bioMerieux DENSIMAT User Manual

Ref : 99535 Version C

Manuel d'utilisation DENSIMAT

DENSIMAT User's Manual

Gebrauchsanweisung DENSIMAT

Manuale d’Uso DENSIMAT

Manual de usuario DENSIMAT

Manual de utilização DENSIMAT

bioMérieux S.A. 69280 Marcy l'Etoile / France

Tel. 33 (0)4 78 87 20 00 - Fax 33 (0)4 78 87 20 90

http://www.biomerieux.com

Printed in France / 673 620 399 RCS Lyon

English

DENSIMAT

User's Manual

Revisions

The list of revisions below summarizes replacements or additional pages in the DENSIMAT User's Manual.

Version Date of printing Modifications Page(s) modified

A 10/95 Creation All

B rev. 09.03 09/03 CE marking All

C 03/07 Insertion of an addendum in the section

"Environment".

Deletion of information concerning the

2.5 ml ampoules.

Addition of a message concerning recycling of waste.

3-1

7-1 and 8-1

General Warnings

4501-1584 A en

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 Center 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 Mapua 491 Taquara - Jacarepaguá CEP 22710 261 Rio de Janeiro R.J Rio de Janeiro R.J tel. (55) 21 2444 1400 fax (55) 21 2445 6025

Canada

bioMérieux Canada, Inc. 7815, Henri-Bourassa West Saint Laurent, QC H4S 1P7 tel. (1) 514 336 7321 fax (1) 514 807 0015

Chile

bioMérieux Chile S.A. Seminario 131 Providencia Santiago tel. (56) 2634 20 92 fax (56) 2634 20 93

China

bioMérieux China Limited

Room 1601-02B & 10 Est Ocean Centre n° 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 / 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 S.A. 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.

Fóti út. 56 (5th Floor) 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) 0 6 523081 fax (39) 0 6 52308240

Ivory Coast

bioMérieux Afrique Occidentale

08 BP 2634 Abidjan 08 tel. (225) 22 40 93 93 / (225) 22 40 41 40 fax (225) 22 40 93 94

Japan

bioMérieux Japan, Ltd

Seizan Bldg., 12-28 Kita-Ayoama 2-chome Minato-ku, Tokyo 107-0061 tel. (81) 3 5411 87 11 fax (81) 3 5411 87 10

Korea

bioMérieux Korea Co., Ltd

st

1

& 2nd Floor, Yoosung Building # 830-67 Yoksam-dong, Kangnam ku Seoul 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

22/10 Airbourne Road North Harbour Auckland tel. (64) 9 415 0601 fax (64) 9 415 0603

Norway

bioMérieux Norge AS

∅kernveien 145 N - 0513 Oslo tel. (47) 23 37 55 50 fax (47) 23 37 55 51

Philippines (The)

Representation office

bioMérieux Philippines Rep. Office 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.

Rua Alto do Montijo, Lotes 1 e 2 - Portela de Carnaxide 2794-070 Carnaxide tel. (351) 21 424 59 80 fax (351) 21 418 32 67

Russia

o.o.o. bioMérieux

Petrovsko-Razoumovskii proyezd, 29 127287 Moscow tel. (7) 495 777 27 09 fax (7) 495 777 27 08 / (7) 495 214 95 41

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

Distribution in over 130 countries

Thaïland

bioMérieux Thaïland Ltd

Regent House Bldg, 16 th 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 20 00 fax (1) 919 620 22 11

Vietnam

Representation office

bioMérieux Vietnam Rep. Office

Room 4A, 4th Floor Green House Building 62A Pham Ngoc Thach Street, Ward 6 District 3 Ho Chi Minh City tel. (84) 88 209 906 fax (84) 88 209 905

4501-1576-C en

This manual is periodically updated. The updates shall be included in the new releases of the Software.

Information supplied in this manual may be subject to modifications before the products described become available.

This manual may contain information or references relating to certain bioMérieux S.A. products, software or services which are not available in the country of release; this shall not mean that bioMérieux S.A. intends to market such products, software or services in such country

To request copies of publications or for any technical request, contact bioMérieux S.A. or your local distributor.

