Stratus® CS 200 System PEP to Go

SIEMENS SIEMENS 00 Strateet Cs 200 Stratus® CS 200 System PEP to Go Answers for life. GPE15008.023 Effective Date: 4/19/2013 Stratus CS 200 System Quick Reference Guide Table of Contents 1. Hardware Overview 2. Software Overview 3. Train the Operator 4. Daily Setup 5. Processing a Sample Tube 6. Processing a Sample Cup 7. Quality Control 8. Calibration 9. Maintenance 10. Troubleshooting CINI TestPak IEMENS © Siemens AG 2013. All rights reserved. Stratus CS 200 System Quick Reference Guide Hardware Overview 1. Waste Container Area 2. Rotor Table 3. Sample Door 4. Sample Volume Gauge SIEMENS 5 4 6 5. Printer 6. Touchscreen 3 7. Tip Manager 9 8. Pak Manager Well 9. Sample Barcode Reader 2 7 Stratus CS 200 8 1 © Siemens AG 2013. All rights reserved. Stratus CS 200 System Quick Reference Guide Software Overview SIEMENS Patient ? SIEMENS Menus ? Mode: Patient Enter Patient ID: Home Enter Sample ID: Home Enter Operator ID: Collection Collection Time Time Reports Reagent Reagent Status Status Maintenance Change Change Mode Mode Menus Menus Reset Sample Sample Rotor Rotor 2 3 Cup Cup 5 6 Pak Pak 5 Tips 7 8 9 Tips 7 8 9 Wasto Wasto Alarm Alarm o ID ID Delete Enter Delete Enter A Tip Tray A Tip Tray 03/05/2013 15:12 Stop Start 03/05/2013 15:12 Stop Start C Mode Screens Menu Screens Mode screens are active when the analyzer is Menu screens used for viewing and printing processing. During normal operation, mode information, configuring and maintaining the screens are the primary display. analyzer, and troubleshooting. To use other modes, select Change Mode Display the Main Menu be selecting Menus from the Home screen. from the Home screen. The menu screen shows two main functions: Reports and © Siemens AG 2013. All rights reserved. Maintenance. Stratus CS 200 System Quick Reference Guide Train the Operator SIEMENS Advanced Setup ? For operator training, select the Training Mode to simulate the Stratus CS 200 processing without using Home Training Mode is ON sample or consumables. Substitute these training paks: Collection Time 3 Training (TRNG) TestPaks Reagent 1 Training (TRNG) DilPak Status Change 1 Training (TRNG) CalPak Mode Menus Nex Setting Accept To use these paks, set the analyzer to Training Mode: Samplo 1. From the Home screen, select Menus. 2 3 Rotor 2. Select Maintenance and then press Setup. Cup 5 6 3. Select Advanced. Enter your password and Pak select the Enter button. Tips 7 8 19 4. Select More three times and then select Wasto Training Mode. Alarm o 5. Press Next Setting to display ON and select ID Accept. Delete Enter 6. Select the Home button. A Tip Tray Before processing, replace the waste container 03/05/2013 7. 15:12 Stop Start with a new one to catch the reusable TRNG Paks. Note: Be sure to set Training Mode to OFF when you want to resume normal operation. © Siemens AG 2013. All rights reserved. Stratus CS 200 System Quick Reference Guide Daily Setup Perform the following procedures before processing patient samples. Replace the Waste Container Verify the Tip Supply 1. Open the left front door. 1. Open the tip manager door. 2. Carefully pull out the waste container. 2. Remove empty tip trays. 3. Place a lid on the used waste container. 3. Insert new, full tip trays. 4. Dispose of the used container according to facility 4. Close the tip manager door. specific procedures. 5. Insert a new waste container. 6. Close the left front door. Stratus CS 200 © Siemens AG 2013. All rights reserved. Stratus CS 200 System Quick Reference Guide Verify the Thermal Printer Paper Supply 1. Select the Paper Advance icon. If the edges of the paper are pink, replace the paper. 2. Lift the printer lid; remove and discard the used paper roll from the spindle. 3. Insert the spindle into the new thermal paper roll. 4. Position the spindle in the holder so that the paper feeds from the bottom of the roll. 5. To release the roller, push the green lever toward the back of instrument. 