Bayer HealthCare CERTEGRA MEDRAD Stellant FLEX Operation Manual
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Bayer HealthCare CERTEGRA MEDRAD Stellant FLEX Operation Manual

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Summary of Contents for Bayer HealthCare CERTEGRA MEDRAD Stellant FLEX

  • Page 1 Operation Manual...
  • Page 3 Operation Manual MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Operation Manual The MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation has an expected service life* of 7 years from the date of product installation when operated according to the instructions provided with this device. These 7 years include suggested or mandatory actions of preventative maintenance and repair activities, as well as required calibration(s) that are needed.
  • Page 4 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation...

  • Page 5: Table Of Contents

    Operation Manual 1 Introduction ....................1 1.1 Certifications..................................1 1.2 Intended Patient Population ............................1 1.3 Indications For Use ................................ 1 1.4 Contraindications ................................1 1.5 Restricted Sales ................................1 1.6 Required Training ................................1 1.7 Disclaimers..................................1 1.8 The Equipotential Connector (EPC)..........................2 1.9 Installation..................................
  • Page 6 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation 6.1 Injector Head Control ..............................25 6.2 Injector Head Components ............................26 6.2.1 Syringe Heat Maintainer ..........................26 6.2.2 Manual Knob..............................27 6.2.3 Arm Lights................................27 6.3 Handswitch ..................................27 7 Powering Up and Shutting Down the System......... 29 7.1 Power Up the System..............................29 7.2 Shut Down the System ..............................29 7.2.1 Hard Shutdown..............................29...
  • Page 7 Operation Manual 12 Removing Disposables ................57 13 Advanced Operations ................59 13.1 System Setup ................................59 13.1.1 System Setup Configurable Items ......................60 13.2 Setup of P3T Software Functionality........................61 13.2.1 P3T Setup Configurable Items........................61 13.3 Protocol Manager Setup............................62 13.3.1 Delete a Protocol.............................62 13.3.2 Rearrange Protocol List ..........................63 13.3.3 Hide/Show a Region ............................63 13.3.4 Rename a Region............................64...
  • Page 8 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation 16.1 Mounting Options..............................85 16.2 Injector Head Extension Cables..........................85 16.3 Workstation Extension Cables ..........................85 16.4 Accessories ...................................86 16.5 Manuals..................................86 16.6 Sterile Disposables ..............................86 17 Specifications ..................87 17.1 Workstation Specifications ............................87 17.1.1 Workstation Dimensions and Weight......................87 17.1.2 Workstation Connections ..........................88 17.1.3 Workstation Input Power Requirements ....................88 17.2 Workstation with Pod Specifications ........................89...

  • Page 9: Introduction

    Operation Manual 1 - 1 Introduction This manual applies to the MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation (Stellant FLEX with Certegra Workstation), also referred to as the system throughout this document, Catalog Numbers: FLEX. Read all the information contained in this manual. Understanding this information will assist users in operating the Stellant FLEX with Certegra Workstation in a safe manner.

  • Page 10: The Equipotential Connector (Epc)

    1 - 2 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation 1.8 The Equipotential Connector (EPC) The Equipotential Connector (EPC) is an electrically bonded terminal on the injector that is used as a connection point between other medical electrical equipment. The EPC’s function is to minimize any voltage potentials differences between all connected equipment.

  • Page 11: Symbols

    Operation Manual 2 - 3 Symbols 2.1 - General Symbols 2.2 - Injection System Buttons and Icons 2.1 General Symbols Warning: Refer to warnings and cautions on instructions for use packaged in each carton. (ISO 7010, W001) Attention: Refer to warnings and cautions on instructions for use packaged in each carton.
  • Page 12 2 - 4 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Indicates that the information is a warning. Warnings advise you of circumstances WARNING that could result in injury or death to the patient or operator. Read and understand the warnings before operating the injection system.
  • Page 13 Operation Manual 2 - 5 Keep Dry (ISO 15223-1, 5.3.4) Fragile, Handle With Care (ISO 15223-1, 5.3.1) Indicates that this device conforms to the requirements of the European Medical Device Directive 93/42/EEC. Identifies a type BF applied part complying with IEC 60601-1 standards. (IEC 60417, 5333) Medical - General Medical Equipment As To Electrical Shock, Fire, and Mechanical Hazards Only...
  • Page 14 2 - 6 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Identifies a terminal suitable for direct current. (IEC TR 60878, 5031) Identifies a transfer of displayed image to a second screen. (IEC TR 60878, 5892) Identifies a handswitch connection. (IEC TR 60878, 5322) Identifies an input terminal.

