Sysmex® CS-2500 System PEP to Go

SIEMENS Healthineers sysmex 88 -- CS-2500 -- --- --- - Sysmex® CS-2500 System PEP to Go Template Effective Date: 05/27/2019 | HOOD05162003010284 Job Aid Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Table of Contents System Overview 3 Supply and Reagent Management 12 Sample Processing 20 Calibration 34 Quality Control (QC) 39 Maintenance 44 Troubleshooting 57 Administration 70 2 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers System Overview External Hardware Overview 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 • Green – ready to start analysis Flashing green – warming up/analyzing 1 • • Orange – consumables are used up • Flashing orange – analysis being performed • Red – analysis stopped due to an error 5. Start button • Starts analysis 3 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers System Overview External Hardware Overview (continued) 6 6. Cuvette hopper sysmex • Holds approx. 500 cuvettes • Load up to the red line 7. Mechanical stop Immediately stops all mechanical movement CS-2500 • 8. Cuvette trash box 7 • Holds used and discarded cuvettes 8 4 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers System Overview Left Side Hardware Overview 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 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers System Overview Right Side Hardware Overview 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 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers System Overview Internal Hardware Overview 1. Sample arm • Cap piercing • Primary aspirating and dispensing of sample • Normal mode testing • Sample volume check 2. Dispensing table 3 • Holds sample cuvette with stir bars • Transports cuvettes for processing 2 3. Reagent table • Holds reagents, calibrators, controls and cleaners 1 4 • Reagent table temperature: 10±2˚ C 4. STAT/buffer table • 5 buffer/diluent positions at room temperature • 5 STAT sample positions 7 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers System Overview IPU - admin ( Laboratory Supervisor ) X 00 00 Display Screen Overview 1 AA 3 8 (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 STAT Reagent Information Calib. Curve QC Chart Order 3. Status bar • Displays the status of the IPU and instrument 2 0 0 September Joblist Status Maint. Shutdown Logoff >Program Version Settings Operation Log Version Information Test 3 01-69A OFF 20: 36 8 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers System Overview 1 2 3 4 5 6 7 8 9 DIPU - admin ( Labor ervisor ) X 00 Software Overview 3 8 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 STAT Reagent Information Calib. Curve QC Chart Order • Displays calibration curves for each assay and Normal/ISI values 3. QC Chart 0 0 • Displays results of QC analysis in a progressive line graph September 4. Order Registers samples, QC and calibrations Joblist Status Maint. Shutdown Logoff • 5. Joblist 10 • Displays results, orders and status of samples 11 6. Status ---- >Program Version • Displays instrument consumables and temperatures 7. Maint. Settings Operation Log Version Information Test • Documents maintenance tasks 8. Shutdown 9. Start 01-69A 10. Settings > Reagent Lot Master OFF 20: 36 • Enter lot numbers and expiration dates 9 11. Operation Log Effective Date: 14-Jan-2021 | HOOD05162003158939 • Records instrument activities with user name Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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 10 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers System Overview 55 IPU X A (1) Sign Off Menu Reagent Calib. Curve QC Chart Order Joblist Status Maint Shutdown STAT Stop Start 1. Press Logoff on the IPU menu THHHHE Logon 2. Press OK • The IPU logs off and the Logon dialog box appears STAT R 7 8 9 Order Logon Name User Password 4 5 6 1 2 3 Sign On 0 - C Joblist Logoff 1. Select the appropriate user logon button ALPH Enter 2. Enter the password 3. Press OK OK Cancel Settings Operation Log Version Information Test 01-69A A OFF 20:51 11 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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 DD i Sup 48 h A3-5 DDi Reag Clean I switch buttons 48 h A3-2 A3-4 h Reagent Fbg Edit Reagent Info. DDi Buf BCPCSubs A2-5 48 h h A4-1 Clean II A2-6 96 A3-6 DDi Buf CAL Fbg h TestThr Seq. 3 Lot Group 48 h 120 h 96 Settings Usable Vol. A2-4 D3-1 A4-2 A2-3 CaC12 D1-2 D3-2 APTT FSL A4-3 No. of Tests Measurement Remaining 96 h 96 h Reagent CaC12 BCPCAct Volume 96 h 96 Mixing No Mixing D1-1 D4-1 A2-2 A4-4 ATReag L Select holders BCPCAct Lot No. 547224 Holder number 29 h 96 h A2-1 CAL A4-5 Vial GW 15 ATSubs D2-2 D4-2 Customize Sequence A2-1 48 A1-6 A4-6 Exp. Date 2020/08/12 PT THS" BCPCSubs Reagent name 96 h Set Date 2020/06/10 CaC12 D5-2 CtIN CAL 96 h 16 A1-5 Set Time 16:38:58 Clean I A1-4 A5-2 A5-1 QC priority No validated DD i Sup h Fbg APTT FSL 96 48 h Elap. Time 0 Hours 96 h More enabled calibration curve A5-4 (1/2) A1-2 Change A1-3 A5-6 PT Inn 72 h A5-3 Remaining reagent Inn APTT FSL 99 96 h A1-1 A5-5 SB- SB-2 SB-3 SB-4 SB-5 volume Fbg OVB DDiDil DDiDil ATBuf 96 24 h 48 h 48 h 48 h Close X 12 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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. DDi Buf BCPCSubs A2-1 A2-5 Clean II A2-6 48 h 96 h A3-6 A4-1 A2-1 CAL PT THS h DDi Buf TestThr Fbg 96 h Seq 3 Lot Group 48 h PT THS 120 h Settings 30 h Usable Vol. 30 h A2-4 D3-1 A4-2 M ment CaC12 D1-2 D3-2 APTT FSL A4-3 No. of Tests Remaining 96 96 h Reagent CaC12 BCPCAct Volume Mixing No Mixing A2-2 DI- D4-1 A4-4 Select holders ATReag L BCPCAct Lot No. 547224 29 h 96 h A2-1 CAL 02-2 Vial GW 15 ATSubs D4-2 4-5 Customize Number of tests 48 h A1-6 A4-6 Exp. Date 2020/08/12 Usable Volume D2-1 D5-1 BCPCSUDS CaC12 96 h Set Date 2020/06/10 A2-1 CtIN h D5-2 16 h Set Time 16:38:58 A2-1 PT THS A1-5 Clean I A1-4 96 A5-2 A5-1 PT THS 30 test h Fbg APTT FSL DDi Sup 96 h 48 h Elap. Time 0 Hours 96 h More 33. 