6. Thread the paper through the roller. 7. Push the green lever forward to lock the roller in place. 8. Select the Paper Advance icon three times. 9. Feed the paper through the slot in the printer lid and close the lid. 10. Select the Paper Advance icon until about 5 cm (2 inches) of paper are visible. © Siemens AG 2013. All rights reserved. Stratus CS 200 System Quick Reference Guide Run a System Check 1. Select Change Mode on the Home screen 2. Close the sample door. . Tinel DE/ 01/23/2013 ... 3. Use the arrow buttons to highlight System Check; System Check Pass select Accept. 4. Enter the System Check ID; select Enter. System alignment test Value PASS Alignment Value 139 Limit >90 5. Enter the Operator ID; select Enter. System temperature test PASS 6. Select Start. Temperature Value 37.0 Limit 36.8 - 37.2 7. Review the printed report. Fluidic susten tests Value PASS If the status of all components is PASS, proceed Limit with processing. Level 1 vacuum Level 2 pressure 10 <34 If the status of any component is FAIL, refer to the Pressure setpoint 435 <34 320 - 600 Pressure range 640 440 - 720 System Check Troubleshooting section of the Operator’s Manual. System fluorometer tests PASS Value Level 1 Limit 8.513 < 200 8. Retain System Check reports with your quality Level 2 467.27 453.65 - 476.91 control records. Eleo. Noise 0.141 < 1.5 Printed: 01/23/2013- 13:24 © Siemens AG 2013. All rights reserved. Stratus CS 200 System Quick Reference Guide Processing a Sample Tube Collecting Whole Blood Refer to the Qualified Sample Collection Tubes Appendix in the Operator’s Guide for the appropriate tube types. For complete anticoagulant mixing, gently invert (do not shake) the tube 8 to 10 times immediately after collection. The applied barcode label should not extend beyond the bottom of the tube. Load and Process a Sample Tube 1. Compare the tube to the sample volume gauge. If the sample level is below the level on the gauge or the fill line, do not use the tube. Centrifuge the sample and transfer the plasma to a sample cup. 2. Select Home. 3. Scan the barcode label on the tube. 4. Verify the Patient ID or Sample ID is displayed correctly. If necessary, manually enter the information using the touchscreen. 5306243324 © Siemens AG 2013. All rights reserved. Stratus CS 200 System Quick Reference Guide 5. Enter the Operator ID, Collection Time or comment code, if required. 6. Select Accept. 7. Invert the stoppered tube gently a few times. 8. Gently place the tube into the cannula, ensuring the tube snaps into place. Caution: Do not pierce the tube stopper. 9. Insert the cannula/tube assembly into the sample door opening and close the sample door. 10.Load a new rotor in the rotor table. Make certain that the small opening faces up. 11.Load up to 4 TestPaks in the Pak Manager well. 12.Select Start. SIEMENS © Siemens AG 2013. All rights reserved. Stratus CS 200 System Quick Reference Guide Processing a Sample Cup 1. Pipette the plasma into the sample cup. Ensure there are no particulates in the sample Number of Tests Sample Needed and no air bubbles on the surface. 2. Fill the sample cup to the bottom edge of the 1 200 µL / 0.2 cc rim or refer to the table on the right to determine the amount of plasma required to 2 300 µL / 0.3 cc perform the test. 3. Place the sample cup in the cup position on 3 400 µL / 0.4 cc the rotor table. Warning: Make certain the sample cup is firmly seated in the cup position. 4 500 µL / 0.5 cc 4. On the Home screen, enter the Patient ID or Sample ID; select Enter. 5. Enter the Operator ID or Collection Time, if required. 6. Select Accept. 