  • Page 15: Injection System Buttons And Icons

    Operation Manual 2 - 7 2.2 Injection System Buttons and Icons 2.2.1 Injector Head Icons Auto Fill Fill Load Prime Move Piston I Checked For Air Button/Icon Description Button/Icon Description Fill buttons: Activates the Fill buttons. Syringe A (green) Syringe B (blue) Adjusts volume to the desired amount in small increments/ Prime button...

  • Page 16: Display Buttons And Icons

    2 - 8 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Button/Icon Description Button/Icon Description Manual knob indicators (not Initiates the injection. shown): Holds the injection for a Syringe A (green) maximum of 20 minutes. Syringe B (blue) Identifies heat maintainer Identifies handswitch connection on underside of connection on underside of...

  • Page 17: Base Unit Icons

    Operation Manual 2 - 9 Button/Icon Description Button/Icon Description I Checked for Air confirmation icon. Illuminates yellow after If XDS is available, indicates the the operator has confirmed status of the XDS accessory. inspection of the fluid path for air. The Injector icon identifies various states of the injector: Indicates that the Informatics...
  • Page 18 2 - 10 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation...

  • Page 19: Warnings, Precautions, And Notices

    Operation Manual 3 - 11 Warnings, Precautions, and Notices 3.1 - Warnings 3.2 - Cautions 3.3 - Notices 3.1 Warnings WARNINGS Air Embolism Hazard - Serious patient injury or death may result. Use only disposables or accessories supplied by Bayer. Refer to 16.6 - Sterile Disposables.

  • Page 20: Cautions

    3 - 12 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation WARNINGS Hot surface Do not touch. Hazard Do not lean against the injection system when installed on any type of mounted configuration. 3.2 Cautions  CAUTIONS Mechanical Hazard - Minor or moderate patient and/or worker injury may result. Only use the system as defined in this manual.

  • Page 21: Notices

    Operation Manual 3 - 13 3.3 Notices NOTICE: Electro-Mechanical Hazard - Equipment damage may result. Allow the system to stabilize at room temperature before use due to condensation that may cause electrical damage. Mechanical Hazard - Equipment damage may result. Do not touch the display screen with a sharp object in order to perform the calibration.
  • Page 22 3 - 14 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation...

  • Page 23: System Overview

    Operation Manual 4 - 15 System Overview This section describes: 4.1 - System Diagram 4.2 - Fluid Delivery Basics 4.3 - Syringe Installation Features 4.4 - Programming Mode 4.5 - Basic Informatics 4.6 - Using the Pedestal with Integrated IV Pole 4.1 System Diagram The system is comprised of the injector head, a workstation, and base unit.

  • Page 24: Protocol

    4 - 16 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation 4.2.1 Protocol A protocol defines how the fluid injection procedure will proceed and is comprised of three elements: phases, a pressure limit, and an optional number of reminders. Phases are steps that define the actual movement of fluid. The pressure limit is a setting that governs the fluid pressure generated within the system during the injection sequence.

  • Page 25: Response To Occlusions

    Operation Manual 4 - 17 4.2.4.1 Flow Rate Reduction As flow rate is reduced, the resulting measured fluid pressure is decreased. The system continues to deliver the phase volume at this reduced flow rate resulting in a phase duration exceeding the targeted duration. 4.2.5 Response to Occlusions When injecting into an occlusion, a stall condition or high pressure disarm results.

  • Page 26: Programming Mode

    4 - 18 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation The disposable syringes also include six identical barcodes at the bottom of the barrel. The syringe can be installed without aligning the barcodes. When a syringe is installed, the system reads one of the barcodes to identify the syringe size and if the syringe has expired or has been installed multiple times.

  • Page 27: Understanding The Display And Workstation

    Operation Manual 5 - 19 Understanding the Display and Workstation 5.1 - Home Screen 5.2 - Workstation Descriptions 5.1 Home Screen Figure 5 - 1: Home Screen Name Description Shows the volume in the syringes. Volume Remaining An outline of the syringe displays if no syringe is present. A dotted line displays on the syringe graphic to indicate that there is not enough Add Volume volume in the syringe to complete the current protocol.
  • Page 28 5 - 20 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Name Description Date and Time Shows the current date and time. Protocol Name Displays the name of the protocol. Pressure Limit Displays the current pressure limit. Select to modify. Reminders Displays the number of set reminders.
  • Page 29 Operation Manual 5 - 21 Figure 5 - 3: Protocol Manager Name Description Region of Interest Shows list of folders in which protocols are stored. Protocol List List of protocols stored in the highlighted Region of Interest. Protocol Preview Displays details of selected protocol. View All Displays all stored protocols.

