mini VIDAS® Procedures Manual Revisions-1 Revisions The list of revisions below summarizes remplacements or additional pages in your Procedures Manual. Version Date of printing Modifications Page (s) modified A 03/1996 Creation All B 03/2003 New format (7x9) - Manual update All C 04/2005 Modification relating to the new mini VIDAS® model
• For other specific materials and disposables, please refer to the Instrument User Manual. • Instruments of the VIDAS ® family: VIDAS ® , MINI VIDAS ® or VIDAS ® 3. WARNINGS AND PRECAUTIONS
bioMerieux mini VIDAS User Manual. Page 1 User Manual Industry Use - US version bioMérieux SA 376 Chemin de l’Orme 69280 Marcy-l’Etoile - France Tél: 33 (0)4 78 87 20 00 Fax: 33 (0)4 78 87 20 90 www.biomerieux.com... Page 2 (when applicable), and precautions are strictly followed as detailed in the instructions for use (IFU).
Refer to MINI VIDAS® user’s manual for detailed data. 3 HOW TO PERFORM A CALIBRATION? Read the MLE bar code 1 Integrate factory data into the instrument When using a new lot Calibrate Adjustment of the instrument to the factory data 2 When using a new lot + Every 14 or 28 days Control TypingFile Size: 2MB
mini VIDAS Procedures Manual. Revisions-1 4501-1618 A en. The content of this manual is based on the Software release 5.3.0. 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.
Refer to VIDAS ® user’s manual for detailed data VIDAS® QCV reference 30706 INTERPRETATION OF QCV TEST: • Check the TV1 value and R3 value for each position. • TV1 must be > = the value indicated on the kit label. IN CASE OF OUT OF RANGE RESULTS • For TV1: If the result of a particular position is outside the range, two newFile Size: 2MB
Remove the paper roll from the printer. Check to see that the door to the SPR block is completely closed and restart the assay. Select [Keypad Test] in the Test Menu. See the message Unable to complete LIS upload of results. The figure below is an example of a possible error message screen for a start error. If an assay does not have an ID, a warning message is generated. Taking a section off line Use this procedure to take a section off-line. Later, if you find that you need to change the settings, you can make the necessary adjustments. The manual bar code entry screen appears again. The Software version begins to print and the display returns to the Version Menu. Make sure that you enter the lines in exactly the same order as they appear on the MLE card. Details are given in the following subsection, Remedies for start errors. It is critical that SPRs be paired only with strips that have matching dots, otherwise the test result will be invalid. Use powderless gloves. Should any defect occur during such period, bioMrieux S. For some qualitative assays e. If you select this key, a screen is displayed showing the internal temperature of each reagent strip tray and SPR block. A portion of an assay list printout appears below. The updates shall be included in the new releases of the Software. Change the reagent strip and start again. The User ID screen appears:. Apply gentle pressure on the center of the card to seat it. The reading screen is updated. Continue until reading is sucessful. The rights to use this manual granted herein are non-exclusive and limited to the extent necessary to use the Software and Instrument. Following is an example. Page The Position screen appears with the new dilution factor displayed. Retry the read operation, or enter the data manually. After that, the software automatically expires the standard, requiring that you run another from the same lot. Page Within a single batch, each reagent tray carries a different number corresponding to the order of manufacture. The number of codes still to be read to complete the update. Different symbols are used for different error messages. Determine the type of run required refer to page in this chapter for information on the type of runs and how to plan them. Select an assay whose dose units you want to set. Print page 1 Print document pages. An intermediate screen appears for assays that have more than one version; the version used is represented in the first two characters of the strip's bar code. If these instructions are not complied with, the computer could become infected with computer viruses. You should only read codes belonging to the same series. You can also remove the AC power cord at this time. Do not mix reagents from different lots. The error message alert system For this reason, it may differ from the one presented in this document. Routine procedures Calibration Recalibration H ow t o c a l i b r a t e Master Lot data Principle of calibration Before each new lot of reagents is used, master lot data must be entered into the instrument using the Master Lot Entry card bar code included in each kit. To enter up to eight lines of text, Repeat steps 5 to 7. The screen will display the other results awaiting validation, if any. The user should be aware that, if the maintenance operations are not performed, are only partially performed, or are not performed as described in this manual, bioMrieux SA is in no case liable for any false test results obtained. The controls are tested in the same run to check the recalibration. Page Stopping A Section Select the Halt retain setup option to stop the section and retain the tests defined in the positions. The SPR color-coded dot must match the dot on the corresponding reagent strip. Section see Shutting Down the System on page
