you attempt to use the option, the screen
displays the following message:
This option is used with Cassette Only mode.
1
2
3
Figure 6-13: Cassette Setup Screen
The screen has places for up to ten cassette names. You do not enter
these names on this screen. That is done in the Cassette Names
function on the Configuration menu.
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Processing VITEK® 2 Test Cards
Processing Test Cards in Cassette Only Mode
2)
Select one of the cassette names (1, Figure 6-13) from the list shown by
pressing its corresponding number on the keypad.
The selected name is highlighted.
Note:
If you need to add a new cassette name, refer to the section Cassette Names
on page 5-3.
3)
If necessary, press the Change Dilution Mode button (3) to change the
current dilution mode (2).
BIOHAZARD WARNING
Biohazardous spills can occur inside the VITEK® 2 instrument
if the Dilution Mode option is not properly set, especially if prediluted samples are used with the mode set to Automatic. All
organism suspensions should be considered as potentially
infectious. Qualified laboratory personnel should use
acceptable procedures for biohazardous material.
4)
Press Enter to accept the information as shown on the screen.
Loading a Cassette
BIOHAZARD WARNING
The cassette should be considered as potentially contaminated
and should be handled appropriately. Qualified laboratory
personnel should take the usual precautions necessary for
infectious agents
Before you load a cassette you should always check the Status screen. Look
at the parameters in Table 6-8 to make sure it is okay to load the cassette.
Table 6-8: Cassette Load Parameters (Cassette Only Mode)
Parameter
What to Look For
Status
This field should read OK.
MAX Available Slots
The value in this field should be greater than or equal to
the number of test cards you are loading.
Available ID Slots
(VITEK® 2 XL only)
The value in this field should be greater than or equal to
the number of identification test cards you are loading.
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Processing VITEK® 2 Test Cards
Processing Test Cards in Cassette Only Mode
Table 6-8: Cassette Load Parameters (Cassette Only Mode) (Continued)
Parameter
Tips and Saline
What to Look For
The level of both disposables should be greater than or
equal to the number of test cards you are loading.
Note: This parameter may be ignored if you are operating
in the manual dilution mode.
Cassette Name
The name of the previously used cassette is shown, and
will be applied to this cassette unless you change it.
Dilution Mode
Make sure that the mode displayed matches the way in
which you are processing the test cards.
Using the Cassette Load Station
The Cassette Load Station is composed of the cassette load door and a
green indicator light (illustrated in Chapter 4).
The indicator light tells you the status of the Load Station (Table 4-2).
Before you attempt to load a cassette, make sure the indicator light is on or
blinking.
Loading a Cassette
1)
Open the Cassette Load Station by lifting the cassette load door up.
There should be an empty boat at the station, or one with a cassette that
contains waste.
CAUTION: Do not attempt to load a cassette if a boat is not at the
station. Damage to the cassette and the VITEK® 2 instrument is
possible.
2)
Place the cassette in the boat so that the specimen test tubes are
towards the front of the instrument.
Figure 6-14: Correct Orientation of Cassette
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Processing VITEK® 2 Test Cards
Note:
Processing Test Cards in Cassette Only Mode
The boat is shaped such that it will only accept a cassette in the proper
orientation.
3)
Close the cassette load door.
The Cassette icon appears on the Status screen.
4)
Monitor the instrument until the Cassette icon disappears and the boat
moves forward to process cards.
Monitoring Test Card Processing
After a cassette is loaded, the test cards in it are scanned by the bar code
reader in VITEK® 2. This information is sent to the workstation so that you
can see a listing of the test cards in the Directory window. Additional
information is provided once the test cards reach the Card Incubator and
Reader Station and are read for the first time.
Entering Data for a Cassette
During the first minute after you load a cassette, the bar code on each test
card is read. From this bar code reading, the instrument knows the number of
test cards in the cassette, the type of test cards, and the position of each test
card. This information, along with the cassette name you selected in the
Cassette Setup function, is sent to the workstation.
The information can be viewed in the Cassette Edit window, which is part of
the VITEK® 2 workstation software. You can access that screen and, using
the Cassette Worksheet, fill in the remaining information for the cassette once
the test cards have been loaded into the carousel.
For information on using the Cassette Edit window, please refer to this topic
in the VITEK® 2 Software and AES User Manual.
Tracking Cassettes and Cards
The Cassette Name and Load Time, which appear in the VITEK® 2
Directory window at the workstation, help you identify each cassette in the
VITEK® 2 instrument. Table 6-9 shows how you can track each test card.
Table 6-9: Card Identity Components (Cassette Only Mode)
Identifier
Cassette Name
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Example
RMT
Source
The three-character cassette name that
is entered in the Cassette Name
function.
6-27
Processing VITEK® 2 Test Cards
Batch Loads (Smart Carrier or Cassette Only Mode)
Table 6-9: Card Identity Components (Cassette Only Mode) (Continued)
Identifier
Example
Source
Slot position (1–15) of
the test card in the
cassette.
03
The actual test card position in the
cassette as read by the VITEK® 2 bar
code reader.
Load Time
Apr 03
08:35:40
The date and time the test card was read
by the VITEK® 2 bar code reader.
The Cassette Name can represent any laboratory parameter you choose,
such as a technologist’s initials, a specimen source, or a work shift.
Batch Loads (Smart Carrier or Cassette Only Mode)
Selecting Batch Loading
Batches of three or four cassettes can be loaded in rapid succession using
the Batch Load function.
Before You Begin
Because a batch load requires most or all of the VITEK® 2 resources, you
should do the following before initiating a batch load:
1)
Batch loading requires at least three cassettes, so check your work load
to make sure that you are processing enough test cards.
2)
Check the Status screen to make sure that:
• The number of available slots equals or exceeds the number of test
cards that you are loading.
• The quantities of tips and saline is sufficient for the number of test
cards that you are loading.
Starting a Batch Load
This process begins with the preparation of the cassettes. Refer to one of the
following two procedures:
• Cassette preparation in Smart Carrier mode, page 6-16.
• Cassette preparation in Cassette Only mode, page 6-22.
Note:
You must prepare all three or four of the cassettes to be included in the batch
load before proceeding.
1)
6-28
Bring the cassettes to the VITEK® 2 instrument.
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Processing VITEK® 2 Test Cards
2)
Batch Loads (Smart Carrier or Cassette Only Mode)
Access the Batch Load function on the Main Menu.
The VITEK® 2 instrument checks to ensure that at least three boats are
available, and that there are no test cards currently in the card transport
system. It then displays the following screen:
Figure 6-15: Batch Load Screen
Note:
This screen does not appear if there are only three boats in the instrument. In
that case, a batch load of three cassettes is assumed.
If less than three boats are available, or if the card transport system is
unavailable, the following message appears:
The card transport system is not available for batch
load. Load a single boat or try again later.
3)
Press the option button that corresponds to the number of cassettes that
you want to load.
• The following screen displays for Smart Carrier Mode:
Figure 6-16: Smart Carrier Mode Batch Load Screen
• The following screen displays for Cassette Only Mode:
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Unloading the Cassette and Removing Waste
Processing VITEK® 2 Test Cards
Figure 6-17: Cassette Only Mode Batch Load Screen
4)
Open the door to the Load Station, place the cassette in the boat, and
close the door.
The instrument moves the boat away from the Load Station, moves the
next boat into the station, and redisplays the screen shown in the
previous step.
5)
Repeat Step 4 as required for the other cassettes.
Unloading the Cassette and Removing Waste
This section describes two procedures that you need to perform on a regular
basis. One is to remove empty cassettes from the instrument, which should
be done whenever the light at the Cassette Load Station is blinking. The other
is to remove ejected test cards, which should be done routinely whenever a
new cassette is loaded. Performing these activities ensures that VITEK® 2
can continue to support your laboratory’s work load.
Unloading a Cassette
During test card processing, test cards are unloaded from the cassette and
placed into the carousel at the Card Reader and Incubator Station. This
means that when the boat and cassette return to the unload station, only the
specimen test tubes and the severed transfer tubes remain in the cassette.
The cassette must be removed so that the boat is available to accept another
cassette.
1)
When you are processing test cards, look for the green indicator light at
the unload station to be blinking.
This indicates that an empty cassette is at the station.
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Unloading the Cassette and Removing Waste
For more information about the indicator light, see the section Using the
Cassette Load Station on page 6-19 or on page 6-26.
2)
Note:
Open the cassette load door and remove the cassette from the boat.
The boat itself should not be removed.
3)
Close the cassette load door.
CAUTION: Leaving the door to the Cassette Unload station open
will interfere with the proper processing of the test cards in the
VITEK® 2 instrument.
4)
Dispose of the materials in the cassette. The cassette can now be used
to process additional test cards.
BIOHAZARD WARNING
All of the materials in an empty cassette should be treated as
biohazards and disposed of accordingly. All organism
suspensions should be considered as potentially infectious.
Qualified laboratory personnel should use acceptable
procedures for biohazardous material.
Removing Ejected Test Cards
When a test card is ejected, it is removed from the carousel in the Card
Reader and Incubator Station, and placed in the Waste Collection Station
(see Figure 6-18). This station has a capacity of 60 test cards, equivalent to
the capacity of the carousel. However, it is recommend that you check and
empty the Waste Collection Station every time you load a new cassette.
Note:
Once cards have been removed from the Waste Collection Station, never
reinsert them. This will cause the instrument to jam.
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6-31
Processing VITEK® 2 Test Cards
Unloading the Cassette and Removing Waste
1
2
Figure 6-18: The Waste Collection Station
Removing the Waste Collection Tray
Note:
1)
Open the Waste Collection Station door. Note that waste test cards are
held in a removable tray.
2)
Place the index finger of one hand on the sliding retainer bar (1,
Figure 6-18) to prevent it from snapping back.
3)
Remove the waste collection tray (2) from the station by lifting the front
edge of the tray slightly and then pulling it toward you.
4)
When the tray is clear of the station, allow the sliding retainer bar to
slowly slide back into place.
5)
Dispose of the test cards in the tray.
Once cards have been removed from the Waste Collection Station, never
reinsert them. This will cause the instrument to jam.
BIOHAZARD WARNING
Although VITEK® 2 test cards are sealed, they should be
treated as biohazards and disposed of accordingly.
Replacing the Waste Collection Tray
Note:
6-32
1)
Slide the tray onto its shelf, lifting the front edge to clear the retaining
brackets.
2)
Close the waste collection door.
If the waste collection tray is not replaced, the instrument cannot eject cards
and eventually stops processing.
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510731-10EN1
MAINTAINING THE VITEK® 2 INSTRUMENT
7
Introduction
This chapter includes the procedures required to maintain the VITEK® 2
instrument. Maintenance includes monitoring and changing the disposables,
cleaning the boats and the carousel, and general maintenance and cleaning.
Note:
The Maintenance Log provided at the end of this chapter lists recommended
maintenance procedures and their frequency. Please make one copy for your
use and keep the original with this manual.
Note:
Avoid pressing the Help (?) key when the instrument is performing
maintenance functions. On rare occasions the interface may display a blank
screen after reviewing a message during a maintenance function. If that
occurs, recycle the power.
Chapter Contents
Maintaining Disposables • 7-3
Monitoring the Disposables • 7-3
The Dispenser/Pipettor Accessory Kit • 7-4
Installing an Accessory Kit, Part A: Saline and Tubing • 7-4
Installing an Accessory Kit, Part B: Pipette Tips • 7-8
Cleaning the Carousel • 7-10
Removing the Carousel for Cleaning • 7-10
Carousel Cleaning Methods • 7-15
Replacing the Carousel After Cleaning • 7-15
Cleaning the Cassettes • 7-19
Replacing the Button Memory Module • 7-20
Cleaning the Boats • 7-21
Removing Boats for Cleaning • 7-21
Cleaning the Boats • 7-23
Replacing Boats after Cleaning • 7-23
Cleaning the Instrument Interior • 7-24
Shutting Down the Instrument • 7-25
Cleaning the Test Card Collection Tray • 7-25
Cleaning Optics (Normal Maintenance) • 7-26
Cleaning the Base Pan, Vacuum Seal and Vacuum Chamber • 7-28
Cleaning the Drip Pan • 7-29
Removing the Drip Pan • 7-30
®
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7-1
Maintaining the VITEK® 2 Instrument
Cleaning the Drip Pan • 7-30
Replacing the Drip Pan • 7-31
Turning the Instrument On • 7-31
Cleaning the SCS • 7-32
7-2
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Maintaining Disposables
Maintaining Disposables
Chapter 6 introduced the Status screen and how to incorporate it into your
workflow. A specific part of that screen is devoted to the maintenance of the
VITEK® 2 disposables.
1
2
Figure 7-1: VITEK® 2 Status Screen
Monitoring the Disposables
Note the two bar graphs at the bottom of the screen. The Tips graph (1,
Figure 7-1) displays the current level of pipette tips that remain in the
instrument. The Saline graph (2) displays the level of saline that remains in
the instrument.
Interpreting the Graphs
As the two disposables are used, the shaded portion of the graphs moves to
the left. At the same time, the value inside the graph decreases
correspondingly. The graphs are marked to show full (330), three-quarter
(248), one-half (165), and one-quarter (83) capacity. If the level of either
disposable drops below 40, the value changes to Low.
What do these numbers mean and how should you use them? The graphs
and their values refer specifically to the number of antimicrobial susceptibility
tests (AST) that can be processed. This means that the graphs and values
are important only when you are processing ASTs in the Automatic Dilution
mode, that is, when the VITEK® 2 instrument is performing the dilution of the
AST inocula. For example, when one of the graphs is at one-half capacity, it
means that enough of that disposable remains to process approximately 160
ASTs.
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7-3
Maintaining the VITEK® 2 Instrument
Maintaining Disposables
Using the Graphs
The best way to use the graphs is to periodically compare the levels of the
graphs to the number of ASTs you anticipate during a period. If the
disposables level is lower than the anticipated work load, install an accessory
kit before you begin (see following sections). In this way, your workflow will
not be interrupted during test card processing. When comparing the
disposables level to your work load, it is important to remember that the
graphs are APPROXIMATIONS of the actual level of disposables.
Expiration of Disposables
VITEK® 2 is programmed to measure the amount of time that the disposables
have been in the instrument. When the specified time limit is exceeded,
VITEK® 2 displays an error message telling you that a disposable has
expired.
The Dispenser/Pipettor Accessory Kit
If the disposables have reached a low level, or if they have expired, you need
to install a Dispenser/Pipettor Accessory Kit. The kit consists of a container of
pipette tips and a saline dispenser tube with its associated tubing. The
following two sections in this chapter describe how to install an accessory kit.
Installing an Accessory Kit, Part A: Saline and Tubing
Note:
If the card transport system is processing cassettes through the Card
Transport Station, the following message appears:
Card transport system is busy. Please try later.
CAUTION: Use aseptic technique when installing an accessory
kit.