  • Page 30: Workstation Descriptions

    5 - 22 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Name Description Help Launches the Help system. Refer to 13.6 - Help for more information. Shutdown Accesses the Shutdown options. 5.2 Workstation Descriptions NOTE: Two models of the Certegra® Workstation can operate with the system. Buttons and icons will differ slightly with each model.
  • Page 31 Operation Manual 5 - 23 Figure 5 - 6: Workstation, Rear and Side Port View Icon Description Icon Description Identifies power input and Identifies computer network supply connection. connection. Identifies connection for screen Identifies USB connections. extension or transfer to a Port 4, identified with yellow second display.

  • Page 32: Workstation With Pod Buttons And Icons

    5 - 24 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation 5.2.2 Workstation with Pod Buttons and Icons Figure 5 - 7: Workstation with Pod NOTE: Pod and display connection icons not shown. Refer to 17.2.2 - Workstation with Pod, Pod Connections 17.2.3 - Workstation with Pod, Display Connections for more information.

  • Page 33: Understanding The Injector Head And Handswitch

    Operation Manual 6 - 25 Understanding the Injector Head and Handswitch 6.1 - Injector Head Control 6.2 - Injector Head Components 6.3 - Handswitch 6.1 Injector Head Control Auto Fill Fill Load Prime Move Piston I Checked For Air Figure 6 - 1: Injector Head Control Name Description Syringe A...

  • Page 34: Injector Head Components

    6 - 26 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Name Description Heat Maintainer Refer to 6.2.1 - Syringe Heat Maintainer for more information. (Side A or B) Syringe Installed - Indicates the volume loaded in the syringe. Volume Auto Load Active - Indicates the volume to be loaded into the syringe.

  • Page 35: Manual Knob

    Operation Manual 6 - 27 6.2.2 Manual Knob WARNING Air Embolism Hazard - Serious patient injury or death may result. Ensure patient is not connected while purging air from syringe, or engaging or advancing plunger Use the manual knob to purge air, check backflow of blood, and assist in ensuring correct catheter placement. NOTE: For all non-automatic movements, it is critical for volume accuracy to ensure that the manual knob is turned one full turn clockwise after every reverse movement.
  • Page 36 6 - 28 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation...

  • Page 37: Powering Up And Shutting Down The System

    Operation Manual 7 - 29 Powering Up and Shutting Down the System 7.1 Power Up the System  CAUTION Electric Shock Hazard - Minor or moderate patient and/or worker injury may result. Verify the voltage and frequency as labeled matches the voltage and frequency of the electrical outlet.
  • Page 38 7 - 30 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation...

  • Page 39: Protocol Management

    Operation Manual 8 - 31 Protocol Management 8.1 - Create or Edit a Protocol 8.2 - Save a Protocol 8.3 - Recall a Saved Protocol 8.4 - DualFlow WARNING Vessel Hazard - Serious patient injury or death may result. Ensure the programmed flow rate meets facility guidelines. 8.1 Create or Edit a Protocol Create and edit protocols from the Home screen.
  • Page 40 8 - 32 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Table 8 - 1: Phase Types Phase Type Description Hold Phase where the injection is stopped until it is restarted. Phase where the injection is stopped for a programmed amount of time. The injection resumes Pause when the pause time elapses.
  • Page 41 Operation Manual 8 - 33 Figure 8 - 3: Insufficient Syringe Volume Optionally, modify the default pressure limit. Select Pressure Limit. b. Select a pressure limit from the pick list. NOTE: Ensure that the pressure is set for the patient per facility guidelines. NOTE: Ensure the proper pressure is set for the catheter and other disposables connected to the system.

  • Page 42: Save A Protocol

    8 - 34 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation b. Select an empty reminder slot (2) to enter additional reminders, or select an existing reminder (2) to modify the parameter. Select Enter (3) when all reminders are entered. d.

  • Page 43: Dualflow

    Operation Manual 8 - 35 Figure 8 - 6: Recall Protocol To edit the protocol, refer to 8.1 - Create or Edit a Protocol. To use the protocol for an injection, refer to 10 - Arming Injecting. NOTE: Presets for P3T will be indicated with the P3T logo. For more information regarding P3T Presets, refer to the appropriate Certegra®...

