Bayer HealthCare MEDRAD Stellant Operation Manual
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Bayer HealthCare MEDRAD Stellant Operation Manual

Ct injection system
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MEDRAD® Stellant CT Injection System
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with Certegra® Workstation
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Summary of Contents for Bayer HealthCare MEDRAD Stellant

  • Page 1 Operation Manual MEDRAD® Stellant CT Injection System with Certegra® Workstation...
  • Page 3 Stellant CT ® MEDRAD Injection System with Certegra Workstation ® Operation Manual ® ® The MEDRAD Stellant 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.
  • Page 4 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation...

  • Page 5: Table Of Contents

    Table of Contents Table of Contents 1 Introduction ..............................1 - 1 1.1 Certifications ............................1 - 1 1.2 Intended Patient Population ........................ 1 - 1 1.3 Indications for Use..........................1 - 1 1.4 Contraindications..........................1 - 1 1.5 Restricted Sales ..........................1 - 1 1.6 Required Training ..........................
  • Page 6 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 6.2.1 Syringe Heat Maintainer ......................6 - 24 6.2.2 Manual Knob........................... 6 - 25 6.2.3 Arm Lights ..........................6 - 25 6.3 Handswitch ............................6 - 25 7 Powering Up and Shutting Down the System..................... 7 - 27 7.1 Power Up the System ........................
  • Page 7 Table of Contents 13.3.4 Rename a Region ........................ 13 - 57 13.4 Fluid Delivery Setup........................13 - 58 13.4.1 Fluid Delivery Setup Configurable Items ................13 - 58 13.5 Informatics Setup ......................... 13 - 60 13.6 Help ............................. 13 - 60 13.6.1 Accessing the Help System ....................
  • Page 8 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 17.2.3 Workstation with Pod, Display Connections ................. 17 - 82 17.2.4 Workstation with Pod, Display Input Power Requirements............ 17 - 83 17.3 Base Unit Specifications ....................... 17 - 84 17.3.1 Base Unit Dimensions and Weight ..................17 - 84 17.3.2 Base Unit Connections......................

  • Page 9: Introduction

    Introduction ® ® This manual applies to the MEDRAD Stellant CT Injection System with Certegra Workstation (Stellant with Certegra Workstation), also referred to as the system throughout this document, System Catalog Numbers: SCT-310, SCT-321, SCT-322. Read all the information contained in this manual. Understanding this information will assist users in operating the Stellant with Certegra Workstation in a safe manner.

  • Page 10: The Equipotential Connector (Epc)

    ® ® MEDRAD Stellant 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

    Symbols • "General Symbols" • "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 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation Indicates that the information is a caution. Cautions advise you of CAUTION circumstances that could result in minor or moderate injury to the patient or operator. Read and understand the cautions before operating the injection system.
  • Page 13 Symbols This Side Up (ISO 7000, 0623) 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 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation Identifies an input terminal. (IEC TR 60878, 5034) Identifies an output terminal. (IEC TR 60878, 5035) Identifies a terminal suitable for direct current. (IEC TR 60878, 5031) Identifies an on/off switch for equipment. (IEC TR 60878, 5009) Identifies a computer network.

  • Page 15: Injection System Buttons And Icons

    Symbols 2.2 Injection System Buttons and Icons 2.2.1 Injector Head Icons 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 decrements.

  • Page 16: Display Buttons And Icons

    ® ® MEDRAD Stellant 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 maximum • Syringe A (green) of 20 minutes. • Syringe B (blue) Identifies heat maintainer Identifies handswitch connection connection on underside of on underside of injector head (not...

  • Page 17: Base Unit Icons

    Symbols Button/Icon Description Button/Icon Description The Check for Air icon illuminates yellow when the operator has If XDS is available, indicates status confirmed inspecting the fluid of the XDS accessory. path for air. The Injector icon identifies various states of the injector: •...
  • Page 18 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 2 - 10...

  • Page 19: Warnings, Precautions, And Notices

    Warnings, Precautions, and Notices • "Warnings" • "Cautions" • "Notices" 3.1 Warnings WARNING Air Embolism Hazard - Serious patient injury or death may result. • Use only disposables or accessories supplied by Bayer. Refer to "Sterile Disposables" • Use catheters and connectors with pressure ratings compatible with this system. Refer to "Maximum Flow Rate Performance"...

