Bayer HealthCare Certegra Operation Manual
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Bayer HealthCare Certegra Operation Manual

Bayer HealthCare Certegra Operation Manual

Applications and workstation accessories
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Summary of Contents for Bayer HealthCare Certegra

  • Page 1 REPLACE IMAGE AS NEEDED Operation Manual Certegra® Applications and Workstation Accessories ®...
  • Page 3 Operation Manual Certegra® Applications and Workstation Accessories Operation Manual Report any serious incident that has occurred in relation to this device to Bayer (radiology.bayer.com/contact) and to your local European competent authority (or, where applicable, to the appropriate regulatory authority of the country in which the incident has occurred).
  • Page 4 Certegra® Applications and Workstation Accessories...

  • Page 5: Table Of Contents

    Operation Manual 1 Introduction ....................1 1.1 Certegra® Workstation................................1 1.1.1 Workstation Cybersecurity............................1 1.2 PACS, Speech Recognition (SR) Systems, and RIS ......................1 2 Symbols ...................... 3 2.1 Manufacturing Symbols................................3 2.2 Shipper Symbols ..................................3 2.3 Regulatory Classifications ..............................4 3 Informatics Panel..................
  • Page 6 Certegra® Applications and Workstation Accessories 4 Modality Worklist ..................27 4.1 Select a Patient ..................................27 4.1.1 Setup the Patient and Study Information for a Contrast Injection..............27 4.1.2 Anonymous Patient Entry for a Contrast Injection ....................28 4.2 Update the Patient Worklist from the Modality Worklist Server................29 4.3 Find a Patient in the Patient Worklist ..........................30...
  • Page 7 Operation Manual 7.4.1 Help Page ..................................56 8 Mandatory Fields ..................59 8.1 Configuration and Setup...............................59 8.1.1 Login....................................59 8.1.2 Enable Mandatory Fields ............................59 8.1.3 Configure Settings for Mandatory Fields ......................60 8.2 Use of Mandatory Fields ..............................60 8.2.1 Mandatory Fields Pre-Injection (Informatics Panel) ..................60 8.2.2 Mandatory Fields Post-Injection (Data Confirmation) ..................61 9 Multiple Accession Number ..............
  • Page 8 12.4.3.2 Edit Technologist Barcode ........................101 12.4.3.3 Delete Technologist Barcode ........................101 12.4.3.4 Import Technologist Barcode........................102 12.4.3.5 Search for Technologist..........................102 12.4.3.6 Edit Tech ID Displayed on the Certegra Workstation ............... 102 12.4.4 Export Barcode Configurations .......................... 102 12.4.5 Import Barcode Configurations ......................... 103...
  • Page 9 13.1.1 Hand-Held Scan ..............................105 13.1.2 Hands-Free Scan ..............................105 13.1.3 Beeps and LED Indications ..........................106 13.2 Scan Barcodes for the Certegra Workstation......................107 13.2.1 Scan Barcodes Pre-Injection..........................107 13.2.2 Scan Barcodes Post-Injection..........................108 13.3 Troubleshooting Barcode Reader Accessory....................... 109 13.3.1 Reset Default Parameters (Optional)........................
  • Page 10 Certegra® Applications and Workstation Accessories...

  • Page 11: Introduction

    Bayer and country-specific operating instructions. 1.1.1 Workstation Cybersecurity When Informatics is enabled, the Certegra Workstation hard drive can contain Protected Health Information (PHI). The security and privacy of this information must be safeguarded by all individuals interacting with the device. Prior to disposing of the workstation, this information must be removed from the hard drive inside the system.
  • Page 12 1 - 2 Certegra® Applications and Workstation Accessories...

  • Page 13: Symbols

    Operation Manual 2 - 3 Symbols 2.1 Manufacturing Symbols Authorized Representative in the European Community (ISO 15223-1, 5.1.2) 2.2 Shipper Symbols Date of Manufacture (ISO 15223-1, 5.1.3) Temperature range (ISO 15223-1, 5.3.7) Humidity range (ISO 15223-1, 5.3.8) Atmospheric pressure range (ISO 15223-1, 5.3.9) Serial Number (ISO 15223-1, 5.1.7) Catalog Number (ISO 15223-1, 5.1.6) This side up (ISO 7000, 0623)

  • Page 14: Regulatory Classifications

    2 - 4 Certegra® Applications and Workstation Accessories 2.3 Regulatory Classifications Indicates that this device conforms to the requirements of the European Medical Device Directive 93/42/EEC. Tested to comply with FCC standards. Indicates that this product contains certain toxic or hazardous substances or elements and can be used safely during its environmental protection use period, indicated by the number in the center of the logo.

  • Page 15: Informatics Panel

    3 - 5 Informatics Panel The Informatics Panel is the left-hand section of the Certegra Workstation user interface and enables the interaction with the licensed applications and management of informatics. The Informatics Panel manages information important to injection procedure. Key groups of information managed through the Informatics Panel include patient information, procedure information, fluid information, procedure notes, and events information.
  • Page 16 3 - 6 Certegra® Applications and Workstation Accessories The Patient tab displays. Enter information into all relevant fields: Patient’s ID, Last Name, First Name Select ID, Last Name, or First Name field (Figure 3 - 2: Patient Tab - Patient ID, Last Name, First Name Entry).

