Biomerieux Previ Isola User Manual

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USER MANUAL

4501-1671 - C - en

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

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

RCS Lyon 673 620 399

http://www.biomerieux.com

29730

Version C

03/2009

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Revisions

The list of revisions below summarizes replacements or additional pages in your User Manual.

Version Date of printing Modifications Pages modified

A 10/2008 Creation All

B Not used

C 03/2009

− New software version

− Deletion of Modify button

− Addition of information for loading labels

− Modification to Figure 4-21 : Barcode (DOB removed)

− Correction of folder name in Instrument Log Files section

− New Maintenance Menu screenshot

− New order for performing maintenance operations

− Deletion of Label roll length sensing procedure

− Deletion of severity column in List of Error Messages

− Addition of Event no. 20110 in List of Error Messages

− Addition of Event no. 35026 in List of Error Messages

− Additions to Error, Cause and Recovery table

− Updated procedure for replacing the PREVITM Isola HEPA

filter

− New procedure for pipettor decontamination

All

2-24

4-16

4-25

7-6

8-2

8-3 to 8-20

8-28

9-1 to 9-9

9-6

9-9

9-11 to 9-14

9-18 to 9-22

9-23 to 9-24

− New procedure for reinitializing the instrument after the

pipettor descends into a plate on the process station

9-25

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4501-1618 B en

Warning

IMPORTANT! Use of the instrument and manual implies acceptance of the clauses below and the

The contents of this manual are based on the software release V 1.1.

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.

clauses set out in the regulatory booklet. Users are invited to refer to these clauses.

Trademarks

bioMérieux, the blue logo, PREVI, VITEK and DENSICHEK are used, pending and/or registered trademarks belonging to bioMérieux S.A. or one of its subsidiaries.

Windows is a trademark belonging to Microsoft.

Monovette is a trademark of Sarstedt AG & Co.

Vacutainer is a trademark of Becton, Dickinson and Company.

ATCC is a trademark of American Type Culture Collection.

Sterilin is a trademark of Bibby Sterilin Ltd.

Microstreak is a trademark of Lab Tech.

Any other name or trademark is the property of its respective owner.

Photos: bioMérieux / Printed in France / bioMérieux S.A. RCS Lyon 673 620 399

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4501-1577 B en

SOFTWARE LICENSE AGREEMENT

User: No.: Software: Release: Computer: Brand name: Printer: Brand name: Disk player: Brand name:

The use of this Software is strictly governed by the following terms and conditions.

I - Purpose of this Agreement / Rights granted

bioMérieux S.A. hereby grants, to the User who, by using this manual, accepts a non-exclusive right to use the Software. The license is personal, non transferable, non assignable and does not comprise the right to grant sub-licenses.

The User expressly agrees, in its own name and behalf as well as in the name and on behalf of its employees, agents and collaborators, not to make any copy of the Software-except one single backup copy for archival purposes- display the Software on any computer other than the Computer, reproduce, sell, rent, lease, modify, adapt, translate or otherwise dispose of, all or part of the Software, the equipment, the user manual and its related documentation.

Specifically, the User agrees not to decompile, reverse engineer or disassemble all or part of the Software.

II - Intellectual Property

III - Warranties

All intellectual property rights including patrimonial rights, in and to the Software are and shall remain bioMérieux S.A. exclusive property, subject to possible third party rights. Consequently, the User is not entitled to copy or reproduce the Software except as set forth above.

Except as expressly specified above, nothing contained herein shall be construed as conferring to the User any right, title or interest in and to the Software.

Provided that this Agreement duly signed is received by bioMérieux S.A. within ten (10) business days from the delivery, bioMérieux S.A. warrants that the Software is free from defect in materials and workmanship under normal conditions of use during three (3) months from the delivery. Should any defect occur during such period, bioMérieux S.A. or one of its authorized distributors in the country of sale shall replace the Software provided that the User makes its request in writing together with copy of the Software invoice and, as the case may be, the defective media.

Apart from the foregoing, the Software is provided "AS IS" and no warranty, whether express or implied, of merchantability, safety, quality, or fitness for a particular purpose is given hereunder nor any warranty that the Software shall not infringe upon the intellectual property rights of any third party.

The warranty provided herein shall apply provided that Software is used under normal conditions and to the exclusion of any replacement caused by accidental or willful damage, or misuse of the software or accident whatsoever.

It is expressly understood that, according to this License, bioMérieux S.A. shall not perform any service related to the training, assistance or maintenance of the Software unless otherwise agreed upon between the parties through a separate written agreement setting forth the terms and conditions (in particular, financial conditions) of such training, assistance or maintenance.

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IV - Liability

In no event shall bioMérieux S.A. be held liable for any consequences that may arise from any modifications made to the Software without its intervention, or, should the software be connected to the user’s network or system, for any malfunctions or damage to the software caused directly or indirectly by the network or system, in particular in the event of failure of the security system, or the consequences of installing software on the same hardware as this Software without the intervention and/or authorisation of bioMérieux S.A.

In no event shall bioMérieux S.A. be liable for any direct, indirect, special, consequential or nonconsequential, incidental, material or immaterial damage (including loss of goodwill, profits, data or any other economic advantage) related to, arising out of or in connection with, any use of the Software and/or its results by the User and/or any third party, including without limitation, its clients, customers and sub-contactors. User hereby agrees to indemnify, defend and hold bioMérieux S.A. harmless from all claims, damages, expenses, suits, losses or liabilities relating to, arising out of or in connection with User or such parties as well for any action of such third parties against bioMérieux S.A.

Should this provision be held unenforceable or void, the User irrevocably agrees that bioMérieux S.A. liability and expenses for all causes shall not exceed the total amount actually paid by the User hereunder for the software release concerned by the claim.

V - Applicable Law and settlement of disputes

This agreement is governed and construed in accordance with French Law.

Parties shall make their best efforts to settle any dispute through amicable discussions. In the event no amicable settlement is reached in the period of three (3) months after communication of the claim, any litigation shall be held in the exclusive jurisdiction of the courts of Lyon, France.

Done ..............................................................................

This…….....................day of..........................................

Signature and User's stamp:

COPY TO BE RETURNED TO bioMérieux

S.A.

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4501-1577 B en

SOFTWARE LICENSE AGREEMENT

User: No.: Software: Release: Computer: Brand name: Printer: Brand name: Disk player: Brand name:

The use of this Software is strictly governed by the following terms and conditions.

I - Purpose of this Agreement / Rights granted

Specifically, the User agrees not to decompile, reverse engineer or disassemble all or part of the Software.

II - Intellectual Property

III - Warranties

Except as expressly specified above, nothing contained herein shall be construed as conferring to the User any right, title or interest in and to the Software.

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IV - Liability

V - Applicable Law and settlement of disputes

This agreement is governed and construed in accordance with French Law.

Done ..............................................................................

This…….....................day of..........................................

Signature and User's stamp:

COPY TO BE KEPT BY USER

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1 How to use this Manual

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

Warnings................................................................................................................................................................... 1-1

2 Description

Intended Use............................................................................................................................................................. 2-1

System Capabilities...................................................................................................................................................2-1

Workflow Principle..................................................................................................................................................... 2-2

System Architecture.................................................................................................................................................. 2-3

System Components................................................................................................................................................. 2-4

Workstation ............................................................................................................................................................... 2-5

Description......................................................................................................................................................... 2-5

Instrument ................................................................................................................................................................. 2-6

Sample racks ..................................................................................................................................................... 2-9

Sample tubes................................................................................................................................................... 2-10

Tubes compatible for use with the PREVI Isola .......................................................................................2-10

Fill heights.................................................................................................................................................2-10

Prepoured media (Plates) ................................................................................................................................ 2-10

Plates compatible for use with the PREVI Isola .......................................................................................2-10

Input cassettes................................................................................................................................................. 2-11

Output cassettes.............................................................................................................................................. 2-12

Touch-screen ................................................................................................................................................... 2-12

PREVI Isola Waste Paper Bin ......................................................................................................................... 2-13

Waste drawer................................................................................................................................................... 2-13

Interlocks................................................................................................................................................................. 2-14

Consumables .......................................................................................................................................................... 2-15

PREVI Isola Applicators .................................................................................................................................. 2-15

PREVI Isola Applicator cartridge ..................................................................................................................... 2-15

PREVI Isola Tips ............................................................................................................................................. 2-16

PREVI Isola Labels .........................................................................................................................................2-16

PREVI Isola biohazardous Waste Bin ............................................................................................................. 2-16

PREVI Isola HEPA filter ..................................................................................................................................2-17

Instrument Operating Principle................................................................................................................................ 2-18

Index next sample............................................................................................................................................ 2-19

Read sample barcode...................................................................................................................................... 2-19

Retrieve sample data ....................................................................................................................................... 2-20

Pick up tip ........................................................................................................................................................ 2-20

Aspirate sample ............................................................................................................................................... 2-20

Perform plate workflow ....................................................................................................................................2-21

Retrieve input plate...................................................................................................................................2-21

Transfer to plate transfer robot .................................................................................................................2-21

Transfer to process station .......................................................................................................................2-21

Measure agar height, dispense sample ....................................................................................................2-21

Pick up applicator .....................................................................................................................................2-21

Streak plate...............................................................................................................................................2-21

Discard applicator ..................................................................................................................................... 2-21

If Bi – plate................................................................................................................................................ 2-21

Transfer to transfer robot ..........................................................................................................................2-21

Label plate ................................................................................................................................................2-22

Transfer to output robot ............................................................................................................................2-22

Dispose of tip ................................................................................................................................................... 2-22

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Isola User Manual I-1

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Table of Contents

Workstation Software.............................................................................................................................................. 2-23

Principle ........................................................................................................................................................... 2-23

General screen layout...................................................................................................................................... 2-23

Menu bar.......................................................................................................................................................... 2-24

Title and button bar .......................................................................................................................................... 2-24

Working area ................................................................................................................................................... 2-24

Status bar ........................................................................................................................................................ 2-24

Instrument Software................................................................................................................................................ 2-25

Main screen and general layout....................................................................................................................... 2-25

Alarm zone....................................................................................................................................................... 2-26

Title bar............................................................................................................................................................ 2-26

Status bar ........................................................................................................................................................ 2-26

Navigation/action bar ....................................................................................................................................... 2-27

Working area ................................................................................................................................................... 2-28

3 Getting Started

Assembly and Installation .........................................................................................................................................3-1

Choosing a location ...........................................................................................................................................3-1

Electrical connections ........................................................................................................................................ 3-1

Hazardous Magnetic Fields Precautions................................................................................................................... 3-1

Moving the Instrument............................................................................................................................................... 3-1

Barcode Reader Installation...................................................................................................................................... 3-1

Installation of the PREVI Isola and BCI .................................................................................................................... 3-2

Checking installation .......................................................................................................................................... 3-2

Powering up the Workstation .................................................................................................................................... 3-3

Connecting to BCI NET .....................................................................................................................................3-3

Connecting to BCI RS232.................................................................................................................................. 3-3

Starting the Workstation Software............................................................................................................................. 3-4

Entry of an incorrect user name or password ....................................................................................................3-4

Changing work sessions .................................................................................................................................... 3-5

Inactivity timeout ................................................................................................................................................ 3-5

Defining Plate Panels................................................................................................................................................ 3-6

Creating a plate panel........................................................................................................................................ 3-7

Modifying a plate panel ...................................................................................................................................... 3-9

Deleting a plate panel ........................................................................................................................................ 3-9

Printing a plate panel ....................................................................................................................................... 3-10

Defining Plate Types ............................................................................................................................................... 3-11

Creating a plate type........................................................................................................................................ 3-11

Modifying a plate type ...................................................................................................................................... 3-12

Deleting a plate type ........................................................................................................................................ 3-12

Defining Incubation Types....................................................................................................................................... 3-13

Creating an incubation type .............................................................................................................................3-13

Modifying an incubation type ........................................................................................................................... 3-14

Deleting an incubation type.............................................................................................................................. 3-14

Assigning Plate Panels to Specimen Types............................................................................................................ 3-15

