PEPconnect

Atellica® IM Analyzer with Direct Load 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 -44 44 UWV IM SIEMENS ..... Atellica® IM Analyzer with Direct Load Atellica Solution Healthineers ... Supply and Reagent Management PEP to Go 1 Template Effective Date: 05/27/2019 | HOOD05162003010284 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Direct Load SIEMENS Reagent Management Healthineers Reviewing Reagent Inventory SIEMENS Healthingers Atellica Solution Version 1.14.0.2975003 P-P1-04 1 1 160 The Reagent Overview screen allows the operator to SyMem Samples Inventory Calibration Paberd Orders Workbest Maintenance Setup review the status of onboard reagents. 2 Reagent Overview Reagent Loader Resgent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs To review reagent inventory: 3 Reagents Reagent Details Reagent Inventory Onboard Stability Sequence Calibration Cal Type In QC Status Calibration Intervall Use Status Lot Cal Eligibility $1-4053 1. On the Command bar, select Inventory 4:90 ml Name ThCG ROBA 000165 0719 Lot ID 991 TSH3U 37 54 d 21 h 001050 21d23h Lot 313 Pack Pack Location IM reagent compartment 2. Select the Reagent Overview tab Position 61 TSHGU 120 54d21h 001051 21 d 23 h Lot 313 Pack Count 86 OBS 6/25/2018 11:00:00 AM 3. To sort, select a column heading: THOG 86 20 d 21 h 014060 27 d 22h Pack 991 Lot and Pack Calibration Expiration 7/2/2018 12:01:06 PM ThCG 82 20 d 21 h 014061 27 d 22 h Pack 901 Lot and Pack Pack Status ➢ Inventory: to bring reagents that are empty or 4 ThCG 20 d 21h 014063 27 422h Pack 001 Lot and Pack Calibrate Lot Calibrate Pack running low to the top of the screen Tnl_UL 56 d 23h 034282 14 10h 991 Pack Tnl_U DO 56 6 23h 03-4283 14 10h Lot 991 Pack ➢ Calibration Status: to bring reagents that have an Tnl_UL 0 54d21h 034286 d 10h Lot invalid calibration or have not been calibrated to 3HAVM 29 d 22h 000229 16 d 22 h Lot 177 aHAMMA 14.10 ml 30 d 14 h 001099 3329 the top of the screen Refresh Edt 000 0 00 00000 ➢ Group by reagent Disable Reagent Pack Disable Reagent Lot Unload Calibration Interval: to bring the reagents that have Unload Immediately a calibration that will expire soon to the top of the ? PEP. LabManager Monday, June 04. 2018 1:09 15 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: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Direct Load SIEMENS Reagent Management Healthineers Reviewing Reagent Inventory (continued) SIEMENS P-P1-04 Healthingers Atellica Solution Version 1.14.0.2975003 SyMem Workbed Setup Samples Calibration Maintenance 5. At the bottom of the Reagent Details area of the Inventory Pabert Orders Reagent Overview Reagent Loader Resgent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs screen, there are buttons that can be used to order a Coto0 calibration on that reagent pack Reagents Reagent Details Reagent Inventory Onboard Sequence Calibration Calibration Cal Type In QC Lot Stability Status 6. There are options at the bottom of the screen to Use Status Cal Eligibility 01-4053 nterval Name ThCG ROBA 4:90 ml 000165 0719 Lot ID 991 disable a selected reagent pack, to disable an entire TSH3U 37 54 d 21 h 001050 21d23h Lot 313 Pack Pack Location IM reagent compartment Position 61 reagent lot, or to manually unload a reagent pack TSHGU 120 54d21h 001051 21 d 23 h Lot 313 Pack Count 86 OBS 6/25/2018 11:00:00 AM THOG 86 20 d 21 h 014060 27 d 22h Pack 991 Lot and Pack Calibration Expiration 7/2/2018 12:01:05 PM ThCG 82 20 d 21 h 014061 27 d 22 h Pack 901 Lot and Pack Pack Status 5 ThCG 20 d 21 h 014063 7422h Pack 001 Lot and Pack Calibrate Lot Calibrate Pack Tni_UL 56 d 23 h 034282 14 10h 991 Pack Tnl_U 56 6 23h 03-4283 1 4 10h Lot 991 Pack Tnl_UL 0 54d21h 034286 d 10h Lot 3HAVM 29 d 22 h 000229 16 d 22 h Lot 177 aHAMMA 14.10 ml 30 d 14h 001099 3329 Refresh Edt Group by reagent 6 Disable Reagent Pack Disable Reagent Lot Unload Unload Immediately ? PEP. [] LabManager Monday, June 04. 2018 1:09 15 PM NOTE: For more information on ordering calibrations, refer to the “Manually Ordering Calibration Tests” training topic in PEPconnect. 