Liability disclaimer

THIS MANUAL IS PROVIDED "AS IS" WITHOUT ANY WARRANTY, EITHER EXPRESS OR

, OF MERCHANTABILITY, SAFETY, QUALITY, ACCURACY OR THE PERFORMANCE OF

IMPLIED PRODUCTS DESCRIBED IN THIS MANUAL WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE INFRINGEMENT OF THIRD PARTIES

In no event shall bioMérieux S.A. be liable for any direct, consequential, incidental or indirect damage or consequence related to, arising out of or in connection with, any use of this manual and/or its results by the User and/or any third party.

In no event shall this manual be construed as an undertaking of bioMérieux S.A. bioMérieux S.A. reserves the right to modify this manual without notice and shall incur no liability as a result of such modification.

This manual is provided for information purposes only.

. IN ADDITION, THERE SHALL BE NO IMPLIED

, NOR NON

' INTELLECTUAL PROPERTY RIGHTS.

Intellectual Property

bioMérieux S.A. is the sole owner of copyright, patrimonial rights and any other intellectual property rights in and to this manual and its content, except for the potential third parties' rights.This manual and its content are protected under the p r o v i s i o n s o f s e c t i o n L . 111-1 a n d f o l l o w i n g a r t i c l e s o f t h e F r e n c h I n t e l l e c t u a l P r operty Code and International Copyright and Author Rights Treaties.

The rights to use this manual granted herein are non-exclusive and limited to the extent necessary to use the Software and Instrument. In no event shall the Users be granted any other right to use this manual including without limitation, the right to reproduce, represent, adapt or translate all or part of this manual by any means whatsoever without the prior written consent of bioMérieux S.A.

Any use of this manual other than expressly permitted hereunder may be prosecuted.

IMPORTANT!

USE OF THIS MANUAL CONSTITUTES ACCEPTANCE OF THE TERMS AND CONDITIONS SET FORTH HEREIN.

bioMérieux, the blue logo API, and ATB are used, pending and/or registered trademarks belonging to bioMérieux SA or one of its subsidiaries.

PANASONIC is a used, pending and/or registered trademark belonging to Matsushita Electric Industrial Co. Ltd. Corporation.

General Warnings

DANGER! All biological fluids should be considered as potentially infectious.

Protective gloves must be worn when manipulating blood, products

derived from blood or objects contaminated with blood.

Qualified laboratory personnel should use acceptable procedures for

biohazardous material.

IMPORTANT! The user is advised to read and understand all instructions in this manual

to be able to derive the best performance from the DENSIMAT.

The accuracy of results obtained with this instrument depends, in particular, on the maintenance operations described in this manual.

The user should be aware that if the maintenance operations are not performed, are only partially performed, or are not performed as described in this manual, bioMérieux S.A. is in no case liable for any false test results obtained.

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 it will not prevent DENSIMAT from operating correctly.

WARNING! This product complies with the directives and standards mentioned in the

certificate supplied with it. Its design enables it to be operated in a residential, commercial or “light industrial” environment and provides reasonable protection against electromagnetic interference.

This equipment generates, uses and can radiate radio frequency energy, and, if not installed in accordance with the instruction manual, may cause harmful interference to radio communications.

We recommend that you observe the different warnings inscribed on the instrument itself and indicated in the documentation supplied

WARNING! Changes to the equipment not expressly approved by bioMérieux S.A.

could void the user’s authority to operate the equipment. The user will be required to repair damage at his own expense.

bioMérieux S.A. is in no case liable for any damage that may arise from failure to comply with technical specifications in this manual, from the handling of biological fluids or any operation conducted on the equipment not in compliance with these mandatory standards.

WARNING! This statement only applies to the EC and instruments bearing the

symbol with regard to the waste electrical and electronic equipment.

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 that you contact bioMérieux to assure for its appropriate disposal.

To guarantee the safety of personnel involved in dismantling this equipment prior to recycling, it is imperative to decontaminate all the surfaces, including those which are difficult to reach, in accordance with the applicable principles of good laboratory practice.

, even if it is decontaminated. It is imperative

Table of contents

List of figures II -1

How to use this manual 1-1

1

Finding topics and procedures ................................................................................................................ 1-2

Typographic conventions ........................................................................................................................ 1-3

Graphic symbols ..................................................................................................................................... 1-4

2 Description and use 2-1

3 Technical specifications 3-1

4 Principle 4-1

5 Unpacking and repacking 5-1

6 Installation 6-1

Kit contents ............................................................................................................................................. 6-1

Location .................................................................................................................................................. 6-1

Electrical adjustment............................................................................................................................... 6-2

Autonomy of batteries ............................................................................................................................. 6-2

7 Procedure 7-1

Adjusting the inoculum............................................................................................................................ 7-1

Precautions for use ................................................................................................................................. 7-2

8 Verification of the accuracy 8-1

9 Cleaning DENSIMAT 9-1

Cleaning.................................................................................................................................................. 9-2

10 Maintenance 10-1

11 Glossary 11-1

12 Index 12-1

User's Manual DENSIMAT I-1

List of figures

Note : Screen captures and figures are given as examples only.

