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33 (0)4 78 87 20 00 Seizan Bldg., Media Square fax 33 (0)4 78 87 20 90 12-28 Kita-Ayoama 2-chome 18-19 Place des Carabiniers http://www.biomerieux.com Minato-ku, Bruxelles 1030 Tokyo 107-0061 Germany tel. (32) 2 743 01 70 tel. (81) 3 5411 86 91 bioMérieux Deutschland GmbH...
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Norway Spain Turkey bioMérieux Norge AS bioMérieux España S.A. bioMérieux Diagnostik A.S. ∅kernveien 145 Manual Tovar, 45-47 Değirmen Sok. Nida Plaza Kat:6 28034 Madrid 34742 Kozyataği / Istanbul N - 0513 Oslo tel. (34) 91 358 11 42 tel. (90) 216 444 00 83 tel.
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V.B 02/2005 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 contain information references relating certain ®...
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VIDAS are used, pending and/or registered trademarks belonging to bioMérieux SA or one of its subsidiaries. Windows is a used, pending and/or registered trademark belonging to Microsoft Corporation. Dacron is a used, pending and/or registered trademark belonging to Invista North America, SARL.
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This product is an in vitro diagnostic medical device. It complies with the directives and standards mentioned in the certificate supplied with it. The user is advised to read and understand all instructions in this manual to be able to derive the best performance from the VIDAS. bioMérieux...
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IMPORTANT! Electromagnetic Compatibility (EMC): This is a Class A product. In a residential area, this product may cause harmful interference in which case the user may be required to take adequate measures at his own expense. The equipment may also cause inteference if not installed in accordance with the instructions given in this manual.
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R e v i s i o n s The list of revisions below summarizes replacements or additional pages in your VIDAS Instrument User’s Manual. Manual Reason Page(s) New VIDAS model V.A 03.2005 New software version V.B 12.2005 ® VIDAS...
Optical system..........................2-26 Pipette mechanisms ........................2-28 VIDAS temperature ........................2-28 3 Getting started Recommendations for installation and use ..................3-2 Unpacking the VIDAS .......................... 3-4 Assembly and installation ........................3-5 Choosing a location........................3-6 4 Starting the VIDAS Switching on............................4-2 Installing the hand-held bar code reader....................
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Cleaning the spill tray ........................6-12 Reassembling the strip preparation tray and switching the analytical module back on ..........................6-13 Using the reagent for testing the pipette mechanisms: Quality Control VIDAS (QCV) – Reference 30706 ......................... 6-13 Decontamination of the VIDAS ......................6-14 ®...
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Fig. 2-15: Dynamic reactions ........................2-23 Fig. 2-16: Example of a protocol......................2-24 Fig. 2-17: Fluorescent reading......................... 2-25 Getting started Fig. 3-1: Gripping area (only concerns VIDAS blue) .................. 3-4 Starting the VIDAS Fig. 4-1: Power switch ..........................4-2 Fig. 4-2 : Configuration options........................4-4 Fig.
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Fig. 6-16: Cleaning the spill tray ......................6-18 Fig. 6-17: Replacing the front panel......................6-19 ® Fig. 6-18: Shutting down Windows ......................6-20 Fig. 6-19: Shutting down the computer ....................6-21 Note: Software screens and figures are given for information purposes only. ® VIDAS Instrument User's manual...
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I n t r o d u c t i o n This manual deals exclusively with the VIDAS equipment and consumables. The software and procedures for use are described in the VIDAS PC User's Manual. The table of contents lists all the chapters of this manual. Each chapter is subdivided into sections corresponding to a procedure or a precise description.
One of these labels is applied to the equipment to certify that it has been decontamination properly decontaminated: labels − before any operation by a service technician, − before it is returned to the factory, if necessary. ® VIDAS Instrument User's manual...
W a r n i n g s The following warnings are used throughout the manual: − for safety reasons (DANGER!), − to ensure that VIDAS is maintained in good working condition (CAUTION!), − or to allow optimum use of your VIDAS (IMPORTANT! or WARNING!). ®...
Alternating current Both direct and alternating current Three-phase alternating current Earth (ground) TERMINAL PROTECTIVE CONDUCTOR TERMINAL Frame or chassis TERMINAL Equipotentiality ON (power supply) OFF (power supply) "ON" (only for a component of the system equipment) ® VIDAS Instrument User's manual...