Papanikoli 70 Halandri Athens tel. Fti t. Estate New Delhi tel. Media Square Place des Carabiniers Bruxelles tel. Business Park Kosice, Jinonick 80 00 Praha 5 tel. Pulo Lentut No. J Rio de Janeiro R. J tel. Seminario Providencia Santiago tel. A Via Fiume Bianco, 56 Roma tel. Progreso Mxico , D. Box 23 AA Boxtel tel. Manual Tovar, Madrid tel. Zeromskiego 17 Warsaw tel. Turkey bioMrieux Diagnostik A. Deirmen Sok. Revisions The list of revisions below summarizes remplacements or additional pages in your Procedures Manual. The content of this manual is based on the Software release 5. 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 bioMrieux S. In no event shall bioMrieux S. In no event shall this manual be construed as an undertaking of bioMrieux S. This manual is provided for information purposes only. Intellectual Property bioMrieux S. This manual and its content are protected under the provisions of section L. The rights to use this manual granted herein are non-exclusive and limited to the extent necessary to use the Software and Instrument. In no event shall the Users be granted any other right to use this manual including without limitation, the right to reproduce, represent, adapt or translate all or part of this manual by any means whatsoever without the prior written consent of bioMrieux S. Any use of this manual other than expressly permitted hereunder may be prosecuted. 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 All intellectual property rights including patrimonial rights, in and to the Software are and shall remain bioMrieux S. 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. Should any defect occur during such period, bioMrieux S. 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, bioMrieux S. User hereby agrees to indemnify, defend and hold bioMrieux S. Should this provision be held unenforceable or void, the User irrevocably agrees that bioMrieux S. 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. Signature and User's stamp:. Parties shall make their best efforts to settle any dispute trough amicable discussions. All biological fluids should be considered as potentially infectious.
If an assay does not have an ID, a warning message is generated. Select a section. Setting the Report Header This option is used to define a line of up to 32 characters. See Step 1. Page User Maintenance Routine cleaning which should be performed on a periodic basis. On-screen, you can verify if a dilution factor is being used by the presence of a boxed number, as in Position 4 in the following figure. Inspect the card for proper placement in the reagent strip tray, debris, or smudges. Select [Sound Menu]. The sample is placed in the sample well. Routine procedures Planning a run As s a y c o m p a t i b i l i t y When planning a run, you may need to decide whether you can run different assay types at the same time. Current Sections results NOT validated. Unidirectional interface optional See section "LIS user options" on page of chapter 3 and appendix E in this manual. The selected character then appears in the cursor box. The mini VIDAS goes through a series of preprocessing steps that include reading the bar code on the label of each reagent strip, and performing an optical check of the substrate. Dual strips fit in the reagent strip tray exactly like single strips, but they require two channels. The symbol is removed when you disable a selected option. Specifically, the User agrees not to decompile, reverse engineer or disassemble all or part of the Software. Use this procedure to stop the processing of one or both sections. Make sure the protocol memory card is in the memory card slot. Replace the reagent strip. Disconnect the power cord from the power outlet. Page External Printer Installation 1. Getting started The following selections appear: [HH. Use one or both of these sets to input repetitive characters for sample IDs. The reagents are calibrated according to two different modes, depending on whether the assays are quantitative or qualitative. To resolve this situation, you must use the result validation and upload procedures to reduce the number of results in those queues. J Rio de Janeiro R. The sample must not contain any solid matter that could clog the tip of the SPR. The assay list includes the complete name of each assay and its assay code. This method is used in dual reagent strip qualitative assays. Apply gentle pressure on the center of the card to seat it. The SPR color-coded dot must match the dot on the corresponding reagent strip. There are configuration options to set an initial volume and a final volume. Results and reports The assay report Q u a l i t a t i ve a s s a y s : s i n g l e r e a g e n t s t r i p The figure below shows the parts of the report that appear after the header information. Page Assigning A Dilution Factor A dilution factor can be assigned or changed at any time before the completion of a run. Remove the paper roll from the printer. Before selecting an external printer, see Appendix D for external printer installation instructions. Do not use the strips if the aluminum foil is damaged or if reagents are leaking, as this could affect the accuracy of test results. The Master Lot Data report is printed automatically. If the bar code is valid, the display returns to the Error message screen. The screen will display the other results awaiting validation, if any. The first status screen then appears with the status of the started section now being "Barcode". The content of this manual is based on the Software release 5. From this point, the parking process cannot be interrupted. Page Error Messages On Assay Reports The test result should not be taken into account, and it is recommended to repeat calibration for the test. Okay There is no error in this position. The two reagent strip trays are retracted fully into the instrument.
