CS-2500 System and CS-5100 System Key Task Guide

SIEMENS Healthineers Template Effective Date: 05/27/2019 | HOOD05162003010284 CS-2500 System and CS-5100 System Key Task Guide Template Effective Date: 10 Aug 2021 | HILS2223 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Table of Contents System Overview 3 Supply and Reagent Management 16 Sample Processing 26 Calibration 40 Quality Control (QC) 45 Maintenance 50 Troubleshooting 73 Administration 86 2 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers System Overview External Hardware Overview – CS-2500 System 1. Sampler sysmex • Holds 5 racks of 10 tubes 3 • Barcode reader for samples • Automatically delivers sample racks 2 4 2. Light shield CS-2500 • Protects the sample arm and probes 3. Reagent section lid 5 • Access to the reagent tables 4. Alarm indicator A • Green – ready to start analysis 1 • Flashing green – warming up/analyzing • Orange – consumables are used up • Flashing orange – analysis being performed • Red – analysis stopped due to an error 5. Start button • Starts analysis 3 Job Aid Effective Date: 15 May 2024 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers System Overview External Hardware Overview – CS-2500 System (continued) 6 sysmex 6. Cuvette hopper • Holds approx. 500 cuvettes • Load up to the red line CS-2500 7. Mechanical stop Immediately stops all mechanical movement 7 • 8. Cuvette trash box • Holds used and discarded cuvettes 8 4 Job Aid Effective Date: 15 May 2024 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers System Overview Left Side Hardware Overview – CS-2500 System 1. Power switch 2 1 • Turns the Main Unit ON and OFF 2. Fuse box and power cord 3. Trap chamber • Prevents fluid from entering the compressor 4. Adjustment knobs • -0.067 MPa vacuum • 0.10 MPa pressure 5. Filter No. 16 • Prevents dust from entering the system 3 4 5 5 Job Aid Effective Date: 15 May 2024 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers System Overview Right Side Hardware Overview – CS-2500 System 2 1. Halogen lamp • Light source for all assays 2. IPU connector • Connects Main Unit to computer CS-2500 3 3. Air filters • Prevents dust from entering the system 1 6 Job Aid Effective Date: 15 May 2024 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers System Overview External Hardware Overview – CS-5100 System 3 1. Sampler Winner 7 5 • Holds 10 racks of 10 tubes Barcode reader for samples 2 4 • x • Automatically delivers sample racks 2. Light shield • Protects the sample arm and probes 3. Alarm indicator 6 • Green – ready to start analysis 1 • Flashing green – warming up/analyzing • Orange – consumables are used up • Flashing orange – analysis being performed • Red – analysis stopped due to an error 4. Start button • Starts analysis 5. Monitor • Touch screen • Displays IPU screen 6. IPU • Main unit of IPU 7. Mechanical stop 7 • Immediately stops all mechanical movement Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers System Overview External Hardware Overview CS 5100 System - (continued) 8. Power switch 7 • Turns the power ON/OFF 9. Cuvette trash box • Behind right door of main 8 9 10 11 unit • Discards used cuvettes 10. Halogen lamp • Light source for multi- wavelength transmitted light detection method 8 11. Right air filter • Blocks the entry of dust into the instrument 8 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers System Overview Internal Hardware Overview – CS-2500 System 1. Sample arm • Cap piercing • Primary aspirating and dispensing of sample • Normal mode testing • Sample volume check 3 2. Dispensing table • Holds sample cuvette with stir bars • Transports cuvettes for processing 2 3. Reagent table • Holds reagents, calibrators, controls and cleaners 1 4 e • Reagent table temperature: 10±2˚ C 4. STAT/buffer table • 5 buffer/diluent positions at room temperature • 5 STAT sample positions 9 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers System Overview Internal Hardware Overview CS-5100 System 1. Sample arm A • Cap piercing • Primary aspirating and dispensing of sample • Normal mode testing • Sample volume check 2. Dispensing table A • Sample bolus dispense for HIL detection • Holds sample aliquot cuvettes 3. Reagent table • Holds reagents, calibrators, controls, and cleaners 1 • Reagent table temperature: 10±2˚C 4. Dispensing table LED • Green – allowed to open cover 3 • Flashing green – not allowed to open cover 5. Reagent table cover LED • Green – allowed to open cover 2 • Flashing green – not allowed to open cover 4 5 10 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers System Overview Internal Hardware Overview - CS-5100 System (continued) 6. Sample arm B 9 Secondary dispensing and sample aspiration in 8 • micro-sample mode 7. Reagent arm A 7 • Aspirates the intermediate reagent and adds it into the sample 6 8. Reagent arm B • Aspirates the last reagent and adds it into the sample 10 9. Reagent arm C • Aspirates the last reagent and adds it into the sample 10. Left air filter • Blocks the entry of dust into the instrument 11 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers System Overview IPU - admin ( Laboratory Supervisor ) X Display Screen Overview 1 () Menu Reagent Calib. Curve QC Chart Order Joblist Status Maint Shutdown STAT Stop Start 1. Toolbar • Contains shortcut buttons for main functions 2. View Displays the operational functions of the instrument --- • 3. Status bar STAT Reagent Information Calib. Curve QC Chart Order • Displays the status of the IPU and instrument 2 Joblist Status Maint. Shutdown Logoff oneypo komojop >Program ---- Version Settings Operation Log Version Information Test Operation 3 OFF 21:09 12 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers System Overview 1 2 3 4 5 6 7 8 9 IPU - admin ( Labo pervisor ) X Software Overview Menu Reagent Calib. Curve QC Chart Order Joblist Status Maint Shutdown STAT Stop Start 1. Reagent • Displays the status of the reagent tables and STAT/buffer table 2. Calib. Curve --- Displays calibration curves for each assay and Normal/ISI STAT Reagent Information Calib. Curve QC Chart Order • values 3. QC Chart • Displays results of QC analysis in a progressive line graph 4. Order Xj • Registers samples, QC and calibrations Joblist Status Maint. Shutdown Logoff 5. Joblist Displays results, orders and status of samples 10 11 • 6. Status >Program • Displays instrument consumables and temperatures ---- Version 7. Maint. Documents maintenance tasks Settings Operation Log Version Information Test Operation • 8. Shutdown 9. Start 10. Settings > Reagent Lot Master OFF 21:09 • Enter lot numbers and expiration dates 13 11. Operation Log Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 • Records instrument activities with user-name Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers System Overview Status Bar Temperature Reagent Cuvettes Rinse Black – All temperatures are in normal Black – There is a sufficient amount range Yellow – Low level Red – Some temperatures are outside normal range Red – Out. Needs replacement Grey – The Main Unit is not connected Grey – The Main Unit is not connected. Cannot detect level Siemens Ready HOST Help button Status of host computer Status of Main Unit Displays error messages Green – Connected Green – Ready and corrective action Red – Communication error Orange – Analyzing, consumable is used up Icon not displayed – disconnected Red – Error in the System Settings Grey –Main Unit is not connected 14 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers System Overview Logon Sign Off 7 8 9 1. Press Logoff on the IPU menu Logon Name User 2. Press OK • The IPU logs off and the Logon dialog box appears Password 4 5 6 1 2 3 Sign On 0 - C 1. Select the appropriate user logon button 2. Enter the password 3. Press OK ALPH Enter OK Cancel 15 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Supply and Reagent Management Reagent table status Reagent holder information indicator area display area Reagent Screen Overview A3-3 Holder A1-1 Tests Change/Add Reagent holder display A3-1 DDi Sup A3-5 DDi Reag 48 h Clean I switch buttons 48 h A3-2 A3-4 h Reagent Fbg Edit Reagent Info. DDiBuf BCPCSubs A2-5 A2-6 48 h 96 h A3-6 A4-1 Clean II h DDi Buf CAL TestThr Fbg 96 h Seq. 3 Lot Group 48 h 120 h Settings Usable Vol. A2-4 D3-1 A4-2 A2-3 CaCl2 D1-2 D3-2 APTT FSL No. of Tests Measurement Remaining 96 h 96 h A4-3 Reagent CaC12 BCPCAct Volume 96 h 96 Mixing No Mixing D1-1 D4-1 A2-2 A4-4 L Select holders ATReag BCPCAct Lot No. 547224 Holder number 29 h 96 h A2-1 CAL A4-5 GW 15 ATSubs D2-2 D4-2 Vial Customize A2-1 48 A1-6 A4-6 Exp. Date 2020/08/12 Sequence PT THS BCPCSubs Reagent name 96 h Set Date 2020/06/10 CaC12 CtIN QC) : CAL A1-5 96 h D5-2 16 h A1-4 A5-2 A5-1 Set Time 16:38:58 QC priority No validated Clean I Fbg APTT FSL DD i Sup Elap. Time 0 Hours 96 96 h 48 h More enabled calibration curve (1/2) A1-2 A5-4 A1-3 A5-6 PT Inn Change 72 h A5-3 Remaining reagent PT Inn APTT FSL 99 96 h A1-1 15-5 SB-1 SB-2 SB-3 SB-4 SB-5 volume Fbg OVB DDiDil DDiDil ATBuf 96 h 24 h 48 h 48 h 48 h Close X 16 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Supply and Reagent Management Reagent Holder Display Switch Buttons A3-3 Holder A1-1 Tests Change/Add A3-1 DDi Sup 48 h A3-5 Remaining stable time DDi Reag Clean I 48 h A3-2 A3-4 h Reagent Fbg Elapsed time Edit Reagent Info. DDiBuf BCPCSubs A2-1 A2-5 A2-6 48 h 96 h A3-6 A4-1 A2-1 Clean II CAL PT THS h DDi Buf TestThr Fbg Lot Group PT THS 48 h 120 h 96 h Seq 3 Settings 30 h D3-1 Usable Vol. 30 h A2-4 A4-2 CaC12 D1-2 D3-2 APTT FSL A4-3 No. of Tests Remaining CaC12 96 h 96 h Reagent BCPCAct Volume Mixing No Mixing DI- D4-1 A2-2 A4-4 Select holders ATReag L BCPCAct Lot No. 547224 29 h 96 h A2-1 CAL ATSubs D2-2 D4-2 4-5 Vial GW 15 Customize Number of tests 48 h A1-6 A4-6 Exp. Date 2020/08/12 Usable Volume D2-1 D5-1 BCPUSUDS 96 h Set Date 2020/06/10 A2-1 CaC12 D5-2 CtIN h A1-5 96 h 16 A5-1 Set Time 16:38:58 A2-1 PT THS Clean I A1-4 A5-2 PT THS 30 test h Fbg APTT FSL DD i Sup 48 h Elap. Time 0 Hours 96 h 96 h More 33. 