4. Principle

Fig. 4-1: DENSIMAT reading principle.................................................................................................... 4-2

Fig. 4-2: DENSIMAT display panel ......................................................................................................... 4-3

9. Cleaning DENSIMAT

Fig. 9-1: Preparing the cleaning device................................................................................................... 9-3

User's Manual DENSIMAT II-1

1 How to use this manual

Introduction

This manual includes chapters which cover the description, installation, preparation prior to use, use and maintenance of the DENSIMAT

CAUTION! The user is advised to read and understand all the instructions in this

manual to be able to derive the best performance from the DENSIMAT.

.

User's Manual DENSIMAT 1-1

How to use this manual

Finding topics and procedures

To help you find the information you want, this manual is divided into 12 chapters.

− The first 10 contain the topics and procedures.

− Chapter 11 is the Glossary of technical terms.

− Chapter 12 is the Index.

Table of contents

List of figures

Graphic symbols

Page headers and page footers

Glossary

Index

The main table of contents of the manual is located on page I-1. It lists each chapter and the procedures and/or topics contained in the manual.

Page II-1 contains a list of the figures in this manual.

The standard symbols used for our instruments and their meanings can be found on pages 1-4 and 1-6.

Apart from the first page of every chapter, each page of this manual includes a page header and a footer.

Each page header includes the chapter title and the title of the procedure or its corresponding description.

The footers contain the title of the manual, the name of the product and the page number.

The glossary is located in chapter 11. It gives the definition of the main technical terms used in the manual.

The index is located in chapter 12 at the back of the manual. It is used to locate a particular description or procedure.

1-2 User's Manual DENSIMAT

How to use this manual

Typographic conventions

• Type

Following are the terms and visual cues used in this manual to aid in your understanding of the procedures.

The bullet point is used to denote an action to be performed.

1

2

3

User's Manual DENSIMAT 1-3

4

5

How to use this manual

Graphic symbols

4501-1582 A en

The standard symbols used for the bioMerieux systems and their meanings can be found below:

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 (power supply)

OFF (power supply)

ON" (only for a component of the system equipment)

1-4 User's Manual DENSIMAT

How to use this manual

Graphic symbols

"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)

Rrisk of electric shock

i

LOT

Caution, consult accompanying documents

High temperature

Potential pinch point

Biological risks

Consult Instructions for Use

Batch code

1

2

3

or REF

EC REP

User's Manual DENSIMAT 1-5

Catalogue number

Temperature limitation

Authorised Representative in the European Community

Keep dry

4

5

How to use this manual

Graphic symbols

IVD

SN or SN

Manufacturer

Date of manufacture

In Vitro Diagnostic Medical Device

Serial number

Keep away from magnetic field

Separate collection for waste electrical and electronic equipment

1-6 User's Manual DENSIMAT

2 Description and use

DENSIMAT is designed to measure the optical density of a bacterial inoculum produced in an ampoule of liquid medium.

It gives values in McFarland units, proportional to the average values of bacterial concentrations obtained with Gram-negative rods isolated from clinical specimens.

Only tests.

Measurement of the density can be performed in an ampoule of distilled water (Suspension Medium), saline solution (NaCl 0.85% Medium), or in the liquid media included with the strips:

API 20 A Medium, API STAPH Medium, API 50 CH Medium, API 50 CHB

Medium, DENSIMAT Is designed for use in laboratories by specially trained

technologists.

®

API

or ATBTM ampoules should be used as they undergo quality control

API 50 CHL Medium, API 50 CHE Medium, ATB PBS.

User's Manual DENSIMAT

2-1

3 Technical specifications

DENSIMAT is designed to measure the bacterial density in an ampoule of liquid medium.