1)
Access the Change Saline function using the path:
Main Menu > Utilities > Maintenance > Change Saline
The following prompt appears:
About to change saline. Do you wish to continue?
2)
Press Yes to continue with the saline change.
After you proceed the instrument displays the following message:
Proceed with saline change?
7-4
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Maintaining the VITEK® 2 Instrument
3)
Maintaining Disposables
Open the front access door (1, Figure 7-2) to expose the Dispenser
Station, then lift the saline access door (2) to expose the saline bag.
2
3
1
5
4
Figure 7-2: Location of Saline Dispensing Chamber
Note:
4)
Pull on the filter disk (3) to remove it from its connector.
5)
While pushing the Dispenser Release button (4), carefully pull the shot
tube (5) out of its housing.
6)
The entire assembly is now disconnected. Since they are Single Use
Only items, you must discard the saline tube, its tubing, and the saline
bag.
Since the saline dispenser tube does not come in contact with any specimen,
it is not considered a biohazard. Use normal laboratory precautions when
disposing of this assembly.
CAUTION: To prevent possible contamination of the saline, use
aseptic technique when handling the saline dispenser tube.
7)
Remove a new bag of 0.45% sterile saline from its protective pouch.
8)
Remove a new tubing assembly from its container.
9)
Remove the covers from the large port of the saline bag and from the
cannula of the tubing assembly.
10) Insert the cannula (6, Figure 7-3) from the tubing assembly into the port
(7) of the saline bag.
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Maintaining the VITEK® 2 Instrument
Maintaining Disposables
6
7
Figure 7-3: Cannula and Tubing Assembly
11) Place the new bag of saline on its shelf on the top of the instrument,
placing the eyelet of the bag over the post at the back of the shelf.
12) While pushing the release button (8, Figure 7-4), insert the saline
dispenser tube (9) into its housing. After the tube is fully inserted, release
the button.
10
11
9
8
Figure 7-4: Saline Dispensing Chamber
Note:
Make sure that the saline dispenser tube is firmly seated in the housing and
that the tubing flows smoothly without any kinks or twisting.
13) Grasp the filter disk (10) and firmly push it onto the connector located
above the saline dispenser tube.
Avoid excessive pressure, however, as it could cause the filter to break.
14) Press the round plate (11) to allow saline to flow into the saline dispenser
tube. Do not allow the saline level to fill above the top inlet port (12,
Figure 7-5).
7-6
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Maintaining Disposables
12
Figure 7-5: Saline Fill Line
15) Release the round plate (11, Figure 7-4).
16) Close both the front access door and the saline access door to the
instrument.
17) Press Done.
The following message appears:
Performing Dispenser Self Test
The self test checks for proper installation of the saline dispenser tube. It
is recommended that you wait for the test to complete (about 20
seconds) before leaving the instrument.
If the test is successful, the Maintenance menu appears.
If the test fails, the following message displays:
Saline Dispenser Tube installation error
There is a problem with the saline dispenser tube installation. Inspect the
tube installation and correct it as needed.
18) Press Continue to return to the Change Saline screen.
19) At the Change Saline screen, press Cancel to return to the Maintenance
menu or Done to repeat the test.
20) Perform the Dispenser/Pipettor diagnostic test, described on page 8-21,
to ensure that the Dispenser Station is functioning properly.
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Maintaining the VITEK® 2 Instrument
Maintaining Disposables
Installing an Accessory Kit, Part B: Pipette Tips
If the card transport system is processing cassettes through the Card
Transport Station, the following message appears:
Card Transport System is busy. Please try later.
CAUTION: Use aseptic technique when installing an accessory
kit.
1)
Access the Change Pipette Tips function using the path:
Main Menu > Utilities > Maintenance > Change Pipette Tips
2)
The following message appears:
About to change pipette tips. Do you wish to continue?
3)
Press Yes to continue with the pipette tip change.
The following message appears:
Proceed with adding pipette tips.
4)
Open the front access door (1, Figure 7-2) of VITEK® 2 to expose the
Pipettor Station.
5)
Open the Pipette Tip access door.
6)
Rotate the pipette tip container (2, Figure 7-6) 90° in a counterclockwise
direction.
2
3
Figure 7-6: Location of Pipettor Tip Container
7-8
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Maintaining Disposables
7)
Remove the pipette container from its base using a pulling motion.
8)
Discard any pipette tips that remain in the container.
CAUTION: To avoid contaminating new pipette tips, do not touch
the inside of the pipette container.
Note:
Discarding the remaining tips is required in order for VITEK® 2 to maintain an
accurate count of them. This action also minimizes the risk of contamination.
9)
Open a pipette tip replacement pack and hold it in one hand (see
Figure 7-7).
CAUTION: The exposed ends (5, Figure 7-7) of the pipette tips
are the ones that come in contact with your specimens.
Appropriate precautions to prevent contamination during this
procedure are advised.
10) Hold the empty pipette container
(4) in your other hand with its open
end down and lower it over the
exposed ends (5) of the pipette
tips.
11) Invert the container and pack (6)
so that the pipette tips fall into the
container from the pack.
4
12) Replace the pipette tip container
on its base, making sure that it is
firmly seated.
5
There is a key pin on the side of
the container that must mate with
a slot on the container base.
Note:
If the container is not seated correctly,
you will not be able to rotate it back into
position.
6
Figure 7-7: Pipette Tip Replacement
13) Rotate the container 90° in a clockwise direction, making sure that it is
fully seated in the down position.
14) Close both access doors and press Done.
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Maintaining the VITEK® 2 Instrument
Cleaning the Carousel
The following message appears:
Performing Pipettor Self Test
The Pipettor self test only checks the electric motors in the Pipettor
Station. If the motors pass the test, no further message is displayed, and
you are done with the installation.
If a problem is found, the following message appears:
Pipette Tip installation error
When this message appears, call bioMérieux for assistance.
15) Perform the Dispenser/Pipettor diagnostic test, described on page 8-20,
to ensure that the Pipettor Station is functioning properly.
Cleaning the Carousel
The four sections of a carousel should be removed and cleaned monthly, or
as conditions require.
Removing the Carousel for Cleaning
BIOHAZARD WARNING
The carousel should be considered as potentially contaminated
and should be handled appropriately. Qualified laboratory
personnel should take the usual precautions necessary for
infectious agents.
Note:
This procedure must be performed when the VITEK® 2 instrument is
completely idle (no cards are processing anywhere in the instrument).
1)
Access the Carousel Cleaning function using the path:
Main Menu > Utilities > Maintenance > Cleaning > Carousel
Cleaning
Note:
If there are cards processing anywhere in the instrument, a screen prompts
you to make sure processing is complete and all cards have been ejected
from the instrument before cleaning.
If you have a VITEK® 2 XL, the screen in Figure 7-8 displays allowing you to
select a Reader.
7-10
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Maintaining the VITEK® 2 Instrument
Cleaning the Carousel
Figure 7-8: VITEK® 2 XL Carousel Cleaning Screen
If cards are not processing in the selected incubator, and the carousel
sections have not been removed, the following screen displays:
Figure 7-9: VITEK® 2 XL Preparing for Section Removal Screen
Note:
When the Continue button is pressed, you are required to remove all of the
sections. This will require about four minutes. The Cancel button provided
here is the only opportunity to cancel this operation.
2)
Press Continue.
The following message displays:
Remove the incubator access cover now
Note:
3)
Open the Waste Collection door for the carousel being cleaned.
4)
Open the top access door for the carousel being cleaned.
The remaining steps may be easier if you also remove the Waste Collection
tray.
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Maintaining the VITEK® 2 Instrument
Cleaning the Carousel
Note:
There are two types of incubator access covers for the VITEK® 2 instrument.
Perform the first part of Step 5 if the machined incubator access cover is in
use. Perform the second part of Step 5 if the molded incubator access cover
is in use.
5)
Remove the incubator access cover (1, Figure 7-10) from the carousel
by holding the retaining pin (2) on the top of the cover to the right while
pulling the cover slightly forward and to the right, out of the instrument.
2
1
Figure 7-10: Machined Incubator Access Cover
or
Remove the incubator access cover (3, Figure 7-11) from the carousel
by lifting the top of the cover straight up from the instrument.
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Cleaning the Carousel
3
Figure 7-11: Molded Incubator Access Cover
When you remove the cover, the message on the screen changes to:
Preparing for Section Removal
6)
When the carousel is in position, the following screen displays:
Figure 7-12: Carousel Cleaning Prompt
7)
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The carousel is removed in four sections. Grasp the first carousel section
and pull it slightly forward (toward the front of the instrument). You
should then be able to pull the section up and to the right, as shown in
Figure 7-13.
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Maintaining the VITEK® 2 Instrument
Cleaning the Carousel
Figure 7-13: Removing a Carousel Section
8)
Press the Press here after completion option button to indicate
removal of the carousel section.
The following message displays:
Current number of sections: 3 of 4
The carousel turns 90° so that the next section can be removed. During
this time the message Preparing for Section Removal displays
again on the screen.
9)
Repeat this procedure, starting at Step 6, until all four carousel sections
have been removed.
10) Press the Press here after completion option button.
The following message displays:
Replace the incubator access cover now
Note:
There are two types of incubator access covers for the VITEK® 2 instrument.
Perform the first part of Step 11 if the machined incubator access cover is in
use. Perform the second part of Step 11 if the molded incubator access cover
is in use.
11) Hold the retaining pin on the top of the cover to the right and carefully
replace the incubator access cover over the carousel. Release the
retaining pin when the cover is in place.
or
Install the carousel cover over the carousel.
Once you have replaced the incubator access cover, the Cleaning menu
appears.
For instructions on replacing the carousel, see the procedure Replacing the
Carousel After Cleaning on page 7-15.
7-14
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Cleaning the Carousel
Carousel Cleaning Methods
The four sections of the carousel should be thoroughly cleaned and dried
before they are replaced in the VITEK® 2 instrument. The carousel material is
designed to withstand any of the following cleaning methods:
• Automatic dishwasher with standard laboratory detergent
CAUTION: Dishwasher temperatures during the washing and
drying cycles must not exceed 85 °C (185 °F). Exceeding this
temperature will cause damage to the carousel sections. Use the
top rack of the dishwasher.
• 10% bleach solution
• Phenolic cleaning solution
Note:
To disinfect a contaminated surface, use the 10% bleach solution and allow it
to remain in contact with the contaminated surface for five minutes.
Replacing the Carousel After Cleaning
After the four carousel sections have been removed, the Cleaning menu
displays.
1)
Access the Carousel Cleaning function using the path:
VITEK 2 Main Menu > Utilities > Maintenance > Cleaning > Carousel
Cleaning
The following screen message displays:
Preparing for Section Replacement
Note:
If the power has cycled, the screen below displays automatically.
2)
Press Continue to continue with the carousel replacement.
The following message displays:
Remove the incubator access cover now
Note:
There are two types of incubator access covers for the VITEK® 2 instrument.
Perform the first part of Step 3 if the machined incubator access cover is in
use. Perform the second part of Step 3 if the molded incubator access cover
is in use.
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Maintaining the VITEK® 2 Instrument
Cleaning the Carousel
3)
Remove the incubator access cover (1, Figure 7-14) from the carousel
by holding the retaining pin (2) on the top of the cover to the right while
pulling the cover slightly forward and to the right, out of the instrument.
2
1
Figure 7-14: Machined Incubator Access Cover
or
Remove the incubator acces cover (3, Figure 7-15) from the carousel by
lifting the top of the cover straight up from the instrument.
3
Figure 7-15: Molded Incubator Access Cover
7-16
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Maintaining the VITEK® 2 Instrument
Cleaning the Carousel
When the access cover has been removed, the following message
displays:
Preparing for section replacement
When the carousel is in position, the following screen displays:
Figure 7-16: Carousel Cleaning Replace Section Now Screen
4)
Take any one of the carousel sections and orient it as shown in
Figure 7-17. The bottom of the section should be touching the base plate
(3, Figure 7-17), and the top portion should be tilted slightly toward the
front of the instrument.
3
4
Figure 7-17: Orientation of the Carousel
5)
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Slide the section down along the base plate while maintaining the tilted
angle.
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Maintaining the VITEK® 2 Instrument
Cleaning the Carousel
6)
When the section has been pushed down all the way, release the top
portion, allowing it to rest against the base plate.
When you perform Step 6, two pins on the back of the section should
engage the two holes (4) in the base plate and secure the section.
7)
Press the Press here after completion option button to indicate that the
section is in place.
The carousel turns 90° to move the first section out of the way and the
following message appears:
Preparing for Section Replacement
8)
Repeat this procedure, starting at Step 4, until all four carousel sections
have been replaced.
The screen displays the following message:
Replace the incubator access cover now
Note:
There are two types of incubator access covers for the VITEK® 2 instrument.
Perform the first part of Step 9 if the machined incubator access cover is in
use. Perform the second part of Step 9 if the molded incubator access cover
is in use.
9)
Hold the retaining pin on the top of the cover to the right and carefully
replace the incubator access cover over the carousel. Release the
retaining pin when the cover is in place.
or
Install the carousel cover over the carousel.
10) Lower the top access door for the carousel being cleaned.
Note:
Replace the Waste Collection Tray if it was removed earlier.
11) Close the Waste Collection door.
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Maintaining the VITEK® 2 Instrument
Cleaning the Cassettes
Cleaning the Cassettes
Cassettes should be cleaned monthly, or as conditions require.
BIOHAZARD WARNING
The cassettes should be considered as potentially
contaminated and should be handled appropriately. Qualified
laboratory personnel should take the usual precautions
necessary for infectious agents.
CAUTION: Exposing the button memory to the recommended
cassette cleaning procedures can cause irreparable damage to
the unit.
The cassette material is designed to withstand any of the following cleaning
methods:
• Automatic dishwasher with standard laboratory detergent
CAUTION: Dishwasher temperatures during the washing and
drying cycles must not exceed 85 °C (185 °F). Exceeding this
temperature will cause damage to the cassettes. Use the top
rack of the dishwasher.
• 10% bleach solution
• Phenolic cleaning solution
Note:
To disinfect a contaminated surface, use the 10% bleach solution and allow it
to remain in contact with the contaminated surface for five minutes.
1)
Turn an empty cassette over so that its underside is facing you, as
shown in Figure 7-18.
2)
Apply a slight inward pressure to the plastic tab (1, Figure 7-18) that
extends from the memory module (2).
3)
At the same time, pull the button memory module away from the
cassette.
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Maintaining the VITEK® 2 Instrument
Cleaning the Cassettes
1
2
Figure 7-18: Removing the Button Memory Module
4)
Clean the metal contacts (3, Figure 7-19) on the module with an alcohol
wipe.
3
Figure 7-19: Metal Contacts on Cassette
Note:
When cleaning multiple cassettes, it is not necessary to match a button
memory module to a particular cassette. The units are completely
interchangeable.
5)
The cassettes should be thoroughly cleaned and dried before they are
used again.
Replacing the Button Memory Module
7-20
1)
Turn the cassette over and hold it in your right hand.
