Dimension® Systems User-Defined Methods Online Training

Continue Continue Untitled Scene Master Template HOOD05162003052540 | Effective Date: 26-Nov-2019 ? Dimension® Systems User-Defined Methods Online Training Learn how to configure methods that are not currently marketed by Siemens Healthineers Define customer responsibilities related to User-Defined Methods Enter User-Defined method parameters Program the Dimension® System to calculate results List the steps to implement and create User-Defined Methods 1 4 3 2 5 Fill and load the Flex® reagent cartridge Welcome Welcome to the Dimension Systems User-Defined Methods Online Training. In this course you will learn how to configure methods that are not currently marketed by Siemens Healthineers. This course will cover the following 5 learning objectives. ? Customer Responsibilities The User-Defined Method feature on a Dimension System allows you to define your own assays using reagents that are not purchased from Siemens Healthineers When implementing a User-Defined Method, you are responsible for: Selecting proper reagents Entering test parameters Using proper test protocols Determining the correctness of results Resolving any associated errors or omissions Customer Responsibilities The User-Defined Method feature on the Dimension Systems allows you to define your own assays using reagents that are not purchased from Siemens Healthineers. When implementing a User-Defined Method, you are responsible for selecting the proper reagents, entering test parameters and using the proper test protocols. You are also responsible for the correctness of the test results and any associated errors or omissions. Siemens Healthineers does not manufacture the reagents that are utilized in the User-Defined Flex reagent cartridge. Therefore, the Dimension System warranties do not extend to the performance of User-Defined reagents. ? Implementing User-Defined Methods Overview To implement a User-Defined Method: Enter assay reaction parameters Program the User-Defined calculations Accept the template Store and print the assay reaction parameters and calculation routine Enter the User-Defined method parameters Fill and load a Flex® reagent cartridge Calibrate the assay Run QC samples Run patient samples Select the numbered steps below to learn about implementing User-Defined Methods 1 1 1 2 2 2 3 3 3 4 4 4 5 5 5 6 6 6 7 7 7 8 8 8 9 9 9 Implementing User-Defined Methods Overview dimension_userdefinedmethods_overview.mp3 Base Layer: The User-Defined Methods feature is an advanced function that allows you to define methods which use reagents and methods that are not currently marketed by Siemens Healthineers. Up to 15 User-Defined Methods can be defined and stored in the Dimension EXL with LM System and Dimension EXL 200 System software. Up to 10 User-Defined Methods can be defined and stored in the RXL Max System and Xpand/Xpand Plus System software. Select the numbered steps below for an overview of how to implement User-Defined Methods. 1. Enter Assay Reaction Parameters: After signing into the Dimension System software, on the User-Defined Method screen, identify the method and enter the assay reaction parameters including reagent and sample deliveries, photometry reading times and Flex reagent cartridge configuration. Configure the Continuous Cuvette feature and Weighted Calibration option for User-Defined Methods on the User Defined Secondary menu, as needed. Validated application sheets are located on the Siemens Document Library 2. Program the User-Defined Calculations: For each method, program the User-Defined calculations on the User-Defined Method Template screen. You can program single-point, two-point and three-point calculations 3. Accept the Template: After programming the User-Defined calculations on the User-Defined Method Template screen, select F4: ACCEPT to accept the template The User-Defined Method: Multipoint MAU Calculation screen appears with the calculation in acceptable programming terms 4. Store and Print Assay Reaction Parameters and Calculation Routine: After programming, return to the first User-Defined Method screen. Select F4: STORE to store the method reaction parameters Select F8: PRINT to print the parameters 5. Enter the User-Defined Method Parameters: Enter the method parameters for all User-Defined Methods before loading a User-Defined Flex reagent cartridge onto the Dimension System or running a sample. These are different parameters than were entered on the User-Defined Method screen and provide Dimension System assay-specific information, some of which is included in the results report. The procedure for entering method parameters for User-Defined Methods is the same as for Siemens Healthineers methods. 