Atellica® CH Analyzer with Direct Load Supply and Reagent Management PEP to Go Version 1.25 and Below

SIEMENS Healthineers Atellica® CH Analyzer with Direct Load Supply and Reagent Management 9 CH PEP to Go SIEMENS Atellica Solution Healthineers" ... 1 Template Effective Date: 05/27/2019 | HOOD05162003010284 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Reagent Management Healthineers Reviewing Reagent Inventory SIEMENS Heolthineers Atellica" Solution Version 1.14.0.2975003 P-P1-04 The Reagent Overview screen allows the operator to review 1 System Samples Inventory Calitxation OC Patient Orders Workdiz Maintenance Setup the status of reagents. 2 Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Let Comparison Cal-QC Storage Inventory Cal-QC Needs CN00110 To view reagent inventory: Reagents 3 Reagent Details Reagent Inventory Onboard Sequence Calibration Calibration Cal Type In Stability Status Interval QC Status Lot Cal Eligibility 00266 1. On the Command bar, select Inventory Amylas AST 476 86 d 22 h 00428700218 26 d 22 h Let 270428 Name Lot and Pack Lot ID 27043 Acet Pack Location CH Reagent Compartment 1 2. Select the Reagent Overview tab 44 11d2h 00102/00102 0d 221 Pack 160161 Pack Position 43 Acet 255 86 d 0h 00102/ 00102 0d22 h Pack 160162 Lot and Pack Status 4 00266 Sequence Number 00266 3. To sort, select a column heading 1700 88 d 22 h 00080 50 d 16 h Lot 200227 Lot and Pack 00922 Paired Pack 00922 Count Remaining 338 338 1698 86 d 22 h 00187 57 d 3 Lot 200227 Lot and Pack Onboard Stability 8/22/2018:1:36:31 PM ➢ Inventory: to bring reagents that are empty or 63 d 22 h 00220 47 d 23 h 200227 Lot Expiration 9/1/2018 11:59:59 PM Calibration Expiration 5/31/2018 10:29:05 AM running low to the top of the screen Amylas 338 79d 0h 00266/ 00922 Odon 270433 Lot and Pack Well t Test Count 103. 469 21 d 22 h 01230 0d 22 Lot 841088 Pack Roady ➢ Time Punctured 5/24/2018 1:38:04 PM Calibration Status: to bring reagents that have an Ca 851 50 d 20 h 00301/00252 2 d 221 Pack 270449 Lot and Pack Calibrate Pack invalid calibration or have not been calibrated to the Well2 Chol 2 388 13d 21h :00657 1423h Pack 270467 Pack Test Count 175 Sealed top of the screen Crea_2 910 84 d 21 h 00061 / 00045 0d 21h Lot 200249 Lot and Pack Calibrate Lot Calibrate Pack DLDL 53 1242h 00292 / 00290 1282h 444445 Pack ➢ Calibration Interval: to bring the reagents that have a Group by reagent Disable Reagent Pack Disable Reagent Lot Unload calibration that will expire soon to the top of the ? PEP LabManager os Monday, June 04, 201& 1:00.14 PM screen 4. To view details about a reagent pack, select the checkbox for the reagent ➢ Reagent Details for that pack will display on the right side of the screen *This procedure is continued on the next slide. 2 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Reagent Management Healthineers Reviewing Reagent Inventory (continued) SIEMENS P-P1-04 Heolthineers Atellica" Solution Version 1.14.0.2975003 5. At the bottom of the Reagent Details area of the System Samples Inventory Calitration OC Patient Orders Workdiz Maintenance Setup screen, there are buttons that can be used to order a Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Let Comparison Cal-QC Storage Inventory Cal-QC Needs calibration on that reagent pack CN00110 Reagents Reagent Details 6. There are options at the bottom of the screen to Reagent Inventory Onboard Stability Sequence Calibration Calibration Interval Cal Type In QC Status Lot Cal Eligibility 00266 Use Name Amylas disable a selected reagent pack, to disable an entire AST 476 86 d 22 h 00428700218 26 d 22 h Let 270428 Lot and Pack Lot ID 27043 Acet 44 11d2h 00102/00102 CH Reagent Compartment 1 0d 221 Pack 160161 Pack Pack Location Position reagent lot, or to manually unload a reagent pack 43 Acet 255 86 d 0h 00102/ 00102 0d22 h Pack 160162 Lot and Pack Status 00266 Sequence Number 00266 1700 88 d 22 h 00080 50 d 16 h Lot 200227 Lot and Pack 00922 Paired Pack 00922 Count Remaining 338 338 1698 86 d 22 h 00187 57 d 3 Lot 200227 Lot and Pack Onboard Stability 8/22/2018:1:36:31 PM 63 d 22h 00220 47 d 23h 200227 Lot Expiration 9/1/2018 11:59:59 PM Calibration Expiration 5/31/2018 10:29:05 AM Amylas 338 79d 0h 00266/ 00922 Odon 270433 Lot and Pack Well t 01230 0d 22 841088 Pack Test Count 103. Roady 469 21 d 22 h Lot Time Punctured 5/24/2018 1:38:04 PM 00301/00252 2 d 221 Pack 270449 Lot and Pack 5 Calibrate Pack Ca 851 50 d 20 h Well2 Chol 2 388 13d 21h :00657 1423h Pack 270467 Pack Test Count 175 Sealed Crea_2 910 84 d 21 h 00061 / 00045 Od 21h Lot 260249 Lot and Pack Calibrate Lot Calibrate Pack DLDL 53 1242h 00292 / 0000 1282 Let 444445 Pack 6 Group by reagent Disable Reagent Pack Disable Reagent Lot Unload ? PEP LabManager 12 osº Monday, June 04, 201& 1:00.14 PM NOTE: For more information on ordering calibrations, refer to the “Manually Ordering Calibration Tests” training topic in PEPconnect. 