PEPconnect

Atellica® IM Analyzer Calibration 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® IM Analyzer Calibration PEP to Go Effective Date: 11/12/2018 | HOOD05162002965558 Unrestricted © Siemens Healthcare GmbH, 2018 Atellica® IM Analyzer SIEMENS Calibration Healthineers IM Assay Reagent Calibrations • The system uses a Master Curve and a 2-point, automatic, or operator initiated calibration to calibrate qualitative and quantitative tests. Using a Master Curve and 2-point assay reagent calibration eliminates the need to measure a full standard curve or to include a calibration each time the system performs a test • The calibration interval is assay-specific. Refer to the assay-specific Instructions For Use document (IFU) for the calibration interval Master Curve: • Generated during the manufacturing process using reagents from a specific lot by performing the test on standards of varying concentrations on multiple systems over several days • Determines the relationship between the defined analyte levels and the measured relative light units (RLUs) • Encoded in a 2D barcode on the lot-specific Master Curve and Test Definition (MC TDEF) sheet 2 Effective Date: 11/12/2018 | HOOD05162002965558 Unrestricted © Siemens Healthcare GmbH, 2018 Atellica® IM Analyzer SIEMENS Calibration Healthineers IM Calibration Acceptance Criteria The IM Analyzer uses the following criteria to evaluate calibrations: • Slope • Ratio • Low Cal Deviation • High Cal Deviation Defined IM Assay Reagent Calibration Ranges The Master Curve and Test Definition (MC TDEF) 2D barcode includes the defined ranges for the IM calibration acceptance criteria. Observed IM Assay Reagent Calibration Ranges • After performing 4 valid calibrations for a new reagent lot and calibrator lot combination, the IM Analyzer calculates observed ranges for the acceptance criteria • The system compares results from subsequent calibrations using the same reagent lot and calibrator lot combination to the defined ranges from the Master Curve definition and to the observed ranges the system calculates • Observed ranges are specific for the system and are narrower than the defined ranges • If a calibration result falls outside of the observed range, but within the defined range, the calibration status will be “Awaiting Acceptance”. On the Calibration Results screen, the operator can select to Accept or Reject the calibration 3 Effective Date: 11/12/2018 | HOOD05162002965558 Unrestricted © Siemens Healthcare GmbH, 2018 Atellica® IM Analyzer SIEMENS Calibration Healthineers IM Assay Reagent Calibration Workflow 1. Ensure the following items are on the system: Assay master curves and test definitions – Calibrator definitions (for more information, refer to the Atellica® Solution Calibration training topic) – Assay reagents (for more information, refer to the Atellica IM Analyzer Supply and Reagent Management training topic) – 2. Confirm the system is in 1 of the following states: (for more information, refer to the Atellica Solution Software Overview training topic) Ready – Standby – Processing – 3. Prepare the calibrator samples according to the calibrator Instructions for Use (IFU) 4. Create a calibration order (for more information, refer to the Atellica Solution Calibration training topic) 5. Print the calibrator sample barcodes and place the barcode labels on the appropriate calibrator sample tubes (for more information, refer to the Atellica Solution Calibration training topic) 6. Place the calibrator samples in a sample rack and load the rack on the system (for more information, refer to the Atellica Solution Calibration training topic). To process immediately, load calibrator samples in a STAT rack 7. Review the calibration results (for more information, refer to the Atellica Solution Calibration training topic) 4 Effective Date: 11/12/2018 | HOOD05162002965558 Unrestricted © Siemens Healthcare GmbH, 2018 Atellica® IM Analyzer SIEMENS Calibration Healthineers Scanning IM Master Curve and Assay Test Definition 2D Barcodes • Each IM assay reagent kit includes a Master Curve and Test Definition (MC TDEF) 2D barcode • The MC TDEF insert can have 1 or more 2D barcodes SIEMENS Heolthineers Atellica Solution Version 1.14.0.2951003 P-P1-03 • The MC TDEF barcode(s) must be scanned when a 2 System Samples Calibration Patient Orders Workkst Maintenance Setup new lot of reagent is loaded on the system 3 Test Definition Settings Accounts Assay List Fiber Lots .. To scan the MC TDEF barcode(s): CH Test Definition Test- Definition Calculation Calibration Ranges ... 4 Test Identification Advanced 1. Ensure the analyzer is in one of the following states: IM Test Definition AFP Test Name:D AFP Replicates Acceptable CV % Reflex Group Setup aHAVM Patient 0.00 Ratios, Panels, and Off- Ready, Standby, Stopped, Startup, or Warming up System AHBOM Test Type Standard Control 0:00 Repeat Conditions Test Display Order BNP Test Version 1 1 Overdilution Point 15 Reset Defaults 2. At the Command Bar, select Setup CA125 Display Name AFP Open Channel CA19 Print Name AFP Specimen Type Serum;Amniotic Fluit Select the Test Definition tab Sont Test Definition CEA LIS Code AFP Compatibility Code 1 3. Cont LOING Minimum SW Version 1 Dig Stahas Released 4. Select IM Test Definition EHY Fer General Anonymous 5. Select Scan Barcodes FSH F13 Result Review Mode None Centrifuge before Repeating FT4 Reuse Result for Ratio 6. Scan the first 2D barcode Control bracketed Test HBs Result Tiene Lienit hours Levels 4 - Bracket Timeout (>tours) |24 - Reminder Boura), 0- Rg:42 Analyte Stabaty minutes 7. Scan the remaining 2D barcodes in consecutive order Ro:82 5 8 • The barcode scanner audio confirms successful Scan Barcodes Savr Carical scans ? Back LabManager Tuesday, Apri 17, 2018 2:16 PM 8. Select Save NOTE: Do not scan the linear barcode on the bottom of the MC TDEF insert, if present. The linear barcode is for manufacturer use only. 5 Effective Date: 11/12/2018 | HOOD05162002965558 Unrestricted © Siemens Healthcare GmbH, 2018 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 2018 Global Siemens Healthineers Headquarters Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84 0 siemens.com/healthineers 6 Effective Date: 11/12/2018 | HOOD05162002965558 Unrestricted © Siemens Healthcare GmbH, 2018