3 mL A1-2 (1/2) A5-4 A1-3 A5-6 PT Inn 72 h A5-3 Change PT Inn APTT FSL -99 96 h A1-1 A5-5 SB- SB-2 SB-3 SB-4 SB-5 Fbg OVB DDiDil DDiDil ATBuf 96 24 h 48 h 48 h 48 h Close X 17 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Supply and Reagent Management Reagent Message Cause Corrective Action A2-1 This state occurs if a mixed and cooled reagent is mistakenly placed in a different holder, or if a barcode is read that was not registered Remove the reagent and load it into the correct location or in the Reagent Lot Master, or if diluent is placed in racks A and D enter the barcode ID into the Reagent Lot Master screen A-23 PTAn This state occurs if the reagent lot has expired Replace with a new lot of reagent ? This state occurs if a barcode read error occurred Readjust the reagent vial in the reagent table or manually edit the reagent information ? This state occurs if the read reagent ID was not Enter the reagent lot information into the Reagent Lot registered in the reagent lot master Master screen under the settings menu or enter the expiration date manually under Edit Reagent Information 41-3 nn This state occurs if the reagent stability has expired Replace with a new vial of reagent -99 18 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Supply and Reagent Management Reagent Lot Master Setup X Valid Reagent ID Reagent Reagent Type Lot No Exp. Date User Definition Enter Reagent Information Manually or Using 5025 SHP Ca 503267 2020/04/25 Detailed Display K 5004 XII F 503403 2020/08/12 the Vial Barcode 5035 V F 504946 2020/08/12 5027 CtIN 5 Co 507746 2019/11/29 Add 508 PlSubs R 508684 2020/08/12 0000 1. Navigate to Reagent Lot Master from the IPU menu 5087 PIReag R 508783 2020/08/12 2. Enter the lot number in the Lot No. field or scan the 1D 5142 BCPCSubs R 514298 2020/08/12 Import 5334 VWFBuf R 533404 2020/08/12 vial barcode with the barcode reader 5335 vWFReag R 533504 2020/08/12 Export 3. Place the cursor in the Exp. Date field 5269 PT Inn R 539391 2020/08/12 KK KK KK KKK 0 0 000 4. Enter the Exp. Date using the calendar 2 nt Lot Information 3 Delete 5. Press Add Lot No. 503267| Valid Exp. Date 2020/04/25 4 April 2020 6 6. Press Save User Definition Sun Mon Tue Wed Thu Fri Sat Save 29 30 31 1 2 3 4 Reagent Master Information 5 6 7 10 11 LO 12 13 14 15 16 17 18 Reagent ID 5025 19 20 21 22 23 24 25 26 27 28 29 30 1 2 Note: Expiration dates must always be manually entered 3 4 5 6 7 8 9 Reagent Name SHP for reagents. Expiration dates cannot be entered via Reagent Type Calibrator the barcode scanner. Manufacturer Siemens Year Note: CS-2500 System and CS-5100 System application Month sheets list required reagents, reagent onboard stability and onboard position for each specific assay. Date Close 19 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Supply and Reagent Management Reagent Lot Master Setup X Valid Reagent ID Reagent Reagent Type Lot No. Exp. Date User Definition Enter Reagent Information with the 2D Barcode 5025 SHP Cal 503267 2020/04/25 2020/08/12 Detailed Display K 0004 XII F 503403 5035 V F 504946 2020/08/12 1. Navigate to Reagent Lot Master from the IPU menu 502 CtIN Co 507746 2019/11/29 Add 2. Press Import 5086 PISubs R 508684 2020/08/12 5087 PIReag R 508783 2020/08/12 0 3. Press Barcode 2 514 BCPCSubs R 514298 2020/08/12 Import 4. Scan the 2D barcode on the assay value sheet with the 5334 vWFBuf R 533404 2020/08/12 5335 vWFReag barcode reader Select Import Method Export 5269 PT Inn × 5. Press Save Reagent Lot Information Delete 6. Press Exit Lot No. 503267 Select the import method to the reagent lot master. 7. Press Close User Definition 3 5 Sat Save Reagent Master Information File Barcode Cancel 11 18 Reagent ID 25 Note: 2D barcodes are found on the assay value insert Reagent Name SHP sheet for Siemens’ reagents, calibrators, and all Reagent Type Calibrator assayed controls. Manufacturer Siemens Year Month Date Close 20 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Supply and Reagent Management Reagent Table Loading – CS-2500 System 1. Press Reagent on the IPU menu 2. Highlight a reagent position for removal 3. Press Change/Add on the Operation Panel 4. Lift the reagent section lid 5. Verify the reagent table cover LED is solid green 6. Slide the lock lever and remove the reagent table cover 7. Lift out the rack. Remove empty or expired reagents 8. Add a new reagent vial to rack with the barcode facing out • If applicable, add an anti-evaporation cap 9. Load the reagent rack into the reagent table 10. Slide the lock lever reagent table cover 11. Close the reagent section lid 12. Press OK • The barcode is read 13. Wait for the barcode reading to finish 14. On the Reagent screen, highlight the reagent position just loaded and press Change to update the date and time 21 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Supply and Reagent Management Reagent Table Loading - CS-5100 System 1. Press Reagent on the IPU menu o 2. Highlight a reagent position for removal 3. Press Change/Add on the Operation Panel 4. Open the light shield lid 5. Verify the light shield lid LED is solid green 6. Open the reagent table cover 7. Lift out the rack. Remove empty or expired reagents 8. Add a new reagent vial to rack with the barcode facing out • If applicable, add an anti-evaporation cap 9. Close the reagent table cover 10. Close the light shield lid 11. Press OK • The barcode is read 12. Wait for the barcode reading to finish 13. On the Reagent screen, highlight the reagent position just loaded and press Change to update the date and time 22 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Supply and Reagent Management STAT/Buffer Table Loading – CS-2500 System CS-2500 To load barcoded vials: 1. Verify the STAT/buffer table cover LED is green 2. Open the STAT/buffer table cover 3. Place reagent in an adaptor, if necessary, with the barcode facing out 4. Place into the STAT/buffer table and close the cover 5. Press OK 6. On the Reagent screen, highlight the reagent position just loaded and press Change to update the date and time To load a 4mL cup: 1. Verify the STAT/buffer table cover LED is green 2. Place 4mL cup into an adaptor and load 3. Close the STAT/buffer table cover 4. Press OK 5. On the Reagent screen, the position is displayed as a red question mark 6. Highlight the red question mark position Note: Reagents can be loaded during analysis to the inner reagent 7. Press Edit Reagent Info. on the Operation Panel table. CS-2500 System application sheets provide onboard 8. Select the reagent name, vial type (4mL cup), and verify the lot number positioning and stability of all required reagents per assay. 9. Press OK 10. With the cup position highlighted, press Change to update the date and 23 time Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Supply and Reagent Management STAT/Buffer Table Loading – CS-5100 System To load barcoded vials: 1. Verify the STAT/buffer table cover LED is green 2. Open the STAT/buffer table cover 3. Place reagent in an adaptor, if necessary, with the barcode facing out 4. Place into the STAT/buffer table and close the cover 5. Press OK 2 3 4 5 6. On the Reagent screen, highlight the reagent position just loaded and press Change to update the date and time To load a 4mL cup: 1. Verify the STAT/buffer table cover LED is green 2. Place 4mL cup into an adaptor and load 3. Close the STAT/buffer table cover 4. Press OK 5. On the Reagent screen, the position is displayed as a red question mark 6. Highlight the red question mark position Note: Reagents can be loaded during analysis to the inner reagent 7. Press Edit Reagent Info. on the Operation Panel table. CS-5100 System application sheets provide onboard 8. Select the reagent name, vial type (4mL cup), and verify the lot number positioning and stability of all required reagents per assay. 9. Press OK 10. With the cup position highlighted, press Change to update the date and 24 time Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Supply and Reagent Management C-Rack and SLD Mini/Micro* Cup 1. Reconstitute the requested control or calibrator observing package insert instructions 2. Aspirate the entire content of the GW5 or HMB1* vial using an appropriate pipette 3. Slowly dispense the entire volume into a new SLD mini/micro* cup, avoiding any air bubble formation 4. After reagent transfer, carefully check for bubbles and, if 1325 1324 1322 required, remove using a smaller pipette tip 5. Set the SLD mini/micro* cup into the corresponding GW5 or HBM1* vial 6. Remove the C-rack using the Reagent Table Loading Vial Type Cup Type Reagent Rack instructions 7. Insert the vial with SLD mini/micro* cup into the C-rack GW5 SLD mini cup Reagent rack C-1 and place back into the Reagent Table Reagent rack C-2 8. Close the cover and press OK to read the barcode Reagent rack C-3* 9. On the Reagent screen, highlight the vial just loaded and HBM1* SLD micro cup* Reagent rack C-4* press Change to update the date and time * SLD micro cup, HBM1 vial and reagent racks C-3/C-4 for Note: C-rack is used for controls and calibrators. use outside of the United States only 25 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Sample Processing IPU - admin ( Laboratory Supervisor ) X (1) LIS Order Processing 3 8 3 Menu Reagent Calib. Curve QC Chart Order Joblist Status Maint. Shutdown STAT Stop Start 1. Place rack with barcoded sample tubes on the sampler 2. Check the host connection status • Host connection status icon must be green or orange 3. Press Start 4. After barcode reading, confirm the sample order status and STAT Reagent Information Calib. Curve QC Chart Order progress on the Joblist screen 1 Joblist Status Maint. Shutdown Logoff A >Program - ------ Version Settings Operation Log Version Information Test Operation 2 OFF 21:09 HOST 26 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Sample Processing Manual Order Processing Order Entry Unregistered Rack-Pos : 000001 6 With inge O Ordinary Sample No. Sample O QC Sample Pos. 1. 7 Th Place rack with sample tubes on the sampler Sample No. Control Preset 1 2. Press Order Edit Sample Info. Lot No. 2 Repeat 3. Enter the Rack No. 8 3 4. Select a tube position to input an order PT-IN 4 IN APTT- Fbg -D INN-A FSL Order Entry 5. Press Order Entry on the Operation Panel 5 7 8 9 5 6. Select Ordinary Sample INN-D TT-Th Di BC-PC V-INN Detailed 6 4 5 6 Settings 7. Place the cursor in Sample No. and input the sample ID if the 7 VWF-A VWF-A g med XII-F sample does not contain a barcode g lov SI LA1 1 2 3 Regist. 8 • If the sample does contain a barcode, the 2D barcode LA2 BC-PL 9 G BC-C1 VIII MDA 0 C reader can be used to input the sample ID 10 Select the assays to be analyzed CAT PCATO FVPCA FVPCA 8. T TO ALPI Enter More 9. Select the down arrow to order the next sample (1/2) More 10. Press OK 9 ( 1/ 2 ) 10 11. Press Start LA LAR LA R OK Cancel 12. Confirm the sample order status on the Joblist screen Close X 27 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Sample Processing Micro Mode Unregistered Rack No. Switch 000001 Change Order 1. Follow the Manual Ordering Processing steps on the previous page to ID the sample and order test(s) Pos. Sample No. Mc PT-IN APTT- Fbg-D INN-A INN-D TT-Th ESL Detailed Settings Di 2. Select the Mc column on the Order screen 1 Rack-Pos : 000001-01 Sample No.: 1234 3. Load the un-capped tube onto the system 2 Sample Comment: 4. Press Start 3 Reflex Assay Group Repli Select Measurement Time Measurement Redilution Re-analysis Time 4 5 Micro- APTT-FSL 180 180 Sample Mode 6 320 7 Extend Measurement Time 8 9 Cancel 1. Follow the Manual Ordering Processing steps on previous More 10 page to ID the sample and order test(s) [1/1] 2. Press Detailed Settings OK Cancel 3. Select the box below Measurement Time 4. Select a measurement time LA LAR LAR LA R PCA FVPCA NR T NR FVL R AcR R 5. Press OK Close X 6. Press Start 28 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Sample Processing Status Rack No. Mo Sample PT INN sec TT Thr sec -Pos. Sample No de Sample Info. Comment F Date Start End K Time Time R sec sec < Joblist Status Display 00002-04 615n-15m-4 N M F V 2016/11/09 15:07 15:14 11.6 00002-05 615n-15m-5 N M F V 2016/11/09 15:08 15:14 11.5 100001-01 612n-15m-1 N M Hem F V 2016/11/09 1523 15:30 11.5 Pending Order is registered but analysis has not started 00001-02 612n-15m-2 N M Hem F V 2016/11/09 1523 15:30 11.5 100001-03 612n-15m-3 N M Hem F V 2016/11/09 15:24 15:30 11.5 00001-04 612n-15m-4 N M Hem - F V 2016/11/09 1524 15:31 11.5 Processing Assay groups are being analyzed 00001-05 612n-15m-5 N M Hem F / 2016/11/09 1524 15:31 11.6 Review 00001-01 615n-12m-1 N M F 2016/11/09 15:39 15:45 * ***** On Hold All assay groups have been analyzed but the Review 100001-02 615n-12m-2 M F / 2016/11/09 15:39 15:46 * ***** Z calibration curve has not been validated Review 00001-03 615n-12m-3 N M F V 2016/11/09 15:40 15:46 * ***** Review 100001-04 615n-12m-4 N M F V 2016/11/09 15:40 15:46 * ***** (Blank) Analysis of all assay groups has been completed Review 00001-05 615n-12m-5 N M V 2016/11/09 15:40 15:47 ***** normally Review 00001-01 711m-0-1 N M Hem Lip - F V 2016/11/24 08:42 08:49 * ****** Review 00001-02 711m-0-2 N M Hem Lip - F V 2016/11/24 08:43 08:49 ***** Review Analysis completed but requires confirmation Review 100001-03 8789 N M Lip - F V 2016/11/24 08:43 08:50 * ***** Review 00001-04 711m-0-4 N M Hem Lip - F V 2016/11/24 08:43 0850 ***** * Review 100001-05 711m-0-5 N M L* F V 2016/11/24 08:44 08:50 * ***** Error Analysis completed but an error has occurred Review 100001-01 70-111-1 N M F V 2016/11/24 08:59 09:06 * 10.7 Review 00001-02 70-111-2 N M F V 2016/11/24 09:00 09:06 10.7 * Review 00001-03 70-111-3 N M F V 2016/11/24 09:00 09:06 * 10.7 « A A A List 29 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Sample Processing PT PT INR PTT Fbg C sec sec mg/dl 28.1 ***** * Joblist Analysis Progress 10.9 47.3 Test ordered 26.8 Sample dispensed 274 113 Sample incubating 10.7 27. O Sample measuring * ****.