3 IM Effective Date: 01-APR-2021 | HOOD05162003178151 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Reagent Management Healthineers Reviewing Reagent Needs Reagent Needs posts a need for a reagent based on the expected tests for that day compared to the current inventory. *NOTE: The predictive forecast and alert threshold are both configured in the Reagent The reasons for a posted need include the following: Requirements Settings screen. • Predictive: Suggested need based on the number of tests per day defined by the operator or system historic assay utilization NOTE: The reagent needs for IM diluents and IM/CH wash fluids are posted based only on • Below Threshold: The reagent inventory level is below the alert threshold* the Threshold criteria, not based on the • Pending Orders: There are existing orders in the Worklist and no reagent is onboard for the prediction. assay A need is red when the current inventory drops below a threshold defined by the operator on the Reagent Requirements Settings screen or when there are pending orders with no reagent available. To view the Reagent Needs: 1 K System Sample Inventory Calibration QC Patient Orders Worklist Maintenance 1. On the Command bar, select Inventory Reagent Overview Reagent Loader 2 Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Calibration Needs QC Needs Name 2. Select the Reagent Needs tab 3 Average Tests Tests Remaining Packs to Load Analyzers Reasons aTGDil 0 1 00109,1A00104,00109 Predictive o 3. If desired, sort the data by selecting one of the RPC2 70 70 GGW7_SAM Below Threshold column headings RPC1 70 70 GGW7_SAM Below Threshold RPC4 35 35 GGW7_SAM Below Threshold - 4 *This topic is continued on the next slide. Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Reagent Management Healthineers Reviewing Reagent Needs Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Calibration Needs QC Needs If a need is determined for a reagent, that reagent will display Name Average Tests Tests Remaining Packs to Load Analyzers Reasons on the screen. The information listed for each reagent includes: MDil13 0 00109,1A00104,00109 Predictive RPC2 70 70 GGW7_SAM Below Threshold • Average Tests: The forecasted need run based on the RPC1 70 70 GGW7_SAM Below Threshold configuration on the Reagent Requirements Settings screen RPC4 35 35 GGW7_SAM Below Threshold • Tests Remaining: System calculates as the difference between the Average Tests (or volume) and the amount performed • Packs to Load: The number of reagent packs to load o System calculates as Tests Remaining ÷ tests per pack • Analyzers: The analyzer(s) where that reagent pack could be loaded ? LabManager Tuesday, July 09, 2019 1:01:56 PM NOTE: The Reagent Needs can be printed by selecting the Print icon in the Status bar. 5 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Reagent Management Healthineers Loading CH Reagent Packs 1. Open the reagent tray lid 2. Insert up to six reagent packs 3. Close the reagent tray lid ➢ When the reagent tray lid closes, the gripper scans the packs and automatically loads valid packs 4. Review the Reagent Loader screen and resolve any loading issues that may occur NOTE: Some reagent packs must be manually prepared and mixed before loading them on the CH analyzer. Refer to the assay IFU for preparation instructions. All material needed for manual preparation of the reagent are found in the reagent package. NOTE: Opening the reagent tray drawer during the loading process halts the loader and moves the reagent tray back to the loading area. 6 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Reagent Management Healthineers Loading Atellica® Alliance Application Assay Reagents on the CH Analyzer 1. Refer to the preparation instructions listed in the