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Sysmex® CS-2500 System Uploading New Quality Control Lot Numbers Job Aid

This job aid provides instructions on how to upload new quality control lot numbers using the control registration tool on the Sysmex CS-2500 System.

Sysmex® CS-2500 System Uploading New Quality SIEMENS Healthineers Control Lot Numbers Add a New Lot to the QC Chart Control Registration Perform QC Analysis with a New Lot Compare the QC Charts of Current and New Lots Change to a New Lot 1 HOOD05162002598522 © Siemens AG 2013. All rights reserved. Page 1 Effective date: 06/02/2017 Sysmex® CS-2500 System Uploading New Quality SIEMENS Healthineers Control Lot Numbers Add a New Lot to the QC Chart 1. Press QC Chart on the IPU toolbar or 1 menu screen. () Menu eagent Calib. Curve QC Chart Order Joblist Status Maint. Shutdown STAT Stop Start 2. On the QC Chart screen press Add Lot Routine DDi Lot Roll More Delete on the operation panel. DDi C DiCt12 56210 Current Add Lot 2 3.41 N 9 Follow the instructions displayed on the 2.36 mg/L Mean 2.37 3. 2.84 2.27 12/21/2016 SD 0.12 Change Lot 10:40 AM CV 5.1 Control Registration screen. DDi C DDiCtl1 562204 Current Change 0.37 N 9 0.31 0.29 mg/L Mean 0.28 12/21/2016 SD 0.01 Switch 0.25 Display 10:39 AM CV 3.6 print Report More (2/3) 2 HOOD05162002598522 © Siemens AG 2013. All rights reserved. Page 2 Effective date: 06/02/2017 Sysmex® CS-2500 System Uploading New Quality SIEMENS Healthineers Control Lot Numbers Control Registration () Menu Reagent Calib. Curve QC Chart Order Joblist Status Maint. Shutdown STAT Stop Start Control Registration Routine DDi Lot R Control Information Registration 7 8 9 DDi C DDict 12 Lot No. urrent Add Lot 3.41 2 Assay Parameter Control 4 5 6 N 9 2.84 Selection lean 2.37 Change 2.27 SD 0.12 Lot Exp. Date 1 2 3 CV 5.1 3.QC Chart Settings DDi C DiCtl1 urrent Change Scale 0 c 0.37 N 9 0.31 4.QC Barcode Settings an 0.28 0.25 ALPH SD 0.01 Switch Display CV 3.6 5.Preset Settings Print Rupert 6.Confirmation of the Settings Completion More (2/3) Use QC Barcode Use Preset Close X Next Cancel 3 HOOD05162002598522 © Siemens AG 2013. All rights reserved. Page 3 Effective date: 06/02/2017 Sysmex® CS-2500 System Uploading New Quality SIEMENS Healthineers Control Lot Numbers Control Information Registration Control Registration 1. Input the lot number, control, and 1 Control Information Registration 7 8 9 expiration date of the control lot you want Lot No. 528137 2 to add or change as a new lot. 2. Assay Parameter Selection Control Citrol 1 4 6 2. If the QC lot is already registered in the Exp. Date 2018/02/02 1 2 3 Reagent Lot Master, select the correct lot 3.QC Chart Settings number from the pull-down arrow. 1 0 C 4.QC Barcode Settings 3. Select the Use QC Barcode checkbox to ALPH update QC barcode settings if applicable. 5.Preset Settings 4. Select the Use Preset checkbox to update 6.Confirmation of the preset registration orders if applicable. Settings Completion 5. Press Next. 3 Use QC Barcode Use Preset 4 5 Next Cancel 4 HOOD05162002598522 © Siemens AG 2013. All rights reserved. Page 4 Effective date: 06/02/2017 Sysmex® CS-2500 System Uploading New Quality SIEMENS Healthineers Control Lot Numbers Assay Parameter Selection Control Registration 1. Select the assay parameters to use the quality 1 Control Information Registration 528137 Citrol 1 2018/02/02 control with. V Select an assay parameter. • If the new lot was preregistered in Reagent Lot 2 Assay Parameter Selection QC Assay Group Master, assays are automatically checked based 1 V APTT FSL sec PT INN sec on settings selected during lot registration. 