2)
Hold the memory module by the extended tab (1, Figure 7-20) in your
right hand so that the two metal contacts (2) will line up with the two
holes in the side of the cassette (3).
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Cleaning the Boats
1
2
4
3
Figure 7-20: Replacing the Button Memory Module
3)
Place the other end of the module against the holding bracket (4) and
push the module towards the side of the cassette.
The module should snap into place.
Cleaning the Boats
Note:
The procedures in this section should be performed monthly, or as conditions
require.
Note:
Do not replace the boats if you are going to clean the inside of the instrument
using the procedures that begin on page 7-24.
Removing Boats for Cleaning
BIOHAZARD WARNING
The boats should be considered as potentially contaminated
and should be handled appropriately. Qualified laboratory
personnel should take the usual precautions necessary for
infectious agents.
Note:
This procedure should be performed while the instrument is idle. If you are
performing this procedure to remove only a particular boat, the system can
continue to process with as few as one boat.
1)
Access the Boat Cleaning function using the path:
Main Menu > Utilities > Maintenance > Cleaning > Boat Cleaning
The following screen appears:
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Maintaining the VITEK® 2 Instrument
Cleaning the Boats
Figure 7-21: Boat Cleaning Prompt
2)
Press Remove Boat. If there are boats in the card transport system, and
it is not idle, the instrument displays the message:
Card transport system is busy. Please try later.
If the system is idle, the instrument moves a boat to the boat dock while
displaying this message:
Moving Boat to Boat Dock.
When the boat is ready for removal, the following message appears:
Boat is at Boat Dock. Please remove it.
3)
Open the front access door.
A boat will be positioned below the Dispenser/Pipettor Station.
Note:
A boat may be positioned at the Cassette Load Station, but it must NOT be
removed from that position.
4)
Remove the boat from below the Dispenser/Pipettor Station and press
the Press here after completion option button (see Step 2 on
page 7-22).
The screen displays:
Current Number of Boats: 3 of 4.
7-22
5)
Repeat this procedure, starting at Step 2, until all 4 boats have been
removed.
6)
Press the Previous Screen key.
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Cleaning the Boats
Cleaning the Boats
The four boats should be thoroughly cleaned and dried before they are
replaced in the VITEK® 2 instrument. The boat material is designed to
withstand any of the following cleaning methods.
• Automatic dishwasher with standard laboratory detergent
CAUTION: Dishwasher temperatures during the washing and
drying cycles must not exceed 85° C (185° F). Exceeding this
temperature will cause damage to the boats. Use the top rack of
the dishwasher.
• 10% bleach solution
• Phenolic cleaning solution
Note:
To disinfect a contaminated surface, use the 10% bleach solution and allow it
to remain in contact with the contaminated surface for five minutes.
Replacing Boats after Cleaning
Note:
If you are performing monthly maintenance on the entire instrument, do not
replace the boats until after you clean the base pan. Refer to the procedure
on page 7-28.
1)
Access the Boat Cleaning function using the path:
Main Menu > Utilities > Maintenance > Cleaning > Boat Cleaning
The following message appears:
Current number of boats: 0 of 4
2)
Press Replace Boat. If there are boats in the card transport system, and
it is not idle, the instrument displays the message:
Card transport system is busy. Please try later.
3)
If the system is idle, the instrument prepares for the boat replacement,
and then displays this message:
Replace Boat.
4)
Note:
Open the front access door and replace the boat below the Pipettor
Station.
Boats must NOT be replaced at the Cassette Load/Unload Station.
5)
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Make sure that:
7-23
Maintaining the VITEK® 2 Instrument
Cleaning the Instrument Interior
• The front legs (1, Figure 7-22) of the boat are positioned in the channel
of the base pan.
• The boat is oriented with the arrow (2) pointing toward the back.
2
1
Figure 7-22: Positioning of Boat
6)
Press the Press here after completion option button shown below after
replacing the boat.
The first screen reappears with the boat count at 1 of 4.
7)
Repeat this procedure, starting at Step 2, until all four boats have been
replaced.
8)
Press the Previous Screen key when the display shows:
Current number of Boats: 4 of 4.
Cleaning the Instrument Interior
This section describes the procedure for cleaning the inside of the instrument,
when the instrument has been shut down and no cards are processing.
To troubleshoot optics while cards are processing, see Cleaning Optics
(Cards Processing) on page 8-23.
The procedures in this section should be performed monthly, or as conditions
require.
BIOHAZARD WARNING
All organism suspensions should be considered as potentially
infectious. Qualified laboratory personnel should use
acceptable procedures for biohazardous material.
7-24
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Maintaining the VITEK® 2 Instrument
Cleaning the Instrument Interior
CAUTION: There are elevated temperatures and hot surfaces
inside the instrument. Shut down the instrument before starting
the cleaning or any other procedures inside the instrument.
Shutting Down the Instrument
Note:
Finish processing all cards before beginning this procedure.
1)
Access the Shut Down function using the path:
Main Menu > Utilities > Maintenance > Shut Down
If any cards are processing the instrument displays this message:
Cards are currently processing. Do you wish to
continue?
CAUTION: If you select Yes to continue with shutting down the
instrument, the cards being processed may be TERMINATED.
The instrument displays the following prompt:
Shutting down instrument. Do you wish to continue?
2)
Press Yes to shut down the instrument.
The instrument briefly displays the following message while it moves
some internal components to their shutdown positions:
Shutting Down Instrument
When this process is complete, the instrument displays the message:
Shut down has completed. Turn power off when ready.
3)
Press the AC power switch to shut the instrument off.
4)
Remove the AC power cord to prevent any possible electrical hazard.
It is now safe to access the inside of the instrument.
Cleaning the Test Card Collection Tray
1)
Open the Waste Collection door and remove the test card collection tray.
2)
Thoroughly clean and dry the tray before replacing it in the VITEK® 2
instrument.
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7-25
Maintaining the VITEK® 2 Instrument
Cleaning the Instrument Interior
The tray material is designed to withstand any of the following cleaning
methods:
• Automatic dishwasher with standard laboratory detergent
CAUTION: Dishwasher temperatures during the washing and
drying cycles must not exceed 85 °C (185 °F). Exceeding this
temperature will cause damage to the cassettes. Use the top
rack of the dishwasher.
• 10% bleach solution
• Phenolic cleaning solution
Note:
To disinfect a contaminated surface, use the 10% bleach solution and allow it
to remain in contact with the contaminated surface for five minutes.
3)
Replace the test card collection tray in the Waste Collection Station.
Cleaning Optics (Normal Maintenance)
Note:
Perform the procedure Shutting Down the Instrument on page 7-25 before
cleaning the optics.
CAUTION: Do not wear powdered latex gloves while cleaning the
optics. The gloves that contain a powder can interfere with the
optics.
CAUTION: Do not use commercial glass cleaner when cleaning
the optics. This may result in calibration failures observed as the
optics age. Clean optics using a quality, lint free lens paper that
has been slightly moistened with alcohol.
1)
Open the Waste Collection door.
2)
Lift the top access door.
This exposes the transmittance (1, Figure 7-23) optics.
7-26
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Maintaining the VITEK® 2 Instrument
Cleaning the Instrument Interior
1
Figure 7-23: Optics
The optics consist of multiple units that are hinged on the bottom and
held in place by spring-loaded levers.
3)
Using your right hand, grasp the optics unit and place your thumb on the
lever (2, Figure 7-24).
2
Figure 7-24: Opening the Optics
Note:
4)
Push down on the lever to release the unit and allow it to rotate on its
hinges.
5)
Inspect the glass on both surfaces for cracks or scratches.
Any apparent crack or scratch should be reported to bioMérieux.
6)
Using a quality, lint free lens paper that has been slightly moistened with
alcohol, clean both glass surfaces of each Transmittance Optics.
7)
While cleaning the emitter side of the Transmittance Optics, push the
reader head plate down and clean the glass as close to the belt as
possible.
If foreign material remains on either surface, repeat this step using an
alcohol wipe. Squeeze out excess alcohol before using, and dry the
surface with lens paper. Make sure that you do not leave streaks on the
glass.
8)
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Rotate the unit back into place while pushing down slightly on the lever
until it is secured.
7-27
Maintaining the VITEK® 2 Instrument
Cleaning the Instrument Interior
9)
Replace the empty test card collection tray in the Waste Collection
Station.
10) Close the top access door.
11) Close the Waste Collection door.
Note:
After cleaning the optics and returning power to the instrument, perform the
Optical Diagnostic Test on page 8-26.
If you are not performing the remaining cleaning procedures in this section,
skip to the procedure Turning the Instrument On on page 7-31.
Cleaning the Base Pan, Vacuum Seal and Vacuum Chamber
Note:
Perform the instrument shutdown procedure on page 7-25 before proceeding
with this procedure.
Note:
If the boats have not already been removed, perform the procedure to
remove them. (See page 7-21.)
BIOHAZARD WARNING
The base pan should not be cleaned unless the drip pan is
properly installed. See Cleaning the Drip Pan on page 7-29 for
instructions on cleaning the drip pan.
The base pan, vacuum seal, and vacuum chamber are designed to withstand
any of the following cleaning methods.
• 10% bleach solution
• Phenolic cleaning solution
Note:
Remove all boats (see Removing Boats for Cleaning on page 7-21) and shut
down the instrument (see Shutting Down the Instrument on page 7-25) before
performing this procedure.
The base pan is the surface on which the boats move. The vacuum seal is
the bottom surface of the vacuum chamber where the chamber makes
contact with a boat (1, Figure 7-25).
7-28
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Maintaining the VITEK® 2 Instrument
Cleaning the Drip Pan
1
Figure 7-25: Vacuum Seal
1)
Using a solution of disinfectant and warm water, wipe off any dust or dirt
from the surface of the base pan.
Particular attention should be paid to the area beneath the Dispenser/
Pipettor Station, where drips or spills may have occurred.
Note:
Note:
To disinfect a contaminated surface, use the 10% bleach solution and allow it
to remain in contact with the contaminated surface for five minutes.
2)
Using plain water, wipe the same surfaces again to remove any
disinfectant residue.
3)
Repeat Step 1 and Step 2 to clean the vacuum seal and the interior
surface of the vacuum chamber.
The remaining cleaning procedures in this section do not require that the
instrument be shut down. You can now turn the instrument back on. See
Turning the Instrument On on page 7-31.
Cleaning the Drip Pan
BIOHAZARD WARNING
All organism suspensions should be considered as potentially
infectious. Qualified laboratory personnel should use
acceptable procedures for biohazardous material.
Note:
This procedure should be performed monthly, or as conditions require.
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7-29
Maintaining the VITEK® 2 Instrument
Cleaning the Drip Pan
VITEK® 2 has a small container, called the drip pan, located underneath the
Dispenser/Pipettor Station. The pan is designed to catch any spills that occur
at this station.
Note:
This procedure should be performed after you clean the base pan. See
Cleaning the Base Pan, Vacuum Seal and Vacuum Chamber on page 7-28.
Removing the Drip Pan
BIOHAZARD WARNING
The contents of the drip pan may include biohazardous
materials. Take appropriate precautions.
1)
Lower the bottom access door located in the bottom, front portion of the
instrument.
The plate is held magnetically and should swing down on its hinges
when you pull on it at both ends.
2)
Grasp the handle of the drip pan (1, Figure 7-26) and carefully pull it from
the instrument.
1
Figure 7-26: Drip Pan Handle
Cleaning the Drip Pan
The drip pan should be thoroughly cleaned and dried before it is replaced in
the VITEK® 2 instrument. The pan material is designed to withstand any of
the following cleaning methods:
• Automatic dishwasher with standard laboratory detergent
7-30
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Maintaining the VITEK® 2 Instrument
Cleaning the Drip Pan
CAUTION: Dishwasher temperatures during the washing and
drying cycles must not exceed 85 °C (185 °F). Exceeding this
temperature will cause damage to the drip pan. Use the top rack
of the dishwasher.
• 10% bleach solution
• Phenolic cleaning solution
Note:
To disinfect a contaminated surface, use the 10% bleach solution and allow it
to remain in contact with the contaminated surface for five minutes.
Replacing the Drip Pan
1)
Holding the pan by its handle, push it into the space provided for it under
the front of the instrument.
2)
Close the bottom access door by pushing it up.
The door is held in place magnetically.
Turning the Instrument On
1)
Move the AC power switch to the ON position.
The system goes through the initialization process. When the Status
screen appears it will display a status of Cleaning, indicating that all four
boats have been removed.
2)
Perform the boat replacement procedure that begins on page 7-23.
After all four boats have been replaced, the Status screen should display
a status of OK.
Note:
If the instrument was shut down for a long period of time, the status may be
Warming. Wait until the status is OK before resuming test card processing.
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Maintaining the VITEK® 2 Instrument
Cleaning the SCS
Cleaning the SCS
BIOHAZARD WARNING
All organism suspensions should be considered as potentially
infectious. Qualified laboratory personnel should use
acceptable procedures for biohazardous material.
Note:
This procedure should be performed monthly, or as conditions require.
The SCS base unit, keypad, display, and bar code scanner (except the clear
lens) are designed to withstand any of the following cleaning solutions when
applied first to a cleaning cloth and then to the SCS:
• 10% bleach solution
• Phenolic cleaning solution
To clean the SCS:
1)
Remove the cassette if one is on the SCS base unit.
2)
Push the power switch on the SCS to the off position.
3)
Remove the SCS AC power cord from its outlet.
4)
Note the metal contacts (1, Figure 7-27), and take care only to wipe them
gently in an up and down motion.
CAUTION: To prevent damage to the metal contacts on the SCS
base unit, make sure that you wipe them GENTLY in an up and
down motion, rather than side to side.
1
Figure 7-27: SCS Base Unit Metal Contacts
7-32
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Maintaining the VITEK® 2 Instrument
Cleaning the SCS
5)
Clean all surfaces of the SCS base unit, keypad, display, and bar code
scanner, except the clear lens of the scanner.
6)
Wipe the clear lens of the bar code scanner using a quality, lint free lens
paper that has been moistened with a commercial glass cleaner. If
foreign material remains on the surface, repeat this step using an alcohol
wipe.
7)
Allow all parts to dry thoroughly before reconnecting the power cord and
switching the power on.
The VITEK® 2 and VITEK® 2 XL Maintenance Logs on the following pages
list recommended maintenance procedures and their frequency. Make one
copy for your use and keep the original in this manual.
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Cleaning the SCS
7-34
Maintaining the VITEK® 2 Instrument
VITEK® 2 Instrument User Manual
510731-10EN1
Day of Month:
1
2
Month____________Year____________
3
4
5
6
7
8
9
10
11
12
13
14
15
Change Saline A/R
Change Pipette Tips A/R
Clean Boats*
Clean Carousel*
16
Maintaining the VITEK® 2 Instrument
VITEK® 2 Instrument User Manual
510731-10EN1
VITEK® 2 Maintenance Log
Clean Cassettes*
Clean Optics*
Clean Waste Tray*
Clean Base Pan*
Clean Vacuum Seal*
Clean Vacuum Chamber*
Clean Drip Pan*
Check Instrument QC
Status Report for the
Carousel Temperature**
Optics Systems**
Clean Smart Carrier*
** = Daily
7-35
MASTER COPY
Make additional copies for your own use.