Assay application sheet and prepare accordingly 2. Locate a new Atellica reagent pack. Mark the pack with reagent name, lot and expiration date 3. Remove the cap and transfer the prepared Atellica Alliance Application reagent into Well 1 of the pack. Never fill Well 2 4. Replace the cap 5. Open the reagent tray lid 6. Insert up to six reagent packs 7. Close the reagent tray lid ➢ When the reagent tray lid closes, the gripper scans the packs and automatically loads valid packs *This procedure is continued on the next slide NOTE: Opening the reagent tray drawer during the loading process halts the loader and moves the reagent tray back to the loading area. 7 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Reagent Management Healthineers Loading Atellica® Alliance Application Assay Reagents on the CH Analyzer (continued) 8. Review the Reagent Loader screen 9. From the Select Assay drop down menu, select appropriate assay 10. In Select Assay type, select P1 or P2 11. To choose an existing lot: A. From the drop down menu select the lot B. Verify the lot expiration C. Select OK 12. To enter a new Lot: A. Select New Lot B. Enter the Lot and Expiration C. Select OK 13. Review Reagent Loader screen and resolve any issues NOTE: Opening the reagent tray drawer during the loading process halts the loader and moves the reagent tray back to the loading area. 8 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Reagent Management Healthineers Unloading Reagent Packs - Automatically SIEMENS Healthingers Atellica" Solution Version 1.14.0.2974006 SP00107 The system is configured to automatically send reagent packs A System Samples Inventory Calibration Qc Patient Orders Worklot Maintenance Setup to the reagent tray when the packs are empty or expired. B Reagent Overvie Reagent Loader Reagent Needs Supplies Overview ent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs The system will alert the operator that there are reagents CM00110 waiting in the reagent tray to be removed by displaying an Reagent Loader Loader Status alert on the Inventory button in the Command Bar. Reagent loader lid is closed 6 5 4 3 2 1 1. To view the reagents that are waiting to be removed: Idie A. On the Command bar, select Inventory Reagent Inventory P1 Reagents P2 Reagents Theo P1 Theo P2 B. Select the Reagent Loader tab 51 Empty 51 Empty 19 in Use 19 In Use 2. Open the reagent tray lid 3. Remove reagent packs from the reagent tray Empty Empty 4. Close the reagent tray lid LOT 160138-00195 LOY 100138-00428 8 11/6/2017 2 11.6/2017 ➢ Once the lid is closed, the analyzer scans the tray and OBS 18 d 5h OBS 18 d 5h displays as all empty Clear All ? PEP LabManager Thursday, October 19, 2017 1:00:41 PM 9 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Reagent Management Healthineers Unloading Reagent Packs - Manually SIEMENS Heotthineers Atellica Solution Version 1.14.0.2975003 P-P1-04 1 System Samples Inventory Calibrabon OC Pabient Orders Workdet Maintenance Setup Reagent packs can be removed manually by the operator. 2 Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs Use this procedure to allow in-process tests, associated with the selected reagent packs, to complete before Reagents Reagent Details Reagent Inventory Sequence Calibration Calibration Cal Type In QC Cal Eligibility 00266 removal: 00922 Status Interval Use Status Lot 270428 Name AST 6 d 22 h 00428/00218 Amylas 476 26 d 22 h Lot Lot and Pack Lot ID 270433 1. On the Command bar, select Inventory 00102 /00102 160161 Pack Location CH Reagent Compartment 1 Acet 44 11 d2h 0d 22 h Pack Pack Position 43 Acet 255 86 doh 00102/00102 0d 22h Pack 160162 Lot and Pack Status 2. Select the Reagent Overview tab Sequence Number 00266 Alb 1700 6 d 22h 00060 58 d 16 h Lot 200227 Lot and Pack Paired Pack 00922 Count Remaining 338 86 d 22 h 00187 57 d 3 h Lot 200227 Lot and Pack 3. Select appropriate reagent packs Onboard Stability 8/22/2018 1:36:31 PM 63 d 22 h 00220 47.d 23h 200227 Lot Expiration 9/1/2018 11:59:59 PM Calibration Expiration 5/31/2018 10:29:05 AM 4. Select Unload 3 Amyla 338 79don 00266 7 00922 odon 270433 Lot and Pack Well 1 0d22h 841088 Pack Test Count 103 Ready 469 1 822h 01230 Lot Time Punctured 5/24/2018 1:38:04 PM 5. Check the status of the selected reagent packs in the Ca 851 50 d 20 h 00301/00252 2d22h Pack 270449 Lot and Pack