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Mobius AIRO Mobile CT System User Manual

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AIRO 
®
Mobile CT System
USER MANUAL
R
ONLY
0123
x
Copyright © 2020, Mobius Imaging LLC. All rights reserved.
MI-42-0001 Rev. 19

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  • Page 1 AIRO  ® Mobile CT System USER MANUAL ONLY 0123 Copyright © 2020, Mobius Imaging LLC. All rights reserved. MI-42-0001 Rev. 19...
  • Page 2 Mobius Imaging, LLC makes no representations or warranties regarding the contents of this manual. Mobius Imaging, LLC reserves the right to revise this manual and to make changes to the content contained herein from time to time without notice or obligation to notify any person of such revision or changes, unless otherwise required by law.

  • Page 3: Table Of Contents

    ..............3 1.4 AIRO Mobile CT System .
  • Page 4 TABLE OF CONTENTS 2.4 CPR Mode ................17 2.4.1 Performing CPR on Patient in System .
  • Page 5 TABLE OF CONTENTS 3.3 Transportation ............... . 43 3.3.1 Turn On Power .
  • Page 6 TABLE OF CONTENTS 6.6 Welcome Screen ..............77 6.6.1 Welcome Screen and Functions .
  • Page 7 TABLE OF CONTENTS 6.13 Head Scanning ..............133 6.13.1 Setup Patient .
  • Page 8 TABLE OF CONTENTS 8 QUALITY TESTING ............. 173 8.1 Chapter Overview .
  • Page 9 TABLE OF CONTENTS 9.6 X-ray Specifications ..............210 9.6.1 Generator (High Voltage Power Supply) .
  • Page 10 TABLE OF CONTENTS 10.3.5 Technical Statements ..............242 10.3.6 Definitions of the Measurement Bases of the Technique Factors .
  • Page 11 TABLE OF CONTENTS 13 DETACHABLE PENDANT ..........269 13.1 Chapter Overview .
  • Page 12 TABLE OF CONTENTS This Page Intentionally Left Blank MI-42-0001 Rev. 19...

  • Page 13: General Information

    GENERAL INFORMATION: Chapter Overview GENERAL INFORMATION Chapter Overview 1.1.1 Contents Topics Covered Section Contact Data User Manual AIRO Mobile CT System Overview of Components Legal Information Training and Documentation MI-42-0001 Rev. 19...

  • Page 14: Contact Data

    Authorized EU STRYKER European Operations Limited Representative Anngrove IDA Business & Technology Park, Carrigtwohill CO. CORK IRELAND T45HX08 Mobius Imaging, LLC. Manufacturer 2 Shaker Road Suite F100 Shirley, MA 01464 www.mobiusimaging.com Tel: +1 (978) 796-5068  info@mobiusimaging.com MI-42-0001 Rev. 19...

  • Page 15: User Manual

    GENERAL INFORMATION: User Manual User Manual 1.3.1 System Described Catalog Number/ Model Reference Model(s) described in User Manual ® MobiCT 1.3.2 Symbols Used in This Manual General Warnings and cautions appear in this document and on the equipment. Heed all warnings and cautions when using AIRO. Warnings Warnings are indicated by triangular warning symbols.

  • Page 16: Airo Mobile Ct System

    GENERAL INFORMATION: AIRO Mobile CT System AIRO Mobile CT System 1.4.1 Overview AIRO Mobile CT System (“AIRO”) is a mobile computed tomography (CT) system. AIRO includes Device Description a mobile base that supports the Gimbal, Ring, and a Column for controlling compatible operating tables (typical).
  • Page 17 GENERAL INFORMATION: AIRO Mobile CT System Contraindications AIRO is contraindicated as the principal means of guidance during invasive procedures when real- time imaging is needed (e.g., CT Fluoroscopy procedures). In addition, the physician must verify navigation accuracy using an adequate verification method when used with Navigation Systems during surgical procedures.

  • Page 18: Pediatric Use Summary

    GENERAL INFORMATION: AIRO Mobile CT System Intended Location AIRO is to be used only in areas that the responsible organization has designated and declared suitable for safe operation. AIRO is controlled inside the treatment room during scan mode. For scanning purposes, AIRO is not Place of Control intended to be controlled from outside the treatment room.
  • Page 19 GENERAL INFORMATION: AIRO Mobile CT System AIRO Specific AIRO includes the following specific design features and instructions that enable safer use of our Pediatric Features device with pediatric and adult patients: and Instructions Feature References See AIRO User Manual sections: •...

  • Page 20: Overview Of Components

    GENERAL INFORMATION: Overview of Components Overview of Components 1.5.1 Transport Mode Diagram: Transport Mode Figure 2 Component Function/Usage Ring Scans patient and sends data to Pendant. Touchscreen that controls system movement, imaging, and data Pendant Display storage. Power Panel Key switch and On button, USB port. Gimbal Holds the Ring and Pendant Display.

  • Page 21: Scan Mode

    GENERAL INFORMATION: Overview of Components Ring. Doing so can cause irreparable damage to the Ring Cover, especially in the area of the window. If a damaged Ring Cover is not replaced, further damage to the system can occur due to the ingress of fluids. 1.5.2 Scan Mode Diagram: Scan...

  • Page 22: Legal Information

    (mailto:technicalsupport@mobiusimaging.com). A WEEE Statement is available upon request. Patents Mobius Imaging LLC has intellectual property rights relating to technology embodied in the product described in this manual. In particular, and without limitation, these intellectual property rights may include one or more of the patents listed at https://www.stryker.com/us/en/about/patents/Spine-...

  • Page 23: Training And Documentation

    GENERAL INFORMATION: Training and Documentation Training and Documentation 1.7.1 Training Users must receive and complete training from Mobius Imaging or its authorized agents before using Required Training AIRO. For training, contact your distributor or Mobius Imaging. NOTE: The User Manual does not replace training.
  • Page 24 GENERAL INFORMATION: Training and Documentation Available Manuals Document Part Number AIRO User Manual MI-42-0001 AIRO Pre-installation Guide MI-42-0002 MI-42-0003 (AIRO with original Trumpf Column) AIRO Emergency Instructions MI-42-0174 (AIRO with updated Trumpf Column) AIRO Application Guide Protocols and MI-42-0005 Principles AIRO Original Trumpf Column MI-42-0167 (AIRO with original Trumpf Column) Supplement...

  • Page 25: Safety

    SAFETY: Chapter Overview SAFETY Chapter Overview 2.1.1 Contents Topics Covered Section Responsibilities In Case of Emergency CPR Mode Draping and Sterile Fields Data Safety Radiation Safety Mechanical Motion Safety Electrical Safety Transportation Safety 2.10 Fire Safety 2.11 Power Failure 2.12 MI-42-0001 Rev.

  • Page 26: Responsibilities

    SAFETY: Responsibilities Responsibilities 2.2.1 After-Sale Operating and Safety Practices The manufacturer assumes no responsibility or liability for after-sale operating and safety practices; Manufacturer nor can it be responsible for personal injury or damage resulting from misuse of its systems. Owner The owner must designate areas suitable for safe operation and service of the system and ensure that it is used only in these designated areas.

  • Page 27: In Case Of Emergency

    Customers using the Emergency interlock will need to disconnect the interlock switch and connect to a custom connector, provided by Mobius, in order to enable the system to be transported. To schedule Emergency interlock installation and purchase the mating and custom connectors, contact your distributor.
  • Page 28 SAFETY: In Case of Emergency How to Release the No motorized system movements are possible after an Emergency Stop. Patient • You will be able to push the Gimbal and Ring out of the way. • You will not be able to detach the surgical table from the column. Steps 1.

  • Page 29: Cpr Mode

    SAFETY: CPR Mode CPR Mode 2.4.1 Performing CPR on Patient in System The equipment positions for performing CPR are Table Position Figure 5 Position of Table for Performing CPR Parallel to base, column at lowest shuttle- Acceptable accessible position Parallel to base, column at lowest shuttle- Acceptable accessible position Any other orientation...

  • Page 30: Draping And Sterile Fields

    SAFETY: Draping and Sterile Fields Draping and Sterile Fields 2.5.1 Operating Room Use When AIRO is used in a sterile field environment during intra-operative procedures, add an Drape the Patient additional transparent plastic drape over the patient to maintain the sterile environment while scanning.

  • Page 31: Data Safety

    SAFETY: Data Safety Data Safety 2.6.1 Protecting AIRO from Computer Viruses The organization using the system is solely responsible for protecting AIRO from computer viruses. Responsibility AIRO is designed for direct connections to DICOM server nodes only. To prevent virus corruption, the organization should not allow external software or devices to be installed.

  • Page 32: Radiation Safety

    SAFETY: Radiation Safety Radiation Safety 2.7.1 General Radiation Safety Information General Warning AIRO produces ionizing radiation. Excessive exposure could cause serious injury.  As a result, visually monitor both system and patient during scans. If the Ring does not move in the specified direction while radiation warning signals are provided (see below), terminate the scan to ensure patient safety.

  • Page 33: Safety Features Against Excessive Radiation

    By default, AIRO includes standard Computed Tomography Dose Index volume (CTDI ) dose check values in accordance with AAPM guidelines. Mobius Imaging defines four levels of users, User, Manager, Technician, and Service. However, only Service-level users are allowed to change the default dose check values.
  • Page 34 SAFETY: Radiation Safety Figure 7 After verifying that the generated parameters are appropriate and accepting them by touching Next, the system displays a Dose Notification. Figure 8 Steps 1. On the Dose Notification screen, compare the scan’s CTDI value or DLP value to the protocol’s listed dose check notification value.
  • Page 35 SAFETY: Radiation Safety A Dose Alert requests both an Operator ID and a diagnostic reason for exceeding the recommended daily dosage. The system then requires a password for manager-level or higher users before it performs the scan (see Figure 10). Figure 9 Figure 10 Steps...

  • Page 36: Profile Of Stray Radiation

    SAFETY: Radiation Safety Dose Notifications Because AIRO estimates the CTDI or DLP dose for the next scan and tracks the CTDI or DLP and Alerts for totals for a patient’s study, dose Notifications and Alerts can occur when a scan’s standard, fixed mA Modulated Scans estimate: •...
  • Page 37 SAFETY: Radiation Safety Horizontal Profile Values in mR/ Values in mR/exposure Exposure kV 120, mAs 192, mA 100, Sec. 1.92 1.085 1.509 1.929 1.929 1.929 1.509 1.085 1.589 2.614 4.018 4.481 4.018 2.614 1.589 2.271 4.692 10.999 18.588 10.999 4.692 2.271 0.239 0.292...

  • Page 38: Protective Barriers

    SAFETY: Radiation Safety Vertical Profile Values in uGy/mAs Values in uGy/mAs kV 120, mAs 192, mA 100, Sec. 1.92 0.054 0.070 0.066 0.023 0.010 0.061 0.050 0.038 0.074 0.122 0.180 0.058 0.077 0.112 0.071 0.044 0.086 0.184 0.507 Gantry 0.404 0.168 0.086 0.049...

  • Page 39: Assessing Patient Risk

    SAFETY: Radiation Safety 2.7.7 Assessing Patient Risk How to Assess Patient Risk Steps 1. Enter the patient’s height and weight. Then specify the area to be 6.8.2–6.8.17 scanned. 2. Review the automatically calculated radiation dosage on the display. 6.8.18 NOTE: Always check the displayed projected radiation dose before initiating the scan. 2.7.8 Reducing Risk from X-ray Dose How to Reduce...

  • Page 40: Laser Safety

    SAFETY: Radiation Safety Implanted and Body-worn Medical Devices The X-rays produced during scanning may interfere with active implantable medical devices and body worn active medical devices. Contact the manufacturer of the device for information before conducting scans. Precautions when Defibrillator is Used There is a potential of patient burns when a defibrillator is used, if proper safety precautions are not observed.

