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Atellica® CH Analyzer with Sample Handler Supply and Reagent Management PEP to Go Version 1.25 and Below

PEP to Go is an education resource material designed to support competency mastery on-the-job.

SIEMENS Healthineers Atellica® CH Analyzer with Sample Handler Supply and Reagent Management PEP to Go 1 Template Effective Date: 05/27/2019 | HOOD05162003010284 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Sample Handler SIEMENS Reagent Management Healthineers Reviewing Reagent Inventory SIEMENS Healthineers Atellica® Solution Version 1.14.0.2975003 P-P1-04 The Reagent Overview screen allows the operator to review 1 999 System Samples Inventory Calibration Oc Patient Orders Worklist Maintenance Setup the status of reagents. 2 Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs CM00110 3 To review reagent inventory: 4 CM00113 00104 Reagents Reagent Details 1. On the Command bar, select Inventory Reagent Inventory Onboard Sequence Calibration Calibration QC Stability Status Cal Type In Interval Use Status Lot Cal Eligibility 00266 00922 476 86 d 22 h 00428 / 00218 26 d 22 h 270428 Lot and Pack Name Amylas AST Lot Lot ID 270433 2. Select the Reagent Overview tab Acet 44 11 d 2 h 00102 / 00102 0 d 22 Pack 160161 Pack Pack Location CH Reagent Compartment 1 Position 43 Acet 255 86 d 0 h 00102 / 00102 0 d 22h Pack 160162 Lot and Pack Status Idle 3. Select the CH analyzer graphic to view the CH reagents Sequence Number 00266 Alb 1700 86 d 22 h 00060 58 d 16 h Lot 260227 Lot and Pack 00922 Paired Pack 00922 1698 36 d 22 h 00187 57 d 3 h 260227 Lot and Pack Count Remaining 338 338 Alb Lot 4. To sort, select a column heading Onboard Stability 8/22/2018 1:36:31 PM 5 Alb o 63 d 22 h 00220 47 d 23 h 260227 Lot Expiration 9/1/2018 11:59:59 PM Calibration Expiration 5/31/2018 10:29:05 AM ➢ Amylas 338 79 d 0 h 00266 / 00922 Odoh 270433 Inventory: to bring reagents that are empty or running Lot and Pack Well 1 CO2_C 469 21 d 22 h 01230 0 d 22h Lot 841088 Pack Test Count 163 Ready low to the top of the screen Time Punctured 5/24/2018 1:38:04 PM Ca 851 50 d 20 h 00301 / 00252 2 d 22 Pack 270449 Lot and Pack Calibrate Lot Calibrate Pack Chol_2 Well 2 ➢ 386 13 d 21 h 00657 1 d 23h Pack 270467 Pack Calibration Status: to bring reagents that have an Test Count 175 Sealed Crea_2 910 84 d 21 h 00061 / 00045 0 d 21h Lot 260249 Lot and Pack invalid calibration or have not been calibrated to the Calibrate Lot Calibrate Pack DLDL 53 12 d 2 h 00292 / 00290 12 d 2 h Lot 444445 Pack Submit top of the screen Group by reagent Disable Reagent Pack Disable Reagent Lot Unload ➢ Calibration Interval: to bring the reagents that have a ? PEP LabManager Monday, June 04, 2018 1:06:14 PM calibration that will expire soon to the top of the screen 5. To view details about a reagent pack, select the checkbox for the reagent *This procedure is continued on the next slide. ➢ Reagent Details for that pack will display on the right 2 side of the screen Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Sample Handler SIEMENS Reagent Management Healthineers Reviewing Reagent Inventory (continued) SIEMENS Healthineers Atellica® Solution Version 1.14.0.2975003 P-P1-04 6. At the bottom of the Reagent Details area of the screen, 999 System Samples Inventory Calibration Oc Patient Orders Worklist Maintenance Setup there are buttons that can be used to order a Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs calibration on that reagent pack CM00110 CM00113 00104 Reagents Reagent Details 7. There are options at the bottom of the screen to disable Reagent Inventory Onboard Stability Sequence Calibration Calibration Cal Type In Status QC Interval Status Lot Cal Eligibility 00266 00922 Use Name Amylas a selected reagent pack, to disable an