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REINFORCED INSULATION (equivalent to Class II of IEC 536) Risk of electric shock Caution: see accompanying documents High temperature Potential pinch point Potential biohazard Consult Instructions for Use Batch code Catalogue number Temperature limitation Authorised representative of the European Community Keep dry ® VIDAS Instrument User's manual...
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How to use this manual Graphic symbols Manufacturer Date of manufacture In Vitro Diagnostic Medical Device Serial number Keep away from magnetic field Separate collection for waste electrical and electronic equipment ® VIDAS Instrument User's manual...
− the VIDAS analytical module divided into five independent sections each containing six assays with compatible protocols, − the VIDAS PC software allowing up to two VIDAS modules to be operated, − the reagents presented in kits of 60, 30 or 10 unit tests including : ®...
Functional description Configuration components The VIDAS can be divided into three categories of components : − hardware, − software, − consumables. Hardware VIDAS consists of: One or 2 analytical modules, each containing 5 sections of 6 positions each (capacity to process over 200 samples per day).
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− The indicator light goes off when the reagent strips and SPR s are unloaded. The VIDAS handles reagents via five six-channel pipetting systems (1 system per section) which carry out all reagent transfers, dilution and washing by means of the SPRs.
Functional description Configuration components Microprocessor In addition to the central processing unit, each VIDAS section contains its own microprocessor. Each microprocessor controls the movements required by each assay, depending on the protocol applying. Each section is therefore independent and autonomous .
Functional description Configuration components Strip preparation tray A retractable strip preparation tray is located under each reagent strip tray. (only concerns VIDAS blue) ② ① Fig. 2-5: Opening the strip Fig. 2-4: Strip preparation tray preparation tray closed Fig. 2-6: Reagent strips placed on Fig.
During processing, the SPR block and SPRs form a pipetting device that is used throughout the assay. The reagent is cycled in and out of each SPR by a piston-driven air system. Fig. 2-8: SPR block ® VIDAS Instrument User's manual...
The thermistors used in the VIDAS are accurate to within 0.2°C. Only thermistor systems that meet this criterion on manufacture are installed in the VIDAS. Note: To display the SPR block and tray temperatures, see the VIDAS PC User's Manual. Bar code readers Two bar code readers: −...
C o m p u t e r m o d u l e The computer is designed to operate the analytical module(s) (up to 2) and to manage assays using the VIDAS PC software (see the VIDAS PC User's Manual).
− a diluent (as required), − a package insert − a MLE card. Single reagent strip The VIDAS single reagent strip contains ten wells. The sample is placed in the first well. The other eight wells contain the necessary reagents (conjugate, diluent, wash buffer).
The sample test strip contains a reagent which is not included in the sample reference strip. A comparison of the measurements from the two strips determines the test result. Fig. 2-11: Dual reagent strip ® VIDAS Instrument User's manual 2-13...
Configuration components R e a g e n t s t r i p l a b e l Each VIDAS reagent strip has a label and a color-coded dot. Both are identified by the same 2-4 character and/or figure code.
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4: ID A blank space is provided to write the sample ID (if necessary) . 5: Lot number The lot number is used by the VIDAS to code the expiration date of the reagent lot. 6: Expiration date This corresponds to the expiration date of the reagent lot. When the bar code reader reads this date, the VIDAS compares it to the date stored in its memory to ensure that the lot has not passed its expiration date.
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Each SPR for a specific assay is identified by a color-coded cap and a letter and/or figure code representing the assay name. ® Fig. 2-14: SPR The VIDAS uses the SPR to perform the following operations: − sampling, − incubation, − mixing, −...
Type of installation: equipment Installation category (voltage overload II (according to standard IEC 61010.1) category): no. 2 (according to standard IEC Degree of pollution: 61010.1) Maximum installation altitude: 2 000 m ® VIDAS Instrument User's manual 2-17...
Functional description General features and technical specifications P h y s i c a l f e a t u r e s D i m e n s i o n s VIDAS blue VIDAS Instrument packed Instrument alone...
General features and technical specifications E l e c t r i c a l s p e c i f i c a t i o n s Class I equipment VIDAS blue VIDAS Voltage 100 – 240 VAC 100 - 120 VAC 3 - 1.2 A...
− 30 test positions: 5 sections each containing 6 positions. − Up to 50 tests/hour depending on the type of test used (see test duration indicated on each VIDAS assay package insert). Motors − Automatic control by means of stepper motors.