  • Page 44: Programming A Dualflow Phase

    8 - 36 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation 8.4.2 Programming a DualFlow Phase Select a Phase button (1). Figure 8 - 7: Select Phase Button Select DualFlow (2). Enter the percentage of Contrast to be injected during the DualFlow phase. The system automatically calculates the percentage of Saline.
  • Page 45 Operation Manual 8 - 37 DualFlow automatically determines the individual volumes of Contrast and Saline and the individual flow rates needed for the Contrast and Saline portions of the DualFlow phase. For example, if the user enters a total Flow Rate of 4.0 mL/sec and a total Volume of 60 mL, the individual volume and flow rate of Contrast and Saline for the DualFlow phase would be as follows (based on the sample percentages of Contrast): Sample Ratio...
  • Page 46 8 - 38 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation...

  • Page 47: Preparing For Injection

    Operation Manual 9 - 39 Preparing for Injection 9.1 - Control Room Preparation 9.2 - Scan Room Preparation 9.1 Control Room Preparation WARNING Vessel Hazard - Serious patient injury or death may result. Ensure that the programmed flow rate meets facility guidelines. ...
  • Page 48 9 - 40 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Select View All to see all saved protocols. (2) iii. Select applicable protocol from list. (3) iv. Review all protocol values. (4) Select OK to use or edit the protocol. (5) vi.

  • Page 49: Scan Room Preparation

    Operation Manual 9 - 41 9.2 Scan Room Preparation WARNINGS Air Embolism Hazard - Serious patient injury or death may result. Expel all trapped air from the syringe(s), connectors, tubing, and catheter before connecting the system to the patient. Carefully read the instructions for loading and the use of the syringe Beacon and MEDRAD®...

  • Page 50: Fluid Detection Methods

    9 - 42 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation  CAUTION Mechanical Hazard - Patient injury could result if the syringe is not properly engaged. Ensure the syringe is properly snapped into the front of the injector head before injecting. Improper engagement or rotating syringe may cause the syringe to leak, to become damaged, or to come off during the injection, and can result in an under-volume delivery and the syringe becoming a projectile.

  • Page 51: Install And Fill A Syringe

    Operation Manual 9 - 43 To get the best visibility of the Beacon, the syringe should be viewed from an angle perpendicular to the syringe barrel, and the injector head must be in the upright (fill) position. Empty Syringe Full Syringe Partially Empty Syringe (5 mL or more of air) Figure 9 - 5: Beacon Visibility...
  • Page 52 9 - 44 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation NOTE: The syringe can be installed without aligning the barcodes. NOTE: Syringes can be loaded with any of the following four configurations: One (1) 150 mL syringe Two (2) 150 mL syringes One (1) 200 mL syringe Two (2) 200 mL syringes NOTE: If performing a contrast-only injection, place syringe onto Side A.

  • Page 53: Attach And Prime The Tubing

    Operation Manual 9 - 45 Remove filling device. Connect the disposable tubing as outlined in 9.2.3 - Attach and Prime the Tubing. 9.2.3 Attach and Prime the Tubing NOTICE: Mechanical Hazard - Equipment damage may result. Do not install disposables with excessive force. Remove the connector tube from the package.

  • Page 54: Connect The Tubing To Patient

    9 - 46 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Move Piston Prime (not recommended): Press Move Piston and use the piston controls to prime the tubing. NOTE: Leave the Prime Tube attached until immediately prior to patient connection. 9.2.4 Connect the Tubing to Patient WARNING Air Embolism Hazard - Serious patient injury or death may result.

  • Page 55: Arming And Injecting

    Operation Manual 10 - 47 Arming and Injecting 10.1 - Add Volume Indicator 10.2 - Arm the Injector 10.3 - Initiating an Injection 10.4 - Operator-Initiated Hold 10.5 - Injection Aborted 10.6 - Viewing Injection Progress 10.7 - Viewing Reminders 10.1 Add Volume Indicator Whenever the Total Volume is greater than the Volume Remaining, the Home Screen provides on-screen Add Volume indicators to communicate how much fluid should be added to perform the protocol (Figure 10 - 1: Add...
  • Page 56 10 - 48 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Figure 10 - 2: I Checked for Air Confirmation Select Yes to acknowledge that the user has confirmed that all air has been expelled from the syringe and tubing. NOTE: On the display, the I Checked for Air icon illuminates, and on the injector head, I Checked for Air confirmation button illuminates.