Printing plate panels assigned to specimen types ...........................................................................................3-17

Automatically Assigning Plate Panels to Samples .................................................................................................. 3-18

Defining Plate Cassettes Configurations................................................................................................................. 3-19

Creating a plate cassettes configuration .......................................................................................................... 3-19

Modifying a plate cassettes configuration ........................................................................................................ 3-21

Deleting a plate cassettes configuration .......................................................................................................... 3-21

Assigning Plate Panels to Samples ........................................................................................................................ 3-22

Viewing and Printing Worklists................................................................................................................................ 3-24

General Settings ..................................................................................................................................................... 3-26

I-2 PREVI

Isola User Manual

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Table of Contents

4 Using the System

Basic Workflow .........................................................................................................................................................4-1

Starting the System................................................................................................................................................... 4-2

Powering up the instrument ............................................................................................................................... 4-2

Screensaver....................................................................................................................................................... 4-2

Prerequisites for Sample Processing ........................................................................................................................ 4-4

Pre-start Checks ....................................................................................................................................................... 4-4

Selecting Plates ........................................................................................................................................................ 4-5

Loading Plates .......................................................................................................................................................... 4-7

Loading plates during processing ......................................................................................................................4-7

Loading plates without removing the input cassette........................................................................................... 4-8

Plate cassettes status ........................................................................................................................................ 4-9

Loading PREVI Isola Applicators............................................................................................................................ 4-10

Loading PREVI Isola Tips....................................................................................................................................... 4-13

Loading PREVI Isola Labels................................................................................................................................... 4-15

Monitoring Consumables and Waste Bins Status ................................................................................................... 4-17

Consumables ................................................................................................................................................... 4-17

PREVI Isola Waste Bins.................................................................................................................................. 4-18

Sample Preparation ................................................................................................................................................4-19

Recommended procedures.............................................................................................................................. 4-19

Urine .........................................................................................................................................................4-19

Feces........................................................................................................................................................4-19

Dry mono swab......................................................................................................................................... 4-19

Swab in a liquid transport medium............................................................................................................ 4-19

Swab in gel transport medium ..................................................................................................................4-19

Blood ........................................................................................................................................................4-19

Liquid respiratory samples........................................................................................................................4-19

Placing Sample Tubes in Racks ............................................................................................................................. 4-20

Loading Sample Racks ........................................................................................................................................... 4-21

Processing Samples ...............................................................................................................................................4-23

Processing hints............................................................................................................................................... 4-27

Pausing the Instrument ........................................................................................................................................... 4-28

Instrument-generated pause............................................................................................................................ 4-28

User-generated pause ..................................................................................................................................... 4-28

Stopping the Instrument .......................................................................................................................................... 4-29

Instrument-generated stop (Error case) ........................................................................................................... 4-29

Resuming operations after stopping .........................................................................................................4-29

User-generated stop ........................................................................................................................................ 4-31

Resuming operations after stopping .........................................................................................................4-31

Unloading Processed Plates ................................................................................................................................... 4-32

Unloading processed plates on completion of processing ............................................................................... 4-32

Unloading processed plates during processing ............................................................................................... 4-33

Remove a full output cassette...................................................................................................................4-33

Remove plates from the cassettes in situ .................................................................................................4-33

Unloading unprocessed plates......................................................................................................................... 4-33

Unloading Sample Tubes........................................................................................................................................ 4-34

Removing Waste..................................................................................................................................................... 4-35

PREVI Isola biohazardous Waste Bin ............................................................................................................. 4-35

PREVI Isola Waste Paper Bin ......................................................................................................................... 4-36

Powering Down the Instrument ............................................................................................................................... 4-37

Examples of Correct Streaking Patterns ................................................................................................................. 4-38

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Isola User Manual I-3

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Table of Contents

5 Quality Control

Intended Use............................................................................................................................................................. 5-1

Material ..................................................................................................................................................................... 5-1

Workstation Preparation............................................................................................................................................ 5-1

Instrument Preparation.............................................................................................................................................. 5-2

Sample Tube Preparation ......................................................................................................................................... 5-2

Sample Run and Plate Incubation............................................................................................................................. 5-2

Results ...................................................................................................................................................................... 5-2

Score determination .................................................................................................................................................. 5-3

Reference Appearance ............................................................................................................................................. 5-3

Results ...................................................................................................................................................................... 5-4

6 Information Technology Security

User Management..................................................................................................................................................... 6-1

User groups ....................................................................................................................................................... 6-1

Creating a new user account ............................................................................................................................. 6-2

Assigning user permissions and rights............................................................................................................... 6-5

Disabling a user account.................................................................................................................................. 6-10

Unlocking a user account................................................................................................................................. 6-11

Changing of a password by a user................................................................................................................... 6-12

Antivirus .................................................................................................................................................................. 6-13

Windows Update..................................................................................................................................................... 6-13

IT Verification Protocol ............................................................................................................................................ 6-13

Printer Verification Protocol..................................................................................................................................... 6-14

7 Data Backup, Restore and Audit Trail

Presentation.............................................................................................................................................................. 7-1

Manual data backup.................................................................................................................................................. 7-1

Data restoration from a removable medium .............................................................................................................. 7-1

Audit trail data viewing using the event viewer.......................................................................................................... 7-2

Saving the Audit Trail ................................................................................................................................................ 7-4

Instrument and Workstation Log File Retrieval .........................................................................................................7-6

Instrument log files............................................................................................................................................. 7-6

Workstation and data server log files ................................................................................................................. 7-6

Full System Backup and Restoration ........................................................................................................................ 7-7

Full System Backup ........................................................................................................................................... 7-7

Full System Restoration..................................................................................................................................... 7-7

8 Maintenance

Introduction ............................................................................................................................................................... 8-1

Safety Precautions and Controls............................................................................................................................... 8-1

Biological safety requirements ........................................................................................................................... 8-1

Recommended maintenance product ................................................................................................................ 8-1

Presentation of the Maintenance Menu..................................................................................................................... 8-2

Maintenance Logs..................................................................................................................................................... 8-3

Daily Maintenance Procedures ................................................................................................................................. 8-4

Clean the tray under input cassettes.................................................................................................................. 8-4

Clean the waste chute top, the area around the waste chute top and the waste chute chimney ....................... 8-5

Clean the process station drip tray..................................................................................................................... 8-6

Clean the pipettor, drip tray and area under and around the drip tray................................................................ 8-7

Clean the sample racks .....................................................................................................................................8-8

Clean the sample rack tray and sample spill tray............................................................................................... 8-9

Clean the tray under output cassettes .............................................................................................................8-11

Clean the waste chute deflector....................................................................................................................... 8-12

Check, replace or empty the waste bins, and clean the deflector .................................................................... 8-13

I-4 PREVI

Isola User Manual

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Table of Contents

Weekly Maintenance Procedures ........................................................................................................................... 8-14

Clean the inside of input and output cassettes ................................................................................................ 8-14

Clean the area around the applicator cartridge and the tip tray .......................................................................8-15

Clean the process station, reference block, transfer robot suction cups, and agar sensor ..............................8-15

Clean the printer and the printer platen............................................................................................................ 8-18

Clean the print head......................................................................................................................................... 8-19

Clean the touch-screen.................................................................................................................................... 8-19

Clean the external surfaces of the instrument.................................................................................................. 8-20

Clean the waste drawer ................................................................................................................................... 8-20

Maintenance Operations Performed by bioMérieux ................................................................................................ 8-21

Spill Management ...................................................................................................................................................8-21

Materials required ............................................................................................................................................ 8-21

Decontamination Procedures.................................................................................................................................. 8-21

Basic decontamination..................................................................................................................................... 8-21

Removal and Disposal of Materials and Waste....................................................................................................... 8-22

Disposal of used consumables ........................................................................................................................ 8-22

Loading PREVI Isola Label Rolls............................................................................................................................ 8-23

Replacing Fuses ..................................................................................................................................................... 8-29

Replacing the PREVI Isola HEPA Filter.................................................................................................................. 8-29

9 Troubleshooting

Introduction ............................................................................................................................................................... 9-1

List of Error Messages .............................................................................................................................................. 9-2

Event Log................................................................................................................................................................ 9-10

Error, Cause and Recovery..................................................................................................................................... 9-11

Recovery from events with “Warning” severity........................................................................................................ 9-15

Recovery from events with “Error” severity ............................................................................................................. 9-15

Recovery from Events with “Fatal” Severity ............................................................................................................ 9-16

Restarting the Instrument Software......................................................................................................................... 9-16

PREVI Isola HEPA Filter ........................................................................................................................................9-17

Replacing the PREVI Isola HEPA filter............................................................................................................ 9-18

Pipettor.................................................................................................................................................................... 9-23

Clean and decontaminate the pipettor if it descends into a sample tube ......................................................... 9-23

Material required.......................................................................................................................................9-23

Procedure .................................................................................................................................................9-23

Possible issues after cleaning...................................................................................................................9-25

Reinitialize the instrument after the pipettor descends into a plate on the process station ..............................9-25

Procedure .................................................................................................................................................9-25

Examples of Incorrect Inoculation and Streaking Patterns...................................................................................... 9-26

Back up Instrument Log Files.................................................................................................................................. 9-27

Anonymization of Patient Data................................................................................................................................ 9-27

10 General System Characteristics

Dimensions ...................................................................................................................................................... 10-1

Weight.............................................................................................................................................................. 10-1

Electrical specifications.................................................................................................................................... 10-1

Environmental considerations.......................................................................................................................... 10-1

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Isola User Manual I-5

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Table of Contents

11 Appendices

Appendix A: Packing list.......................................................................................................................................... 11-1

Instrument kit ...................................................................................................................................................11-1

User Manual kit................................................................................................................................................ 11-1

Workstation PC kit ...........................................................................................................................................11-1

Appendix B: Stopping and Restarting the Data Server ...........................................................................................11-2

Stopping the data server.................................................................................................................................. 11-2

Restarting the data server................................................................................................................................ 11-4

12 Glossary

I-6 PREVI

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List of Figures

2 Description

Figure 2-1 : Workflow Principle ................................................................................................................................. 2-2

Figure 2-2 : System Architecture............................................................................................................................... 2-3

Figure 2-3 : System Components .............................................................................................................................2-4

Figure 2-4 : Front view of the PREVI Isola with covers on........................................................................................ 2-6

Figure 2-5 : Front view of the PREVI Isola – front covers removed.......................................................................... 2-7

Figure 2-6 : Back view of the PREVI Isola with covers on........................................................................................ 2-8

Figure 2-7 : Sample racks ......................................................................................................................................... 2-9

Figure 2-8 : Fill heights............................................................................................................................................ 2-10

Figure 2-9 : Input cassette – front ...........................................................................................................................2-11

Figure 2-10 : Input cassette – back......................................................................................................................... 2-11

Figure 2-11 : Output cassette - front .......................................................................................................................2-12

Figure 2-12 : Output cassette - back....................................................................................................................... 2-12

Figure 2-13: Touch-screen...................................................................................................................................... 2-12

Figure 2-14 : PREVI Isola Waste Paper Bin ........................................................................................................... 2-13

Figure 2-15 : Waste Drawer .................................................................................................................................... 2-13

Figure 2-16 : PREVI Isola Applicator ...................................................................................................................... 2-15

Figure 2-17 : PREVI Isola Applicator cartridge ....................................................................................................... 2-15

Figure 2-18 : PREVI Isola Tips in tray ....................................................................................................................2-16

Figure 2-19 : Simplified sample workflow................................................................................................................ 2-18

Figure 2-20 : Positioning a barcode label on a tube ................................................................................................ 2-19

Figure 2-21 : General screen layout........................................................................................................................ 2-23

Figure 2-22 : Main screen layout............................................................................................................................. 2-25

Figure 2-23 : Working area .....................................................................................................................................2-28

3 Getting Started

Figure 3-1 : Login pop-up window............................................................................................................................. 3-4

Figure 3-2 : “Invalid user name / password” window................................................................................................. 3-4

Figure 3-3 : Workstation software shutdown window ................................................................................................3-5

Figure 3-4 : “Plate Panels” screen ............................................................................................................................ 3-6