  • Page 41: Reducing Risk From Incorrect Scan

    SAFETY: Radiation Safety 2.7.10 Reducing Risk from Incorrect Scan How to Reduce If a scan is initiated with incorrect parameters: Risk From Incorrect Scan Figure 12 Step a button Release Scan 2.7.11 Reduce Risk of Skin Burns How to Reduce Risk by Checking Distance There is a risk of patient skin burn if patient anatomy is closer than 5 cm (2”) to the...

  • Page 42: Mechanical Motion Safety

    SAFETY: Mechanical Motion Safety Mechanical Motion Safety 2.8.1 Overview AIRO moves during normal use. This section covers safety near the moving parts. How to Avoid Injury from Moving Parts NOTE: The person operating the AIRO controls is responsible for evaluating the risk of collisions and avoiding them.

  • Page 43: Safety Precautions In The Patient Environment

    SAFETY: Mechanical Motion Safety Side View: Figure 14 2.8.3 Safety Precautions in the Patient Environment Safety Precautions The system is designed to be operated from a distance with the Pendant when it is in scan mode. This allows operators to assure patient safety from collisions by observing the motion of the Ring and table from multiple viewpoints.
  • Page 44 SAFETY: Mechanical Motion Safety Avoiding Collisions Situation Risk Mitigation Evaluate the area for possible collisions. Transferring the table Clear the area of objects, furniture, and bystanders before any transfer. Monitor all movements. Moving the Ring or the operating table Stop movements by releasing the button on the controls. Anticipate the system path.

  • Page 45: Electrical Safety

    SAFETY: Electrical Safety Electrical Safety 2.9.1 Overview Safety Precautions To avoid risk of electric shock, the following safety precautions must be observed: - This equipment must only be connected to a supply mains with protective earth - Do not attempt to service AIRO. Do not attempt to replace the power line cord. There are no user serviceable parts.

  • Page 46: Transportation Safety

    SAFETY: Transportation Safety 2.10 Transportation Safety 2.10.1 Overview Follow user instructions. Safety Precautions Cautions and AIRO’s size creates a risk of collision with people and objects. The system is designed to be driven Warnings by trained personnel in an average hospital setting with level floors, low thresholds, standard size doors and industrial elevators.
  • Page 47 SAFETY: Transportation Safety Maximum Stopping The maximum stopping distance in a worst-case normal use floor surface is less than 1.0 m. Distance AIRO weighs over 975 Kg (2150 lbs). Collision creates a risk of injury to personnel or damage to objects. MI-42-0001 Rev.

  • Page 48: Fire Safety

    SAFETY: Fire Safety 2.11 Fire Safety 2.11.1 Fire Extinguishers Each AIRO system uses seven battery packs with state-of-the-art Lithium Iron Phosphate cells. Only These are much more stable than other types of Lithium batteries. As a result, the risk of “thermal runaway”...

  • Page 49: Power Failure

    SAFETY: Power Failure 2.12 Power Failure 2.12.1 In Case of Power Failure AIRO recovers automatically from brief power interruptions (e.g., accidental unplugging). The Power Interruption system shows an error message and reboots when the power is restored. What Happens if the Power Fails Power Failure During a Scan...

  • Page 50: Restoring A Session

    SAFETY: Power Failure Functions Available • The table and column function normally, including putting the table into zero position and releasing it from the column. • AIRO is transportable using internal battery power (same as normal use). NOTE: Scans cannot be performed until main power is restored. Battery Failure All functions cease if the batteries fully discharge.

  • Page 51: Transport Mode

    TRANSPORT MODE: Chapter Overview TRANSPORT MODE Chapter Overview 3.1.1 Contents Topics Covered Section Controls Transportation Powering Down MI-42-0001 Rev. 19...

  • Page 52: Controls

    TRANSPORT MODE: Controls Controls 3.2.1 Pendant and Power Diagram of Controls Figure 16 Component Function/Usage All controls for transport and scanning except power Pendant NOTE: The column has separate controls. Transport mode: Displays front image for moving the system Pendant Display Scan mode: Displays features, options, and controls for operating, configuring, and maintaining system Holster...

  • Page 53: Power Switches

    TRANSPORT MODE: Controls 3.2.2 Power Switches Mains Power Figure 17 Component Icon Function/Usage Holster Holds Pendant Standby position: No functions available except battery charging Key Switch On position: Turns on system power Illuminates yellow when the key switch is in the On Power position and the Start button...

  • Page 54: Power And Network Cables

    TRANSPORT MODE: Controls 3.2.3 Power and Network Cables Location of Cables The power, network, and Ethernet cables attach to the end of the base that is opposite the column. NOTE: Unplug cords before attempting transport. Figure 18 Components Equipotential stud used to provide a means of linking the earth ground of the system to other equipment to minimize any electrical potential difference between them.

  • Page 55: Transportation

    TRANSPORT MODE: Transportation Transportation 3.3.1 Turn On Power How to Turn On the NOTES:When powering on the system: System • Always fully charge the system before you use it. It takes approximately 10 - 12 hours to fully charge the system. •...
  • Page 56 TRANSPORT MODE: Transportation NOTE: By default, AIRO systems have user-level, manager-level, technician-level, and service- level log-ins. Check with your system service provider to verify the system password setup. Figure 20 shows the User log-in on system start up. Figure 21 shows the Technician log-in after security lock out.

  • Page 57: Starting From Parked Position

    TRANSPORT MODE: Transportation 3.3.3 Starting from Parked Position How to Confirm AIRO is Ready for Transport Figure 22 Steps 1. Ensure that the system is powered on. See section 3.3.1 Turn On Power. 2. Log in with a user-level or higher password. See section 3.3.2 Logging In. 3.
  • Page 58 TRANSPORT MODE: Transportation Steps Pendant Cable without Strain Relief: Coil counter-clockwise from bottom-right hook. Pendant Cable with Strain Relief Coil clockwise from top-right hook. 5. Look at the base of the system and verify that: • The base is raised. •...
  • Page 59 TRANSPORT MODE: Transportation Optional Steps Conditions System prompts you to unplug cord(s). System is plugged in Make sure there is room for the Ring to rotate. From the Choose Mode screen, select Transport. The screen shows instructions for latching the Ring into the Transport position.
  • Page 60 TRANSPORT MODE: Transportation Optional Steps Conditions Latch the Ring in Scan position. NOTE: This is to keep the Ring from turning while you push it. Make sure there is room for the Ring to rotate. From the Choose Mode screen, select Transport. The screen shows instructions for latching the Ring into the Transport position.

  • Page 61: Menu In Transport Mode

    TRANSPORT MODE: Transportation 3.3.4 Menu in Transport Mode Overview The main Menu in Transport mode provides universal options to access Home/Choose Mode, Scan, system Information, and System Lock features. Universal Option: Menu in Transport Mode Figure 23 Step Touch Menu at any time to access the Menu with Transport mode options.

  • Page 62: Starting From Scan Mode

    TRANSPORT MODE: Transportation 3.3.5 Starting from Scan Mode Using the Latch Use the latch to unlock the Ring. Figure 24 Hardwired Pendant Latch Detachable Pendant Latch Figure 25 NOTE: The latch locks when the Ring is pushed fully into the scan or transport position. Steps 1.

  • Page 63: Rotating And Latching The Ring In Transport Or Scan Position

    To scan toward the base-column (STB) along the Z-axis, rotate the Ring so that it both is at 90° across the base and has the Mobius AIRO logo away from the column. To scan away from the base-column (SAB) along the Z-axis, rotate the Ring so that it both is at 90°...
  • Page 64 2. Rotate the Ring until it latches into position: • Transport position: Parallel with the base • Scan position: At a 90° angle to the base with the Mobius AIRO logo: - Away from the column to scan toward base-column (STB).

  • Page 65: Raising The System For Transport

    TRANSPORT MODE: Transportation 3.3.7 Raising the System for Transport How to Raise the When the system has been in Scan mode or parked with the base lowered, the system prompts System users to raise the base up before it enables Transport mode. Figure 27 Step Press and hold Up...
  • Page 66 TRANSPORT MODE: Transportation Steps 1. Use the display to see in front of the system. Use the buttons to drive in forward or reverse. NOTE: The right and left buttons are not enabled in Transport mode. To turn, keep holding the hand grips on the holster and push right or left. NOTE: The front-view camera display is only a visual aid to driving.

  • Page 67: After Transport

    TRANSPORT MODE: Transportation Crossing AIRO is designed to pass safely over hospital doorway thresholds and into elevators. Thresholds It will not cross barriers higher than 9.5 mm (3/8“). Using Elevators When using elevators: • Always travel in the elevator with the system. •...
  • Page 68 TRANSPORT MODE: Transportation Figure 29 Components Component CT technician holding Pendant Protective barriers Patient on operating table Gimbal Ring Other medical personnel MI-42-0001 Rev. 19...
  • Page 69 TRANSPORT MODE: Transportation How to Ensure Air must be allowed to circulate through the vents to ensure proper operation and to avoid Ventilation overheating. Do not block or cover ventilation openings on the system, for example, with drapes. This creates a fire hazard. Figure 30 Step Allow air to circulate freely around the intake and exhaust vents...

  • Page 70: Lowering The System

    TRANSPORT MODE: Transportation 3.3.11 Lowering the System How to Lower the System Figure 31 Steps Either touch Menu on the Transport screen to bring up the main Menu options on the Pendant (see Figure 23), or access the Choose Mode screen (see Figure 31).

  • Page 71: Unlocking And Rotating The Ring

    Latching the Ring in Transport or Scan Position. The Ring will lock in at +/-90°. NOTE: Rotate the Ring so that the Mobius AIRO logo faces opposite the direction of the scan. The scan will either be conducted toward the column or away from the column.

  • Page 72: Setting The Orientation For Scanning

    The Ring rotates +/- 90°. This allows users to scan toward either end of the patient support. Orientation for Scanning Step Turn the Ring manually so that the Mobius AIRO logo faces opposite the direction of the scan. See section 3.3.6 Rotating and Latching the Ring in Transport or Scan Position. Next Step Step •...
  • Page 73 TRANSPORT MODE: Transportation Steps Select Home to exit camera view. Turn the key switch to the standby position. 3. Plug in the power cord. MI-42-0001 Rev. 19...

  • Page 74: Powering Down

    TRANSPORT MODE: Powering Down Powering Down 3.4.1 Set to Standby Mode Whenever AIRO is not in use it should be in Transport position, plugged in, and set to Standby. Overview How to Enter Standby Mode Steps 1. Leave the system with the base up and on its casters. 2.

  • Page 75: Column And Table

    COLUMN AND TABLE: COLUMN AND TABLE Information about AIRO-integrated columns and compatible tabletops is available for: • Original Trumpf TruSystem 7500 Column. See chapter 2 ORIGINAL COLUMN AND TABLE in MI-42-0167 AIRO Original Trumpf Column Supplement. • Updated Trumpf TruSystem 7500 Column. See chapter 2 UPDATED COLUMN AND TABLE in MI-42-0165 AIRO Updated Trumpf Column Supplement.
  • Page 76 COLUMN AND TABLE: If the symbol “Follow Instructions For Use” (see Figure 34) appears on the side of the Trumpf column, the AIRO has an updated column which supports the new Trumpf Carbon Spine Surgical Tabletop. Because of changes to the updated column keypad and wireless remote control, users must refer to the MI-42-0165 AIRO Updated Trumpf Column Supplement for operating instructions.

  • Page 77: Transferring The Table

    TRANSFERRING THE TABLE: TRANSFERRING THE TABLE Information about transferring tables is available for: • Original Trumpf TruSystem 7500 Columns in chapter 3 TRANSFERRING THE TABLE of MI- 42-0167 AIRO Original Trumpf Column Supplement. • Updated Trumpf TruSystem 7500 Columns in chapter 3 TRANSFERRING THE TABLE of MI- 42-0165 AIRO Updated Trumpf Column Supplement.
  • Page 78 TRANSFERRING THE TABLE: This Page Intentionally Left Blank MI-42-0001 Rev. 19...