6. Fill and Load a Flex Reagent Cartridge: After entering the method parameters, fill an empty, vented six-well Flex reagent cartridge for User-Defined Methods with your own reagents. Load it onto the Dimension System following the same process for manually entering a reagent cartridge barcode 7. Calibrate the Assay: Calibrate User-Defined Methods following the same process for calibrating Siemens Healthineers methods. You are responsible for determining how often calibration must be performed 8. Run QC Samples: Order a quality control test for a User-Defined Method following the same process for Siemens Healthineers methods Determine the quality control products to be used and how often to use them 9. Run Patient Samples: You can request and process User-Defined Methods along with Siemens Healthineers methods in random, batch or panel modes Refer to the User Defined Keystrokes in the Operator’s Guide to request a User-Defined Method. These keystrokes may be different on the analyzer if these methods were programmed to other keys. Be sure to enter the method parameters before running a sample with a User-Defined Method Select the X in the upper right corner to continue. 9. Run Patient Samples Request and process User-Defined Methods along with Siemens Healthineers methods in random, batch or panel modes* Refer to the User Defined Keystrokes in the Operator’s Guide to request a User-Defined Method. These keystrokes may be different on the analyzer if these methods were programmed to other keys *Note: Be sure to enter the method parameters before running a sample with a User-Defined Method 9 8. Run QC Samples Order a quality control test for a User-Defined Method following the same process for Siemens Healthineers methods 8 7. Calibrate the Assay Calibrate User-Defined Methods following the same process for calibrating Siemens Healthineers methods 7 6. Fill and Load a Flex Reagent Cartridge Fill an empty, vented six-well Flex reagent cartridge for User-Defined Methods with your own reagents 6 5. Enter the User-Defined Method Parameters Enter the following information on the System Configuration screen for the method to operate: Reference interval Assay range Calculation type C terms Lot number 5 4. Store and Print Assay Reaction Parameters and Calculation Routine Return to the first User-Defined Method screen and select F4: STORE to store the method reaction parameters Select F8: PRINT to print the parameters 4 3. Accept the Template Select F4: ACCEPT to accept the template 3 2. Program the User-Defined Calculations Program the User-Defined calculations for each method on the User-Defined Method Template screen 2 1. Enter Assay Reaction Parameters On the User-Defined Method screen enter the following from the Assay Application sheet: Identify the method Define reagent and sample deliveries Define the photometry reading times Define the Flex reagent cartridge configuration Configure the Continuous Cuvette feature and Weighted Calibration option for User-Defined Methods as needed 1 ? Entering Assay Reaction Parameters In this video you will learn how to: Enter assay reaction parameters for the User-Defined Method Program the user defined calculations from the application sheet using a pre-defined template Store the assay reaction parameters and calculation routine Start Entering Assay Reaction Parameters In this video, you will learn how to program the analyzer to calculate results for the User-Defined Method using the data from the Assay Application sheet. Select the button to begin. ? Entering User-Defined Method Parameters Enter the method parameters for all User-Defined Methods before loading a User-Defined Flex reagent cartridge onto the Dimension System or running samples Enter information in these areas for the method to operate: Reference interval Assay range Calculation type C terms Lot number Start Entering User-Defined Method Parameters Enter the method parameters for all User-Defined Methods on the Method Parameters screen before loading a User-Defined Flex reagent cartridge onto the Dimension System or running samples. These are different parameters than were entered on the User-Defined Method screen and provide Dimension System assay-specific information, some of which is included in the results report. These parameters include linear range, reference range, auto-dilution volume, CO, C1 and more. The procedure for entering method parameters for User-Defined Methods is the same as for Siemens Healthineers methods. Select the button to learn more about entering User-Defined Method parameters. ? Filling and Loading a Flex Reagent Cartridge Filling a Flex Reagent Cartridge Loading a Flex Reagent Cartridge Select the tab arrows to learn more about filling and loading a Flex reagent cartridge Filling and Loading a Flex Reagent Cartridge Filling and Loading a Flex Reagent Cartridge (Base Layer Audio) For a User-Defined Method, fill an empty vented six well Flex reagent cartridge with your own liquid reagents and load it onto the