  • Page 20: Cautions

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 3.2 Cautions CAUTION Mechanical Hazard - Minor or moderate patient and/or worker injury may result. • Only use the system as defined in this manual. Follow the system communication if a system fault is communicated or in the event of a system malfunction.

  • Page 21: System Overview

    System Overview • "System Diagram" • "Fluid Delivery Basics" • "Syringe Installation Features" • "Programming Mode" • "Basic Informatics" • "Using the Pedestal with Integrated IV Pole" 4.1 System Diagram The system is comprised of the injector head, a workstation, and base unit. The three components are connected by a communications link.

  • Page 22: Protocol Manager

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation system during the injection sequence. Reminders are user-determined timing notifications to be gener- ated during the injection sequence. 4.2.1.1 Phase There are three types of phases: • Fluid Delivery Phase: Defines the flow rate, volume, and duration of a fluid to be injected. •...

  • Page 23: Response To Occlusions

    System Overview 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 24: Programming Mode

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 4.4 Programming Mode After values for any two parameters are entered, the system calculates the value for the third. By default, values for flow rate and volume are entered, and the system calculates duration. Programming Mode is used to toggle the value calculated by the system.

  • Page 25: Understanding The Display And Workstation

    Understanding the Display and Workstation • "Home Screen" • "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 Add Volume is not enough volume in the syringe to complete the current...
  • Page 26 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation Name Description Reset Resets the protocol to the default factory values. Date and Time Shows the current date and time. Protocol Name Displays the name of the protocol. Pressure Limit Displays the current pressure limit.
  • Page 27 Understanding the Display and Workstation 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 28: Workstation Descriptions

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation Name Description Launches the Help system. Refer to "Advanced Operations" Help more information. Shutdown Accesses the Shutdown options. 5.2 Workstation Descriptions ® NOTE: Three models of the Certegra Workstation can operate with the system. Buttons and icons will differ slightly with each model.
  • Page 29 Understanding the Display and Workstation 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 Identifies USB connections. screen extension or transfer to Port 4, identified with yellow a second display.

  • Page 30: Workstation With Pod Buttons And Icons

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 5.2.2 Workstation with Pod Buttons and Icons NOTE: The Workstation with Pod comes in black or white. White model pictured below. Figure 5 - 7: Workstation with Pod NOTE: Pod and display connection icons not shown. Refer to "Workstation with Pod, Pod Connections"...

  • Page 31: Understanding The Injector Head And Handswitch

    Understanding the Injector Head and Handswitch • "Injector Head Control" • "Injector Head Components" • "Handswitch" 6.1 Injector Head Control Figure 6 - 1: Injector Head Control Name Description Syringe A Contrast syringe 6 - 23...

  • Page 32: Injector Head Components

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation Name Description Syringe B Saline syringe Heat Maintainer Refer to "Syringe Heat Maintainer" for more information. (Side A or B) • Syringe Installed - Indicates the volume loaded in the syringe.

  • Page 33: Manual Knob

    Understanding the Injector Head and Handswitch 6.2.2 Manual Knob WARNING Air Embolism Hazard - Serious patient injury or death may result. • Ensure that patient is not connected while purging air from syringe, or engaging or advancing plunger. An operator can use the manual knob to purge air, check backflow of blood, and to assist in ensuring correct catheter placement.
  • Page 34 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 6 - 26...

  • Page 35: Powering Up And Shutting Down The System

    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 that the voltage and frequency as labeled matches the voltage and frequency of the electrical outlet.
  • Page 36 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 7 - 28...

  • Page 37: Protocol Management

    Protocol Management • "Create or Edit a Protocol" • "Save a Protocol" • "Recall a Saved Protocol" • "DualFlow" WARNING Vessel Hazard - Serious patient injury or death may result. • Ensure that the programmed flow rate meets facility guidelines. 8.1 Create or Edit a Protocol Create or edit protocols from the Home screen.
  • Page 38 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation NOTE: A user may delete phases from a protocol. The Delete functionality is only available when editing a protocol with more than one phase. NOTE: A test injection can be used to confirm that the catheter is properly placed. NOTE: A hold phase cannot be the first phase in a protocol.