  • Page 79: Scanning

    SCANNING: Chapter Overview SCANNING Chapter Overview 6.1.1 Contents Topics Covered Section System and Controls Before Scanning Moving the Ring in Scan Mode Prepare Scan Field of View Welcome Screen Daily Warm Up Scan Typical Scan Sequence: New Scan View an Existing Scan Emergency Scanning 6.10 Editing Patient Data...

  • Page 80: System And Controls

    SCANNING: System and Controls System and Controls 6.2.1 AIRO System Diagram of System Configured for Scanning Figure 35 Component Function/Usage Ring Scans patient and sends data to Pendant Window Opening through which scan is taken Supports and moves the system, includes power and data connections.

  • Page 81: Pendant Display

    SCANNING: System and Controls 6.2.2 Pendant Display Diagram of Pendant Display Figure 36 Component Function/Usage Touch to enter data or select functions Touchscreen Serves as display for camera view Reset Button Press to clear the Emergency Stop Emergency Stop or  Press to halt all scanning and mechanical motion functions E-Stop •...

  • Page 82: Before Scanning

    SCANNING: Before Scanning Before Scanning 6.3.1 Overview Before Scanning Steps 1. Follow the instructions to set up for scan. 3.3.10 2. Confirm Ring is facing the direction of the intended scan before moving the patient 6.8.6 to the column. • MI-42-0167 AIRO Original Trumpf Column Supplement chapter 3 Transfer patient and patient support to •...
  • Page 83 SCANNING: Before Scanning Step Select Scan on the touchscreen. NOTE: If the system is not lowered, you are prompted to lower the system. See section 3.3.11 Lowering the System How to Home Ring After operators select Scan, AIRO checks that the Ring is perpendicular. If adjustment is needed, Tilt the Home the Tilt screen appears.
  • Page 84 SCANNING: Before Scanning Figure 39 Condition Options • A Warm-up scan must be performed before any other scans can be performed. Warm-up Scan NOTE:If Warm-up Scan is listed on the Required Maintenance Scans dialog, touching OK may launch the Warm-up Scan. See section 6.7 Daily Warm Up Scan. •...

  • Page 85: Connecting System

    SCANNING: Before Scanning System Enforced The warm-up scan is enforced if the last scan on the system was performed more than 18 hours Maintenance Scans earlier. Unlike the warm-up scan, Gain Calibration, quality checks and the E-Stop tests are not enforced. Scanning can be performed if the tests have expired.
  • Page 86 SCANNING: Before Scanning Task Bar icons Ethernet connection to hospital network (green when connected) Ethernet connection to navigation system (green when connected) System temperature: Cyan - tube is cold, a warm-up scan must be performed Green - 0 to 33% of tube heat capacity is used Yellow - 33% to 66% of tube heat capacity is used Orange - 66% to 100% of tube heat capacity is used Red - Over 100% of tube heat capacity is used.

  • Page 87: Moving The Ring In Scan Mode

    SCANNING: Moving the Ring in Scan Mode Moving the Ring in Scan Mode 6.4.1 Translating the Ring (Z-axis) When in Scan mode, use the direction keys on the Pendant Display to control Ring translation. How to Translate the Ring on the Base Figure 41 Step...

  • Page 88: Prepare Scan Field Of View

    SCANNING: Prepare Scan Field of View Prepare Scan Field of View 6.5.1 Position and Diameter of Scan Field of View Scan Field of View Figure 42 The scan field of view is a 51.2 cm (20.2”) diameter circle at the center of and parallel to the bore. 6.5.2 Remove Non-Essential Objects Non-Essential...

  • Page 89: Welcome Screen

    SCANNING: Welcome Screen Welcome Screen 6.6.1 Welcome Screen and Functions Options on the Welcome Screen Figure 43 Figure 44 Steps 1. Select a feature by touching the icon. 2. If displayed, touch OK to clear the Required Maintenance Scans dialog. NOTE: If a Warm-up Scan is listed in the dialog, touching OK launches the Warm-up Scan sequence.
  • Page 90 SCANNING: Welcome Screen Options Function Select to start the scan workflow. 6.8.1 Select to launch the DICOM Viewer and display existing images that 6.8.3 are on the system. Select to view the Service Functions screen and access system configuration and maintenance features. Service warning icon: •...

  • Page 91: Daily Warm Up Scan

    SCANNING: Daily Warm Up Scan Daily Warm Up Scan 6.7.1 Overview Daily Warm Up scans ensure that the system is configured for current operating conditions. As a Definition result, the Maintenance Warning icon appears every 18 hours to indicate that users must run another Warm Up scan before continuing to scan patients.
  • Page 92 SCANNING: Daily Warm Up Scan Figure 46 Steps 1. Verify that the system temperature icon is cyan, indicating that the warm-up scan is required. See Figure 45. 2. Touch Next to show the Warm Up Scan Preparing screen. 3. Wait until the indicator for the Scan button is Green, then follow on-screen instructions. 4.

  • Page 93: Menu In Scan Mode

    SCANNING: Daily Warm Up Scan 6.7.4 Menu in Scan Mode Universal Option: Menu in Scan Mode Figure 47 Step Touch Menu at any time to access the main Menu with Scan mode options. Scan Mode Options Select Home to return to the Choose Mode screen. See section 6.3.2 Choosing Scan Mode. Select New Scan to enter information and setup a new scan.

  • Page 94: Typical Scan Sequence: New Scan

    SCANNING: Typical Scan Sequence: New Scan Typical Scan Sequence: New Scan 6.8.1 New Scan How to Initiate a New Scan Figure 48 Step Select New Scan . AIRO displays the Patient Data screen. MI-42-0001 Rev. 19...
  • Page 95 SCANNING: Typical Scan Sequence: New Scan Select Source of Patient Data Figure 49 Options Select New Patient to create a new patient record on AIRO. 6.8.2 Select Existing Patients to access the list of patient records 6.8.3 currently on AIRO. Select Hospital to access the hospital network: 6.8.4...

  • Page 96: Entering New Patient Data

    SCANNING: Typical Scan Sequence: New Scan 6.8.2 Entering New Patient Data How to Enter New Patient Data Figure 50 Figure 51 MI-42-0001 Rev. 19...
  • Page 97 SCANNING: Typical Scan Sequence: New Scan Steps Select New Patient from the Patient Data screen. 2. Type in patient name, date of birth, and if available patient ID NOTE: Patient data entered here affects suggested scan protocols. However, specific scan ...

  • Page 98: Select Existing Patient Data

    SCANNING: Typical Scan Sequence: New Scan 6.8.3 Select Existing Patient Data How to Select a Patient With Existing Scans Figure 52 Steps Select Existing Patients from the Patient Data Screen. See section  6.8.1 New Scan. 2. Select an existing Patient Name from the list or search by patient name or ID To facilitate the search for patient records, the patient list includes: •...

  • Page 99: Entering Patient Data From Hospital Worklist

    SCANNING: Typical Scan Sequence: New Scan 6.8.4 Entering Patient Data from Hospital Worklist How to Enter Patient Data from Hospital Worklist Figure 53 Figure 54 Figure 55 MI-42-0001 Rev. 19...
  • Page 100 SCANNING: Typical Scan Sequence: New Scan Figure 56 Steps Select Hospital from Patient Data Screen. See section 6.8.1 New Scan. NOTE: The Network icon must be green before Hospital patient lists and worklists will be available. 2. From the screen showing configured servers, select a server Available PACS servers have green status icons 3.

  • Page 101: Entering Patient Data From Navigation System

    SCANNING: Typical Scan Sequence: New Scan 6.8.5 Entering Patient Data from Navigation System How to Enter Patient Data from Navigation System Figure 57 Figure 58 Figure 59 MI-42-0001 Rev. 19...
  • Page 102 SCANNING: Typical Scan Sequence: New Scan Figure 60 Steps Select Navigation from the Patient Data Screen. See section 6.8.1 New Scan. NOTE: The Navigation icon must be green before Navigation worklists will be available. 2. From the screen showing navigation systems, select a system Available systems have green status icons 3.

  • Page 103: Confirming Scan Direction

    SCANNING: Typical Scan Sequence: New Scan 6.8.6 Confirming Scan Direction How to Confirm the Scan Direction Figure 61 Figure 62 Step Confirm the Ring orientation and the direction of Z-axis translation for scanning. Two orientations are possible: • Confirm Scan Direction Away From Column (Figure 61) shows the system in SAB orientation with the SAB icon and scan direction indicator arrow •...
  • Page 104 SCANNING: Typical Scan Sequence: New Scan Options If the Ring is not locked in the +90°/-90° position, you are prompted to lock the Ring. If the Ring is in the wrong orientation, move the table and rotate the Ring to the correct orientation.

  • Page 105: Selecting Patient Type And Patient Category

    SCANNING: Typical Scan Sequence: New Scan 6.8.7 Selecting Patient Type and Patient Category How to Choose the The patient types and patient categories available for the selected, or active, patient are displayed Patient Type and on the Patient Category selection screen. For example, after selecting the Adult patient type, both Patient Category the Adult Original and the Adult Alternate patient categories appear.
  • Page 106 SCANNING: Typical Scan Sequence: New Scan Figure 64 Figure 65 NOTE: The Pediatric patient type and patient categories shown in Figure 64 and Figure 65 do not appear when the Pediatrics feature is disabled. MI-42-0001 Rev. 19...
  • Page 107 SCANNING: Typical Scan Sequence: New Scan Steps 1. For the listed patient , select the appropriate patient type Available patient categories for the selected patient type appear in the middle section of the screen. 2. Select the required patient category NOTES: •...

  • Page 108: Selecting Exam Region, Protocol, And Scan Type

    SCANNING: Typical Scan Sequence: New Scan Options • Select Continue to proceed if the mismatch is known and appropriate. NOTE: To simplify scan setup for patients that fall outside typical ranges, talk with your technical service provider about adding customized scan protocols to your AIRO. •...
  • Page 109 SCANNING: Typical Scan Sequence: New Scan Figure 67 Steps 1. Select main body region to be scanned (left column). 2. Select the protocol for the sub-region to be scanned (middle column). 3. Select scan type: Helical or Axial (right column). 4.
  • Page 110 SCANNING: Typical Scan Sequence: New Scan How To Set the Scan Parameters Figure 68 Steps 1. (Optional) Select to display the on-screen keyboard and type a custom Study Description. The value defaults to the name of the selected exam region (optional custom example shown 2.
  • Page 111 SCANNING: Typical Scan Sequence: New Scan How to verify Navigation System is Operational Figure 69 Step Verify Navigation System is operational. NOTES: • This screen only appears for scans when AIRO connects to a navigation system, and the operator selects Navigation: > with on the Set Scan Parameters screen. See Figure 68. •...

  • Page 112: Selecting Patient Orientation And Position

    SCANNING: Typical Scan Sequence: New Scan 6.8.9 Selecting Patient Orientation and Position How to Select Orientation and Position Figure 70 Figure 71 Steps 1. From the default screen, select patient orientation. See Figure 70. 2. Select patient position. See Figure 71. NOTE: Display also shows direction of scan.

  • Page 113: Selecting 2D Scout Scan View

    SCANNING: Typical Scan Sequence: New Scan 6.8.10 Selecting 2D Scout Scan View Overview After setting the patient position, you can verify that the region of interest appears in the center of the field of view by selecting an optional low-intensity Scout Scan. The three available options are: •...
  • Page 114 SCANNING: Typical Scan Sequence: New Scan Figure 73 Step Select the A-P or Lateral view. When either are selected for Helical scans, Modulated Scan Available (see Figure 73 ) is checked (see Figure 74 NOTE: Modulated scanning is only available in the Helical Scan workflow after running either an A-P or Lateral scout scan.
  • Page 115 SCANNING: Typical Scan Sequence: New Scan Options Action After selecting A-P or Lateral, touch Next to set initial start and end points See section 6.8.11 Positioning With Lasers. for the scan. Perform steps as described in scout scan sections 6.8.11, 6.8.12, and 6.8.13, setting the start and end points for the scan.