* *** ** ***** 50 * * * * ***** ****** 50 * Joblist Assessment Flags * ***** *** ** * ***** 50 * Display 16.5 1.56 34.5 * 245 * * * Display Meaning Priority 16.4 1.55 * * * Low-reliability 1 16.4 ** 1.55 34.5 245 * * * d Dilution analysis O O 2 < The value below report limit 3 11.0 > The value above report limit 3 27.4 + The value above mark limit 4 263 30 The value below mark limit 4 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 - Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Sample Processing Status Rack No. Sample No Mo Sample Info. Sample Date Start End R PT INN sec TT Thr sec K -Pos de Comment Time Time sec sec T < Joblist Analysis Result Errors 000002-04 615n-15m-4 M - F V 2016/11/09 15:07 15:14 11.6 Z 000002-05 615n-15m-5 M - V 2016/11/09 15:08 15:14 11.5 Z 000001-01 612n-15m-1 M Hem - F V 2016/11/09 15:23 15:30 11.5 Z Display Meaning 000001-02 612n-15m-2 N M Hem F V 2016/11/09 1523 15:30 11.5 000001-03 612n-15m-3 N M Hem V 2016/11/09 15:24 15:30 11.5 Analysis result could not be obtained due to 000001-04 612n-15m-4 **** * N M Hem - V 2016/11/09 15:24 15:31 11.5 T . an error 000001-05 612n-15m-5 N M Hem 2016/11/09 1524 15:31 11.6 < Review 000001-01 615n-12m-1 M V 2016/11/09 15:39 15:45 ***** Z T Calculated parameters could not be Review 000001-02 615n-12m-2 M V 2016/11/09 15:39 15:46 ***** - - - - - Z . calculated Review 000001-03 615n-12m-3 N M V 2016/11/09 15:40 15:46 * ***** Calibration curve not validated, preventing Review 000001-04 615n-12m-4 N M F V 2016/11/09 15:40 15:46 * ***** XXXX.X calculated parameter Review 000001-05 615n-12m-5 N M V 2016/11/09 15:40 15:47 ***** T Review 000001-01 711m-0-1 N M Hem Lip - V 2016/11/24 08:42 08:49 * ***** T ++++.+ Number of displayed digits exceeded Review 000001-02 711m-0-2 N M Hem Lip V 2016/11/24 08:43 08:49 ***** Review 000001-03 8789 N M Lip - F V 2016/11/24 08:43 08:50 ***** 000001-04 Hem F V ***** / / / /. / Input value error occurred during average Review 711m-0-4 N M Lip - 2016/11/24 08:43 08:50 Review 000001-05 711m-0-5 N M H* L* - F V 2016/11/24 08:44 0850 ***** calculation process of duplicated analyses Review 000001-01 70-111-1 N M V 2016/11/24 08:59 09:06 * 10.7 Review 000001-02 70-111-2 N M - V 2016/11/24 09:00 09:06 10.7 * Review 000001-03 70-111-3 N M F V 2016/11/24 09:00 09:06 * 10.7 A A A List 31 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Sample Processing Browser Information Review Final Remeasure HOST No 320 M 09/27/2018 09:13:44 Not Validated Lip 000050-02 .................................................................................... 1. Highlight a sample on the Joblist 2. Press Browser on the Operation Panel Routine Lot Roll More Detail X 3. Press the Detail key PT PT & 16.4 Sample No 320 M PT 6.7 sec 4. The Details screen displays: PT INR & 1.55 Result 245 mg/dL Sample volume errors Assay Group Value Units • PT * 16.4 sec A PT INR 1.55 - • Analysis result errors Dilution Ratio / 1 Ratio /1 Detail • Wave changes 0 15 30 45 60 • Hardware or reagent errors Information Code Content 5. Press the graph for Reaction Curve 0002.0000.0000 Slight Coagulation 0000.0000.0800 Wave Changed 800nm A information 1000.3000.0000 Lipemic Sample Close 32 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Sample Processing Sample No. 320 M Date/ 09/27/2018 09:13:44 Result Assay Group PT Detail Time Assay Group Value Units Reaction Curve Information PT & 16.4 sec PT INR & 1.55 4000- 1. Press the desired graph on the Browser screen to 3600 view its reaction curve Zoom 3200 2. View the reaction curve shape In Evaluation Info Evaluation Data Measurement Info 3. Press the following tabs for additional information: 2800- Evaluation Into • Evaluation Info tab Zoom Out 2400 Information Value o bH: baseline Wave [nm] 800 2000 bH_point_time 9.5 dH: reaction intensity bH 899 o 1600 End_point_time 24.5 Coag %: where the clot time is read dH 53 o Coag% 50 o Wavelength: alternative wavelength used 1200 dOD 0.0264 Slo pe 12.42 o Start and end time for chromogenic/D Di 800- Clotting Point • Evaluation Data tab 400 o Displays 1%-100% time for the reaction curve • Measurement Info tab 10 20 30 40 50 60 [sec] o Reagent lot used o Dilution ratio o Reagent elapsed time – hours onboard Auto Scale Zoom Zoom Calibration curve ID Out In o o Pre-analytical check levels o QC performed date o Reagent table temperature 33 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Sample Processing Hemolysis, Icterus*, Lipemia and Tube Volume Status Rack No. Sample No Mo Sample Info. Sample V Date Start End R PT INN sec TT Thr sec Check from the Joblist -Pos de Comment Time Time sec sec T 000002-04 615n-15m-4 N F V 2016/11/09 15:07 15:14 11.6 000002-05 615n-15m-5 N F V 2016/11/09 15:08 15:14 11.5 1. Press Joblist 000001-01 612n-15m-1 N Hem - F V 2016/11/09 1523 15:30 11.5 2. View the Sample Info. column. Described below are the 000001-02 612n-15m-2 N Hem F V 2016/11/09 15:23 15:30 11.5 possible HI*L Check results: 000001-03 612n-15m-3 N Hem F V 2016/11/09 15:24 15:30 11.5 Hem – flag for hemolysis 000001-04 612n-15m-4 N Hem - F V 2016/11/09 1524 15:31 11.5 • 000001-05 612n-15m-5 N Hem - F V 2016/11/09 1524 15:31 11.6 • Ict – flag for icterus* Review 000001-01 615n-12m-1 N F V 2016/11/09 15:39 15:45 * ***** • Lip – flag for lipemia Review 000001-02 615n-12m-2 N F V 2016/11/09 15:39 15:46 * ***** • H* interference in Hemolysis reading Review 000001-03 615n-12m-3 N F V 2016/11/09 15:40 15:46 ***** Check tube manually Review 000001-04 615n-12m-4 N F V 2016/11/09 15:40 15:46 ** ***** I* interference in Icterus reading* 615n-12m-5 N F V 2016/11/09 15:40 • Review 000001-05 15:47 ****** * Check tube manually Review 000001-01 711m-0-1 N Hem Lip - F V 2016/11/24 08:42 08:49 ***** * L* interference in Lipemia reading Review 000001-02 711m-0-2 N Hem Lip - F V 2016/11/24 08:43 08:49 ***** * • Review 000001-03 8789 N Lip - F V 2016/11/24 08:43 08:50 ***** * Check tube manually Review 000001-04 711m-0-4 N Hem Lip - F V 2016/11/24 08:43 0850 * ***** • Vol – Sample tube fill out of range Review 000001-05 711m-0-5 N H* L - F V 2016/11/24 08:44 08:50 ***** Review 000001-01 70-111-1 N - F V 2016/11/24 08:59 09:06 10.7 * F 10.7 * * Icterus check for use outside of the United States Review 000001-02 70-111-2 N - V 2016/11/24 09:00 09:06 Review 000001-03 70-111-3 N - F V 2016/11/24 09:00 09:0 * 10.7 only 34 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Sample Processing Sample No. 320 M Date/ Detail Time 09/27/2018 09:13:44 Result Assay Group PT Assay Group Value Units Hemolysis, Icterus*, Lipemia and Tube Volume PT & 16.4 sec PT INR & 1.55 Levels from the Browser 4000 - 3600 1. From the Joblist, highlight a desired sample result Zoom 3200 In 2. Press Browser on the Operation Panel Evaluation Info Evaluation Data Measurement Info 2800 3. Press on the reaction curve graph Zoom Measurement Info 2400 - 4. Select the Measurement Info tab to display the flagging Out Name Value level value 2000 Temperature 37.0 1600 Channel No. 2 Management ID 1 023 * Icterus check for use outside of the United States only 1200- Reagent Lot PT Inn:539378 800 Clotting Point Dilution Ratio 1 / 1 400 Elapsed Time PT Inn:19 Hem Detection Level o 10 20 30 40 50 60 [sec] Ict Detection Level Lip Detection Level 5 Vol Detection Level Auto Scale Zoom Zoom Calibration Curve ID 103 Out In QO Performed Date 09/27/201 8 09:09:30 Reagent Table Temp. 10.4 35 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Sample Processing Multiple Dilution Analysis (MDA) Order Unregistered Rack No 000001 Change Switch Order 1. Press Order Pos Sample No. Mc PT PTT Fbg AT DDi PTN PTTN V-INN VII-I 2. Select the Sample No. for which you want to set the Preset Detailed Settings MDA method 2 Rack-Pos : -02 Sample No.: 2 85241 85241 Sample Comment: 4 Repeat 3 3. Press Detailed Settings on the Operation Panel Reflex Assay Group Replications Dilution Ratio Measurement Time Redilution Re-analysis 4 Order Entry 4. Press the box below Dilution Ratio 5 Micro- VII-INN 1 1/1 180 Sample Detailed 3 Mode 5. Select the appropriate MDA dilution ratio 9 Select Dilution Ratio Press More for additional dilution ratios 1/1 MDA 2 Regist • 8 5 6. Press OK 9 MDA 3 NDA lowe Press Start 10 MDA E MDAL 6 More 7. [1/1] MDA H 1/2 More (1/2) Ext. OK Cancel 1/4 1/8 NOTE: Dilution ratios may vary depending on in-country PTPTT More ( 1/2 ) availability. Cancel Close X NOTE: Cross mixing test (if enabled) can be used to help clinicians make decisions regarding factor deficiencies and circulating inhibitor patterns (for example, lupus anticoagulant). 36 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Sample Processing Status Sample No Rack No. Sample Into. Mo V R Time V INN X / INN" sec VII INN"S -Pos. de F VII INN" sec sec sec sec PT INR PTT Fbg C mal Fba DDi C mg/L Order Entry Multiple Dilution Analysis (MDA) Results 2354 000003-02 Vol N V F 17:07 1212 ***** 8824 000003-03 17:09 121.8 18.6 Browser 4 8824 000003-03 17:09 119.3 25.4 8824 000003-03 17:09 132.5 33.5 Press Joblist 8824 000003-03 F 17:09 1945 ***** Validate 1. 85241 000003-01 NV 08:34 116.4 18.9 2 2. View the Sample No. displaying the MDA results and the 85241 000003-01 N V 08:34 1156 d 25.8 Display Condition 85241 000003-01 N V 08:34 122.3 d 34.7 corresponding mean 3 85241 000003-01 N F 08:34 1181 d ***** REAGUU MV 902 Find WO CUIIN003188 3. Highlight the line displaying the mean result Final Remeasure 4. Press Browser on the Operation Panel Hem Tot A HOST No 85241 M 02/22/2017 08:26:18 5. The Browser Main screen displays the reaction curves, Validated Lip Vol # 000003-01 analysis results, and reference information from the Routine Lot Roll More selected line on the Joblist screen 6. Press on a desired reaction curve graph to display: • Large graph of results • Dilutions with results • Mean result 75 VII-INN 6 VII INN sec d ***** VII INN % sec 118.1 % NOTE: If any errors occur during analysis, Detail flags on 5 the Browser Main screen. 