entire reagent lot, AST 476 86 d 22 h 00428 / 00218 26 d 22 h Lot 270428 Lot and Pack Lot ID 270433 or to manually unload a reagent pack Acet 44 11 d 2 h 00102 / 00102 0 d 22 Pack 160161 Pack Pack Location CH Reagent Compartment 1 Position 43 Acet 255 86 d 0 h 00102 / 00102 0 d 22h Pack 160162 Lot and Pack Status Idle Sequence Number 00266 Alb 1700 86 d 22 h 00060 58 d 16 h Lot 260227 Lot and Pack 00922 Paired Pack 00922 Lot and Pack Count Remaining 338 338 Alb 1698 36 d 22 h 00187 57 d 3 h Lot 260227 Onboard Stability 8/22/2018 1:36:31 PM Alb O 63 d 22 h 00220 47 d 23 h 260227 Lot Expiration 9/1/2018 11:59:59 PM Calibration Expiration 5/31/2018 10:29:05 AM Amylas 338 79 d 0 h 00266 / 00922 Odoh 270433 Lot and Pack Well 1 CO2_C 469 21 d 22 h 01230 0 d 22h Lot 841088 Pack Test Count 163 Ready Time Punctured 5/24/2018 1:38:04 PM Ca 851 50 d 20 h 00301 / 00252 2 d 22 Pack 270449 Lot and Pack 6 Calibrate Lot Calibrate Pack Well 2 Chol_2 386 13 d 21 h 00657 1 d 23h Pack 270467 Pack Test Count 175 Sealed Crea_2 910 84 d 21 h 00061 / 00045 0 d 21h Lot 260249 Lot and Pack Calibrate Lot Calibrate Pack DLDL 53 12 d 2 h 00292 / 00290 12 d 2 Lot 444445 Pack 7 Submit Group by reagent Disable Reagent Pack Disable Reagent Lot Unload ? PEP LabManager Monday, June 04, 2018 1:06:14 PM LID 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 Sample Handler 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 prediction. • Pending Orders: There are existing orders in the Worklist and no reagent is onboard for the 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 Sample Handler 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 Sample Handler 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 Sample Handler 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 Sample Handler 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 Sample Handler SIEMENS Reagent Management Healthineers Unloading Reagent Packs - Automatically SIEMENS Healthingers Atellica Solution Version 1.14.0.2974008 P-P1-05 A The system is configured to automatically send reagent packs System Samples Calibration OC Patent Orders Worklhe Maintenance Setup Reagent Overview B Reagent Loader Reageer Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs to the reagent tray when the packs are empty or expired. C-P1-06 C-PI-OS P5-06 The system will alert the operator that there are reagents Reagent Loader Loader Status waiting in the reagent tray to be removed by displaying an Reagent loader lid is closed 6 5 4 3 2 alert on the Inventory button in the Command Bar. Idie 1. To view the reagents that are waiting to be removed: Reagent Inventory P1 Reagents P2 Reagents Ca PZ Ca P A. On the Command bar, select Inventory 42 Empty 42 Empty 28 In Use 28 In Use B. Select the Reagent Loader tab Empty 2. Open the reagent tray lid Empty LOT 260241-00115 LOT 200241-00025 3. Remove reagent packs from the reagent tray 1122/2017 11/23/2017 OBS 51 d 1h OBS 52 d 1 h 4. Close the reagent tray lid Clear All ➢ Once the lid is closed, the analyzer scans the tray and ? PEP si LabManager os Monday, October 02, 2017 11:00 AM displays as all empty 9 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Sample Handler SIEMENS Reagent Management Healthineers Unloading Reagent Packs - Manually SIEMENS Healthineers Atellica Solution Version 1.14.0.2975003 P-P1-04 1 Reagent packs can be removed manually by the operator. Use System Samples Inventory Calibration Patient Orders Worklist Maintenance Setup this procedure to allow in-process tests, associated with the 2 Reagent Overview Reagent Loader 5 Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs CM00110 selected reagent packs, to complete before removal: CM00113 00104 Reagents Reagent Details Reagent Inventory Onboard Calibration Cal Type In Stability Sequence Calibration Status