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

SIEMENS Healthineers Atellica® IM Analyzer with Sample Handler 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 Sample Handler SIEMENS Reagent Management Healthineers Reviewing Reagent Inventory SIEMENS Healthineers Atellica Solution Version 1.14.0.2975003 P-P1-04 1 The Reagent Overview screen allows the operator to review System Samples Inventory Calibration OC Patient Orders Worklist Maintenance Setup the status of onboard reagents. 2 Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs 3 1A00104 To view reagent inventory: Reagents 4 CM00113 00109 Reagent Details Reagent Inventory Onboard Sequence Calibration Calibration Cal Type In QC Stability Status Interval Use Status Lot Cal Eligibility 014063 1. On the Command bar, select Inventory RgtBA Name ThCG 4.90 mL 000165 0719 Lot ID 991 TSH3UL 37 54 d 21 h 001050 21 d 23 h Lot 313 Pack Pack Location IM reagent compartment 2. Select the Reagent Overview tab Position 61 TSH3UL 120 54 d 21 h 001051 21 d 23 h Lot 313 Pack Count 86 ThCG Select the IM analyzer icon to view the IM reagents 20 d 21 014060 27 d 22 h 991 3. 86 Pack Lot and Pack OBS 6/25/2018 11:00:00 AM Calibration Expiration 7/2/2018 12:01:06 PM ThCG 82 20 d 21 h 01406 27 d 22 h Pack 991 Lot and Pack Pack Status To sort, select a column heading: 5 4. ThCG 86 20 d 21 h 014063 27 d 22 h Pack 991 Lot and Pack Calibrate Lot Calibrate Pack Tnt_UL 89 56 d 23 h 034282 1 d 10h Lot 991 Pack ➢ Inventory: to bring reagents that are empty or Tnl_UL 90 56 d 23 h 034283 1 d 10 h Lot 991 Pack running low to the top of the screen Tnl_UL 0 54 d 21 h 034286 1 d 10 h Lot 991 aHAVM 94 29 d 22 h 000229 16 d 22 h Lot 177 ➢ Calibration Status: to bring reagents that have an aHAVMA 14.10 ml 30 d 14 h 001099 3329 Refresh Edit invalid calibration or have not been calibrated to the Group by reagent Disable Reagent Pack Disable Reagent Lot Unload Unload Immediately top of the screen ? PER ES LabManager Monday, June 04, 2018 1:09:15 PM ➢ Calibration Interval: to bring the reagents that have a 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: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM 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, 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 A00104 calibration on that reagent pack COUTTS 00109 Reagents Reagent Details 7. There are options at the bottom of the screen to disable Reagent Inventory Onboard QC Stability Sequence Calibration Calibration Cal Type In Status Interval Use Status Lot Cal Eligibility 014063 RgtBA Name ThCG 4.90 mL - 000165 - 0719 a selected reagent pack, to disable an entire reagent lot, Lot ID 991 TSH3UL 37 54 d 21 h 001050 21 d 23 h Lot 313 Pack Pack Location IM reagent compartment Position 61 or to manually unload a reagent pack TSH3UL 120 54 d 21 h 001051 21 d 23 h Lot 313 Pack Count 86 ThCG 20 d 21 014060 27 d 22 h Pack 991 Lot and Pack OBS 6/25/2018 11:00:00 AM 86 Calibration Expiration 7/2/2018 12:01:06 PM ThCG 82 20 d 21 h 01406 27 d 22 h Pack 991 Lot and Pack Pack Status 6 ThCG 86 20 d 21 h 014063 27 d 22 h Pack 991 Lot and Pack Calibrate Lot Calibrate Pack Tnt_UL 89 56 d 23 h 034282 1 d 10h Lot 991 Pack Tnl_UL 90 56 d 23 h 034283 1 d 10 h Lot 991 Pack Tnl_UL 54 d 21 h 034286 1 d 10 h Lot 991 o aHAVM 94 29 d 22 h 000229 16 d 22 h Lot 177 aHAVMA 14.10 ml 30 d 14 001099 3329 Refresh Edit Group by reagent 7 Disable Reagent Pack Disable Reagent Lot Unload Unload Immediately ? PER 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 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: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM 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 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 Sample Handler 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 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 Sample Handler 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 NOTE: If foam appears inside the pack, use a slower mixing speed. laboratory film 10. Load the reagent pack onto the analyzer 3 4 IND RxOnly For USA RxOnly Fit in vero diagnostic use inthe quantitaties T4 the Nunca". MAralytel For Profession Che Containa: Lito fisacoct 10 DmL: Spat Phase 25 0 ml ReadyPack" FU USA T4 7 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Sample Handler 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 the pack is well-seated in the slot 4. Close the reagent drawer *This procedure is continued on the next slide. 2 3 . 