Composition: plastic polymer Work volume: 5 - 350 µl R e a g e n t s t r i p External dimensions VIDAS assay Length 157 mm (6.2 inches) Width 18 mm (0.7 inches) Depth 15 mm (0.6 inches)
The hapten to be detected competes with the labeled hapten. ALKALINE PHOSPHATASE The fluorescence level measured is inversely proportional to the MARKED HAPTEN quantity of haptens present in the sample. HAPTEN TO BE DETECTED ® 2-22 VIDAS Instrument User's manual...
− final reading. Assays using the same protocol can be carried out in the same section. The VIDAS will automatically group compatible assays. M e t h o d The sample (serum or pre-treated) must be placed in the sample well on the reagent strip as indicated in the appropriate assay package insert.
This error report will also be generated if you have inserted more strips than expected. Whatever the cause, refer to the VIDAS PC User's Manual. Substrate fluorescence error ( ERRSUB ) The software contains standard fluorescence levels designed to guarantee reagent quality.
SPR washing operations are also programmed. Determining background At this stage, the VIDAS makes a fluorescent reading of the substrate. This fluorescence value will appear on the result sheet under the heading BKG (background).
O p t i c a l s y s t e m s e l f - t e s t s The VIDAS carries out periodic readings in air and on the solid standard and sends an error message if these readings fall out of expected bounds.
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The long-life reference material is placed in a well inside the module, between sections A and B. The optical system periodically measures the reference and the results are monitored by the VIDAS to ensure that optical drift is minimal. Every 12 hours, the VIDAS carries out a calibration check, consisting of three readings of the solid standard.
(-2°C, + 1°C) with a maximum variation of ± 1°C from the average for the five sections. If a temperature error occurs, the VIDAS halts all assays in progress. No further assays can be launched in this section until the temperature returns to its normal operating range.
G e t t i n g s t a r t e d I n t r o d u c t i o n This chapter gives recommendations for installation and use of the VIDAS instrument. CAUTION! You are advised to read this chapter in full and follow the different instructions in order to use the VIDAS correctly.
CAUTION! The VIDAS weighs 65 kg (143 ⅓ lbs). Two people should lift it out of its box and place it on the benchtop. The instrument must be placed on a flat surface with a maximum horizontality defect of 5°.
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Never connect the VIDAS to the same power supply as devices which generate high current surges (centrifuges) or which, due to frequent start- ups, generate interferences if they are ill-protected (freezers, water baths...).
The VIDAS weighs 65 kg (143 ⅓ lbs). Two people should lift it out of its box and place it on the benchtop. The instrument must be placed on a flat surface with a maximum horizontality defect of 5°.
The computer media (floppy disks or CD ROMs) containing the VIDAS software programs or the user’s backups used for installation or reinstallation must be stored in an appropriate location.
Leave sufficient clearance around the analytical module for the circulation of air, essential to proper temperature control, and for easy access to the power switch. Do not install the UPS near the right-hand side of your analytical module. ® VIDAS Instrument User's manual...
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S ta r t i n g t h e V I D A S I n t r o d u c t i o n This chapter describes: − the procedure for switching on the VIDAS instrument, − the procedure for installing the hand-held bar code reader. ®...
Switch on the printer and screen. Step 4 • Switch on the computer. Refer to the section entitled "Starting VIDAS PC" in Chapter 3 of the VIDAS PC User's Manual. Step 5 • Turn the power switch on the analytical module to the "OFF" position.
Repeat this procedure for each computer dedicated to your VIDAS configuration. Perform this procedure BEFORE using new VIDAS reagent kits. Note: This procedure does not involve the analytical module. It only applies to the VIDAS PC software host computer. ® VIDAS...
C h e c k i n g t h e k e y b o a r d l a n g u a g e Check the VIDAS PC computer keyboard language before configuring the bar code reader. To do this, ®...
Starting the VIDAS Installing the hand-held bar code reader The options screen is displayed. Select the "Languages" tab. Click "Details...". The "Text Services and Input Languages" window is displayed. Select the "Settings" tab . The default language is indicated: •...
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Installing the hand-held bar code reader Sw i t c h i n g o f f t h e c o mp u t e r The VIDAS PC host computer should be switched off. To do this, •...
Fig. 4-4 : Shutting down Windows The following window appears. Fig. 4-5 : Shutting down the computer Select "Shut down". Click "OK". The computer will stop and shut down. For further information, refer to the VIDAS PC User’s Manual. ® VIDAS Instrument User's manual...