Use Status Lot Cal Eligibility 00266 00922 1. On the Command bar, select Inventory Name Amylas AST 476 36 d 22 h 00428 / 00218 26 d 22 h Lot 270428 Lot and Pack Lot ID Lot ID 270433 2. Select the Reagent Overview tab Acet 44 11 d 2h 00102 / 00102 0 d 22 h Pack 160161 Pack Pack Location CH Reagent Compartment 1 Position 43 Acet 255 86 d 0 h 00102 / 00102 0 d 22h Pack 160162 Lot and Pack Status Idle Sequence Number 00266 3. Select appropriate reagent packs Alb 1700 86 d 22 h 00060 58 d 16 h Lot 260227 Lot and Pack Paired Pack 00922 Alb 1698 86 d 22 h 00187 57 d 3 Lot 260227 Lot and Pack Count Remaining 338 Onboard Stability 8/22/2018 1:36:31 PM 4. Select Unload Alb 0 63 d 22 h 00220 47 d 23 h 260227 Lot Expiration 9/1/2018 11:59:59 PM Calibration Expiration 5/31/2018 10:29:05 AM Check the status of the selected reagent packs in the 3 Amyla 338 79d 0h 00266 / 00922 OdOh 270433 Lot and Pack Well 1 5. CO2_C 469 21 d 22 h 01230 0 d 22 h Lot 841088 Pack Test Count 163 Ready Time Punctured 5/24/2018 1:38:04 PM Reagent Loader screen before opening the reagent tray Ca 851 50 d 20 h 00301 / 00252 2 d 22 h Pack 270449 Lot and Pack Calibrate Lot Calibrate Pack lid Chol_2 Well 2 386 13 d 21 h 00657 1 d 23h Pack 270467 Pack Test Count 175 Sealed Crea_2 910 84 d 21 h 00061 / 00045 0 d 21h Lot 260249 Lot and Pack Calibrate Lot Calibrate Pack 6. Open the reagent tray lid DLDL 53 12 d 2h 00292 / 00290 12 d 2 h Lot 444445 Pack Submit Group by reagent Disable Reagent Pack Disable Reagent Lot 4 Unload 7. Remove reagent packs from the reagent tray ? PEP LabManager Monday, June 04, 2018 1:06:14 PM 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 Sample Handler SIEMENS Reagent Management Healthineers Reagent Loader Glyph Descriptions Atellica Solution Version 1.14.0.2974006 P-P1-05 System Samples Caltrato Oc Pabent Orders Workist Lantenance Setup A. Estimated amount of pretreatment reagent remaining Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Let Comparison Cal-QC Storage Inventory Cal-QC Needs @8 C-P1-06 P5-06 B. Estimated amount of IMT tests remaining Reagent Loader Loader Status Reagent loader lid is closed C. Empty position 6 5 4 3 2 1 V Idie D. Low or expiring soon Reagent Inventory P1 Reagents P2 Reagents Ca P2 Ca P1 ALT P 42 Empty 42 Empty E. Empty, expired, or unassigned operator-defined pack 28 In Uso 28 In Use F. Bad barcode or barcode read error Empty Empty 850 Tests G. Ready for use LOT 260241-00115 [LOT 200241-00025 LOT 200300-00223 2 11/22/2017 11/23/2017 11/27/2017 OBS 51 d 1h OBS 52 6 1h OBS 56 d 7h Clear All A B F G ? PEP LabManager C D E Monday, October 02, 2017 11:00 AM 11 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Sample Handler 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 A System Samples Inventory Calibration Patient Orders Work Best Maintenance Setup IMT fluids need to be replenished by displaying an alert Reagent Overview Reagent Loader Reagent Needs 2 Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs on the Inventory button in the Command Bar. 3 2 CM00110 1-000 To check the status of waste and supplies: System Fluids Volume Status OBS Lot Expiration Lot Sequence Number CH Cleaner On reserve 23 d 21 5/21/2018 0000089472 00325 Replace System Fluids 1. On the Command bar, select Inventory V CH Conditioner OK 17 dOh 5/17/2018 0000089475 00223 2. Select the Supplies Overview tab V CH Wash 5 OK 21d0h 227/2018 0000086578 00456 V CH Diluent OK 23 d 2 5/23/2018 0000089477 00090 3. Select the CH analyzer 4. Identify system fluid alerts If appropriate, replace the system fluids, pretreatment IMT Status OBS 5. Lot Expiration Lot Sequence Number IMT Std B + Sat Bridge 57% OK 23 d 22 h 5/30/2018 0000089784 00497 Replace IMT pack, or IMT fluids IMT Standard A OK 23 d 22 h 11/2/2018 0000282736 00030 V IMT Duent 96% OK 29 0 0h 