25 Testr 1.000 Press Detail to find additional information Ser 1.000 Detail • 10 50 100 about the error code 37 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Sample Processing Status Rack No Sample No. F G H Date Start End Sample In to Seq. MO R PT INN sec PT INN"INR APTT FSL sec Fbg DT"sec FbE DT -Pos. Time de sec sec sec 5/L Print a Single Sample Result Review 000020-04 0254 F G 2019/09/25 14:30 14:39 194 N **** * < 1. Press Joblist Review 000020-05 0255 G 2019/09/25 14:33 14:44 195 N 213 2.13 * **** * 27.2 0.54 Print 2. Select a sample result The result will be printed 3. Press Print on the Operation Panel Review 000020-05 0255 < 4. Select Cursor Data Target Data 5. Select a format: Graph, List, Simple Review 000020-05 0255 F Cursor Data Marked Data O All 6. Press Print 000020-06 0256 F < Format Review 000020-07 0257 F ¥ Graph Print List Print O Simple Print Review 000020-08 0258 F < 000020-09 0259 F V G Print Cancel Review 000020-10 0260 F Review REAGOO CtIN507746* F V G 2019/09/25 15:23 15:30 201 M ***** A A A List 38 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Sample Processing Status Rack No. Sample No. F V G H Date Start End Sample Info. Seq. Mo R PT INN"sec PT INN"INR APTT FSL"sec FbE DT"sec FbE DT -Pos. Time Time sec sec sec 5/L Print Multiple Sample Results Review 000020-04 0254 F V G 2019/09/25 14:30 14:39 - 194 N * ***** 1. Press Joblist Review 000020-05 0255 G 2019/09/25 14:33 14:44 195 N 213 2.13 * ***** 27.2 054 Print 2. Press Mark on the Operation Panel The result will be printed 3. Select the samples from the analysis results list: Review 000020-05 0255 V G • Current: mark currently highlighted sample Target Data Same Date: mark samples with same Review 000020-05 0255 F O < • Cursor Data Marked Data All analysis date 000020-06 0256 F • All: all displayed samples Format • Release All: clear marked samples Review 000020-07 0257 F V G 4. Press Back Graph Print O 5. Press Print List Print Simple Print Review 000020-08 0258 F V G 6. Select Marked Data 7. Select a format 000020-09 0259 F V G Print Press Print Cancel 8. 9. Return to Mark and select Release All Review 000020-10 0260 F V 10. Press Back Review REAGOO CtIN507746* F V G 2019/09/25 15:23 |15:30 201 M ***** A A List 39 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Calibration CS-2500 Load Reagents 1. Enter reagent and calibrator lot information in the Reagent Lot Master • Refer to the Supply and Reagent Management section for more details 1323 1322 1321 2. Load reagents • Refer to the Supply and Reagent Management section for more details Note: Calibrator plasma should be transferred into a SLD mini/micro* cup. Refer to the Supply and Reagent Management section for more details. * SLD micro cup for use outside of the United States only. GSA-500 50ml 1156 D.1 40 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Calibration Calibration Curve Order Entry Order the Calibration Assay Group: Fbg Reagent Lot OVB Fbg 547558 Change 1. Press Order Parameter Calibrator lot Assay Shoot unit 503261 Value 2. Press Switch Order on the Operation Panel Press Holder Calib Curve Order Fbg C SHP 3. 503261 249 mg/dL 4. Select the desired assay to be calibrated 5. Press Change and select the correct reagent lot number 6. Press OK 7. Select the correct calibrator lot number from the list • Assay value automatically displays 8. For manual entry of an assay value: place the cursor in the Assay Sheet Value field and enter the value using your keypad 9. Press OK 10. Press Start 11. To view the calibration status and progress, press Joblist OK Cancel 41 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Calibration Assay Fbg-DT Assay Parameter Fbg DT Current Calib. Curve (Solid Line) Compared Calib. Curve View the New Calibration Curve Reagent Lot OYB Fbg Validated by sysmex Reagent Lot (Group) 547293 (Group) Validated by Updated on 2019/09/19 07:39 ID 20 Updated on ID 1. Press Calib. Curve Current Compare Log-Log Point-to-Point Press Change log (X) = alog (Y) +b 2. 100.0 3. Select the correct assay Fbg DT sec 4. Select the lot number 0.60 24.8 -50.0 E M 1.30 13.0 2.50 7.0 Compare New Versus Current 5.00 3. -20. 7.50 3.2 Calibration Curve -10.0 1. Press Calib. Curve 5.0 2. Press Detailed Display on the Operation Panel 3. Press Select Compared Calib. Curve 4. Select a calibration curve to compare and press Load Exp. Date 2020/04/25 -2.0 Cursor Position 5. Compare the calibration curves ‹ Axis Point Y Axis Point 6. Press Close 1.26 g/L Current Calib. Curve 13.3 sec 0.20 0.50 .00 2.00 1.0 5.00 Fbg DT Compared Calib. Curve sec 42 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Calibration Validate or Delete the New Calibration Curve Assay Group Reagent Lot (Group) Updated 2019/09/19 ID 20 Validate Validated OVB Fbg Change Fbg-DT 547293 Validated by sysmex 1. Display the desired calibration curve Detailed Display 2. Press Validate to validate the calibration curve Fbg DT 3. Press Delete to delete the displayed calibration curve Edit Log-Log Point-to-Point 4. Press OK log (X) = alog (Y) +b Fbg DT 100.0 sec Print 5. Press Print 0.60 24.8 -50.0 1.30 13.0 Calib. Info. Note: Validate the calibration by performing QC. 2.50 7.0 M 5.00 3.8 -20.0 Delete 7.50 3.2 -10.0 5.0 Restore Old Calibration Curves More 2.1 (1/2) 1. Display the calibration curve 1.0 2. Press Restore on the Operation Panel Exp. Date 2020/04/25 0.20 0.50 1.00 2.00 5.00 Fbg DT • If Restore is not displayed, press More Close X 3. Select the desired calibration curve to restore 4. Press OK 5. Press Validate 43 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Calibration Edit Calibration Curve 22 Validate Validated PT INN INR Enter the ISI and Normal Value Detailed Display PT IN 1. Enter the PT lot and ISI value in the Reagent Lot Master 7 8 9 Edit with the 2D barcode from the PT ISI value sheet 4 5 6 sec 100.0 • Refer to the Supply and Reagent Management section Print for more details -70.0 1 2 3 Calib. Info. 2. Load the PT reagent onto the Reagent Table -50.0 0 C 40.0 3. Press Calib. Curve -30.0 Delete 4. Press Change Enter 5. Press PT 20.0 6. Select the correct lot number -15.0 7. Press Edit -10.0 More 8. Select the INR tab at the top of the dialog box Normal Value (1/2) Normal 10.0 sec 7.0 9. Press Lot Master to enter the ISI ISI Value 1.00 Non Exp. 0 Exp. Date: 2020/09/23 -5.0 10. Press Yes 10.00 11. For manual entry of normal and ISI values: Load Lot Master OK Cancel Close • Place the cursor in the Normal Value field and type in your laboratories established normal value. Press Enter. ISI Value can be entered manually, if needed Note: ISI value with 2D barcode is found on the table of assigned values sheet for Innovin® reagents. PT normal patient mean is established by laboratory. 12. Press OK These are required for every new lot of Innovin reagent. 13. Select Validate 14. Press Ok 44 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Quality Control Process from the Reagent Table: QC Files Order Entry Switch Order O Q001 - 0020 O Control, Lot No. 1. Load QC onto a C-rack Sample No. 0011 Control • Refer to the Supply and Reagent Management section Control Citrol 1 Lot No. 528150 ot No. Order Entry to load QC material in a C-rack using a SLD mini/micro* cup QC02 Line PT PTT Clear Fbg PTN QC07 2. Press Order QC13 3. Press Switch Order on the Operation Panel APTTN OCO QCO3 4. Press Holder QC Order QC01 Regist 5. Press Order Entry on the Operation Panel OC11 QC06 6. Select the QC01 - QC20 tab QC04 7. Select the QC file from the list on the right 8. Select the appropriate assay(s) 9. Select the down arrow to order the next control More (1/2) 10. Press OK once all controls have been ordered 11. Press Start OK Cancel Close X * SLD micro cup for use outside of the United States only. 45 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Quality Control Process from the Reagent Table: Control Lot No. Order Entry Switch Order O OC01 - QC20 O Control, Lot No VII-I NN 1. Load QC onto a C-rack Sample No. Control Citrol 1 • Refer to the Supply and Reagent Management section Control Lot No. Lot No 548165 Order Entry to load QC material in a C-rack using a SLD mini/micro* cup 548165 Line PT PTT Fbg PTN Clear 2. Press Order 3. Press Switch Order on the Operation Panel PTTN 4. Press Holder QC Order Regist 5. Press Order Entry on the Operation Panel 6. Select the Control Lot No. tab 7. Select a control material from the list 8. Place the cursor in the Lot No. field and select the appropriate lot from the list More (1/2) 9. Select the appropriate assay(s) 10. Select the down arrow to order the next control OK Cancel Close X 11. Press OK once all controls have been ordered 12. Press Start * SLD micro cup for use outside of the United States only. 46 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Quality Control Process from the Sample Rack Order Entry Unregistered Rack-Pos : 000001-02 Switch Order Ordinary Pos. Sample O QC Sample Sample No. Mc 1. Load QC in a sample rack in a sample cup Sample No. Control CtIN Preset 1 QC CtIN507746 Mc 2. Press Order Edit Sample Info. Lot No. 2 Repeat 3. Enter the Rack Number 3 PT-IN 507746 4. Select a position to input the order N APTT- FSL Fbg-D INN-A 4 T Order Entry 5. Press Order Entry on the Operation Panel 5 INN-D 6. Select QC Sample Di TT-Th BC-PC V-INN Detailed 6 Settings 7. Select the appropriate control from the list 7 VIWF-A VWF-A XII- Place the cursor in the Lot No. field and select the g med 8. g low SL LA1 Regist 8 appropriate lot number LA2 BC-PL G BC-C1 VIII 9 MDA 9. Select the appropriate assay(s) 10 10. Press the down arrow to order the next control PCAT PCATO FVPCA T FVPCA TO More (1/2) 11. Press OK once all controls have been ordered More 12. For Micro Mode – select the MC column for each control (1/2) 13. Place the sample rack in the sampler LA LAR LA R OK Close X Cancel 14. Press Start 47 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Quality Control QC Chart Find More Error To add a comment to a QC point: PT INN sec CtIN 507746 Current Confirm Data 1. Press QC Chart on the IPU menu Detailed Data 12.5 X 2. Highlight a desired QC Chart 10.9 Assay Parameter PT INN sec Management ID 5023 9.3 Control CtIN Control Lot No. 507746 Change Cursor 3. Place the cursor on the desired point Analyzed on 2019/09/18 11:33:46 Target Value 10.9 sec 4. Press Confirm Data on the Operation Panel Analysis Result **** sec Target Value Difference APTT FSL sec CtIN Reagent Lot No. PT Inn:539391 Target/Limit Settings 5. Enter a comment 28.1 Error Cannot check the analysis result due to the error data. 6. To exclude a QC point, select the Exclude from 24.4 1 Formula 20.7 Auto QC Setting automatic calculation checkbox Rerun 7. Press Update Comment QCBarcode Setting Exclude from automatic calculation More (1/3) Update Cancel Close X 48 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Quality Control Export QC Information More Delete QC Print X Output Target To print a QC report: PT INN"sec O Active Tab Select a tab for printing All Add Lot 1. 