Starting the VIDAS Installing the hand-held bar code reader P r e p a r i n g t h e r e a d e r The reader is supplied in a kit containing: − 1 bar code reader (1), −...
• Enter your user name and password. Note: If the VIDAS is switched off, follow the instructions in section "Switching on, page 4-2. If the VIDAS system was already equipped with a reader, the old reader’s configurations will be replaced by the default configuration of the new bar code reader.
Starting the VIDAS Installing the hand-held bar code reader C o n f i g u r i n g t h e b a r c o d e r e a d e r IMPORTANT! The reader you have received has already been configured by bioMérieux and takes into account most of the existing types of bar codes.
A beep and a green LED indicate that reading has been performed correctly. Nota : If pdf bar codes are read, refer to the VIDAS PC User’s Manual, Chapter "Updating a VIDAS assay". When reading is complete: •...
This chapter contains the procedure to be followed to carry out routine operations on the VIDAS. Before applying these procedures, you will have already: − switched on VIDAS. ® − defined the system configuration options explained in the VIDAS PC User's Manual. ® VIDAS...
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Step 6 Step 7 ® Close the door of the SPR block. Lower the section's cover. (Basic VIDAS work flow continued on next page) Fig. 5-1: Basic VIDAS work flow ® VIDAS Instrument User's manual...
SPRs. Fig. 5-2: Basic VIDAS work flow (cont'd) Note: For details of routine use of your VIDAS, refer to the VIDAS PC User's Manual. The following procedure outlines the common work flow steps that are used for VIDAS immunoassay tests.
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It is very important that all the correct SPRs are properly placed in the SPR block and the dot on top has a hole. The VIDAS cannot detect the type of SPR used nor the absence or presence of SPRs.
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Step 9 Section status switches from and then . After having checked the reagent, VIDAS indicates the time of completion. Step 10 When the assays are completed: − A report is automatically printed (depending on the software configuration). − Section status switches from (time of completion of the assay) to −...
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I n t r o d u c t i o n This chapter deals with: − the routine maintenance operations which should be performed by the user. ® − the preventive maintenance operations performed bioMérieux technicians or a qualified person trained by bioMérieux. ® VIDAS Instrument User's manual...
Preventive maintenance P r e v e n t i v e m a i n t e n a n c e Optimum performance of the VIDAS (within the limits of manufacturer specifications) depends on the preventive maintenance being performed by ®...
No specific tools are required for preventive maintenance of VIDAS. The basic equipment and products required are: − sponges (Part no. 99 087), − a flat screw-driver (VIDAS), − a screwdriver for recessed head screws (only concerns VIDAS blue), − disposable powderless gloves (latex-type), ® − Dacron swabs (Part no.
− Cleaning of accidental spills (accidental contamination), which should be dealt with immediately. DANGER ! Turn the VIDAS power switch to "OFF" and then disconnect the power cord. Use POWDERLESS disposable gloves. This operation must be performed once all assays are completed.
Maintenance Decontamination of the VIDAS blue ® C l e a n i n g t h e S P R b l o c k (weekly) DANGER ! This operation must be performed once all assays are completed. Use POWDERLESS disposable gloves.
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Maintenance Decontamination of the VIDAS blue ® Fig. 6-2: Cleaning the SPR block • ® Using a Dacron swab moistened with a detergent solution, carefully clean ® the interior of each SPR sleeve (see Fig. 6-2). • Repeat the previous operation using a new Dacron swab moistened with a bleach solution containing 0.5-0.6% active chlorine (5.5 to 6.6 g/l sodium...
Maintenance Decontamination of the VIDAS blue • Close the SPR block door. Fig. 6-4: Do not clean the seals situated above the SPR block CAUTION! Do not clean the seals situated above the SPR block (see Fig. 6-4) as they do not require cleaning other than when preventive maintenance is ®...
Maintenance Decontamination of the VIDAS blue ④ ③ Fig. 6-6: Cleaning the strip preparation tray • Using curved forceps and a sponge moistened with a detergent, carefully clean the front of the strip preparation tray (Fig. 6-6) and the 6 channels by sliding the sponge along each one.
Maintenance Decontamination of the VIDAS blue C l e a n i n g t h e r e a g e n t s t r i p t r a y s (monthly) • Raise the strip preparation tray until it is in its upright position.
