Atellica® CH Analyzer Calibration PEP to Go Version 1.25 and Below

SIEMENS Healthineers Atellica® CH Analyzer Calibration PEP to Go Effective Date: 11/12/2018 | HOOD05162002965558 Unrestricted © Siemens Healthcare GmbH, 2018 Atellica® CH Analyzer SIEMENS Calibration Healthineers CH Assay Reagent Calibrations • Calibration establishes the relationship between the system response (absorbance values) and reported results (concentration) for a given assay • The relationship is determined by measuring the absorbance of a material with known concentrations (or levels) of the analytes for the assay Types of assay reagent calibrations on the CH Analyzer:  Linear CH Assay Reagent Calibrations: Generate a 2-point calibration curve by using 2 to 3 calibrator levels that span the analyte measurement range –  Nonlinear CH Assay Reagent Calibrations: Generate a complex calibration curve by using up to 6 multiple calibrator levels that span the analyte measurement range – Use 1 of 2 different types of calibrator kits: – o Multiple calibrator kit: contains vials of increasing analyte concentration. Level 1, or blank, contains the lowest concentration of analyte in the kit. Levels 2 to 6 increase in concentration. The level 1 can be one of the following:  CH Diluent (reagent blank)  Calibrator material o Single calibrator kit: contains 1 vial of concentrated analyte. For multi-level calibrations using a single calibrator, the system dilutes the concentrated calibrator with saline to make multi-level calibrator samples. If the assay calibration requires a blank, the system uses CH diluent or an assay-specific material that the calibrator lot-specific value sheet specifies 2 Effective Date: 11/12/2018 | HOOD05162002965558 Unrestricted © Siemens Healthcare GmbH, 2018 Atellica® CH Analyzer SIEMENS Calibration Healthineers CH Assay Reagent Calibration Workflow 1. Ensure the following items are on the system: Assay test definitions – • Navigate to Setup > Test Definition > CH Test Definition • To confirm a test definition exists for an assay, locate and select the assay from the Assay list Calibrator definitions (for more information, refer to the Atellica® Solution Calibration training topic) – Assay reagents (for more information, refer to the Atellica CH 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 3 7. Review the calibration results (for more information, refer to the Atellica Solution Calibration training topic) Effective Date: 11/12/2018 | HOOD05162002965558 Unrestricted © Siemens Healthcare GmbH, 2018 Atellica® CH Analyzer SIEMENS Calibration Healthineers C0 Adjust Pack Calibrations The CH Analyzer supports 2 types of pack calibrations:  Full – multiple calibrator levels are used  C0 Adjust – only a low level calibrator is used o For Siemens assays that use C0 Adjust pack calibrations, CH Diluent is used as the calibrator o For open channel assays that use C0 Adjust pack calibrations, either a zero level calibrator or CH Diluent is used as the calibrator The CH assay test definition specifies the type of pack calibration an assay requires. Only certain assays use C0 Adjust pack calibrations. For assays that use C0 Adjust pack calibrations:  When the system alerts that a pack calibration is needed because the previous pack calibration has expired, and the operator orders a pack calibration, the system will perform a C0 Adjust pack calibration. For Siemens assays, the operator does not need to load calibrator samples in this case because the system automatically uses CH Diluent  When the system alerts that a pack calibration is needed because the previous lot calibration has expired, and the operator orders a pack calibration, the system will perform a full pack calibration. The operator must load the appropriate calibrator level samples 4 Effective Date: 11/12/2018 | HOOD05162002965558 Unrestricted © Siemens Healthcare GmbH, 2018 Atellica® CH Analyzer SIEMENS Calibration Healthineers IMT Calibrations  The CH Analyzer uses a 2-point calibration to automatically calibrate the IMT subsystem in the following situations: • System startup • After a reset from a paused or stopped state • 4-hour intervals • After 250 tests have been completed since the last calibration • A-LYTE® multisensor temperature changes outside of specifications • IMT successful error recovery • IMT cleaning procedure • A-LYTE multisensor, Standard A, or Standard B replacement  The operator can also manually calibrate the IMT subsystem if needed during troubleshooting  The materials used for IMT calibration are the IMT fluids (Standard A and Standard B)  During IMT calibrations, the system does not process IMT tests 5 Effective Date: 11/12/2018 | HOOD05162002965558 Unrestricted © Siemens Healthcare GmbH, 2018 Atellica® CH Analyzer SIEMENS Calibration Healthineers Viewing IMT Calibrations 1. On the Command Bar, select Calibration SIEMENS. 2. Select the IMT Calibration tab Healthineers Atellica Solution Version 1.16.0.3124001 GGSWSH 1 3. View results System Samples Inventory Calibration QC Patient Orders Worklist Maintenance Setup Calibration Overview Create Calibration Orders 2 Calibration Results Calibrator Definitions IMT Calibration IMT Calibration Error at: 10/01/2018 10:18:36 PM GGSWCC13 Calibrate IMT lon Slope STD A STD B Slope Ranges V Na+ 59.02 2.9199 mV -14.4271 mV 50 to 63 K+ 15.35 -33.2082 mV 51.2559 mV 50 to 63 CI- Chloride drift exceeded threshold 83.08 54.0064 mV 69.5494 mV -60 to -40 value V Air Reading 1.2V 1.2 V V Liquid Reading 0.23 V 0.234 V V IMT Pumping Rate 30.03 ul per Revolution Errors First STD A STD B Second STD A Chloride drift exceeded threshold value IMT Status IMT Calibration Completed 6 Effective Date: 11/12/2018 | HOOD05162002965558 Unrestricted © Siemens Healthcare GmbH, 2018 Atellica® CH Analyzer SIEMENS Calibration Healthineers Manually Calibrating IMT The system will automatically calibrate the IMT. If there is a need to manually calibrate: 1. On the Command Bar, select Calibration 2. Select the IMT Calibration tab SIEMENS Healthineers Atellica Solution Version 1.16.0.3124001 P-P1-04 3. Select Calibrate IMT 1 System Samples Inventory Calibration QC Patient Orders Worklist Maintenance Setup Calibration Overview Create Calibration Orders Calibration Results Calibrator Definitions 2 IMT Calibration C-P1-05 IMT Calibration completed at: 10/29/2018 2:56 PM 3 Calibrate IMT lon Slope STDA STD B Slope Ranges V Na+ 60.86 29.5482 mV 11.6402 mV 50 to 63 V K+ 60.95 -64.3556 mV 7.2439 mV 50 to 63 V CI- -51.37 61.4375 mV 51.8696 mV -60 to -40 V Air Reading 0.9166 V 1.0468 V V Liquid Reading 0.1336 V 0.1179 V V IMT Pumping Rate 53.93 ul per Revolution IMT Status IMT Calibration Completed 7 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 8 Effective Date: 11/12/2018 | HOOD05162002965558 Unrestricted © Siemens Healthcare GmbH, 2018