A/R = As Required
Maintenance Logs
* = Monthly
Day of Month:
17
18
19
Month____________Year____________
20
21
22
23
24
25
26
27
28
29
30
31
Change Saline A/R
Maintenance Logs
7-36
VITEK® 2 Maintenance Log
Change Pipette Tips A/R
Clean Boats*
Clean Carousel*
Clean Cassettes*
Clean Optics*
Clean Waste Tray*
Clean Base Pan*
Clean Vacuum Seal*
Clean Vacuum Chamber*
Clean Drip Pan*
Check Instrument QC
Status Report for the
VITEK® 2 Instrument User Manual
510731-10EN1
Optics System*
Clean Smart Carrier*
* = Monthly
** = Daily
MASTER COPY
Make additional copies for your own use.
A/R = As Required
Maintaining the VITEK® 2 Instrument
Carousel Temp.*
Day of Month:
1
2
3
Month____________Year____________
4
5
6
7
8
9
10
11
12
13
14
15
16
Change Saline A/R
Change Pipette Tips A/R
Clean Boats*
Clean Carousel A & B*
Maintaining the VITEK® 2 Instrument
VITEK® 2 Instrument User Manual
510731-10EN1
VITEK® 2 XL Maintenance Log
Clean Cassettes*
Clean Optics A & B*
Clean Waste Tray A & B*
Clean Base Pan*
Clean Vacuum Seal*
Clean Vacuum Chamber*
Clean Drip Pan*
Check Instrument QC
Status Report for the
Carousel Temp. A & B**
Optics Systems A & B**
Clean Smart Carrier*
** = Daily
7-37
MASTER COPY
Make additional copies for your own use.
A/R = As Required
Maintenance Logs
* = Monthly
Day of Month:
17
18
19
Month____________Year____________
20
21
22
23
24
25
26
27
28
29
30
31
Change Saline A/R
Maintenance Logs
7-38
VITEK® 2 XL Maintenance Log
Change Pipette Tips A/R
Clean Boats*
Clean Carousel A & B*
Clean Cassettes*
Clean Optics A & B*
Clean Waste Tray A & B*
Clean Base Pan*
Clean Vacuum Seal*
Clean Vacuum Chamber
*
Clean Drip Pan*
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Carousel Temp. A & B**
Optics Systems A & B**
Clean Smart Carrier*
* = Monthly
** = Daily
MASTER COPY
Make additional copies for your own use.
A/R = As Required
Maintaining the VITEK® 2 Instrument
Check Instrument QC
Status Report for the
TROUBLESHOOTING THE VITEK® 2 INSTRUMENT
8
Introduction
This chapter helps you to resolve any problems that may occur while
operating the VITEK® 2 instrument. The first section, Error Handling System,
explains how the instrument reacts to an error, and how you, the user, should
respond. The second section, Status Screen Error Conditions, covers the
Instrument Halted screen, Message Status screen, and Error Status screen.
The third section, Cassette Load Processing Errors, covers a specific set of
errors that are the ones most likely to occur in normal operation. Other
sections cover the Bar Code Reader, and instrument diagnostics and quality
control status.
Error Messages and Recovery Procedures
This section contains a listing of all the possible error messages that could
occur on the VITEK® 2 instrument and the SCS. This is the first place you
should go if an error occurs and you need to find out what to do.
Chapter Contents
Error Handling System • 8-3
Error Alarms • 8-4
Types of Errors • 8-4
Status Screen Error Conditions • 8-4
Instrument Halted Screen • 8-5
Message Status Screen • 8-8
Error Status Screen • 8-10
Cassette Load Processing Errors • 8-10
Types of Errors • 8-10
Workflow Considerations • 8-11
Bar Code Read Failure • 8-11
SCS and Bar Code Reader Conflict • 8-13
Inoculum Errors • 8-14
Card Capacity Errors • 8-16
Disposables Errors • 8-17
Working Without the Bar Code Reader • 8-17
Entering Bar Codes Manually • 8-17
Instrument Diagnostics • 8-18
Instrument Diagnostics Menu • 8-18
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Troubleshooting the VITEK® 2 Instrument
Diagnostic Tests • 8-19
Cleaning Optics (Cards Processing) • 8-23
Optical Diagnostic Test • 8-26
Boat Transport Positions • 8-26
Power Failures • 8-28
Displaying Version Information • 8-28
Using Error Message and Recovery Table • 8-29
Restarting the Instrument • 8-29
8-2
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Error Handling System
Error Handling System
The VITEK® 2 instrument continually monitors itself to ensure that it is
operating within specifications. To do this it uses numerous optical,
mechanical, and temperature sensors, located within each subsystem. If a
sensor detects a problem, the VITEK® 2 instrument is programmed to alert
you to the situation, and to provide you with the information you need to
resolve the problem. We refer to this process as the Error Handling System.
Figure 8-1 illustrates these elements.
The VITEK® 2 Instrument
Instrument Sensors:
• Detect an error
Visual/Audible Alarms:
• Notify User
Instrument Programming:
• Interprets sensor signal
• Attempts to self-correct
• Selects error message
• Activates alarms
• Send message to queue
Error/Message Queue
The VITEK® 2 User
Error/Message Queue:
• Access the queue
• Record message and
code
Troubleshooting Chapter:
• Look up error code
• Follow recovery procedure
Figure 8-1: VITEK® 2 Error Handling System
The first element of the Error Handling System is the VITEK® 2 instrument.
First it must detect the error. In many cases, the instrument will attempt to
correct the problem by retrying an operation. If that fails, the instrument
selects the appropriate error message, activates the error alarms, and places
the message in the error/message queue.
The second element of the Error Handling System is you, the VITEK® 2 user.
First, you must:
• Respond to the alarm by accessing the error/message queue on the
instrument interface.
• Read and record all messages in the queue.
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Status Screen Error Conditions
Troubleshooting the VITEK® 2 Instrument
• Look up the error code from the message in this chapter and follow the
recovery procedure.
Error Alarms
VITEK® 2 has two alarms to alert you to the presence of an error condition.
The dual alarms are provided in case the VITEK® 2 instrument and the
workstation are in different locations. When they are in close proximity, the
audible alarm on the instrument can be disabled as a configuration option.
Audible Alarm. This alarm sounds both at the VITEK® 2 instrument, and at
the workstation. Another instrument configuration option allows you to set the
volume of the audible alarm.
Visual Alarm. This alarm uses the screen on the interface display. When the
visual alarm is activated, the screen flashes to indicate the presence of an
error condition. An instrument configuration option allows you to disable the
visual alarm.
CAUTION: Do not disable both the audible and the visual alarms.
Doing so eliminates all indicators of an error condition, which
could result in the termination of tests in progress.
Types of Errors
There are three basic types of errors:
• Errors that cause the Reader or Card Transport system to halt.
• Minor errors, during which the Reader or Card Transport system continues.
• Errors that occur while loading a new cassette.
Note:
All errors/messages are logged in the Error Log whether or not they are
resolved. The log is cleared when the instrument is turned off.
Status Screen Error Conditions
Depending on the type of error, you will see one or more types of screens.
• Instrument Halted Screen. Indicates an error has caused the Reader or
Card Transport system to halt.
8-4
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Status Screen Error Conditions
• Status screen with a status of Messages. Indicates there are error
messages that need to be reviewed. These are minor errors that do not
cause the Reader or Card Transport to halt.
There are two ways you can handle a Status screen with a status of
Messages.
• Review the message and resolve the condition as indicated in Table 8-2.
• Review the message and decide not to resolve the condition.
Note:
If the first error recovery procedure directs you to contact bioMérieux, do so
immediately.
• Status screen with a status of Error Indicates a message has been
reviewed but not resolved, or the recovery procedure was not successful.
This status can only be cleared by resolving the condition that caused the
original error.
Instrument Halted Screen
1
2
3
4
5
6
Figure 8-2: Instrument Halted Status Screen
1 – Reader. This field indicates whether the Reader Station is still
processing, or has been halted due to the error.
2 – Card Transport. This field indicates whether the card transport system is
still processing, or has been halted due to the error.
3 – Minutes. This field indicates how many minutes the error condition has
existed.
4 – Message Pending. This field indicates how many messages are
currently in the error/message queue. You can access the error/message
queue by pressing the Help (?) key.
5 – Go Option Button. Press Go to resume processing after you have
corrected the problem.
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Troubleshooting the VITEK® 2 Instrument
Status Screen Error Conditions
6 – 05:16. Time error occurred.
Reviewing an Instrument Halted Screen
1)
Note:
Press Help (?) to view the error/message queue.
If there is more than one message, use the Down Arrow to review and
address each message.
2)
Note the error code number, primary error code, and secondary error
code listed on the error/message queue.
3)
If the secondary error code listed is Card Transport System Failure,
proceed to Resolving a Transport Halted Screen to resolve the error.
4)
Look up the primary error code and then the secondary error code in
Table 8-2 in this chapter. If an error recovery procedure is given, follow
its directions, then continue with Step 5.
5)
Press the Previous Screen key to exit the error/message queue and
return to the Halted screen.
6)
Press Go to resume processing.
• If the recovery procedure was successful, the Status screen appears
with a Status of OK.
• If the Instrument Halted screen reappears, record the error code
number and call bioMérieux.
Resolving a Transport Halted Screen
Note:
Only cards loaded into the jammed boat will be terminated. After the jam has
been cleared, cards loaded into other non-jammed boats will continue to
process and will be finalized when card processing is completed.
1)
Press the Previous Screen key to exit the error/message queue and
return to the Halted screen.
2)
Press Go to access the Transport Halted screen.
3)
Open the front access door and the cassette load/unload door to check
for any jams or obstructions throughout the transport system. Things to
look for are:
• pipette tips that have fallen onto the base pan
• test cards that are not seated properly in the cassette
• boats that are not seated properly in their track
8-6
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Troubleshooting the VITEK® 2 Instrument
Status Screen Error Conditions
1
Figure 8-3: Transport Halted Screen (VITEK® 2)
1
Figure 8-4: Transport Halted Screen (VITEK® 2 XL)
4)
Note:
View the Transport Halted screen to find the jammed boat (1, Figure 8-3
or Figure 8-4 ).
Jammed boats are indicated by dotted line rectangles. Non-jammed boats
are indicated by solid line rectangles.
5)
Move the jammed boat to the major base pan position indicated with the
animated dotted lined rectangle and arrow on the Transport Halted
screen.
Note:
An arrow inside the dotted line rectangle indicates the direction to move the
jammed boat. The dotted line rectangle and arrow will animate from the
jammed position to the new desired position.
IMPORTANT:
Jammed boats should only be moved as indicated on the Transport
Halted screen. If a jammed boat is not moved to the location indicated
by the animation on the Transport Halted screen, the instrument will
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8-7
Troubleshooting the VITEK® 2 Instrument
Status Screen Error Conditions
indicate a Card Transport System Failure error again after the system
has rebooted.
6)
Close the front access door and the cassette load/unload door.
LASER WARNING
All access doors and covers must remain closed when
processing cards to avoid exposure to laser light.
7)
Press Go to exit the Transport Halted screen.
8)
The instrument will make a clicking noise and automatically reboot.
• If the recovery procedure was successful, the Status screen appears
with a Status of OK once the instrument has rebooted.
• If the Instrument Halted screen reappears, record the error code
number and call bioMérieux.
Message Status Screen
This status indicates that there is an error message in the error/message
queue that has not been viewed. Notice that the Status field (1, Figure 8-5)
has changed to Messages, indicating that there are error messages in the
error/message queue.
1
Figure 8-5: VITEK® 2 Status Screen
Press Help (?) to view the error/message queue.
If there is more than one message or error, press the Down Arrow to review
and address each message.
8-8
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Status Screen Error Conditions
2
3
4
5
6
Figure 8-6: Message Queue
2 — Primary Error Code. The first line in the error/message queue gives you
the Primary Error Code (in this case, Hardware Error). For examples of other
Primary Error Codes, see Table 8-2.
3 — Secondary Error Code. The second line of the error/message queue
tells you the Secondary Error Code (in this case, Optical Controller Failure).
For examples of other Secondary Error Codes, see Table 8-2.
4 — Message Counter. The third line in the error/message queue is the
message counter (in this case, 2 of 5). The counter tells you how many
messages are in the queue.
5 — Error Code. The last line of the queue is the error code (in this case,
106). This code contains information for a bioMérieux service representative,
should you need to call for assistance.
6 — 12:00. Time the error occurred.
Reviewing a Message Status Screen
1)
Note:
Press Help (?) to view the error/message queue.
If there is more than one message, use the Down Arrow to review and
address each message.
2)
Note the error code number, primary error code, and secondary error
code listed on the error/message queue.
3)
Look up the primary error code and then the secondary error code in
Table 8-2. If an error recovery procedure is given, follow its directions,
then continue with Step 4.
4)
Press the Previous Screen key to exit the error/message queue and
return to the Status screen.
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Troubleshooting the VITEK® 2 Instrument
Cassette Load Processing Errors
• If the recovery procedure was successful, the Status screen appears
with a Status of OK.
• If the Instrument Halted screen reappears, record the error code
number and call bioMérieux.
• If a problem still exists, the word Errors will be displayed in the status
field. The word Messages will display if a new message has been
generated.
If a problem recurs, contact bioMérieux.
Error Status Screen
This status appears after the error/message queue is accessed if the error
condition has not been resolved or the recovery procedure was not
successful. This status can be cleared only by resolving the condition that
generated the original message.
Review the error/message queue for any error messages the VITEK® 2
instrument has generated. Resolve the problem as indicated in Table 8-2.
Reviewing an Error Status Screen
When the status of Messages has changed to Errors this indicates one of
two conditions:
• The message was reviewed but not resolved. Follow Step 1 through Step 4
in the procedure Reviewing a Message Status Screen on page 8-9.
• The recovery procedure was not successful. Call bioMérieux.
Cassette Load Processing Errors
Cassette load processing errors are a special set of errors that occur
immediately following the loading of a cassette. You should be familiar with
this type of error because:
• They are often caused by problems that can be resolved quickly, thereby
preventing any interruption in your workflow.
• They occur at predictable times.
Types of Errors
During the first minute of processing, a cassette passes through the Bar
Code and Button Memory stations. During this time the button memory of a
smart cassette and the bar codes on all test cards are read. From this
information, VITEK® 2 can detect the following errors:
8-10
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Cassette Load Processing Errors
• The bar code reader was unable to read one or more bar codes on the test
cards.
• The card has passed its expiration date.