Maintenance Decontamination of the VIDAS blue • Manually pull the reagent strip trays to their outermost position (see Fig. 6-9). Fig. 6-9: Repositioning the strip sections trays • Moisten a sponge in the detergent solution. Holding the sponge with curved forceps, carefully clean the 6 channels of the reagent strip tray by sliding the sponge along each channel.
Maintenance Decontamination of the VIDAS blue C l e a n i n g t h e s p i l l t r a y (monthly) • Remove the plastic tray that sits underneath each reagent strip tray by sliding it towards you (see Fig.
Maintenance Using the reagent for testing the pipette mechanisms: Quality Control VIDAS (QCV) – Reference 30706 R e a s s e m b l i n g t h e s t r i p p r e p a r a t i o n t r a y a n d sw i t c h i n g t h e a n a l y t i c a l mo d u l e...
− Cleaning of accidental spills (accidental contamination), which should be dealt with immediately. DANGER ! Turn the VIDAS power switch to "OFF" and then disconnect the power cord. Use POWDERLESS disposable gloves. This operation must be performed once all assays are completed.
Maintenance Decontamination of the VIDAS ® C l e a n i n g t h e S P R b l o c k (weekly) DANGER ! This operation must be performed once all assays are completed. Use POWDERLESS disposable gloves.
Maintenance Decontamination of the VIDAS ® Fig. 6-13: Cleaning the rear of the SPR block • Using curved forceps, moisten a sponge with detergent and swab the rear of the SPR block, pushing each SPR sleeve individually back towards the interior of the section (see Fig.
Maintenance Decontamination of the VIDAS C l e a n i n g t h e r e a g e n t s t r i p t r a y s (monthly) • Manually pull the reagent strip trays to their outermost position (see Fig.
Maintenance Decontamination of the VIDAS C l e a n i n g t h e s p i l l t r a y (monthly) • Remove the plastic tray that sits underneath each reagent strip tray by sliding it towards you (see Fig. 6-16).
Maintenance Using the reagent for testing the pipette mechanisms: Quality Control VIDAS (QCV) – Reference 30706 R e p l a c i n g t h e f r o n t p a n e l a n d sw i t c h i n g t h e a n a l y t i c a l m o d u l e b a c k o n Fig.
Click on the button in the bottom left-hand corner of the screen or press one of the "Windows" keys either side of the space bar, • Select "Shut down". ® Fig. 6-18: Shutting down Windows ® 6-20 VIDAS Instrument User's manual...
Clean the screen with a dry anti-static cloth or use a special screen cleaner. • Turn on the screen and the computer. Refer to the section entitled "Starting VIDAS PC" in Chapter 3 of the VIDAS PC User's Manual. The VIDAS retests some of its mechanical and optical systems.
Refer to the Printer User’s Manual. B a r c o d e r e a d e r C l e a n i n g (as required) • Clean the reader window using a soft cloth. ® 6-22 VIDAS Instrument User's manual...
I n t r o d u c t i o n This chapter describes the problems that may occur with the bar code reader. In case of a problem, see Chapter 12 "Troubleshooting" in the VIDAS PC User's Manual.
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Repeat the reading. If these failures recur, call bioMérieux Technical Assistance or your local bioMérieux representative. Error 161 If the VIDAS PC software displays "Error 161" following a reading: • Refer to Chapter 12 in the VIDAS PC User’s Manual. ®...
These calculations can be different for each type of assay and enable interpretation of the assay result. A two-, three- or four-character designation for an assay used in the VIDAS. SSAY CODE Assays are entered into the system, for example, to create a Work List, using the assay code.
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A physical process in which a substance emits light at a certain wavelength LUORESCENCE after exposure to light at another wavelength. This is the measurement process used in the VIDAS. The last well on the Reagent Strip. It is made of optically clear plastic that PTICAL CUVETTE permits the scanner to take an accurate fluorometric reading of the substrate.
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Relative Fluorescence Value. The difference between the final and the initial (background) fluorescent readings of a reagent strip. The patient material being tested. AMPLE A microprocessor-controlled assay processing unit in the VIDAS instrument. ECTION Each module has five sections, labeled A through E. Each incubator ®...
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Glossary For qualitative tests. The result calculated by VIDAS using the RFV ALUE (Relative Fluorescence Value) of the sample and which enables the interpretation of results. VIDAS The VIDAS analyzer / reader. MODULE ® VIDAS Instrument User's manual...
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N o t e s ....................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................® VIDAS Instrument User's manual NOTES-1...
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