  • Page 57: Arm From The Scan Room

    Operation Manual 10 - 49 An injection has completed. NOTE: When armed, the injector head Arm button illuminates, the injector head Arm Lights blink, and the display shows a Disarm icon. 10.2.2 Arm from the Scan Room Press the I Checked for Air confirmation button on the injector head to acknowledge that the user has confirmed that all air has been expelled from the syringe and tubing.

  • Page 58: Operator-Initiated Hold

    10 - 50 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Press Start/Hold on the injector head, the workstation, or the handswitch. NOTE: Refer to Table 6 - 1 for description on how the Arm Lights function while armed, injecting, and/or during a hold.

  • Page 59: Viewing Reminders

    Operation Manual 10 - 51 Figure 10 - 4: Injection Views Name Description Pressure The graph shows the pressure sensed by the system during an injection. Graph Phase View The system highlights each phase as it starts. Shows the duration of the injection. Elapsed Time If a test injection is programmed, the elapsed time begins after the test injection.
  • Page 60 10 - 52 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation...

  • Page 61: Completing An Injection

    Operation Manual 11 - 53 Completing an Injection 11.1 - Injection Complete 11.2 - Injection Aborted 11.3 - Exiting Injection Complete 11.1 Injection Complete When an injection completes, the workstation and the injector head emit an audible tone, the Injection Completed screen displays a summary of injection parameters and the actual parameters delivered (Figure 11 - 1: Injection Complete - Summary), and the elapsed time of the injection continues to increment until the Injection Completed screen is exited.

  • Page 62: Injection Aborted

    11 - 54 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Figure 11 - 2: Injection Complete - Graph Select the left or right arrow to scroll through the injection history. Displays a graphical representation of the phases and pressure limits of the completed injection. NOTE: Elapsed time continues while this screen is displayed.

  • Page 63: Exiting Injection Complete

    Operation Manual 11 - 55 11.3 Exiting Injection Complete 11.3.1 Conducting Another Injection NOTE: The system resets the Reminders to zero when the Injection Completed screen is exited. NOTE: Depending on how Fluid Delivery Setup is configured, the protocol may reset after the injection. By default, the system keeps the previous protocol for the next injection.
  • Page 64 11 - 56 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation...

  • Page 65: Removing Disposables

    Operation Manual 12 - 57 Removing Disposables WARNING Biological Contamination Hazard - Serious patient and/or worker injury or death may result. Properly discard fluid source containers and disposable items after use (refer to disposable label for specifics), or if there is any possibility that contamination may have occurred. Do not reuse single-use fluid sources.
  • Page 66 12 - 58 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation...

  • Page 67: Advanced Operations

    Operation Manual 13 - 59 Advanced Operations 13.1 - System Setup 13.2 - Setup of P3T Software Functionality 13.3 - Protocol Manager Setup 13.4 - Fluid Delivery Setup 13.5 - Informatics Setup 13.6 - Help 13.7 - Fluid A 13.1 System Setup System Setup enables the configuration of settings that affect operation of the overall system.

  • Page 68: System Setup Configurable Items

    13 - 60 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Select a System Setup Option (Figure 13 - 2: Setup Screen (System Setup Screen Shown)). Figure 13 - 2: Setup Screen (System Setup Screen Shown) Set the parameter for the selected option (Figure 13 - 3: Option Parameters (System Setup Screen Shown)). Figure 13 - 3: Option Parameters (System Setup Screen Shown) Select OK.

  • Page 69: Setup Of P3T Software Functionality

    Operation Manual 13 - 61 Table 13 - 1: Configurable Items Configurable Item Description Date/Time Sets the system date and time. Date Format Sets the date format. Time Format Sets the time format. Reminder Audio Enables or disables audio for Reminders. Enables ISI if ISI is available.

  • Page 70: Protocol Manager Setup

    13 - 62 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation 13.3 Protocol Manager Setup Protocol Manager Setup manages the organization and display of protocols that are stored in the Protocol Manager. To create or edit a specific protocol, refer to 8.1 - Create or Edit a Protocol.

  • Page 71: Rearrange Protocol List

    Operation Manual 13 - 63 13.3.2 Rearrange Protocol List Select Protocol Manager. Select the desired folder, or select View All. Select the protocol name. Select Move Up or Move Down (Figure 13 - 7: Rearrange Protocol List). Figure 13 - 7: Rearrange Protocol List 13.3.3 Hide/Show a Region From the launch menu, select Setup.

  • Page 72: Rename A Region

    13 - 64 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation 13.3.4 Rename a Region From the launch menu, select Setup. Select Protocol Setup. Select the desired region. Select RENAME (Figure 13 - 9: Rename a Region). Figure 13 - 9: Rename a Region Enter the name, and select Enter.