  • Page 39: Save A Protocol

    Protocol Management Figure 8 - 3: Enter Reminders b. Select an empty reminder slot (2) to enter additional reminders, or select an existing reminder (2) to modify the parameter. c. Select Enter (3) when all reminders are entered. d. Enter the time (4) for the reminder in minutes and seconds. e.

  • Page 40: Recall A Saved Protocol

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 8.3 Recall a Saved Protocol 1. Select Protocol Manager. 2. Select the desired region or select View All (1). Refer to Figure 8 - 5: Recall Protocol. 3. Select the protocol name (2). 4.

  • Page 41: Programming A Dualflow Phase

    Protocol Management 8.4.2 Programming a DualFlow Phase 1. Select a Phase button (1). Figure 8 - 6: Select Phase Button 2. Select DualFlow (2). 3. Enter the percentage of Contrast to be injected during the DualFlow phase. The system auto- matically calculates the percentage of Saline.
  • Page 42 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 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 43: Preparing For Injection

    Preparing for Injection • "Control Room Preparation" • "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. CAUTION Minor or moderate patient injury may result. •...

  • Page 44: Scan Room Preparation

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation Figure 9 - 2: Create a Protocol Select an arrow to create a phase. (1) ii. Choose a phase type from the list. (2) iii. Add/edit volumes and flow rates. (3) iv.

  • Page 45: Fluid Detection Methods

    Preparing for Injection WARNING Environmental Contamination Hazard - Serious patient or worker injury or death may result. • Follow aseptic technique when handling disposable components. Specifically, maintain sterility of all disposable components. • Do not disassemble any disposable components. • Visually inspect contents and package before each use.

  • Page 46: Install And Fill A Syringe

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation Empty Syringe Filled Syringe Figure 9 - 3: FluiDots FluiDots must be viewed through fluid in the syringe. If viewed through an empty syringe, they will not change shape. FluiDots must be viewed in a properly illuminated environment providing enough light to permit easy viewing.

  • Page 47: Attach And Prime The Tubing

    Preparing for Injection NOTE: The system draws in the configured Auto Load Purge Volume and then expels this volume. The Auto Load Purge volume should be set to 30, 20, 10, or 0 mL, depending on the filling device. Refer to "Fluid Delivery Setup".

  • Page 48: Connect The Tubing To Patient

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation NOTE: Use the appropriate fluid to prime the tubing. (Syringe A is the contrast syringe and Syringe B is the saline syringe.) c. 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.

  • Page 49: Arming And Injecting

    Arming and Injecting • "Add Volume Indicator" • "Arm the Injector" • "Initiating an Injection" • "Operator-initiated Hold" • "Injection Aborted" • "Viewing Injection Progress" • "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.
  • Page 50 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation Figure 10 - 2: Check for Air Confirmation a. 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 Check for Air icon illuminates, and on the injector head, Check for Air button illuminates.

  • Page 51: Arm From The Scan Room

    Arming and Injecting 10.2.2 Arm from the Scan Room 1. Press the Check for Air button on the injector head to acknowledge that the user has con- firmed that all air has been expelled from the syringe and tubing. NOTE: If the last piston movement was a reverse movement, or if a syringe required by the protocol is not present, the system does not permit arming and communicates this to the operator.

  • Page 52: Operator-Initiated Hold

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation NOTE: Hold Phase - If the protocol contains a Hold Phase, the system holds the injection until the operator presses Start/Hold on the injector head, workstation, or handswitch to resume the protocol.

  • Page 53: Viewing Reminders

    Arming and Injecting Pressure Limit Displays the programmed pressure limit on the pressure graph. Line Injection Displays the injection. Information Indicators of Start Shows the start of each phase. of Phase NOTE: Elapsed time continues during an operator-initiated Hold. NOTE: The Pause symbol and Injector icon will blink during either an operator-initiated Hold or a Programmed Hold.
  • Page 54 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 10 - 46...

  • Page 55: Completing An Injection

    Completing an Injection • "Injection Complete" • "Injection Aborted" • "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.