  • Page 116: Positioning With Lasers

    SCANNING: Typical Scan Sequence: New Scan Steps 1. When the Select 2D scout scan screen shows the dose caution , review: • kV and mA parameters of the 3D scan • kV and mA parameters of the 2D scout scan 2.
  • Page 117 SCANNING: Typical Scan Sequence: New Scan Turning Positioning The lasers simplify both positioning the patient and choosing a scan’s start and end points. Although Lasers On and Off lasers can be switched on throughout scan setup, minimizing patient exposure is recommended. Turn lasers On to set the start and end points.

  • Page 118: Setting 2D Scout Scan End Position

    SCANNING: Typical Scan Sequence: New Scan 6.8.12 Setting 2D Scout Scan End Position How to Set the 2D End Position Figure 77 Step Using the left and right arrows move Ring to end position. NOTE: Minimum Scout Scan length is 7.9cm (3.11 in.). Keep continuous visual contact with the system and the patient when system components are in motion.

  • Page 119: Setting The 2D Start Position

    SCANNING: Typical Scan Sequence: New Scan 6.8.13 Setting the 2D Start Position How to Set the 2D Start Position Figure 78 Step Using the arrows move Ring to start position. NOTE: Minimum Scout Scan length is 7.9cm (3.11 in.). Keep continuous visual contact with the system and the patient when system components are in motion.

  • Page 120: Verifying 2D Parameters And Scanning

    SCANNING: Typical Scan Sequence: New Scan 6.8.14 Verifying 2D Parameters and Scanning How to Verify Parameters and Scan Figure 79 Figure 80 Steps 1. Review the displayed scan parameters NOTE: When the Green LED is illuminated the system is ready to scan. See Figure 36. 2.
  • Page 121 SCANNING: Typical Scan Sequence: New Scan Steps 4. To scan when the Green LED is lit , press and hold Scan Keep continuous visual contact with the system and the patient when system components are in motion. NOTES: • The positioning lights show the point of scan on the patient. •...

  • Page 122: Selecting 3D Scan Region

    SCANNING: Typical Scan Sequence: New Scan 6.8.15 Selecting 3D Scan Region Overview After verifying the parameters and running a Scout Scan, an image appears on the Pendant screen. On-screen controls set viewing options and adjust the scan area for the 3D scan. NOTES: •...
  • Page 123 SCANNING: Typical Scan Sequence: New Scan Figure 83 Category Adjustments Visible in Scout Scan Image (Figure 83) Scan Area Box on image shows: • Left boundary adjustment • Right boundary adjustment • Field of View narrowed to approximately torso width NOTE: Dashed yellow lines indicate width of beam outside the Field of View at isocenter.
  • Page 124 SCANNING: Typical Scan Sequence: New Scan How to Adjust Window viewer settings change the Contrast and Center Level settings to help users differentiate Scout Scan View elements in the image that have different densities. Settings Figure 84 Steps 1. Select the Windowing icon on the right side of the screen to enable Contrast Window and Center Level controls.
  • Page 125 SCANNING: Typical Scan Sequence: New Scan How to Zoom Zoom settings allow users to focus close-up on the details of specific sections of the image or return to the overall full screen view. Figure 85 Helical scanning is a continuous volume imaging mode. The data acquisition and Ring movement are performed simultaneously for the entire scan duration.

  • Page 126: Selecting A Constant Or Modulated Scan

    SCANNING: Typical Scan Sequence: New Scan 6.8.16 Selecting a Constant or Modulated Scan Overview After setting the Scan Area on the Scout Scan image (see section 6.8.15 Selecting 3D Scan Region), select either Constant Tube Current or Modulated Tube Current. The summaries list the key parameters for the dosages of each option.

  • Page 127: Move Ring To Start Position

    SCANNING: Typical Scan Sequence: New Scan 6.8.17 Move Ring to Start Position How to Move Ring to Start Position Figure 87 Step Press and hold Scan to move the Ring to the start position. Keep continuous visual contact with the system and the patient when system components are in motion.

  • Page 128: Verifying 3D Parameters And Scanning

    SCANNING: Typical Scan Sequence: New Scan 6.8.18 Verifying 3D Parameters and Scanning How to Verify the 3D Parameters and Scan Figure 88 Figure 89 Figure 90 MI-42-0001 Rev. 19...
  • Page 129 SCANNING: Typical Scan Sequence: New Scan Steps 1. If a Dose Notification or Dose Alert appears: • Provide requested information. • If required, provide a password for manager-level or higher users, • Touch Next. See section 2.7.3 Dose Notifications and Alerts. 2.

  • Page 130: Summary Of 3D Image Controls

    SCANNING: Typical Scan Sequence: New Scan 6.8.19 Summary of 3D Image Controls Overview The system displays the reconstructed CT scan data in the DICOM Viewer for evaluating the image. The viewer: • Orients the image based on the scan direction. •...

  • Page 131: Main Image View

    SCANNING: Typical Scan Sequence: New Scan Verify Image with Before using viewing controls to adjust view of the 3D image, verify that the DICOM markers Patient Position displayed in the default view match the actual position of the patient. Steps 1.

  • Page 132: Window/Level

    SCANNING: Typical Scan Sequence: New Scan 6.8.21 Window/Level How to Change the Window and Level in the Viewer Figure 93 Figure 94 Steps 1. Touch Window button to see menu. NOTE: The menu in Figure 94 is an example. Different exam regions and protocols may have different menu options.

  • Page 133: Image Controls

    SCANNING: Typical Scan Sequence: New Scan 6.8.22 Image Controls How to Use the Image Controls Functions To pan To zoom in or out To rotate To scroll up or down To set slice thickness of view See section 6.8.23 Setting Slice Thickness To recenter Step Touch a button to activate a function.

  • Page 134: Setting Slice Thickness

    SCANNING: Typical Scan Sequence: New Scan How to View Slice Position and Scan Metrics Figure 95 The DICOM Viewer shows various metrics in the upper left corner of the primary viewing window. While scrolling through the slices of Constant Tube Current scans (Axial or Helical) only the slice indicator changes.

  • Page 135: Sending Scan To Dicom Or Usb

    SCANNING: Typical Scan Sequence: New Scan Figure 97 Steps 1. Touch Thickness button to see menu. 2. Touch a menu item selection. 3. Touch the button again to hide menu. 6.8.24 Sending Scan to DICOM or USB How to Send the Scan Figure 98 Steps...

  • Page 136: Next Steps

    SCANNING: Typical Scan Sequence: New Scan Steps Action 1. Select the node name under Server. To send the scan to 2. Select Send to DICOM node a DICOM node 3. Touch OK to acknowledge data transfer. 1. Insert USB storage device into USB port on holster. 2.
  • Page 137 SCANNING: Typical Scan Sequence: New Scan Option Result Goes to Confirm Scan Direction screen for a new scan in the current study. 6.8.6 Returns to Welcome screen for a new study and new or selected patient. 6.6.1 MI-42-0001 Rev. 19...

  • Page 138: View An Existing Scan

    SCANNING: View an Existing Scan View an Existing Scan How to View an Existing Scan Figure 100 Figure 101 Steps 1. From the Welcome screen, select DICOM Viewer. See section 6.6.1 Welcome Screen and Functions. 2. Select a patient record To help ensure correct patient record selection, the screen provides: •...
  • Page 139 SCANNING: View an Existing Scan Steps 3. Select a study To help identify the correct study, the screen provides: • Study ID generated by AIRO • Date and time of last series or scan in study • Count of series or scans contained in the study •...
  • Page 140 SCANNING: View an Existing Scan How to View Series Details Figure 102 For more information about a particular scan or series: Step Select the Details on the Please select a series screen. See in Figure 101. Figure 102 shows an example details report. Option Action View currently selected scan.

  • Page 141: Emergency Scanning

    SCANNING: Emergency Scanning 6.10 Emergency Scanning 6.10.1 Taking Emergency Scans How to Take Emergency Scans Figure 103 Figure 104 Steps 1. From the Welcome screen, or any other screen showing the icon, touch Quick Scan 2. Fill in the patient’s height and weight 3.

  • Page 142: Editing Patient Data

    SCANNING: Editing Patient Data 6.11 Editing Patient Data 6.11.1 Editing or Adding Patient Data How to Edit or Delete Patient Data Figure 105 Steps 1. Display the Welcome screen. See section 3.3.4 Menu in Transport Mode or section 6.7.4 Menu in Scan Mode. 2.
  • Page 143 SCANNING: Editing Patient Data Change Patient Information and Save Figure 106 Steps 1. Edit patient information as required. NOTE: Emergency scans will have the first name “Date [2015-11-13]” and the last name “Time [14:28:26]”. The patient name is the date and time the scan was taken. AIRO automatically generates a unique patient ID.

  • Page 144: After Scanning

    SCANNING: After Scanning 6.12 After Scanning 6.12.1 Post-Scanning Steps Where to Find Instructions Instructions • MI-42-0167 AIRO Original Trumpf Column Supplement section 3.2.2 • Mi-42-0165 AIRO Updated Trumpf Column Review Patient Transfer Safety. Supplement section 3.2.2 For more information about which integrated column your AIRO features, see chapter ...

  • Page 145: Head Scanning

    SCANNING: Head Scanning 6.13 Head Scanning 6.13.1 Setup Patient Cranial Fixation To reduce the risk of excessive image artifacts, be sure to angle the skull clamp such that it is substantially angled with respect to the tomographic scan (CT Ring rotation) plane - see Figure 107 below.

  • Page 146: Setup Airo

    SCANNING: Head Scanning 6.13.2 Setup AIRO Feet-first Patient A separate table system (one that is not mounted on the integrated Trumpf Column) can be utilized Orientation in a feet-first orientation for head scanning. (Optional) Figure 108 Figure 109 MI-42-0001 Rev. 19...
  • Page 147 SCANNING: Head Scanning Figure 110 In order to properly introduce the AIRO system in this configuration, the following steps should be followed: Steps 1. During the patient setup, ensure that there is adequate space for the AIRO system to maneuver near the planned patient access direction. 2.
  • Page 148 SCANNING: Head Scanning This Page Intentionally Left Blank MI-42-0001 Rev. 19...

  • Page 149: Maintenance

    MAINTENANCE: Chapter Overview MAINTENANCE Chapter Overview 7.1.1 Contents Topics Covered Section Service Functions Daily Gain Calibration Cleaning, Disinfection, and Sterilization Inspections Preventative Maintenance Temporary Disuse Disposal Instructions MI-42-0001 Rev. 19...

  • Page 150: Service Functions

    MAINTENANCE: Service Functions Service Functions 7.2.1 Service Functions Screen The Service Functions screen provides access to AIRO configuration and maintenance features. Overview Available categories are: • Hospital Service — Includes routine maintenance and scan quality-check procedures for on- site hospital technicians. •...

  • Page 151: Hospital Service

    MAINTENANCE: Service Functions Options 1. To access the features available to on-site hospital technicians, select Hospital Service 2. On the Technician log-in screen, enter a technician-level or 3.3.2 higher password. 3. Select the required Hospital Service feature. 7.2.2 1. Contact Support to find out which options are available from Brainlab.
  • Page 152 MAINTENANCE: Service Functions Options Select Configure to export log files, export Gain Cal, calibrate 7.2.3 the Pendant, and view the QC pattern. Select Add New Phantom to add a new test phantom. 7.2.4 Select Gain Calibration to perform the daily Gain Calibration. 7.3.3 Select E-Stop Test to perform the daily Emergency Stop test.