Figure 3-5 : Create a plate panel .............................................................................................................................. 3-7

Figure 3-6 : “Plate Panel” error message .................................................................................................................. 3-8

Figure 3-7 : “Invalid entry” error message................................................................................................................. 3-8

Figure 3-8 : “Delete a plate panel” confirmation message......................................................................................... 3-9

Figure 3-9 : “Plate Panel Printing” selection window............................................................................................... 3-10

Figure 3-10 : Plate panel “Print Preview” window ...................................................................................................3-10

Figure 3-11 : “Plate Panels” plate types screen ...................................................................................................... 3-11

Figure 3-12 : Define incubation types...................................................................................................................... 3-13

Figure 3-13 : Incubation types................................................................................................................................. 3-14

Figure 3-14 : “Specimen Types” screen .................................................................................................................. 3-15

Figure 3-15 : Specimen types “Print Preview” window............................................................................................ 3-17

Figure 3-16 : “Plate Cassettes Configuration” screen .............................................................................................3-19

Figure 3-17 : New plate cassettes configuration ..................................................................................................... 3-20

Figure 3-18 : “Invalid Input” error message ............................................................................................................. 3-20

Figure 3-19 : “Delete a plate cassettes configuration” confirmation message......................................................... 3-21

Figure 3-20 : “Sample Assignment“ screen............................................................................................................. 3-22

Figure 3-21 : “Sample Assignment“ screen with sample ......................................................................................... 3-23

Figure 3-22 : “Worklist” screen................................................................................................................................ 3-24

Figure 3-23 : Worklist “Print Preview” window......................................................................................................... 3-25

Figure 3-24 : “General Settings” screen .................................................................................................................. 3-26

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Isola User Manual II-1

Page 18

List of Figures

4 Using the System

Figure 4-1 : Basic workflow diagram ......................................................................................................................... 4-1

Figure 4-2 : Powering up the instrument ................................................................................................................... 4-2

Figure 4-3 : Main screen ........................................................................................................................................... 4-3

Figure 4-4 : “Select Plates” screen............................................................................................................................ 4-5

Figure 4-5 : Load plates agar-side up .......................................................................................................................4-7

Figure 4-6 : Loading plates without removing the input cassette ..............................................................................4-8

Figure 4-7 : Main screen – “Cassettes status” ..........................................................................................................4-9

Figure 4-8 : “Load Applicators and Tips” screen .....................................................................................................4-10

Figure 4-9 : Pulling the top lock............................................................................................................................... 4-11

Figure 4-10 : Inserting the cartridge ........................................................................................................................ 4-11

Figure 4-11 : “Load Applicators and Tips” screen ...................................................................................................4-13

Figure 4-12 : Inserting the PREVI Isola Tip tray .....................................................................................................4-14

Figure 4-13 : “Load Labels” screen ......................................................................................................................... 4-15

Figure 4-14 : "Main screen – consumable status"................................................................................................... 4-17

Figure 4-15 : Sample tubes in racks........................................................................................................................ 4-20

Figure 4-16 : Correct position of tubes in rack ........................................................................................................ 4-20

Figure 4-17 : “Load Samples” screen...................................................................................................................... 4-21

Figure 4-18 : Load sample racks............................................................................................................................. 4-22

Figure 4-19 : “Preparing to start processing …” screen ..........................................................................................4-23

Figure 4-20 : Processing screen ............................................................................................................................. 4-24

Figure 4-21 : Barcode ............................................................................................................................................. 4-25

Figure 4-22 : Sample processing status.................................................................................................................. 4-26

Figure 4-23 : “Processing Complete” screen........................................................................................................... 4-27

Figure 4-24 : “Fatal Error” screen............................................................................................................................ 4-29

Figure 4-25 : “Shutdown Requested” window – instrument processing .................................................................. 4-30

Figure 4-26 : Opening guard and removing output cassette ................................................................................... 4-32

Figure 4-27 : Correct streaking patterns.................................................................................................................. 4-38

5 Quality Control

Figure 5-1 : Score determination.............................................................................................................................. 5-3

Figure 5-2 : Reference appearance ......................................................................................................................... 5-3

6 Information Technology Security

Figure 6-1 : Opening the Computer Management window........................................................................................ 6-2

Figure 6-2 : "Computer Management" screen........................................................................................................... 6-2

Figure 6-3 : "New User" screen................................................................................................................................. 6-3

Figure 6-4 : "New User" creation box ........................................................................................................................ 6-3

Figure 6-5 : "New User" creation box with data entered............................................................................................ 6-4

Figure 6-6 : "User Rights Management" screen ........................................................................................................ 6-5

Figure 6-7 : User “Properties" screen........................................................................................................................ 6-5

Figure 6-8 : "User properties" – " Member Of “ tab screen........................................................................................ 6-6

Figure 6-9 : "Select Groups" screen.......................................................................................................................... 6-6

Figure 6-10 : "Select Groups" screen (cont’d)........................................................................................................... 6-7

Figure 6-11 : "Select Groups" screen (cont’d)........................................................................................................... 6-7

Figure 6-12 : "Select Groups" screen (cont’d)........................................................................................................... 6-8

Figure 6-13 : "Select Groups" screen (cont’d)........................................................................................................... 6-8

Figure 6-14 : "Properties" screen – "Member Of" tab screen .................................................................................... 6-9

Figure 6-15 : "User Rights Management" screen.................................................................................................... 6-10

Figure 6-16 : "User Properties" - "General" tab screen ........................................................................................... 6-10

Figure 6-17 : "User Rights Management" screen.................................................................................................... 6-11

Figure 6-18 : " Windows Security" window................................................................................................................ 6-12

Figure 6-19 : "Change Password" window .............................................................................................................. 6-12

II-2 PREVI

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List of Figures

7 Data Backup, Restore and Audit Trail

Figure 7-1 : Event viewer shortcut ............................................................................................................................7-2

Figure 7-2 : “Event viewer” window........................................................................................................................... 7-2

Figure 7-3 : Event viewer “AS_Audit” window........................................................................................................... 7-3

Figure 7-4 : “Event Properties” window ..................................................................................................................... 7-3

Figure 7-5 : “Save Log File AS…” window ................................................................................................................ 7-4

Figure 7-6 : Save “AS_Audit” As… window............................................................................................................... 7-5

8 Maintenance

Figure 8-1 : Maintenance Menu.................................................................................................................................. 8-2

Figure 8-2 : Removing the tray under the input cassettes ............................................................................................ 8-4

Figure 8-3 : Removing the waste chute top................................................................................................................. 8-5

Figure 8-4 : Removing the process station drip tray..................................................................................................... 8-6

Figure 8-5 : Cleaning the pipettor ...............................................................................................................................8-7

Figure 8-6 : Drip tray to the right of the process station................................................................................................ 8-8

Figure 8-7 : Sample rack tray presented for cleaning................................................................................................... 8-9

Figure 8-8 : Applying cleaning solution ....................................................................................................................... 8-9

Figure 8-9 : Removing the sample spill tray .............................................................................................................. 8-10

Figure 8-10 : Lifting up the sample spill tray.............................................................................................................. 8-10

Figure 8-11 : Removing the tray under output cassettes............................................................................................ 8-11

Figure 8-12 : Removing the waste chute deflector ...................................................................................................8-12

Figure 8-13 : Waste chute deflector ........................................................................................................................ 8-12

Figure 8-14 : PREVI Isola Waste Bins in drawer....................................................................................................... 8-13

Figure 8-15 : Cleaning inside cassettes .................................................................................................................... 8-14

Figure 8-16 : Wiping inside cassettes ..................................................................................................................... 8-14

Figure 8-17 : Cleaning the process station.............................................................................................................. 8-15

Figure 8-18 : Reference block................................................................................................................................. 8-16

Figure 8-19 : Robot suction cups ............................................................................................................................8-16

Figure 8-20 : Cleaning the agar sensor................................................................................................................... 8-17

Figure 8-21 : Cleaning the platen............................................................................................................................ 8-18

Figure 8-22 : Print head ..........................................................................................................................................8-19

Figure 8-23 : Raising the roller arms ....................................................................................................................... 8-23

Figure 8-24 : Raising the release latches................................................................................................................ 8-23

Figure 8-25 : Removing the empty roll .................................................................................................................... 8-23

Figure 8-26 : Correct position of new roll ................................................................................................................ 8-24

Figure 8-27 : Using the guides ................................................................................................................................ 8-24

Figure 8-28 : Feeding label backing through the printer.......................................................................................... 8-25

Figure 8-29 : Instructions for loading labels on instrument touch-screen ................................................................ 8-25

Figure 8-30 : Pull mechanism slot (top view) .......................................................................................................... 8-26

Figure 8-31 : Label backing correctly pulled into the slot (top view)........................................................................ 8-26

Figure 8-32 : Lowering the roller arms ....................................................................................................................8-26

Figure 8-33 : Turning the label roll ..........................................................................................................................8-27

Figure 8-34 : Metal plate not to be removed ........................................................................................................... 8-27

Figure 8-35 : Label backing coming out of deflector ............................................................................................... 8-28

Figure 8-36 : Main power inlet fuses ....................................................................................................................... 8-29

9 Troubleshooting

Figure 9-1 : Event Log screen................................................................................................................................. 9-10

Figure 9-2 : Warning Message................................................................................................................................ 9-15

Figure 9-3 : Error Message ..................................................................................................................................... 9-15

Figure 9-4 : Fatal Message ..................................................................................................................................... 9-16

Figure 9-5 : PREVI Isola HEPA filter error message ..............................................................................................9-17

Figure 9-6 : Unlocking the latch .............................................................................................................................. 9-18

Figure 9-7 : Unhooking the latch ............................................................................................................................. 9-18

PREVI

Isola User Manual II-3

Page 20

List of Figures

Figure 9-8 : Preparing to place the PREVI Isola HEPA filter in a plastic bag.......................................................... 9-19

Figure 9-9 : Sliding the PREVI Isola HEPA filter out of its housing......................................................................... 9-19

Figure 9-10 : Removing the PREVI Isola HEPA filter from its housing ................................................................... 9-20

Figure 9-11 : Covering the PREVI Isola HEPA filter as it comes out of its housing ................................................ 9-20

Figure 9-12 : Covering the PREVI Isola HEPA filter until fully extracted................................................................. 9-20

Figure 9-13 : PREVI Isola HEPA filter in the plastic bag......................................................................................... 9-21

Figure 9-14 : New PREVI Isola HEPA filter in place ............................................................................................... 9-21

Figure 9-15 : Unscrew the pipettor barrel................................................................................................................ 9-23

Figure 9-16 : Cleaning the black pipettor piston...................................................................................................... 9-24

Figure 9-17 : Cleaning the inside of the pipettor barrel ...........................................................................................9-24

Figure 9-18 : Cleaning the outisde of the pipettor barrel ......................................................................................... 9-24

Figure 9-19 : Pipettor that has descended into a plate............................................................................................ 9-25

Figure 9-20 : Incorrect inoculation and streaking patterns ...................................................................................... 9-26

Figure 9-21 : “Database Anonymiser” screen .........................................................................................................9-27

Figure 9-22 : Database successfully anonymized................................................................................................... 9-27

11 Appendices

Figure 11-1 : Opening the “Services” window ......................................................................................................... 11-2

Figure 11-2 : “Services” window.............................................................................................................................. 11-2

Figure 11-3 : “DataServer” selection window .......................................................................................................... 11-3

Figure 11-4 : “Service Control” dialog box............................................................................................................... 11-3

Figure 11-5 : Selecting the “Start” link..................................................................................................................... 11-4

Screenshots and figures are given for information purposes only.

II-4 PREVI

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List of Tables

2. Description

Table 2-1 : Workstation software buttons............................................................................................................... 2-24

Table 2-2 : Alarm types .......................................................................................................................................... 2-26

Table 2-3 : Navigation/action bar buttons............................................................................................................... 2-27

4. Using the System

Table 4-1 : Plate cassettes status icons................................................................................................................... 4-9

Table 4-2 : Consumables status icons ................................................................................................................... 4-17

Table 4-3 : Waste bin filling level icons .................................................................................................................. 4-18

Table 4-4 : Sample processing status icons........................................................................................................... 4-26

PREVI

Isola User Manual III-1

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Page 23

1 How to use this Manual

This manual provides the appropriate instructions to install, operate and maintain the PREVI Isola.