Calibrate Pack Vell 2 Reagent Loader screen before opening the reagent tray Chol 2 386 13d21h 00657 1423 h Pack 270467 Pack Test Count 175 Sealed Crea_2 04d21h 00081 / 00045 0d21h Lot 260249 Lot and Pack lid Calibrate Lot Calibrate Pack DLOL 12 d2h 00292 / 00290 12d2h 444445 100000000000 Disable Reagent Pack 4 Disable Reagent Lot Unload 6. Open the reagent tray lid Group by reagent ? PEP LabManager Monday, June 04, 2018 1 06:14 PM 7. Remove reagent packs from the reagent tray 8. Close the reagent tray lid ➢ Once the lid is closed, the analyzer scans the tray and displays as all empty 10 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Reagent Management Healthineers SIEMENS Healthingers Atellica Solution Version 1.14.0.2974006 SP00107 Reagent Loader Glyph Descriptions System Samples vendory Calibration Oc Patient Orders Workout Martchance Setup A. Estimated amount of pretreatment reagent remaining Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs CM00110 B. Estimated amount of IMT tests remaining Reagent Loader Loader Status Reagent loader lid is closed 6 5 4 3 2 1 C. Empty position V Idie D. Low or expiring soon Reagent Inventory P1 Reagents P2 Reagents Theo P2 Theo P1 51 Empt 51 Empty E. Empty, expired, or unassigned operator-defined pack 19 In Us 19 In Use F. Bad barcode or barcode read error Empty Empty [LOT 180138-00196 LOT 100138-00428 G. Ready for use 116/2017 11.6/2017 OBS 18 d 5h OBS 18 d 5h Clear All ? PEP LabManager Thursday, October 19, 2017 1:00:41 PM A B C D E F G 11 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Supply Management Healthineers Checking CH System and IMT Fluids from Primary Display SIEMENS Healthingers Atellica Solution Version 1.14.0.2974006 P-P1-04 The system will alert the operator that system fluids and 1 System Samples Inventory Calibration Oc Patient Orders Work ist Maintenance Setup IMT fluids need to be replenished by displaying an alert Reagent Overview Reagent Losder Reagent Nee 2 Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs on the Inventory button in the Command Bar. To check the status of waste and supplies: System Fluids Status OBS Lot Expiration Lot Sequence Number CHf Cleaner On reserve 23 d 2 h 5/21/2018 0000089472 00325 Replace System Fluids 1. On the Command bar, select Inventory V CH Conditioner OK 17 d0h 5/17/2018 0000089475 00223 2. Select the Supplies Overview tab V CH Wash OK 21d0h 2/27/2018 0000086578 00456 ¥ CH Diluent OK 23 d 2h 5/23/2018 0000089477 00090 3. Identify system fluid alerts 0000 4. If appropriate, replace the system fluids, pretreatment pack, or IMT fluids IMT Status OBS Lot Expiration Lot Sequence Number IMT Std B . Sat Bridge 57% OK 23 d 22 h 5/30/2018 0000089784 00497 Replace IMT. IMT Standard A $6% OK 23 d 22 h 11/2/2018 0000282736 00030 V IMT Dtuent 3 96% OK 29 d0h 5/2/2018 0000088644 00147 IMT Sensor 4827 OK 1300h 11/21/2017 170004 00307 ? PEP LabManager 500 Wednesday, June De, 2018 1:39 PM 12 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Supply Management Healthineers Replacing IMT Fluids from Primary Display 1. Ensure the analyzer is in Ready, Processing, or Standby state by navigating to Replace IMT Supplies X System > Status and checking the status of the appropriate module Perform the IMT Advanced Clean Maintenance procedure when and before replacing the A-LYTE multisensor. 2. Open the IMT fluids lid To begin the Advanced Clean before replacing the A-LYTE mulitsensor, select Perform IMT Advanced Clean 3. On the Command bar, select Inventory > Supplies Overview > Replace IMT Supplies To replace IMT supplies directly without performing the IMT Advanced Clean, select Replace IMT Supplies 4. If an IMT Advanced Clean is required at the next multisensor replacement, a window displays with options to either perform IMT Advanced Clean or replace To exit, select Cancel. IMT supplies (see image on the right) Perform IMT Advanced Clean Replace IMT Supplies Cancel • If you are only replacing the IMT fluids and are not replacing the A-LYTE multisensor, select Replace IMT Supplies then Pause IMT and wait for this process to complete 5. Locate and remove the appropriate IMT fluid container 6. Discard the IMT fluid container per laboratory protocol NOTE: Do not refill an IMT fluid container. Refilling a container can cause contamination. Remove the bottle from the IMT fluids area and install a new container. *This procedure is continued on the next slide. 