Stratus® CS System PEP to Go

SIEMENS - -- SIEMENS Stratus CS Stratus® CS System PEP to Go Answers for life. GPE15008.029 Effective Date: 10/22/2013 Stratus CS 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 CTNI TestPak SIEMENS X 8. Calibration 9. Maintenance 10. Troubleshooting IS © Siemens AG 2013. All rights reserved. Stratus CS System Quick Reference Guide Hardware Overview 1. Waste Container Area 2. Rotor Table 3. Sample Door 4. Sample Volume Gauge 5 5. Printer 4 6. Display 6 7. Tip Manager 3 8. Pak Manager Well 9 9. Sample Barcode Reader 7 2 8 Stratus CS SIEMENS 1 © Siemens AG 2013. All rights reserved. Stratus CS System Quick Reference Guide Software Overview Mode: Patient 01/24/13 14:27 Patient Mode Method Enter Patient ID: System Check Mod QC Low Mode CKME Enter Sample ID: Enter Operator QC Hi Mode ID: Calibration Mode Collection Reagent Miso Mode Time Status Change Mode Manual Dilution Next Menus Mode (F1 Method Accept F1 F2 F3 F4 F1 F2 F3 F4 ? Exit Exit Sample/ Sample/ 7 8 9 Delete Door 7 8 9 € Delete D Door o Rotor @ Rotor · Cup . Cup 4 5 6 4 5 6 . Pak . Pak 0 Tips . TIDS 2 3 Star · Waste 1 2 3 Star . Waste Alarm . Alarm 0 G Enter 0 Enter ID < < 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 To view available menus, select Menus (F4) (F3) to display the mode menu screen. from a mode screen. © Siemens AG 2013. All rights reserved. Stratus CS System Quick Reference Guide Train the Operator For operator training, select the Training Mode to simulate the Stratus CS processing without using sample or consumables. Substitute these training paks: 3 Training (TRNG) TestPaks 1 Training (TRNG) DilPak Reset Reports Maintenance 1 Training (TRNG) CalPak F1 F2 F3 F4 Exit To use these paks, set the analyzer to Training Mode: ? 1. From the Patient Mode screen, select Menus (F4). 7 Sample/ 8 9 Delete Door Rotor 2. Select Maintenance (F4) and then press Cup Setup (F1). 4 5 6 Pak 3. Select Advanced (F4). Enter your password Tips and select the Enter key. 1 2 3 Star @ Waste Alarm 4. Select More (F4) three times and then select 0 Enter Training Mode (F2). < > Stop 5. Press Next Setting (F3) to display ON and select Accept (F4). 6. Press the exit key and the paper advance key at the same time to return to the mode screen. Note: 7. Before processing, replace the waste container Be sure to set Training Mode to OFF when you want to with a new one to catch the reusable TRNG resume normal operation. Return TRNG Paks to the Paks. Training Materials Kit to be reused for the next training session. © Siemens AG 2013. All rights reserved. Stratus CS 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. MEMEN'S SUS © Siemens AG 2013. All rights reserved. Stratus CS System Quick Reference Guide Verify the Thermal Printer Paper Supply 1. Select the Paper Advance key. 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. Thread the paper through the roller. 6. Select the Paper Advance key three times. 7. Feed the paper through the slot in the printer lid and close the lid. 8. Select the Paper Advance key until about 5 cm (2 inches) of paper are visible. © Siemens AG 2013. All rights reserved. Stratus CS System Quick Reference Guide Run a System Check 1. Select Change Mode (F3) from the Patient Mode screen. . Tinel DE/ 01/23/2013 ... 2. Close the sample door. System Check Pass 3. Use the arrow keys to move the cursor to System Check Mode; select Accept (F4). System alignment test PASS 4. Enter the System Check ID; select the Enter key. Alignment Value Value 139 Limit >90 5. Enter the Operator ID; select the Enter key. System temperature test PASS Temperature Value Limit 6. Select the green Start key. 37.0 36.8 - 37.2 Fluidic susten tests PASS 7. Review the printed report. Value Limit If the status of all components is PASS, proceed Level 1 vacuum Level 2 pressure 10 <34 with processing. Pressure setpoint 435 <34 320 - 600 Pressure range 640 440 - 720 If the status of any component is FAIL, refer to the System Check Troubleshooting section of the System fluorometer tests PASS Value Level 1 Limit Operator’s Guide. 8.513 Level 2 < 200 8. Retain System Check reports with your quality Eleo. Noise 467.27 453.65 - 476.91 0.141 < 1.5 control records. Printed: 01/23/2013- 13:24 © Siemens AG 2013. All rights reserved. Stratus CS 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. Scan the barcode label on the tube. 3. Verify the Patient ID or Sample ID is displayed correctly. If necessary, manually enter the information using the keypad. © Siemens AG 2013. All rights reserved. Stratus CS System Quick Reference Guide FZ F4 5. Enter the Operator ID, Collection Time or comment code, if required. 6. Select Accept (F4). 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.Make sure all of the red checklist lights are out. 13.Press the green Start key. x ETNI TestRak SIEMENS --- © Siemens AG 2013. All rights reserved. Stratus CS 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 the Enter key. 5. Enter the Operator ID or Collection Time, if required. 6. Select Accept (F4). 7. Load up to 4 TestPaks in the Pak Manager well. 8. Close the sample door. 9. Select the green Start key. © Siemens AG 2013. All rights reserved. Stratus CS System Quick Reference Guide Quality Control Preparing QC Material Prepare the control material according to the manufacturer’s instructions. Thoroughly mix the material before placing it in a sample cup. Patient Mode System Check Mode Method QC Low Mode CKMB QC Hi Mode Calibration Mode QC Miso Mode Processing QC Manual Dilution Mode (F1) Next Method Accept 1. Fill the sample cup to the bottom edge of the rim. Ensure there are no particulates in the F1 F2 F3 F4 samples and no air bubbles on the surface. 2. From the Patient Mode screen, select Change ? Exit Mode (F3). 3. Highlight the required QC Mode. Sample 4. Select Next Method (F3) to select an assay. 7 8 9 Delete Door Rotor 5. Select Accept (F4). Cup 4 5 6 6. Select the Enter key. Pak Tips 7. If required, enter the Operator ID. 1 2 3 Star Waste 8. Place the sample cup in the cup position on Alarm the rotor table. 0 Enter ID 9. Close the sample door. < > O 10.Place one TestPak per assay in the Pak Manager well. 11.Select the green Start key. © Siemens AG 2013. All rights reserved. Stratus CS System Quick Reference Guide Calibration 1. From the Patient Mode screen, select Change Mode (F3). 2. Move the cursor to Calibration Mode and select Accept (F4). X SIEMENS 3. Enter the Operator ID and select the Enter key. 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 the Start key. 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 • VES “Troubleshooting Calibration” section of the Operator’s Guide. ............................... -- ---- © Siemens AG 2013. All rights reserved. Stratus CS 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 • Note: Record all completed tasks on maintenance log sheets. © Siemens AG 2013. All rights reserved. Stratus CS 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 Patient Mode screen, navigate to Menus (F4) > Reports (F3) > System Status (F4) > Error Log (F3). • Use the arrow keys to move the cursor to the error you want to print. Select More Info (F4) to print the single error. Select Print Log (F3) 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 Guide. 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 Customer Care Center – Technical Solutions 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