  • Page 153: Option: Configure

    MAINTENANCE: Service Functions 7.2.3 Option: Configure How to Select Configuration Options Figure 113 Options Select Calibrate Touch to run the Pendant/Touchscreen calibration program. Follow on-screen instructions. With a USB storage device connected, select Export logs to USB to copy log and system configuration files to the USB device. Select QC Pattern to view the Quality Check image pattern.
  • Page 154 MAINTENANCE: Service Functions How to Export Gain Calibration File Figure 114 Steps 1. From the Hospital Service screen, select Configure. See Figure 112. 2. From the System Configuration screen, select Export Gain Cal to USB. See Figure 113. The Choose Gain Cal to Export dialog appears. 3.

  • Page 155: Option: Add New Phantom

    MAINTENANCE: Service Functions AIRO provides a QC Pattern for verifying screen resolution. The hardwired Pendant has an 800 x 600 pixel screen that displays the 600 x 600 QC Pattern shown in Figure 115. The Detachable Pendant has a 1280 x 800 pixel screen that displays a similar 800 x 800 QC Pattern. To view the QC Pattern: Steps 1.

  • Page 156: E-Stop Test

    MAINTENANCE: Service Functions 7.2.5 E-Stop Test Overview An E-Stop, or Emergency Stop, test verifies that the scanner stops moving over the scan area and ceases emitting x-rays in case of an emergency during a scan. Ring rotation does not stop immediately.

  • Page 157: Option: Using Custom Kv Settings In Manual Or Single Shot Scans

    MAINTENANCE: Service Functions How to perform the After preparing for an E-Stop test, start the scan. E-Stop scan Figure 118 Steps 1. Press and hold the green Scan button 2. Wait until Z-axis translation has started. 3. Press the red E-Stop button 4.

  • Page 158: Option: Manual Scan

    MAINTENANCE: Service Functions 7.2.7 Option: Manual Scan How to perform a Manual Scan Figure 120 NOTE: The Manual Scan feature is not intended for use on patients. Steps 1. Select Manual Scan from the Hospital Service screen. 7.2.2 2. Choose a Phantom from the Phantom Selection list. 3.

  • Page 159: Option: Single Shot Scan

    MAINTENANCE: Service Functions 7.2.8 Option: Single Shot Scan How to perform a Single Shot Scan Figure 121 NOTE: The Single Shot Scan feature is not intended for use on patients. Steps  7.2.1 1. Select Single Shot from the Hospital Service screen. &...
  • Page 160 MAINTENANCE: Service Functions the 120 kV metrics. 100kV and 80kV HU values are only accurate for water. Other materials are not evaluated. Although the system uses the data differently for Full and Daily QC scans, the scan procedures are the same. For information about running QC scans, see section 8.3 Testing Image Quality.

  • Page 161: Option: Dose Check Report

    MAINTENANCE: Service Functions 7.2.10 Option: Dose Check Report Overview AIRO Dose Check Reports provide system-wide data about X-Ray radiation dosages for system scans and any dosage alert incidents. The report lists: • Global Protocols by name/category • All Local Protocols set up for specific procedures or patients •...

  • Page 162: Brainlab Service

    MAINTENANCE: Service Functions Exporting the Dose In addition to viewing the system Dose Check Report, users with technician-level or higher Check Report passwords can export the report to a USB storage device. Figure 124 Steps 1. After viewing the Dose Check Report (Figure 123), connect a USB storage device to the USB port on the Pendant Holster.
  • Page 163 MAINTENANCE: Service Functions Options Select SAB Navigation Calibration to calibrate the Curve Navigation system in the Scan Away from Base-column direction. Select STB Navigation Calibration to calibrate the Curve Navigation system in the Scan Towards Base-column direction. Select Manual Scan to run the verification portion of the Curve 7.2.7 Navigation system calibration process.

  • Page 164: Daily Gain Calibration

    MAINTENANCE: Daily Gain Calibration Daily Gain Calibration 7.3.1 Overview Calibrations should be performed daily or according to the responsible organization’s procedure. Calibrate A gain calibration scan consists of a scan of the air. Gain calibrations auto-correct gain and offset settings for 120 kV, 100 kV, and 80 kV scans before diagnostic scans begin. NOTES: •...

  • Page 165: Perform Gain Calibration

    MAINTENANCE: Daily Gain Calibration 7.3.3 Perform Gain Calibration Start Up and Enter Scan Mode Steps 1. If necessary, transport and set up for scan. 2. Log in with a user-level or higher password. 3.3.2 3. Choose Scan mode. 6.3.2 Select Service Functions from the Steps Welcome Screen...
  • Page 166 MAINTENANCE: Daily Gain Calibration Confirm Readiness Figure 126 Steps 1. Confirm that the table is removed and the area is safe. 2. Ensure that the environment is safe for X-ray exposure.  NOTE: For instructions to ensure the area meets the safety requirements, see section 2.7 Radiation Safety.
  • Page 167 MAINTENANCE: Daily Gain Calibration Perform Gain Calibration Scan Figure 127 Step Press and hold Green button to Scan. NOTE: When the Green LED is illuminated the system is ready to scan. MI-42-0001 Rev. 19...
  • Page 168 MAINTENANCE: Daily Gain Calibration Pass or Fail Notice After the scan, a notice appears. Figure 128 Figure 129 MI-42-0001 Rev. 19...

  • Page 169: Image Quality Assessment

    MAINTENANCE: Daily Gain Calibration Figure 130 Options All performed gain calibrations for 120 kV, 100 kV, and 80 kV are within specified accuracy • To proceed touch Next. NOTES:  • Systems with the Pediatrics feature enabled run a Daily Gain Calibration that includes 120 kV, 100 kV, and 80 kV tests.
  • Page 170 MAINTENANCE: Daily Gain Calibration NOTES: • Ring orientation does not matter when taking assessment scans. Use either STB or SAB.  • The original Trumpf Column Remote displays table height in millimeters.  - When the original Trumpf Column Remote is available, record table heights as displayed on ...
  • Page 171 MAINTENANCE: Daily Gain Calibration Steps Place the Gammex holder on a radio-lucent column tabletop or support. NOTE: If the AIRO has a column-less configuration, ensure that the structure supporting the Gammex 464 is radio-lucent, and that it can position the Gammex at isocenter, 75mm (2.95 in.) above isocenter, and 150mm (5.9 in.) above isocenter.
  • Page 172 MAINTENANCE: Daily Gain Calibration Steps Select the following parameters, and then touch Next.: • Type: Axial • Dosage - kV: 120 - mA: 100 • Kernel: Standard • Field Of View: Large • Navigation: without Select Head First and Supine, and then touch Next. Select Skip Scout Scan, and then touch Next.
  • Page 173 MAINTENANCE: Daily Gain Calibration Raise Gammex 464 When required, raise the phantom a required distance above system isocenter. Different system Phantom above configurations require different setups. Isocenter • For systems that feature Trumpf TruSystem Columns, use either column remotes or column keypads to raise phantoms on compatible, radio-lucent tables.
  • Page 174 Gammex 464 Phantom positioned at isocenter. Figure 134 shows images from the phantom positioned above isocenter that have highlighted residual issues. NOTE: The following procedure outlines viewing the 3D images on the AIRO pendant. Mobius Imaging recommends exporting the DICOM series for the scans and viewing them on a diagnostic quality monitor using DICOM viewer software.
  • Page 175 6.8.19 Summary of 3D Image Controls through 6.8.23 Setting Slice Thickness. If artifacts similar to those shown in Figure 133 and Figure 134 appear in the image assessment scan results, contact your distributor or Mobius Imaging Technical Support. See section 1.2 Contact Data. MI-42-0001 Rev. 19...

  • Page 176: Cleaning, Disinfection, And Sterilization

    MAINTENANCE: Cleaning, Disinfection, and Sterilization Cleaning, Disinfection, and Sterilization 7.4.1 Cleanable Parts The CT system is not waterproof. It is not designed to protect the internal components from the Warnings and Cautions ingress of liquid. Do not use sprays. Sprays may expose electrical components to moisture which can damage the equipment.
  • Page 177 MAINTENANCE: Cleaning, Disinfection, and Sterilization Cleaning Steps 1. Submerge a cloth rag into the warm water. Ring the rag out so it is not dripping. 2. Wipe down all external surfaces of the Ring, Gimbal, Base, Trumpf Column, Pendant and Pendant cord, and system power cord.
  • Page 178 MAINTENANCE: Cleaning, Disinfection, and Sterilization Tilting the Ring for The Ring may be tilted in Hospital Service mode to allow cleaning access to all parts of the system. Cleaning Figure 135 Figure 136 Figure 137 Steps 1. Decide in which direction the Ring needs to tilt and ensure there are no objects or obstacles in the way.

  • Page 179: Sterilization

    Mobius Imaging and distributors of the AIRO bear no responsibility for sterilization of system surfaces. Mobius Imaging and distributors of the system shall not be held liable for any contagion which may have stemmed from contaminated stains on the system surfaces.

  • Page 180: Application Of Mineral Oil To Airo Base Rails

    Mineral Oil After cleaning, it is required that the rails be immediately dried, and then wiped down with Mineral Oil Wipes, (Architec Products p/n BLKOILWV or Mobius approved equivalent). The application of Application Mineral Oil removes residual cleaning solution and helps protect against corrosion, without affecting the performance of the rails or bearings.

  • Page 181: Inspections

    MAINTENANCE: Inspections Inspections 7.5.1 Daily The responsible organization and personnel using the machine are responsible for performing daily Wear or Damage inspections. Each day before using the system, inspect it and make sure that: • No signs of wear or damage appear on the system •...

  • Page 182: Preventative Maintenance

    MAINTENANCE: Preventative Maintenance Preventative Maintenance 7.6.1 Preventative Maintenance is Required Preventative maintenance must be performed twice a year to ensure functionality and safety. The Interval owner/responsible organization is responsible for timely maintenance. Exceeding the six month period for preventative maintenance is considered improper use.

  • Page 183: Temporary Disuse

    MAINTENANCE: Temporary Disuse Temporary Disuse 7.7.1 Temporary Disuse Normally, AIRO is left plugged in whenever it is not being moved. Temporary disuse is defined as Definition: Unplugged Over 2 when AIRO is left unplugged for over 2 days. Days Example: The system was accidentally left unplugged over the weekend. AIRO can be left unplugged for up to one month, but this is not advised.

  • Page 184: Disposal Instructions

    MAINTENANCE: Disposal Instructions Disposal Instructions 7.8.1 Disposal of System and Batteries Do not dispose of AIRO or its components. Only dispose of electrical and electronic equipment in How to Dispose of System accordance with statutory regulations. For information regarding the WEEE (Waste Electrical and Electronic Equipment) directive, contact technical support.

  • Page 185: Quality Testing

    QUALITY TESTING: Chapter Overview QUALITY TESTING Chapter Overview 8.1.1 Contents Topics Covered Section Test Object and Software Testing Image Quality Quality Check Reporting Exposure Testing MI-42-0001 Rev. 19...

  • Page 186: Test Object And Software

    QUALITY TESTING: Test Object and Software Test Object and Software 8.2.1 Description Manufacturer and Model Numbers of Supplied Quality Assurance Materials Manufacturer and Model Phantom and Software Test object (phantom) Gammex 464 Installed Test Image AIRO is delivered from the manufacturer with a phantom scan loaded on the system. This provides a scan for comparison with scans done after delivery and installation.