13 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Supply Management Healthineers Replacing IMT Fluids from Primary Display (continued) 7. Using the handheld barcode reader, scan the new IMT fluid container 8. Ensure the module displays the correct Lot, Sequence, and Expiration under the appropriate fluid 9. Holding the new IMT fluid container vertically with the septum facing down, insert the new container into position 10. To replace each additional IMT fluid, repeat steps 5-9 SIEMENS v 11. Close the IMT fluids lid 12. Select Save NOTE: Do not touch the cannulas in the keyed areas at the bottom of the system fluids drawer. The cannulas can puncture skin. NOTE: The system and IMT fluid containers only fit in the designated position when the cannulas puncture the septum. 14 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Supply Management Healthineers Replacing CH System Fluids from Primary Display SIEMENS Healthinger? Atellica Solution Version 1.14.0.2974006 P-P1-04 1. On the Command bar, select Inventory 1 System Samples Inventory Calibration Patient Orders Work best Maintenance Setup Reagent Overview Reagent Losder Reagent Needs 2 Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs 2. Select Supplies Overview 3 3. Select the CH analyzer System Fluids Volume Status OBS Lot Expiration Lot Sequence Number CH Cleaner On reserve 23 d 2 5/21/2018 0000089472 00325 5 Replace System Fluids 4. Determine the system fluids that require replacement V CH Conditioner 6 OK 17 do 5/17/2018 0000089475 00223 5. Select Replace System Fluids V CH Wash 5 OK 21d0h 2/27/2018 0000086578 00456 V CH DIvent OK 3d2h 5/23/2018 0000089477 00090 6. Open the system fluids drawer 0000 7. Locate and tighten the cap of the system fluid container to be removed IMT Volume Status OBS Lot Expiration Lot Sequence Number IMT Std B + Sat Bridge 57% OK 23 d 22 h 5/30/2018 0000089784 00497 Replace IMT. 8. Remove the appropriate system fluid container IMT Standard A 2 OK 23 d 22 h 11/2/2018 0000282736 00030 9. Discard the system fluid container according to laboratory V IMT Diluent 96% OK 29 0 0 5/2/2018 0000068644 00147 100 protocol IMT Sensor 4827 OK 13d0h 11/21/2017 170004 00307 10. Scan the new CH fluid container using the barcode on the ? PEP LabManager Wednesday, June 06, 2018 1:39 PM front label NOTE: Do not load the same system fluids container multiple times. Removing 11. Ensure the module display shows the correct Lot and Lot and reloading a system fluid container can cause the punctured membrane to Expiration. If the Lot and Lot Expiration are incorrect, enter leak. Load only new and unused containers on the analyzer. the Lot and Lot Expiration listed on the container manually into the system software 12. Select Save *This procedure is continued on the next slide. 15 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Supply Management Healthineers Replacing CH System Fluids from Primary Display (continued) 13. Holding the new system container vertically with the septum facing down, firmly insert the container straight down into the drawer with the label away from the analyzer NOTE: The fluid containers are keyed to fit only in the designated drawer position. NOTE: The container only delivers fluid when the operator fully seats it into the designated location. Refer to the fluid chart within the drawer for correct container placement. To securely seat the 4 container, do not insert container at an angle. 14. Ensure the container is seated securely with the tabs on both sides of the container even with the drawer surface *This procedure is continued on the next slide. 16 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Sample Handler SIEMENS Supply Management Healthineers Replacing CH System Fluids from Primary Display (continued) 15. To prevent a vacuum from forming inside the container that could cause the analyzer to stop processing, vent the container. To vent the container, squeeze and twist the cap counterclockwise to pass the first designated stop, then no longer squeeze but twist the cap until it reaches the next designated stop 16. Close the system fluid drawer 4 17 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Supply Management Healthineers Replacing the Pretreatment Pack For laboratories processing Hemoglobin A1c_E tests, the pretreatment is stored onboard the CH Analyzer to dilute and lyse red blood cells in whole blood samples. There are 2 options for how the pretreatment can be stored onboard. Each system is configured to be able to use one of these: A. Pretreatment pack: 40-mL B. High-Volume pretreatment bottle: 180-mL A1c_E Pretreatment Pack location (behind IMT fluids) A B NOTE: Refer to the follow slides for the procedures on how to load each of these bottles. NOTE: Do not handle pretreatment solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or a protective face shield. Pretreatment solution can cause skin irritation. 