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 PREVI Isola.

Finding topics and procedures

This manual is divided into 12 chapters.

Table of contents

List of figures

Page headers and page footers

Glossary

Warnings

The Table of Contents of the manual is located on pages I-1 to I-6. It lists each chapter and the procedures and/or topics contained in the chapter.

Pages II-1 to II-4 contain a list of the figures in this manual.

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 a procedure or its corresponding description.

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

The glossary is located in Chapter 12. It gives the definition of the main technical terms used in the manual.

Different types of warnings are used throughout the manual:

− For safety reasons (DANGER!).

− To ensure that the instrument is maintained in good working condition (CAUTION!).

− For regulatory reasons (WARNING!) or,

− For optimum performance of operations, procedures, etc. (IMPORTANT!).

Please also read the “General safety and regulatory information” booklet provided with the instrument.

PREVI

Isola User Manual 1-1

Page 24

Page 25

2 Description

Intended Use

The PREVI Isola is an automated device intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

System Capabilities

The PREVI Isola has been designed to allow the user:

− to load between 1 and 114 samples for processing,

− to load up to 150 plates.

The PREVI Isola:

− provides automated PPM inoculation,

− provides automated streaking of PPM,

− delivers 180 plates per hour of operation, based on a protocol of 2 plates/sample,

− ensures there is no possibility of cross-contamination during the process,

− is equipped with a PREVI Isola HEPA filter to avoid contamination in the laboratory

during processing.

PREVI

Isola User Manual 2-1

Page 26

Description

Sample

Workflow Principle

Specimen collection

Incubation

User

Specimen reception &

sample preparation

Laboratory Manager

Sample data

LIS

Sample data

Configuration

Figure 2-1 : Workflow Principle

2-2 PREVI

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System Architecture

Description

System Architecture

PREVI Isola

Instrument 1

PREVI Isola

Instrument 2

PREVI Isola

Instrument 3

Data Server

WORKSTATION

BCI

LIS

PREVI Isola

Instrument 4

Figure 2-2 : System Architecture

LIS

Laboratory Information System.

BCI

Workstation

Bi-directional Computer Interface, a bridge to LIS.

User interface application which runs on a PC that is separate from the instrument.

Data Server

The database holding amongst other things, the plate panel definitions, and the sample assignments.

PREVI Isola

The plate processing instrument.

Note: Four PREVI Isola instruments can be connected to a workstation.

PREVI

Isola User Manual 2-3

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Description

System Components

The main system components are:

− an instrument

− a standalone computer - workstation

with an internal computer and a touch-screen

− a UPS (optional)

− two types of cassettes (input

− five types of sample racks

, output )

− consumables (PREVI Isola Applicators, PREVI Isola Tips, PREVI Isola Labels,

PREVI Isola Waste Bins)

− a waste paper bin (for label backing)

Figure 2-3 : System Components

2-4 PREVI

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Workstation

Description

Note: Since the PREVI Isola system operates on a Microsoft Windows OS, it can be connected to

Description

Workstation

The workstation is composed of:

− 1 computer

− 1 screen

− 1 keyboard

− 1 mouse

− 1 barcode reader

− 1 printer (optional)

an external printer compatible with Microsoft Windows.

To validate this printer, please perform the Printer Verification Protocol, page 6-14.

PREVI

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Description

Instrument

Figure 2-4 : Front view of the PREVI Isola with covers on

Consumable lid

Provides access to the consumables tray for loading/unloading of tips and applicators.

Process station lid (nose cone and center cover).

Provides access to the processing area for wiping down the process stations.

Printer access door

Provides access for loading labels into the printer.

Output cassette guard

Sample lid

Provides access to the sample loading bay for loading/unloading of sample racks.

Waste drawer

CAUTION! The PREVI Isola contains moving mechanisms. Do not remove the process station lid

while the instrument is in operation.

2-6 PREVI

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Description

Instrument

Figure 2-5 : Front view of the PREVI Isola – front covers removed

Input cassette

Output cassette

LCD touch-screen and graphic user interface

Consumables tray

Plate process station

Sample loading bay with rack tray

Waste drawer

Label printer

PREVI

Isola User Manual 2-7

Page 32

Description

Instrument

Figure 2-6 : Back view of the PREVI Isola with covers on

Power connection socket

A standard socket for power connection is located on the lower right-hand side of the rear panel for connecting to main power. The power connection socket contains two fuses.

Power ON switch

The Power ON switch is located on the left-hand side of the PREVI Isola.

Rating plate

The rating plate details essential regulatory information.

Serial number

This number is unique to each instrument and should be quoted when requesting technical support.

PREVI Isola HEPA filter location

Wall bumpers

The two wall bumpers fitted to the rear of the instrument provide minimum safe spacing from the wall.

USB Ports

2-8 PREVI

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Sample racks

Description

Instrument

Test samples are loaded in racks designed to accept one of eight types of tubes, when the sample tray presents to the front right-hand side of the PREVI Isola.

Each type of rack has an associated aspiration height.

PREVI Isola Rack 1 PREVI Isola Rack 2

PREVI Isola Rack 4 PREVI Isola Rack 5

PREVI

PREVI Isola Rack 6 (Swab)

Figure 2-7 : Sample racks

Isola User Manual 2-9

Page 34

Description

Instrument

Sample tubes

Tubes compatible for use with the PREVI Isola

Tube Description Supplier’s

Sterilin (Barloworld) 2mL Tube NA2 1 2 48.5 1900 18

Greiner VITEK® 2 tube (same dimensions as Sarstedt Haemolysis Tube)

ESwab 480CE 6 1 80 1000 69

Sarstedt Monovette Tube*

Sarstedt 10 mL tube 62.9924.283 2 10

Becton Dickinson Vacutainer 364948 2 10

Starplex Urine Container B902.10 4 90

Sarstedt Pot TP 30-001 or

Part Number

69285 1 6 74.6 1900 48.9 2900 35.6

10.252 &

10.253

TP 30-004

Rack

Name

Volume

(ml)

2 10 102 6000 50 9000 24 15

5 40 69.2 18000 41 37000 10 29.8

Total

Height

(mm)

100 5500 50 9000 21 16

100 6500 45 10000 20 16

76 33000 50 70000 22 43

Min

Volume

µL

Min

Height

Max

Volume

µL

2500 5 11.5

4000 40 13

Max

Height

* IMPORTANT! With Sarstedt Monovette tubes, if the sample volume is small, the plunger should not

be pushed up over the 6 ml mark otherwise the pipettor will collide with the plunger.

Fill heights

The Maximum Fill Height (measured from the top of the tube) is defined so as not to pollute the pipettor body.

The Minimum Fill Height (measured from the top of the tube) is defined to enable the pipettor to aspirate 95

µL.

IMPORTANT! Tubes must never be filled above the maximum fill height as this would affect pipettor

performance.

Diameter

(mm)

12.8

Figure 2-8 : Fill heights

Prepoured media (Plates)

Plates compatible for use with the PREVI Isola

The instrument supports round plates and bi-plates with a 90 – 94 mm outer diameter and a total plate height of between 13.6 mm and 16 mm.

For plates with a nesting feature, please contact bioMérieux S.A. or your local bioMérieux representative.

2-10 PREVI

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Input cassettes

Description

Instrument

The PREVI Isola is equipped with five input cassettes. Input cassettes are blue.

Plates are loaded into the input cassettes agar-side up.

Each cassette is designed to hold up to 30 plates and the plates are loaded into the cassettes according to the agar type. The agar type is displayed on the PREVI Isola touch-screen as are the details of incubation requirements for completed plates.

Figure 2-9 : Input cassette – front Figure 2-10 : Input cassette – back

Handle

Cassette lock

Plate retention pin

Input cassette base

Plate level sensor window

IMPORTANT! Input cassettes will only fit in the input-side positions and output cassettes will only fit

in output-side positions.

PREVI

Isola User Manual 2-11

Page 36

Description

Instrument

Output cassettes

The PREVI Isola is equipped with three output cassettes. Output cassettes are yellow.

On completion of processing, plates are stored, agar-side up, according to the incubation type, in the output cassettes.

Each output cassette is designed to hold up to 30 plates.

Figure 2-11 : Output cassette - front Figure 2-12 : Output cassette - back

Handle

Cassette lock

Output cassette base

Plate level sensor window

IMPORTANT! Input cassettes will only fit in the input-side positions and output cassettes will only fit

in output-side positions.

Touch-screen

The PREVI Isola touch-screen is used to operate the instrument and inform the user of the progress of streaking and the availability of consumables.

Figure 2-13: Touch-screen

2-12 PREVI

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PREVI Isola Waste Paper Bin

The PREVI Isola includes a waste paper bin for the label backing.

Waste drawer

Description

Instrument

Figure 2-14 : PREVI Isola Waste Paper Bin

The waste drawer provides access to the PREVI Isola Waste Bins.

The instrument includes two different types of waste bins:

− one for biohazardous waste (PREVI Isola Tips and PREVI Isola Applicators),

− one for waste paper (label backing).

Waste applicators and tips are disposed of down a waste chute which ensures that the biocontaminated tips and applicators are disposed of properly.

PREVI

Figure 2-15 : Waste Drawer

Isola User Manual 2-13

Page 38

Description

Interlocks

The following PREVI Isola covers are equipped with interlocks for safety reasons:

− Consumable lid

− Process station lid

− Sample lid

− Output cassettes guard

− Printer access door

− HEPA filter latch

The process station lid should not be opened during operation.

The output cassette guard stops the instrument if it is opened during operation.

If the sample lid and consumable lid are opened during processing, a warning is generated but the instrument is not stopped.

CAUTION! Do not bypass interlock systems for any reason. Interlock systems are a safety feature

designed to protect the user from injury and the instrument from damage.

The waste drawer is not equipped with an interlock. Nevertheless, it should not be opened during processing.

2-14 PREVI

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Consumables

PREVI Isola Applicators

PREVI Isola Applicators are single use microbiological sample applicators designed to streak

agar plates

Note: PREVI Isola Applicators are designed for single use. The PREVI Isola automatically discards

used applicators to the PREVI Isola biohazardous Waste Bin. Discarded applicators may be biohazardous.

Description

Consumables

Figure 2-16 : PREVI Isola Applicator

PREVI Isola Applicator cartridge

PREVI Isola Applicator cartridges are pre-loaded with 120 PREVI Isola Applicators. They are

designed for single-use.

supplier

bioMérieux

Part Number

29509

PREVI

Figure 2-17 : PREVI Isola Applicator cartridge

Isola User Manual 2-15

Page 40

Description

Consumables

PREVI Isola Tips

PREVI Isola Tips supplier Part Number

bioMérieux

29508

The PREVI Isola

Tips are designed for single use (1 tip = 1 sample).

Figure 2-18 : PREVI Isola Tips in tray

Note: PREVI Isola Tips are designed for single use. The PREVI Isola automatically discards used

tips to the PREVI Isola biohazardous Waste Bin. Discarded tips may be biohazardous.

IMPORTANT! The PREVI Isola must be used with PREVI

PREVI Isola Labels

A barcode label (30mm x 25mm), machine and human readable, is applied to the base of each plate after completion of processing and prior to re-inversion of the base and reapplication of the lid.

IMPORTANT! The PREVI Isola must be used with PREVI Isola Labels only.

PREVI Isola Labels supplier Part Number

bioMérieux

PREVI Isola biohazardous Waste Bin

bioMérieux recommends the use of the following type of bin for biohazardous waste:

PREVI Isola biohazardous Waste Bin

supplier

bioMérieux 29718

Isola Tips only.

29720

Part Number

2-16 PREVI

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Page 41

PREVI Isola HEPA filter

The High Efficiency Particulate Air (HEPA) filter removes airborne particles from within the

PREVI Isola.

