BioMerieux VITEK 2 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

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

EC REP

[04]

iManual Name

702358-4EN1 REV nn/nnnn

Argentina

bioMérieux Argentina

Av. Congreso 1745

C1428BUE

Capital Federal Buenos Aires

tel. (54) 11 5555 6800

fax (54) 11 5555 6888

Australia

bioMérieux Australia P/L

Unit 25 - Parkview Business Centre

1, Maitland Place

Baulkham Hills NSW 2153

tel. (61) 2 8852 4700

fax (61) 2 8852 4777

Austria

bioMérieux Austria GmbH

Eduard-Kittenberger-Gasse 97

Top 3

A-1230 Wien

tel. (43) 186 50 650

fax (43) 186 50 661

Belgium

bioMérieux Benelux s.a./n.v.

Media Square

18–19 Place des Carabiniers

Bruxelles 1030

tel. (32) 2 743 01 70

fax (32) 2 733 55 97

Brazil

bioMérieux Brasil SA

Estrada Do Mapuá

491 Taquara - Jacarepaguá

CEP 22710 261

Rio de Janeiro RJ

tel. (55) 21 2444 1400

fax (55) 21 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

bioMérieux China Limited

Room 2605, South Tower,

World Trade Center

371-375 Huan Shi Dong East Road

510095 Guangzhou

tel. (86) 20 8762 7010

fax (86) 20 8762 7015

Colombia

bioMérieux Colombia Ltda

Avenida 15 No. 100-43

Piso 2

Bogotá, D.C.

tel. (57) 1 520 0080

fax (57) 1 520 0088

(57) 1 520 0831

Czech Republic

bioMérieux CZ s.r.o.

Business Park Kosice

Jinonická 80

158 00 Praha 5

tel. (420) 2 57 290 623

(420) 2 57 290 232

fax (420) 2 57 290 964

Denmark

bioMérieux Danmark Aps

Smedeholm 13C

2730 Herlev

tel. (45) 70 10 84 00

fax (45) 70 10 84 01

Finland

bioMérieux Suomi Oy

Konalantie 47 C

FI-00390 Helsinki

tel. (358) 9 8545 6000

fax (358) 9 8545 6045

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 ii

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

Philippines (The)

Representation Office

bioMérieux Philippines

11th Floor, Pearlbank Centre

146 Valero Street, Salcedo Village

1227 Makati City

tel. (632) 817 7741

fax (632) 812 0896

Poland

bioMérieux Polska Sp. Z.o.o.

Ul. Zeromskiego 17

01-882 Warsaw

tel. (48) 22 569 85 00

fax (48) 22 569 85 54

Portugal

bioMérieux Portugal, Lda.

Av. 25 de Abril de 1974, nº 23-3º

2795-197 LINDA-A-VELHA

tel. (351) 21 415 23 50

fax (351) 21 418 32 67

Russia

o.o.o. bioMérieux

Derbenevskaya ul. 20, str. 11

115 114 Moscow

tel. (7) 495 221 10 79

fax (7) 495 221 10 79

Spain

bioMérieux España S.A.

Manual Tovar, 45–47

28034 Madrid

tel. (34) 91 358 11 42

fax (34) 91 358 06 29

Sweden

bioMérieux Sverige AB

Hantverksvägen 15

436 33 Askim

tel. (46) 31 68 84 90

fax (46) 31 68 48 48

Switzerland

bioMérieux Suisse s.a.

51, avenue Blanc

Case postale 2150

1211 Genève 2

tel. (41) 22 906 57 60

fax (41) 22 906 57 42

Taiwan

Representation Office

bioMérieux China Limited

Taiwan Branch

RM 608, No. 6-3 Ching Cheng Street

Taipei 105

tel. (886) 2 2545 2250

fax (886) 2 2545 0959

Thailand

bioMérieux Thailand Ltd

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

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.

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.

Manual Name i

702357-3EN1 REV nn/nnnn

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

Standard Symbols

ii Manual Name

702357-3EN1 REV nn/nnnn

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

Manual Name iii

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

Standard Symbols

iv Manual Name

702357-3EN1 REV nn/nnnn

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)

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