12.5 2. Press Print Report on the Operation Panel 10.9 9 Target Data 7 8 Change 9.3 Lot 3. Select Active Tab All 4. Select Date Range and enter the start and 4 6 APTT FSL sec Change Scale end dates 28.1 Date Range 1 2 3 5. Select the format: List 1 24.4 Switch 20.7 Display 6. Press Print Start Date Up 0 C End Date Print To export QC data to a file: 2019 09 18 2020 / 08 19 Report Down - 1. Press QC Chart on the IPU menu 2. Highlight a desired QC chart Print Format More (2/3) 3. Press Export on the Operation Panel Graph List(1 line) List(2 lines) 4. Select a location to store the file 5. Name the file 6. Press Save Print Cancel Close X 49 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance Shutdown Startup 1. Verify CA CLEAN I is set on reagent table A (table A or B for 1. Turn the IPU power ON the CS-2500 System) 2. The Logon dialog box appears when the startup is complete 2. Press Shutdown 3. Select the correct logon button • Reagent cooling is continued: instrument goes into 4. Enter Logon Name and Password sleep mode. Reagents in the Main Unit are still cooled 5. Press OK • Turn the Main Unit OFF: shuts down the instrument 6. Turn the Main Unit switch ON without reagents in the Main Unit cooled 3. Press OK 4. The shutdown process starts and a progress bar appears • If Automatically Shut Down IPU is selected on the Timer screen of System Settings, the IPU is automatically shut down in 30 seconds and turned off after shutdown of the instrument is completed. Skip to step 8 5. Press OK after shutdown process is complete 6. Press the X in the upper-right corner of the screen 7. Turn the IPU power OFF Select the Windows Start Icon  Select Shutdown • 8. Turn the Main Unit switch OFF 50 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance Rinse Daily Maintenance Month Daily 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18|19 20 21 22 23 24 25 26 27 28 29 30 31 Rinee Probe Discard used cuvettes Change Waste Tank Daily Maintenance Dispose of waste Check and discard trap chamber fluid Shutdown Manual Maintenance Weekly 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 1. Press Status Clean the instrument Rince the Rinse Tank Lamp Check cuvettes, cuvette trash, rinse, waste Calibration • Monthly History 3 History 2 History 1 Remarks Check temperatures Clean the filter 2020/08/21 • As-Needed Maintenance-Replacement of Supplies Replace 2. Press Maint. Piercer Check Item Hastory 3 History 2 History 1 Cycle Counts Remarks 3. Empty the cuvette trash box Air pressure adjustment 2020/08/08 2020/08/09 2020/08/21 Prime 2020/08/09 2020/09/11 2020/09/19 Remove jammed cuvette Wipe off • Reset the trash counter Piorcer Wipe off piercer 2020/08/08 2020/09/06 2020/09/10 Chean Sysmex racks 2020/08/21 4. Press Change Waste Tank on the Operation Panel Lamp replacement and calibration 2020/07/19 877 / 1,000 h Replace the fuses of the Pneumatic Unit • Empty waste, press OK Piercer 2020/07/26 2020/09/11 46 / 40,000 Times Sample Syringe A 21,141 / 1,200,000 Times 5. Check/Replace DI water Sample Syringe B 31,311 / 1,200,000 Times Reagent Syringe A 21,505 / 1,200,000 Times 6. Add cuvettes Reagent Syringe B 25,902 / 1,200,000 Times Reagent Syringe C 14,168 / 1,200,000 Times Waste Tube (Waste Tubing 1) 21,443 / 2,250,000 Times • DO NOT fill above the red line Waste Tube (Waste Tubing 2) 17,902 / 2,250,000 Times 7. Press Manual Maintenance on the Operation Panel, Waste Tube (CP) 5,190 / 300,000 Times Uber Defined Maintenance 1 check off completed items User Defined Maintenance 2 User Defined Maintenance 3 Close X 8. Go to the Operations Log, enter initials for maintenance items completed Press Reagent Note: During the daily shutdown and startup a rinse probe is performed. While the 9. Check number of tests and elapsed time. Prepare as system is down trap chamber fluid should be checked and discarded and • condensation should be removed from the reagent table and reagent table needed cover. 10. Run QC 51 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance Weekly Maintenance < This Month » 2020/10 Rinse Probe Daily Maintenance Daily 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Rince Probe Clean the instrument exterior and interior: Discard used cuvettes Change Waste Tank Dispose of waste Check and discard trap chamber fluid Shutdown Manual Maintenance 1. Shut down the Main Unit and unplug the power cord Weekly 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Clean the instrument 2. Wipe the instrument with a moistened paper towel Rince the Rinse Tank Lamp Monthly Hastory 3 |History 2 History 1 Calibration with water and a neutral detergent Remarks Clean the filter 2020/08/21 As-Needed Maintenance-Replacement of Supplies Replace Piercer Clean the rinse tank: Check Item History 3 History 2 |History 1 Remarks Air pressure adjustment 2020/08/08 2020/08/09 2020/08/21 Cycle Counts Prime 2020/08/09 2020/09/11 2020/09/19 Remove jammed cuvette Wipe off Piercer 1. Remove the cap of the rinse tank and float switch Wipe off piercer 2020/08/08 2020/09/06 2020/09/10 Chan Sysmex racks 2020/08/21 2. Use water or isopropyl alcohol to wash the inside of Lamp replacement and calibration 2020/07/19 877 / 1,000 h Replace the fuses of the Pneumatic Unit the tank and float switch, then rinse with distilled Piercer 2020/07/26 2020/09/11 46 / 40,000 Times Sample Syringe A 21,141 / 1,200,000 Times Sample Syringe B 31,311 / 1,200,000 Times water Reagent Syringe A 21,505 / 1,200,000 Times More Reagent Syringe B 25,902 / 1,200,000 Times 3. Replenish the rinse water Reagent Syringe C 14,168 / 1,200,000 Times Waste Tube (Waste Tubing 1) 21,443 / 2,250,000 Times 4. Attach the float switch and tighten the cap Waste Tube (Waste Tubing 2) 17,902 / 2,250,000 Times Waste Tube (CP) 5,190 / 300,000 Times Uber Defined Maintenance 1 User Defined Maintenance 2 User Defined Maintenance 3 Close X For CS-2500 Systems: • Replace the trash box liner CS2, if used Note: Document manual maintenance in the Maint. screen under Manual • Remove water from tray no. 48, if water has Maintenance in the Operation Panel. accumulated 52 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance Monthly Maintenance – CS-2500 System This Month > > 2020/08 Rinse Probe V Daily Maintenance Daily 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Clean the filters (rear): Rinse Probe 00000000000 Discard used cuvettes OO Change Waste Tank Dispose of waste Check and discard trap chamber fluid O 00 Shutdown 00000 1. Remove filters #514 and #513 Manual Maintenance OOOOON Weekly 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 2. Use a vacuum or similar tool to remove dust Clean the instrument O Rinse the Rinse Tank O Replace Trash Box Liner O Lamp from the filter Calibration 3. Install the clean filters Monthly History 3 History 2 History 1 Remarks Clean the filter 2020/08/19 As-Needed Maintenance-Replacement of Supplies Check Item Clean the filters (left side): History 3 History 2 History 1 Cycle Counts Remarks Air pressure adjustment Prime 2019/08/19 2019/08/20 Wipe off Piercer Remove jammed cuvette Wipe off piercer 1. Remove filter #16A Clean Sysmex racks 2020/08/19 Lamp replacement and calibration 2. Use a vacuum or similar tool to remove dust Replace the fuses of the Pneumatic Unit Piercer from the filter Sample Syringe Reagent Syringe More Waste Tube (CP) (1/2) 3. Install the clean filter User Defined Maintenance 1 User Defined Maintenance 2 User Defined Maintenance 3 Note: Document manual maintenance in the Close X Maint. screen under Manual Maintenance in the Operation Panel. 53 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance Monthly Maintenance – CS-5100 System < This Rinse Month » 2020/10 Probe Daily Maintenance Daily 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30|31 Rince Probe Clean the filter (left side): Discard used cuvettes Change Waste Tank Dispose of waste Check and discard trap chamber fluid Shutdown Manual Maintenance 1. Open the light shield lid Weekly 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Clean the instrument 2. Push the top of the filter Rince the Rinse Tank Lamp 3. Pull out the filter Monthly History 3 |History 2 History 1 Remarks Calibration Clean the filter 2020/08/21 4. Use a vacuum or similar tool to remove dust As-Needed Maintenance-Replacement of Supplies Replace Piercer from the filter Check Item Hetory 3 History 2 Hstory 1 Cycle Counts Remarks Air pressure adjustment 2020/08/08 2020/08/09 2020/08/21 5. Install a clean filter Prime 2020/08/09 2020/09/11 2020/09/19 Remove jammed cuvette Wipe off Piercer 6. Close the light shield lid Wipe off piercer 2020/08/08 2020/09/06 2020/09/10 Chean Sysmex racks 2020/08/21 Lamp replacement and calibration 2020/07/19 877 / 1,000 h Replace the fuses of the Pneumatic Unit Clean the filter (right side): Piercer 2020/07/26 2020/09/11 46 / 40,000 Times Sample Syringe A 21,141 / 1,200,000 Times Sample Syringe B 31,311 / 1,200,000 Times Reagent Syringe A 21,505 / 1,200,000 Times More Reagent Syringe B 25,902 / 1,200,000 Times 1. Push the top of the filter cover Reagent Syringe C 14,168 / 1,200,000 Times Waste Tube (Waste Tubing 1) 21,443 / 2,250,000 Times 2. Remove the cover by tilting it slightly toward Waste Tube (Waste Tubing 2) 17,902 / 2,250,000 Times Waste Tube (CP) 5,190 / 300,000 Times you Uber Defined Maintenance 1 User Defined Maintenance 2 3. Remove the filter mount User Defined Maintenance 3 Close X 4. Use a vacuum or similar tool to remove dust from the filter Note: Document manual maintenance in the Maint. screen under Manual 5. Attach a clean filter to the filter cover Maintenance in the Operation Panel. 6. Install the filter cover 54 7. Close the filter cover Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance As Needed Maintenance – CS-2500 System Adjust the 0.10 MPa pressure (range 0.10 to 0.11) : Adjust the 0.22 MPa pressure (range 0.22 to 0.24) : 1. Press Maint. on the IPU menu 1. Press Maint. on the IPU menu 2. Press Pressure Adjustment on the Operation Panel 2. Press Pressure Adjustment on the Operation Panel 3. Open the cover door on the left side of the Main Unit 3. The 0.22 MPa adjustment knob is located on the pneumatic 4. Pull the 0.10 MPa adjustment knob toward you to unlock unit 5. Adjust the pressure slowly 4. Loosen the fixing screw on the adjustment knob 6. Once adjustment is complete, press the adjustment knob in 5. Adjust the pressure slowly until it locks 6. Once adjustment is complete, tighten the fixing screw while 7. Close the cover door taking care not to rotate the adjustment knob 8. Press OK 7. Press OK 55 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance As Needed Maintenance – CS-2500 System This Rinse Daily Maintenance Month > > 2020/08 Probe V (continued) Daily 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Rinse Probe 000000000000 Discard used cuvettes O Change Waste Tank Dispose of waste Check and discard trap chamber fluid O O O Adjust the -0.067 MPa pressure (range -0.057 to -0.053) : O O O Shutdown Manual Maintenance OOOOON Weekly 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Clean the instrument O 1. Press Maint. on the IPU menu Rinse the Rinse Tank O Replace Trash Box Liner O Lamp Calibration 2. Press Pressure Adjustment on the Operation Panel Monthly History 3 History 2 History 1 Remarks 3. Open the cover door on the left side of the Main Unit Clean the filter 2020/08/19 4. Loosen the fixing nut of the bellows unit As-Needed Maintenance-Replacement of Supplies Check Item History 3 History 2 History 1 Cycle Counts Remarks 5. Adjust the pressure slowly Air pressure adjustment 02/14/2019 05/13/2019 05/16/2019 Prime 04/25/2019 05/16/2019 06/20/2019 Wipe off Piercer 6. Once adjustment is complete, tighten the fixing nut while Remove jammed cuvette 08/09/2018 03/28/2019 07/17/2019 Wipe off piercer 03/28/2019 04/25/2019 taking care not to rotate the adjustment knob Clean Sysmex racks 05/16/2019 06/20/2019 07/29/2019 Lamp replacement and calibration 02/14/2019 05/13/2019 05/16/2019 213 / 1,000 h Close the cover door Replace the fuses of the Pneumatic Unit 7. Piercer 1,287 / 40,000 Times Sample Syringe 22,245 Times 8. Press OK Reagent Syringe 39,380 Times More Waste Tube (CP) 4,059 / 720,000 Times (1/2) User Defined Maintenance 1 User Defined Maintenance 2 User Defined Maintenance 3 Close X 56 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance As Needed Maintenance – CS-2500 System (continued) Remove jammed cuvettes from the cuvette hopper: 1. Open the reagent section lid 2. Loosen the cover fastening screw and open the cuvette hopper cover • Verify the status display of the instrument is Ready or Int. Ready 3. Insert the cuvette removal rod and stir 4. Remove the cuvette removal rod, close the cuvette hopper cover and screw in the cover fastening screw 5. Close the reagent section lid A 6. Press Start Remove jammed cuvettes from the cuvette disposal: 1. Turn OFF the Main Unit 2. Remove the cuvette trash box 3. Insert the cuvette removal rod and stir 4. Return the cuvette trash box to its original position 57 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance As Needed Maintenance – CS-2500 System (continued) Wipe the piercer clean: Prime the hydraulic line: 1. Verify the light shield lid is closed 2. Press Maint. on the IPU menu 1. Press Maint. on the IPU menu Press Prime on the Operation Panel 3. Press Wipe off Piercer on the Operation Panel 2. 