8 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Sample Handler 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 SIEMENS Reagent Loader LabManager Off 1 Reagent Drawer 2 Unlock 3 SIEMENS Healthineers IVD Atellico" IM Clear All T4 For USA For in vitro diagnostic use in the quantitative RxOnly determination of thyroxine (Ta) in human serum using zc4 the Atellica " IM Analyzer V150 ... For Professional Use 4 Contains: Lite Reagent 10.0 ml; Solid Phase 25.0 ml ft Manual Entry 5 ? 9 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Sample Handler SIEMENS Reagent Management Healthineers Unlocking the IM Reagent Drawer SIEMENS Reagent Loader The IM Reagent drawer will be locked if the loader is in the process LabManager Off of loading or unloading reagents. Opening the reagent tray drawer 1 Reagent Drawer during the loading process halts the loader and moves the reagent tray back to the loading area. If the operator unlocks the reagent 2 drawer when packs are loading, the in-process pack loads, the 2 Unlock remaining packs cancel, and the drawer unlocks. 3 To Unlock the IM Reagent Drawer: Clear All 4 1. From the Module Display, select Inventory > Reagent Loader Manual Entry 2. In Loader Status, select Unlock 5 ? 10 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Sample Handler SIEMENS Reagent Management Healthineers Rescanning or Manually Entering IM Reagent Packs From the Module Display The operator can manually enter barcode data, if needed. Manual entry of barcode data can be done from the Primary Display or the Module display. To rescan or manually enter a barcode from the Module Display: SIEMENS Healthineers Reagent Loader 1. To rescan a reagent pack: LabManager Stopped Enter or scan the reagent pack barcode for reagent position: 5 5 Type O Primary Ancillary A. Hold the reagent pack 150 mm (6 inches) at a 45◦ angle Barcode 00318015000390 Verity 5 under the module display barcode reader Assay 3 ? OK Cancel CE B. Ensure the correct information displays C. Place the reagent pack in the specified position 2. To manually enter a reagent pack: SEMENS Healthineers RxOnly A. From the Module Display select Inventory > Reagent Loader Abellico" IM T4 Vise. B. Select a reagent position =** C. Select Manual Entry D. Select a Type E. Enter the barcode number F. Select OK NOTE: The Pack Label is the number under the barcode on the reagent pack. When entered, it identifies the assay, lot and expiration date. 11 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Sample Handler SIEMENS Reagent Management Healthineers Loading IM Humidity Packs Humidity packs maintain reagent compartment humidity between To load humidity packs: 70–100%. The operator loads 7 empty humidity packs initially. The 1. Open the reagent drawer system automatically fills the packs with water during the daily maintenance procedure. The system monitors humidity in the 2. Insert 5 empty humidity packs reagent compartment and, if the humidity falls below 70%, may 3. Close the reagent drawer require up to 3 additional humidity packs for a total of 10. 4. To load 2 more packs, repeat steps 1-3 after the system finishes loading the first 5 humidity packs Humidity A78713658000058 12 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Sample Handler SIEMENS Reagent Management Healthineers Unloading IM Reagent Packs - Automatically MAMENS Healthingers Atellica" Solution Version 1.14.0.2974006 P-P1-0 A The system is configured to automatically send reagent System Samples Inventory Calibration Patient Orders Worklit Maintenance Setup B packs to the reagent drawer when the packs are empty or Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs P1-02 C expired. PIC2 Reagent Drawer The system will alert the operator that there are reagents waiting in the reagent drawer to be removed by displaying 2 an alert on the Inventory button in the Command Bar. Loader Status 1. To view the reagents that are waiting to be removed: 3 A. On the Command bar, select Inventory B. Select the Reagent Loader tab No Activity Reagent Inventory C. Select the IM analyzer icon 5 LOT Primary Reagents Ancillary Reagents 12 Empty 20 Empty AFP Depleted 2017-12-14 30 le Usie 13 in Use 2. Open the reagent drawer OBS 53 Days 0 Hours 3. Remove reagent packs from the reagent drawer Manual Entry Clear A ? PEP LabManager Wednesday, June 06, 2018 1:36 PM 4. Close the reagent drawer ➢ Once the drawer is closed, the analyzer scans the drawer and displays as all empty 13 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Sample Handler SIEMENS Reagent Management Healthineers Unloading IM Reagent Packs - Manually SIEMENS Healthingers Atellica Solution Version 1.14.0.2974006 P-P1-04 HHh 1 Reagent packs can be removed manually by the operator. System Samples Inventory Calbration Patent Orders Working Maintenance Schip 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 3 00109 the selected reagent packs, to complete before removal: 00100 Reagents Reagent Details Reagent