  • Page 17: Clear All Patient Information For Next Injection

    Operation Manual 3 - 7 Figure 3 - 4: Patient Tab - Weight Selection Enter the appropriate data with the numeric keypad. iii. Press Enter to accept changes made to a patient’s weight or height, or press Cancel to ignore changes made.

  • Page 18: Cancel Edits To Patient Information For Next Injection

    3 - 8 Certegra® Applications and Workstation Accessories Select the Patient Information area from the Informatics Panel. Press Clear All. A message displays. Press Yes to confirm, or press No to return to the Patient tab. Press OK to save changes made.
  • Page 19 Operation Manual 3 - 9 Figure 3 - 7: Procedure Tab - Technologist ID Entry Enter technologist ID with the alphanumeric keyboard. iii. Press Enter to save changes made, or press Cancel to ignore changes made. b. Injection Site Select Injection Site field (Figure 3 - 8: Procedure Tab - Injection Site Selection). Figure 3 - 8: Procedure Tab - Injection Site Selection Select the value from the Injection Site list.
  • Page 20 3 - 10 Certegra® Applications and Workstation Accessories Figure 3 - 9: Procedure Tab - Accession Number/Study Description Entry Enter data with the alphanumeric keyboard. iii. Press Enter to save changes made to the accession number or the study description, or press Can- cel to ignore changes made.

  • Page 21: Clear All Procedure Information For Next Injection

    Operation Manual 3 - 11 3.3.2 Clear All Procedure Information for Next Injection Prior to the injection, clear procedure information from the injection record by using the Procedure tab of the Informatics Panel. Select the Procedure area from the Informatics Panel. Press Clear All.
  • Page 22 3 - 12 Certegra® Applications and Workstation Accessories Figure 3 - 12: Informatics Panel - Fluids The Fluid A tab displays (Figure 3 - 13: Fluid A Tab). NOTE: Select Fluid B to open the Fluid B tab. Figure 3 - 13: Fluid A Tab...
  • Page 23 Operation Manual 3 - 13 Figure 3 - 14: Fluid Source A Selection Select the value from the Fluid Source list. When the value is selected, the Fluid Source field updates, and the list disappears. NOTE: If the correct fluid source does not show under the Fluid Source list, but arrows appear, press the Up or Down arrows to show additional entries.

  • Page 24: Retrieve Previous Contrast Data (Fluid A Button)

    Use the Fluid A button to retrieve previous contrast data for the next injection. The Fluid A button stores the last scanned or manually entered contrast data. On the Certegra Workstation main screen, select Fluid A (Figure 3 - 18: Fluid A Button).

  • Page 25: Clear All Fluid Information For Next Injection (Fluid A Or Fluid B)

    Figure 3 - 19: Fluid A Window on Home Screen Select OK to confirm selection of the contrast information displayed, or select Cancel to cancel the operation and return to the Certegra Workstation home screen. 3.4.3 Clear All Fluid Information for Next Injection (Fluid A or Fluid B) Prior to the injection, clear fluid information from an injection record by using the Fluid tab of the Informatics Panel.

  • Page 26: Cancel Edits To Fluid Information For Next Injection

    3 - 16 Certegra® Applications and Workstation Accessories Press OK to save changes made. 3.4.4 Cancel Edits to Fluid Information for Next Injection On the Fluid A or Fluid B tab, cancel any edits to the fluid information for the next injection by pressing Cancel. Any changes made are canceled, and the system returns to the Home screen.

  • Page 27: Clear All Notes Information For Next Injection

    Operation Manual 3 - 17 Figure 3 - 21: Informatics Panel - Patient, Procedure, Fluids, and Events The Patient Information window displays. Select the Notes tab (Figure 3 - 22: Notes Tab). NOTE: If the Events area from the Informatics Panel was selected, press Edit Notes. A keyboard automatically displays.

  • Page 28: Managing Events Information

    Certegra® Applications and Workstation Accessories NOTE: Notes can be edited from the Events tab but cannot be cleared. If the Events area from the Informatics Panel was selected, press Cancel to return to the Certegra Workstation home screen. Select the Notes tab.

  • Page 29: Edit Notes From The Events Panel

    Operation Manual 3 - 19 Figure 3 - 24: Events Tab Details 3.6.2 Edit Notes from the Events Panel NOTE: Notes can be edited from the Events tab but cannot be cleared. To clear notes, refer to 3.5.2 - Clear All Notes Information for Next Injection.

  • Page 30: Screen Navigation And Layout

    3 - 20 Certegra® Applications and Workstation Accessories 3.7 Screen Navigation and Layout 3.7.1 Informatics Panel Figure 3 - 26: Informatics Panel Table 3 - 1: Informatics Panel Screen Navigation and Layout Name Description Shows key patient information: Patient Name, ID, Date of Birth, Weight.