  • Page 187: Testing Image Quality

    QUALITY TESTING: Testing Image Quality Testing Image Quality 8.3.1 Testing Image Quality with the Phantom Daily Image Quality Test Steps 1. Scan phantom 8.3.2 2. Evaluate image quality 8.3.2 Scan a Phantom for Quality Testing Pre-Scan Checks Steps 1. AIRO warm-up procedure has been performed. 2.
  • Page 188 QUALITY TESTING: Testing Image Quality Figure 140 NOTE: Figure 139 does not appear when the Pediatrics feature is disabled. Steps 1. Select Service Functions from the Welcome screen. 2. Select Hospital Service from the Service Functions screen. 7.2.1 3. Log in with a technician-level or higher password. 3.3.2 4.
  • Page 189 QUALITY TESTING: Testing Image Quality Steps 9. Align lasers (horizontal and vertical) on the Gammex 464 Phantom positioned near the middle of the Gimbal’s range of motion as shown f. NOTE: In multi-kV Daily or Full QC scan cycles, do not realign the lasers or move the phantom between the selected kV scans.
  • Page 190 QUALITY TESTING: Testing Image Quality NOTES: • AIRO will automatically scan the length of the Phantom, process the data, and run the Quality Checks. • QC Image Data is automatically stored on AIRO under Existing Scans with a patient name of Phantom.
  • Page 191 QUALITY TESTING: Testing Image Quality Options • To proceed touch Next. • To reset, touch Back. Review and Export Image Quality Result Figure 142 Figure 143 NOTE: Figure 142 and Figure 143 are results summaries for Daily Quality Checks. MI-42-0001 Rev. 19...
  • Page 192 QUALITY TESTING: Testing Image Quality Steps 1. Review the Image Quality results The screen shows the current measured results, AIRO’s typical results, and the valid ranges for each test, For more information on viewing: • Daily QC results, see section How to View and Export the Daily Quality Check Report on page 183, •...
  • Page 193 QUALITY TESTING: Testing Image Quality Figure 145 Figure 146 Steps 1. Using the viewer tools , review the QC 3D image. For information on reviewing 3D images, see sections 6.8.20 through 6.8.23. NOTE: The DICOM Viewer is used only for image evaluation. Use an external diagnostic viewing device that meets local regulatory requirements when examining images for diagnostic purposes.
  • Page 194 QUALITY TESTING: Testing Image Quality Steps 4. On the dialog asking to continue without sending results to a DICOM node , select OK. See Figure 146. If multiple kV levels were selected during QC scan setup, the scan for the next kV level in the cycle starts.

  • Page 195: Quality Check Reporting

    QUALITY TESTING: Quality Check Reporting Quality Check Reporting 8.4.1 Examining Image Quality Report QC tests are based on American College of Radiology (ACR) Quality Control Testing and generate AIRO QC Test and Image Quality AIRO Image Quality Reports (QC Reports). Two test/report cycles exist. Daily QC tests and daily QC Reports evaluate system imaging for daily procedures.
  • Page 196 4. To view the exported quality report, use a web browser on a facility computer to open the Mobius Airo Image Quality Report Helical.html or Mobius Airo Image Quality Report Axial.html file in the Airo IQ Report archive folder on the USB storage device.
  • Page 197 USB storage device. For cases where the user needs control over the size and location of the ROI, Mobius recommends importing the scan DICOM data (exported to USB or pushed to a DICOM server) into a 3rd-party application that supports these features.
  • Page 198 USB storage device. For cases where the user needs control over the size and location of the ROI, Mobius recommends importing the scan DICOM data (exported to USB or pushed to a DICOM server) into a 3rd-party application that supports these features.
  • Page 199 QUALITY TESTING: Quality Check Reporting Manufacturer: Mobius Imaging, LLC Scan Date: 2017-11-30 12:47 Serial Number: Scan Direction: SAB Scan Type: Helical Scan kV: Scan mA: Introduction ® This report documents the Image Quality results obtained on a given date from a given AIRO X-ray CT System as performed by a particular operator (all documented on the cover page).
  • Page 200 QUALITY TESTING: Quality Check Reporting MI-42-0001 Rev. 19...
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  • Page 207: Exposure Testing

    0.0088 is the factor used to convert mR to mGy, - and N x T is the beam thickness in mm (33.92 mm for the Mobius AIRO) 7. Measured CTDIw (CTDI weighted) as follows, for both body and head phantoms: - CTDIw (mGy) = [CTDI 100, center x 0.333] + [CTDI 100, entrance x 0.667]...
  • Page 208 QUALITY TESTING: Exposure Testing Sources of 1. Variability associated with ion chamber. Generally, properly calibrated ion chambers are Variability expected to perform within an error margin of well under 5%. 2. Variability associated with entrance exposure measurement at 12 o'clock. Since the radiation beam may not turn on and off exactly at the 12 o'clock position during a single spin, some variability may be observed in Entrance mR measurements.

  • Page 209: Technical Description

    TECHNICAL DESCRIPTION: Chapter Overview TECHNICAL DESCRIPTION Chapter Overview 9.1.1 Contents Topics Covered Section Introduction Technical Description Special Installation Requirements Electrical Specifications X-ray Specifications Performance Characteristics Environmental Requirements Safety Classifications Replacing Fuses and Other Parts 9.10 Network/Data Coupling to Other Equipment 9.11 Regulatory Compliances and Approvals 9.12...

  • Page 210: Introduction

    Your support contact will make available on request circuit diagrams, component part lists, Circuit Diagrams and Parts Lists descriptions, calibration instructions or other information that will assist Service Personnel to repair parts that are designated as repairable by Mobius Imaging. See section 1.2 Contact Data. 9.2.2 Warning Regarding Modifications No User-Modifiable There are no user modifiable parts.

  • Page 211: Technical Description

    TECHNICAL DESCRIPTION: Technical Description Technical Description 9.3.1 Brief Description and Operating Principle AIRO is a 3rd-generation high resolution, large bore (107 cm), 51.2 cm field of view, X-ray AIRO Description Computed Tomography Scanner. A ‘scan’ is comprised of a set of 2D axial slice images that are reconstructed from a series acquisition of 2D-projection images.
  • Page 212 TECHNICAL DESCRIPTION: Technical Description Sequential Axial AIRO also offers sequential axial or “Step and Shoot” images of the body. At the start of a sequential, Scan Mode axial–mode scan, AIRO takes a full 360 degree image of a 31 mm section of the scan area. It then switches off the X-rays and moves to the next 31 mm scan section along the Z-axis (Figure 152).

  • Page 213: Significant Characteristics

    TECHNICAL DESCRIPTION: Technical Description 9.3.2 Significant Characteristics Significant Characteristics Attribute Description Mobile AIRO is mobile, and its transport is power-assisted. The imaging bore accommodates patients in procedure-specific Large Imaging Bore positions and orientations. The bore is aligned with the base for transportation and storage. In transportation mode, AIRO can move through an average sized Compact doorway, be transported by elevator, and traverse a 9.5 mm (3/8”)

  • Page 214: Physical Characteristics

    TECHNICAL DESCRIPTION: Technical Description Electrical and AIRO software converts user commands to actions that AIRO processes to capture, display or Software transfer images to external devices. When the system is not scanning, the Ring program and the Architecture Gimbal program exchange data and commands. The software controls the Ring and Gimbal hardware using firmware which controls digital and analog control and data signals.

  • Page 215: Diagrams

    TECHNICAL DESCRIPTION: Technical Description 9.3.5 Diagrams Ring and Base: Scan Mode Figure 153 Ring and Base: Transport Mode Figure 154 MI-42-0001 Rev. 19...
  • Page 216 TECHNICAL DESCRIPTION: Technical Description Scan Position Footprint 1938.8 mm 76.3 in 1931.4 mm 76.0 in Figure 155 Transport Position Footprint 598mm 23.5in 2299.7mm 90.5in Figure 156 MI-42-0001 Rev. 19...

  • Page 217: Pendant Specifications

    TECHNICAL DESCRIPTION: Technical Description 9.3.6 Pendant Specifications AIRO Hardwired Pendant Specifications Figure 157 Figure 158 Figure 159 Category Specification 26 cm (10 in.) x 4 cm (1.6 in.) x 17 cm (7 in.) Physical Dimensions Weight 1.4 kg (3 lbs.) 4-wire resistive touch display Touchscreen 17 cm (7 in.) x 17 cm (7 in.)
  • Page 218 TECHNICAL DESCRIPTION: Technical Description Hardwired Pendant Holster Specifications Figure 160 Category Specification 27.86 cm (10.97 in.) x 29.44 cm (11.59 in.) Physical Dimensions Weight: 2.00 kg (4.4 lbs) Key switch positions: Operate/Standby Controls Power switch functionality: Power On Status LEDs: System charging and Power on USB Port USB 3.0 MI-42-0001 Rev.

  • Page 219: Operating Table Specifications

    TECHNICAL DESCRIPTION: Technical Description 9.3.7 Operating Table Specifications Operating table specifications are available for: • Original Trumpf TruSystem 7500 Column in section 4.2.1 Original Operating Table Specifications of MI-42-0167 AIRO Original Trumpf Column Supplement. • Updated Trumpf TruSystem 7500 Column in section 4.2.1 Updated Operating Table Specifications of MI-42-0165 AIRO Updated Trumpf Column Supplement.

  • Page 220: Special Installation Requirements

    No User Installation Only qualified service personnel or their authorized agents may install AIRO. Detailed instructions and requirements are in the Installation Procedure. For more information, contact Mobius Imaging or your local service representative. See section  1.2 Contact Data.

  • Page 221: Electrical Specifications

    TECHNICAL DESCRIPTION: Electrical Specifications Electrical Specifications 9.5.1 Specifications Electrical Specifications Category Specification Internal Power Source Suitable for connection to Supply Mains only Other Power Sources None Rated Supply Voltage 100 - 240 VAC Rated Frequency Range 50/60 Hz Power Requirements 1500 VA Phase Single...

  • Page 222: X-Ray Specifications

    TECHNICAL DESCRIPTION: X-ray Specifications X-ray Specifications 9.6.1 Generator (High Voltage Power Supply) Generator (HVPS) Category Specification Type High Frequency Location Ring Method of Cooling Air cooled Power Rating [kW] Peak power 32 kW 2 full energy scans per hour (120 kV x 250 mA x 20 sec, twice per Duty Cycle hour) Input power...

  • Page 223: X-Ray Source Assembly

    TECHNICAL DESCRIPTION: X-ray Specifications 9.6.2 X-ray Source Assembly X-ray Tube Category Specification Tube type Rotating Anode Design Anode end grounded with metal housing Beam shape Cone Target 7 degrees rhenium-tungsten-molybdenum 80, 100, 120 kV Tube voltage and accuracy +/- 2%. Accuracy: 5 - 250 mA Tube current and accuracy...

  • Page 224: Performance Characteristics

    TECHNICAL DESCRIPTION: Performance Characteristics Performance Characteristics 9.7.1 General Performance Characteristics Scanning Capabilities for Category Specification Helical Mode Rotation time 1.92 sec Scan range Scan time 42 sec for 1 m scan range Helical scan pitch 1.415 Slice thickness 32 x 1.0 mm Image reconstruction time 24 images per sec Scanning...

  • Page 225: Range, Accuracy, And Precision

    TECHNICAL DESCRIPTION: Performance Characteristics 9.7.2 Range, Accuracy, and Precision Range and Accuracy Parameter Value Range 60 to 125 kVp Accuracy +/- 10% over the range Graph of Accuracy of Radiation Output Machine Settings 29” Figure 161 Precision Parameter Value Pass/Fail Criteria Highest Percent Error 4.7% @ 60 kVp, 25 mA Lowest Percent Error...

  • Page 226: Environmental Requirements

    TECHNICAL DESCRIPTION: Environmental Requirements Environmental Requirements Environmental Requirements: To avoid damaging the system in transport, storage, or unpacking, observe the marked restrictions on the equipment and any protective packaging. Specification Operating and Hospital Transport and Warehouse Category Storage (see note 1) Storage (see note 2) Temperature 10°C (50°F) to 25°C (77°F)

  • Page 227: Safety Classifications

    TECHNICAL DESCRIPTION: Safety Classifications Safety Classifications 9.9.1 List of Safety Classifications Category Specification Type of protection from electrical shock Class 1 Trumpf table top: B (Applied Part) Degree of protection from electrical shock Rest of system: None Degree of protection from ingress of water IPX0 and particulate matter Not suitable for use in an Oxygen Rich...

  • Page 228: Replacing Fuses And Other Parts

    TECHNICAL DESCRIPTION: Replacing Fuses and Other Parts 9.10 Replacing Fuses and Other Parts 9.10.1 Replacing Parts Fuses Do not attempt to replace parts or otherwise install or maintain the equipment. Only qualified technical service personnel may replace the batteries. Unauthorized service can result in severe injury or death and/or equipment damage.

