Syva® Viva-ProE™ system; Software Best Practices Job Aid

BEST PRACTICES SOFTWARE– VIVA-PROE™ = SIEMENS Untributed by Siemens Viva-ProE System Doc.No. TT-002-00 BEST PRACTICES SOFTWARE– VIVA-PROE™ Table of contents 1. Important instructions 4 1.1 Red Flags 4 1.2 Pre-conditions for configuration of tests, calibrator and control (lots) 5 1.3 EDIT button unavailable 6 1.4 Process button not active/highlighted 6 1.5 Proper Programming 6 1.6 Backups and Archives 7 Doc.No. TT-002-00 | 2 BEST PRACTICES SOFTWARE– VIVA-PROE™ Introduction Viva-ProE™ software best practices The Pro Series Software is the touch navigation and operator interface for Viva-ProE™. Touch screen operation with easy touch design significantly boosts laboratory productivity and reduces errors. Smart icons guide the operator logically and effortlessly through their routine daily workflow to improve walk-away time. This allows the operator to focus on other areas. The software is designed to have intuitive ease of use across a wide range of laboratory settings, from labs with basic IT to those with fully automated informatics, from new operators to those with deep experience. This best practice manual is intended for anyone involved with the Viva-ProE™ software. The instructions that follow guarantee the best usage for operating the device. Doc.No. TT-002-00 | 3 BEST PRACTICES SOFTWARE– VIVA-PROE™ 1. Important Instructions 1.1 RED FLAGS Note: If a test is marked with a red flag ( ), it cannot be processed. There are issues to be resolved first! Check the Info Panel Red flag ( ) on Calibrate button in Calibrations - Review menu is explained in Calibrations - Review - Details and in the Info panel on the Home screen, this flag can be caused by: • Reagent not loaded, expired or insufficient • Calibration or control data unavailable • Calibrator lot expired or invalid Red flag ( ) on Control button in Controls - Review menu is explained in Controls - Review - Details and in the Info panel on the Home screen, this flag can be caused by: • Reagent not loaded, expired or insufficient • Calibration data unavailable • Control lot expired or invalid Red flag ( ) on Test button in Patients Request menu is explained in the Info Panel on the Home screen. However, if the Start of Day, Reagents, Calibrations and Controls menus are not flagged, this flag should not appear on the Test button. This flag can be caused by: • Reagent not loaded (or loaded on a different reagent rotor), expired or insufficient • Calibration or control data unavailable • QC expired or not valid Doc.No. TT-002-00 | 4 BEST PRACTICES SOFTWARE– VIVA-PROE™ 1.2 PRE-CONDITIONS FOR CONFIGURATION OF TESTS, CALIBRATOR AND CONTROL (LOTS) To be able to execute the following actions, check if the indicated pre-conditions are met: Action Necessary pre-conditions Configure • System in standby. new calibrator lot • Log in as (super)user administrator or higher. • If any tests are in progress, cancel the tests. • Unload and remove any calibration requests in calibration menu by selecting review, check each test, and deselect the requests by clicking on all blue ovals to turn them gray. * This will deselect any requests pending • Unload and remove any control requests in control menu by selecting review, check each test, and deselect the requests by clicking on all blue ovals to turn them gray. * This will deselect any requests pending • Check if there are Patients requests. If so, unload and delete the requests. • If delete or unload button is grayed out, delete them from the Results screen by selecting the sample ID > selecting the test > then selecting cancel, reject, or accept Configure • System in standby. new control lot • Log in as (super)user administrator or higher. • If any tests are in progress, cancel the tests. • Unload and remove any calibration requests in calibration menu by selecting review, check each test, and deselect the requests by clicking on all blue ovals to turn them gray. * This will deselect any requests pending • Unload and remove any control requests in control menu by selecting review, check each test, and deselect the requests by clicking on all blue ovals to turn them gray. * This will deselect any requests pending • Check if there are Patients requests. If so, unload and delete the requests. • If delete or unload button is grayed out, delete them from the Results screen by selecting the sample ID > selecting the test > then selecting cancel, reject, or accept Delete an • existing test System in standby. • Log in as (super)user administrator or higher. • If any tests are in progress, cancel the tests. • Unload and remove any calibration requests in calibration menu by selecting review, check each test, and deselect the requests by clicking on all blue ovals to turn them gray. * This will deselect any requests pending • Unload and remove any control requests in control menu by selecting review, check each test, and deselect the requests by