  • Page 31: Patient Tab

    Operation Manual 3 - 21 3.7.2 Patient Tab Figure 3 - 27: Patient Tab Table 3 - 2: Patient Tab Screen Navigation and Layout Name Description Patient's ID or Medical Record Number (MRN) Last Name, First Name Patient's name: last name and first name Patients date of birth Weight Patient's weight...

  • Page 32: Procedure Tab

    3 - 22 Certegra® Applications and Workstation Accessories 3.7.3 Procedure Tab Figure 3 - 28: Procedure Tab Table 3 - 3: Procedure Tab Screen Navigation and Layout Name Description Injection Site Position on the patient where the IV catheter is placed...

  • Page 33: Fluid A And Fluid B Tabs

    Operation Manual 3 - 23 3.7.4 Fluid A and Fluid B Tabs NOTE: Figure 3 - 29: Fluid Tab shows the Fluid A tab. The Fluid B tab is identical to the Fluid A tab. Figure 3 - 29: Fluid Tab Table 3 - 4: Fluid A and Fluid B Tab Screen Navigation and Layout Name Description...

  • Page 34: Notes Tab

    3 - 24 Certegra® Applications and Workstation Accessories 3.7.5 Notes Tab Figure 3 - 30: Notes Tab Table 3 - 5: Notes Tab Screen Navigation and Layout Name Description Procedure and Event Notes View of notes currently entered Edit Notes button Enables edits to the Procedure and Events Notes paragraph.

  • Page 35: Events Tab

    Operation Manual 3 - 25 3.7.6 Events Tab Figure 3 - 31: Events Tab Table 3 - 6: Events Tab Screen Navigation and Layout Name Description Displays a list of both successful and unsuccessful events with time Events Details stamps. Refer to 3.6.1 - View Events Information. Procedure and Event Notes View of notes currently entered OK button...
  • Page 36 3 - 26 Certegra® Applications and Workstation Accessories...

  • Page 37: Modality Worklist

    Informatics Panel. When the application accesses the department's Modality Worklist server, a set of patient and study records are pulled into the Certegra Workstation's system to create an internal Patient Worklist.

  • Page 38: Anonymous Patient Entry For A Contrast Injection

    Select the patient by pressing any of the elements associated with the patient entry row in the Patient Worklist. This confirms the patient and study selection for the next injection procedure, returns the system to the Certegra Workstation home screen, and populates the Patient and Procedure tabs with the appropriate information.

  • Page 39: Update The Patient Worklist From The Modality Worklist Server

    Select the Anonymous Patient button (Figure 4 - 3: Anonymous Patient). Figure 4 - 3: Anonymous Patient The system returns to the Certegra Workstation home screen. The Patient field is populated with a pre- determined first and last name, and other specific fields are cleared.

  • Page 40: Find A Patient In The Patient Worklist

    4.3 Find a Patient in the Patient Worklist To open the Patient Worklist, select Patient Worklist from the Certegra Workstation home screen. An active call is made to the department's Modality Worklist server, and the resulting entries display on the Patient Worklist screen.
  • Page 41 Operation Manual 4 - 31 Select the appropriate filter criteria (Figure 4 - 6: Select Filter). Figure 4 - 6: Select Filter NOTE: For filter criteria Station Name, ID, Accession Number, Referring Physician, and Study Description, the system uses the concepts of implicit wildcarding and “starts with” to create a filter that returns all entries that start with the typed characters.
  • Page 42 4 - 32 Certegra® Applications and Workstation Accessories Figure 4 - 7: Patient Worklist - Select Date iii. Use the arrows to increase or decrease the value, or press Today to use the current date. iv. Press OK to accept changes made, or press Cancel to ignore changes made.

  • Page 43: Remove A Filter On The Worklist

    Operation Manual 4 - 33 g. Study Description Enter filter data with the alphanumeric keyboard. Press Enter to accept changes made, or press Cancel to ignore changes made. Filter data is automatically created after selecting the appropriate filter criteria and pressing Enter. The system applies the selected filter criteria and filter data to the Patient Worklist and displays only those Patient Worklist records that match the filter.

  • Page 44: Screen Navigation And Layout

    4 - 34 Certegra® Applications and Workstation Accessories 4.4 Screen Navigation and Layout 4.4.1 Main Patient Worklist Figure 4 - 10: Patient Worklist Main Screen Table 4 - 1: Areas of Information for Patient Worklist Main Screen Name Description Shows the date range of the studies displayed that have been pulled from Date Range the Modality Worklist server.
  • Page 45 Operation Manual 4 - 35 Table 4 - 1: Areas of Information for Patient Worklist Main Screen Name Description Sorting is enabled and highlighted by a caret in the corner of the column: Selecting the “Patient Name” column header toggles between alphabetic sorts of Patient Names from A to Z and Z to A.

  • Page 46: Detailed Worklist Entry Screen

    Exits the Patient Worklist screen without selecting a patient and returns the Exit button system to the Certegra Workstation home screen. 4.4.2 Detailed Worklist Entry Screen The Detailed Worklist Entry screen displays the complete set of information retrieved from the department's Modality Worklist server that may not have been displayed in the main Patient Worklist screen.