Dimension System after you have entered all method parameters on the Method Parameters screen. Load the User-Defined Flex reagent cartridge onto the Dimension System as you would when manually entering a reagent cartridge barcode. Select the tab arrows to learn more about filling and loading a Flex reagent cartridge for a User-Defined Method. Loading a Flex Reagent Cartridge Before loading a User-Defined Flex reagent cartridge, ensure that you have entered all method parameters in the Method Parameters screen Select F4: SYSTEM PREP > F1: INVENTORY > F4: ADD REAGENT Place the Flex reagent cartridge in the automatic loader Enter the Flex reagent cartridge information when prompted, using the keyboard Hover over the markers on the right to learn more about entering Method, Lot Number and Sequence information Select F1: ACCEPT Method Enter the same name that you assigned to this method on the Method Parameters screen Lot Number Assign a unique, six-character number A valid lot number consists of six characters, such as FM4082 in the following sequence: Any two letters (FM); the last digit of the year the Flex reagent cartridge will expire (4 for 2014); the month and day the reagent cartridge will expire, expressed as a Julian date, (i.e., March 23 = 082). Refer to your laboratory’s policy for a predetermined naming convention Sequence Number Assign a unique five-digit number. This number must be different for all reagent cartridges for this method Select the X in the upper right corner to continue Filling a Flex Reagent Cartridge For User-Defined Methods, use the empty six-well Flex reagent cartridge and add your own liquid reagents. Note the order of the wells on the diagram. The narrow end is well 6 and the thicker end is well 1. Do not use an eight-well Flex reagent cartridge because this will damage the reagent probe To fill a Flex reagent cartridge, puncture the clear film covering the individual wells as needed.* Fill the wells with the volume of reagent entered in the Cartridge Configuration section of the User-Defined Method screen. Use only liquid reagents. No onboard preparation is permitted *Note: Do not remove the clear film or re-seal any puncture holes Warning: Use caution when considering reagents such as strong alkaline and acid solutions, organic solvents, viscous liquids, heavy metals, or metal chelating agents. They may have adverse effects on the system. Wear the appropriate Personal Protective Equipment (PPE) when working with these types of reagents Select the X in the upper right corner to continue ? Course Review Congratulations. You have completed the Dimension Systems User-Defined Methods course. Select the numbered buttons below to review the material before proceeding to the final assessment. Enter User-Defined Method parameters Program the Dimension System to calculate results List the steps to implement and create User-Defined Methods Define customer responsibilities related to User-Defined Methods 1 1 2 2 2 3 3 3 4 4 4 5 5 5 Fill and load the Flex reagent cartridge Course Review Fill and load the Flex reagent cartridge For User-Defined Methods, use the empty six-well Flex reagent cartridge and add your own reagents. The narrow end of the Flex reagent cartridge is well 6 and the thicker end is well 1. Do not use an eight-well Flex reagent cartridge because this will damage the reagent probe. To fill a Flex reagent cartridge, puncture the clear film covering the individual wells as needed.* Fill the wells with the volume of reagent entered in the Cartridge Configuration section of the User-Defined Method screen. Use only liquid reagents. No onboard preparation is permitted *Note: Do not remove the clear film or re-seal any puncture holes Warning: Use caution when considering reagents such as strong alkaline and acid solutions, organic solvents, viscous liquids, heavy metals, or metal chelating agents. They may have adverse effects on the system. Wear the appropriate Personal Protective Equipment when working with these types of reagents Before loading a User-Defined Flex reagent cartridge, be sure that the method parameters have already been entered in the Method Parameters screen Select F4: SYSTEM PREP > F1: INVENTORY > F4: ADD REAGENT Place the Flex reagent cartridge in the automatic loader Enter the Flex reagent cartridge information when prompted using the keyboard Method-enter the same name that you assigned to this method on the Method Parameters screen Lot number-assign a unique, six-character number Sequence number-assign a unique five-digit number. This number must be different for all reagent cartridges for this method Select F1: ACCEPT Select the X in the upper right corner to continue Select the X in the upper right corner to continue Enter the method parameters for all User-Defined Methods on the Method Parameters screen before loading a User-Defined Flex reagent cartridge