3 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM 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 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: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM 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 OS 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: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Direct Load SIEMENS Reagent Management Healthineers Handling IM Reagent Packs NOTE: During off-system storage, solid phase particles settle as a pellet at the bottom of the primary reagent pack. 1. If shutting down the analyzer reagent compartment refrigeration for longer than 2 hours, remove and store the reagent packs A. Cover the pierced film area of the reagent pack with self- T4 Contains: Lite Reagent 10.0 ... Solo Phase 25.0 ml 150 --- Sievemuy Healthcare Diagnostics tor sealing laboratory film ReadyPack" 511 Benedict Avenue B. Store any off-system reagent packs at 2-8 ◦ C C. Before loading primary reagent packs onto the system, manually mix the packs to re-suspend the particles homogeneously D. Return the reagent packs to the system when the reagent compartment temperature is 2-8 ◦ C E. Verify reagent performance based on acceptable QC results or laboratory criteria 2. If the analyzer has not mixed primary reagent packs for 30 minutes or longer, remove all primary reagent packs and manually mix before resuming normal operations 6 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Direct Load SIEMENS Reagent Management Healthineers Manually Mixing IM Primary Reagents Primary reagents must be manually mixed before being loaded on the system: 6. Return the pack to a horizontal position 1. If the reagent pack is pierced, gently press on the self-sealing laboratory 7. Repeat steps 2–5 a minimum of 20 times or until: film that covers the pierced film area, while mixing, to prevent leakage ➢ Any clumps are broken up and no longer visible on the 2. With the film side up, loosely hold the reagent pack at each end bottom of the pack 3. Raise one end of the pack 90◦ to its vertical position ➢ No large aggregates are visible floating inside the pack 4. Return the pack to a horizontal position 8. Mix 5–10 times more to ensure complete mixing 5. Raise the other end of the pack 90◦ again to its vertical position 9. If the reagent pack is pierced, remove the self-sealing laboratory film NOTE: If foam appears inside the pack, use a slower mixing speed. 10. Load the reagent pack onto the analyzer 3 4 SIEMENS ND RxOnly Heolthineers Atellico" IM For USA RxOnly T4 Far in vitro diagnostic ane is the partfalse delamirando of Itjaine | Tal in human terum asing For Piolosnione Chus Containsct te Reagent 100 ml. Soit Phase 25 DeL Viso .. 7 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Direct Load SIEMENS Reagent Management Healthineers Loading IM Reagent Packs – Primary and Ancillary 1. Ensure the system is in the Ready or Inprocess state 3. Insert any combination of up to 5 primary or ancillary 2. Manually mix primary reagent packs and open the reagent packs. Ensure the top barcode is on the right reagent drawer side of the drawer and each pack is well-seated in the slot 4. Close the reagent drawer *This procedure is continued on the next slide. 2 3 e 8 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Direct Load SIEMENS Reagent Management Healthineers Loading IM Reagent Packs – Primary and Ancillary (continued) 5. When the reagent tray drawer closes, the gripper 6. Review the Reagent Loader screen and resolve any scans the packs and automatically loads valid packs loading issues that may occur HEMENS P-P1-04 Grolthingers Atellico" Solution Version 1.14.0.2974006 K System Inventory Patient Orders Maintenance Reagent Overview Reagent Leader Reagent Needs Supplies Overview Reagent Lot Comparison Caf-GC Soorage Inventory Caf-QC Needs P1-06 Reagent Drawer 1 2 Loader Status 3 ENS Healthineers IVD Atellico" IM For USA T4 For in vitro diagnostic use in the quantitative RxOnly -- y determination of thyroxine (T4) in human serum using the AtellicaTM IM Analyzer. Reagent Inventory For Professional Use ¥150 ... Contains: Lite Reagent 10.0 ml: Solid Phase 25.0 ml Readypack" Reagents Reagents ft 5 LOT 100 24 Empty DEAWM 100 Tests 2010-11-21 OBS 30 Days 2 Hours Manual Entry Cheat A ? PEP Wednesday, June 06. 2018 1 38 PM 9 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Direct Load SIEMENS Reagent Management Healthineers Unlocking the IM Reagent Drawer MAMANS Healthingers Atellica Solution Version 1.14.0.2974006 P.P1-04 1 The IM Reagent drawer will be locked if the loader is in Cyctom Camplos Inventory Calibration Cc Pationl Orders Workick Maintenants Gotup Reagint Overview 2 Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-CC Storage Invernory Ca-QC Needs the process of loading or unloading reagents. Opening P1-06 the reagent tray drawer during the loading process halts Reagent Drawer the loader and moves the reagent tray back to the loading area. If the operator unlocks the reagent drawer when packs are loading, the in-process pack loads, the 2 remaining packs cancel, and the drawer unlocks. 3 Unlock Drawer Univer et closed Loader Statue 3 To Unlock the IM Reagent Drawer: 1. From the Primary Display, select Inventory 2. Select Reagent Loader Reagent Inventory 5 Reagents Ancilary Reagen's 0 Enpty 24 Empty 3. Select Unlock Drawer 42 1 Use Manual Entry Clear All ? 