  • Page 47: Filter Creation Screen

    Pressing Yes confirms the patient and study selection for the next injection Patient Selection procedure, returns the system to the Certegra Workstation home screen, and Buttons populates the Patient and Procedure tabs with the appropriate information.
  • Page 48 4 - 38 Certegra® Applications and Workstation Accessories Table 4 - 3: Filter Creation Screen Areas with Navigation Elements Name Description Filters the Worklist and displays only those patients with studies that have Study Description study descriptions that meet the filter data criteria.

  • Page 49: Informatics Panel And Modality Worklist Setup Options

    Operation Manual 5 - 39 Informatics Panel and Modality Worklist Setup Options The Modality Worklist feature has two configuration components: System Configuration, which is meant to be done once for a particular facility during system installation and altered infrequently, and Implementation Configuration, which is done during installation but can also be modified during operation.
  • Page 50 Table 5 - 1: Informatics Setup Configuration Categories Configuration Description Selectable Value Category Enables and disables the Informatics Informatics Panel Panel on the Certegra Workstation user On, Off interface. Patient Worklist Default Sets the default sorting method for the Patient Name, Time, and Date Sort Patient Worklist.

  • Page 51: Configuring Informatics Panel Defaults

    5.2 Configuring Informatics Panel Defaults 5.2.1 Enable or Disable the Display of the Informatics Panel From the Certegra Workstation launch menu, select Informatics Setup. Press Informatics Panel (Figure 5 - 4: Informatics Panel Configuration Item). Figure 5 - 4: Informatics Panel Configuration Item Press On or Off to enable or disable the Informatics Panel, respectively.

  • Page 52: Create A Default Setting For Categories With Specific Values

    5 - 42 Certegra® Applications and Workstation Accessories 5.2.2 Create a Default Setting for Categories with Specific Values From the Certegra Workstation launch menu, select Informatics Setup. Select one of the categories to set a default value. Select the desired default value.

  • Page 53: Add A Value To A User-Created List

    Press OK to make the change. Press Yes to confirm the change made. 5.3.2 Add a Value to a User-Created List From the Certegra Workstation launch menu, select Informatics Setup. Select one of the categories to add a value. Press Add New.
  • Page 54 5 - 44 Certegra® Applications and Workstation Accessories Select Hide or Show. Press Yes to confirm the change made.

  • Page 55: Data Confirmation

    Operation Manual 6 - 45 Data Confirmation Use the Data Confirmation feature to review, edit, and confirm Informatics exam data post-injection to ensure the correct information is captured as part of the patient’s electronic record and (if configured) sent to external systems. NOTE: MEDRAD®...
  • Page 56 6 - 46 Certegra® Applications and Workstation Accessories Figure 6 - 2: Data Confirmation Screen Table 6 - 1: Data Confirmation Areas of Information Name Description Shows patient data for the exam. Patient Data Enables access to Patient Tab to edit data.

  • Page 57: Updating Exam Information Using Data Confirmation

    Operation Manual 6 - 47 Table 6 - 1: Data Confirmation Areas of Information Name Description Records the current exam data, as well as injection data, to the patient’s electronic record and (if configured) sends the applicable information to external systems. Save button Exits the Data Confirmation screen and returns the system to the Injection Completed screen (Figure 6 - 3: Injection Completed Screen - Next Injection).
  • Page 58 6 - 48 Certegra® Applications and Workstation Accessories NOTE: Patient and study information displayed on the Data Confirmation window can be updated using the barcode reader accessory. Refer to 13.2.2 - Scan Barcodes Post-Injection for more information. To update exam data using Data Confirmation: Select the Edit Patient Data field (Figure 6 - 4: Edit Patient Data).

  • Page 59: Retrieve Contrast Data (Fluid A Button)

    Operation Manual 6 - 49 6.3.2 Retrieve Contrast Data (Fluid A Button) Use the Fluid A button in Data Confirmation to retrieve contrast data for the completed injection. The Fluid A button stores the last scanned or manually entered contrast data. Select Fluid A (Figure 6 - 6: Fluid A Button in Data Confirmation).

  • Page 60: Update Patient Worklist Selection Using Anonymous Patient

    6 - 50 Certegra® Applications and Workstation Accessories Figure 6 - 8: Patient Worklist Button The Patient Worklist screen displays. Select the proper Worklist item. The newly selected patient information displays on the Data Confirmation screen. Figure 6 - 9: Informatics Data Confirmation Select Save to save changes made and return to the Injection Completed screen.
  • Page 61 NOTE: Anonymous patient can also be selected before the injection using Informatics Panel. Refer to 4.1.2 Anonymous Patient Entry for a Contrast Injection for more information. Select Patient Worklist from the Certegra Workstation home screen. An active call is made to the facility’s Modality Worklist server. The resulting entries display on the Patient Worklist screen.
  • Page 62 6 - 52 Certegra® Applications and Workstation Accessories...