Description

Consumables

PREVI Isola HEPA filter supplier Part Number

bioMérieux 29711

PREVI

Isola User Manual 2-17

Page 42

Description

Instrument Operating Principle

Start Sample

Workflow

Index Next Sample

Read Sample Barcode

Start Plate

Workflow

Retrieve Input Plate

Transfer to Plate

Transfer Robot

Barcode?

Retrieve Sample Data

Sample data?

Pick up Tip

Aspirate Sample

Perform Plate Workflows

Wait for Plate Workflow

Completion

[Yes]

[No]

Transfer to

Process Station

Measure Agar Height

Height Check OK?

Dispense Sample

Pick up Applicator

Streak Plate

Discard Applicator

Bi-Plate?

[No]

[Yes]

[No]

Bad Plate

[Yes]

2nd Dispense Sample

2nd Pick up

Applicator

2nd Streak Plate

2nd Discard

Applicator

Dispose Tip

Transfer to Plate

Transfer Robot

End of Sample

Workflow

Label Plate

Transfer to

Output Robot

End of Plate

Workflow

Figure 2-19 : Simplified sample workflow

2-18 PREVI

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Page 43

Index next sample

Read sample barcode

Description

Instrument Operating Principle

The instrument indexes the next sample in the sample tray.

The sample tube is presented before an internal barcode reader in order to read the tube barcode and identify the sample.

The internal barcode reader can read the following barcode formats:

− UPC

− EAN

− JAN

− Code 128

− Code 39

− ITF

− Codabar

− Code 93

The quality of the barcode label can affect the scanning performance. Poor quality labels are more difficult to decode and may result in non-reads or potential misreads. The barcode label should be printed to specifications. This means that the bars are printed within spec, with the correct widths, no ink spread, crisp edges and no voids. There should be sufficient quiet zone (white space) on both ends of the barcode label. For best results, the paper or label stock should have matte finish to diffuse light. The print contrast signal (which is a comparison of the reflectance of the bars and the background stock) should be as high as practical.

The instrument is configured to work best with barcodes where the line width is between

7.5 and 10 mil. This is determined by the distance from the barcode scanner to the barcodes.

Each barcode label should be affixed vertically on an upright tube with a maximum alignment of +/- 4° in relation to the vertical axis of the tube.

The position of the label on the upright tube does not affect the reading. Preferably affix the label in the middle of the tube as indicated below.

PREVI

Figure 2-20 : Positioning a barcode label on a tube

A = Maximum label size which depends on the tube (see the following table).

B = Maximum barcode symbols size which depends on the tube (see the following table).

Isola User Manual 2-19

Page 44

Description

Instrument Operating Principle

Sterelin 2mL 1 48.5 24 19.5 17.5

Greiner VITEK® 2 1 74.6 49 45.6 43.6

ESwab 6 (Swab) 80 55 51 49

Tubes Rack

name

Tube Height

(mm)

A[mm] B[mm] for

(7.5mil)

B[mm] for

(10mil)

Retrieve sample data

Pick up tip

Sarstedt Monovette

2 102 77 73 71

Tube (10mL)

Sarstedt Tube (10mL) 2 100 75 71 69

BD Vacutainer (10mL) 2 100 75 71 69

Starplex Urine

4 76 51 47 45

Container (90mL)

Sarstedt Pot (40mL) 5 69.2 44 40.2 38.2

After reading the tube barcode, the instrument software requests the Data Server for sample Information in order to process the sample.

If the sample is identified, the Data Server returns the streaking parameters for this sample (i.e. plate panel and streaking protocol).

If the sample is not identified, it is skipped by the instrument and the instrument indexes the next sample.

The electronic pipettor is mounted on the pipettor robot. The pipettor robot picks up the tip to be used for sample aspiration.

Aspirate sample

Sample aspiration is performed by the electronic pipettor.

The pipettor using the tip, aspirates samples from pre-defined depths within sample tubes.

Before aspiration, the camera detects the presence of a tip. Should the camera report the absence of a disposable tip, the pipettor continues to return to the tip tray until a disposable tip is retrieved.

After aspiration, the camera detects the sample presence.

After aspiration the workflow continues with the processing of the plates for the sample.

2-20 PREVI

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Perform plate workflow

Retrieve input plate

The plate input robot (left-hand side) retrieves agar plates from the input cassettes for delivery to the plate transfer robot.

Transfer to plate transfer robot

The plate transfer robot accepts agar plates retrieved from the input cassette by the plate input robot.

Transfer to process station

The plate transfer robot removes the lids by suction, maintains lid orientation, inverts the base of the plates and delivers them to the process station for inoculation and streaking.

The plate process station holds the agar plates in position for ultrasonic detection of agar height and plate orientation (whole or half-plate presence) before inoculation and streaking can occur.

Measure agar height, dispense sample

An ultrasonic measurement device reports the distance between the tip and the agar plate and the pipettor then delivers the aspirated sample to the agar plate and disposes the tip to waste. The aspirated samples are delivered to the agar surface from an internally predefined height. The total volume dispensed is no more than 95 µL and the number of plates streaked with a single sample depends on the volume per plate which can be 10 µL or 20 µL.

Description

Instrument Operating Principle

Pick up applicator

Applicators are retrieved from the applicator cartridge by the applicator robot and positioned over an inoculated agar plate for streaking. An applicator presence sensor reports applicator presence.

Should the presence sensor report the absence of an applicator, the applicator robot continues to return to the applicator cartridge until a disposable applicator is retrieved.

The applicator is picked up at the same time as the agar height is measured and the sample dispensed.

Streak plate

The plate process station rotates to a maximum of 330° during the streaking process. Halfplate rotation is to a maximum of 110°.

Discard applicator

After plate streaking the applicator is discarded to waste.

If Bi – plate

If the processed plate is a bi-plate, the sample is dispensed a second time on the other half of the plate. The applicator robot picks up another applicator and the plate is streaked on the second half. When streaking is complete the applicator is discarded.

Transfer to transfer robot

On completion of inoculation and streaking, the plate transfer robot accepts the processed plate bases from the process station for barcode labeling, re-inversion of the bases and return of the lids.

The plates are then delivered to the plate output robot for stacking into the output cassettes agar side up.

PREVI

Isola User Manual 2-21

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Description

Instrument Operating Principle

Label plate

Plate barcode labeling is carried out by the barcode printer installed in the PREVI Isola below the plate transfer robot.

A barcode label is applied to the base of each plate after completion of processing and prior to re-inversion of the base and re-application of the lid.

Transfer to output robot

The plate output robot (right-hand side) transports processed plates from the plate transfer robot to the output cassettes.

Dispose of tip

On completion of the plate panel for a sample, the tip is disposed of by the pipettor robot into the biohazardous waste bin.

2-22 PREVI

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Workstation Software

Principle

The PREVI Isola needs to know what types of plates are to be streaked and what type of incubation atmosphere they require. This is defined by plate panels which are assigned to specimen types (see Assigning Plate Panels to Specimen Types, page 3-15) or samples (see Assigning Plate Panels to Samples, page 3-22).

If a plate panel has been assigned to a specimen type, it will automatically be assigned to all the samples of this specimen type when they are received from the LIS through BCI (see Automatically Assigning Plate Panels to Samples, page 3-18). However, this assignment can also be changed manually for individual samples (see Assigning Plate Panels to Samples, page 3-22).

The PREVI Isola also needs to know in which input cassette each plate type is available and which output cassette is assigned to each incubation type. This is defined by plate cassettes configurations (see Defining Plate Cassettes Configurations, page 3-19 and Selecting Plates, page 4-5).

The workstation software is an application running on the laboratory computer used to assign test panels to samples for processing by the PREVI Isola and to monitor sample processing status logs.

Description

Workstation Software

General screen layout

All the screens of the workstation software have the same general layout:

Figure 2-21 : General screen layout

PREVI

Each screen is composed of four parts:

Menu bar

Title and button bar

Working area

Status bar

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Description

Workstation Software

Menu bar

Title and button bar

The menu bar includes three menus with submenus:

Samples Configuration Help

− Assign Samples − Plate Panels − About

− Show Worklist − Specimen Types

− Plate Cassettes Configuration

− General Settings

The title and button bar displays the title of the submenu selected from the menu bar.

It also contains buttons to perform actions.

Button

Working area

Status bar

Name

Add a row Delete New Print Save Validate Undo

Table 2-1 : Workstation software buttons

The working area is different for each screen.

The status bar displays the user’s login and a button for quitting or changing users.

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Instrument Software

The instrument software allows the user to operate the instrument through a graphical interface.

Main screen and general layout

All the screens of the instrument software have the same general layout.

Description

Instrument Software

PREVI

Figure 2-22 : Main screen layout

Each screen is composed of five parts:

Alarm zone

Title bar

Navigation/action bar

Working area

Status bar

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Description

Instrument Software

Alarm zone

The alarm zone comprises four buttons, which correspond to four alarm types: Instrument, Connection, Consumables, Samples.

Alarm Type OK Warning Error

Instrument

Connection

(Instrument-Workstation)

Consumables

Title bar

Samples

Table 2-2 : Alarm types

When there is a warning or an error, the alarm button blinks.

When it blinks, the user should touch it to display the “Event Log” screen (see Event Log, page 9-10). The button will stop blinking.

The title bar contains either the status of the instrument (when the main screen is displayed):

− Ready

− Processing

− Pausing

− Paused

− Error

− etc.

or the purpose of the screen (when another screen is displayed).

Status bar

The two most recently generated messages are displayed in the status bar, along with the current time and date, and the instrument name (PREVI Isola).

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Navigation/action bar

The buttons in the navigation/action bar are used either to navigate to different screens, or to perform actions, or both.

The appearance of the buttons varies according to their status.

When a button is pressed, it becomes yellow. When it is disabled, it is greyed out.

Description

Instrument Software

Disabled

Pressed Enabled

The navigation buttons (except the Home button) are toggle buttons: when the user touches a navigation button to switch to a different screen (for example: the Samples Screen), the button remains pressed (it stays yellow), and if the user touches that button again, the software navigates back to the main screen.

Button Name Action

Home Navigates to the main screen.

Samples Navigates to the “Samples” screen and presents the sample tray for

loading/unloading (see Loading Sample Racks, page 4-21).

Plates Navigates to the “Plates” screen (see Selecting Plates, page 4-5).

Applicators & Tips Navigates to the “Applicators and Tips” screen and presents the

consumable tray for loading of applicators and tips (see Loading PREVI Isola Applicators, page 4-10).

Label Roll Navigates to the “Load Labels” screen and moves the plate transfer

robot out of the way of the printer so that the user has clear access to the printer (see Loading PREVI Isola Labels, page 4-15).

PREVI

Empty Waste Bin Only enabled when the main screen is displayed.

Start/Resume Processing

The user touches this button to signal the instrument software that the waste bin has been emptied (see Removing Waste, page 4-35).

Only enabled when the main screen is displayed.

It starts processing, or resumes processing after pause (see Processing Samples, page 4-23).

Pause Processing Pauses processing after completing the current samples (see

Pausing the Instrument, page 4-28).

Stop Processing Stops processing (see User-generated stop, page 4-31).

Maintenance Navigates to the “Maintenance” screen (see Presentation of the

Maintenance Menu, page 8-2).

Immediate stop/Shut down

Stops the instrument immediately and allows the user to choose whether to reinitialize it or shut it down (see Powering Down the Instrument, page 4-37).

Table 2-3 : Navigation/action bar buttons

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Description

Instrument Software

Working area

The working area is different for each screen.

The working area of the main screen is composed of three parts.

Figure 2-23 : Working area

Sample processing status

Plate cassette status

Consumables status

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3 Getting Started

Assembly and Installation

DANGER! The PREVI Isola must be installed by bioMérieux S.A. Technical Assistance or your

local bioMérieux representative.

CAUTION! Before unpacking the various PREVI Isola components, it is advisable to have

previously planned where they will be placed.