  • Page 229: Network/Data Coupling To Other Equipment

    TECHNICAL DESCRIPTION: Network/Data Coupling to Other Equipment 9.11 Network/Data Coupling to Other Equipment 9.11.1 Overview AIRO is designed to be connected to other equipment by network and data couplings. Network and Data Coupling Characteristics The necessary characteristics of the network/data coupling for AIRO are Gigabit Ethernet RJ-45. Hazards The hazardous situations resulting from a failure of the network/data coupling to provide the specified characteristics are the inability to transfer information or retrieve worklist or patient...

  • Page 230: Regulatory Compliances And Approvals

    TECHNICAL DESCRIPTION: Regulatory Compliances and Approvals 9.12 Regulatory Compliances and Approvals 9.12.1 Summary of Standards Compliance AIRO was tested to IEC 60601 requirements for ME systems and complies with the following List and Description regulatory standards: Performance Standards Description Medical electrical equipment Part 1: General IEC 60601-1:2005 + CORR.

  • Page 231: General Electromagnetic Immunity

    TECHNICAL DESCRIPTION: Regulatory Compliances and Approvals 9.12.2 General Electromagnetic Immunity Electromagnetic AIRO is intended for use in the electromagnetic environment specified in the following sections. Environment The owner of the equipment is responsible ensuring that the systems are used in such an environment.
  • Page 232 TECHNICAL DESCRIPTION: Regulatory Compliances and Approvals Immunity IEC 60601 Test Electromagnetic Environment - Test Level and Guidance Compliance Level Floors should be wood, concrete or ceramic Electrostatic +/- 8 kV contact tile. If floors are covered with synthetic discharge (ESD) material, the relative humidity should be at +/- 15 kV air IEC 61000-4-2...
  • Page 233 TECHNICAL DESCRIPTION: Regulatory Compliances and Approvals Electromagnetic AIRO is intended for use in the electromagnetic environment specified below. Immunity Testing Immunity IEC 60601 Compliance Electromagnetic Environment – Guidance Test Test Level Level Conducted 3 V/rms Portable and mobile RF communications RF IEC 150 KHz equipment should be used no closer to any part of...

  • Page 234: Rf Communications Equipment

    20 dBm max Interference NOTE: Try to avoid using AIRO with HF Surgical Equipment. Although Mobius Imaging believes that the AIRO should not make any unintended movements due to electromagnetic interference in the presence of high frequency surgical devices, cardiac defibrillators, and their monitors, these combinations have not been tested.

  • Page 235: Symbols

    TECHNICAL DESCRIPTION: Symbols 9.14 Symbols 9.14.1 Symbols Used Symbols and Explanations Symbol Explanation Warning. Consult the accompanying documents for important safety-related information such as warnings and precautions that cannot, for a variety of reasons, be presented on the device itself. Potential equalization point Ethernet port for communication with the image guidance system software from your navigation system vendor.

  • Page 236: Labels

    Manufacturer name and address Type B Applied Part according to IEC 60601-1 Read product documentation and follow instruction for use. Mobius Imaging LLC system Unique Device Identification (UDI) label Maximum total mass of system, accessories, Maximum Total Mass compatible equipment, and patient with specified subtotals.
  • Page 237 TECHNICAL DESCRIPTION: Labels Label Explanation Surgical Column Label For information about: • Original Trumpf TruSystem 7500 Column, see section 4.3 Original Column Labels in MI-42- 0167 AIRO Original Trumpf Column Supplement. • Updated Trumpf TruSystem 7500 Column, see section 4.3 Updated Column Labels in MI-42- 0165 AIRO Updated Trumpf Column Supplement.
  • Page 238 • For AIROs with hardwired Pendants, on the ® AIRO Mobile CT System Support: Gantry/Ring just above the Pendant Holster. Mobius Imaging LLC • For AIROs with Detachable Pendants, on the 2 Shaker Rd, F100 upper pivot housing between the Pendant Shirley, MA 01464, USA Holster and the Ring.
  • Page 239 TECHNICAL DESCRIPTION: Labels Label Explanation Pediatric warning label Appears only on systems running AIRO Software v1.3 or earlier. Does not appear on systems running AIRO Software v2.0, v2.1, or later. Columnless warning label The AIRO System must be moved out of the Appears on Columnless AIRO systems used for room when performing Proton Therapy proton therapy.

  • Page 240: Location Of Certification And Safety Labels

    TECHNICAL DESCRIPTION: Location of Certification and Safety Labels 9.16 Location of Certification and Safety Labels 9.16.1 System Chassis Locations System Certification Labels (All Systems) Figure 162 Label X-Ray Tube certification AIRO Certification Labels on Systems with Hardwired Pendants Figure 163 MI-42-0001 Rev.
  • Page 241 TECHNICAL DESCRIPTION: Location of Certification and Safety Labels Label in Location Label in Location Pediatric Warning (only on systems X-Ray Unit Warning with AIRO Software v1.3 and earlier) Support Contact Laser Warning Columnless Warning (only on System Name Plate with CE, ETL, and columnless systems) WEEE certifications Overbalancing Warning...
  • Page 242 TECHNICAL DESCRIPTION: Location of Certification and Safety Labels This Page Intentionally Left Blank MI-42-0001 Rev. 19...

  • Page 243: 10 Ct User Information

    CT USER INFORMATION: Chapter Overview 10 CT USER INFORMATION 10.1 Chapter Overview 10.1.1 Contents Topics Covered Section No Quick-change X-ray Tubes 10.2 Dosage Factors and Image Quality 10.3 Deterministic Effects 10.4 MI-42-0001 Rev. 19...

  • Page 244: No Quick-Change X-Ray Tubes

    CT USER INFORMATION: No Quick-change X-ray Tubes 10.2 No Quick-change X-ray Tubes 10.2.1 No Quick-change X-ray Tubes Quick-change X-ray AIRO does not permit the use of quick-change X-ray tubes. Tubes MI-42-0001 Rev. 19...

  • Page 245: Dosage Factors And Image Quality

    CT USER INFORMATION: Dosage Factors and Image Quality 10.3 Dosage Factors and Image Quality 10.3.1 Conditions of Operation This section contains the information for CT users required by FDA 21CFR-1020.33. About this Section The generator is capable of delivering kilo voltages from 60 to 125 kV. The typical kV for both body and head scans is 120 kV.
  • Page 246 CT USER INFORMATION: Dosage Factors and Image Quality CTDI Measured CTDI (center): Around Axis of Rotation Position Center, Phantom Body 1.92 12.54 Head 1.92 33.69 CTDI measured 1 CTDI at 1 cm interior to phantom surface, at the location where the exposure is maximum obtainable at this depth.
  • Page 247 CT USER INFORMATION: Dosage Factors and Image Quality CTDI Per Condition CTDI (center) for different selectable CT conditions of operation. The value at 120kV, 192 mAs of Operation is treated as 1.00, and other measurements are normalized to this value. Conditions of operation selected are the minimum, midrange and maximum values of voltage (80, 100, and 120 kV) and tube current - time product (48, 96, 192 and 240 mAs).
  • Page 248 CT USER INFORMATION: Dosage Factors and Image Quality CTDI Per Peak Tube CTDI at the maximum of the 4 entrance locations for different selectable CT conditions of Potential operation. The value at 120 kV, 192 mAs is treated as 1.00, and other measurements are normalized to this value.
  • Page 249 CT USER INFORMATION: Dosage Factors and Image Quality CTDI 100, 1.92 21.13 1.92 35.47 1.92 52.00 Dose Profiles Dose profiles were obtained by exposing Laser Luminescent Dosimeter (LLD) rods obtained from, Technique Factors and analyzed by, Landauer, Inc., Chicago, IL. A plot of the dose profile at isocenter, in free air during one axial scan is presented.
  • Page 250 CT USER INFORMATION: Dosage Factors and Image Quality Variable Value Exposure length Integral 123348.35 mrad-mm (central 33.9 mm) Exposure length Integral 115862.90 mrad-mm (central 31.8 mm) CTDI (mrad) 4865.30 CTDI (mGy) 48.65 Z eff (Helical) 74.7% Z eff (Axial) 70.2% Geometric Efficiency in Z Exposure at 120 kV, 100 mA, 1.92 sec (192 mAs)
  • Page 251 CT USER INFORMATION: Dosage Factors and Image Quality Variable Value Head phantom position Center Beam collimation  1.92 33.92 Exposure length Integral 119218.6 mrad-mm Nominal slice thickness (mm) 33.92 CTDI (mrad) 3514.7 CTDI (mGy) 35.147 Dose Profile: Body Phantom Figure 166 Variable Value Body phantom position...

  • Page 252: Statement Of Maximum Deviations

    CT USER INFORMATION: Dosage Factors and Image Quality 10.3.3 Statement of Maximum Deviations Maximum Unless specified, no value should exceed the allowable deviation of ± 10% (suggested). For CTDI Deviations CTDI and DLP, measured values should not differ from displayed values by ± 30%. NOTE: The 30% allowable error is suggested because most physicists routinely measure entrance CTDI at the 12 o’clock position, which can be higher than CTDI...
  • Page 253 CT USER INFORMATION: Dosage Factors and Image Quality Typical Values Circular ROI Diameters Mean CT NUMBER HU Noise HU Uniformity HU 60mm @ ISO 0 +- 7 8 +- 40% 15mm @ ISO 0 +- 7 10 +- 40% 15mm @ 12 o’clock 0 +- 7 6 +- 40% <...

  • Page 254: Technical Statements

    CT USER INFORMATION: Dosage Factors and Image Quality Tomographic Using the same protocol as specified for MTF measurements, typical FWHM is 1.5mm ± 0.4 mm for Section Thickness both helical and axial scanning modes. and Slice Sensitivity Profile (SSP) Figure 168 10.3.5 Technical Statements Tube Housing...
  • Page 255 CT USER INFORMATION: Dosage Factors and Image Quality Anode Heating and FP-1000 Cooling Curves Figure 169 MCS-1000 Figure 170 MI-42-0001 Rev. 19...
  • Page 256 CT USER INFORMATION: Dosage Factors and Image Quality Tube Housing Cooling Curves Figure 171 Figure 172 MI-42-0001 Rev. 19...
  • Page 257 CT USER INFORMATION: Dosage Factors and Image Quality Tube Rating Charts Maximum allowed tube current (mA) as a function of the following starting heat storage and tube voltages: Focal spot 1.0 x 1.0 mm 7 degrees, 3 phase, 7200 RPM Vol....

  • Page 258: Definitions Of The Measurement Bases Of The Technique Factors

    CT USER INFORMATION: Dosage Factors and Image Quality Parameters Range Accuracy Minimum battery charge for proper 280 Vdc operation 120 kV, 250mA, 21.75 s Maximum Operating Points 120 kV, 125mA, 43.5 s 30 minute cooling time between maximum scans Tube Voltage: +/- 1% Tube current: +/- 2% Maximum Deviation from...
  • Page 259 CT USER INFORMATION: Dosage Factors and Image Quality Effect of Radiation The radiation detector is used to normalize the detector data. This minimizes artifacts due to Detector on Image variations in intensity of the x-ray source. Half-value layers (HVL) were measured using a Radcal 2026 with its 20X6-6 ion chamber placed at Half-Value Layers isocenter.

  • Page 260: Deterministic Effects

    NOTE: These clinical protocols are proposed by the manufacturer, pre-loaded on the equipment, displayed prior to scan, and recorded with each scan. They constitute recommendations to be applied directly so as to allow optimized operation. See the Mobius Imaging LLC Application Guide for Protocols and Principles (document MI-42-0005).

  • Page 261: Allowed Equipment

    ALLOWED EQUIPMENT: Chapter Overview 11 ALLOWED EQUIPMENT 11.1 Chapter Overview 11.1.1 Contents Topics Covered Section Compatibility with Other Medical Devices and Software 11.2 MI-42-0001 Rev. 19...