• An inconsistency was found between the information read from the button
memory on the cassette and the bar codes on the test cards. For example,
the button memory told VITEK® 2 that a Gram negative susceptibility card
is in slot 4 of the cassette. The bar code reader, however, found that slot to
be empty.
• (Automatic dilution mode only.) The bar code reader detected a
susceptibility card for which there is no inoculum.
• The number of test cards in the cassette exceeds the number of available
slots currently in the reader carousel.
• There is an insufficient quantity of pipette tips or saline to process the
number of cards being loaded.
Workflow Considerations
For any type of load error, the VITEK® 2 instrument backs the cassette out to
the Load Station so that you can resolve the error. If the cassette loading
door is not opened within 10 minutes, the instrument assumes that no
corrective action will be taken. The errors are ignored and the cassette is
restarted. Any test card in the cassette that has a load error will not be
processed. The cards remain in the cassette when the cassette returns to be
unloaded.
Whenever you load a cassette, the cassette icon appears on the Status
screen. You should wait until the icon disappears before leaving the
instrument.
Bar Code Read Failure
As a cassette passes through the Bar Code Reader Station, the bar code on
each test card is read. If the bar code reader is unable to read any of the bar
codes:
• The cassette is backed out to the Cassette Load Station.
• The error alarm is activated.
Resolving Bar Code Read Errors
1)
Press the Help (?) key to display the Error queue.
For a bar code error, you see the following message:
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Cassette Load Processing Errors
Troubleshooting the VITEK® 2 Instrument
Figure 8-7: Bar Code Error Message
2)
Open the door to the Cassette Load Station and remove the cassette.
The door should remain open while resolving the bar code error.
BIOHAZARD WARNING
The cassette should be considered as potentially contaminated
and should be handled appropriately. Qualified laboratory
personnel should take the usual precautions necessary for
infectious agents.
3)
Remove the card from the slot indicated in the message.
4)
Press the Previous Screen key twice to exit the error queue to the Main
Menu.
5)
Access the Resolve Bar Code Errors option on the Main Menu.
The Resolve Bar Code Error screen appears (Figure 8-8).
Figure 8-8: Resolving Bar Code Errors
6)
8-12
Using the numeric keypad, enter the bar code from the bar code label.
Press Enter.
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Troubleshooting the VITEK® 2 Instrument
Note:
Cassette Load Processing Errors
The bar code you enter may be longer than the space provided on the
screen. When this occurs, the first portion of the bar code scrolls off the
display and the symbol > appears.
7)
VITEK® 2 checks your entry for:
• A valid bar code number.
• An expiration date.
• A card type match based on the bar code entered compared with the
information read from the button memory on the cassette (Smart
Carrier Mode only). See the following section for more information.
If there is another bad bar code, the screen in Step 5 reappears with the
new slot number. Repeat Step 6. After the last bar code is entered, the
display returns to the Main Menu.
8)
Place the cassette back into the Cassette Load Station and close the
door.
This restarts the processing cycle for this cassette.
SCS and Bar Code Reader Conflict
This type of error only occurs when VITEK® 2 is operating in Smart Carrier
mode. That is because the error is based on a comparison of the information
read from the bar codes with that read from the cassette memory. The card
type is part of the information read on the bar code. Therefore, a card type
error occurs if a test card type that is different from the one expected
according to the cassette memory. If the instrument detects a card type error:
• The cassette is backed out to the Cassette Load Station.
• The error alarm is activated.
Resolving SCS and Bar Code Reader Conflicts
1)
Press Help (?) to display the error/message queue.
For a card type error you see the following screen:
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Cassette Load Processing Errors
Troubleshooting the VITEK® 2 Instrument
Figure 8-9: Card Type Error Message
2)
Open the Cassette Load Station door, remove the cassette, and place it
on the SCS.
BIOHAZARD WARNING
The cassette should be considered as potentially contaminated
and should be handled appropriately. Qualified laboratory
personnel should take the usual precautions necessary for
infectious agents.
3)
Press F3 to display the Summary screen.
4)
Check the positions and the types of test cards against the data
displayed on the screen.
5)
Move the test cards and their dilution tubes, as necessary, to match the
data on the screen.
6)
Place the cassette back in the Cassette Load Station and close the door.
This restarts the processing cycle for the cassette.
Inoculum Errors
When VITEK® 2 is operating in the Automatic Dilution mode, every
susceptibility test card must be provided with an inoculum source. The
inoculum must be placed in the slot that immediately precedes the
susceptibility card. It can be placed next to an empty slot, or a slot containing
a matching identification card.
Note:
8-14
For Gram negative test cards, the inoculum can be followed by one or two
susceptibility cards.
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Troubleshooting the VITEK® 2 Instrument
Note:
Cassette Load Processing Errors
A matching identification card is one having the same accession ID and test
type (gram +/gram -) as the susceptibility card.
During the bar code read, the instrument checks for one of these two
conditions. If the instrument detects an inoculum error:
• The cassette is backed out to the Cassette Load Station.
• The error alarm is activated.
Resolving an Inoculum Error
1)
Press the Error/Message key to display the message queue.
For an inoculum source error you see the following screen:
Figure 8-10: Inoculum Source Error Message
Note:
Another inoculum error message is “Grouping Error at Slot: NN”.
2)
Open the Cassette Load door and remove the cassette.
BIOHAZARD WARNING
The cassette should be considered as potentially contaminated
and should be handled appropriately. Qualified laboratory
personnel should take the usual precautions necessary for
infectious agents.
3)
Place the inoculum source next to the appropriate slot.
4)
Place the cassette back into the Cassette Load Station and close the
door.
This restarts the processing cycle for the cassette.
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Troubleshooting the VITEK® 2 Instrument
Cassette Load Processing Errors
Card Capacity Errors
As the bar codes on the test cards are read, the cards are counted. The count
is compared to the number of empty slots currently available in the reader
carousel. If the number of cards exceeds the number of available slots:
• The cassette is backed out to the Cassette Load Station.
• The error alarm is activated.
Resolving a Card Capacity Error
1)
Press Help (?) to display the error/message queue.
For a card capacity error you see the following screen:
Figure 8-11: Card Capacity Warning Message
2)
Open the Cassette Load door and remove the cassette.
You can remove a number of test cards from the cassette to resolve this
type of error. However, there is another option available because it takes
several minutes for a cassette to reach the Reader Station. During this
time, additional carousel slots can be made available by ejecting cards
whose tests have finalized. Continue the procedure as follows:
3)
Consult the card directory at the workstation. Count the number of cards
whose tests have finalized and that can be ejected.
4)
Eject those cards using the workstation software.
5)
If there are still too many test cards in the current cassette, remove the
needed number of cards.
6)
Place the cassette back into the Cassette Load/Unload Station and close
the door.
This restarts the processing cycle for the cassette.
Note:
8-16
If the instrument’s card capacity is exceeded, the extra test cards are not
processed, and will be unusable.
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Troubleshooting the VITEK® 2 Instrument
Working Without the Bar Code Reader
Disposables Errors
When a cassette begins processing, VITEK® 2 calculates the quantity of
disposables that will be needed. If the calculated value exceeds the current
level of a disposable:
• The cassette is backed out to the Cassette Load Station.
• The error alarm is activated.
How to Resolve a Disposables Error
1)
Press the Help (?) key to display one of the following messages:
Tip Level Low or Saline Level Low
2)
Open the Cassette Load door and remove the cassette.
3)
Perform the procedure in Chapter 7 to install a new VITEK® 2 accessory
kit and saline bag.
4)
Place the cassette back into the Cassette Load Station and close the
door.
Working Without the Bar Code Reader
A good reading of the test card bar code is required by the system to know
the card type and how to process it. The primary method of entering these
bar codes is the Bar Code Reader Station in the VITEK® 2 instrument. There
are also two backup methods:
• The bar code scanner on a Smart Carrier Station, which is then transferred
to VITEK® 2 via the smart cassette.
• Manually on the VITEK® 2 interface keypad.
If the Bar Code Reader Station fails, one of the two backup methods could be
used.
Entering Bar Codes Manually
Failure of the Bar Code Reader Station on the VITEK® 2 instrument would
result in a bar code read error for every card processed. This can be avoided
by disabling the station, and then entering bar codes via the Smart Carrier
Station, or manually on the VITEK® 2 keypad.
Disabling the Bar Code Reader
1)
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Access the Bar Code Reader configuration option using the path:
8-17
Troubleshooting the VITEK® 2 Instrument
Instrument Diagnostics
Main Menu > Utilities > Configuration
The Bar Code Reader screen appears:
Figure 8-12: Bar Code Reader Screen
2)
Press Down Arrow to disable the bar code reader.
Entering Bar Codes Manually
3)
Access the Resolve Bar Code Errors option on the Main Menu.
4)
Using the numeric keypad, enter the bar code from the bar code label.
5)
Press Enter to accept the entry. Repeat this step for each test card in the
cassette.
Note:
The bar code you enter may be longer than the space provided on the
screen. When this occurs, the first portion of the bar code scrolls off the
display and the symbol > appears.
Note:
Press Enter to bypass empty slots.
6)
Press Done when all the cards have been entered for the Cassette.
Instrument Diagnostics
Some of the error recovery procedures in this chapter ask you to perform a
diagnostic test on one of the stations in the VITEK® 2 instrument. This section
tells you how to access and use those tests.
Instrument Diagnostics Menu
All of the diagnostic tests for the instrument are located on the Diagnostics
menu, which can be accessed using the following path:
Main Menu > Utilities > Diagnostics
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Troubleshooting the VITEK® 2 Instrument
Instrument Diagnostics
Diagnostic Tests
Following are the tests found on the Diagnostics menu, and their function:
Diagnostic Test
Function
Possible Results
Temperature
Reads the temperature in the reader
carousel.
Displays the carousel
temperature in degrees Celsius.
Also displays the word Low or
High if the temperature is out of
specification.
Optics
Performs a self-test of the
transmittance optics systems.
Pass/Fail
Card Transport
Performs a self-test of the Card
Transport system.
Pass/Fail
Vacuum
Performs a vacuum test of the Filler
station.
Pass/Fail
Dispenser/Pipettor
Performs a saline dispensing and a
simulated organism suspension
transfer.
Pass/Fail
Error/Message Log
Stores all errors/messages occurring
since the power was last turned on.
When you power off the VITEK® 2 all
messages and errors are deleted
from this log.
NA
Note:
Some of the diagnostic test functions contain a confirmation screen. These
are included for the diagnostic tests that take several minutes to run. The
confirmation window asks if you want to continue.
Checking the Instrument Temperature
Access the Temperature Diagnostics using the path:
Main Menu > Utilities > Diagnostics > Temperature
If you have a VITEK® 2 XL, the screen in Figure 8-13 displays.
Figure 8-13: Temperature Diagnostics Screen (VITEK® 2 XL)
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Troubleshooting the VITEK® 2 Instrument
Instrument Diagnostics
If you have a VITEK® 2, the screen in Figure 8-14 displays.
Figure 8-14: Temperature Diagnostics Screen (VITEK® 2)
The screen displays the Incubator temperature and the temperature inside
the instrument.
Dispenser/Pipettor Diagnostic Test
Note:
The transport system must be idle to perform this test.
This test is designed to be performed:
• after installing an Accessory Kit to confirm correct operation of the
dispenser/Pipettor Station.
• during the error recovery procedure for a dispenser or Pipettor failure.
1)
Prepare a cassette with the following items:
• Two test tubes containing 3.0 mL saline, placed in test tube slots
1 and 3.
• Three blank test tubes, placed into test tube slots 2, 4, and 5.
Note:
This cassette does NOT require the use of the Smart Carrier Station.
2)
Access the Dispenser/Pipettor diagnostic test using the path:
Main Menu > Utilities > Diagnostics > Dispenser/Pipettor
The following message displays:
About to perform dispenser Pipettor test. Do you wish
to continue?
3)
Press Yes.
A message on the display will instruct you to load the cassette that you
prepared in Step 1.
8-20
4)
Open the Cassette Load door, load the cassette and close the Cassette
Load door.
5)
While the instrument is performing this test, open the front door of the
instrument and visually check the saline dispenser for any of the
abnormal conditions listed below.
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Instrument Diagnostics
• Look for repeated back and forth movement while the saline dispenser
is in the upright position. The saline dispenser tube should move
smoothly up and down when filling each AST tube.
• Look for saline remaining in the saline dispenser tube when it returns
to the upright position.
• Look for a saline stream and/or drops released from the saline
dispenser tube when it is filling with saline.
• Look for a saline stream and/or drops released from the saline
dispenser tube as it returns to the upright position.
• Look for lower volumes of saline while saline is being dispensed,
comparing tubes 2, 4 and 5 to each other.
• Observe the instrument user interface screen for Pipettor Failure 21 or
any Dispenser Failures.
IMPORTANT:
Ensure there is no sunlight shining directly on the saline dispenser.
You can continue to use Automatic Dilution Mode if none of the abnormal
conditions are observed.
If you see any of the above abnormal conditions or instrument errors continue
to occur, please discontinue using Automatic Dilution Mode and contact
bioMérieux immediately. You can configure the instrument to use the
Predilution Mode as described in Chapter 5 of this manual.
Dispenser/Pipettor Volumetric Test
This test is not required by bioMérieux as part of the recommended routine
maintenance procedures. This test has been provided for those laboratories
who are required to verify the accuracy of the volumes dispensed by the
Pipettor/Dispenser by regulatory/licensing agencies.
Note:
The transport system must be idle to perform this test.
1)
Prepare a test cassette with the following items:
• Two test tubes containing 3.0 mL saline, placed in test tube slots
1 and 3.
• Three blank test tubes, placed into test tube slots 2, 4, and 5.
Note:
This cassette does NOT require the use of the Smart Carrier Station.
2)
Record the weights of the test tubes placed in test tube slots 1, 3, and 5
using Table 8-1.
• Record the weight of the tube in slot 1 in the Pipettor Low Volume
section. Test tube 1 — Before test (B).
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Troubleshooting the VITEK® 2 Instrument
Instrument Diagnostics
• Record the weight of the tube in slot 3 in the Pipettor High Volume
section. Test tube 3 — Before test (B).
• Record the weight of the tube in slot 5 in the Diluter section. Test tube
5 — Before test (B).
Use Table 8-1 to record the weights of your test tubes. Make one copy for
your use and keep the original in this manual.
Table 8-1: Dispenser/Pipettor Volumetric Test
Pipettor Low Volume
Results
Date
Tested
Performed
By
Test tube 1 — Before test (B)
Test tube 1 — After test (A)
Weight of 1 (B) — 1(A)
Acceptable range 0.095 g to 0.105 g
Pipettor High Volume
Test tube 3 — Before test (B)
Test tube 3 — After test (A)
Weight of 3 (B) — 3 (A)
Acceptable range 0.285 g to 0.315 g
Diluter
Test tube 5 — Before test (B)
Test tube 5 — After test (A)
Weight of 5 (A) — 5 (B)
Acceptable range 2.33 g to 2.63 g
3)
Access the Dispenser/Pipettor diagnostic test using the path:
Main Menu > Utilities > Diagnostics > Dispenser/Pipettor
The following message displays:
About to perform dispenser Pipettor test. Do you wish
to continue?