5/2/2018 0000088644 00147 IMT Sensor 4827 OK 13d0h 11/21/2017 170004 00307 1100 ? PEP LabManager 500 DS Wednesday, June 06, 2018 1:39 PM 12 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Sample Handler SIEMENS Supply Management Healthineers Replacing IMT Fluids from Module Display 1. Ensure the analyzer is in Ready, Processing, or Standby state by navigating Replace IMT Supplies X to 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. Select IMT Supplies on the module display 4. If an IMT Advanced Clean is required at the next multisensor replacement, To replace IMT supplies directly without performing the IMT Advanced Clean, select Replace IMT Supplies a window displays with options to either perform IMT Advanced Clean or replace IMT supplies (see image on the right) To exit, select Cancel. • If you are only replacing the IMT fluids and are not replacing the A-LYTE Perform IMT Advanced Clean Replace IMT Supplies Cancel multisensor, select Replace IMT Supplies and wait for the analyzer to pause 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 Sample Handler SIEMENS Supply Management Healthineers Replacing IMT Fluids from Module Display (continued) 7. Using the module display, 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 GIFMENS A 10. To replace each additional IMT fluid, repeat steps 5-9 11. Close the IMT fluids lid 12. Select OK SIEMENS IMT Supplies LabManager Standby NOTE: Do not touch the cannulas in the keyed areas at the bottom of the system fluids drawer. The cannulas can puncture skin. To replace IMT Sensor and IMT Fluids, pause the IMT system by opening the IMT i Supplies lid, and then scan or manually enter the IMT Sensor or IMT Fluid barcode. NOTE: The system and IMT fluid containers only fit in the designated position when the cannulas puncture the septum. TD-LYTE O 1 0 2 3 IMT Sensor IMT Std B + Salt Bridge IMT Standard A IMT Diluent Pause IMT ? 14 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 Module Display SIEMENS System Fluids n 1. Open the system fluids drawer LabManager Standby ➢ The System Fluids screen will display on the module display 2. Locate and tighten the cap of the system fluid container to be Tighten the cap before removing removed O 6 O 7 the fluid container. 3. Remove the appropriate system fluid container 4. Discard the system fluid container according to laboratory protocol CH Conditioner CH Cleaner 5. Using the module display, scan the new fluid container using the O barcode on the front label. To scan the new fluid container: O 4 O 5 A. Hold the container 150 mm (6 inches) at a 45 ◦ angle under the module display barcode reader CH Diluent CH Wash ? B. Ensure the module display shows the correct Lot and Lot Expiration. If the Lot and Lot Expiration are incorrect, enter the Lot and Lot Expiration listed on the container manually into the NOTE: Do not load the same system fluids container multiple times. system software Removing and reloading a system fluid container can cause the 6. Select OK punctured membrane to leak. Load only new and unused containers on the analyzer. *This procedure is continued on the next slide. 15 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 Module Display (continued) 7. 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 4 the drawer for correct container placement. To securely seat the container, do not insert container at an angle. 8. 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 Module Display (continued) 9. 