Choosing a location

WARNING! Avoid exposing the PREVI Isola to direct sunlight, excessive heat, humidity or dust. Leave sufficient space around the PREVI Isola (minimum 50 cm on each side and at the

rear of the instrument) to allow airflow and easy handling of the instrument. The rear of the instrument is equipped with wall bumpers to

Do not obstruct the hardware ventilation apertures.

prevent impacts with the wall.

Electrical connections

CAUTION! Nothing should be placed on top of connection cables, whether temporarily,

permanently or intermittently. Cables should not be laid across passage-ways. Computer cables must not intersect or be placed close to power supply cables. Cables should not be looped or knotted, or be rolled up near or on other electrical equipment.

Hazardous Magnetic Fields Precautions

WARNING! This product contains very strong permanent magnet arrays.

Extreme care should be taken when handling tools and other magnetic material in close proximity to the magnet arrays, as sudden high mechanical forces may be generated.

Magnetically sensitive items such as computer discs and tapes, audio and video cassettes, and credit cards should be kept well clear of the magnet arrays, as these items may be damaged by strong magnetic fields.

People wearing a pacemaker should not use this product, as the strong magnetic fields associated with this product may adversely affect or damage the pacemaker.

Moving the Instrument

WARNING! The instrument should be moved by personnel who are authorized to do so by

bioMérieux S.A.

Barcode Reader Installation

Sample barcodes can be entered manually or scanned using the hand-held barcode reader that is connected to the workstation.

For installation of the barcode reader, please refer to the installation procedure included in

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Isola User Manual 3-1

the barcode reader package.

Page 54

Getting Started

Installation of the PREVI Isola and BCI

Installation of the PREVI Isola and BCI software is performed by bioMérieux or your local bioMérieux representative.

Users are trained during installation of the PREVI Isola so that they are able to derive the best performance from the instrument.

WARNING! The different equipment, software, and configuration software (especially date, time,

language, keyboard type, and other formats) composing the PREVI Isola have been validated by bioMérieux additions to a configuration that do not correspond to one of the validated subunits can lead to malfunctions.

Checking installation

After the PREVI Isola has been installed, bioMérieux S.A. Technical Assistance or your local bioMérieux representative will perform a test to check that the system is operating correctly.

WARNING! If the equipment is used in a manner not specified in the instructions for use provided

by bioMérieux, the protection provided by the equipment may be impaired.

S.A. to function together as an integrated unit. Any changes or

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Getting Started

Powering up the Workstation

IMPORTANT! The workstation must be running when the instrument is in use and when the LIS

sends information to the PREVI Isola.

• Power up the workstation.

Initialization begins.

The Windows software opens:

The Windows loading screen is displayed,

• Enter your login and password.

The Windows session opens.

Connecting to BCI NET

For further information on how to use BCI NET, refer to the BCI NET User’s Manual.

IMPORTANT! BCI NET must be running when the instrument is in use and when the LIS sends

information to the PREVI Isola.

Connecting to BCI RS232

For further information on how to use BCI RS232, refer to the BCI RS232 User’s Manual.

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Getting Started

Starting the Workstation Software

• Open a Windows session.

• Start the workstation software by double-clicking on the application icon .

The login pop-up window is displayed.

Figure 3-1 : Login pop-up window

• Enter the user name and password which is the same as for Windows.

• Click “OK”.

The user is logged on and has access to the functions that are available to his/her group.

Entry of an incorrect user name or password

If an incorrect user name or password has been entered or if a user account has been locked, the following window is displayed:

Figure 3-2 : “Invalid user name / password” window

• Click “OK” to close the window.

• Enter a new user name and password to start the application.

IMPORTANT! After three unsuccessful attempts to enter the password, the user will not be able to

start the application as the account will have locked. It can only be unlocked by a user with Administrator or Power User privileges.

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Changing work sessions

Each user has a login and personal password which are required to open a work session on the workstation software.

If another person needs to use the instrument, they will have to open a work session on the workstation software using the login:

• Click in the status bar.

• Click “Logout” .

Getting Started

Starting the Workstation Software

The workstation software shutdown window is displayed:

Figure 3-3 : Workstation software shutdown window

The new login window is displayed.

Inactivity timeout

If the workstation software remains inactive for more than 15 minutes, it automatically logs out.

Any changes which have not been saved beforehand will be lost.

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Getting Started

Defining Plate Panels

The PREVI Isola needs to know what types of plates are to be streaked. This is defined by plate panels which are assigned to specimen types or samples.

The following screen is used to create Plate Types, Incubation Types and Plate Panels.

In the “Configuration” menu,

• Select “Plate Panels” to display the “Plate Panels” screen.

Figure 3-4 : “Plate Panels” screen

The “Plate Panels” navigation tree displays the list of all existing plate panels, sorted alphabetically.

By default, the first plate panel (if any) is selected and its composition is displayed in the table in the upper part of the screen.

The table in the lower part of the screen contains two tabs for creating plate types and incubation types.

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Creating a plate panel

• Click on the button.

Getting Started

Defining Plate Panels

The plate panel composition part of the screen is refreshed. The field name and the composition table are empty.

Figure 3-5 : Create a plate panel

• Enter the name of the desired plate panel.

The plate panel name must be unique and include up to 50 characters.

Note: It is recommended to enter names that will remind you of the types of specimens for which

this plate panel will be used.

A plate panel can only include 5 plate types.

• Fill the plate panel composition table.

To do this,

• Click on the button (1).

A row is added to the composition table.

The maximum number of rows accepted in the plate panel composition table is 5.

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Getting Started

Defining Plate Panels

Note: A plate type or incubation type can be selected using either the full name or the abbreviated

If more than the maximum number of rows is created, an error message is displayed.

Figure 3-6 : “Plate Panel” error message

• Select a plate type and an incubation type from the drop-down lists.

name.

If the lists do not contain the plate types and incubation types required, they can be created using the tables in the lower part of the screen (see page 3-11).

• Click on the button to cancel,

• Click to save the new plate panel.

If a field is not adequately filled i.e. missing mandatory information, or invalid contents, an error message is displayed and the invalid field is flagged ( ). Place the pointer on the icon to obtain more information about the error.

Figure 3-7 : “Invalid entry” error message

• Proceed in the same manner until the plate panel is complete.

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Getting Started

Defining Plate Panels

Modifying a plate panel

IMPORTANT! Only plate panels that are not in use (i.e. not assigned to any specimen types or

samples, or only to samples no longer in the database) can be modified.

• In the “Configuration” menu, select “Plate Panels” to display the “Plate Panels” screen.

• Click on a plate panel in the navigation tree.

The selected plate panel is displayed in the plate panel composition part of the screen.

• Modify the name and/or the composition of the plate panel: you can add rows by clicking

You can also select a different plate type or incubation type for an existing row.

Note: If you try to modify a plate panel that is in use, an error message is displayed: “This plate

panel cannot be modified as it is in use” and the change is cancelled.

and delete rows by clicking on .

• Click on the button to cancel,

• Click on the button to save the modified plate panel.

The plate panel screen is refreshed and the name of the modified plate panel is updated in the navigation tree.

Deleting a plate panel

IMPORTANT! Only plate panels that are not in use (i.e. not assigned to any specimen types or

samples, or only to samples no longer in the database) can be deleted.

• In the “Configuration” menu, select “Plate Panels” to display the “Plate Panels” screen.

• Click on a plate panel in the navigation tree.

The selected Plate Panel is displayed in the plate panel composition part of the screen.

PREVI

• Click on the button in the title and button bar to delete the plate panel.

A confirmation message is displayed:

Figure 3-8 : “Delete a plate panel” confirmation message

• Click “OK” to confirm deletion of the plate panel.

The “Plate Panel” screen is refreshed.

The deleted plate panel is removed from the navigation tree, the first plate panel (if any) is selected and its composition is displayed in the upper part of the screen.

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Getting Started

Defining Plate Panels

Printing a plate panel

To print plate panels,

• Click on the button.

The selected plate panels or all the plate panels depending on the choice, are displayed in a “Print Preview” window.

A plate panel printing selection window is displayed:

Figure 3-9 : “Plate Panel Printing” selection window

Figure 3-10 : Plate panel “Print Preview” window

• Click on the “Print” button in the “Print Preview” window.

A printing dialog box is displayed.

• Select a printer and click “OK”.

The report is printed.

• Close the “Print Preview” window.

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Defining Plate Types

Getting Started

Defining Plate Types

Creating a plate type

Note: If possible, to reduce the risk of errors, it is recommended to use the code that is printed on

Figure 3-11 : “Plate Panels” plate types screen

In the “Configuration” menu,

• Select “Plate Panels” to display the “Plate Panels” screen.

• Click on the “Plate Types” tab.

In the “Plate Types” tab,

• Click on the button (1).

A row is added to the end of the plate type table.

• Enter the abbreviated plate type name.

The abbreviated plate type name must be unique and include up to 4 characters.

the plates.

• Enter the plate type composition.

The plate type composition must be unique and include up to 50 characters.

• Select the “Geometry” from the drop-down list.

PREVI

• Click on the button to cancel,

• Click to save the new plate panel.

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Getting Started

Defining Plate Types

• Proceed in the same manner until the plate panel is complete.

Modifying a plate type

To modify an abbreviated plate type name and composition,

• Click in the field to modify and then enter the new name.

Modification of the geometry name is not allowed.

Deleting a plate type

Only plate types which are not used by at least one plate panel or plate cassettes configuration can be deleted.

• Select a plate type.

• Click on the button to delete the plate type.

The “Plate Panel” screen is refreshed. The deleted plate type is removed from the plate type table and the next plate (if any) is selected.

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Defining Incubation Types

In the “Configuration” menu,

• Select “Plate Panels”.

In the “Plate Panels” screen,

• Click on the “Incubation Type” tab.

The “Incubation Types” table contains the list of all the existing incubation types.

Getting Started

Defining Incubation Types

Creating an incubation type

In the “Incubation Types” tab,

• Click on the button (1).

A row is added to the end of the incubation type table.

• Enter the abbreviated incubation type name.

The abbreviated incubation type name must be unique and include up to 4 characters.

Note: It is recommended to use names that remind you of the incubator in which the plates will be

loaded.

• Enter the full incubation type name.

The full incubation type name must be unique and include up to 50 characters.

Figure 3-12 : Define incubation types

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Getting Started

Defining Incubation Types

• Click on the button to cancel,

• Click on in the title and button bar to save the new incubation types.

Figure 3-13 : Incubation types

• Proceed in the same manner for all the incubation types to be created.

Modifying an incubation type

IMPORTANT! Only incubation types that are not used by at least one plate panel or plate cassettes

configuration can be modified.

• Select the incubation type to modify.

• Modify its abbreviated name and/or its full name.

• Click on the button to cancel,

• Click on the button to save the modified incubation type.

Deleting an incubation type

IMPORTANT! Only incubation types that are not used by at least one plate panel or plate cassettes

configuration can be deleted.

• Select an incubation type.

• Click on the button to delete the incubation type.

The incubation types table is refreshed. The deleted incubation type is removed from the incubation types table and the next row (if any) is selected.

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Assigning Plate Panels to Specimen Types

The PREVI Isola needs to know what types of plates are to be streaked. This is defined by plate panels which are assigned to specimen types or samples.

Due to the limitation of the maximum sample volume pipetted, certain streaking protocols are not compatible with certain plate panels.

In the “Configuration” menu,

• Select “Specimen Types”.

The following screen is used to assign plate panels to specimen types.

Getting Started

Figure 3-14 : “Specimen Types” screen

If a plate panel has been assigned to a specimen type, it will automatically be assigned to all the samples of that specimen type when they are received from the LIS. (see Automatically Assigning Plate Panels to Samples, page 3-18).

To have different plate panels for the same specimen type depending on other data, e.g. age of patient, result of another test, use the specimen details field.

A row must be created for each specimen type to process on the PREVI Isola (or several rows if different plate panels are required according to the specimen details).

• Click on the button.

A row is added to the end of the specimen type table.

If a field is not adequately filled i.e. missing mandatory information, or invalid contents, an error message is displayed and the invalid field is flagged ( ). Place the pointer on the

icon to obtain more information about the error.

• Enter the name and LIS code of the specimen type.