onto the system or running a sample. These are different parameters than were entered on the User-Defined Method screen and provide Dimension System assay-specific information, some of which is included in the results report. The procedure for entering method parameters for User-Defined Methods is the same as for Siemens Healthineers methods Enter information in these areas for the method to operate: Reference interval Assay range Calculation type C terms Lot number Enter User-Defined Method parameters Select the X in the upper right corner to continue. Program the Dimension System to calculate results for the User-Defined Method using data from the Assay Application sheet Select F7: DIAGNOSTICS > F8: OPEN CHANNELS to access the User-Defined Method screen Enter the new method on an unused channel (select F5: NEXT CHANNEL to locate the next unused channel), name the method and select Enter to store the name Enter the following for the method: mode and standard curve, reagent and sample delivery calculations, photometry reading times and Flex reagent cartridge configurations for each well Select F2: SETUP to configure the Continuous Cuvette feature and Weighted Calibration features if supported in your application sheet Select F7: CALCULATION to enter Multipoint MAU Calculation template information from your application sheet. Program the Dimension System to calculate results List the steps to implement and create User-Defined Methods The process to implement a User-Defined Method includes: Enter assay reaction parameters Program the User-Defined calculations Accept the template Store and print the assay reaction parameters and calculation routine Enter the User-Defined Method parameters Fill and load a Flex reagent cartridge Calibrate the assay Run QC samples Run patient samples Select the X in the upper right corner to continue Define customer responsibilities related to User- Defined Methods The User-Defined Method feature on Dimension Systems allows you to define your own assays using reagents that are not purchased from Siemens Healthineers When implementing a User-Defined Method, you are responsible for: Selecting proper reagents Entering test parameters Using proper test protocols Determining the correctness of results Resolving any associated errors or omissions Note: Siemens Healthineers does not manufacture the reagents that are utilized in the User-Defined Flex reagent cartridge. Therefore, the Dimension System warranties do not extend to the performance of user defined reagents Select the X in the upper right corner to continue Disclaimer 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 Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. Please 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. © Siemens Healthcare GmbH 2022 Siemens Healthineers Headquarters\Siemens Healthcare GmbH\Henkestr. 127\ 91052 Erlangen, Germany\Telephone: +49 9131 84-0\siemens-healthineers.com ? Disclaimer Assessment This assessment will test your retention of the presented content. A passing score of 80% or higher is required to complete the course and earn your certificate. You may repeat the assessment as many times as needed. Start ? Assessment Select the best answer. ? Question 1 of 8 Which of the following is true regarding Flex reagent cartridges for User-Defined Methods? The film covering on the individual wells must be completely removed The Dimension System can prepare reagents onboard Punctured wells can be re-sealed Add your own liquid reagents to the Flex reagent cartridge Multiple Choice Correct Incorrect Punctured wells cannot be re-sealed Incorrect The Dimension System cannot prepare reagents onboard Incorrect The film covering should not be completely removed Select the best answer. ? Question 2 of 8 Which of the following are customer responsibilities regarding User-Defined Methods on Dimension Systems? Selecting proper reagents, entering test parameters and using proper test protocols Only using reagents manufactured by Siemens Healthineers Selecting proper reagents and using proper test protocols Selecting proper reagents and using proper test protocols Selecting proper reagents and using proper test protocols Multiple Choice Correct Incorrect Customers are responsible for selecting proper reagents, entering test parameters and using proper test protocols Incorrect Siemens Healthineers does not manufacture the reagents utilized in the User-Defined Flex reagent cartridge Select the best answer. ? Question 3 of 8 How many wells should the empty Flex reagent cartridge contain for a User-Defined Method? Five Four Six Eight Multiple Choice Correct The empty Flex reagent cartridge for a User-Defined Method should not contain eight wells Incorrect Incorrect The empty Flex reagent cartridge for a User-Defined Method should not contain four wells Incorrect The empty Flex reagent cartridge for