  • Page 63: Certegra Manager

    7.1 Certegra Manager Login Login to the Certegra Manager to access any of the features listed in Table 7 - 2: - Certegra Manager Features and Functions. NOTE: Access to the Certegra Manager is restricted to authorized users. A valid username and password must be entered to log in.

  • Page 64: Compatibility Specifications

    Mozilla Firefox version 14 and above 7.3 Roles and Access User roles and user access to certain functions in Certegra Manager are defined in Table 7 - 1: - Certegra Manager User Roles and Access. Table 7 - 1: Certegra Manager User Roles and Access...

  • Page 65: Certegra Manager Navigation

    Operation Manual 7 - 55 7.4 Certegra Manager Navigation The features under Certegra Manager are defined in Table 7 - 2: - Certegra Manager Features and Functions. Table 7 - 2: Certegra Manager Features and Functions Home Page Options Features and Functions...

  • Page 66: Help Page

    Figure 7 - 6: Drop-Down Menu Options 7.4.1 Help Page Use the Help page to view and download the Certegra® Applications and Workstation Accessories operation manual. Select Help from any page within Certegra Manager (Figure 7 - 7: Help Page).
  • Page 67 Operation Manual 7 - 57 Figure 7 - 8: List of Languages for Operation Manual To save or view the operation manual, select the PDF button next to the appropriate language. A separate window opens with the appropriate operation manual. To return to Manage Injections page, select X in the corner of the display or close the window.
  • Page 68 7 - 58 Certegra® Applications and Workstation Accessories...

  • Page 69: Mandatory Fields

    Figure 8 - 1: Configuration Settings for Mandatory Fields 8.1.2 Enable Mandatory Fields Login to Certegra Manager and navigate to the Mandatory Fields page. Refer to 8.1.1 - Login for instructions. To enable Mandatory Fields, select the check box next to Enable Mandatory Fields until the check mark...

  • Page 70: Configure Settings For Mandatory Fields

    8.1.3 Configure Settings for Mandatory Fields Login to Certegra Manager and navigate to the Mandatory Fields page. Refer to 8.1.1 - Login for instructions. Configure the mandatory field settings. Under each category, select the check box next to the appropriate field(s).

  • Page 71: Mandatory Fields Post-Injection (Data Confirmation)

    Press OK to accept changes made, or press Cancel to ignore all changes made. Select Save to save changes made to patient, procedure, and/or fluid information and return to the Certegra Workstation home screen. 8.2.2 Mandatory Fields Post-Injection (Data Confirmation) If Data Confirmation is enabled, the Injection Completed Screen displays with the Review Data button when an injection is completed.
  • Page 72 8 - 62 Certegra® Applications and Workstation Accessories Figure 8 - 5: Data Confirmation Screen On the Data Confirmation screen, red asterisks and red text indicates a mandatory field that is missing required information (Figure 8 - 6: Missing Mandatory Fields).
  • Page 73 Operation Manual 8 - 63 Figure 8 - 7: Data Confirmation - Missing Mandatory Fields The selected field tab displays with the missing mandatory fields indicated by an asterisks and highlighted in red (Figure 8 - 8: Missing Mandatory Fields). Figure 8 - 8: Missing Mandatory Fields Update the missing mandatory fields.
  • Page 74 8 - 64 Certegra® Applications and Workstation Accessories...

  • Page 75: Multiple Accession Number

    A license is required to enable the Multiple Accession Number feature. Contact Bayer for more information. 9.2 Enable Login to the Certegra Manager to enable Multiple Accession Number, listed under System Configurations. Login to Certegra Manager. Refer to 7.1 - Certegra Manager Login for instructions.

  • Page 76: Select Accession Numbers Using Barcode Reader Accessory

    9 - 66 Certegra® Applications and Workstation Accessories If one or more accession numbers are selected, the number of accession numbers assigned to the injection displays in parenthesis under the procedure. 9.3.2 Select Accession Numbers Using Barcode Reader Accessory If an MRN or accession number barcode is scanned using a barcode reader accessory, an active call is made to the facility’s Modality Worklist server to find the applicable patient record.

  • Page 77: Data Manager

    Operation Manual 10 - 67 Data Manager Data Manager is a key feature of the Certegra platform that allows hospital personnel to perform data management activities from a supported injection system when an injection is completed. These activities are as follows: Injection Capture: Transfer injection information from an injection system to Data Manager.

  • Page 78: Log In

    Access No Access 10.4 Log In Login to Certegra Manager to access Data Manager. If already logged into Certegra Manager, skip to step 2. Login to Certegra Manager. Refer to 7.1 - Certegra Manager Login for instructions. Select Data Manager.

  • Page 79: Manage Injections

    Operation Manual 10 - 69 Select the Confirm button to save changes made, or select the Cancel button to cancel the operation (Figure 10 - 3: Confirm or Cancel Injector Details). Confirm Button Cancel Button Figure 10 - 3: Confirm or Cancel Injector Details A confirmation window displays the updated names for review (Figure 10 - 4: Confirmation Window).
  • Page 80 10 - 70 Certegra® Applications and Workstation Accessories Under Manage Injections, select Match (Figure 10 - 5: Match Injection Record). Figure 10 - 5: Match Injection Record Search for a specific injection record using the provided search criteria. NOTE: Specifying a start and end date is required.