18 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Supply Management Healthineers Replacing the 40-mL Pretreatment Pack from Primary Display 1. Stop the CH analyzer and unlock the front cover: System Samples Inventory Calibration QC Patient Orders Worklist Maintenance Setup Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs A. Navigate to the CH Status screen: System > Status > CM00110 All CM00113 00104 CH icon System Fluids Volume Status OBS Lot Expiration Lot Sequence Number B. Select the Stop icon CH Cleaner 7 On reserve 23 d 2 h 5/21/2018 0000089472 00325 Replace System Fluids V CH Conditioner OK 17 d 0 5/17/2018 0000089475 00223 C. Select the icon to unlock the CH front cover V CH Wash OK 21 d 0h 2/27/2018 0000086578 00456 2. Lift open the CH front cover V CH Diluent OK 23 d 2 h 5/23/2018 0000089477 00090 3. Grasp the pretreatment pack and pull up and out. Discard Pretreatment OK 6 d 23 h 10/16/2018 0000170006 10112 Replace Pretreatment the pretreatment pack per laboratory procedures 4. On the Command bar, select Inventory > Supplies IMT Volume Status OBS Lot Expiration Lot Sequence Number Overview > Replace Pretreatment IMT Std B + Salt Bridge 1 57% OK 23 d 22 h 5/30/2018 0000089784 00497 Replace IMT ¥ IMT Standard A 2 46% OK 23 d 22 h 11/2/2018 0000282736 00030 5. Read message and select OK V IMT Diluent 96% OK 29 d 0 h 5/2/2018 0000088644 00147 6. Using the handheld scanner, scan the new pretreatment IMT Sensor 3477 Expires Soon 1d 3h 4/6/2018 170004 00295 pack 7. Confirm that the correct Lot and Expiration display *This procedure is continued on the next slide. 19 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Supply Management Healthineers Replacing the 40-mL Pretreatment Pack from Primary Display (continued) 8. Insert the new pack into the CH analyzer. Remove cap and discard 9. Select OK 10. Close the CH front cover 11. Resume the CH analyzer by selecting the Resume icon on the CH System Status screen NOTE: Do not handle pretreatment solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or a protective face shield. Pretreatment solution can cause skin irritation. 20 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Supply Management Healthineers Replacing the High-Volume Pretreatment Bottle from Primary Display For laboratories processing high volumes of Hemoglobin A1c_E tests, a 180-mL bottle of pretreatment is stored onboard. Each 180-mL bottle is reusable. The laboratory stocks a 1-L bottle of pretreatment then rinses, dries, labels, and fills the 180-mL bottles as required. To prepare the 180-mL pretreatment bottle: 180-mL 1. If appropriate, rinse all empty 180-mL pretreatment bottles and caps with special reagent water and let them completely dry before filling 2. To fill empty 180-mL pretreatment bottle: A. Using the 1-L pretreatment bottle, fill a 180-mL bottle to the fill line with 180-mL of pretreatment B. Place the cap on the prefilled 180-mL pretreatment bottle C. Record the Lot and Expiration on a label and affix it to the bottle NOTE: When filling the 180-mL bottle, be careful to avoid introducing D. Place the cap on the 1-L pretreatment bottle bubbles into the pretreatment. 3. Store the capped opened 1-L pretreatment bottle at 2–8°C until the NOTE: If a bottle has an existing label, ensure the Lot and Expiration expiration date are the same as on the 1-L pretreatment bottle. If not, remove the existing label and replace with a new label that contains the *This procedure is continued on the next slide. appropriate Lot and Expiration. 