3 mL (1/2) A1-2 A5-4 A1-3 A5-6 PT Inn Change 72 h A5-3 PÌ Inn APTT FSL -99 96 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 Close X 13 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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 A1-3 PT Inn This state occurs if the reagent stability has expired Replace with a new vial of reagent -99 14 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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 F 504946 2020/08/12 < 5027 CtIN Co 507746 2019/11/29 Add 5 5086 PISubs R 508684 2020/08/12 1. Press Reagent Lot Master on 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 0 0 0 0 00000 4. Enter the Exp. Date using the calendar 2 ent 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 8 9 10 11 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 3 4 5 6 7 8 Reagent Name SHP entered for reagents. Expiration dates cannot Reagent Type Calibrator be entered via the barcode scanner. Manufacturer Siemens 1 Year Note: Sysmex CS-2500 System application sheets list Month required reagents, reagent onboard stability and onboard position for each specific assay. Date Close 15 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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 Ca 503267 2020/04/25 Detailed Display K 0004 XII F 503403 2020/08/12 5035 V F 504946 2020/08/12 1. Press Reagent Lot Master on the IPU menu 502 CtIN Co 507746 2019/11/29 Add 2. Press Import 5086 PISubs R 508684 2020/08/12 0 5087 PIReag R 508783 2020/08/12 3. Press Barcode 2 5142 BCPCSubs Import R 514298 2020/08/12 4. Scan the 2D barcode on the assay value sheet with the 5334 vWFBuf R 533404 2020/08/12 5335 vWFReag conrad Export barcode reader 5269 PT Inn Select Import Method × 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 Reagent Type Calibrator all assayed controls. Manufacturer Siemens Year Month Date Close 16 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Supply and Reagent Management Reagent Table Loading 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 17 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Supply and Reagent Management STAT/Buffer Table Loading 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. Sysmex CS-2500 System application sheets provide 8. Select the reagent name, vial type (4mL cup), and verify the lot number onboard positioning and stability of all required reagents 9. Press OK per assay. 10. With the cup position highlighted, press Change to update the date and 18 time Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Supply and Reagent Management C-Rack and SLD Mini/Micro* Cup 1. Reconstitute the requested control or calibrator observing CS-2500 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 required, remove using a smaller pipette tip 5. Set the SLD mini/micro* cup into the corresponding GW5 or A 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 and GW5 SLD mini cup Reagent rack C-1 place back into the Reagent Table Reagent rack C-2 8. Lock the lever 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 19 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Sample Processing IPU - admin ( Laboratory Supervisor) X (1) LIS Order Processing 3 Menu Reagent Calib. Curve QC Chart Order Stop Joblist Status Maint Shutdown STAT 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 STAT Reagent Information Calib. Curve QC Chart Order 4. After barcode reading, confirm the sample order status and progress on the Joblist screen September () Joblist Status Maint. Shutdown Logoff 1 ----- >Program Version Settings Operation Log Version Information Test CS2500 A 2 OFF 21:15 HOST 20 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Sample Processing Order X Manual Order Processing 3 8 (1) 11 Menu Reagent Calib. Curve QC Chart Order Joblist Status Maint. Shutdown STAT Stop Start Order Entry Unregistered Rack-Pos : 000001 Switch ange Order 1. Place rack with sample tubes on the sampler 6 Ordinary Pos. Sample No. Sample 7 QC Sample Th 2. Press Order Sample No. Control Preset 3. Enter the Rack No. 1 Edit Sample Info. Lot No. 4. Select a tube position to input an order 2 Repeat 8 5. Press Order Entry on the Operation Panel 3 PT-IN APTT- Fbg-D INN-A 6. Select Ordinary Sample 4 N FSL T T Order Entry 5 7 8 9 Place the cursor in Sample No. and input the sample ID if the 5 7. INN- TT-Th Di BC-PC V-INN Detailed 4 6 Settings sample does not contain a barcode 6 5 7 vWF-A VWF-A g low SL LA1 • If the sample does contain a barcode, the 2D barcode g med II-F 1 2 3 Regist. 8 reader can be used to input the sample ID BC-PL VIII 9 LA2 G BC-C1 MDA 8. Select the assays to be analyzed 0 C 10 9. Select the down arrow to order the next sample PCAT PCATO FVPCA T FVPCA TO ALPH Enter More 10. Press OK (1/2) More 11. Press Start 9 (1/2) 10 12. Confirm the sample order status on the Joblist screen LA LAR LAR OK Cancel Close X CS2500 A OFF 19:51 21 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Sample Processing Micro Mode Unregistered Rack No. 000001 Change Switch Ouder 1. Follow the Manual Ordering Processing steps on the Pos. Sample No. Mc PT-IN APTT- Fbg-D INN-A INN-D TT-Th previous page to ID the sample and order test(s) M ESI Detailed Settings Di 2. Select the Mc column on the Order screen 1 Rack-Pos : 000001-01 Sample No.: 1234 Load the un-capped tube onto the system 2 Sample Comment: 3. 