The specimen type name must be unique and include up to 40 characters and the LIS code must be unique and include up to 10 characters.

• Select a streaking protocol from the drop-down list.

There is one streaking protocol per specimen group (urine, feces, swabs, blood, liquid respiratory, enrichment broth, quality control).

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Getting Started

Assigning Plate Panels to Specimen Types

• Select a plate panel from the drop-down list (if the required plate panel is not found, it

must be created: see Creating a plate panel, page 3-7).

• The composition of the selected plate panel is displayed in the plate panel composition

table in the lower part of the screen.

• If specimen details are required, proceed in the same way, but fill the specimen details

field. The specimen details must be unique and include up to 40 characters and the LIS code must be unique and include up to 10 characters.

To delete a specimen type and/or specimen details,

• Select the row to delete and click on the button.

Note: Only specimen types/specimen details which are not in use (i.e. not assigned to any samples

or only to samples no longer in the database) can be deleted.

When deleting a specimen type, all the specimen details associated with it must be deleted beforehand.

The specimen types table is refreshed.

The deleted specimen type is removed from the specimen types table and the next row (if any) is selected.

• Click on the button to cancel,

• Click on the button to save changes.

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Printing plate panels assigned to specimen types

To print plate panels assigned to specimen types,

• Click on the button.

The report is displayed in a “Print Preview” window.

Getting Started

Assigning Plate Panels to Specimen Types

Figure 3-15 : Specimen types “Print Preview” window

• Click on the “Print” button in the “Print Preview” window.

A printing dialog box is displayed.

• Select a printer and click “OK”.

The report is printed.

• Close the “Print Preview” window.

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Getting Started

Automatically Assigning Plate Panels to Samples

The software will consult the specimen types table for each sample received from the LIS (see Assigning Plate Panels to Specimen Types, page 3-15).

It will first take into account the specimen details to assign a plate panel to a sample.

If the specimen details have not been sent by the LIS, it will assign the plate panel defined for the specimen type to the sample, if any.

If no row has been created in the specimen types table for specimen details, the plate panel defined for the specimen type will be used, if any.

However, if a row has been created for specimen details with a “<not defined>” plate panel, the plate panel of the specimen type will not be used. This ensures that certain specimen details will not be taken into account by the PREVI Isola unless they are assigned plate panels manually.

Examples:

1. In this case:

If the Specimen Details field is not filled in for the urine sample, it will not be processed.

2. In this case:

If the Specimen Details field is not filled in for the urine sample, it will be processed like a positive urine.

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Defining Plate Cassettes Configurations

The PREVI Isola needs to know in which input cassette it can find each type of plate. This is defined by plate cassettes configurations.

The plate cassette configurations are created using the workstation software and are then selected on the instrument touch-screen.

IMPORTANT! If a plate type is used in several plate cassettes configurations, it is recommended if

possible, to always assign it to the same input cassette. This will reduce the number of manipulations and the risk of error.

It is also recommended to assign incubation types to the same output cassettes to reduce the risk of error.

In the “Configuration” menu,

• Select “Plate Cassettes”.

The “Plate Cassettes Configuration” screen is displayed.

Creating a plate cassettes configuration

Getting Started

Defining Plate Cassettes Configurations

• Click on the button.

The “Plate Cassettes Configuration” screen is refreshed. All the fields are empty.

PREVI

Figure 3-16 : “Plate Cassettes Configuration” screen

• Enter a name for the new plate cassettes configuration.

The plate cassettes configuration name must be unique and include up to 50 characters.

Note: It is recommended to use names that remind you of the types of specimens that can be

processed with this plate cassettes configuration.

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Getting Started

Defining Plate Cassettes Configurations

• Select a plate type from the drop-down list for each input cassette.

• Select an incubation type from the drop-down list for each output cassette.

Note: A plate type or incubation type can be selected using either the full name or the abbreviated

name.

Figure 3-17 : New plate cassettes configuration

• Click to save the new plate cassettes configuration,

• Click on the button to cancel.

Figure 3-18 : “Invalid Input” error message

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Modifying a plate cassettes configuration

• In the “Configuration” menu, select “Plate Cassettes” to display the “Plate Cassettes

Configuration” screen.

• Click on a plate cassettes configuration in the navigation tree.

The selected plate cassettes configuration name and composition are displayed.

• Modify the name and/or the composition of the plate cassettes configuration.

• Click on the button to cancel,

• Click on the button to save the modified plate cassettes configuration.

The plate cassettes configuration screen is refreshed and the name of the modified plate cassettes configuration is updated in the navigation tree.

Getting Started

Defining Plate Cassettes Configurations

Deleting a plate cassettes configuration

• In the “Configuration” menu, select “Plate Cassettes” to display the “Plate Cassettes

Configuration” screen.

• Click on a plate cassettes configuration in the navigation tree.

The selected plate cassettes configuration name and composition are displayed.

• Click on the button in the title and button bar to delete the plate cassettes

configuration.

A confirmation message is displayed:

Figure 3-19 : “Delete a plate cassettes configuration” confirmation message

• Click “OK” to confirm deletion of the plate cassettes configuration.

The “Plate Cassettes Configuration” screen is refreshed.

The deleted plate cassettes configuration is removed from the navigation tree.

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Getting Started

Assigning Plate Panels to Samples

Plate panels are normally automatically assigned to samples when the sample data are received from the LIS (see Automatically Assigning Plate Panels to Samples, page 3-18).

This assignment is based on specimen types and details (see Assigning Plate Panels to Specimen Types, page 3-15). However, this assignment can also be changed manually for individual samples.

Manual assignment of plate panels to samples is also used for quality control.

In the “Samples” menu,

• Select “Assign Samples” to display the “Sample Assignment” screen.

The “Sample Assignment” screen is displayed.

Figure 3-20 : “Sample Assignment“ screen

• Select a streaking protocol and a plate panel using the drop-down lists at the top of the

screen.

• Scan the barcode on the sample tube.

• Alternatively, you can enter the barcode manually and click on the button or the

<Enter> key.

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Getting Started

Assigning Plate Panels to Samples

The samples will be added to the table.

Figure 3-21 : “Sample Assignment“ screen with sample

• Proceed in the same manner for each sample.

• Click on the button to cancel,

• Click on the button to save.

The samples disappear from the table and can be viewed in the worklist screen (see Viewing and Printing Worklists, page 3-24).

Note: The drop-down lists include two special values: “default” and “not defined”. “Default” allows

you to cancel a manual assignment and revert to the default plate panel and streaking protocol of the specimen type. ”Not defined” should only be used if you do not want the instrument to process a sample.

IMPORTANT! If an incorrect streaking protocol or plate panel is assigned to a sample which is then

processed, the sample will have to be reprocessed. However, before it is reprocessed, it must be given a new sample ID. The barcode on the sample tube must be modified to include this new sample ID.

To process the same specimen ID with different sample IDs, contact bioMérieux.

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Getting Started

Viewing and Printing Worklists

The “Worklist” screen is used to view a list of samples with their processing state, in particular to check that all samples for which data have been received from the LIS have been processed successfully.

In the “Samples” menu,

• Select “Show Worklist”.

The “Worklist” screen is displayed.

Figure 3-22 : “Worklist” screen

Data can be filtered according to the specimen collection date, specimen type, processing state or sample ID.

• Select the criteria and then,

• Click .

Columns can be moved by dragging and dropping.

Rows can be sorted by clicking on the header of the corresponding column.

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Getting Started

Viewing and Printing Worklists

To print a worklist,

• Click on the button.

The report is displayed in a “Print Preview” window.

Figure 3-23 : Worklist “Print Preview” window

• Click on the “Print” button in the “Print Preview” window.

A printing dialog box is displayed.

• Select a printer and click “OK”.

• Close the “Print Preview” window.

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Getting Started

General Settings

In the “Configuration” menu,

• Select “General Settings”.

The “General Settings” screen is displayed.

Figure 3-24 : “General Settings” screen

The following parameters can be defined in the “General Settings” screen:

Data retention period (days)

This defines the number of days that data are stored in the database after the most

recent modification.

Archive time of day

This defines the time at which archiving will be performed.

Archiving should be programmed to occur when the instrument is not in use and when the antivirus full scan is not running.

Logout timeout (min)

This defines the period of inactivity (in minutes) after which the user will be logged off

from the application.

BCI Configuration

The BCI configuration is done by bioMérieux at installation and should not be modified

by the user.

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4 Using the System

Basic Workflow

Power Up

Check and Load Consumables

Applicators

Pipettor Tips

Labels

Waste Bins

Load Plates

Prepare Samples

Load Samples

Process Samples

Unload

Samples

Plates

Waste

Pause

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Power Down

Figure 4-1 : Basic workflow diagram

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Using the System

Starting the System

IMPORTANT! The workstation must be running when the system is started (see Powering up the

Workstation, page 3-3).

The PREVI Isola system is started as follows:

− The UPS is powered up (optional device).

− The instrument is powered up.

− The internal computer starts up automatically.

− The instrument software starts.

− The system initializes.

Powering up the instrument

Before initialization,

− All the instrument covers must be closed.

− All the input and output cassettes must be in place on the instrument.

− The waste drawer must be closed.

CAUTION! Input and output cassettes must not be removed during initialization.

• Put the power switch on the instrument in the “I” position.

Figure 4-2 : Powering up the instrument

CAUTION! In case of emergency, switch off the power at the power switch.

Screensaver

If the instrument user interface is not used for a period of time, the screen will become black.

• Simply touch the screen and the main screen will appear.

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Using the System

Starting the System

After the computer completes initialization, the main screen (see Main screen and general layout, page 2-25) appears:

PREVI

Figure 4-3 : Main screen

The instrument is now in “Ready” status.

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Using the System

Prerequisites for Sample Processing

Samples must be in liquid form. Samples not in liquid form must be prepared as outlined in Sample Preparation, on page 4-19.

Samples must be in compatible tubes (see Sample tubes, page 2-10). If a sample is not received in a compatible tube it must be transferred.

Samples for processing must be barcoded in a format accepted by the instrument (see Read sample barcode, page 2-19).

Pre-start Checks

• Check that the instrument is in “Ready” status.

• Make sure that there are sufficient consumables to process samples (see pages 4-5 to

4-15)

• Make sure that the PREVI Isola Waste Bins are in place and empty (see Removing

Waste, page 4-35).

• Select the appropriate plate cassettes configuration and load the corresponding plates

into the input cassettes (see Selecting Plates, page 4-5).

• Make sure that output cassettes are empty (see Unloading Processed Plates,

page 4-32).

IMPORTANT! Please refer to the package inserts for use of the plates and consumables.

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Selecting Plates

IMPORTANT! Please refer to the package inserts for use of the plates.

Note: For information on compatible plates, refer to Plates compatible for use with the PREVI Isola,

page 2-10.

The instrument status should be “Ready” before changing the plate cassettes configuration.

Before loading plates, it is necessary to select the plate cassettes configuration. To do this,

• Touch the button on the instrument touch-screen to display the “Select Plates”

screen:

Using the System

Selecting Plates

PREVI

Figure 4-4 : “Select Plates” screen

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Using the System

Selecting Plates

The “Current Plate Cassettes Configuration” is displayed.

To select a different plate cassettes configuration,

• Scroll using the and buttons in the “New Plate Cassettes Configuration”

zone

• Touch the button to accept the “New Plate Cassettes Configuration”.

The new plate cassettes configuration will now be displayed in the “Current Plate Cassettes Configuration” zone.

• Touch the button to return to the main screen.

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Loading Plates

To load plates,

• Remove the input cassette.

IMPORTANT! Make sure that the plates are not contaminated.

Plates must be loaded upside down (agar side up).

The user is responsible for ensuring that the appropriate plate types are loaded into the correct input cassette.

Using the System

Loading Plates

Figure 4-5 : Load plates agar-side up

• Put the input cassette back in place on the instrument.

IMPORTANT! Make sure the input cassettes are properly installed otherwise the instrument will not

be able to start processing.

Before starting sample processing, ensure that the output cassettes are empty and properly installed.