  • Page 81: Match Additional Studies

    Operation Manual 10 - 71 Figure 10 - 7: Match Selected Injection Record Select Match next to the appropriate injection record to match the injection with any study listed, or select Cancel to cancel the operation. If Match is selected, a confirmation message displays. NOTE: If the incorrect injection record was matched to a study, unmatch the incorrect injection record (refer to 10.6.2 - Unmatch) and re-match the correct injection record.
  • Page 82 10 - 72 Certegra® Applications and Workstation Accessories Search for a specific injection record using the provided search criteria. NOTE: Specifying a start and end date is required. Select Search. Under Search Results, a list of injections based on the search criteria displays (Figure 10 - 9: List of Injections to Unmatch).

  • Page 83: Edit Injection

    Operation Manual 10 - 73 10.6.3 Edit Injection To edit patient, procedure, and fluid data for the selected injection: Under the Injections drop-down menu, select Manage. Under Manage Injections, select Edit (Figure 10 - 11: Edit Injection Record). Figure 10 - 11: Edit Injection Record Search for a specific injection record using the provided search criteria.

  • Page 84: Transfer

    10 - 74 Certegra® Applications and Workstation Accessories List of editable fields: Patient Tab (Patient Data) Patient ID/MRN Patient Name Date of Birth Gender Patient Height Patient Weight Figure 10 - 13: Patient Tab Study Tab (Procedure Details) Injection Site...
  • Page 85 Operation Manual 10 - 75 Under Manage Injections, select Transfer (Figure 10 - 16: Transfer Injection Record). Figure 10 - 16: Transfer Injection Record Search for specific injection record(s) using the provided search criteria. NOTE: Specifying a start and end date is required. Select Search.

  • Page 86: Hide/Unhide

    10 - 76 Certegra® Applications and Workstation Accessories Figure 10 - 18: Transfer Injection(s) Summary 10. If Confirm was selected, a confirmation message displays. 10.6.5 Hide/Unhide NOTE: Hidden injections cannot be managed or exported. To hide or unhide a specific injection record: Under the Injections drop-down menu, select Manage.

  • Page 87: Export

    Operation Manual 10 - 77 Figure 10 - 20: List of Injections to Hide/Unhide Select Hide next to the appropriate injection record to hide the injection, or select Unhide next to the appropriate injection record to un-hide the injection. A summary screen, with the selected injection details and selected operation (Hide / Unhide), displays (Figure 10 - 21: Hide/Unhide Summary Screen).

  • Page 88: Export Injection Summary

    10 - 78 Certegra® Applications and Workstation Accessories Injection Details: Injection details and history records that meet specific search criteria provided. Syringe Usage: Syringe usage details for injections within a specified date range. 10.7.1 Export Injection Summary To export the injection summary for a given date range: Under the Injections drop-down menu, select Export.

  • Page 89: Export Injection Details

    Operation Manual 10 - 79 Figure 10 - 24: Samples of Injection Summary 10.7.2 Export Injection Details To export injection details and injection history records for a given date range: Under the Injections drop-down menu, select Export. Select Injection Details (Figure 10 - 25: Injection Details). Figure 10 - 25: Injection Details Search for a specific injection record using the provided search criteria.
  • Page 90 10 - 80 Certegra® Applications and Workstation Accessories Select Search. A list of injections based on the search criteria displays (Figure 10 - 26: List of Injections to Export). NOTE: If Multiple Accession Number is enabled, the Search Results display injection records grouped and sorted by injection start date.
  • Page 91 Operation Manual 10 - 81 A sample injection details download file is shown in Figure 10 - 28: Samples of Injection Details. Figure 10 - 28: Samples of Injection Details...

  • Page 92: Export Syringe Usage

    10 - 82 Certegra® Applications and Workstation Accessories 10.7.3 Export Syringe Usage To export syringe usage for a given date range: Under the Injections drop-down menu, select Export. Select Syringe Usage (Figure 10 - 29: Syringe Usage). Figure 10 - 29: Syringe Usage Enter the appropriate date range in the Start Date and End Date fields.

  • Page 93: Site Management

    Operation Manual 10 - 83 10.8 Site Management 10.8.1 Backup NOTE: After the backup has started, any other activity within Data Manager cannot be performed until the backup is complete. To back up all of the injection records to the local system: Under the Site Management drop-down menu, select Backup.

  • Page 94: Restore

    10 - 84 Certegra® Applications and Workstation Accessories When the backup is complete, a completion message displays (Figure 10 - 34: Operation Complete). Figure 10 - 34: Operation Complete Select Close to resume using Data Manager. Select Download Backup File to download the backup database file (Figure 10 - 35: Download Backup File).
  • Page 95 Operation Manual 10 - 85 Figure 10 - 36: Restore Database Select the appropriate Certegra database backup file, and select Open (Figure 10 - 37: Select Backup File). Figure 10 - 37: Select Backup File Select Restore. The Database Activity Monitor opens and monitors the progress of the restore (Figure 10 - 38: Database Activity Monitor).