Inventory Onboard Calibration Stability Sequence Calibration Cal Type Qc Lot Lot Expiration 013444 1. On the Command bar, select Inventory Status nterval Status Name ThCG TSH3U 56 43 d.7h 011810 6d2h Lot 303 3/12/2018 12:59:58 AM Lot ID 991 2. Select Reagent Overview TSHGU 110 44 05h 011839 6d2h Lot 303 3/12/2018 12: 59:58 AM Pack Location IM reagent compartment Position 19 4 THCG 743h 013444 odon Lot 991 8/23/2019 11:59:58 PM Count 90 Select the IM analyzer icon OBS 12/7/2017:11:00 AM 3. CEA 60 44 d 5h 999405 843h Lot 001 9/17/2018 11:59:58 PM Calibration Expiration 11/29/2017 11:43 AM CEA 47 4 3 h 999411 843h Lot 991 9/17/2018 11:59:58 PM Pack Status 4. Select the appropriate reagent packs CEA 58 4 3 h 999412 8d3h Lot 001 9(17/2018 11:59:58 PM Refresh Eat Dig 41 111934 27d8h Pack 11/19/2018 11:59:58 PM 5. Select Unload FSH 140 5d8h 000364 1107h Pack 209 12/15/2017 11:59:58 PM 6. Check the status of the appropriate reagent packs from FSH 186 6d7h 000365 11dah Pack 209 12/15/2017 11:59:58 PM F13 52 58 d 3 000977 26 d 9 h Pack 991 8/27/2018:11:59:58 PM the Reagent Loader screen FT3 56 44 d5h 000979 20 d 3 h Pack 901 8/27/2018 11:59:58 PM 7. Open the reagent tray drawer F13 44 39 0 9h 000981 26 d 3 h Packe 991 8/27/2018 11:59:58 PM 10000 0000000 Coup by reagent Disable Reagent Pack Disable Reagent Lot 5 Unload Unload Immediately 8. Remove the reagent packs from the reagent drawer ? PEP LabManager Wednesday, June 06. 2018 1 38 PM 9. If the reagent pack is pierced and intended for reuse, cover the pierced film area of the reagent pack with self- NOTE: Use Unload Immediately to stop processing and sealing laboratory film cancel tests associated with the selected reagent packs. 10. Store usable reagent packs according to the assay IFU 14 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Sample Handler SIEMENS Supply Management Healthineers Checking IM Waste and Supplies Status SIEMENS Healthingers Atellica Solution Version 1.14.0.2974006 P-P1-04 The system will alert the operator that supplies need 1 Symem Samples rivertory Calibration Patient Orders Worklet Maintenance to be replenished or waste is getting full by displaying Reagent Overview Reagent Leader Reagent Needs 2 Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs 3 00104 an alert on the Inventory button in the Command Bar. CMO0110 00104 A System Fluids Volume Status OBS Lot Expiration Lot Sequence Number To check the status of waste and supplies: V IMACid 10 OK 24d7h 26/2018 000008 0007 V IM Base OK 24d7h 2/6/2018 000008 0019 = 1. On the Command bar, select Inventory IM Cleaner On reserve 5d 16h 5/8/2018 000008 0070 2. Select Supplies Overview V IM Wash OK 26 d 16 h 9/23/2018 00028 1215 24 d 4h 9/23/2018 282482 1040 3. Select the IM analyzer icon Replace System Fluids 4. Check the status of the following: B Supplies Status C Waste Status 5 V Tps OK 2 Storage Locations Available 7 Tip Trays In Storage V. Cuvette and To Waste OK A. System Fluids V Cuvettes OK To Tray Waste OK Open To Tray Waste Drawer B. Supplies V Water OK Liquid Waste OK C. Waste 5. If appropriate, replace system fluids or supplies or ? PEP LabManager Wednesday, June 06. 2018 1 38 PM empty the waste 15 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Sample Handler SIEMENS Supply Management Healthineers Checking IM Waste and Supplies Status (continued) Glyph System Fluids Cuvettes Sample Tips Cuvette and Sample Tip Waste Sample Tip Tray Waste Supply level out Supply level out Supply level out Waste level full Waste level full AND there are OR no sample tips remaining in the There is only enough current sample tip tray fluid in the reservoir to process the aspirated tests The bulk system fluid Supply drops below There are less than 120 tips Cuvette Waste or Sample Tip Sample Tip Tray Waste is bottle is empty and the the bin sensor onboard Waste is greater than or equal greater than or equal to 90% of system is using the OR to 90% of its capacity its capacity reservoir The strap was not removed OR OR OR from a tip tray that is The waste status is OK AND the The waste level is full AND The lot or onboard loaded on the system operator removes waste bin there are sample tips stability will expire in remaining in the current less than 48 hours sample tip tray V Supply level OK Supply level OK Supply level OK Waste level OK Waste level OK 16 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Sample Handler SIEMENS Supply Management Healthineers Checking IM Waste and Supplies Status (continued) LabManager Off In addition to the Primary Display, the waste and supplies status can also be viewed on the Module Tips Display. Packs Available for Loading Ok To view the Supplies Status on the Module Display: Tips Trays in Storage: 12 1. From the Module Display select Supplies Cuvettes 2. Review the status of each supply Supplies Ok Water V Ok ? 