4)
Press the Yes option button.
A message on the display will instruct you to load the cassette that you
prepared in Step 1.
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Troubleshooting the VITEK® 2 Instrument
Cleaning Optics (Cards Processing)
5)
Open the cassette load door, load the test cassette and close the
cassette load door.
6)
Allow the cassette to process and return to the cassette load/unload
door. Remove the cassette.
7)
Record the weights of the test tubes placed in test tube slots 1, 3, and 5
using Table 8-1.
• Record the weight of the tube in slot 1 in the Pipettor Low Volume
section under Test tube 1 — After test (A).
• Record the weight of the tube in slot 3 in the Pipettor High Volume
section under Test tube 3 — After test (A).
• Record the weight of the tube in slot 5 in the Diluter section under Test
tube 5 — After test (A).
8)
Determine if the Dispenser/Pipettor is performing to specification by
performing the following calculations using Table 8-1:
• In the Pipettor Low Volume section, subtract the weight of tube 1(A)
from the weight of 1(B). The value must be 0.095 g and 0.105 g to be
acceptable.
• In the Pipettor High Volume section, subtract the weight of tube 3(A)
from the weight of tube 3(B). The value must be 0.285 g to 0.315 g to
be acceptable.
• In the Diluter section, subtract the weight of tube 5(B) from the weight
of tube 5(A). The value must be 2.33 g to 2.63 g to be acceptable.
Note:
If the values recorded in the tables are not within the recommended range,
call bioMérieux for assistance.
Cleaning Optics (Cards Processing)
This procedure allows you to clean and verify the optics while test cards are
still processing. Use the optics cleaning procedure in Chapter 7 if the
instrument is shut down.
Note:
All steps in this procedure must be completed.
CAUTION: Do not wear powdered latex gloves while cleaning the
optics. The gloves that contain a powder can interfere with the
optics
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8-23
Cleaning Optics (Cards Processing)
Troubleshooting the VITEK® 2 Instrument
CAUTION: Do not use commercial glass cleaner when cleaning
the optics. This may result in calibration failures observed as the
optics age. Clean optics using a quality, lint free lens paper that
has been slightly moistened with alcohol.
1)
Access the Optics Cleaning function using the path:
Main Menu > Utilities > Maintenance > Cleaning > Optics Cleaning
If cards are processing, the following message appears:
Cards are currently processing. Do you wish to
continue?
2)
(VITEK® 2 XL Only) Select a Reader.
3)
Press Yes to continue.
The screen briefly displays the message:
Preparing for Optics Cleaning.
You have five minutes from the time that you press Yes to complete the
cleaning procedure. Test card processing automatically resumes after
that time.
It then displays the following message:
Clean the optics.
4)
Open the Waste Collection Station door and remove the test card
collection tray. Dispose of any test cards in the tray.
5)
Lift the top access door of the instrument.
This exposes the transmittance (1, Figure 8-15) optics.
This provides easier access to the optics and also an opportunity to
clean this component.
1
Figure 8-15: Optics
8-24
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Troubleshooting the VITEK® 2 Instrument
Cleaning Optics (Cards Processing)
The optics consist of multiple units that are hinged on the bottom and held in
place by spring-loaded levers.
Note:
Do each step for all transmittance optic units at the same time.
6)
Using your right hand, grasp the optics unit and place your thumb on the
lever (2, Figure 8-16).
2
Figure 8-16: Opening the Optics
Note:
7)
Push down on the lever to release the unit and allow it to rotate on its
hinges.
8)
Inspect the glass on both surfaces for cracks or scratches.
Any apparent crack or scratch should be reported to bioMérieux.
9)
Using a quality, lint free lens paper that has been slightly moistened with
alcohol, clean both glass surfaces of each Transmittance Optics.
10) While cleaning the emitter side of the Transmittance Optics, push the
reader head plate down and clean the glass as close to the belt as
possible.
If foreign material remains on either surface, repeat this step using an
alcohol wipe. Squeeze out excess alcohol before using, and dry the
surface with lens paper. Make sure that you do not leave streaks on the
glass.
11) Rotate the unit back into place while pushing down slightly on the lever
until it is secured.
12) Replace the empty test card collection tray in the Waste Collection
Station.
13) Close the top access door, then close the Waste Collection Station door.
14) Press Cleaning completed.
Note:
If Step 14 is not completed within the five minutes allowed, test card
processing resumes automatically. If the optics are still open, the instrument
generates an error condition.
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Troubleshooting the VITEK® 2 Instrument
Boat Transport Positions
15) Continue with the Optical Diagnostic Test, noting the conditions of the
test.
Optical Diagnostic Test
The Optical Diagnostic Test should not be performed if ID cards are
processing. However, in some cases you need to perform the optical
diagnostic test in response to an optics error.
• Transmittance Optics Errors with ID Cards Processing — After
cleaning the transmittance optics in response to a transmittance optics
error, await the next read cycle of the cards to determine if the cleaning
was effective.
• Transmittance Optics Errors without ID Cards Processing — You may
perform the Optical Diagnostic Test after cleaning transmittance optics in
response to a transmittance optics error.
CAUTION: Performing the Optical Diagnostic Test while ID cards
are processing may result in ID cards being TERMINATED.
1)
Access the Optical Diagnostic Test using the path:
Main Menu > Utilities > Diagnostics > Optics
2)
(VITEK® 2 XL Only) Select a Reader.
The following message appears for either the VITEK® 2 or VITEK® 2 XL:
About to perform optical test. Do you wish to
continue?
3)
Press Yes to continue.
4)
If the optical test fails, call bioMérieux.
5)
Once the test is complete, press Previous Screen to exit the window.
Boat Transport Positions
The diagram below shows the six boat transport positions. During
troubleshooting of jams involving the card transport system, it is important to
know the boat positions inside the instrument. See Resolving a Transport
8-26
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Troubleshooting the VITEK® 2 Instrument
Boat Transport Positions
Halted Screen on page 8-6 for further information on card transport system
jams.
LASER WARNING
All access doors and covers must remain closed when
processing cards to avoid exposure to laser light.
4
5
6
1
3
2
Figure 8-17: Boat Transport Positions
1 – Cassette Load/Unload Station. Boats must not be removed or replaced
at this station.
This is the area you see when you open the front access door:
2 – Button Memory Station.
3 – Pipettor Station
When a boat is repositioned, center it on the opening between the two guide
rails (see arrow in Figure 8-17) in the major base pan position indicated with
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Troubleshooting the VITEK® 2 Instrument
Power Failures
the animated dotted lined rectangle and arrow on the Transport Halted
screen.
4 – Vacuum Station.
5 – Cut/Seal Station.
6 – Card Load/Unload Station.
Power Failures
What happens in the VITEK® 2 instrument if there is a power failure? The
instrument is supported by a device called an Uninterruptible Power Supply
(UPS). If power is lost, the UPS uses a battery to continue to supply power to
the instrument.
The UPS notifies the VITEK® 2 instrument of a power failure. The following
events then take place in the VITEK® 2 instrument:
• Initiates a Power Failure error message.
• Begins a 20-minute timer.
• Continues processing test cards in the carousel.
• Continues to support the card transport system, but does NOT allow new
cassettes to be loaded.
If power is restored within the 20-minute period, normal operation is resumed.
If the power failure continues after the 20-minute period has expired, VITEK®
2 shuts down the card transport system but continues to process cards in the
carousel. Carousel processing continues as long as the battery in the UPS
supplies power. If the backup battery in the UPS begins to fail before the 20minute period expires, VITEK® 2 terminates the timer and shuts down the
card transport system. Test cards, however, continue to process as long as
any battery power is available.
Displaying Version Information
Allows you to view the current instrument firmware for the VITEK® 2. You
may be requested to supply this information to bioMérieux if you need
assistance with any of the recovery procedures in Table 8-2.
1)
Access version information using the path:
Main Menu > Utilities > Diagnostics > Version Info
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Using Error Message and Recovery Table
A screen displays similar to the one shown in Figure 8-18.
Figure 8-18: Version Information Screen
Using Error Message and Recovery Table
Table 8-2 in this section contains all of the messages that can be displayed in
the error/message queue.
The Error Message and Recovery table is designed to provide you, where
possible, with the recovery procedure that is most likely to restore the
instrument to normal operation. If the described procedure does not prevent
recurrences of the error, call bioMérieux for assistance.
1)
Find the primary error code from the error message in the first column of
the table. Primary error codes are listed alphabetically.
2)
Find the secondary error code from the error message in the second
column of the table.
3)
Read and follow the directions in the Recovery Procedure found in the
third column and address accordingly.
4)
If the error reoccurs or the recovery procedure advises a call to
bioMérieux, inform the service representative of the error number found
in the lower right portion of the message queue.
Restarting the Instrument
Several of the recovery procedures in Table 8-2 instruct you to restart the
instrument. To do this:
1)
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Perform the instrument shutdown procedure on page 7-25.
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Troubleshooting the VITEK® 2 Instrument
Using Error Message and Recovery Table
2)
Wait at least 10 seconds.
3)
Move the AC power switch to the ON position.
Table 8-2: Error Message and Recovery Table
Error Code
Recovery Procedure
Primary
Secondary
Fatal Error
Call bioMérieux
Call bioMérieux for assistance.
Hardware Error
FLASH Memory Failure
Call bioMérieux for assistance.
Incubator Temperature
Controller Failure
Call bioMérieux for assistance.
Internal Clock
Call bioMérieux for assistance.
Internal Data Failure
Call bioMérieux for assistance.
N/A
Call bioMérieux for assistance.
Optical Controller Failure
Note: If the error code number listed is 406 or 407, call
bioMérieux for assistance. Do not perform the Cleaning Optics
(Card Processing) procedure.
1) See Cleaning Optics (Cards Processing) on page 8-23.
2) Call bioMérieux if the problem recurs.
Host
Communication
Error
Serial Number Failure
Call bioMérieux for assistance.
Communication Failure
1) Ensure that the cable between VITEK® 2 to the workstation is
connected securely.
2) Confirm that the workstation is operating.
3) If the error continues, call bioMérieux for assistance.
Note: If this error occurs while a software update is being
performed, or during the automatic data backup, no action is
required.
Card data has been lost
8-30
Call bioMérieux for assistance.
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Using Error Message and Recovery Table
Table 8-2: Error Message and Recovery Table (Continued)
Error Code
Recovery Procedure
Primary
Initialization Error
I
Optical Error
Secondary
Card Sealer Failure
Call bioMérieux for assistance.
Card Transport System
Failure
Call bioMérieux for assistance.
Dispenser Failure
Call bioMérieux for assistance.
Incubator Temperature
Controller Failure
Call bioMérieux for assistance.
Internal Instrument
Temperature Controller
Failure
Call bioMérieux for assistance.
Motor/Sensor Failure
Call bioMérieux for assistance.
Pipettor Failure
Call bioMérieux for assistance.
Power Fail Recovery
Failure
Call bioMérieux for assistance.
Transport Failure
Call bioMérieux for assistance.
Vacuum System Failure
Call bioMérieux for assistance.
Optical Controller Failure
Call bioMérieux for assistance.
• Transmittance
Calibration Failure
1) See Cleaning Optics (Cards Processing) on page 8-23.
2) Call bioMérieux if the problem recurs.
• Transmittance Process
Failure
Processing Error
An optical system is not
available for card type in
slot.
1) Unload cassette from the instrument.
2) See Cleaning Optics (Cards Processing) on page 8-23 to clean
and test the optics.
3) Reload cassette into the instrument.
4) If problem persists, call bioMérieux.
Bar Code Read Failure at
Slot
Follow the procedure for Bar Code Read Failure on page 8-11.
Card has expired at Slot.
Replace the expired test card.
Card Sealer Failure
Call bioMérieux for assistance.
Card Transport System
Failure
2) Call bioMérieux if the problem recurs.
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1) See Resolving a Transport Halted Screen on page 8-6.
8-31
Using Error Message and Recovery Table
Troubleshooting the VITEK® 2 Instrument
Table 8-2: Error Message and Recovery Table (Continued)
Error Code
Recovery Procedure
Primary
Processing Error
(Cont.)
Secondary
Carousel Jam
1) Open the waste collection door and top-right access door.
2) Remove the incubator access cover. (Refer to Step 5 of the
procedure on page 7-12.)
3) Make sure that there is no card jammed between the reader
head and the carousel. If there is, push the card into the
carousel.
4) Make sure that there is no card jammed between the card
loader and the carousel. If there is, push the card back into the
cassette.
5) Install the incubator access cover. (Refer to Step 9 of the
procedure on page 7-18.)
6) Close the top-right access and waste collection doors.
7) Press Go on the Halt screen.
Note: If the Halt screen is not displayed, press Previous Screen
until it is.
8) Call bioMérieux if the problem recurs.
Cassette button memory
failure
1) Unload the cassette from the instrument.
2) Confirm that the instrument is in Smart Carrier Mode. If the
mode setting is correct, position the cassette back on the SCS
and verify that it can read the cassette.
3) If SCS cannot read the cassette, clean the contacts on the
button memory and place the cassette on the SCS. (See
Step 4 in the procedures on page 7-20.) If still not successful,
replace the button memory on the cassette and re-enter the
data on the Smart Carrier Station.
4) If the SCS reads the cassette properly, squeeze out an alcohol
wipe and then wipe the button memory contacts inside the
VITEK® 2 instrument. Re-insert the cassette into the
instrument.
5) If the problem recurs, call bioMérieux.
Note: If the instrument is in Cassette Only mode and this setting is
correct, reload the cassette immediately and the cassette will
process, ignoring information stored on the button memory.
8-32
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Using Error Message and Recovery Table
Table 8-2: Error Message and Recovery Table (Continued)
Error Code
Recovery Procedure
Primary
Processing Error
(Cont.)
Secondary
Dispenser Failure
1) Open the front access door and check for:
• proper installation of the accessory kit. (See Accessory Kit
installation procedure on page 7-4.)
• a sufficient quantity of saline in the bag
• tangles or pinches in the saline tubing
2) If needed, install a new accessory kit.
3) Perform the Dispenser/Pipettor diagnostic test. (See the
procedure on page 8-20.)
4) If the problem continues, call bioMérieux.
5) If the problem recurs, call bioMérieux.
General Failure
1) Press Previous Screen until either the Status screen or the
Halt screen is displayed.
2) If the Status screen is displayed, empty the waste collection
tray. (See page 6-32.) Also follow the procedure on page 8-23
to clean and test the optics.
3) If the Halt screen is displayed, open the waste collection door
and top-right access door.
4) Remove the incubator access cover. (Refer to Step 5 of the
procedure on page 7-12.)
5) Make sure that there is no card jammed between the reader
head and the carousel. If there is, push the card into the
carousel.