  • Page 96: User Management

    10 - 86 Certegra® Applications and Workstation Accessories After successfully restoring the injection records, a message to restart the device displays (Figure 10 - 39: Restore Succeeded). Figure 10 - 39: Restore Succeeded Select OK. The system logs off and redirects to the login page.

  • Page 97: My Account

    Anonymous Patient values are defined and managed under Anonymous Patient in Certegra Manager. Anonymous Patient must be enabled before Anonymous Patient values are defined. Login to the Certegra Manager to access Anonymous Patient, listed under System Configurations. If already logged into Certegra Manager, skip to step 2.

  • Page 98: Data Manager Troubleshooting

    Ensure the Certegra Workstation, including the con- nected injection system, is powered on and is opera- tional. Data Manager is not available from viewing station. Verify Certegra Workstation is connected to the hospi- tal network. Follow any procedures associated with the specific hardware used with Certegra.

  • Page 99: Barcode Reader Accessory And Setup

    NOTE: The images of the barcode reader and accompanying stand are for representational purposes only and may vary slightly from each accessory. All of the following must be completed before the barcode reader can be used with the Certegra Workstation: Scan initialization barcode (11.3 - Scan Initialization Barcode for System Use), Enable barcoding (12.2 - Enable Barcoding), and...

  • Page 100: Assemble Stand

    If applicable, remove the rear cover on the Certegra Workstation using a #2 Phillips screwdriver. NOTE: If necessary, carefully tilt the face of the Certegra Workstation onto a flat service for better access to both the rear cover and the USB ports.

  • Page 101: Mount Stand (Optional)

    If not already completed, define barcodes for injector system use (12 - Barcode Configuration) before using the barcode reader with the Certegra Workstation. 11.4 Verify Setup and Configuration for Use NOTE: If configuration has not yet been completed, refer to 12 - Barcode Configuration.
  • Page 102 11 - 92 Certegra® Applications and Workstation Accessories Scan a Bayer pre-configured or configured barcode. NOTE: Barcode cannot be scanned when the injector is armed or injecting. NOTE: If Multiple Accession Number is enabled and an MRN or accession number barcode is scanned, refer to 9.3.2 - Select Accession Numbers Using Barcode Reader Accessory.

  • Page 103: Barcode Configuration

    Refer to Figure 12 - 3: - Examples of 2D Contrast Barcodes. These 2D barcodes are automatically configured with the Certegra Workstation and do not need to be defined in Barcode Configuration. Scan the Bayer 2D barcode to populate contrast information into the appropriate fields.

  • Page 104: Configure Barcodes & Barcode Patterns For System Use

    12 - 94 Certegra® Applications and Workstation Accessories If only Bayer 2D contrast barcodes will be used at the site, further configuration of contrast barcodes and barcode patterns applicable to contrast is not required. Refer now to 11.4 - Verify Setup and Configuration for Use.

  • Page 105: Non-Bayer 2D Contrast Barcode

    Operation Manual 12 - 95 Table 12 - 1: Example Contrast Barcodes Code Example Contrast Barcode Barcode Value Entered Content (01): Brand Vial size 01303027070991671714099010 123456L Concentration (17): Do NOT enter parentheses. Enter all letters and numbers under the Expiration barcode.

  • Page 106: Edit Contrast Barcode

    12 - 96 Certegra® Applications and Workstation Accessories Figure 12 - 5: Contrast Barcode (CT Left; MR Right) Table 12 - 2: Contrast Barcode Fields and Functions Information Field Function Brand Name Identify the contrast brand name. Concentration Identify the contrast concentration.

  • Page 107: Delete Contrast Barcode

    12.4.1.5 Pre-Configured Contrast When enabled, Barcode Configuration will automatically be linked to the Certegra Workstation and share saved information. If contrast was already programmed on the Certegra Workstation, such information will automatically be added to Barcode Configuration.

  • Page 108: Add Barcode Pattern

    12 - 98 Certegra® Applications and Workstation Accessories Table 12 - 3: Where to Configure Barcode Pattern Content Setup Drop-Down Barcode Pattern Configuration Section Menu Option Patient Barcode Pattern Setup Patient Barcode Pattern Setup Patient/Study Setup 12.4.2.1 Add Barcode Pattern Select Add within the header of the appropriate section.

  • Page 109: Configure Barcode Pattern To Hide Characters (Prefix/Suffix)

    Operation Manual 12 - 99 Table 12 - 4: Barcode Pattern Fields and Functions Information Field Function Identify the barcode pattern as patient MRN or accession number. A Medical Record Number (MRN) is a primary hospital identification number or code for the patient. DICOM Tag* An Accession Number is a series of numbers that hospitals use to identify a specific study or procedure.