3.QC Chart Settings PT INN"INR Fbg DT sec V Fbg DT 2. Select the Monitoring checkbox and the content PTTN 4.QC Barcode Settings PTN from the Check Rule Settings for each assay parameter is applied to all assay parameters 5.Preset Settings selected. V 6.Confirmation of the • The Monitoring checkbox is not displayed when Settings Completion adding a new lot. 3. Press Next. 3 Back Next Cancel 5 HOOD05162002598522 © Siemens AG 2013. All rights reserved. Page 5 Effective date: 06/02/2017 Sysmex® CS-2500 System Uploading New Quality SIEMENS Healthineers Control Lot Numbers QC Chart Settings Control Registration 1. Set the target and limits for quality control Control Information Registration 528137 Citrol 1 2018/02/02 using one of the following methods: 2. Assay Parameter Enter the settings for each assay parameter. • [Detailed Settings] Selection Assay Group Upper Stop Upper Limit Target Lower Limit Lower Stop 1SD Set for each assay parameter APTT FSL sec 3.QC Chart Settings PT INN sec Fbg DT sec [Use the current settings] Fbg DT • PTTN Carry over values from the current lot PTN 4.QC Barcode Settings • [Auto Calc] Calculate automatically 5.Preset Settings • [Lot Master] 6.Confirmation of the Read from 2D barcodes Settings Completion 2. Press Next. 1 Detailed Settings Use the current settings Auto Calc Lot Master 2 Back Next Cancel 6 HOOD05162002598522 © Siemens AG 2013. All rights reserved. Page 6 Effective date: 06/02/2017 Sysmex® CS-2500 System Uploading New Quality SIEMENS Healthineers Control Lot Numbers QC Barcode Settings Control Registration 1.Control Information 1. Select a QC barcode file box. Registration 528137 Citrol 1 2018/02/02 V 2.Assay Parameter Select the QC barcode to reflect the lot change An existing barcode ID file box can be Selection • QC01 QC11 updated or an unused QC file box can be selected. 3.QC Chart Settings QC02 QC12 QC03 C13 1 1. Press Next. 400 Barcode Settings QC04 QC14 QC05 QC15 5.Preset Settings QC06 QC16 QC07 QC17 6. Confirmation of the Settings Completion QC08 QC18 QC09 QC19 QC10 QC20 2 Back Next Cancel 7 HOOD05162002598522 © Siemens AG 2013. All rights reserved. Page 7 Effective date: 06/02/2017 Sysmex® CS-2500 System Uploading New Quality SIEMENS Healthineers Control Lot Numbers Preset Settings Control Registration 1 Control Information 1. If the ordered quality control is using a preset Registration 528137 Citrol 1 2018/02/02 V registered control, the preset settings are Select the Preset to reflect the lot change. 2 Assay Parameter Selection updated. PRESET1 011-020 21-030 131-040 041-050 051-060 061-070 071-080 081-090 090-100 V Pos Control Information 3.00 Chart Settings 2. Select the preset to update on the Presets tab. 1 Ctl1 528137 V 2 Ctl1 528137 4.QC Barcode Settings 3. From Pos. select the order for the sample tube 3 Ctl1 528137 V position you want to update. 4 5.Preset Settings 5 4. Press Next. 6.Confirmation of the 6 Settings Completion 7 8 9 10 4 Back Next Cancel 8 HOOD05162002598522 Maintenance © Siemens AG 2013. All rights reserved. Page 8 Effective date: 06/02/2017 Sysmex® CS-2500 System Uploading New Quality SIEMENS Healthineers Control Lot Numbers Confirmation of the Settings Completion Control Registration I Control Information Registration All settings are complete. 