  • Page 73: Fluid Delivery Setup Configurable Items

    Operation Manual 13 - 65 13.4.1 Fluid Delivery Setup Configurable Items Table 13 - 3: Configurable Items Configurable Item Description Sets the injector to prime both syringes simultaneously or one after the other. The Simultaneous mode controls fluid movement through the union connector, moving both saline and contrast simultaneously during the priming process.

  • Page 74: Informatics Setup

    13 - 66 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Table 13 - 3: Configurable Items Configurable Item Description Reset Protocol after Sets whether or not the protocol is reset to the factory default protocol after an Injection injection completes.

  • Page 75: Fluid A

    Operation Manual 13 - 67 The Help screen will display (Figure 13 - 12: Help System Navigation). Figure 13 - 12: Help System Navigation 13.7 Fluid A Select the Fluid A button to open a pop-up window that shows the most recent Fluid A (contrast) values entered. Keep these values by pressing OK, or select and enter new values by pressing Cancel.
  • Page 76 13 - 68 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation...

  • Page 77: Troubleshooting

    Operation Manual 14 - 69 Troubleshooting 14.1 Injector Head Error Indication 14.2 Error Screen 14.3 Other Troubleshooting Tips 14.4 System Tones 14.1 Injector Head Error Indication The LEDs on the injector head will blink when the system encounters an error. Refer to any error messages that appear on the workstation to recover from the error.
  • Page 78 14 - 70 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation The following is a list of error messages the injection system could display and corrections for those issues. Table 14 - 1: Error Screen Messages Error Message Related Warning Explanation The system compares the syringe manufacturing date to the date the syringe is installed on the system.
  • Page 79 Operation Manual 14 - 71 Table 14 - 1: Error Screen Messages Error Message Related Warning Explanation The system is intended to be used with contrast and saline syringes that are the same volume for a patient injection. If a 150 mL syringe and a 200 mL syringe are both inserted on the system, an error message occurs.

  • Page 80: Other Troubleshooting Tips

    14 - 72 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Table 14 - 1: Error Screen Messages Error Message Related Warning Explanation An error message occurs if the system was unable to read Syringe barcode reader the barcode on a syringe from Bayer. To correct the error: is unresponsive on side Press Shutdown on the Launch menu.

  • Page 81: General Tones

    Operation Manual 14 - 73 14.4.1 General Tones Both the Certegra Workstation and the injector head produce General Tones as a result of key presses and soft button interaction. In many cases, these tones have system settings that can control the volume, and in some cases, these General Tones may be turned off.
  • Page 82 14 - 74 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation...

  • Page 83: Cleaning And Maintenance

    Operation Manual 15 - 75 Cleaning and Maintenance 15.1 - In the Case of Saline or Contrast Media Spills 15.2 - Daily and In the Case of Visible Contamination 15.3 - Daily 15.4 - Monthly 15.5 - Annually 15.6 - Reinstalling the System in Another Room WARNINGS Electro-Mechanical Hazard - Serious injury or death may result from exposure to hazardous voltages existing within the system.

  • Page 84: In The Case Of Saline Or Contrast Media Spills

    15 - 76 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation NOTE: If contrast media has leaked inside any component of the system, contact Bayer for service. NOTE: Failures that occur due to lack of proper maintenance will not be covered under warranty. NOTE: Bayer will make available upon request: •...

  • Page 85: Daily And In The Case Of Visible Contamination

    Operation Manual 15 - 77 Turn off power to the injector. Clean the injector head surfaces (excluding pistons and syringe interface, refer to Figure 15 - 3: Piston) with a clean, soft, non-linting wipe dampened with warm water (wet, but not dripping) for a minimum of 1 minute and until visibly clean.

  • Page 86: Disinfecting The Injector Head

    15 - 78 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Materials: Clean, soft, non-linting wipe Warm water Cleaning Agent: Use either Sani-Cloth® Plus Germicidal Disposable Cloth (EPA registration # 9480-6) or CaviWipes™ Disinfecting Towelettes (EPA registration # 46781-8) within the United States except where noted. Use either Sani-Cloth®...

  • Page 87: Daily

    Operation Manual 15 - 79 NOTE: If in a country where Sani-Cloth® Plus or CaviWipes™ are not available, and using an equivalent disinfecting agent (refer to the materials listed above), follow the same instructions specified in step 2. Using Sani-Cloth® Plus or CaviWipes™, allow surfaces to remain visibly wet for 3 minutes. If needed, use additional wipes to ensure the surfaces remain wet for the full duration.