  • Page 56: Injection Aborted

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation Figure 11 - 2: Injection Complete - Graph 1. Select the left or right arrow to scroll through the injection history. 2. Displays a graphical representation of the phases and pressure limits of the completed injec- tion.
  • Page 57 Completing an Injection 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. 1. Select Same Patient. a. The operator is returned to the Home screen. b.
  • Page 58 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 11 - 50...

  • Page 59: Removing Disposables

    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.
  • Page 60 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 12 - 52...

  • Page 61: Advanced Operations

    Advanced Operations • "System Setup" • "Setup of P3T Software Functionality" • "Protocol Manager Setup" • "Fluid Delivery Setup" • "Informatics Setup" • "Help" • "Fluid A" 13.1 System Setup System Setup enables the operator to configure settings that affect operation of the overall system. 1.

  • Page 62: System Setup Configurable Items

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 4. Set the parameter for the selected option. Refer to Figure 13 - 3: Option Parameters (System Setup Screen Shown). Figure 13 - 3: Option Parameters (System Setup Screen Shown) 5.

  • Page 63: Setup Of P3T Software Functionality

    Advanced Operations 13.2 Setup of P3T Software Functionality NOTE: The P3T functionality described in this section are separately licensable and purchasable options. 1. From the launch menu, select Setup. 2. Select P3T Preset Setup. Refer to Figure 13 - 4: Setup Categories (P3T Setup). Figure 13 - 4: Setup Categories (P3T Setup) 13.2.1 P3T Setup Configurable Items Table 13 - 2: Configurable Items.

  • Page 64: Protocol Manager Setup

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 13.3 Protocol Manager Setup Protocol Manager Setup enables the operator to manage the organization and display of protocol that are stored in the Protocol Manager. To create or edit a specific protocol, refer to "Create or Edit a Pro- tocol"...

  • Page 65: Rearrange Protocol List

    Advanced Operations 13.3.2 Rearrange Protocol List 1. Select Protocol Manager. 2. Select the desired folder or select View All. 3. Select the protocol name. 4. Select Move Up or Move Down. Refer to Figure 13 - 7: Rearrange Protocol List. Figure 13 - 7: Rearrange Protocol List 13.3.3 Hide/Show a Region 1.

  • Page 66: Fluid Delivery Setup

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 4. Select Rename. Refer to Figure 13 - 9: Rename a Region. Figure 13 - 9: Rename a Region 5. Enter the name, and select Enter. 6. Select OK, and select Yes on the confirmation window to rename a region. 13.4 Fluid Delivery Setup Fluid Delivery Setup enables the operator to configure settings that affect the operation of the fluid delivery system specifically.
  • Page 67 Advanced Operations 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 Mode priming process.

  • Page 68: Informatics Setup

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 13.5 Informatics Setup ® Refer to the Certegra Applications and Workstation Accessories manual for instructions on Informat- ics setup. 13.6 Help This section provides instructions on how to access and use the Help system from the Launch Menu. 13.6.1 Accessing the Help System 1.

  • Page 69: Fluid A

    Advanced Operations 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. Refer ®...
  • Page 70 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 13 - 62...

  • Page 71: System Messages

    System Messages • "Injector Head Error Indication" • "Error Screen" • "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 mes- ® sages that appear on the Certegra Workstation to recover from the error.

  • Page 72: Notification Tones

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 14.3.2 Notification Tones Notification Tones are also generated by both the Certegra Workstation as well as the injector head. As these tones are intended to notify the user of items requiring attention or an action to be taken, with few exceptions, these tones cannot be turned off or reduced in volume.

  • Page 73: Cleaning And Maintenance

    Cleaning and Maintenance • "In the Case of Saline or Contrast Media Spills" • "Daily and In the Case of Visible Contamination" • "Daily" • "Monthly" • "Annually" • "Reinstalling the System in Another Room" WARNING Electro-Mechanical Hazard - Serious injury or death may result from exposure to hazardous voltages existing within the system.

  • Page 74: In The Case Of Saline Or Contrast Media Spills

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 15.1 In the Case of Saline or Contrast Media Spills NOTICE Electro-Mechanical Hazard - Equipment damage may result. • Do not use cleaning agents containing quaternary ammonium compounds (e.g. dimethyl ®...