17 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Sample Handler SIEMENS Supply Management Healthineers Checking IM Waste and Supplies Status (continued) LabManager Off To view the waste status on the Module Display: 1. From the Module Display select Waste Cuvette and Tip Waste 2. Review the status of the waste Ok Waste Tip Tray Waste Ok Open Tip Tray Waste Drawer Liquid Waste V Ok ? 18 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Direct Load SIEMENS Supply Management Healthineers Replacing IM Cuvettes 1. Open the cuvette bin lid NOTE: Do not push down the cuvettes, remove the plastic divider, push 2. To open the cuvette packaging, use scissors to ensure that plastic bag cuvettes to the right side of the bin, or overfill the bin enough to prevent the fragments do not drop into the cuvette bin that could cause jams cuvette lid from fully closing. Performing any of these can cause a cuvette jam. 3. Pour cuvettes into the cuvette bin up to the brim in the left side of the cuvette bin Plastic Divider 4. Close the cuvette bin lid Left Side of Right Side of Cuvette Bin Cuvette Bin 19 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Sample Handler SIEMENS Supply Management Healthineers Replacing IM Sample Tips NOTE: Wear new, uncontaminated gloves when handling sample 4. Twist then pull the tab down and out to release the strap from tips to prevent cross contamination. the trays 1. Open the sample tip loading lid 5. Pull the strap out to remove it from the bundle. Note: Leave 2. Remove the protective cover from the sample tip tray bundle the top on the upper trip tray 3. Install the sample tip trays ensuring that the tab is facing the 6. After the analyzer lowers the bundle into the tip tray storage opening on the right and the rounded notches in the trays are area, close the sample tip loading lid facing the back of the system 2 3 4 20 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Sample Handler SIEMENS Supply Management Healthineers Replacing IM System Fluids Using the Module Display 1. Open the system fluids drawer HealthMENS System Fluids ➢ The System Fluids screen will display on the module display 3. IM Wash Select the container location Let 2. Locate and tighten the cap of the system fluid container to be Right removed ? OK Cancel IM Wash 3. Remove the appropriate system fluid container 4. Discard the system fluid container according to laboratory SIEMENS TD 3.0 L IM Wash 2017-09-23 282482 11098501 protocol 5. Using the module display, scan the new fluid container using the barcode on the front label. To scan the new fluid container: A. Hold the container 150 mm (6 inches) at a 45 ◦ angle under the module display barcode reader B. Ensure the module display shows the correct Lot and Lot Expiration under the appropriate fluid 6. Select OK *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. 21 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Sample Handler SIEMENS Supply Management Healthineers Replacing IM System Fluids (continued) 7. Holding the new system container vertically with the septum facing down, firmly insert the container straight down into 8 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. 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. 22 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Sample Handler SIEMENS Supply Management Healthineers Replacing IM System Fluids (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 23 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Sample Handler SIEMENS Supply Management Healthineers Emptying the IM Sample Tip Tray Waste 1. On the module display, select Open Tip Tray Waste Drawer > Yes 2. Open the solid waste door *This procedure is continued on the next slide. 2 SIEMENS Waste ¿ LabManager Off Cuvette and Tip Waste V Ok Tip Tray Waste V Ok 1 Open Tip Tray Waste Drawer Liquid Waste V Ok ? 24 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Sample Handler SIEMENS Supply Management Healthineers Emptying the IM Sample Tip Tray Waste (continued) 3. Pull open the sample tip tray waste drawer 5. Close the sample tip tray waste drawer 4. Remove the empty sample tip trays 6. Select Yes to the message "Did you empty the Sample Tip Tray waste area?“ 3 4 O 25 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® IM Analyzer with Sample Handler 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 to “Did you empty the Sample Tip Tray waste laboratory-approved container for biohazardous waste area?” 2 26 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 27 Effective Date: 13-SEP-2020 | HOOD05162003119956 Unrestricted © Siemens Healthcare GmbH, 2020