4. Press Start 3 Reflex Assay Group Repli Select Measurement Time Measurement Redilution Re-analysis Time 4 5 Micro- APTT-FSL 180 Sample 180 Mode 6 320 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 PCAT FVPCA NR T NR FVL R AcR R 5. Press OK Close X 6. Press Start 22 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Sample Processing Status Rack No. Sample No Mo Sample Info. Sample -Pos de Comment F V Date Start End PT INN sec TT Thr sec Time Time R sec sec Joblist Status Display 00002-04 615n-15m-4 M F V 2016/11/09 15:07 15:14 11.6 Z 00002-05 615n-15m-5 N M F V 2016/11/09 15:08 15:14 11.5 00001-01 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 100001-02 612n-15m-2 N M Hem F V 2016/11/09 1523 15:30 11.5 00001-03 612n-15m-3 N M Hem F V 2016/11/09 1524 15:30 11.5 100001-04 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 V 2016/11/09 1524 15:31 11.6 Review 00001-01 615n-12m-1 N M F V 2016/11/09 15:39 15:45 * ***** All assay groups have been analyzed but the Review 100001-02 615n-12m-2 N M F On Hold V 2016/11/09 15:39 15:46 * ***** calibration curve has not been validated Review 00001-03 615n-12m-3 N M F V 2016/11/09 15:40 15:46 ****** Review 00001-04 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 F V 2016/11/09 15:40 15:47 * ***** normally Review 100001-01 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 00001-03 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 H* L* F V 2016/11/24 08:44 0850 * ***** Error Analysis completed but an error has occurred Review 100001-01 70-111-1 M F V 2016/11/24 08:59 09:06 10.7 * Z Review 100001-02 70-111-2 N M F / 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 23 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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 27.1 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 * * * O O d Dilution analysis 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 24 The value below mark limit 4 Effective Date: 14-Jan-2021 | HOOD05162003158939 - Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Sample Processing Status Rack No. Sample No Mo Sample Info. Sample Date Start End R PT INN sec TT Thr sec de Comment V K -Pos. Time Time sec sec T Joblist Analysis Result Errors 000002-04 615n-15m-4 N M - V 2016/11/09 15:07 15:14 11.6 T 000002-05 615n-15m-5 N M V 2016/11/09 15:08 15:14 115 000001-01 612n-15m-1 N M 15:30 Display Meaning Hem - F V 2016/11/09 1523 11.5 000001-02 612n-15m-2 N M Hem F V 2016/11/09 15:23 15:30 11.5 000001-03 612n-15m-3 N M Hem F 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 1524 15:31 11.5 **** * . an error 000001-05 612n-15m-5 N M Hem - V 2016/11/09 1524 15:31 11.6 7 Review 000001-01 615n-12m-1 N M V 2016/11/09 15:39 15:45 ***** T Calculated parameters could not be Review 000001-02 615n-12m-2 N M 2016/11/09 15:39 15:46 ***** - - - - - < . 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 Review 000001-05 N F V 2016/11/09 15:40 15:47 * calculated parameter 615n-12m-5 M ***** Review 000001-01 711m-0-1 M Hem Lip- F V 2016/11/24 08:42 08:49 * ***** Z Number of displayed digits exceeded Review 000001-02 711m-0-2 N M Hem Lip - A ++++.+ V 2016/11/24 08:43 08:49 * ***** Review 000001-03 8789 N M Lip - F V 2016/11/24 08:43 08:50 * ***** Review 000001-04 711m-0-4 N M Hem Lip - F V 2016/11/24 08:43 08:50 ***** / / / /. / Input value error occurred during average Review 000001-05 711m-0-5 N M H* L - LL V 2016/11/24 08:44 08:50 * ***** 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 TI Review 000001-03 70-111-3 N M V 2016/11/24 09:00 09:06 * 10.7 A A A List 25 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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 >T & 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 atio 1 / Detail • Wave changes 0 15 30 15 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 26 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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 se c 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 Info tab Zoom Evaluation Into • Out 2400 Information Value Wave [nm] 800 o bH: baseline 2000 bH_point_time 9.5 dH: reaction intensity bH 899 o 1600 End_point_time 24.5 dH 53 o Coag %: where the clot time is read Coag% 50 dOD 0.0264 o Wavelength: alternative wavelength used 1200 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 O 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 27 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Sample Processing 1 Hemolysis, Icterus*, Lipemia and Tube Volume 3 8 Menu Reagent Calib. Curve QC Chart Order Joblist Status Maint. Check from the Joblist Status Rack No. Sample -Pos Sample No 2 Sample Info. Comment F V Date Start End Time Time R PT INN sec TT Thr sec sec sec 000002-04 615n-15m-4 V 2016/11/09 15:07 15:14 11.6 T 1. Press Joblist 000002-05 615n-15m-5 V 2016/11/09 15:08 15:14 11.5 T Z 2. View the Sample Info. column. Described below are the 000001-01 612n-15m-1 N Hem V 2016/11/09 1523 15:30 11.5 possible HI*L Check results: 000001-02 612n-15m-2 N Hem - F V 2016/11/09 15:23 15:30 11.5 • Hem – flag for hemolysis 000001-03 612n-15m-3 N Hem - F V 2016/11/09 1524 15:30 11.5 Ict – flag for icterus* 000001-04 612n-15m-4 N Hem V 2016/11/09 1524 