a User-Defined Method should not contain five wells Select four (4) answers. ? Question 4 of 8 Which of the following is an input for the two-point calculation template? Calculation mode Measuring & Blanking filter Measuring & Blanking filter Dilution Dilution IOD/FOD IOD/FOD Depletion factor Depletion factor Multiple Answer Incorrect One or more answers are incorrect. Correct Select the best answer. ? Question 5 of 8 Which of the following is true regarding method parameters for User-Defined Methods? They are entered on the Method Parameters screen after loading a User-Defined Flex reagent cartridge onto the system They are different parameters than the ones entered on the User-Defined Method screen They are the same parameters as the ones entered on the User-Defined Method screen They are entered on the Method Parameters screen before completing the User-Defined Method screen Multiple Choice Correct Correct Method parameters for User-Defined Methods should not be entered on the Method Parameters screen before completing the User-Defined Method screen Incorrect Method parameters for User-Defined Methods are not the same parameters as the ones entered on the User-Defined Method screen Incorrect Method parameters for User-Defined Methods are not entered into the Method Parameters screen after loading a User-Defined Flex reagent cartridge onto the system Select the best answer. ? Question 6 of 8 What is the next step after configuring the Continuous Cuvette option and entering Calibration Weights on the User-Defined Method Secondary Menu screen? Select F4: STORE to store the entries Program the User-Defined calculation on the template and calculation screens Prepare the Flex reagent cartridge for the User-Defined Method Enter the required data on the Method Parameters screen Multiple Choice Incorrect Entering the required data on the Method Parameters screen is not the next step Incorrect Preparing the Flex reagent cartridge for the User-Defined Method is not the next step Incorrect Incorrect F4: STORE is not the next step Select the best answer. ? Question 7 of 8 On which screen would you enter the sample delivery calculations? Method Parameters screen Two-Point Calculation Template Multipoint MAU Calculation screen User-Defined Method screen Multiple Choice Correct Incorrect The Multipoint MAU Calculation screen is not the correct screen Incorrect The Two-Point Calculation Template is not the correct screen Incorrect The Method Parameters screen is not the correct screen Select the best answer. ? Question 8 of 8 On which screen would you enter the upper and lower limits for the reference, assay range and panic intervals for a fluid? Method Parameters screen Two-Point Calculation Template Multipoint MAU Calculation screen User-Defined Method screen Multiple Choice Incorrect The User-Defined Method screen is not the correct screen Incorrect The Multipoint MAU Calculation screen is not the correct screen Incorrect The Two-Point Calculation Template is not the correct screen Incorrect Assessment Results YOUR SCORE: PASSING SCORE: Review Retry Retry Continue Continue Continue %Results.ScorePercent%% %Results.PassPercent%% ? Assessment Results You did not pass the course. Take time to review the assessment then select Retry to continue. Congratulations. You passed the course.. Exit To access your Certificate of Completion, select the Launch button drop down on the course overview page. You can also access the certificate from your PEPconnect transcript. ? You have completed the Dimension Systems User-Defined Methods Online Training. Completion Navigation Help Select the icon above to open the table of contents. Click Next to continue. Next Welcome Slide The timeline displays the slide progression. Slide the orange bar backwards to rewind the timeline. Click Next to continue. Next Timeline Select the CC icon to display closed captioning (subtitles). Click Next to continue. Next Caption Icon add subtitles Select the buttons to learn more about a topic. Be sure to review all topics before navigating to the next slide. Click Next to continue. Next Tab Arrow Slide Select the X to close the pop-up. Click Next to continue. Next Layer Slide Select Submit to record your response. Click the X in the upper right corner to exit the navigation help. Assessment Slide Entering Assay Parameters and Calcs ? Note: Select the X at the top of the page to return back to the course Video Entering User Defined Method Parameters ? Note: Select the X at the top of the page to return back to the course Video Question Bank 1 HOOD05162003271104 | Effective Date 29-APR-2022 1.1 Welcome 1.2 Customer Responsibilities 1.3 Implementing User-Defined Methods Overview 1.4 Entering Assay Reaction Parameters 1.5 Entering User-Defined Method Parameters 1.6 Filling and Loading a Flex Reagent Cartridge 1.7 Course Review 1.8 Disclaimer 1.9 Assessment