21 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Supply Management Healthineers Replacing the High-Volume Pretreatment Bottle from Primary Display (continued) System Samples Inventory Calibration QC Patient Orders Worklist Maintenance Setup To replace the 180-mL pretreatment bottle: Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs CM00110 AI CM00113 00104 1. Pause the CH analyzer and unlock the front cover: System Fluids Volume Status OBS Lot Expiration Lot Sequence Number A. Navigate to the CH Status screen: System > Status > CH CH Cleaner 7 On reserve 23 d 2 h 5/21/2018 0000089472 00325 Replace System Fluids icon V CH Conditioner 6 OK 17 d 0h 5/17/2018 0000089475 00223 V CH Wash 5 OK 21 d 0h 2/27/2018 0000086578 00456 B. Select the Pause icon V CH Diluent 4 OK 23 d 2 h 5/23/2018 0000089477 00090 C. Select the icon to unlock the CH front cover Pretreatment OK 6 d 23 h 10/16/2018 0000170006 10112 Replace Pretreatment -1000 2. Lift open the CH front cover 3. On the Command bar, select Inventory > Supplies IMT Volume Status OBS Lot Expiration Lot Sequence Number Overview IMT Std B + Salt Bridge 57% OK 23 d 22 h 5/30/2018 0000089784 00497 Replace IMT ¥ IMT Standard A 2 46% OK 23 d 22 h 11/2/2018 0000282736 00030 4. Select the appropriate analyzer and then select Replace V IMT Diluent 3 96% OK 29 d 0 h 5/2/2018 0000088644 00147 Pretreatment À IMT Sensor 3477 Expires Soon 1d3h 4/6/2018 170004 00295 E000 5. Locate the prefilled 180-mL pretreatment replacement bottle, enter the Lot and Expiration, then select OK • If the Lot is already entered into the analyzer, the Expiration automatically populates 6. Set this bottle on a flat surface, such as behind the IMT system fluids 22 *This procedure is continued on the next slide. Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Supply Management Healthineers Replacing the High-Volume Pretreatment Bottle from Primary Display (continued) 7. Locate the onboard pretreatment bottle notched lid 8. To remove the empty 180-mL pretreatment bottle: 7 A. Grasp the notched lid then pull up and out of the analyzer B. To remove this notched lid, hold the bottle with 1 hand then grasp the lid with the opposite hand and turn it counterclockwise ET C. Inspect this lid for debris then, if appropriate, rinse with special reagent water and dry with lint-free tissues NOTE: Do not tilt the opened replacement bottle or the empty notch lid bottle of pretreatment. This can cause spills. If spills occur inside the analyzer, B clean it with reagent water and dry all surfaces with a lint-free tissue. NOTE: Do not handle pretreatment solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or a To protective face shield. Pretreatment solution can cause skin irritation. A *This procedure is continued on the next slide. 23 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Supply Management Healthineers Replacing the High-Volume Pretreatment Bottle from Primary Display (continued) A B 9. To install the prepared 180-mL pretreatment replacement bottle: A. Place the notched lid removed in step 7 on the prefilled bottle and turn clockwise until tight B. Grasp the notched lid of the bottle then insert the full pretreatment bottle into the keyed slot 10. Close the CH front cover 11. Select OK 12. Resume the CH analyzer by selecting the Resume icon on the CH System Status screen 13. Rinse the empty pretreatment bottle removed from the analyzer and the cap removed from the stored bottle with special reagent water and let them completely dry 24 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Direct Load SIEMENS Supply Management Healthineers Inventory Glyph Descriptions A A. Supply or reagent pack error such as empty, contaminated, not usable, undefined, or invalid pack B B. Expiring or low reagent pack or supply C. Supply status is OK C D. Reagent pack transfer in process E. System fluid is empty D F. System fluid is partially full G. System fluid is full E F G 25 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 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. Atellica, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc. or its affiliates. All other trademarks and brands are the property of their respective owners. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability. Copyright © Siemens Healthcare GmbH 2021 Global Siemens Healthineers Headquarters Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84 0 siemens.com/healthineers 26 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021