15:31 11.5 • T1 Lip – flag for lipemia 000001-05 612n-15m-5 Hem - F V 2016/11/09 1524 15:31 11.6 z • Review 000001-01 615n-12m-1 N 2016/11/09 15:39 15:45 ****** • H* interference in Hemolysis reading V Review 000001-02 615n-12m-2 N F V 2016/11/09 5:39 15:46 * ***** Check tube manually Review 000001-03 615n-12m-3 N F V 2016/11/09 15:40 15:46 * ***** • I* interference in Icterus reading* Review 000001-04 615n-12m-4 N F V 2016/11/09 15:40 15:46 ***** Check tube manually Review 000001-05 615n-12m-5 N - F V 2016/11/09 15:40 15:47 * ******* Review 000001-01 • L* interference in Lipemia reading 711m-0-1 Hem Lip - V 2016/11/24 08:42 08:49 ***** T1 Z Check tube manually Review 000001-02 711m-0-2 N Hem Lip - F V 2016/11/24 08:43 08:49 * ***** Vol – Sample tube fill out of range Review 000001-03 8789 N Lip - F V 2016/11/24 08:43 08:50 * ***** • Review 000001-04 711m-0-4 N Hem Lip - F V 2016/11/24 08:43 08:50 * ***** Review 000001-05 711m-0-5 N H* L* - F V 2016/11/24 08:44 0850 * ***** * Icterus check for use outside of the United States Review 000001-01 70-111-1 N V 2016/11/24 08:59 09:06 10.7 T only Review 000001-02 70-111-2 N F V 2016/11/24 09:00 09:06 * 10.7 Review 000001-03 70-111-3 N - V 2016/11/24 09:00 09:06 10.7 * T 28 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Sample Processing Sample No. 320 M Date/ Time 09/27/2018 09:13:44 Result Assay Group PT Detail Assay Group Value Units Hemolysis, Icterus*, Lipemia and Tube Volume PT & 16.4 sec PT INR & 1.55 Levels from the Browser 4000 3500 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 29 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Sample Processing 1 Multiple Dilution Analysis (MDA) Order 7 Menu Reagent Calib. Curve QC Chart Order Joblist Status Maint. Shutdown STAT Stoo Start 1. Press Order Unregistered Rack No. 000001 Change Switch Order 2. Select the Sample No. for which you want to set the Pos. Sample No. Mc PT PTT Fbg AT DDi PTN PTTN V-INN NN Preset 1 Detailed Settings MDA method 2 2 8524 Rack-Pos : -02. Sample No. 85241. Sample Comment 4 Repeat 3. Press Detailed Settings on the Operation Panel 3 4 Reflex Assay Group Replications Dilution Ratio Measurement Time Redilution Re-analysis Order Entry 4. Press the box below Dilution Ratio 5 Micro- MI-INN 1 1/1 180 5. Select the appropriate MDA dilution ratio Sample Detailed 3 6 Mode Select Dilution Ratio Sottings Press More for additional dilution ratios 7 • 1/1 MDA 2 Regist 6. Press OK 8 5 9 MDA 3 MDA low3 7. Press Start 10 MDA E MDAL 6 More xt. Ext. [1/1] MDA H Moro 1/2 ( 1 / 2 ) Ext. OK Cancel NOTE: Dilution ratios may vary depending on in-country /4 PTPTT 1/8 More availability. Cancel Close X cs La A NOTE: Cross mixing test (if enabled) can be used to help Ready 14:11 clinicians make decisions regarding factor deficiencies and circulating inhibitor patterns (e.g lupus anticoagulant). 30 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Sample Processing 1 (1) AN Menu Reagent Calib. Curve QC Chart Order Joblist Status Maint. Shutdown STAT Stop Start Status Sample No Rack No Sample Info. Mo V R F End INN X V INN sec VII INN"9 VII INN"sec PT INR PT Fbg C Fba de Time DDIC -Pos. Order Entry sec Sec sec mg/d Multiple Dilution Analysis (MDA) Results mal 2354 000003-02 Vol N V F 17:07 1212 d ***** 8824 000003-03 17:09 1218 18.6 Browser 4 8824 000003-03 17:09 119: 25.4 8824 000003-03 N V 17:09 132 5 d 33.5 1. Press Joblist 8824 000003-03 F 17:09 1245 Validate d ***** 85241 000003-01 V N 08:34 116 4 18.9 2 85241 08:34 1156 2. View the Sample No. displaying the MDA results and the 000003-01 N 25.8 85241 000003-01 N V 08:34 122.3 34.7 corresponding mean 3 85241 000003-01 N V F 08:34 118.1 d ***** Find 902 3. Highlight the line displaying the mean result 4. Press Browser on the Operation Panel Final Remeasure Hein lot No 85241 M 02/22/2017 08:26:18 5. The Browser Main screen displays the reaction curves, Validated Lip Vol A HOST # 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 ***** sec VII INN % 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 SCr 1.000 Detail • 5 10 50 100 about the error code 31 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Sample Processing Status Rack No -Pos. Sample No. F V G H Date Start End Seq. MO Time Sample In fo de R PT INN sec PT INN"INR APTT FSL sec Fbg DT"sec FbE DT 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 V 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 Review 000020-05 0255 F 5. Select a format: Graph, List, Simple Cursor Data Marked Data 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 ¥ Prin Cancel Review 000020-10 0260 F ¥ Review REAGOO CtIN507746* F G 2019/09/25 15:23 15:30 201 M A A A List 32 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Sample Processing Status Rack No. Sample No. F G H Date Start End PT INN"sec Time Sample Info. Seq. R PT INN"INR APTT FSL"sec Fbg DT"sec FbE DT de sec sec sec 6/L Print Multiple Sample Results Review 000020-04 0254 F VG 2019/09/25 14:30 14:39 194 ***** Z 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 0255 The result will be printed. 3. Select the samples from the analysis results list: Review 000020-05 Target Data • Current: mark currently highlighted sample Review 000020-05 0255 F < • Same Date: mark samples with same 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 List Print O Press Print Simple Print 5. Review 000020-08 0258 F V G 6. Select Marked Data 7. Select a format 000020-09 0259 F Print Press Print Cancel 8. 