4. Press OK 3. Press OK Priming starts and a progress bar appears. Once 5. Turn OFF the Main Unit • complete, the dialog box closes 6. Open the light shield lid 7. Set the jig Clean the racks: 8. Wipe the piercer clean with gauze soaked with purified water Racks with rack barcode labels, wipe with soft cloth 9. Remove the jig 1. moistened with water or ethanol 10. Close the light shield lid 11. Turn ON the Main Unit 2. Racks with no rack barcode labels, rinse with water 3. Verify all racks for proper tube adapters and barcode labels 58 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance As Needed Maintenance – CS-5100 System Adjust the 0.10 MPa pressure (range 0.10 to 0.11) : Adjust the 0.22 MPa pressure (range 0.22 to 0.24) : 1. Press Maint. on the IPU menu 1. Press Maint. on the IPU menu 2. Press Pressure Adjustment on the Operation Panel 2. Press Pressure Adjustment on the Operation Panel 3. Open the right door on the Main Unit 3. Open the left door on the Main Unit 4. Pull the 0.10 MPa adjustment knob toward you to unlock • The 0.22 MPa adjustment knob is located on the pneumatic 5. Adjust the pressure slowly unit 6. Once adjustment is complete, press the adjustment knob in until it 4. Loosen the fixing screw on the adjustment knob locks 5. Adjust the pressure slowly 7. Close the Main Unit door 6. Once adjustment is complete, tighten the fixing screw while 8. Press OK taking care not to rotate the adjustment knob 7. Close the Main Unit door 8. Press OK 59 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance As Needed Maintenance – CS-5100 System < This Month » 2020/10 Rinse Probe Daily Maintenance (continued) Daily 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30|31 Rince Probe Discard used cuvettes Change Waste Tank Dispose of waste Check and discard trap chamber fluid Adjust the -0.053 MPa pressure (range -0.057 to -0.053) : Shutdown Manual Maintenance 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Clean the instrument 1. Press Maint. on the IPU menu Rince the Rinse Tank Lamp History 3 | History 2 Calibration Monthly History 1 Remarks 2. Press Pressure Adjustment on the Operation Panel Clean the filter 2020/08/21 3. Open the right door on the Main Unit As-Needed Maintenance-Replacement of Supplies Replace Piercer Check Item History 3 History 2 |History 1 Cycle Counts Remarks 4. Loosen the fixing nut of the bellows unit Air pressure adjustment 2020/08/08 2020/08/09 2020/08/21 Prime 2020/08/09 2020/09/11 2020/09/19 Remove jammed cuvette Wipe off 5. Adjust the pressure slowly Piercer Wipe off piercer 2020/08/08 2020/09/06 2020/09/10 6. Once adjustment is complete, tighten the fixing nut Chean Sysmex racks 2020/08/21 Lamp replacement and calibration 2020/07/19 877 / 1,000 h while taking care not to rotate the adjustment knob Replace the fuses of the Pneumatic Unit Piercer 2020/07/26 2020/09/11 46 / 40,000 Times 7. Close the Main Unit door Sample Syringe A 21,141 / 1,200,000 Times Sample Syringe B 31,311 / 1,200,000 Times More 8. Press OK Reagent Syringe A 21,505 / 1,200,000 Times Reagent Syringe B 25,902 / 1,200,000 Times Reagent Syringe C 14,168 / 1,200,000 Times Waste Tube (Waste Tubing 1) 21,443 / 2,250,000 Times Waste Tube (Waste Tubing 2) 17,902 / 2,250,000 Times Waste Tube (CP) 5,190 / 300,000 Times User Defined Maintenance 1 User Defined Maintenance 2 User Defined Maintenance 3 Close X 60 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance As Needed Maintenance – CS-5100 System (continued) Prime the hydraulic line: Wipe the piercer clean: 1. Open the light shield lid 1. Verify the light shield lid is closed 2. Remove cover No. 1501 2. Press Maint. on the IPU menu 3. Lift reagent arms B and C slightly and turn them towards you 3. Press Wipe off Piercer on the Operation Panel 4. Place cardboard over the detector to block the detector well 4. Press OK 5. Press Maint. on the IPU menu 5. Turn OFF the Main Unit 6. Press Prime on the Operation Panel 6. Open the light shield lid 7. Press OK 7. Set the jig Priming starts and a progress bar appears. Once complete, 8. Wipe the piercer clean with gauze soaked with purified • the dialog box closes water 8. Remove the cardboard 9. Remove the jig 9. Attach cover No. 1501 10. Close the light shield lid 10. Close the light shield lid 11. Turn ON the Main Unit Clean the racks: 1. Racks with rack barcode labels, wipe with soft cloth moistened with water or ethanol 61 2. Racks with no rack barcode labels, rinse with water Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 3. Verify all racks for proper tube adapters and barcode labels Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance As Needed Maintenance – CS-5100 System (continued) Remove jammed cuvettes from the cuvette hopper: 1. Verify the Main Unit is in standby mode 2. Open the light shield lid 3. Turn the incubator until the incubation catcher faces the front of the instrument 4. Remove the rail cover 5. Remove the hopper cover 6. Insert the accessory cuvette removal rod into the hopper and stir the cuvettes 7. Attach the hopper cover 8. Attach the rail cover 9. Close the light shield lid 10. Press Start 62 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance Supply Replacement - CS-2500 System Lamp Replacement: 1. Turn OFF the power of the Main Unit and unplug the power cord • Wait 30 minutes for the lamp to cool 2. Open the lamp cover located on the right side of the Main Unit 3. Press the clamp of the connector and disconnect the connectors 4. Loosen the thumb screw 5. Remove the lamp holder 6. Squeeze and lift the lamp retainer to remove the lamp 7. Install a new lamp in reverse order 8. Reconnect the power and turn the Main Unit ON • Wait 30 minutes before starting the lamp calibration Note: Do not touch the lamp reflector or lamp bulb with your fingers. Lamp performance could be affected. 63 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance Supply Replacement – CS-2500 System Rinse Probe (continued) This Daily Maintenance 2015/10 Lamp Calibration Daily 23 24 25 26 27 28 29 30 31 Change Waste Tank Rinse Probe Discard used cuvettes o calibration will be executed (Execution time : approximately 3 minutes) 00000000 Lamp Calibration: Dispose of waste 0000000 Check and discard trap chamber fluid 00000 Manual Maintenance Shutdown Weekly OK Cancel 23 24 25 26 27 28 29 30 31 Clean the instrument Lamp 1. Select Maint. on the Toolbar Rinse the Rinse Tank Calibration Replace Trash Box Liner 2. Select Lamp Calibration on the Operation Panel Monthly History 3 History 2 |History 1 Remarks Clean the filter 3. Select OK As-Needed Maintenance-Replacement of Supplies Check Item History 3 History 2 |History 1 Cycle Counts Remarks Wipe off 4. Select the correct option when the Lamp Confirmation Air pressure adjustment Piercer Prime dialog box appears Remove jammed cuvette Wipe off piercer Lamp replacement and calibration 225 / 1,000 h • Reset lamp counter: new lamp Replace the fuses of the Pneumatic Unit Piercer 19 / 40,000 Times Sample Syringe 1,409 Times • Do not reset the lamp counter: same lamp Reagent Syringe 2,900 Times Waste Tube (CP) 226 / 720,000 Times More (1/2) 5. Select OK User Defined Maintenance 1 User Defined Maintenance 2 User Defined Maintenance 3 Close X Note: Lamp calibration requires a 30-minute warming-up of the lamp to allow light intensity stabilization. Do not start calibration earlier, this will affect patients’ results. 64 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance Supply Replacement - CS-5100 System Lamp Replacement: 1. Turn OFF the power of the Main Unit and unplug the power cord • Wait 30 minutes for the lamp to cool 2. Open the lamp cover located on the right side of the Main Unit 3. Press the clamp of the connector and disconnect the connectors 4. Loosen the thumb screw 5. Remove the lamp holder 6. Remove the lamp cord from the cord clamp 7. Lift up the lamp brace of the lamp holder and remove the lamp 8. Install a new lamp in reverse order 9. Reconnect the power and turn the Main Unit ON • Wait 30 minutes before starting the lamp calibration Note: Do not touch the lamp reflector or lamp bulb with your fingers. Lamp performance could be affected. 65 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance Supply Replacement - CS-5100 System < This Month » 2020/10 Rinse Probe Daily Maintenance Daily 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30|31 Rince Probe Lamp Calibration Discard used cuvettes Change Waste Tank Dispose of waste Lamp Calibration Check and discard trap chamber fluid Shutdown Lamp calibration will be executed (Execution time approximately 3 minutes) Manual Maintenance 1. Press Maint. on the IPU menu Weekly 123 24 25 26 27 28 29 30 31 Clean the instrument 2. Press Lamp Calibration on the Operation Panel Rince the Rinse Tank Lamp 3. Press Execute Monthly OK Cancel Calibration Clean the filter 4. Select the correct option when the Lamp Confirmation As-Needed Maintenance-Replacement of Supplies Replace Piercer dialog box appears Check Item History 3 History 2 |History 1 Remarks Air pressure adjustment 2020/08/08 2020/08/09 2020/08/21 Cycle Counts 2020/08/09 2020/09/11 2020/09/19 • Reset lamp counter: new lamp Prime Remove jammed cuvette Wipe off Piercer Do not reset the lamp counter: same lamp Wipe off piercer 2020/08/08 2020/09/06 2020/09/10 • Chean Sysmex racks 2020/08/21 5. Press OK Lamp replacement and calibration 2020/07/19 877 / 1,000 h Replace the fuses of the Pneumatic Unit Piercer 2020/07/26 2020/09/11 46 / 40,000 Times Sample Syringe A 21,141 / 1,200,000 Times Sample Syringe B 31,311 / 1,200,000 Times Reagent Syringe A 21,505 / 1,200,000 Times More Reagent Syringe B 25,902 / 1,200,000 Times Note: Lamp calibration requires a 30-minute Reagent Syringe C 14,168 / 1,200,000 Times Waste Tube (Waste Tubing 1) 21,443 / 2,250,000 Times warming-up of the lamp to allow light Waste Tube (Waste Tubing 2) 17,902 / 2,250,000 Times Waste Tube (CP) 5,190 / 300,000 Times intensity stabilization. Do not start Uber Defined Maintenance 1 Uber Defined Maintenance 2 calibration earlier, this will affect patients’ User Defined Maintenance 3 Close X results. 