Loading plates during processing

During processing, the instrument monitors the plates remaining in the input cassettes. If the instrument considers there are not enough plates to process the next sample, it will display an alarm message and will pause.

• Remove the empty input cassette.

• Load plates and put the input cassette back in place.

To resume processing,

• Touch the button on the main screen.

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Using the System

Loading Plates

Loading plates without removing the input cassette

Plates can be loaded at any time without removing the input cassettes.

Figure 4-6 : Loading plates without removing the input cassette

DANGER! Do not put your hands into the lower part of the input cassette while the instrument

is operating.

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Plate cassettes status

The input and output cassettes status is displayed on the main screen.

The name of the selected plate cassettes configuration is displayed at the top.

For each input cassette, the abbreviated name of the assigned plate type is displayed.

For each output cassette, the abbreviated name of the assigned incubation type is displayed.

The cassettes status is refreshed in real-time during processing.

Using the System

Loading Plates

Figure 4-7 : Main screen – “Cassettes status”

An image shows the level of plates in each input or output cassette:

Unknown Empty Nearly full/empty Full

Table 4-1 : Plate cassettes status icons

When an input cassette is nearly empty, the remaining number of plates is displayed above the image.

When an output cassette is nearly full, the instrument displays how many plates can still be inserted.

When an input cassette is removed, the status of all the input cassettes becomes “Empty”.

When an output cassette is removed, the status of all the output cassettes becomes “Full”.

During processing, when the level of plates falls below the sensor, the PREVI Isola considers that there are 5 plates remaining in the input cassette and starts counting down.

Note: If an error occurs, this 5-plate count is lost and the input cassette is considered to be empty.

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Using the System

Loading PREVI Isola Applicators

PREVI Isola Applicator cartridges should be replaced whenever they are empty.

The instrument status should be “Ready” or “Paused” before loading applicators.

To load a new applicator cartridge:

• Touch the button on the instrument touch-screen to display the “Load Applicators

and Tips” screen.

The consumables tray is presented for loading of applicators and tips.

Figure 4-8 : “Load Applicators and Tips” screen

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Using the System

Loading PREVI Isola Applicators

DANGER! Personal protective equipment must be worn when loading applicators.

• Open the consumable lid.

• Release the top lock by pulling it forward.

Figure 4-9 : Pulling the top lock

• Remove and dispose of the used applicator cartridge.

• Open the applicator cartridge packaging.

• Check that the applicator cartridge is not damaged.

• Insert a new applicator cartridge by pulling the top lock forward and then pushing the

cartridge down .

Figure 4-10 : Inserting the cartridge

When the cartridge is fully inserted,

PREVI

• Release the top lock.

• Check that the top lock is holding the cartridge in place.

CAUTION! Do not pinch your fingers in the applicator cartridge holder.

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Using the System

Loading PREVI Isola Applicators

IMPORTANT! Always load FULL applicator cartridges.

• Close the consumable lid.

IMPORTANT! Make sure the consumable lid is properly closed otherwise the instrument will not be

able to start processing.

• Touch the button to indicate that the applicator cartridge has been changed,

• Touch the button to go back to the previous status, in case of error.

• Touch the button to return to the main screen.

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Loading PREVI Isola Tips

PREVI Isola Tips should be replaced whenever a tip tray is empty.

The instrument status should be “Ready” or “Paused” before loading tips.

To load tips:

• Touch the button on the instrument touch-screen to display the “Load Applicators

and Tips” screen.

The consumables tray is presented for loading of applicators and tips.

Using the System

Loading PREVI Isola Tips

PREVI

Figure 4-11 : “Load Applicators and Tips” screen

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Using the System

Loading PREVI Isola Tips

• Open the consumable lid.

• Remove the empty tip tray and discard it.

• Take the new tip tray out of its packaging.

• Remove the lid on the new tip tray.

• Load the new tip tray containing the tips.

Figure 4-12 : Inserting the PREVI Isola Tip tray

IMPORTANT! Use of PREVI Isola Tips is mandatory.

Always load FULL tip trays.

Make sure that the tip tray is correctly loaded.

• Close the consumable lid.

IMPORTANT! Make sure the consumable lid is properly closed otherwise the instrument will not be

able to start processing.

• Touch the button to indicate that the tip tray has been changed,

• Touch the button to go back to the previous status, in case of error.

• Touch the button to return to the main screen.

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Loading PREVI Isola Labels

The instrument status should be “Ready” or “Paused” before loading PREVI Isola Labels.

To load labels:

• Touch the button on the instrument touch-screen to display the “Load Labels”

screen.

Using the System

Loading PREVI Isola Labels

PREVI

Figure 4-13 : “Load Labels” screen

• Open the process station lid.

• Open the printer access door.

• Follow the instructions in Loading PREVI Isola Label Rolls, page 8-23.

• Close the printer access door and then close the process station lid.

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Using the System

Loading PREVI Isola Labels

IMPORTANT! Do not leave any labels stuck on the printer.

• Touch the button to indicate that the label roll has been changed.

The printer will print a test label.

• Open the printer access door and remove the test label.

• Press the black feed button on the printer to pull the paper through.

• Close the printer access door.

• Touch the button to go back to the previous status, in case of error.

Make sure the process station lid and printer access door are properly closed otherwise the instrument will not be able to start processing.

If the printer’s top cover is not properly closed and even if the green indicator light is on, blank labels will be printed. Close the cover firmly (audible click).

• Touch the button to return to the main screen.

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Monitoring Consumables and Waste Bins Status

The consumables status is displayed on the main screen.

Figure 4-14 : "Main screen – consumable status"

The status area is divided into four zones which show the status of applicators, tips, labels and waste bins.

Using the System

Consumables

The stock level of each type of consumable is indicated.

Applicators Tips Label rolls

Full

Sufficient

Nearly Empty

Empty

Unknown

PREVI

Table 4-2 : Consumables status icons

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Using the System

Monitoring Consumables and Waste Bins Status

PREVI Isola Waste Bins

The instrument includes two types of Waste Bins,

− one for biohazardous waste (PREVI Isola Tips and PREVI Isola Applicators)

− one for waste paper (label backing).

Only the filling level of the PREVI Isola biohazardous Waste Bin is monitored.

Empty Low High Full

If the biohazardous waste bin is full, the instrument displays a warning to tell the user to empty it. The instrument will complete processing. The user will have to remove the waste before being able to start a new run.

The determination of waste bin full is made by counting the number of tips and applicators dropped to waste and comparing this to predefined maximum levels for high and full.

Table 4-3 : Waste bin filling level icons

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Using the System

Sample Preparation

DANGER! All organism suspensions should be considered as potentially infectious. Qualified

laboratory personnel should take the usual precautions for biohazardous material.

The PREVI Isola has been designed to inoculate PPM with liquid microbiological samples.

IMPORTANT! Samples must be thoroughly homogenized before being placed in the sample rack.

Swabs, solid and semi-solid specimens must be prepared so that a liquid sample is presented to the instrument in the recommended types of containers (see Recommended procedures below).

The recommended sample volumes must be respected (see page 2-10).

IMPORTANT! Tubes must never be filled above the maximum fill height as this would affect the

pipettor performance.

Once they have been prepared, samples can be kept for up to 40 minutes before processing.

IMPORTANT! The instrument allows isolated colonies to be obtained for samples with a

concentration of microorganisms between 10

and 108 CFU/ml.

Recommended procedures

Urine

• bioMérieux recommends the use of PREVI Isola Rack 2, 4 and 5 tubes (see Sample

racks, page 2-9).

Feces

• In order to obtain a liquid suspension, collect 1 to 2 g of feces and emulsify in 2.5 ml of

VITEK

Saline solution (bioMérieux ref. V1204 or V1211) in a VITEK 2 tube (bioMérieux

ref. 69285).

If a vortex is used,

• Place a cap on the tube beforehand.

• Leave to settle for about 3-5 minutes before processing the sample.

Dry mono swab

• Carefully rotate the swab in a VITEK 2 tube (bioMérieux ref. 69285) containing 2 ml of

VITEK Saline solution (bioMérieux ref. V1204 or V1211).

Swab in a liquid transport medium

• Squeeze and rotate the swab within the fluid.

• Use the swab to prepare any microscope slides.

• Discard the swab.

Swab in gel transport medium

• Squeeze and rotate the swab in a VITEK 2 tube (bioMérieux ref. 69285) containing 2 ml

Blood

of VITEK Saline solution (bioMérieux ref. V1204 or V1211).

• Carefully transfer 2.5 ml of blood culture into a VITEK 2 tube (bioMérieux ref. 69285).

IMPORTANT! Follow good laboratory practices when handling blood culture bottles.

Liquid respiratory samples

• Viscosity similar to water must be obtained for liquid respiratory samples. For instance,

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use a digester solution.

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Using the System

Placing Sample Tubes in Racks

• Check that the sample volume corresponds to requirements (see Fill heights, page 2-10)

and load uncapped sample tubes in the appropriate sample rack.

IMPORTANT! Only recommended sample tube types should be used (see Tubes compatible for use

with the PREVI Isola, page 2-10).

Figure 4-15 : Sample tubes in racks

• Ensure the sample tube barcode is facing the gap in the rack.

Note: The first tube that will be processed is located in the rack closest to the back of the tray in the

position furthest to the left.

Figure 4-16 : Correct position of tubes in rack

IMPORTANT! Check that all the sample tubes have been labeled.

Ensure the sample tube barcode is facing the gap in the rack. If the label is not correctly positioned, the sample will not be taken into account.

Ensure that the sample tubes are placed in the correct racks.

CAUTION! To avoid damage to the pipettor, ensure that the tubes are properly seated in the base

of the rack.

Check that the sample tube caps have been removed.

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Loading Sample Racks

The instrument status should be “Ready” before loading sample racks.

To load sample racks:

• Touch the button on the instrument touch-screen to display the “Load Samples”

screen.

Using the System

Loading Sample Racks

PREVI

Figure 4-17 : “Load Samples” screen

The sample tray presents for loading of sample racks.

• Open the sample lid.

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Using the System

Loading Sample Racks

IMPORTANT! Ensure that the racks are level and seated securely on the sample tray.

• Load the sample racks with barcodes facing forwards.

Figure 4-18 : Load sample racks

Note: Partial filling of racks is acceptable – the instrument will determine that a sample tube location

is empty as it will not read a barcode at that location.

When the sample racks have been loaded:

• Close the sample lid.

IMPORTANT! Make sure the sample lid is properly closed otherwise the instrument will not be able to

start processing.

• Touch the button to return the system to the main screen.

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Biomerieux Previ Isola User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

USER MANUAL

Revisions

Table of Contents

List of Figures

List of Tables

Finding topics and procedures

Warnings

Intended Use

System Capabilities

Workflow Principle

System Architecture

System Components

Workstation

Description

Instrument

Sample racks

Sample tubes

Tubes compatible for use with the PREVI Isola

Fill heights

Prepoured media (Plates)

Input cassettes

Output cassettes

PREVI Isola Waste Paper Bin

Waste drawer

Interlocks

Consumables

PREVI Isola Applicators

PREVI Isola Applicator cartridge

PREVI Isola Tips

PREVI Isola Labels

PREVI Isola biohazardous Waste Bin

PREVI Isola HEPA filter

Instrument Operating Principle

Index next sample

Read sample barcode

Retrieve sample data

Pick up tip

Aspirate sample

Perform plate workflow

Retrieve input plate

Transfer to plate transfer robot

Transfer to process station

Measure agar height, dispense sample

Pick up applicator

Streak plate

Discard applicator

If Bi – plate

Transfer to transfer robot

Label plate

Transfer to output robot

Dispose of tip

Workstation Software

Principle

General screen layout

Menu bar

Title and button bar

Working area

Status bar

Instrument Software

Main screen and general layout

Alarm zone

Title bar

Status bar

Navigation/action bar

Working area

Assembly and Installation

Choosing a location

Electrical connections

Hazardous Magnetic Fields Precautions

Moving the Instrument

Installation of the PREVI Isola and BCI

Checking installation

Powering up the Workstation

Connecting to BCI NET

Connecting to BCI RS232

Starting the Workstation Software