9. Return to Mark and select Release All Review 000020-10 0260 F 10. Press Back Review REAGOO QC CtIN507746* F V G 2019/09/25 15:23 15:30 201 M ***** A A List 33 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Calibration Load Reagents CS-2500 1. Enter reagent and calibrator lot information in the Reagent Lot Master • Refer to the Supply and Reagent Management section for more details 2. Load reagents • Refer to the Supply and Reagent Management section for more details 1524 1323 1322 1121 Note: Calibrator plasma should be transferred into a SLD mini/micro* cup. Refer to the Supply and Reagent Management section for more details. A * SLD micro cup for use outside of the United States only. 34 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Calibration Calibration Curve Order Entry Fbg Order the Calibration Assay Group: Reagent Lot OVB Fbg - 547558 Change 1. Press Order Parameter Calibrator lot Assay Shoot 503261 Value unit 2. Press Switch Order on the Operation Panel Fbg C SHP 503261 Press Holder Calib Curve Order 249 mg/dl 3. 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 35 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Calibration Assay Fbg-DT Assay Parameter Fbg DT Current Calib. Curve (Solid Line) View the New Calibration Curve Reagent Lot Compared Calib. Curve OYB Fbg Reagent Lot (Group) 547293 Validated by sysmex (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 M 1.30 13.0 M 2.50 7.0 Compare New Versus Current M 5.00 3.8 -20.0 H 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 2020/04/25 2.0 press Load Exp. Date Cursor Position 5. Compare the calibration curves < Axis Point Y Axis Point 6. Press Close 1.26 g/L Current Calib. Curve 1.0 13.3 sec 0.20 0.50 1.00 2.00 5.00 Fbg DT Compared Calib. Curve sec 36 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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 100.0 5. Press Print Fbg DT sec Print M 0.6 24.8 -50.0 M 1.30 13.0 Calib. Info. Note: Validate the calibration by performing QC. M 2.50 7.0 5.0 3.8 -20.0 Delete 7.50 3.2 -10.0 -5. Restore Old Calibration Curves More (1/2) 2.0 1. Display the calibration curve 2. Press Restore on the Operation Panel Exp. Date 2020/04/25 0.20 0.50 1.00 2.00 5.00 1.0 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 37 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Calibration Edit Calibration Curve Validate Validated PT INN INR 22 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 6 100.0 Print • Refer to the Supply and Reagent Management section for more details -70.0 1 2 3 Calib. Info. 2. Load the PT reagent onto the Reagent Table -50.0 0 C 4U .U 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 (1/2) 8. Select the INR tab at the top of the dialog box Normal Normal Value 10.0 sec 7.0 9. Press Lot Master to enter the ISI ISI V ISI Value 1.00 Non Exp. 0 Exp. Date: -5.0 10. Press Yes 2020/09/23 10.00 11. For manual entry of normal and ISI values: Cancel Close X Load Lot Master OK • 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 38 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Quality Control Process from the Reagent Table: QC Files Order Entry Switch Order Q001 - 0020 O Control, Lot No. 1. Load QC onto a C-rack Sample No. Control Control Citrol 1 • Refer to the Supply and Reagent Management section Lot No 528150 ot No. Order Entry to load QC material in a C-rack using a SLD mini/micro* QC02 Line cup PT PTT PTN Clear Fbg QC07 2. Press Order QC13 3. Press Switch Order on the Operation Panel APTTN QC05 QC03 4. Press Holder QC Order 0001 Regist QC11 5. Press Order Entry on the Operation Panel 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. 39 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Quality Control Process from the Reagent Table: Control Lot No. Order Entry Switch Order O QC01 - 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* 548165 cup PT Clear PTT Fbg PTN 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. 40 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Quality Control Process from the Sample Rack Order Entry Unregistered Rack-Pos : 000001-02 Switch Order O Ordinary O QC Sample Pos. Sample No Mc Sample 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 APTT- N FSL Fbg-D 507746 4. Select a position to input the order INN-A T Order Entry A 5. Press Order Entry on the Operation Panel 5 INN- TT-TH 6. Select QC Sample Di BC-PC V-INN Detailed 6 Settings 7. Select the appropriate control from the list 7 VWF-A XII-F g med VWF-A g low SL LA1 8. Place the cursor in the Lot No. field and select the 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 FVPCA T 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 LA R LA R Close OK Cancel X 14. Press Start 41 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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 Control CtIN Control Lot No. 507746 Change Cursor 3. Place the cursor on the desired point 9.3 Analyzed on 2019/09/18 11:33:46 Target Value 10.9 sec Analysis Result Target Value Difference 4. Press Confirm Data on the Operation Panel **** sec 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 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 42 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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 All Add Lot 1. Select a tab for printing 12.5 2. Press Print Report on the Operation Panel 10.9 Target Data 7 8 9 Change 9 . Lot 3. Select Active Tab All 4. Select Date Range and enter the start and 4 6 APTT FSL sec 5 Change Scale end dates 28.1 Date Range 2 3 5. Select the