Dimensions

Environment

Electrical characteristics

− Width : 10.7 cm (4.2 inches)

− Depth : 17 cm (6.7 inches)

− Height : 6.2 cm (2.44 inches)

− Mass : 0.5 kg (1.1 lbs)

− Indoor use

− Operating temperature : max 30°C

− Maximum altitude for installation : 2000 m

− Transport and storage temperature : -10°C to +50°C

− Relative humidity : 70%

− Installation category : I (according to standard EN 61010.1)

− Degree of pollution : 2

− Voltage : 7÷8 VDC

− Intensity : 0.15A max

− Automatic switching on when an ampoule is inserted in the optical block.

− The DENSIMAT goes into automatic standby mode after 30 seconds if

there is no change in the O.D.

− The standby mode is indicated by "McF" on the display.

− The DENSIMAT comes out of standby mode when the ampoule is

removed.

− The DENSIMAT is designed to run on 2 Sonneschein batteries Mod. SL760

or equivalent, connected in series. Each unit is an Li/SOCI2 type Lithium battery 3.6V nominal, size AA with a maximum nominal capacity of 1.8 A/H.

− The DENSIMAT can also be supplied with current by one of the following

AC power supply adapters or equivalent ones:

(according to standards EN 61010.1)

User's Manual DENSIMAT

3-1

Technical specifications

Optical characteristics

POWER SUPPLY UL/CSA

INPUT : 115 VAC/60Hz USA STD plug

OUTPUT : 7.5 VDC, 300mA with output connector

mod. PANASONIC

®

Ø = 3.0 x 1.1 mm.

POWER SUPPLY CE Marked

INPUT : 230 VAC/50Hz European STD plug

OUTPUT : 7.5 VDC, 250mA with output connector

mod. PANASONIC

®

Ø = 3.0 x 1.1 mm.

− Light source : LED 950 nm

− Central photosensor

− Lateral photosensor

− Logarithmic display in McFarland units : 0.5 McF to 7.5 McF.

3-2 User's Manual DENSIMAT

4 Principle

DENSIMAT enables precise determination of bacterial density by two measurements.

An incident beam of light is passed through the ampoule and two subsequent measurements are obtained:

− Scattered light S (two photosensors),

− Transmitted light T (one photosensor).

The ratio S/T is directly proportional to the density of the bacterial suspension. The results are displayed on a mobile graduated scale on a liquid crystal display. The number of squares displayed is proportional to the McFarland value. The corresponding numerical value is shown on the right-hand side of the display.

Correspondence McFarland scale/Bacterial concentration/Optical density:

STANDARD

McFARLAND

1) The bacterial concentration varies according to the size of the micro-

2) The values correspond to the optical densities of bacterial suspension. The

BACTERIAL

CONCENTRATION (1)

SCALE

0.5

1 2

3 4

5 6

7

organisms. The figures which are reported represent a mean, valid for the bacteria. For the yeasts, due to their bigger size, these figures have to be divided by 30.

Barium Sulphate (BaSO4) solutions do not present the same optical density since the size and the form of the particles are different from those of bacteria. The light is also diffracted differently.

x10

8

1.5

3 6

9 12

15 18

21

/ml

THEORETICAL

OPTICAL

DENSITY (2)

at 550nm

0.125

0.25

0.50

0.75

1.00

1.25

1.50

1.75

User's Manual DENSIMAT

4-1

Principle

Peripheral photosensors

Central photosensor

DIVISION

RD =

Light source

(photosensor)

Ampoule

light scattered

light dtransmitte

RESULT PRESENTATION

Scale graduated in McFarland units

Fig. 4-1: DENSIMAT reading principle

4-2 User's Manual DENSIMAT

Principle

A

"Bar Graph"

McFarland scale

mpoule

The number of squares displayed is

proportional to the value in McFarland Units

Ø Ø.5 1 McF

1

Battery charge indicator light

Fig. 4-2: DENSIMAT display panel

Ø.4

Numerical value

2

3

4

5

User's Manual DENSIMAT 4-3

5 Unpacking and repacking

Before opening the boxes:

• Make sure that no damage has been caused during transport.

If damage has occurred, make a claim to the transport company and notify Customer Service at bioMérieux S.A.

When opening the boxes:

• Make sure that there are all the items described in the enclosed packing list.

If possible, keep packaging materials in case the instrument has to be moved in the future.

CAUTION! Any damage directly or indirectly resulting from the transport of the

instrument without adequate containers will not be covered by the warranty or maintenance contract.

User's Manual

DENSIMAT 5-1

6 Installation

Before connecting the AC power supply adapter, check that the power supply corresponds to the adapter’s characteristics.