  • Page 262: Compatibility With Other Medical Devices And Software

    Only authorized representatives may install software on the AIRO system. Do not install or remove any software applications. 11.2.3 Accessories List List of Allowed Allowed accessories include: Accessories Accessory Mobius P/N AIRO Switch Keys—two Gen1 keys MI-76-0161 AIRO Spare Keys—two Gen2 keys MI-76-0194 AIRO Key Tether MI-76-0248 Detachable 10-in. Pendant—one pendant MI-76-0237 Detachable 10-in.
  • Page 263 If any other patient table is used it must be 360° radiolucent and meet the requirements of FDA 21CFR1020.30 (n). NOTE: No metal objects should be in the area of the scan. Mobius is not responsible for the quality of scans when metal interference is introduced.
  • Page 264 ALLOWED EQUIPMENT: Compatibility with Other Medical Devices and Software This Page Intentionally Left Blank MI-42-0001 Rev. 19...

  • Page 265: 12 Troubleshooting

    TROUBLESHOOTING: Chapter Overview 12 TROUBLESHOOTING 12.1 Chapter Overview 12.1.1 Contents Topics Covered Section Troubleshooting 12.2 Metal Artifacts in Scans 12.3 Rotation Sensor Error 12.4 Transport Failure 12.5 Table Transfer Errors 12.6 Table Malfunctions 12.7 Malfunctions and Return Instructions 12.8 MI-42-0001 Rev. 19...

  • Page 266: Troubleshooting

    TROUBLESHOOTING: Troubleshooting 12.2 Troubleshooting 12.2.1 Problems and Suggested Actions Possible Problems Possible Problem Steps Cause Cannot connect • Check both ends of cable for proper connection. Network cable is to hospital • Try installing a new cable. not connected network Metal outside •...
  • Page 267 TROUBLESHOOTING: Troubleshooting Possible Problem Steps Cause AIRO will not Power source Check to make sure AIRO is plugged in, restart AIRO, If power on. interrupted. problem persists contact service. AIRO experiences complete loss of Power source See section 12.5 Transport Failure. power and interrupted.
  • Page 268 3. When the scan sequence is complete, remove the mouse cable from the USB port and restart AIRO. Mid-Scan Workaround for Detachable Pendant: Although Mobius Imaging cautions against performing the following during normal operation (see section 13.3.2), if this issue occurs in the middle of a scan sequence —...
  • Page 269 Figure 173 shows an example System Manager Error. Steps Note on-screen error message. 3.4 Follow on-screen instructions and re-start AIRO. & 3.3.1 Contact your distributor or Mobius Imaging if the issue continues to occur. MI-42-0001 Rev. 19...
  • Page 270 TROUBLESHOOTING: Troubleshooting Application Failures Figure 174 Application failures may indicate significant issues with the system. Steps 3.4 Re-start AIRO. & 3.3.1 If the Application Failure screen reappears, take AIRO out of service. Use the on-screen contact information to contact your distributor. NOTE: Figure 174 is an example Application Failure screen.

  • Page 271: Metal Artifacts In Scans

    TROUBLESHOOTING: Metal Artifacts in Scans 12.3 Metal Artifacts in Scans 12.3.1 Recognizing Metal Artifacts in CT Scans How to Recognize Metal Artifacts in Scans Figure 175 Metal objects in scans create streaks that degrade the image quality, and make the scan difficult to interpret.

  • Page 272: Rotation Sensor Error

    TROUBLESHOOTING: Rotation Sensor Error 12.4 Rotation Sensor Error 12.4.1 Verifying Scan Direction During Scan Setup When setting up or scanning a patient, the system verifies the orientation of the Ring. When How to Ensure Rotation Sensor orientation or rotation issues are detected, the system shows a error. Agrees with Scan Setup Figure 176...

  • Page 273: Transport Failure

    TROUBLESHOOTING: Transport Failure 12.5 Transport Failure 12.5.1 Transport Failure What to Do if You Cannot Move AIRO Step Evaluate the situation. Is AIRO raised onto its wheels, or lowered onto the ground? Is the system unplugged? (You must unplug the AIRO before transport.) Situation Likely Cause Response...
  • Page 274 TROUBLESHOOTING: Transport Failure Figure 178 Steps 1. Lift latch to release Gimbal. See Figure 177. 2. Rotate the Gimbal out of Transport position into Scan position This reveals the drive mechanism in the base under the Gimbal viewed from the end opposite the system power cable.

  • Page 275: Cannot Raise System

    TROUBLESHOOTING: Transport Failure 12.5.3 Cannot Raise System How to Move AIRO This manual method of moving the system is restricted to short distances and level surfaces only When the Base Will Not Lift Situation Solution The system is lowered and will not Partially raise the base manually.
  • Page 276 TROUBLESHOOTING: Transport Failure Raise the System Steps 1. Thread the screw from the emergency kit into the center hole ball end down. (See Figure 179 on page 263.) 2. Using the Allen wrench, tighten the screw clockwise until AIRO begins to lift. 3.
  • Page 277 TROUBLESHOOTING: Table Transfer Errors 12.6 Table Transfer Errors For information about solving operating table transfer errors with: • Original Trumpf TruSystem 7500 Column, see section 5.3 Table Transfer Errors in MI-42-0167 AIRO Original Trumpf Column Supplement. • Updated Trumpf TruSystem 7500 Column, see section 5.3 Table Transfer Errors in MI-42-0165 AIRO Updated Trumpf Column Supplement For information about which integrated column your AIRO features, see chapter 4 COLUMN AND TABLE.
  • Page 278 TROUBLESHOOTING: Table Malfunctions 12.7 Table Malfunctions For information about solving operating table malfunctions with: • Original Trumpf TruSystem 7500 Column, see section 5.4 Table Malfunctions in MI-42-0167 AIRO Original Trumpf Column Supplement. • Updated Trumpf TruSystem 7500 Column, see section 5.4 Table Malfunctions in MI-42-0165 AIRO Updated Trumpf Column Supplement For information about which integrated column your AIRO features, see chapter 4 COLUMN AND TABLE.

  • Page 279: Malfunctions And Return Instructions

    TROUBLESHOOTING: Malfunctions and Return Instructions 12.8 Malfunctions and Return Instructions 12.8.1 Malfunctions Do not continue to use the system if: System Damage or Failure • The power plug, cable, or strain relief is damaged (e.g., cable has been run over) or frayed. •...
  • Page 280 TROUBLESHOOTING: Malfunctions and Return Instructions This Page Intentionally Left Blank MI-42-0001 Rev. 19...

  • Page 281: 13 Detachable Pendant

    DETACHABLE PENDANT: Chapter Overview 13 DETACHABLE PENDANT 13.1 Chapter Overview 13.1.1 Contents Topics Covered Section Detachable Pendant and Holster 13.2 Maintenance with Detachable Pendants 13.3 Technical Description for Detachable Pendants 13.4 MI-42-0001 Rev. 19...

  • Page 282: Detachable Pendant And Holster

    Detachable Pendant is larger, the following sections show any significant hardware or procedural differences for patient and operator safety. NOTE: Chapters 1 through 12 of MI-42-0001 Rev 19 AIRO Mobile CT System User Manual have figures and examples that show images from the 800 x 600 pixel, hardwired Pendant. Because the interface functionality is identical for both Pendants, when using a Detachable Pendant, the software is scaled for the larger 1280 x 800 pixel screen.

  • Page 283: Maintenance With Detachable Pendants

    DETACHABLE PENDANT: Maintenance with Detachable Pendants 13.3 Maintenance with Detachable Pendants 13.3.1 Connecting Detachable Pendants How to Connect NOTE: The following procedure applies only to AIRO systems that feature Detachable Pendants. Detachable No similar functionality is available for systems with hardwired Pendants. Pendants If the system features a Detachable Pendant, it uses a barrel-ring connector for connecting and disconnecting the pendant cable to the system at the connector below the Ring latch.See Figure 25.

  • Page 284: Disconnecting Detachable Pendants

    DETACHABLE PENDANT: Maintenance with Detachable Pendants Figure 183 Steps 1. Ensure that the system is powered down, with the Detachable Pendant cable disconnected and cable strain relief released. 2. Locate the barrel-ring connector at the end of the Detachable Pendant cable. See Figure 181.
  • Page 285 DETACHABLE PENDANT: Maintenance with Detachable Pendants Always power down AIRO before connecting or disconnecting the Detachable Pendant. Connecting or disconnecting the pendant during scan work flows or while the system is powered on can result in: - Unused patient dose - Delay of therapy - Nonfunctional system Figure 184...

  • Page 286: Technical Description For Detachable Pendants

    DETACHABLE PENDANT: Technical Description for Detachable Pendants 13.4 Technical Description for Detachable Pendants 13.4.1 Detachable Pendant Specifications AIRO Detachable NOTE: For specifications of the hardwired Pendant hardware, see section 9.3.6 Pendant Pendant Specifications. Specifications Figure 186 Category Specification 35 cm (13.8 in.) x 3 cm (1.1 in.) x 29 cm (11.5 in.) Physical Dimensions Weight 1.7 kg (3.7 lbs.) Capacitive Touch Display...
  • Page 287 DETACHABLE PENDANT: Technical Description for Detachable Pendants AIRO Detachable Pendant Holster Specifications Figure 187 Category Specification 39.93 cm (15.72 in.) x 39.50 cm (15.55 in.) Physical Dimensions Weight: 5.35 kg (11.8 lbs.) Key switch positions: Operate/Standby Controls Power switch functionality: Power On Status LEDs: System charging and Power on USB Port USB 3.0...

  • Page 288: Electromagnetic Emissions And Immunity With Detachable Pendant

    DETACHABLE PENDANT: Technical Description for Detachable Pendants 13.4.2 Electromagnetic Emissions and Immunity with Detachable Pendant Emissions and The item below shows supplemental information for Detachable Pendants on IEC 61000-4-2. Immunity: IEC 61000-4-2 Immunity IEC 60601 Test Level Test Electromagnetic Environment - Guidance and Compliance Level Floors should be wood, concrete or ceramic tile.

  • Page 289: Index

    INDEX INDEX Numerics Compliance ......General electromagnetic immunity ..........3D Image Controls ............Standards .... 60601-9.2 Hazards Associated with Moving Parts Components ............Overview ......Parts lists (available on request) ........System subassemblies ........Confirm the Ring Rotation ......................Connectivity Accessories ............
  • Page 290 INDEX ............Overview Gimbal ....................Requirements Scan mode position .................... Warnings format Transport mode position ......... Dose check report ..........Driving the system ............Hand grips ............Hand position ................Editing patient information Helical scan described ..........Electrical Helical scan pitch ........
  • Page 291 Specifications (detachable) ........Options in transport mode ........Specifications (hardwired) ............Metal objects ........Using cable strain relief ....... Mobius Imaging, LLC. contact information ............Phantom ....... Motion controls (transport mode) ............. Phase ......... Physical Characteristics ........Place of control (setting for use) Power .............
  • Page 292 INDEX ........Supply mains isolation ............. Switch Safety ..........Terminal markings ......Effective type of fire extinguisher ........... Tube voltage ..............Fire ..........Voltage statement ........... Hazard notices Powering ............Labels .............. Down .............. Laser ....................... Mechanical motion Preconditioning. See Environmental requirements..........
  • Page 293 INDEX ........... Helical scans Training ................Holster (detachable pendant) Applications curriculum .................... Holster (hardwired pendant) Materials .................... Image reconstruction matrix Required ..................Image reconstruction time Requirements ..................Maximum operating points Translate the ring ..........Operating table Transport ..........
  • Page 294 INDEX X-ray ............ Beam shape ......Generator assembly specifications ......Source assembly specifications ..........Specifications ..........Tube housing type ........Voltage and data values X-ray dose ..........Average CTDI .......... Body phantom profile ........Conditions of operation ........Controls and generators ........

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