format: List 1 24.4 1 Switch 20.7 Display 6. Press Print 0 C Start Date Up 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 O Graph List(1 line) O List(2 lines) 4. Select a location to store the file 5. Name the file 6. Press Save Print Cancel Close X 43 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Maintenance Shutdown Startup 1. Verify CA CLEAN I is set on reagent table A or B 1. Turn the IPU power ON 2. Press Shutdown 2. The Logon dialog box appears when the startup is complete • Reagent cooling is continued: instrument goes into 3. Select the correct logon button sleep mode. Reagents in the Main Unit are still cooled 4. Enter Logon Name and Password • Turn the Main Unit OFF: shuts down the instrument 5. Press OK without reagents in the Main Unit cooled 6. Turn the Main Unit switch ON 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 44 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Maintenance This Rinse Probe Daily Maintenance Month 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 Discard used cuvettes 0000 Change Waste Tank Daily Maintenance Dispose of waste Check and discard trap chamber fluid 200 Shutdown 000000000000 Manual Maintenance ooooo! OOOOON OOOOO₽ Weekly 1 2 3 4 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 Rinse the Rinse Tank Lamp Replace Trash Box Liner Calibration 000 • Check cuvettes, cuvette trash, rinse, waste Check temperatures Monthly History 3 History 2 History 1 Remarks • Clean the filter 2020/08/19 2. Press Maint. As-Needed Maintenance-Replacement of Supplies Check Item History 3 History 2 History 1 Cycle Counts Remarks 3. Empty the cuvette trash box Air pressure adjustment Prime 2019/08/19 2019/08/20 Wipe off Piercer • Reset the trash counter Remove jammed cuvette Wipe off piercer 4. Press Change Waste Tank on the Operation Panel Clean Sysmex racks 2020/08/19 Lamp replacement and calibration Empty waste, press OK Replace the fuses of the Pneumatic Unit • Piercer 5. Check/Replace DI water Sample Syringe Reagent Syringe More (1/2) 6. Add cuvettes Waste Tube (CP) User Defined Maintenance 1 • DO NOT fill above the red line User Defined Maintenance 2 User Defined Maintenance 3 7. Press Manual Maintenance on the Operation Panel, check off completed items 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 45 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Maintenance Weekly Maintenance < This Rinse Month » 2020/08 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 Clean the instrument exterior and interior: Rinse Probe o0o000000000 Discard used cuvettes OO 00000 Change Waste Tank Dispose of waste Check and discard trap chamber fluid O O 00000 O Shutdown 1. Shut down the Main Unit and unplug the power cord 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. Wipe the instrument with a moistened paper towel Clean the instrument Rinse the Rinse Tank Lamp with water and a neutral detergent Replace Trash Box Liner Calibration ooo Monthly History 3 History 2 History 1 Remarks Clean the filter 2020/08/19 Clean the rinse tank: As-Needed Maintenance-Replacement of Supplies Check Item History 3 History 2 History 1 Cycle Counts Remarks Air pressure adjustment Wipe off Prime 2019/08/19 2019/08/20 Piercer 1. Remove the cap of the rinse tank and float switch Remove jammed cuvette Wipe off piercer 2. Use water or isopropyl alcohol to wash the inside of Clean Sysmex racks 2020/08/19 Lamp replacement and calibration the tank and float switch, then rinse with distilled Replace the fuses of the Pneumatic Unit Piercer water Sample Syringe Reagent Syringe More (1/2) 3. Replenish the rinse water Waste Tube (CP) User Defined Maintenance 1 4. Attach the float switch and tighten the cap User Defined Maintenance 2 User Defined Maintenance 3 Replace the trash box liner CS2, if used Close X Remove water from tray no. 48, if water has accumulated Note: Document manual maintenance in the Maint. screen 46 under Manual Maintenance in the Operation Panel. Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Maintenance Monthly Maintenance < This Month » 2020/08 Rinse Probe 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 00000000 Discard used cuvettes O DO 00 Change Waste Tank Dispose of waste 00000 Check and discard trap chamber fluid 0000 O Shutdown oooooooooooo O 1. Remove filters #514 and #513 Manual Maintenance OOOOON OOOOON Weekly 1 2 3 4 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 Lamp from the filter Replace Trash Box Liner 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 History 1 Clean the filters (left side): History 3 History 2 Cycle Counts Remarks Air pressure adjustment Wipe off Prime 2019/08/19 2019/08/20 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. 