  • Page 75: Daily And In The Case Of Visible Contamination

    Cleaning and Maintenance ping) for a minimum of 1 minute and until visibly clean. Replace wipe if wipe becomes visibly soiled. During the 1 minute cleaning time, make certain that all seams, recessed areas and buttons are clean. Refer to "Cleaning the Pistons and Syringe Interface"...

  • Page 76: Disinfecting The Injector Head

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation Frequency: Daily and In the Case of Visible Contamination Materials: • Clean, soft, non-linting wipe • Warm water • Cleaning Agent: ® • Use either Sani-Cloth Plus Germicidal Disposable Cloth (EPA registration # 9480-6) or CaviWipes™...

  • Page 77: Daily

    Cleaning and Maintenance 1. Ensure the injector head has been thoroughly cleaned. Refer to "Cleaning the Injector Head". ® 2. Use Sani-Cloth Plus or CaviWipes™ to thoroughly wipe all external surfaces with the exception of the syringe piston and syringe interface. Make certain that all seams, recessed areas, and buttons are clean.

  • Page 78: Cleaning The Pistons And Syringe Interface

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 15.3.3 Cleaning the Pistons and Syringe Interface 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 on the syringe pistons or syringe...

  • Page 79: Cleaning The Pedestal With Integrated Iv Pole, Overhead Counterpoise System (Ocs), And Base.15

    Cleaning and Maintenance 7. If any visible contrast media or other debris is evident, repeat cleaning instructions steps 4 through 6 until no visible soil is detected. 15.3.3.2 Syringe Interface Figure 15 - 4: Syringe Interface Materials: • Clean, soft, non-linting wipe •...

  • Page 80: Cleaning The Workstation Screen

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation ® • 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™...

  • Page 81: Monthly

    Cleaning and Maintenance ® 2. Wipe the workstation screen with Sani-Cloth Plus or CaviWipes™ for 1 minute or until visi- bly clean. ® NOTE: If in a country where Sani-Cloth Plus or CaviWipes™ are not available, and using an equivalent cleaning agent (refer to the materials listed above), follow the same instructions specified in step 2.

  • Page 82: Annually

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 5. Install syringes and ensure the piston automatically docks and fully advances the syringe plungers. 6. Perform Auto Load. 7. Arm and initiate an injection. 8. In one of the phases, activate the HOLD feature for at least 10 seconds. 9.

  • Page 83: Options And Accessories

    Options and Accessories • "Mounting Options" • "Injector Head Extension Cables" • "Workstation Extension Cables" • "Accessories" • "Manuals" • "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 "Options and Accessories", and should not be used with other medical devices or medical device technologies.

  • Page 84: Accessories

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 16.4 Accessories Catalog Number Description SSH 200F Syringe Heater 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) ISI 900S...
  • Page 85 Options and Accessories Catalog Number Description SSS-LP-60-T 60” Low Pressure Connector Tubing with 6” “T” Connector and Prime Tube SJS-LP-60-T-J 60" Low Pressure Connector Tubing with 14" "T" Connector and Prime Tube LP-96-T-CV 96" Low Pressure Connector Tubing with "T" Connector and Check Valve 16 - 77...
  • Page 86 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 16 - 78...

  • Page 87: Specifications

    Specifications • "Workstation Specifications" • "Workstation with Pod Specifications" • "Base Unit Specifications" • "Injector Head Specifications" • "Environmental Specifications" • "Over and Under Infusion Protection" • "System Fluid Performance" • "Power Cable Specifications" • "Injection System Cybersecurity and IT Network Connection" •...

  • Page 88: Workstation Connections

    ® ® MEDRAD Stellant 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 (ITE) power supply with output rated 12Vdc, minimum 6A,...

  • Page 89: Workstation With Pod Specifications

    17.2 Workstation with Pod Specifications NOTE: Listed weight and dimensions are approximate. 17.2.1 Workstation with Pod Dimensions and Weight Workstation Workstation with Pod (Black) with Pod (White) 15.75 in 15.58 in 40.00 cm 39.58 cm 13.46 in 12.71 in 34.19 cm 32.28 cm 10.50 in 10.50 in...