6) Make sure that there is no card jammed between the card
loader and the carousel. If there is, push the card back into the
cassette.
7) Install the incubator access cover. (Refer to Step 9 of the
procedure on page 7-18.)
8) Close the top-right access and waste collection doors.
9) Press Go on the Halt screen.
10)Call bioMérieux if the problem recurs.
Note: If any cards terminate and remain in the carousel, wait for
all cards to complete and then perform carousel cleaning. (See
the procedure Removing the Carousel for Cleaning on page 7-10
and the procedure Replacing the Carousel After Cleaning on
page 7-15.)
Grouping Error at Slot
The instrument has found a mated pair in which the test types do
not match. Mated pairs require Gram negative ID and AST cards,
or Gram positive ID and AST cards. Remove the cassette from
the instrument and replace the appropriate test card.
Inoculum source not
available for Slot
Refer to the procedure for Inoculum Errors on page 8-14.
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Using Error Message and Recovery Table
Troubleshooting the VITEK® 2 Instrument
Table 8-2: Error Message and Recovery Table (Continued)
Error Code
Recovery Procedure
Primary
Processing Error
(Cont.)
Secondary
Load Failure
1) If the instrument has not displayed the Halt screen, go to
Step 6 of this recovery procedure.
2) If the Halt screen is displayed, open the waste collection door
and top-right access door.
3) Remove the incubator access cover. (Refer to Step 5 of the
procedure on page 7-12.)
4) Check for a test card jam in the card loader (the mechanism
near the bottom of the carousel that pushes test cards from the
cassette into the carousel). Push any test cards that you find
back into the carousel.
5) Press Go on the Halt screen.
Note: If test cards remain in the carousel, you can allow them to
finish processing. You should not, however, load new cards into
the instrument until after you have completed this recovery
procedure.
6) After all test cards have finished processing, remove the four
carousel sections and remove any test cards that are found.
(See the procedure Removing the Carousel for Cleaning on
page 7-10, and the procedure Replacing the Carousel After
Cleaning on page 7-15.)
You cannot reprocess test cards after a Load Failure. Any test
cards found in the carousel in Step 6 must be discarded.
If the cards terminated immediately after loading, check for
obstructions throughout the transport system and perform the
Card Transport Test on page 8-19.
Pipettor Failure
1) Open the front access door and check for the presence of
pipette tips in the container.
2) If needed, install a new accessory kit. (See the procedure for
adding pipette tips on page 7-8.)
3) Check for the presence of pipette tips that may have fallen onto
the base pan, and remove them.
4) Perform the Dispenser/Pipettor diagnostic test. (See the
procedure on page 8-20.)
5) If the problem continues, call bioMérieux.
Process Jam
Refer to the Recovery Procedures for any messages that have
approximately the same date/time stamp.
Reader Error Occurred
Refer to the procedure on General Failure on page 8-33.
SCS and Bar Code Reader Follow the procedure for SCS and Bar Code Reader Conflict on
conflict at Slot
page 8-13.
8-34
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510731-10EN1
Troubleshooting the VITEK® 2 Instrument
Using Error Message and Recovery Table
Table 8-2: Error Message and Recovery Table (Continued)
Error Code
Recovery Procedure
Primary
Processing Error
(Cont.)
Secondary
SCS information has errors 1) Remove the cassette from VITEK® 2.
at Slot
2) Put the cassette on the SCS.
3) Press F10 to erase the data in the button memory.
4) Re-enter the data for the cassette.
SCS memory contains old 1) Make sure that the VITEK® 2 instrument is in the correct
cassette mode. (See procedure on page 5-5.)
information that has
previously been processed 2) If the problem still continues, call bioMérieux for assistance.
Unknown Card Type at
Slot
1) Make sure that the test card has been entered in the Flex
Panel Entry screen at the workstation computer.
2) Try processing the test card again.
3) If the problem recurs, call bioMérieux for assistance.
Unload Failure
1) Open the Waste Collection Station door and check for jams.
2) Empty the waste collection tray (See page 6-32).
3) Open the top-right access door.
4) Remove the incubator access cover. (Refer to Step 5 of the
procedure on page 7-12.)
5) Make sure that there is no card jammed between the reader
head and the carousel. If there is, push the card into the
carousel.
6) Make sure that there is no card jammed between the card
loader and the carousel. If there is, push the card back into the
cassette.
7) Install the incubator access cover. (Refer to Step 9 of the
procedure on page 7-18.)
8) Close the top-right access and waste collection doors.
If the problem recurs, call bioMérieux for assistance.
Vacuum System Failure
1) After all test cards have finished processing, clean the seal on
the vacuum chamber and all surfaces of the boat. (See page
7-28.)
2) Perform the vacuum test on the Instrument Diagnostics menu.
(See page 8-19.)
Processing
Warning
Cannot unload cards,
waste tray is full
Empty the test card waste collection tray. (See the procedure on
page 6-32.)
Cannot unload cards,
waste tray is not available
Reinstall the test card waste collection tray. (See the procedure
on page 6-32.)
VITEK® 2 Instrument User Manual
510731-10EN1
8-35
Using Error Message and Recovery Table
Troubleshooting the VITEK® 2 Instrument
Table 8-2: Error Message and Recovery Table (Continued)
Error Code
Recovery Procedure
Primary
Processing
Warning (Cont.)
Secondary
Cannot unload cards,
1) Open the Waste Collection Station door and check for jams.
waste tray is not functional 2) Empty the waste collection tray. (See page 6-30).
3) Call bioMérieux for assistance if the problem recurs.
Waste tray cannot hold the Empty the test card waste collection tray. (See procedure on
number of cards currently page 6-30; see also Waste Tray Warning Level on page 5-8.)
in the Carousel
No cards found
1) Unload the cassette from the instrument.
2) Check that the cassette contains a card.
3) Reload the cassette into the instrument.
Cassette Loading door is
open
Close the Cassette Load door. If the error recurs, call bioMérieux
for assistance.
Saline has been in use
longer than the
recommended time
The saline has been in the instrument longer than the specified
time. Replace the saline bag. (See procedure on page 7-4.)
Saline Level Low
Replace the saline bag. (See procedure on page 7-4.)
Tip Level Low
See procedure on Disposables Errors on page 8-17.
Tips have been in use
longer than the
recommended time
The pipette tips have been in the instrument longer than the
specified time. Install a new Accessory Kit. (See procedure on
page 7-8.)
Incubator cover is off
Open the top-right access door and replace or reseat the
incubator cover. (Refer to Step 9 of the procedure on page 7-18.)
Incubator Temperature
HIGH
Ensure that the ambient room temperature is below 30 °C. Wait
15 minutes and recheck. If the incubator temperature has not
returned to normal, call bioMérieux for assistance.
Test cards that are still processing in the carousel will be
terminated after this error occurs. A laboratory report will be
printed with the message:
CARD TERMINATED: Insufficient incubation time
for analysis.
For AST cards, any antibiotics that were finalized prior to the error
will be reported.
8-36
VITEK® 2 Instrument User Manual
510731-10EN1
Troubleshooting the VITEK® 2 Instrument
Using Error Message and Recovery Table
Table 8-2: Error Message and Recovery Table (Continued)
Error Code
Recovery Procedure
Primary
Processing
Warning (Cont.)
Secondary
Incubator Temperature
LOW
Ensure that the ambient room temperature is above 20 °C. Wait
15 minutes and recheck. If the incubator temperature has not
returned to normal, call bioMérieux for assistance.
Test cards that are still processing in the carousel will be
terminated after this error occurs. A laboratory report will be
printed with the message:
CARD TERMINATED: Insufficient incubation time
for analysis.
For AST cards, any antibiotics that were finalized prior to the error
will be reported.
Internal Instrument
Temperature is HIGH
Ensure that the ambient room temperature is below 30 °C. Wait
15 minutes and recheck. If the instrument temperature has not
returned to normal, call bioMérieux for assistance.
Insufficient slots to process Refer to procedures for Card Capacity Errors on page 8-16.
this cassette
You should check the Status screen before loading a cassette to
make sure you have a sufficient number of slots available.
Power Fail. System will
Normal processing will resume when power is restored.
park until power is restored See page 8-28 for description of how instrument handles power
failures.
The Uninterruptible Power
Supply has a Low Battery
Call bioMérieux for assistance if this error occurs when there is
not a power failure. (This would be a normal error during a power
failure.)
See page 8-28 for description of how instrument handles power
failures.
Instrument status is
cleaning
VITEK® 2 Instrument User Manual
510731-10EN1
The instrument did not detect one of the carousel sections. Refer
to Cleaning the Carousel on page 7-10.
8-37
Using Error Message and Recovery Table
8-38
Troubleshooting the VITEK® 2 Instrument
VITEK® 2 Instrument User Manual
510731-10EN1
APPENDIX A: HARDWARE SPECIFICATIONS
A
VITEK® 2 Instrument
Dimensions
Dimension
VITEK® 2
VITEK® 2 XL
Height
67 cm (26.3 in.)
67 cm (26.3 in.)
Width
100 cm (39.4 in.)
140 cm (55.1 in.)
Depth
71 cm (27.7 in.)
71 cm (27.7 in.)
Mass
VITEK® 2
Mass
Approximately 110 kg (240 lb.)
VITEK® 2 XL
Approximately 145 kg (320 lb.)
CAUTION: The VITEK® 2 instrument is heavy. Use at least two
people to move it. Lift handles are provided at each end of the
instrument.
VITEK® 2 Instrument User Manual
510731-10EN1
A-1
VITEK® 2 Instrument
Appendix A: Hardware Specifications
Environment
Note:
The specifications below apply to both the VITEK® 2 and the VITEK® 2 XL.
Indoor usage
Do not install in direct sunlight
Benchtop should be level within 2°
Minimum of 5 cm (2 in) clearance on all sides for adequate ventilation; 50 cm
(20 in) above
Minimum installation altitude: –100m
Maximum installation altitude: 2000m
Ambient room temperature: 20 °C to 30 °C
Shipment and storage temperature: –20 °C to +50 °C
Relative humidity: 20% to 80% non-condensing
Pollution degree 2 in accordance with IEC 664
Overvoltage Category II per IEC 664
A-2
VITEK® 2 Instrument User Manual
510731-10EN1
VITEK® 2 Instrument
Appendix A: Hardware Specifications
Electrical Characteristics
Electrical
Characteristics
Input voltage
VITEK® 2
VITEK® 2 XL
200/240 VAC at 50/60 Hz
200/240 VAC at 50/60 Hz
100/120 VAC at 50/60 Hz
100/120 VAC at 50/60 Hz
Maximum input current
4 amps @ 120 VAC or 2 amps @
240 VAC
5 amps @ 120VAC or 2.8 amps @ 240
VAC
Nominal input current
1.5 amps @ 120 VAC or 0.75 amps @
240 VAC
2.75 amps @ 120 VAC or 1.75 amps @
240 VAC
Power
150 watts nominal, 471 watts peak
200 watts nominal, 569 watts peak
Heat
512 BTU/HR (nominal)
682 BTU/HR (nominal)
Power cord
Detachable 3-wire with ground,
per IEC 227 or IEC 245
Detachable 3-wire with ground,
per IEC 227 or IEC 245
Optical Characteristics
Note:
The specifications below apply to both the VITEK® 2 and the VITEK® 2 XL.
Transmittance Optics
Emission wavelengths: 660 nm, 568 nm, 428 nm LED
Percent transmission range: 30% to 100% ± 10%
VITEK® 2 Instrument User Manual
510731-10EN1
A-3
VITEK® 2 Instrument
Appendix A: Hardware Specifications
General Characteristics
Note:
The specifications below apply to both the VITEK® 2 and the VITEK® 2 XL.
Cassette
Capacity, cassettes: 4 cassettes maximum
Capacity, cards: 15 cards per cassette
Dispenser
Dispensing volume: 2.33 – 2.63 mL
Capacity: 1000 mL, user replaceable
Pipettor
Dispensing volume: 60 μL to 300 μL ± 5% or ± 5 μL, whichever is greater
Pipettor drum capacity: 330 pipette tips minimum, user replaceable
Vacuum (Filler)
Minimum level: 0.89 PSIA ± 0.06 PSIA
Sealer
Mechanical: stub length 0.025 mm to 2.5 mm
Incubator
Temperature: 35.5 °C ± 1 °C average
Capacity: 60 cards per Incubator
A-4
VITEK® 2 Instrument User Manual
510731-10EN1
GLOSSARY
Access Doors VITEK® 2
VITEK® 2 has six doors to enable the operator to access the
internal systems and stations to replenish supplies and
perform maintenance and cleaning procedures: top access
door, saline access door, front access door, bottom access
door, cassette load (and unload) door, and waste collection
access door.
Access Doors VITEK® 2
XL
VITEK® 2 XL has nine doors to enable the operator to access
the internal systems and stations to replenish supplies and
perform maintenance and cleaning procedures: top access
door section A, top access door section B, saline access door,
front access door, front center sliding door, bottom access
door, cassette load (and unload) door, and 2 waste collection
access doors.
Accession/Lab ID
The Accession ID is a unique identifier that associates a
patient culture to a test card in the VITEK® 2 system. The
Accession ID, which can contain up to 20 alphanumeric
characters, is followed by a dash and a single-digit isolate
number. Accession ID is the same as Lab ID.
Accessory Kit
Supplied by bioMérieux, the accessory kit contains the tubing,
disk filter, and shot tube for the Dispenser station, and a
container of pipette tubes.
Aliquot
A calculated unit of saline (see Dispenser/Pipettor) used with
the organism culture to inoculate into the test card.
Antimicrobial
Susceptibility Testing
(AST)
Testing the susceptibility of certain bacteria to known antibiotic
concentrations. VITEK® 2 helps the diagnostician determine
the best medical treatment for the patient’s specific strain of
microorganism tested.
Analytical System
Located in a portion of the instrument called the Reader/
Incubator station, it consists of the carousel, and two optics
systems. The transmittance optics system indirectly measures
organism growth as a function of decreasing light
transmittance.
Automatic Dilution
Mode
One of two possible settings for the Dilution Mode
configuration on the VITEK® 2 instrument. In Automatic
Dilution mode, AST suspensions are diluted by VITEK® 2. In
Pre-diluted mode, the user prepares AST suspensions prior to
loading test cards on the instrument.
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510731-10EN1
Glossary-1
Glossary
Bar Code
An alphanumeric interface identifier label affixed to each
VITEK® 2 test card. The bar code contains the card’s test type,
lot number, and expiration date, which is entered either by the
SCS subsystem by bar code wanding, or when the test card’s
bar code label is read by the bar code reader inside of the
VITEK® 2 instrument.
Boat
The tray-like device that carries the cassette around the
instrument. It forms the bottom of the vacuum chamber and
helps to capture any spills. It is removable for cleaning.
Button Memory
A Button Memory is a microchip located in a clip underneath
the Cassette that stores test card information that is entered at
the Smart Carrier Station. During the entry cycle of processing,
the data is transferred to the workstation computer by the
button memory reader.