66 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance Replace Pneumatic Unit Fuses - CS-5100 System 1. Turn OFF the power of the Main Unit and unplug the power cord 2. Remove the fuse holder 3. Replace the blown fuse with a new fuse 250V 4. Return the fuse holder to its original position T 3.15A 5. Reconnect the power and turn the Main Unit ON Note: Use a fuse of the specified type and rating. Otherwise, smoke or fire may result. If the fuse is blown soon after it has been replaced, there is a problem with the instrument. Please contact your local service representative. 67 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance Replace the Piercer - CS-5100 System 1. Press Maint. on the IPU menu 2. Press Replace Piercer on the Operation Panel 3. Press OK 4. Turn OFF the power of the Main Unit and unplug the power cord 5. Open the light shield lid 6. Remove the arm cover and piercer i. Set the jig for maintenance ii. Attach the piercer replacement jig to the piercer iii. Remove the sample arm A cover iv. Remove the tube v. Remove the connector and wiring vi. Remove the piercer fixing screw vii. Pull out the stopper viii. Pull up the piercer until the needle tip is exposed, then slide down the piercer replacement jig until the needle tip is covered ix. After removing the piercer, twist the lower (thick) part of the piercer replacement jig for one half-turn counter- clockwise while holding the upper (thin) part x. Dispose of the piercer following your laboratory protocol 68 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 *Procedure is continued on the next slide Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance Replace the Piercer - CS-5100 System (continued) 7. Attach a new piercer 8. Replace the arm cover i. Twist the lower (thick) part of the piercer replacement 9. Remove the piercer replacement jig then jig for maintenance jig while holding the upper (thin) part 10. Reconnect the power and turn the Main Unit ON ii. Pass the piercer needle tip through the guide hole of 11. Confirm the Piercer Replacement Procedure Checklist sample arm A 12. Close the light shield lid • Verify the bottom edge of the piercer replacement 13. Press OK jig sits in the center of the hollow in the piercer guide 14. Press Yes iii. Set the piercer so the screw hole of sample arm A aligns with the guide groove on the piercer mount iv. Insert the stopper v. Tighten the piercer fixing screw vi. Connect the connector and fix the cable to the clamp vii. Replace the tube at the top of the piercer and tighten the tube connecting screw then nut viii. Move the piercer mount up and down to verify the piercer moves smoothly vi. Verify the piercer is fixed firmly and there are no cable and/or tube strains 69 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance Backup Select a location to backup the file. C:\NPU_Backup Option Back Up the Database and Setting Files [ Saved date is added to the backup destination 1. Exit the IPU software 2. Press the X located in the upper-right corner of the screen 3. Press OK OK Cancel 4. Power OFF the Main Unit 5. Select Start  All Programs  CS-Tools  Backup 6. Press Option Option 7. Select a Backup Type Backup Type • Backup All Data Backups All Data • Specify Date- select a date range from the calendar and target data to be backed up 0 Specify Date Period 8. Press OK to close the dialog box 2014/11/01 2014/1 1/30 9. Press OK to start the backup November, 2014 Sun Mon Tue Wed Thu Fri Sat Target Data 28 29 30 31 1 2 3 10. Wait for “Backup was completed” message 4 5 6 7 8 9 10 [V] Includes Log Files. 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 1 11. Press OK [V] Includes Operation Log Files. 2 3 6 7 12. Press Cancel 13. Start up the IPU software and Main Unit 14. Log on to IPU software OK Cancel 70 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance = | |PU_Backup 0 X File Home Share View Back Up the Database Externally > This PC > Desktop > IPU_Backup VC Search IPU_Backup Name Date modified Type Size Quick access Desktop 20201207_115513_BACKUP 2021/01/06 12:12 File folder 1. Place an external memory device in the computer 20201208_102121_BACKUP 2021/01/06 12:12 Downloads File folder * 20201209_110545_BACKUP 2021/01/06 12:12 File folder 2. Open the IPU_backup folder in file explorer Documents 20201210_112543_BACKUP 2021/01/06 12:12 File folder Pictures 70001011 100726 BACKUP 2021/01/06 12:12 File folder 3. Right-click the file, select Send to  Compressed (zipped) IPU_Backup Open BACKUP 2021/01/06 12:12 Compressed (zipped) Folder 1 KB This PC Open in new window BACKUP 2021/01/06 12:12 Compressed (zipped) Folder KB folder Pin to Quick access BACKUP 2021/01/06 12:12 Compressed (zipped) Folder 1 KB Desktop 7-Zip BACKUP 2021/01/06 12:12 Compressed (zipped) Folder KB 4. Right-click on the compressed backup file Documents CRC SHA VV Downloads Scan with Windows Defender ... 5. Select Send to  external memory device Music Share with V 6. To delete files from the IPU backup folder, right-click the Pictures Restore previous versions Videos Include in library V file, select Delete : OS (C:) Pin to Start Bluetooth device Send to V Compressed (zipped) folder Cut Desktop (create shortcut) Copy Documents Fax recipient Create shortcut Mail recipient Delete Rename O DVD RW Drive (E:) Properties 9 items item selected 71 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Maintenance Operation Log Filter Condition Filter Date none User none Operation none Detail none Enter Initials: No. Date Time User Operation Comment Commented On Commented By Print 2020/08/19 17:27:10 admin Maintenance 2 2020/08/19 17:27:10 admin Maintenance 3 2020/08/19 17:27:10 admin Maintenance 4 2020/08/19 17:27:10 admin Maintenance Export 1. Press Operation Log on the IPU menu 5 2020/08/19 17:27:10 admin Maintenance 6 2020/08/19 17:27:10 admin Maintenance 2. Highlight the maintenance item 7 2020/08/19 17:27:10 admin Maintenance 8 2020/08/19 17:27:10 admin Maintenance Import 3. Select the Pencil icon 9 2020/06/11 20:41:17 admin Validate Sample 10 2020/06/10 16:39:17 admin Change/Add Read Comment X Enter your initials on the comment line 11 2020/06/10 16:39:16 admin Change/Add Read 4. 12 2020/06/10 16:39:14 admin Change/Add Reag Enter Comment Characters remaining 97 Refresh 13 2020/06/10 16:39:11 admin Change/Add Read 5. Press OK 14 2020/06/10 16:39:10 admin Change/Add Read 15 2020/06/10 16:39:07 admin Change/Add Read 6. Repeat for each maintenance item performed 16 2020/06/10 16:39:05 admin Change/Add Reag 17 2020/06/10 16:39:03 admin OK Cancel 18 Change/Add Reag 19 2020/06/10 16:39:01 admin Change/Add Reag 2020/06/10 16:38:58 admin Change/Add Reagent Export the Operation Log File: Operation Log Detail No. 1 Detail Item Clean Sysmex racks Date 2020/08/19 17:27:10 Count Date Time 2020/08/19 17:27:10 1. Press Filter on the Operation Panel User admin 2. Select the Date checkbox Operation Maintenance 3. Enter Start/End dates using the calendar Comment Commented On Commented By 4. Press OK Close X 5. Press Export on the Operation Panel 6. Name the file and select a location Note: To view a saved file, use Import button and select file. Press Display 7. Press Save Current Log to return to current. 8. Press Filter  Clear  OK 72 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Troubleshooting Review the result of Analysis Result Error the Joblist occurred. Analysis Result Errors View Detail screen for Analysis Result Error and No further action needed. Is the Error code number. No Report result per Status laboratory protocol. Review or Error? On Browser, select the Yes Reaction Curve, review Yellow Evaluation info, evaluation data, and Highlight the measurement info. sample and select Browser Mechanical error, reagent problem, or certain check Red algorithm errors (e.g. Extrapolation boundary over Use CS-2500 and CS- Locate result with error) occurred. 5100 Key Task Guide Detail Key to troubleshoot View Detail screen for Analysis Result Error message. Troubleshoot problem. 73 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Troubleshooting Analysis Result Errors List Code: Message: 0002.0000.0000 Slight Coagulation Error 0004.0000.0000 Analysis Time Over Error 0008.0XXX.0000 Coagulation Curve Error 0008.0128.00XX Early Reaction Error 0000.0000.8000 Coag% Changed 0008.0256.0000 Noise Check Error 0016.0000.0000 Turbidity Level Over Error 0032.0000.0000 No Coagulation Error 0032.0002.0000 Flat Curve Error 74 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Troubleshooting Slight Coagulation Error Joblist Numerical result with asterisk Display The detected coagulation reaction was extremely weak, due to a Cause sample with low fibrinogen concentration, or due to a problem 0% No Coagulation Threshold with the sample or a reagent 100% To ...... Slight Coagulation Threshold • Corrective Verify reagent integrity, sample integrity, patient clinical history, Action and instrument delivery of reagent and sample • Reanalyze sample Normal Sample • Reanalysis produces a result without an asterisk (*). Report the A/D value of photometry Reportable result Result • Reanalysis produces the same error and comparable results. Time Report the mean of the two results 75 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Troubleshooting Analysis Time Over Error Joblist Numerical result Display The coagulation reaction did not finish within the detection time, 0% Cause due to a sample with low coagulation activity, a sample with low Reaction Start Level fibrinogen concentration, or a problem with the sample or reagent. • Check the sample for possible anticoagulant contamination, Corrective hemolysis, and lipemia • Action Verify reagent integrity, sample integrity, patient clinical history, A/D value of photometry and instrument delivery of reagent and sample • Reanalyze sample using a longer measurement time Maximum Reading Time Time • Reportable Reanalysis produces a result without an error. Report the result True End Point ? • Result Reanalysis produces the same error. The sample may not be able to form a firm clot. Follow your laboratory policy 76 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Troubleshooting Coagulation Curve Error Joblist Numerical result Display • This occurs when there is an unexpected fluctuation in the Cause curve. The most common reason is a bubble in the cuvette 0% • In Fibrinogen test: cold buffer or sample inhibitor delta • Verify reagent integrity, sample integrity, patient clinical history, dH Corrective and instrument delivery of reagent and sample Action • Review result reaction curve • Reanalyze sample - 100% • Reanalysis produces a result without an error. Report the result Normal Sample AND value of photometry Reportable • Reanalysis produces the same error. Review acceptability of Result curves. If curves are acceptable and if results are equivalent, Mask Time Check T Time [4 sec.] report the mean • Initial fluctuation drop • Stepping curve Error Sub- Sharp drop • Fbg curve error Note: For more details about specific sub-types refer to the CS- • types 2500 System and CS-5100 System Instructions for Use • Jump up • Terrace and/or Evaluation and Check Algorithm. 