  • Page 90: Workstation With Pod, Display Connections

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation Identifies input and output connections not applicable for Identifies ethernet connection (for ® connecting to the display). MEDRAD Stellant. Not for use with the system. Identifies injector head connection. 17.2.3 Workstation with Pod, Display Connections NOTE: Display connections shown are for Bayer use only.

  • Page 91: Workstation With Pod, Display Input Power Requirements

    Connection not applicable for ® USB connection MEDRAD Stellant. Not for use with the system. 17.2.3.2 White Display Connections Icon (if Icon (if Description Description applicable) applicable) Connection not applicable for ® Indicates power switch for display. MEDRAD Stellant. Not for use with the system.

  • Page 92: Base Unit Specifications

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 17.3 Base Unit Specifications 17.3.1 Base Unit Dimensions and Weight NOTE: Listed weight and dimensions are approximate. Weight: 13.6lbs (6.17 kg) 17.3.2 Base Unit Connections Equipotential connection Power connection Injector head cable clamp Service connection(J112) Future use (P115) Workstation connection (P108)

  • Page 93: Base Unit Input Power Requirements

    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. 100-240 VAC 50-60 Hz 300 VA 17.4 Injector Head Specifications 17.4.1 Injector Head Dimensions and Weight NOTE: Listed weight and dimensions are approximate.

  • Page 94: Operating

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 17.5.2 Operating NOTE: The system may not meet all performance specifications if operated outside of the following conditions. Temperature: C to + 40 C (+50 F to +104 Humidity: 20% to 90% R.H. Air Pressure: 70 kPa to 105 kPa 17.5.3 Protection Against Electrical Shock...

  • Page 95: Fluid Delivery Performance

    internal temperature less than the continuous load operating temperatures, but greater than the no load operating temperatures. Under normal operating conditions with a minimum of 10 minutes between injections, the internal temperature of the head will not raise enough to degrade safety, sys- tem performance or reliability 17.5.7 Fluid Delivery Performance Table 17 - 1: Fluid Delivery Performance...

  • Page 96: System Fluid Performance

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation • Injection monitoring is performed in the injector head to detect over rate or over volume con- ditions due to system faults. The delivered volume is also monitored against the total pro- grammed volume for the injection.

  • Page 97: Programmable Pressure System Performance

    17.7.3 Programmable Pressure System Performance Table 17 - 3: Programmable Pressure System Performance Programmed Pressure Limit High Pressure Disarm 325 psi (2241 kPa) 375 psi (2586 kPa) 300 psi (2068 kPa) 350 psi (2413 kPa) 250 psi (1724 kPa) 300 psi (2068 kPa) 225 psi (1551 kPa) 275 psi (1896 kPa) 200 psi (1379 kPa)

  • Page 98: Certegra® Workstation Cybersecurity

    ® ® MEDRAD Stellant CT Injection System with Certegra Workstation ® 17.9.2 Certegra Workstation Cybersecurity ® When Informatics is enabled, the Certegra Workstation hard drive can contain 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 99: Compliance To Iec 60601-1-2 / 2Nd, 3Rd, And 4Th Editions

    Compliance to IEC 60601-1-2 / 2nd, 3rd, and 4th Editions ® ® The MEDRAD Stellant CT Injection System with Certegra Workstation complies with the require- ments of: IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance –...
  • Page 100 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation CAUTION: System may disarm or fail to operate when exposed to high magnetic fields. Portable and mobile RF communications equipment can affect the system. Recommended separation distances between portable and mobile RF communications equipment and the system The System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
  • Page 101 THE SYSTEM REQUIRES SPECIAL PRECAUTIONS REGARDING EMC. Install and put into service according to the EMC information provided below: Guidance and manufacturer's declaration - electromagnetic emissions 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.
  • Page 102 ® ® MEDRAD Stellant CT Injection System with Certegra Workstation 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.
  • Page 104 All patient data that appear in this document are fictitious. No actual patient information is shown. Bayer, the Bayer Cross, MEDRAD, Imaxeon, Stellant, MEDRAD Stellant, Certegra, P3T, ULTRAVIST, VirtualCare, MEDRAD XDS, XDS, MEDRAD FluiDots, and FluiDots are trademarks owned by and/or registered to Bayer in the U.S. and/or other countries. Other trademarks and company names mentioned herein are properties of their respective owners and are used herein solely for informational purposes.

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