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 10. Close the system fluid drawer 4 17 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Sample Handler 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 Sample Handler SIEMENS Supply Management Healthineers Replacing the 40-mL Pretreatment Pack from Module Display 1. Stop the CH analyzer and unlock the front cover: A. At the module display, select Module State B. Select the Pause icon C. Select the icon to unlock the CH front cover 2. Lift open the CH front cover 3. Grasp the pretreatment pack and pull up and out. Discard the pretreatment pack per SIEMENS CI-CH SIEMENS Supplies laboratory procedures ¿ LabManager Standby LabManager Standby 4. On the module display, select Supplies 4 Pretreatment 5. The pretreatment screen will display. If needed, Lot --- 5 C select Instructions for scanning for guidance on Module State System Fluids Supplies IMT Supplies O Lot Expiration OBS how to hold the pretreatment pack while --- Instructions for Status scanning scanning Manual Entry 6. Using the module display, scan the new pretreatment pack Reagent Loader ? *This procedure is continued on the next slide. 19 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Sample Handler SIEMENS Supply Management Healthineers Replacing the 40-mL Pretreatment Pack from Module Display (continued) Pretreatment Scanned × 7. Confirm that the module display shows the correct Lot and Expiration Pretreatment 7 × 8. Insert the new pack into the CH analyzer. Remove cap and discard Lot 1222222222 Expiration 2/25/2017 12:00:00 AM 9. Select OK 10. Close the CH front cover 11. Resume the CH analyzer by selecting the Resume icon Place Pretreatment in the holder, close the front cover, and start the analyzer. ? 9 OK Cancel 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 Sample Handler SIEMENS Supply Management Healthineers Replacing the High-Volume Pretreatment Bottle from Module 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 Sample Handler SIEMENS Supply Management Healthineers Replacing the High-Volume Pretreatment Bottle from Module Display SIEMENS CI-CH (continued) ¿ LabManager Standby To replace the 180-mL pretreatment bottle: 3 0 1. Stop the CH analyzer and unlock the front cover: A. At the module display, select Module State Module State System Fluids Supplies IMT Supplies B. Select the Pause icon C. Select the icon to unlock the CH front cover 2. Lift open the CH front cover Reagent Loader 3. At the module display, select Supplies SIEMENS Supplies 4. Select Manual Entry ¿ LabManager Standby 5. Locate the prefilled 180-mL pretreatment replacement bottle, enter the Pretreatment Lot and Expiration, then select OK Lot --- Lot Expiration --- • If the Lot is already entered into the analyzer, the Expiration OBS Instructions for automatically populates Status --- scanning 6. Set this bottle on a flat surface, such as behind the module display 4 Manual Entry ? *This procedure is continued on the next slide. 22 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Sample Handler SIEMENS Supply Management Healthineers Replacing the High-Volume Pretreatment Bottle from Module Display (continued) 7. Locate the onboard pretreatment bottle notched lid 7 8. To remove the empty 180-mL pretreatment bottle: 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 Sample Handler SIEMENS Supply Management Healthineers Replacing the High-Volume Pretreatment Bottle from Module Display A B (continued) 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. At the module display, select OK 12. Resume the CH analyzer by selecting the Resume icon Pretreatment Scanned X Pretreatment × 13. Rinse the empty pretreatment bottle removed from the analyzer and the Lot 1222222222 Expiration 2/25/2017 12:00:00 AM cap removed from the stored bottle with special reagent water and let them completely dry Place Pretreatment in the holder, close the front cover, and start the analyzer. ? 11 OK Cancel 24 Effective Date: 01-APR-2021 | HOOD05162003178151 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® CH Analyzer with Sample Handler 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