  • Page 88: Cleaning The Pistons, Syringe Interface, And Light Pipe

    15 - 80 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation 15.3.3 Cleaning the Pistons, Syringe Interface, and Light Pipe NOTICE: Electro-Mechanical Hazard - Equipment damage may result. Do not use cleaning agents containing quaternary ammonium compounds such as Sani-Cloth® Plus and/or ethyl alcohol, such as Lysol®...
  • Page 89 Operation Manual 15 - 81 Thoroughly dry the pistons using a dry, clean, soft, non-linting wipe. Inspect the syringe pistons to ensure all surfaces are clean. If any visible contrast media or other debris is evident, repeat cleaning instructions steps 4 through 6 until no visible soil is detected.

  • Page 90: Cleaning The Pedestal With Integrated Iv Pole, Overhead Counterpoise System (Ocs), And Base

    15 - 82 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation 15.3.4 Cleaning the Pedestal With Integrated IV Pole, Overhead Counterpoise System (OCS), and Base NOTICE: Electro-Mechanical Hazard - Equipment damage may result. Do not use chlorine bleach or bleach equivalents on the pedestal. Frequency: Daily Material: Clean, soft, non-linting wipe...

  • Page 91: Monthly

    Operation Manual 15 - 83 Material: Clean, soft, non-linting wipe Warm water Cleaning Agent: Use either Sani-Cloth® Plus Germicidal Disposable Cloth (EPA registration # 9480-6) or CaviWipes™ Disinfecting Towelettes (EPA registration # 46781-8) within the United States. Use either Sani-Cloth® Plus Germicidal Disposable Cloth or CaviWipes™ Disinfecting Towelettes in all other countries.

  • Page 92: Annually

    15 - 84 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Ensure the heat maintainers are connected. Fully advance and reverse the pistons by using the Move Piston button and the forward/reverse piston controls. Ensure Auto Advance and Auto Retract are enabled. Enter and lock the following protocol: Flow Volume...

  • Page 93: Options And Accessories

    Operation Manual 16 - 85 Options and Accessories 16.1 - Mounting Options 16.2 - Injector Head Extension Cables 16.3 - Workstation Extension Cables 16.4 - Accessories 16.5 - Manuals 16.6 - Sterile Disposables NOTICE: Equipment damage may result or system may fail to operate. The system is meant to connect with the specific devices listed in 16 - Options and Accessories, and...

  • Page 94: Accessories

    16 - 86 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation 16.4 Accessories Catalog Number Description SSH 200F Syringe Heat Maintainer SHS 700 05 Handswitch ISI 700 Imaging System Interface Device ISI 800 Imaging System Interface Device ISI 900H Imaging System Interface Device (Hitachi) ISI 900G Imaging System Interface Device (General Electric)

  • Page 95: Specifications

    Operation Manual 17 - 87 Specifications 17.1 - Workstation Specifications 17.2 - Workstation with Pod Specifications 17.3 - Base Unit Specifications 17.4 - Injector Head Specifications 17.5 - Environmental Specifications 17.6 - Over and Under Infusion Protection 17.7 - System Fluid Performance 17.8 - Power Cable Specifications 17.9 - Cybersecurity and IT Network Connection 17.10 - Fuse Specification...

  • Page 96: Workstation Connections

    17 - 88 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation 17.1.2 Workstation Connections Description Description Power input and supply connection NOTE: For the power input and supply connection, the Workstation requires use of a Listed Class 2, LPS, or Listed Information Computer network connection Technology Equipment...

  • Page 97: Workstation With Pod Specifications

    Operation Manual 17 - 89 17.2 Workstation with Pod Specifications 17.2.1 Workstation with Pod Dimensions and Weight NOTE: Listed weight and dimensions are approximate. 15. in 39. cm 12.7 in 32. cm 10.5 in 10.2 in 26. cm Weight: 17.6 lbs (8.0 kg) 17.2.2 Workstation with Pod, Pod Connections Icon Description...

  • Page 98: Workstation With Pod, Display Connections

    17 - 90 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Identifies injector head connection 17.2.3 Workstation with Pod, Display Connections NOTE: Display connections shown are for Bayer use only. Icon (if Icon (if Description Description applicable) applicable) Connection not applicable for Indicates power switch for MEDRAD®...