8 LabManager 508 Wednesday, June 00, 2018 1:38 PM4 10 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Direct Load SIEMENS Reagent Management Healthineers Manually Entering IM Reagent Pack Barcode Data SIEMENS ... Healthineers AtellicaTM Solution Version 1.11.0.2748003 PU4 1 The operator can manually enter barcode data if needed. System Samples Inventory Calibration cc Patient Orders Workiet Maintenance Setup Reagent Overvien 2 Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Ca-QC Needs To Manually enter a reagent barcode: P1-06 P1-06 Reagent Drawer 1. On the Command bar, select Inventory 2. Select the Reagent Loader tab 2 Enter or scan the reagent pack barcode for reagent position: 5 5 Type Primary O Ancillary 4 8 9 Unlock Drawer 3. Select Manual Entry Urawer is closed 5 Barcode 07016910012004 Verify 5 6 Loader Statue 3 4. Select the pack type. Note, humidity packs are ancillary pack type 7 Assay aHAVM 6 2018-11-21 2 3 DO 5. Enter the barcode number: 8 CK Cancol Supplies Overview 7 2. Select the IM analyzer 3. Determine the system fluids that require replacement 4. Select Replace System Fluids 5. Open the system fluids drawer 6. Locate and tighten the cap of the system fluid container to be removed SIEMENS TD IM Wash 3.0 1. 7. Remove the appropriate system fluid container AN .... [c] 11098501 279741 2016-09-21 *This procedure is continued on the next slide. 19 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Direct Load SIEMENS Supply Management Healthineers Replacing IM System Fluids Using the Handheld Scanner (continued) 9 7 8. Discard the system fluid container according to laboratory protocol 9. Scan the new fluid container using the barcode on the front SIEMENS Healthineers label Atellica" IM IM Cleaner 10. Ensure the analyzer displays the correct Lot, Sequence, and 1.5L Expiration under the appropriate fluid LG1] *2 ** 000008 7794 9 11. Select Save *This procedure is continued on the next slide. NOTE: If replacing the IM Wash the operator will have to select the container location after scanning the fluid container. NOTE: Do not load the same system fluids container multiple times. Removing and reloading a system fluid container can cause the punctured membrane to leak. Load only new and unused containers on the analyzer. 20 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Direct Load SIEMENS Supply Management Healthineers Replacing IM System Fluids Using the Handheld Scanner (continued) 12. 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 container, do not insert container at an angle. 13. 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. 21 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Direct Load SIEMENS Supply Management Healthineers Replacing IM System Fluids Using the Handheld Scanner (continued) 14. 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 15. Close the system fluid drawer 22 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Direct Load SIEMENS Supply Management Healthineers Emptying the IM Sample Tip Tray Waste 1. On the Command bar, select Inventory 2. Select Supplies Overview 3. Select Open Tip Tray Waste Drawer > Yes 4. Open the solid waste door 4 *This procedure is continued on the next slide. Waste Status Cuvette and Tip Waste OK Tip Tray Waste OK 3 Open Tip Tray Waste Drawer Liquid Waste OK Monday, October 02, 2017 11:15 AM 23 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Direct Load SIEMENS Supply Management Healthineers Emptying the IM Sample Tip Tray Waste (continued) 5. Pull open the sample tip tray waste drawer 7. Close the sample tip tray waste drawer 6. Remove the empty sample tip trays 8. Select Yes to the message "Did you empty the Sample Tip Tray waste area?“ 5 6 O 24 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Direct Load SIEMENS Supply Management Healthineers Emptying the IM Solid Waste – Cuvettes and Sample Tips 1. Open the solid waste door 4. Return the bins to the solid waste drawer 2. Pull out the solid waste drawer and remove the solid 5. Push the drawer in and close the door waste bins 6. To confirm the cuvette and sample tip waste is empty, 3. Empty the contents of the solid waste bins into a select Yes on the Primary Display laboratory-approved container for biohazardous waste 25 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 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 2020 Global Siemens Healthineers Headquarters Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84 0 siemens.com/healthineers 26 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020

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