Kit contents

See the manual provided by the manufacturer.

Location

User's Manual

DENSIMAT is designed to be used on a laboratory bench top, but may be

moved depending on the needs of the user.

• Place the instrument on a flat, horizontal surface.

The area should be free of dust. The room temperature and relative humidity should be constant.

Do not place the instrument near strong sources of electromagnetic interference.

During the analytical readings avoid leaving the sources of light.

DENSIMAT 6-1

DENSIMAT under strong

Installation

Electrical adjustment

DENSIMAT is designed to be used with two Lithium batteries (nominal 3.6 V)

described in the technical specifications. However, an AC power adapter can be used.

CAUTION! The AC power supply adapter must have the following technical

specifications:

- Voltage : 7÷8 VDC

- Intensity : 0.2 A min

- Plug mod. PANASONIC® Ø = 3.0x1.1mm

- AC input voltage corresponding to the characteristics of the power

supply in the country where the instrument is installed.

However, it is better to use one of the two power supplied provided by bioMérieux S.A. You will find the details of their characteristics in the section “Technical specifications”.

The socket marked DC-IN has a switch that disconnects the battery supply when the AC adapter is inserted. It is thus possible to use the AC adapter without removing the Lithium batteries.

Note: To order the AC adapter, contact bioMérieux S.A. or your local distributor.

Autonomy of batteries

The Lithium batteries used with the DENSIMAT have an autonomy of over 60 hours of effective use.

A light comes on when the voltage is less than 5.76 VDC and the batteries need to be changed (see Fig. 4-2, on page 4-3).

Note: Although measurement is not affected when the light comes on, it is recommended to

change the batteries immediately to guarantee correct reading of the display.

6-2 User's Manual DENSIMAT

7 Procedure

CAUTION! DENSIMAT is always OFF. It automatically comes ON when you insert an

ampoule and automatically comes OFF when you remove it.

• Prepare a homogeneous bacterial suspension in the ampoule recommended

in the procedure for the reagent used.

• Wipe the ampoule clean.

• Place the ampoule in the well. DENSIMAT comes ON automatically.

• Turn the ampoule until you obtain the minimum stable reading on the scale.

Only the minimum stable value obtained is of significance.

Note: If you are using DENSIMAT with the AC power adapter, you should connect the

instrument to the power supply before starting these operations.

In order to save the batteries:

− It is recommended to first homogenize the bacterial suspension and then place the

ampoule in the DENSIMAT to perform the reading.

− DENSIMAT goes into standby mode after 30 seconds if there is no change in the O.D.

of the suspension. This mode is indicated by “McF” on the display.

Adjusting the inoculum

Most standardized methodologies recommend the use of bacterial suspension with a density equal to a McFarland value.

Therefore, it is often necessary to adjust the bacterial suspension to obtain the recommended standard. The ampoule should remain in place while this adjustment is being made.

− If the density is higher than the standard required, the bacterial suspension should be diluted by adding a certain volume of medium.

− If the density is lower than the standard required, more bacteria should be added.

User's Manual

Note: In order to save the batteries, it is recommended to remove the ampoule from the

DENSIMAT 7-1

DENSIMAT to adjust the inoculum.

Procedure

Precautions for use

IMPORTANT! It is important that the ampoules used are clean.

It is recommended to wipe them clean beforehand.

The measurement of the bacterial density is performed in the lower part of the ampoule (up to 1 cm above the bottom of the ampoule).

Should "Cleaning

The results obtained that are lower than 0.5 McFarland units or higher than

7.5 McF are less significant and should be considered with caution.

IMPORTANT! Only API® or ATBTM ampoules can be read using the values indicated on

DENSIMAT.

DENSIMAT be contaminated, the ampoule well must be cleaned (see

DENSIMAT" on page 9-1).

7-2 User's Manual DENSIMAT

8 Verification of the accuracy

DENSIMAT should be tested:

− if there is any doubt as to the accuracy of the instrument,

− if an accident has occurred during use (broken ampoule, liquid inside the

reading block).

CAUTION! Following the withdrawal of the small ampoules from our catalogue,

verification of the accuracy of the DENSIMAT must only be performed using the large ampoules in the ATB (product no. 15 512), according to the instructions for use of the kit (see the package insert).

− If all the readings obtained are out of range, clean the photosensors (see “Cleaning” on page 9-1) and repeat the test.