Button Memory Reader
A magnetic data storage device that reads the button memory
and sends data entered at the Smart Carrier Station to the
VITEK® 2 workstation computer.
Cannula
A small tube located in the saline dispensing chamber that is
inserted into the saline bag. Also known as the “bag spike”.
Card Transport System
Moves the test cards among the stations within the VITEK® 2
instrument. It consists of the cassette tray, boat, cassette
loading and unloading station, electromechanical arms, card
ejectors, and the waste collector station.
Carousel
The rotating incubator section, which holds up to 60 test cards
per incubator.
Cassette
The cassette is a card and test tube carrier that holds up to 15
tests. It is used for sample preparation and processing inside
the instrument. It can contain a button memory chip that is
used to transfer information from the Smart Carrier Station to
the VITEK® 2 Workstation computer.
CPU
Central Processing Unit, the electronics of the personal
computers and workstations.
Dispenser
Dispenses 2.5 mL of 0.45% saline into an empty susceptibility
card test tube. This system includes a saline dispensing
system, 1,000 mL bag of sterile saline and a “fixed volume”
saline dispenser tube.
Glossary-2
VITEK® 2 Instrument User Manual
510731-10EN1
Glossary
Dispenser/Pipettor
Transfers and mixes the appropriate inoculum volume
predetermined by the test card bar code (60 µL to 300µL - see
Aliquot) to adjacent susceptibility tubes. The system includes a
container for pipette tips, a displacement pump, and various tip
mechanisms.
Disposables
VITEK® 2 disposables are pipette tips, sterile saline, test
cards, and inoculum tubes.
Disposable supplies are biohazardous after use and must be
discarded according to local laws regarding biohazardous
material. They should not be recycled or disposed of with
normal trash, etc.
Filler Station
This station inoculates all of the cards in a cassette with the
suspension contained in their corresponding test tubes. It
utilizes a vacuum chamber and air pump.
Incubator
The incubator contains a heater and a circulating fan used to
incubate the cards during test. The temperature is monitored
and controlled through the use of two remote precision
thermistors monitored by a microprocessor holding the card at
an average temperature of 35.5 °C.
Instrument Bar Code
Reader
This station reads the bar code label on each VITEK® 2 test
card within the first minute after the test cards are read, and
transfers all of the test card bar code data to the VITEK® 2
Workstation computer.
Job Aid Card
A laminated card containing frequently used functions that can
be used as a quick reference tool. There is one Job Aid Card
for the Smart Carrier Station, and another for the VITEK® 2
Instrument.
LED
Light emitting diode, a light emitting device used in optical
displays (and such consumer products as microwave ovens
and digital clocks). Also see Transmittance Optics.
Pre-diluted Mode
One of two possible settings for the Dilution Mode
configuration on the VITEK® 2 instrument. In Pre-diluted
mode, the user prepares AST suspensions prior to loading test
cards on the instrument. See Automatic Dilution Mode.
Saline Dispenser Tube
A “fixed volume” chamber used to measure and dispense
2.5 mL of saline into a susceptibility tube.
Sample Preparation
Stations
This multi-function VITEK® 2 system consists of several
stations: Bar Code Reader, Button Memory Reader,
Dispenser/Pipettor, Filler, and Sealer.
VITEK® 2 Instrument User Manual
510731-10EN1
Glossary-3
Glossary
SCS Base Unit
See Smart Carrier Station (SCS).
Sealer Station
This station, a part of the Sample Preparation System, seals
each test card by cutting and sealing its associated inoculum
transfer tube with a hot wire.
Smart Carrier Station
(SCS)
A laptop computer-like device used to aid in setting up the test
and for entering test information. It consists of the base unit
(computer) with LCD display, bar code scanner, and the
keyboard (slides under base unit).
The system is optional, and offers many productivity and
security features for the user. It has user-configured modes for
automatic dilution for matching ID and AST Test cards.
Test Card
A 3.5 by 2.25 in. (76.2 by 49.45 mm) cassette card with 64
growth wells for biological testing in the VITEK® 2 system.
Each well contains an air-dried suspension of a biochemical or
antimicrobial used to identify microorganisms or to test their
susceptibility pattern.
Transmittance Optics
A combination of light-emitting diodes (emitters) and
photodiodes used to read the growth results in the card wells.
User Interface (UI)
The portion of the VITEK® 2 system in which the user and the
system’s software interact. The system has three user
interfaces:
Workstation computer, consisting of a monitor, keyboard, and
mouse.
VITEK® 2 instrument, consisting of a keypad and screen.
Smart Carrier Station, consisting of a keyboard and screen.
Waste Collection
Station
Once testing is complete, cards are stacked in a tray for
disposal.
Workstation Computer
The workstation computer is the primary processor used in
calculating test results. The workstation can also be used as a
means to interface the VITEK® 2 system with a central
laboratory or hospital computer system.
The workstation computer provides the user with the graphical
interface used with the mouse pointing device and workstation
monitor, and a text interface for the keyboard.
Glossary-4
VITEK® 2 Instrument User Manual
510731-10EN1
INDEX
A
Bar code scanner, SCS 2-7, 6-9, 6-16
Base pan, cleaning 7-28
Access doors 4-4
Base unit, SCS 2-9
Accession/Lab ID Field 6-18
Batch load 6-28
Accessories kit 7-4
installing 7-4–7-10
Batch loading 6-28
Address, cassette 6-21, 6-27
Boat 4-8
Alarm, audible 5-6, 8-4
enabling 5-11
setting volume of 5-12
Button memory
cleaning 7-21–7-23
removing 7-21
removing from a cassette 7-19
Alarm, error 8-4
Alarm, visual 5-7, 8-4
enabling 5-11
Altitude
acceptable operating range A-2
AST Card
card, matching with ID 6-10
dilution mode options 3-5
positioning in cassette 6-18, 6-24
Audible alarm 5-6
enabling 5-11
setting volume of 5-12
Button Memory Reader 4-10
C
Card
AST, matching with ID 6-10
Card capacity errors 8-16
ejected, removal of 6-31
ejector station 4-16
monitoring processing of 6-20, 6-27
Card capacity of the instrument 6-4
Card processing, monitoring 6-20, 6-27
Audible Feedback Volume 5-7
Card type field 6-11
Automatic QC report, scheduling 5-10
Carousel 4-15
cleaning 7-10–7-18
removing 7-10
B
Bar code
entering manually 8-17
information contained within 4-9
Bar code reader 5-6
enabling 5-11
instrument 4-9
load errors 8-11
working without 8-17–8-18
Cassette 4-6, 6-10
cleaning 7-19
data entry without a SCS 6-27
errors in loading 8-10–8-15
loading into the instrument 6-19–6-20, 6-25–6-
27
loading/unloading station 4-7, 6-26
unloading 6-30
Cassette address 6-21, 6-27
Cassette Erase 3-5
Cassette icon 6-6
Cassette Loading Station 4-7
indicator light 6-19
using 6-19, 6-26
Cassette mode 5-5
setting 5-11
VITEK® 2 Instrument User Manual
510731-10EN1
Index-1
Index
status screen indicator for 6-5
Cassette name
defining 5-9
Dispenser station 4-11
on the status screen 6-5
selecting in cassette setup function 6-25
Dispenser/Pipettor Station 4-11
Displaying version info 8-28
Cassette setup function, using 6-24
Disposables 7-3–7-10
changing 7-4–7-10
load errors 8-17
monitoring 6-6, 7-3
Cassette worksheet 6-22
Caution, definition of 1-5
Changing
pipette tips 7-8–7-10
saline 7-4
Documentation for VITEK® 2, overview 1-2
Doors, access 4-4
Character sets, defining for cassette or
instrument name 5-9
Drip pan
cleaning 7-29–7-31
Cleaning
base pan 7-28
boats 7-21–7-24
carousel 7-10–7-18
cassettes 7-19–7-21
drip pan 7-29–7-31
instrument 7-24–7-25
optical diagnostic test 8-26
optics (normal maintenance) 7-26
optics (with cards processing) 8-23
vacuum seal 7-28
E
Ejector station, card 4-16
Enabling
audible alarm 5-11
bar code reader 5-11
visual alarm 5-11
Error
bar code read 8-11
cassette load 8-10
disposables 8-17
inoculum 8-14
instrument capacity 8-16
message and recovery table 8-29
types 8-4
using the status screen 8-4
what to do 8-3–8-10, 8-29
Configuration options, instrument 5-2
effects on the instrument 5-2–5-8
how to set 5-8–5-12
using option boxes in 5-11
Configuration options, SCS
how to set, SCS 3-3
Configuration screen, SCS 3-2
Error handling system 8-3–8-10
Connections
instrument 4-4
Contrast, screen 5-7
setting 5-12
D
External controls
Instrument 4-4
F
Filler station 4-13
cleaning the vacuum seal 7-28
Data entry, cassette 6-17
without a SCS 6-27
Data fields, SCS 6-11
Date, SCS, setting 3-8
Defining
cassette or instrument name 5-9
Dilution mode 3-5, 5-5, 6-5
changing in cassette setup function 6-24–6-25
setting on the instrument 5-11
Index-2
Function keys, SCS 6-13
H
Help (?) Key 4-19
Humidity
acceptable operating range A-2
VITEK® 2 Instrument User Manual
510731-10EN1
Index
I
Keypad, instrument 4-18
Icons, status screen 6-5
ID card
L
Language, SCS interface, setting 3-7
matching with AST 6-10
Indicator light, Cassette Loading Station 6-19
Light, indicator, Cassette Loading Station 6-19
Inoculum errors 8-14
Load errors, cassette 8-10
Instrument
Loading a cassette 6-19–6-20, 6-25–6-27
bar code reader 5-6
card capacity 6-4
cleaning 7-24–7-25
connections 4-4
diagnostic tests 8-19
error handling system 8-3–8-10
external controls 4-4
QC Status 5-4
restarting 8-29
screen 4-18
shut down 7-25
specifications A-1–A-4
status 6-3
temperature, checking 8-19
Loading station. See Cassette Loading Station.
Loading, batch 6-28
Lost Communication icon 6-6
Low Battery icon 6-6
M
Matching, AST and ID cards 6-10
Menu system 6-7–6-9
Modifier field 6-12
option box 6-16
Monitoring
card processing 6-20, 6-27
disposables 6-6, 7-3
Instrument Halted Screen 8-5
Instrument icon 6-6
Instrument name 5-3
defining 5-9
Isolate number field 6-11
N
Name
cassette, defining 5-9
instrument 5-3
instrument, defining 5-9
station, setting 3-3
K
Key
Help (?) 4-19
previous screen 6-9
SCS function 6-13
undo 4-19
Keyboard
SCS 2-8
Keyclick volume 5-7
setting 5-12
Non Standard Card Reading mode 6-4
status screen indicator for 6-4
Note
definition of 1-5
O
Offline tests field 6-11
option box for 6-14
Optical diagnostic test 8-26
Optics 4-16
cleaning (normal maintenance) 7-26
cleaning (with cards processing) 8-23
diagnostic test 8-26
transmittance 4-16
troubleshooting 8-23
VITEK® 2 Instrument User Manual
510731-10EN1
Index-3
Index
Option boxes, SCS 6-14
Option buttons 6-9
Organism ID field 6-11
option box 6-14
P
Pipette tips, changing
See also Disposables 7-8
Pipettor station 4-12–4-13
Power Fail icon 6-6
Power failures 8-28
Previous screen key 6-9
Q
configuration options, setting 3-3
configuration screens 3-2
data entry 6-17
data fields 6-11
function keys 6-13
keyboard 2-8
name 6-10
name, setting 3-3–3-4
option boxes 6-14–6-16
parts 2-6
processing cards with 6-16
slot indicator 6-12
starting 2-9
using 6-9
workflow description 6-17
working without 6-21
Sealer station 4-14
QC status 5-4
scheduling an automatic report 5-10
setting time for 5-10
R
Reader
instrument bar code 4-9
Removing
boats 7-21
button memory from a cassette 7-19
carousel 7-10
drip pan 7-30
ejected card 6-31
waste collection tray 4-17
Setting
audible alarm volume 5-12
cassette mode 5-11
date, SCS 3-8
dilution mode 5-11
dilution mode, SCS 3-5
keyclick volume 5-12
screen contrast 5-12
SCS interface language 3-7
station name 3-3
time for QC status 5-10
time, SCS 3-8
Shutting down the instrument 7-25
Slot indicator, SCS 6-12
Smart Carrier Station. See SCS
Standard Symbols
use in manual 1-5
S
Saline, changing. See also Disposables. 7-4
Starting the SCS 2-9
Scanner, SCS bar code 2-7, 6-16
Station name (SCS), setting 3-3
Scheduling QC status 5-10
Station, instrument
bar code reader 4-9
card ejector 4-16
Screen
contrast 5-7
instrument 4-18
instrument status 6-3
Screen contrast setting 5-12
SCS configuration, accessing 3-3
SCS
advantages of using 6-9
bar code scanner 2-7, 6-16
base unit 2-9
Index-4
cassette loading/unloading 4-7
dispenser 4-11
filler 4-13
pipettor 4-11
sealer 4-14
waste collection 4-17, 6-30
Status
instrument 6-3
VITEK® 2 Instrument User Manual
510731-10EN1
Index
QC 5-4
Status screen 6-3, 7-3
icons 6-5
in an error condition 8-4
with messages 8-8
System Requirements 2-9
T
W
Warning
definition of 1-5
general warnings -i
Waste collection station 4-17
Waste removal 6-30
Waste Tray Warning Level 5-8
Temperature
checking instrument 8-19
operating range A-2
shipping and storing the instrument A-2
Test cards See also the VITEK® 2 Product
Information. 1-2
Workflow
and cassette load errors 8-11
with an SCS 6-17
without a SCS 6-21
Worksheet, cassette 6-22
Time
QC status, setting 5-10
SCS, setting 3-8
Transmittance optics
cleaning 7-26
Transport Halted Screen 8-6
Tray, waste collection 6-30
Troubleshooting error messages 8-29
Typographic conventions 1-3
U
Undo Key 4-19
Unloading a cassette 6-30
Unpacking 2-2
V
Vacuum seal, cleaning 7-28
Version information 8-28
Visual alarm 5-7
enabling 5-11
VITEK® 2 Instrument. See Instrument.
VITEK® 2 Product Information 1-2
Volume
audible alarm 5-6
audible alarm, setting 5-12
keyclick 5-7
keyclick, setting 5-12
VITEK® 2 Instrument User Manual
510731-10EN1
Index-5
Index
Index-6
VITEK® 2 Instrument User Manual
510731-10EN1
NOTES
VITEK® 2 Instrument User Manual
510731-10EN1
Notes-1
Notes
Notes-2
VITEK® 2 Instrument User Manual
510731-10EN1
Notes
VITEK® 2 Instrument User Manual
510731-10EN1
Notes-3
Notes
Notes-4
VITEK® 2 Instrument User Manual
510731-10EN1
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