47 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Maintenance As Needed Maintenance 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 48 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Maintenance As Needed Maintenance (continued) Daily Maintenance < This Month » 2020/08 Rinse Probe 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 Adjust the -0.067 MPa pressure (range -0.057 to -0.053) : Rinse Probe Discard used cuvettes O DO 00000000 00 Change Waste Tank Dispose of waste 0000 00000 Check and discard trap chamber fluid 0000 O Shutdown oooooooooooo O 1. Press Maint. on the IPU menu Manual Maintenance OOOOON OOOOON Weekly 1 2 3 4 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. Press Pressure Adjustment on the Operation Panel Clean the instrument O Rinse the Rinse Tank O Lamp 3. Open the cover door on the left side of the Main Unit Replace Trash Box Liner Calibration 4. Loosen the fixing nut of the bellows unit Monthly History 3 History 2 History 1 Remarks Clean the filter 2020/08/19 5. Adjust the pressure slowly As-Needed Maintenance-Replacement of Supplies Check Item History 3 History 2 History 1 6. Once adjustment is complete, tighten the fixing nut while Cycle Counts Remarks 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 taking care not to rotate the adjustment knob Remove jammed cuvette 08/09/2018 03/28/2019 07/17/2019 Wipe off piercer 03/28/2019 04/25/2019 7. Close the cover door 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 8. Press OK Replace the fuses of the Pneumatic Unit Piercer 1,287 / 40,000 Times Sample Syringe 22,245 Times 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 49 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Maintenance As Needed Maintenance (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 6. Press Start A 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 50 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Maintenance As Needed Maintenance (continued) Prime the hydraulic line: Wipe the piercer clean: 1. Press Maint. on the IPU menu 1. Verify the light shield lid is closed 2. Press Prime on the Operation Panel 2. Press Maint. on the IPU menu 3. Press OK 3. Press Wipe off Piercer on the Operation Panel Priming starts and a progress bar appears. Once 4. Press OK • complete, the dialog box closes 5. Turn OFF the Main Unit 6. Open the light shield lid Clean the Sysmex racks: 7. Set the jig 8. Wipe the piercer clean with gauze soaked with purified 1. Racks with rack barcode labels, wipe with soft cloth water moistened with water or ethanol 9. Remove the jig 2. Racks with no rack barcode labels, rinse with water 10. Close the light shield lid 3. Verify all racks for proper tube adapters and barcode labels 11. Turn ON the Main Unit 51 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Maintenance Supply Replacement 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. 52 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Maintenance Supply Replacement (continued) Rinse Probe This Daily Maintenance 2015/10 Lamp Calibration laooooo Lamp Calibration: Daily 2 Change Waste Tank Rinse Probe Discard used cuvettes Lamp calibration will be executed (Execution time : Dispose of waste approximately 3 minutes) Check and discard trap chamber fluid Manual Maintenance 1. Select Maint. on the Toolbar Shutdown 000008 000OOM 000009 00000% Weekly OK Cance 23 24 25 26 27 28 29 30 31 2. Select Lamp Calibration on the Operation Panel Clean the instrument Lamp Rinse the Rinse Tank Calibration Replace Trash Box Liner 3. Select OK Monthly History 3| History 2|History 1 Remarks 4. Select the correct option when the Lamp Confirmation Clean the filter As-Needed Maintenance-Replacement of Supplies dialog box appears Check Item History 3 |History 2 |History 1 Cycle Counts Remarks Wipe off Air pressure adjustment Piercer Prime • Reset lamp counter: new lamp Remove jammed cuvette Wipe off piercer Do not reset the lamp counter: same lamp Lamp replacement and calibration 225 / 1,000 h • Replace the fuses of the Pneumatic Unit Piercer 19 / 40,000 Times 5. Select OK Sample Syringe 1,409 Times Reagent Syringe 2,900 Times Waste Tube (CP) 226 / 720,000 Times More (1/2) User Defined Maintenance 1 User Defined Maintenance 2 Note: Lamp calibration requires a 30 minute User Defined Maintenance 3 warming-up of the lamp to allow light Close X intensity stabilization. Do not start calibration earlier, this will affect patients’ results. 53 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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. Power OFF the Main Unit OK Cancel 4. Select Start → All Programs → CS-Tools → Backup 5. Press Option 6. Select a Backup Type Option • Backup All Data Backup Type • Specify Date- select a date range from the calendar and Backups All Data target data to be backed up 7. Press OK to close the dialog box 0 Specify Date Period 8. Press OK to start the backup 2014/11/01 2014/11/30 9. Wait for “Backup was completed” message November, 2014 Sun Mon Tue Wed Thu Fri Sat Target Data 28 29 30 31 1 2 3 10. Press OK 4 5 6 7 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 Cancel [W] Includes Operation Log Files. 2 3 5 6 7 12. Start up the IPU software and Main Unit 13. Log on to IPU software OK Cancel 54 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Maintenance = | |PU_Backup 0 X File Home Share View Back Up the Database Externally > This PC > Desktop > IPU_Backup 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 100724 BACKUP 2021/01/06 12:12 File folder 3. Right-click the file, select Send to → Compressed (zipped) PU_Backup Open BACKUP 2021/01/06 12:12 Compressed (zipped) Folder 1 KB Open in new window folder This PC BACKUP 2021/01/06 12:12 Compressed (zipped) Folder KB 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 1 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 DVD RW Drive (E:) Rename Properties 9 items 1 item selected 55 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Maintenance Operation Log Filter Condition Filter Date : none User none Operation : none Detail: none No. Enter Initials: Date Time User Operation Comment Commented On Commented By Print 1 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 2020/08/19 17:27:10 admin Maintenance 7 9 2. Highlight the maintenance item 2020/08/19 