Table Of Contents. Quick Links Download this manual. User Manual. Table of Contents. Previous Page. Next Page. Page 2 when applicable , and precautions are strictly followed as detailed in the instructions for use IFU. Page 4 Selecting a Menu Option Page 6 Assigning a Dilution Factor Page 8 Error Messages E-1 Dimensions E-1 Weight. Note: A Note statement supplies additional information about a topic. Page General Statements It is recommended to evaluate the electromagnetic environment before starting the device. WARNING Only modify the software configuration parameters you are authorized to modify and which are described in the user documentation. IMPORTANT: It is important to follow all the restrictions on use, particularly concerning temperature, storage, installation and voltage, which are indicated on the product label or in the user documentation. Any damage directly or indirectly resulting from the transport of the equipment without adequate containers will not be covered by the warranty. Page Safety Information Class 1 devices are not considered to be hazardous when used for their intended purpose. Page Strip Section French and English. Page Safety Precautions Components should be moved slowly to prevent the buildup of electricity. Failure to comply may result in injury to personnel or damage to the instrument. Page 27 Hot surfaces can cause injury. Page 28 Powderless gloves, a lab coat and safety glasses or goggles must be worn when performing maintenance operations. Always use personal protective equipment, including powderless gloves, a lab coat and safety glasses or goggles when handling reagents. The options are displayed on the screen opposite the keys used to select them. Page Assay Kit Specifications The strip is sealed by a foil to ensure that no evaporation will occur that may compromise the reagents. The substrate well is made of a plastic that complies with the appropriate optical qualities. Page Reagents Eight reagent wells conjugate, diluent, wash buffer 3 — the last well is the optical cuvette in which the fluorescence of the substrate is measured. A comparison of the measurements from the two strips determines the test result. Dual strips fit in the reagent strip tray exactly like single strips, but they require two channels. Page Reagent Strip Label This corresponds to the expiration date of the reagent lot. Page Spr The reagent strip tray then moves in and out to allow liquids to be transferred from one well to another. The software processes the reagents using the strips bar codes and can send the results to a Laboratory Information System uni-directional interface. Calibration Theoretical Principle for Quantitative Assays The principle consists of determining the mathematical equation which represents the calibration curve, i. This readjustment is called recalibration. It may affect the master curve defined at the factory as well as the calibrator's RFV. Page 53 To avoid any deviation, the master lot curve is the one set in the factory and not the last curve readjusted. The software can perfectly manage simultaneous use of several master curves corresponding to different lots for a given assay. Page 54 4 points. Each section labeled A and B can process six single, or three dual, reagent strips for a maximum capacity of twelve single or six dual tests. Page 56 When the section is running a test, the light is on; when the light is off, the section is idle. This unit is responsible for storing and operating the assay protocols. Since not all displays use all five selection keys, the boxed selections and lines indicate the active keys. The Third Status Screen The third status screen is accessed by selecting Display temperatures from the first status screen. Page Online Help 3 — Information: displays the first help screen.