77 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Troubleshooting Early Reaction Error – Slow Reaction • Numerical result with an asterisk if the coagulation time is Joblist Display equal to or longer than the threshold (100 seconds) • No numerical result (***.**) if the coagulation time is less than the threshold value (100 seconds) 0% Cause An abnormal reaction was detected at the initial stage of the TL1 APTT coagulation reaction Width% 50% • Verify reagent integrity, sample integrity, patient clinical history, and instrument delivery of reagent and sample TL2 Corrective • Check Detail key for Analysis Result Error and Error code Normal Sample - - 100% A/D value of photometry Action number • Visually inspect the reaction curve Time1 Time2 Time • Slow Reaction, Error 0008.0128.0001 with a result 100 seconds or more may be reported out after visual inspection of the Reportable reaction curve Note: Do not report results without numerical values. Result • Slow Reaction, Error 0008.0128.0001 with a result less than 100 seconds do not report out. If reanalysis produces the same error code, follow your laboratory policy 78 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Troubleshooting Early Reaction Error – Start Angle • Joblist Display Numerical result with an asterisk for Start Angle 2, Error 0008.0128.0004 • No numerical result (***.**) for Start Angle 1, Error 008.0128.0002 dH1 0% Cause An abnormal reaction was detected at the initial stage of the APTT coagulation reaction Q dH2 • Verify reagent integrity, sample integrity, patient clinical history, and dH instrument delivery of reagent and sample • Check Detail key for Analysis Result Error and Error code number Normal Sample A/D value of photometry If Start Angle 2, Error 0008.0128.0004, visually inspect the reaction curve. - - 100% • Corrective Action Check that the coagulation time fits with the displayed curve. Check that 1s" Check 2nd Check the result matches what is listed at the 50% in Evaluation Data. If the Time Time Time result matches, report the result • If the result does not match the 50%, the result may be higher than your reportable limit. Follow your laboratory policy to report the result Note: Do not report results without numerical values. • Start Angle 2, Error 0008.0128.0004 may be reported out. See corrective Reportable actions • Result Do not report Start Angle 1, Error 0008.0128.0002 o If reanalysis produces the same error code, follow your laboratory policy 79 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Troubleshooting Early Reaction Error – Early % Joblist Display No numerical result Cause An abnormal reaction was detected at the initial stage of the APTT coagulation reaction 0% • Verify reagent integrity, sample integrity, patient clinical Check Point history, and instrument delivery of reagent and sample Corrective • Check Detail key for Analysis Result Error and Error code Action number • Reanalyze sample Normal Sample -- 100% photometry A/D value of • Reanalysis produces a result without an asterisk (*). The result may be reported Time Time Reportable • Reanalysis produces the same error code. Recollect the sample Result or follow your laboratory policy Note: Do not report results without numerical values. 80 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Troubleshooting Coag% Changed Joblist Display Numerical result Cause When Early% or Start Angle occurs the initial reaction part (0%) and the coagulation reaction part are separated, and the coagulation time is re-calculated using the start level 0% determined by Coagulation Waveform Analysis (CWA) Reanalysis solidification start level Initial clotting point (50%) • Verify reagent integrity, sample integrity, patient clinical Reanalysis freezing point (e.g. 60%) history, and instrument delivery of reagent and sample Corrective • Check Detail key for Analysis Result Error and Error code A/D value of photometry Action number 100% • Visually inspect the reaction curve Time • Reportable If the coagulation curve is acceptable, the result may be reported as determined by your laboratory policy. Follow your Result laboratory policy 81 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Troubleshooting Noise Check Error Joblist Display No numerical result The coagulation curve reaction may have been contaminated Cause with some kind of noise 0% Ave1 Ave1 - nSD1 • Verify reagent integrity, sample integrity, patient clinical history, and instrument delivery of reagent and sample Recalibrate the lamp or replace it with a new lamp. A new Diff • Corrective lamp requires lamp calibration. After performing the lamp calibration, perform calibration curve analysis and QC analysis, -- - Ave2 + nSD2 Action photometry A/D value of then check the analysis data 100% --- - --- Ave2 "Normal Sample • Reanalyze sample and make a comprehensive judgement, Mask Time taking sample and reagent, etc. into consideration Time of Baseline Time of End Point Time • Reanalysis produces a result without an asterisk (*). The result Reportable may be reported Result • If reanalysis produces the same error code, follow your Note: Do not report results without numerical values. laboratory policy 82 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Troubleshooting Turbidity Level Over Error Joblist Display No numerical result Sample turbidity was high and the transmitted light was Cause extraordinarily low level • Check the sample for turbidity and lipemia Corrective • Verify reagent integrity, sample integrity, patient clinical Action history, and instrument delivery of reagent and sample • Reanalyze sample AD Low Limit • Reanalysis produces a result without an asterisk (*). The result A/D value of photometry may be reported Reportable Mask Time • Reanalysis produces the same error code. Recollect the sample Result or follow your laboratory policy Time Note: Do not report results without numerical values. 83 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Troubleshooting No Coagulation Error Joblist Display No numerical result The coagulation reaction was not detectable or a weak clot has Cause formed, due to low fibrinogen concentration, a sample containing dH anticoagulant or a reagent problem - - 0% 100%. No Coagulation • Verify reagent integrity, sample integrity, patient clinical Threshold history, and instrument delivery of reagent and sample - Slight Coagulation Corrective Threshold • Action For Out of US only: reanalyze the sample • For US only: reanalyze the sample with a longer measurement time ******** Normal Sample A/D value of photometry • Reanalysis produces a result without an error. The result may be reported Reanalysis produces “No Coagulation” error message again: Time • Reportable o For Out of US only: the sample is below the detection limits Result of the detector, follow your laboratory policy For US only: determine if the result is plausible. May report Note: Do not report results without numerical values. o as greater than your Reportable Limit. Follow your laboratory policy 84 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Troubleshooting Flat Curve Error Joblist Display No numerical result Cause PT test only. This occurs with Warfarin in high dose 0% • Corrective Verify reagent integrity, sample integrity, patient clinical Action history, and instrument delivery of reagent and sample • Reanalyze sample with a longer measurement time 50% • Reanalysis produces a result without an asterisk (*). The result Slope Reportable may be reported • Reanalysis produces the same error; the result is not Normal Sample Result - - 100% A/D value of photometry reportable. Follow your laboratory policy Time width Time Note: Do not report results without numerical values. 85 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Administration DD Logon Name User Name Exp. Date User Right Comment 1 admin administrator 2037/12/31 Laboratory Supervisor Add a New User 2 LT LT 2037/12/31 Lab Technician Up Down 1. Press User Administration on the IPU menu Add 2 2. Press Add 3 3. Enter user information Delete • Logon Name is a mandatory field 4. Enter a password Logon Name LT Change Password 4 December 2037 5. Designate the correct user right User Name LT Sun Mon Tue Wed Thu Fri Sat 29 30 1 2 3 4 5 (Laboratory Supervisor, Lab Technician or 6 7 8 9 10 11 12 Exp. Date 2037/12/31 13 14 15 16 17 18 19 Select Icon Save 7 Night-Shift Operator) 20 21 22 23 24 25 26 27 28 29 30 31 6. Update the user permissions, if applicable 5 Jser Right Lab Technician Close 7. Press Save 8. Press OK Comment Year • The new user information is displayed in the user list Permissions Reagent replacement / addition Month Operation for Quality Control Operation for Calib Curve Results 6 Operation for Analysis Results Validate analysis results Date Maintenance Setting Assay Group Settings 00000000 86 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 CS-2500 System and CS-5100 System SIEMENS Healthineers Administration Register or Change a User’s Change Password Password 1. Press User Administration on the IPU menu Highlight the line of the user Password 7 8 9 2. 3. Press Change Password Current Password 4. To change a user’s password, enter the Up 4 5 6 current password New Password 5. Enter and confirm the new password 6. Press Update New Password Down 1 2 3 (Confirmation) 0 C ALPH Enter Update Cancel 87 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024 SIEMENS Healthineers Please note that the learning material is for training purposes only. For the proper use of the software or hardware, please always use the Operator Manual or Instructions for Use (hereinafter collectively "Operator Manual") issued by Siemens Healthineers. This material is to be used as training material only and shall by no means substitute the Operator Manual. Any material used in this training will not be updated on a regular basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training. The Operator Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. Please note: Some functions shown in this material are optional and might not be part of your system. Certain products, product related claims or functionalities (hereinafter collectively "Functionality") may not (yet) be commercially available in your country. Due to regulatory requirements, the future availability of said Functionalities in any specific country is not guaranteed. Please contact your local Siemens Healthineers sales representative for the most current information. The reproduction, transmission or distribution of this training or its contents is not permitted without express written authority. Offenders will be liable for damages. All names and data of patients, parameters and configuration dependent designations are fictional and examples only. All rights, including rights created by patent grant or registration of a utility model or design, are reserved. Unrestricted | Published by Siemens Healthineers AG | @ Siemens Healthineers AG, 2024 Siemens Healthineers HQ | Siemens Healthineers AG Siemensstr. 3 91301 Forchheim Germany Phone: +49 9191 18-0 siemens-healthineers.com 88 Job Aid Effective Date: 15 May 2024 | HOOD05162003158941 Unrestricted © Siemens Healthineers, 2024