1. Review settings. The QC settings are updated with the following contents. V 2.Assay Parameter Selection Lot No. 528137 2. Press OK. Control Citrol 1 QC Settings and QC Charts are updated. Exp. Date 2018/02/02 3.QC Chart Settings Assay Group V APTT FSL sec PT INN" sec 4.QC Barcode Settings Fbg DT sec Fbg DT V PTTN PTN 5.Preset Settings V 6 Confirmation of the Settings Completion 2 Back OK Cancel 9 HOOD05162002598522 © Siemens AG 2013. All rights reserved. Page 9 Effective date: 06/02/2017 Sysmex® CS-2500 System Uploading New Quality SIEMENS Healthineers Control Lot Numbers Perform QC Analysis with a New Lot 1. Set the reagent/detergent on the reagent table 8. Press OK. and buffer on the STAT/buffer table. • Verify that correct assay reagent lots are 9. Press Regist. on the operation panel. loaded. • Only reagent lots to be used with the new lot of QC should be onboard. 10. Press Joblist on the operation panel. 11. Check that the Status column of the registered row shows 2. Press Order on the IPU toolbar or menu screen. orders Pending. 3. Press Order Entry on the operation panel. 12. Set the sample rack containing controls in the right rack pool 4. Select the QC Sample tab. of the sampler. 13. Press the Start button on the Main Unit or IPU toolbar. 5. Select the control from the control list. 14. Display the QC Chart from the IPU toolbar or menu screen to 6. Select the new lot number. check QC data. 7. Select the appropriate assay group to be analyzed in the assay group list. 10 HOOD05162002598522 © Siemens AG 2013. All rights reserved. Page 10 Effective date: 06/02/2017 Sysmex® CS-2500 System Uploading New Quality SIEMENS Healthineers Control Lot Numbers Comparing the QC Charts of Current and New Lots 1. Press QC Chart on the IPU toolbar or menu 1 screen. Menu Reagent Calib. Curve QC Chart Order Joblist Status Maint. Shutdown STAT Stop Start 2. Select the desired QC chart. Routine DDi Lot Roll More Delete DDi C DDiCtl 562104 Currer Add Lot 3.41 N 9 3. Press Switch Display on the operation panel. 2 2.84 2.36 mg/L Mean 2.37 Switch X 12/21/2016 SD 0.12 Change 2.27 10:40 AM CV 5.1 DDi C DDiCtl1 Current 562204 Current Change Scale 4. On the switch dialog box select between the 0.37 IN 9 0.31 0.29 mg/L Mean 0.28 12/21/2016 SD 0.01 Switch following options: 3 0.25 New 10:39 AM CV 3.6 Print • Current Report • New 4 Current+New More ( 2 /3 ) • Current + New Cancel Note: This feature can be used to switch the Close X display of two QC charts to compare the QC chart of the newly added lot and the current lot. 11 HOOD05162002598522 © Siemens AG 2013. All rights reserved. Page 11 Effective date: 06/02/2017 Sysmex® CS-2500 System Uploading New Quality SIEMENS Healthineers Control Lot Numbers Change to a New Lot 1. Press QC Chart on the IPU toolbar or menu 1 screen. Menu Reagent Calib. Curve QC Chart Order Joblist Status Maint. Shutdown STAT Stop Start Routin DDi More Delete 2. Select the desired QC chart. Lot Roll PT Citrol 1 548018 Current Add Lo 12.1 N 114 3. Press Change Lot on the operation panel. 2 11.1 11.3 sec Mean 11.0 3 10.1 02/16/2017 SD 0.4 Change Lot 3:29 PM CV 3.6 PT Citrol 1 548018 Current Change Scale 4. Follow the instructions displayed on the Control 28.0 N 88 26.0 25.8 sec Mean 25.9 24.0 02/16/2017 SD 1.0 Switch Registration screen. 3:31 PM CV Display 3.9 PT Citrol 548459 Current Print Repor 66.0 N 101 59.3 sec Mean 55.4 48.0 02/16/2017 SD 3.0 3:30 PM CV 5.4 Note: When changing a new lot to the current lot, the PTT Citrol 3 548459 Current 74.3 N 87 target/limits for the new lot become the 66.7 61.9 sec Mean 62.1 57.2 02/16/2017 SD 3.2 3:31 PM CV 5.2 target/limits for the current lot. Close X • Confirm that QC was performed on the added lot and results were checked on the QC chart screen. 12 HOOD05162002598522 © Siemens AG 2013. All rights reserved. Page 12 Effective date: 06/02/2017

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