− If the problem persists, contact bioMérieux S.A. or your local distributor.

IMPORTANT! The Barium sulphate turbidity standards to not suit the standardization of

DENSIMAT.

TM

DENSITOMETER CONTROL KIT

User's Manual

DENSIMAT 8-1

9 Cleaning DENSIMAT

DENSIMAT should be cleaned:

− if an ampoule has been broken inside the reading block,

− if the results obtained are too high.

− when maintenance is carried out (see Chapter 10)

IMPORTANT! A test must be done each time DENSIMAT is cleaned to ensure that it

gives correct results.

User's Manual

DENSIMAT 9-1

Cleaning DENSIMAT

Cleaning

Material

Procedure

− cleaning device

− cotton swab

− 90% alcohol

• Use an alcohol impregnated swab.

• Swab the photosensors situated in the right section of the reading block.

• Test the instrument by referring to “Testing DENSIMAT”. If the results are

incorrect, repeat the cleaning procedure.

Note: The cleaning device is available at bioMérieux S.A. under the reference: 4550409A.

9-2 User's Manual DENSIMAT

Cleaning DENSIMAT

Cleaning

{

|

1

2

3

}

c - Cut the desired length d - Insert the cotton swab in the device e - Clean the photosensors

Fig. 9-1: Preparing the cleaning device

User's Manual DENSIMAT 9-3

9

5

10 Maintenance

The maintenance of the optical block must be carried out once a month in addition to the reasons reported in the section "Cleaning 9-1.

Battery The batteries which are used must imperatively correspond to the type

described in the technical specifications. The use of a different type of battery could severely damage the instrument and

would not be covered by the warranty or maintenance contract.

CAUTION! When replacing the batteries, respect the polarity inside the DENSIMAT

battery compartment.

AC power adapter No maintenance is necessary.

DENSIMAT" on page

User's Manual

DENSIMAT 10-1

11 Glossary

LED 950 NM

MCFARLAND

NEPHELOMETRY

OPTICAL DENSITY (OD)

PHOTOSENSOR

STRIPS

TURBIDIMETRY

Light Emitting Diode 950nm.

Light source emitting on the 950 nm wavelength.

Scale for measurement of bacterial density.

Measurement of the intensity of scattered light (S) at 30°, directly

proportional to the bacterial growth.

The property of a substance to reduce the intensity of a beam of light that

goes through it.

Sensor enabling a quantity of light received to be transformed into electrical

current.

Set of standardised, miniaturised tests on a plastic support.

Measurement of the intensity of transmitted light (T) which is inversely

proportional to the bacterial growth.

User's Manual

DENSIMAT 11-1

12 Index

Page numbers in bold italics correspond to figures or tables.

A

Ampoule .............................................................................................. 2-1, 3-1, 4-1, 4-2, 4-3, 7-1, 7-2, 8-1, 9-1

B

Block...................................................................................................................................................... 8-1, 9-1

D

Density ....................................................................................................................2-1, 3-1, 4-1, 7-1, 7-2, 11-1

M

McFarland.........................................................................................................2-1, 3-2, 4-1, 4-3, 7-1, 7-2, 11-1

P

Photosensor ...................................................................................................................4-1, 4-2, 8-1, 9-2, 11-1

R

Reading ............................................................................................................................4-2, 6-1, 7-1, 8-1, 9-1

S

Suspension..................................................................................................................................... 2-1, 4-1, 7-1

V

Value ................................................................................................................................2-1, 4-1, 4-3, 7-1, 7-2

User's Manual DENSIMAT 12-1

Notes

.................................................................................................................................................................................................................................................................

User's Manual

DENSIMAT Notes-1

4501-1532-en

bioMérieux, the blue logo, API and ATB, are used, pending and/or registered trademarks belonging to bioMérieux SA or one of its subsidiaries.

bioMerieux DENSIMAT User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

DENSIMAT User's Manual

Revisions

Liability disclaimer

List of figures II -1

1 How to use this manual

Finding topics and procedures

Typographic conventions

Graphic symbols

2 Description and use

3 Technical specifications

4 Principle

5 Unpacking and repacking

6 Installation

Kit contents

Location

Electrical adjustment

Autonomy of batteries

7 Procedure

Adjusting the inoculum

Precautions for use

8 Verification of the accuracy

9 Cleaning DENSIMAT

Cleaning

10 Maintenance

11 Glossary

12 Index

Notes