  • Page 99: Base Unit Specifications

    Operation Manual 17 - 91 17.3 Base Unit Specifications 17.3.1 Base Unit Dimensions and Weight NOTE: Listed weight and dimensions are approximate. 11.3 in. 28.6 cm 9.0 in. 11.0 in. 27.9 cm 22.9 cm Weight: 13.6lbs (6.17 kg)

  • Page 100: Base Unit Connections

    17 - 92 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation 17.3.2 Base Unit Connections Equipotential connection Power connection Injector head cable clamp Service connection (J112) Future use (P115) Workstation connection (P108) Injector head connection (J113) 17.3.3 Base Unit Input Power Requirements NOTE: Base unit input power requirements apply to the system as the system receives its power through the base unit.

  • Page 101: Injector Head Specifications

    Operation Manual 17 - 93 17.4 Injector Head Specifications 17.4.1 Injector Head Dimensions and Weight NOTE: Listed weight and dimensions are approximate. 20.5 in. 51.1 cm 14.4 in. 36.6 cm 59.5 in. 51.0 in. 129.1 cm 151.1 cm 24.8 in. 33.0 in.

  • Page 102: Protection Against Electrical Shock

    17 - 94 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation 17.5.3 Protection Against Electrical Shock Per IEC 60601-1, the system is designed as a Class 1 or 2 Medical Device with a type BF applied part. Type BF corresponds to the degree of protection against electrical shock by the applied part of the Medical Device. Class 1 Equipment requires a protective earth connection (electrical grounding) to ensure protection against electrical shock in the event of a failure of the basic insulation system.

  • Page 103: Over And Under Infusion Protection

    Operation Manual 17 - 95 Table 17 - 1: Fluid Delivery Performance Description Specification Programmable Pressure Pressure Limit selections (PSI / kPa): Choice of 50/345, 100/689, 150/1034, 200/ limit (PSI / kPa) 1379, 225/1551, 250/1724, 300/2068, 325/2241 Pause 1 second to 900 seconds in 1 second increments Hold Maximum Hold time is 20 minutes Syringes (Volume Capacity)

  • Page 104: Factors Affecting Flow Rates

    17 - 96 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation 17.7.1 Factors Affecting Flow Rates An injector's ability to generate pressure is only one factor affecting maximum flow rates. Other factors include: Catheter diameter Viscosity (thickness) of the fluid Tube length Number of tubing sections Tube diameter...

  • Page 105: Power Cable Specifications

    Operation Manual 17 - 97 Table 17 - 3: Programmable Pressure System Performance Programmed Pressure High Pressure Disarm Limit 50 psi (345 kPa) 100 psi (689 kPa) 17.8 Power Cable Specifications The specifications required by the injection system relative to the power cable (plug, receptacle, and cord) are: Operating temperature: 60 °C minimum Receptacle type: IEC 60320 C13 Normal cord voltage: 300 VAC minimum...

  • Page 106: Fuse Specification

    17 - 98 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Changes in the IT Network configuration Connecting additional items to the IT Network Disconnecting items from the IT Network Updating equipment connected to the IT Network Upgrading equipment connected to the IT Network 17.10 Fuse Specification FUSE,3.15A,250V,5X20MM,IEC TYPE T, HIGH.

  • Page 107: Addendum - Compliance To Iec 60601-1-2: 3Rd And 4Th Editions

    Operation Manual 18 - 99 Addendum – Compliance to IEC 60601-1-2: 3rd and 4th Editions The MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation complies with the requirements of: IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests CISPR 11: Industrial, scientific and medical (ISM) radio-frequency equipment - Electromagnetic disturbance characteristics - Limits and methods of measurement...
  • Page 108 18 - 100 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation  CAUTION Electro-magnetic Hazard - Equipment damage may result or system may fail to operate. System may disarm or fail to operate when exposed to high magnetic fields. Portable and mobile RF communications equipment can affect the system.
  • Page 109 Operation Manual 18 - 101 Guidance and manufacturer’s declaration - electromagnetic immunity The system is intended for use in the electromagnetic environment specified below. The customer or user of the system should assure that it is used in such an environment. Immunity test IEC 60601 test Compliance level Electromagnetic environment - guidance...
  • Page 110 18 - 102 MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Guidance and manufacturer's declaration - electromagnetic immunity 3Vrms from 80 MHz to 2.7 GHz at 80% AM 1kHz and specific ISM bands listed below: 1.17 p 80 MHz to 800 MHz Field Frequency Modulation...
  • Page 112 Bayer reserves the right to modify the specifications and features described herein or to discontinue any product or service identified in this publication at any time without prior notice or obligation. Please contact your authorized Bayer representative for the most current information. All patient data that appear in this document are fictitious.

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