  • Page 110: Edit Barcode Pattern

    12 - 100 Certegra® Applications and Workstation Accessories NOTE: When configured, the prefix and/or suffix will be grayed out in the “Barcode Pattern” field. In Figure 12 - 7: - Prefix/Suffix, the barcode pattern established is “**###@.” In this example, the “**” and the “@”...

  • Page 111: Add Technologist Barcode

    Operation Manual 12 - 101 Figure 12 - 8: Technologist Setup 12.4.3.1 Add Technologist Barcode Select Add within the Technologist header. A window displays. Fill in the required fields, and select Add when finished. Figure 12 - 9: Technologist Table 12 - 5: Barcode Pattern Fields and Functions Information Field Function Badge Barcode...

  • Page 112: Import Technologist Barcode

    Type either the badge barcode or Tech ID into the Search tool. Search results display under the Technologist section. 12.4.3.6 Edit Tech ID Displayed on the Certegra Workstation Under the Technologist section, select BADGEBARCODE to display the badge barcode for the technologist or TECHID to display the Tech ID for the technologist.

  • Page 113: Import Barcode Configurations

    Operation Manual 12 - 103 Figure 12 - 11: Export Successful Select Download to download the file. 12.4.5 Import Barcode Configurations NOTE: If importing configurations from a differing modality (CT or MR), Barcode Configuration automatically blocks conflicting contrast information. Contrast information not conflicting will be imported.
  • Page 114 12 - 104 Certegra® Applications and Workstation Accessories The following errors can occur when configuring barcode patterns: Duplicate Barcode Pattern Name: An error message occurs if adding or editing a barcode pattern with the same name as an existing pattern. If this error occurs, rename the barcode pattern.

  • Page 115: General Barcode Information

    Certegra Workstation. Refer to 11 - Barcode Reader Accessory and Setup. b. Or the barcode is not read, in which case the aiming dot turns off.

  • Page 116: Beeps And Led Indications

    13 - 106 Certegra® Applications and Workstation Accessories Figure 13 - 2: Insert Scanner into Stand Adjust the scan angle by bending the stand neck as necessary. Place barcode into the reader’s field of view. If the barcode has been successfully scanned, the reader emits a short high beep, and the LED momentarily shuts off.

  • Page 117: Scan Barcodes For The Certegra Workstation

    The barcode reader emits a short high beep; b. The scanned data will automatically appear in: the Informatics Panel if the barcode is scanned from the Certegra Workstation main screen, or the applicable field(s) if the barcode is scanned with the Patient Information window open; and A green checkmark appears under the Events area of the Informatics Panel (Figure 13 - 3: - Events Tab - Barcode Scans).

  • Page 118: Scan Barcodes Post-Injection

    13 - 108 Certegra® Applications and Workstation Accessories Figure 13 - 3: Events Tab - Barcode Scans NOTE: For more information, select the Events area on the Informatics Panel to display the Events tab. Figure 13 - 4: Events Tab Details - Barcode Scans 13.2.2 Scan Barcodes Post-Injection...

  • Page 119: Troubleshooting Barcode Reader Accessory

    Operation Manual 13 - 109 Figure 13 - 5: Data Confirmation Window Scan a Bayer pre-configured or configured barcode. NOTE: Barcode cannot be scanned when the injector is armed or injecting. NOTE: Barcodes can be scanned in any order. NOTE: If Multiple Accession Number is enabled and an MRN or accession number barcode is scanned, refer to 9.3.2 - Select Accession Numbers Using Barcode Reader Accessory.

  • Page 120: Reset Default Parameters (Optional)

    13.3.2 Removing the USB Cable If Necessary NOTE: The barcode reader will not be powered if the cable is not plugged into the Certegra Workstation. If applicable, remove the rear cover on the Certegra Workstation using a #2 Phillips screwdriver.

  • Page 121: Maintenance And Cleaning

    Carefully slide out cable. To reconnect the USB cable to the barcode reader, refer to 11.2.1 - Install USB Cable. If not reattaching the barcode reader to the Certegra Workstation, reinstall the rear cover if removed using a #2 Phillips screwdriver.

  • Page 122: Monthly

    Technologists) and trained in the use of all equipment used for performing such scans. The Barcode Configuration feature under the Certegra Manager website may be used by either clinical or non- clinical users (e.g. Administrators or IT/Biomed Technicians) responsible for configuration tasks in support of the system’s operation.
  • Page 123 Operation Manual 13 - 113 Catalog Number Description BCRMRXP MEDRAD® MRXperion Barcoding Accessory MEDRAD® Stellant FLEX with Certegra® BCRFLEX Workstation Barcoding Accessory...
  • Page 124 13 - 114 Certegra® Applications and Workstation Accessories...
  • Page 126 All patient data that appear in this document are fictitious. No actual patient information is shown. Bayer, the Bayer Cross, Certegra, MEDRAD, MRXperion, MEDRAD MRXperion, Stellant, MEDRAD Stellant, Stellant FLEX, MEDRAD Stellant FLEX, P3T, VirtualCare, Ultravist, and Magnevist are trademarks owned by and/or registered to Bayer in the US and/or other countries.

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