17:27:10 admin Maintenance 8 2020/08/19 17:27:10 admin Maintenance Import 9 3. Select the Pencil icon 2020/06/11 20:41:17 admin Validate Sample 10 2020/06/10 16:39:17 admin Change/Add Read Comment X 11 2020/06/10 16:39:16 admin Change/Add Read 4. Enter your initials on the comment line 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 Read 17 2020/06/10 Change/Add Read OK Cancel 16:39:03 admin 18 2020/06/10 16:39:01 admin Change/Add Read 19 2020/06/10 16:38:58 admin Change/Add Reagent Export the Operation Log File: Operation Log Detail No 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 Close 4. Press OK 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 56 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS -2500 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 Error code number. No further action needed. Is the 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 Sysmex CS -2500 Locate result with error) occurred. PEP to Go to Detail Key troubleshoot Analysis View Detail screen for Result Error message. Troubleshoot problem. 57 Effective Date: 14 -Jan -2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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 58 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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% Il ---------- Slight Coagulation Threshold • Corrective Verify reagent integrity, sample integrity, patient clinical history, Action and instrument delivery of reagent and sample • Reanalyze sample • Reanalysis produces a result without an asterisk (*). Report the Normal Sample A/D value of photometry Reportable result Result • Reanalysis produces the same error and comparable results. Time Report the mean of the two results 59 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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 • A/D value of photometry Action Verify reagent integrity, sample integrity, patient clinical history, 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 60 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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 ni 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 18hmmm ........... " Normal Sample A/D 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- • Fbg curve error Note: For more details about specific sub-types refer to the • Sharp drop types • Jump up Terrace Sysmex CS-2500 Instructions for Use and/or Evaluation • and Check Algorithm. 61 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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 62 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Troubleshooting Early Reaction Error – Start Angle • Numerical result with an asterisk for Start Angle 2, Error 0008.0128.0004 Joblist Display • 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 63 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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. 64 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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 65 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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, 100% -- >ANAF -- - Ave2 + nSD2 Action photometry A/D value of then check the analysis data --- - Ave2 Mask Time Normal Sample • Reanalyze sample and make a comprehensive judgement, 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 66 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Troubleshooting Turbidity Level Over Error Joblist Display No numerical result Cause Sample turbidity was high and the transmitted light was 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 • Reanalysis produces a result without an asterisk (*). The result AD Low Limit Reportable may be reported A/D value of photometry 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. 67 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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 Threshold • Verify reagent integrity, sample integrity, patient clinical 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 68 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 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. 69 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Administration DD Logon Name User Name Exp. Date User Right Comment 1 admin Add a New User administrator 2037/12/31 Laboratory Supervisor 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 10 11 12 CO LO Exp. Date 2037/12/31 13 14 15 16 17 18 19 Select Icon Save Night-Shift Operator) 7 20 21 22 23 24 25 26 27 28 29 30 31 6. Update the user permissions, if applicable 5 Jser Right Lab Technician V Close 7. Press Save 8. Press OK Comment Yea • 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 70 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 Sysmex® CS-2500 System SIEMENS Healthineers Administration Register or Change a User’s Change Password Password 1. Press User Administration on the IPU menu 2. Highlight the line of the user Password 7 8 9 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 71 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021 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's Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. 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. Copyright © Siemens Healthcare GmbH 2021 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Telephone: +49 9131 84-0 siemens.com/healthineers 72 Effective Date: 14-Jan-2021 | HOOD05162003158939 Unrestricted © Siemens Healthineers, 2021