7. Load up to 4 TestPaks in the Pak Manager well. 8. Close the sample door. 9. Select Start. Stratus CS 200 © Siemens AG 2013. All rights reserved. Stratus CS 200 System Quick Reference Guide Quality Control Preparing QC Material ? Prepare the control material according to the SIEMENS Change Mode manufacturer’s instructions. Thoroughly mix the Patient Mode Method System Check Mode CKMB material before placing it in a sample cup. QC Low Mode Home QC Hi Mode Calibration Mode Collection QC Misc Mode Processing QC Time Man Dil Mod 1. Fill the sample cup to the bottom edge of the Reagent Status rim. Ensure there are no particulates in the Change samples and no air bubbles on the surface. Mode 2. From the Home screen, select Change Mode. Menus Next Method Accept 3. Highlight the required QC Mode. Sample 4. Select Next Method to select an assay. Rotor 3 5. Select Accept. Cup 5 6 6. Select Enter. Pak 7. If required, enter the Operator ID. Tips 7 8 8. Place the sample cup in the cup position on Waste the rotor table. Alitrm O ID 9. Close the sample door. Delete Enter 10.Place one TestPak per assay in the Pak A Tip Tray Manager well. 03/05/2013 11.Select Start. 15:12 Stop Start © Siemens AG 2013. All rights reserved. Stratus CS 200 System Quick Reference Guide Calibration 1. From the Home screen, select Change Mode. 2. Highlight Calibration Mode and select Accept. 3. Enter the Operator ID and select Enter. 4. Load one CalPak into the Pak Manager well. 5. Load three TestPaks of the same lot number for the assay being calibrated. 6. Close the sample door. 7. Select Start. 8. Review the Calibration Report. Calibration Pass – confirm the • calibration by running QC for the assay before using the TestPak lot for processing samples. Calibration Fail – follow the tratto: 2.0.04.2 • sooMrsulte Printout “Addressing Failed Calibration” section 201211002 of the Operator’s Guide. cint CalPak -32121002 Bun Tont: 01/21/2013 14:50 ...................................... Calilestien FASS ...................................... Printed: #171/2012 15:14 © Siemens AG 2013. All rights reserved. Stratus CS 200 System Quick Reference Guide Maintenance Standard Maintenance 1. Clean up spills immediately. The instrument and area around it should be kept clean. 2. Routinely clean the outside surfaces of the entire instrument following facility specific biohazard procedures. Monthly Maintenance 1. Clean/Replace the Air Filter 2. Clean Instrument Surfaces: • Sample door area • Lower cannula chamber seal Waste container area • Tip chute • Pak shield • • Touchscreen Note: Record all completed tasks on maintenance log sheets. © Siemens AG 2013. All rights reserved. Stratus CS 200 System Quick Reference Guide Troubleshooting Troubleshooting Error Codes If an error occurs during processing, the error is stored in the error log. 1. From the Home screen, navigate to Menus > Reports > System Status > Error Log. Highlight an error and select More Info to • print the single error. Select Print Log to print all errors. Select Stop • to stop printing. 2. Locate the resolution to the error code in the Error Codes section of the Operator’s Manual. 3. Follow the steps in the Resolution column. 4. After completing a step, try to resume normal operation. If the problem persists, proceed to the next step. 5. Continue working through the resolution procedure in this manner until the error clears. 6. Contact the Siemens Technical Solutions Center or refer to the local support team if the problem persists. © Siemens AG 2013. All rights reserved. Note: This document is for supplemental use only, and not meant to be used in place of primary technical materials. © 2014 Siemens Healthcare Diagnostics Inc. All rights reserved. This guide and the software described within, are copyrighted. No part of this may be copied, reproduced, translated, or reduced to any electronic medium or machine-readable form without the prior written consent of Siemens Healthcare Diagnostics. All trademarks are the property of their respective owners. Global Siemens Headquarters Global Siemens Healthcare Headquarters Global Division Siemens AG Siemens AG Siemens Healthcare Diagnostics Inc. Wittelsbacherplatz 2 Healthcare Sector 511 Benedict Avenue 80333 Muenchen Henkestrasse 127 Tarrytown, NY 10591-5005 Germany 91052 Erlangen USA Germany www.siemens.com/diagnostics