clicking on all blue ovals to turn them gray. * This will deselect any requests pending • Check if there are Patients requests. If so, unload and delete the requests. • If delete or unload button is grayed out, delete them from the Results screen by selecting the sample ID > selecting the test > then selecting cancel, reject, or accept • Unload the reagents for the test (don't forget possible diluents), NO switch rotor. • Remove the test from panels (or delete panels that contain this test). Configure > Tests > Panels > select Panel > Edit > turn oval from blue to gray > Accept Doc.No. TT-002-00 | 5 BEST PRACTICES SOFTWARE– VIVA-PROE™ 1.3 EDIT BUTTON UNAVAILABLE When you have reagents loaded and/or have requests in one of the worklists, the application will not allow you to modify or edit test parameters or system parameters. Remember that the application will Auto-Request calibrators and controls, so requests will be made automatically once you load reagents. Even though you think there are no requests in the list, it is always good to check. When the EDIT button is not available, please follow the following steps to "unlock" the EDIT button. 1. Select the lock at the top right-hand corner of the main menu and click “Switch User.” 2. Type in your Username and Password for (super) user administrator or higher. 3. Unload all samples in the unload screen 4. Check if there are Patients requests. If so, delete the requests. a. If delete or unload button is grayed out, delete them from the Results screen by selecting the sample ID > selecting the test > then selecting cancel, reject, or accept 5. Check if there are control requests. If so, press review, check each test, and deselect the requests by clicking on all blue ovals to turn them gray. This will deselect the requests pending. 6. Check if there are Calibrator requests. If so, press review, check each test, and deselect the requests by clicking on all blue ovals to turn them gray. This will deselect the requests pending. 7. Switch Rotor by selecting Reagents > select Switch Rotor > select a rotor that has no reagents loaded. 1.4 PROCESS BUTTON NOT ACTIVE/HIGHLIGHTED If the assays, calibrators and controls are not completely programmed the process button may not be active. In case the process button does not light up after loading requests, you may not have entered the calibrator and/or control lot information. This should be indicated in the Info panel on the Home screen. Note: Cover must be closed before the process button becomes active. 1.5 SCANNING SAMPLES/ LIS COMMUNICATION When placing numerous samples onboard at the same time, always ensure: • The instrument has finished scanning all samples and querying the host before the “Process” button is selected • There are requested assays populated for each of the scanned samples before the “Process” button is selected • Alternatively, pressing pause and resume will also add the remaining samples to the process list Note: The process of allowing the instrument to fully scan/query all samples can take multiple minutes to complete. 1.6 PROPER PROGRAMMING OF USER DEFINABLE CHANNELS When programming please follow the following steps in the indicated order: 1. Select the lock at the top right-hand corner of the main menu and click “Switch User.” 2. Type in your Username and Password for (super) user administrator or higher 3. Program the calibrator name(s) that you are going to use and the number of calibrator points 4. Program the assay(s), select the calibrator(s) from the list 5. Program the Calibrator Lot information 6. Program Control names and add the applicable tests to the controls 7. Program the Control Lot information. 8. Load the reagents. Doc.No. TT-002-00 | 6 BEST PRACTICES SOFTWARE– VIVA-PROE™ 1.7 BACKUPS AND ARCHIVES Especially when installing the system and after assay programming, it is good practice to regularly create backups manually. Once programmed, the system will create backups automatically, as defined in the Configure >System> Instrument > Daily Operations. Patient data of two or more days old is archived. The backups and archives are stored on the hard drive. It is good practice to copy and paste the backups and archives to external storage media regularly and store this in a safe location for data preservation and troubleshooting purposes. If this is not done regularly data might lost in case of a hard drive crash. ELITechGroup B.V. 1 Van Rensselaerweg 4 6956 AV Spankeren The Netherlands Phone: +31 313 430 500 ccsupport@elitechgroup.com www.elitechgroup.com 1 also trading as: ELITechGroup Clinical Systems Distributor (US): Distributor (outside US): Siemens Healthcare Diagnostics Inc. Siemens Healthcare Diagnostics Products Gmbh P.O. Box 6101 European Headquarters Glasgow Business Community Ludwig-Erhard Str. 12 Newark, DE 19714-6101 U.S.A. 65760 Eschborn Germany Phone: 1-800-227-8994 www.siemens.com/diagnostics www.siemens.com/diagnostics Doc.No. TT-002-00 | 7